1992 DES Case: Silveri v. Eli Lilly & Co.

Abstract

“Plaintiff Angela Silveri, who is allegedly suffering from adenocarcinoma, moves for permission to introduce proof to show that Eli Lilly and Co. (“Lilly”) is responsible for the defective design of DES.” …

… “Plaintiff argues that the “Sage rule” should apply to Lilly because Lilly was mainly responsible for developing the use of DES in pregnancy. Applying the Sage rule would permit the plaintiff to escape from the Hymowitz rule limiting recovery against Lilly to its share of the market.

IN RE DES CASES, Leagle, 19921337789FSupp548_11222, April 10, 1992.

The Hymowitz court held that where a plaintiff is unable to identify the manufacturer or manufacturers of the DES which injured her, the defendants are severally liable under a market share theory. No other theory is available.”…

… “Angela Silveri also urges this court to permit her to proceed on a concert of action theory.”…

… read the full paper IN RE DES CASES, on Leagle.

More DES DiEthylStilbestrol Resources

Matter of New York County DES Litigation

Abstract

” Plaintiffs on this appeal take issue with that portion of decretal paragraph 9 of the order which directed that:

“all complaints are hereby deemed amended so as to replace allegations of joint and several liability (and collective theories of liability) with allegations of several liability as defined by the decision in Hymowitz v. Eli Lilly and Company without further need of motion practice.”

Plaintiffs assert that the IAS court’s decision to dismiss causes of action based on a concerted action theory was not in accordance with the Court of Appeals’ decision in Hymowitz (supra). Plaintiffs also contend that they cannot be precluded from pleading and proving a concerted action theory of liability simply because no agreement has been proven in previous DES actions.

MATTER OF NEW YORK COUNTY DES LITIG., Leagle, 1991218168AD2d50_1209, May 28, 1991.

The Court of Appeals in Hymowitz (supra) was squarely confronted with the issue of the theory of liability under which DES litigants in New York could proceed where the identification of the drug manufacturer that injured plaintiff was impossible.“…

… “The court believed it was necessary to hold the liability of DES producers to be several only and avoid extending the theory of concerted action to DES cases because its concomitant requirement of joint and several liability expanded the burden of small manufacturers beyond a rational and fair limit.“…

… read the full paper MATTER OF NEW YORK COUNTY DES LITIG., on Leagle.

More DES DiEthylStilbestrol Resources

Market Share Liability in DES Cases

INTRODUCTION

As our society progresses in complexity, theories of tort law have evolved in order to provide redress for the harms caused in a changing world. Tort law evolution has resulted in the creation of new remedies and, in many instances, the erosion of certain preconditions for recovery in tort. Nevertheless, with limited exceptions, there has not been significant erosion of the requirement that a plaintiff must first be able to identify the person or entity that caused her injury before she can recover in tort. In the past decade, however, a small number of courts have abrogated this principle, which is referred to as “causation in fact.” In the place of causation of fact, these courts have adopted the concept of “market share liability.”

Market Share Liability in DES Cases: The Unwarranted Erosion of Causation in Fact, DePaul Law Review, Volume 40, Article 5, Issue 3, Spring 1991.

The market share liability theory has developed mainly through lawsuits filed by women who claim to suffer injuries resulting from their mothers’ ingestion of the drug Diethylstilbestrol (“DES”) while pregnant. These plaintiffs are commonly referred to as the “DES daughters“. The time that passes between the maternal ingestion of DES and the diagnosis of the injuries is generally twenty or more years because the injuries do not manifest themselves until sometime after the daughter has reached puberty. A DES daughter is often unable to identify the specific manufacturer of the drug her mother took for two key reasons: the long passage of time and the fungible nature of DES. Faced with the possibility of leaving these plaintiffs without a remedy as a result of their inability to identify the manufacturer, some courts have instead abolished the traditional requirement of establishing causation in fact. In place of causation in fact, these courts have adopted a theory that imposes liability upon any defendant who participated in the manufacturing or marketing of DES in the relevant market. Under this “market share liability” theory, each defendant is liable for the proportion of the judgment that its share of the market represented during the relevant time period.

Market share liability has been controversial since its inception. The concept has been adopted with varying modifications by a handful of courts e and promoted by a larger number of legal commentators. At the same time, other courts have denounced the theory of market share liability when faced with the opportunity to adopt the proposition in either DES cases or cases involving other products. Currently, only nine state supreme courts have addressed the market share liability issue in a DES case. Most likely, however, other jurisdictions will eventually be forced to face this issue, especially in light of the fact that DES was used nationwide, some plaintiffs have achieved success with the theory, and there is the potential for large recoveries.

Most legal commentary on the issue of market share liability has supported the adoption of the theory. Commentators and courts that support the market share liability theory correctly argue that there is a need to adapt our existing tort law in the face of progress. They also argue that there is strong emotional appeal to insure a remedy for all plaintiffs, especially plaintiffs who are innocent of any wrongdoing. However, this Article contends that courts should not develop a market share liability concept.

This Article begins with a brief history of the development of the drug DES. In the next section, this Article reviews the tort requirement of causation in fact. The third section outlines the DES cases in which state supreme courts have adopted market share liability, and the fourth section addresses cases where courts have rejected the theory in the DES context and in other actions.

The Article concludes that market share liability is an unsound concept, that it represents too wide a leap in our tort principles, and that the abrogation of such a fundamental tort requirement is unwarranted. Two ideas are presented to support this conclusion. First, there is insufficient data to accurately develop the required market shares for each of the hundreds of pharmaceutical companies that produced DES. This lack of data precludes the fair allocation of liability for DES related injuries among all DES manufacturers. Second, upon close scrutiny, the underlying policies offered to justify adoption of the market share liability theory are either not achieved by the theory, and even if they can be achieved, they do not provide sufficient reasons to adopt it. This Article proposes that the judicial development of market share liability involves making public policy determinations that more appropriately should be left for state legislatures. A legislative response, similar to the federal legislation established to compensate persons injured by childhood vaccines such as the diphtheria, pertussis, and tetanus (“DPT”) vaccine is a proper method of compensation, and one that will not require a radical change in a state’s tort law.

I. HISTORY OF DES

DES is a synthetic substance that duplicates the activity of estrogen, a female hormone crucial to sexual development and fertility. In 1940, a number of pharmaceutical companies sought Food and Drug Administration (“FDA”) approval to market DES in up to five milligram doses to treat vaginitis, engorgement of the breasts, excessive menstrual bleeding, and symptoms of menopause. The FDA approved the use of DES for these purposes in 1941, and, in 1947, the FDA approved the use of DES as a miscarriage preventative. In 1952, the FDA declared that DES was no longer a “new drug” within the meaning of the Federal Food, Drug, and Cosmetic Act,16 and was therefore considered safe for general use. This status allowed DES manufacturers to market the drug without submitting data to the FDA concerning its safety and effectiveness for any desired use.

In 1971, two medical studies suggested that there was a statistically significant association between the outbreak of clear cell adenocarcinoma, a form of cancer, in young women and the maternal ingestion of DES during pregnancy. The mothers of the women stricken with clear cell adenocarcinoma generally had used DES as a miscarriage preventative. Later that year, the FDA contraindicated the sale of DES for use by pregnant women. According to estimates, by the time of the FDA ban, as many as 300 companies had produced DES for sale. Each company’s product was essentially fungible, in that each product contained the same chemical composition. However, DES was marketed in a number of different colors, dosages, sizes, and shapes.

DES is no longer used as a miscarriage preventative. The drug is, however, still prescribed as an estrogen replacement for women with hormone deficiencies, for treatment of unusual menopausal symptoms, and for treatment of certain kinds of cancer of the breast and prostate. DES is also a major ingredient in the “morning-after pill,” a post coital contraceptive.

Since the 1970s, hundreds of daughters of women who took DES while pregnant have filed lawsuits against DES manufacturers. Generally, the complaints allege that the drug companies failed to test DES properly and to warn women adequately of its dangers. The injuries these women suffered are unquestionably serious. Some women have died, and others have required partial or total hysterectomies due to cancer that may be linked to their mother’s ingestion of the drug. DES manufacturers, however, contend that statistics regarding DES daughters have not shown a high incidence of cancer, and that it is not generally accepted that the injuries suffered are the consequence of the maternal ingestion of DES.

Some DES plaintiffs who could identify the manufacturer of the DES their mothers ingested have been able to proceed to trial. Other DES plaintiffs allege, after extensive discovery, that they are unable to satisfy the identification element. A number of circumstances contribute to the barrier of establishing causation in fact in these cases. The effect of prenatal exposure to DES usually does not manifest itself until at least after the child reaches puberty, and more years may pass before the cancer is linked to DES. During this long interval, whatever records the doctor, pharmacy, or manufacturer maintained often become lost or destroyed, and the memories of the persons involved have faded. Contributing to the lack of records is the fact that the manufacturers were not required by law to maintain records for long periods of time. Moreover, during the twenty-five years that DES was used to treat pregnancy-related problems, as many as 300 companies manufactured the fungible product. Additionally, many manufacturers no longer exist, having either merged with other concerns, or having gone bankrupt.

II. THE IDENTIFICATION REQUIREMENT

Typically, the tort causes of action DES daughters advance are based on negligence or strict liability theories. A fundamental principle of these theories, and of tort law in general, holds that the plaintiff has the burden of proving, by a preponderance of the evidence, that the named defendant caused the harm or injury complained of; mere conjecture or speculation as to the identity of the responsible party is insufficient proof of causation. This principle is known as the identification requirement. The requirement is one aspect of the element of causation in fact, which in turn is a common element to virtually all tort law litigation. The issue of identification, although important and present in every negligence and strict liability action, is infrequently litigated. Normally, plaintiffs know the identity of the manufacturer or seller of a product, or the identity is not difficult to discover. This is not true, however, in market share cases. Therefore, an essential issue each court must address when faced with a request to adopt market share liability is whether it is advisable to abolish the identification requirement.

The identification element of causation in fact serves important functions in the law of torts. One goal of our tort law is to compensate victims for their injuries. However, our justice system has so far determined that a no-fault society, one in which all injuries are compensable, is not desirable. Instead, tort law only redresses those injuries that result from a defendant’s culpability and then only if the defendant can be identified.

In promoting the goal of compensating victims, however, it is necessary to avoid establishing laws that act as an excessive deterrent to useful activity, such as the production of socially desirable products. Therefore, tort law’s goal of compensation must be balanced against a second tort law interest, that of protecting people from excessive liability. Requiring the plaintiff first to identify the responsible defendant as a condition of liability insures that a defendant will only be held liable for those injuries he more than likely caused.39 Because causation in fact limits a defendant’s potential liability to injuries that the defendant actually caused, the goal of preventing excessive deterrence is promoted. Otherwise, if potential liability is excessive, a person’s useful conduct along with his undesirable conduct will be inhibited. Moreover, although causation in fact restricts liability, it also helps to assign blameworthiness to the culpable party.

Notwithstanding the benefits that causation in fact provides, a narrow line of cases have created exceptions to the requirement of proof of causation in fact. The particular exceptions that DES plaintiffs most often raise are enterprise liability and alternative liability. These two exceptions allow a plaintiff to shift the burden of proof on the causation issue to a defendant or a group of defendants. Liability may attach to the group of defendants as a whole if a particular defendant is not identified as the party responsible for the injury. Besides market share liability, DES daughters have pursued two other causes of action with more lenient identification burdens: concert of action and civil conspiracy. These two causes of action are not exactly exceptions to the identification requirement. Although DES plaintiffs typically allege elements of each of these causes of action, the courts almost always reject all but the market share liability theory.

There has been a split among courts on the question of whether to adopt market share liability in negligence and strict liability actions brought against drug manufacturers for injuries suffered by women whose mothers ingested DES while pregnant. Currently, the highest courts of California, Washington, Wisconsin, New York, and, most recently, Florida have adopted some form of the market share liability theory in DES daughter cases. The supreme courts of Illinois, Missouri, and Iowa have specifically rejected the market share liability theory in DES cases.

III. JUDICIALLY PROMULGATED MARKET SHARE THEORIES

None of the five states that have adopted the market share liability concept have implemented the same procedure. All five states, however, have a number of similarities in the procedures adopted. This section generally discusses the concept of market share liability as a unified principle, noting the important variations each state has included in the particular form adopted.

A. Reasons for Adopting a Market Share Liability Theory

The DES cases are examples of the reality that in our complex industrialized society, advances in science and technology have created fungible goods that may harm consumers and that are difficult to trace to a specific producer. Courts faced with cases involving fungible products must determine whether they will fashion a procedure to allow the plaintiff to overcome the obstacles of identification that these technological advances cause. Courts in the DES cases answering this question affirmatively generally rely on three basic policy reasons as justification for adopting market share liability.

The first policy is that as between an innocent plaintiff and a manufacturer of a defective product, the manufacturer should bear the cost of the injury. The courts conclude that the plaintiff in these cases is not at fault in failing to provide evidence of causation, reasoning that the conduct of the defendants played a significant role in creating the unavailability of proof. The Washington and Wisconsin courts expanded on this justification, explaining that because each defendant contributed to the risk of injury to the public and consequently to the risk of injury to the plaintiff, each defendant shared, in some degree, culpability for producing or marketing DES.

Courts also articulate two other policy reasons to support the adoption of market share liability. The second policy justification is that as between the injured plaintiff and the possibly responsible drug company, the drug company is in a better position to absorb the cost of the injury. The large pharmaceutical companies, the courts conclude, not only can insure against the costs of injury, they also can pass on these costs to the public. The final reason given to support market share liability adoption is that because the manufacturer is in the best position to recognize defects in its products and to guard against them, holding the producer liable for these defects provides an incentive to produce safe products.

B. Market Share Liability Theory

These three policy reasons have prompted courts to reevaluate their state’s tort laws in an attempt to hold DES manufacturers responsible for injuries their drugs caused. The first court to adopt market share liability was the California Supreme Court in Sindell v. Abbott Laboratories. The Sindell court based the market share liability theory it adopted, and some of its rationale in adopting the theory, on a student law review article. The article argued that, in DES cases, some form of enterprise liability should be fashioned. The court, however, did not literally follow the article’s proposal.  Similarly, each court adopting market share liability since Sindell has likewise placed its own twist on the market share liability theory.

The preliminary component of any case using market share liability concerns the number of defendants who must be joined. In Sindell, the court held that the plaintiff had to join as defendants the manufacturers of a substantial percentage of the DES sold in the relevant market. This requirement must be met before defendants may cross-claim against other possibly responsible manufacturers. The substantial share component was important in the concept of the market share liability theory conceived in the law review comment the court relied upon. The substantial share requirement diminishes the likelihood that a manufacturer will be liable for injuries a product it did not produce caused. Therefore, the substantial share requirement helps preserve the causation in fact element to a limited extent because a manufacturer who contributed to a substantial share of a market for DES will more likely be liable for injuries its products actually caused.

On the other hand, the other four states, which have adopted market share lability have not adopted the substantial share component of the California theory. In Washington, Wisconsin, and New York, the plaintiff need only sue one drug company that produced DES and that company’s DES sales need not constitute a substantial share of the market. Inevitably, though, a single named defendant will implead other companies that sold DES in the relevant market.

The next element necessary to succeed in a market share liability action is that the plaintiff must prove a prima facie case on every element of a negligence or strict liability action except identification of the direct tortfeasor. Therefore, the plaintiff must prove, by the preponderance of the evidence, that her mother took DES, that the DES caused subsequent injuries, that the defendant produced or marketed the type of DES the plaintiff’s mother ingested, and that the production and marketing of DES breached a legally recognized duty to the plaintiff.

Once the plaintiff has presented a prima facie case of negligence, the burden shifts to the defendant to exculpate itself. In order to do so, a defendant must prove by a preponderance of evidence that it did not produce or market the type of DES the mother took, that it did not produce or market DES for the prevention of miscarriage in that geographical area, or that it did not produce or market DES at that time.

In Hymowitz v. Eli Lilly & Company, New York’s highest court, the Court of Appeals, made it difficult for a defendant to exculpate itself. New York uses a national market. Therefore, a defendant can only exculpate itself through proof that it did not participate in the marketing of DES for pregnancy use.80 Even conclusive proof that the defendant-manufacturer could not have caused a particular plaintiff’s injury is insufficient for exculpation purposes in New York.

If the defendant fails to exculpate itself, the court next defines the relevant geographic market area for the purpose of measuring and apportioning liability. Remaining defendants which provided DES in the relevant geographic market become members of the plaintiff’s DES market. The relevant geographic market area ideally is defined on a local level, however, where local market share evidence is unavailable, county, state, or even national market share figures are admissible to determine the defendant’s market share. Damages are then apportioned according to the likelihood that any of the defendants supplied the product. This apportionment is achieved by holding each defendant liable for the proportion of the judgment its share of the market represents. The intended result of market share liability is that a manufacturer’s liability for an injury will be approximately equivalent to the amount of damage caused by the DES the manufacturer supplied in the relevant market area.

New York is the only state which refuses to narrow the relevant market. Rather, New York uses a national market. New York rejected the idea that a market share liability theory could be finely tailored so that liability for many injuries would equal the injuries actually caused by the product of a particular manufacturer. Nevertheless, the New York court realized that a national market could not provide a reasonable link between liability and the risk a defendant created toward a particular plaintiff. Instead, a national market apportions liability so as to correspond to the overall culpability of each defendant, measured by the amount of risk of injury each defendant created to the public-at-large.

A last common characteristic of market share liability is that the liability is not joint and several; rather, it is only several.  In adopting market share liability, the New York Court of Appeals concluded that joint and several liability would represent a retreat from the attempt to achieve as close an approximation as possible between a defendant’s liability for damages and its individual responsibility for the injuries that the products it manufactured caused. In cases in which all manufacturers in the market are not joined, a plaintiff will receive less that 100% recovery because liability will be limited to the market share represented.

Beyond this basic framework of market share liability, each state has developed certain important distinctions. The unique twists to the theory adopted by California and New York courts have already been discussed. However, Washington and Wisconsin also have developed profound variations in their versions of market share liability. These variations generally relate to the apportionment of damages.

The market share liability theory that the Washington court has adopted is known as “alternative market share liability” because of its similarities to alternative liability. Under the Washington theory, after defining the geographic market, all defendants are presumed to have equal market shares and are liable on a pro rata basis. Manufacturers may rebut this presumption by proving their actual market share. A defendant proving actual market share in the relevant market is only liable for a percentage of damages equivalent to the market share.  The presumptive share of the remaining defendants that are unable to establish their actual market share is then adjusted upward, so that 100% of the market is accounted for. If all defendants are able to establish their actual market share and the percentage of the market represented is less than 100%, plaintiff’s recovery is limited to the percentage of the market that is actually represented.

Wisconsin’s theory, on the other hand is known as the “risk contribution theory,” and relies on that state’s comparative negligence statute for apportioning damages. Under Wisconsin’s theory, if only one company is sued and no others are impleaded, that company is liable for all the damages if it cannot exculpate itself. If more than one defendant is joined or impleaded, then damages are determined according to the jury’s assignment of liability under Wisconsin’s comparative negligence statute. A number of factors may be considered in apportioning damages. These factors include the market share of the defendant, whether the company conducted safety tests on DES, the role the company played in seeking FDA approval of the drug, and whether the company issued warnings about the dangers of DES.

IV. COURTS THAT HAVE REJECTED MARKET SHARE LIABILITY

DES CASES

The concept of market share liability has not received strong support. The supreme courts of Illinois, Missouri, and Iowa have refused outright to adopt the market share liability theory in the context of DES daughter cases. The extent of each court’s analysis varies, although there are certain common justifications that each court has given for its holding. Each court has recognized the strong appeal of imposing liability on manufacturers that profited from the sale of a product that has injured an innocent victim.108 However, these courts have realized that the market share liability theory was too great a deviation from existing tort law and, therefore, as the theory presently existed, was not a viable concept. The market share liability theory, as these courts perceived it, did not present sufficient policy reasons to alter causation in fact. Rather, if any change was to be made to the existing tort laws, the courts reasoned that the legislature, and not the courts, would be better equipped to construct a solution to the DES liability problem.

In addition, the Illinois and Missouri courts stressed that the inadequacies of the data available on manufacturers’ market share made the concept unworkable. As a result, these two courts reasoned that it would be unfair to award damages based on inaccurate evidence. Both courts also declined to embrace the underlying policy reasons on which the courts that accepted market share liability relied. In Zafft v. Eli Lilly & Co., the Missouri Supreme Court discounted the argument that “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury” because “defendants can better absorb the cost of injury. The Zafft court stated that this argument ‘ignored the strong countervailing interests that support the causation in fact requirement. The Illinois and Missouri courts also both recognized that adoption of market share liability would have little effect on production of safer products. In fact, these courts believed adoption of market share liability would have a detrimental effect on desired pharmaceutical research and development. In addition, the Illinois Supreme Court disputed whether the theory would have any significant effect on enhancing record keeping.

The Illinois Supreme Court, in Smith v. Eli Lilly & Co., further explained that the market share liability theory had the potential for treating plaintiffs who were unable to identify the culpable manufacturer better than the average plaintiff who was able to do so. Where the manufacturer can be identified, a plaintiff runs the risk that the culpable party may not be amenable to suit or may be insolvent. The Smith court also refuted the plaintiff’s contention that the defendants’ breach of a duty to her formed a basis for adopting the theory. Moreover, the Smith court concluded that imposing liability under the market share liability theory would make the remaining manufacturers of DES the insurers of the industry. The Illinois court reasoned that imposing liability would be especially unfair because the relevant industry existed between twenty and forty years ago and there were some 300 manufacturers involved; however, only the few manufacturers still in existence would have to shoulder the liability costs. Lastly, the Smith court rejected the plaintiff’s analogies to res ipsa loquitur and alternative liability as too tenuous.

Most federal courts that have addressed the issue of whether to apply market share liability in a DES case have declined to adopt the theory.127 The federal courts generally characterize the theory as a radical departure from the common law of the state in which they sit. Therefore, without a clear direction from a state’s supreme court, a federal court sitting in diversity would be usurping the proper authority of a state court.

For example, in Mizell v. Eli Lilly & Co., the South Carolina federal district court refused to apply California’s market share lability law. Even though the Sindell rule was the appropriate law according to conflict of law principles, the Mizell court refused to apply market share liability because it violated the public policy of the forum state, South Carolina. The Mizell court concluded that “market share represents a radical departure from the body of products liability law that has been developed in South Carolina” and has the potential for placing liability on defendants who bear no responsibility for the defective product.

Likewise, in Tidler v. Eli Lilly & Co., a case decided under Maryland law, the Court of Appeals for the District of Columbia declined to adopt the market share liability theory. The Tidler court reasoned “that the theory that plaintiffs would have us ‘construct’ requires that we build on a new foundation, not on the structural underpinnings of the traditional common law of torts. Neither the highest court of Maryland nor the District of Columbia had addressed the issue. The Tidler court, therefore, held that such a marked deviation from the common law was beyond the authority of a federal court bound by the Erie doctrine.

B. Attempts to Expand Market Share Liability

Beyond DES Cases Plaintiffs have attempted to extend market share liability to contexts other than DES cases but with considerably less success. In Shackil v. Lederle Laboratories, the New Jersey Supreme Court refused to apply market share liability in an action filed against manufacturers of the diphtheria, pertussis, and tetanus (“DPT”) vaccine. The plaintiff in Shackil allegedly became severely retarded as a result of receiving a DPT vaccine.  The plaintiff was unable to identify the specific manufacturer of the DPT vaccine she received. As a result, the plaintiff sued a number of manufacturers that potentially could have produced the vaccine she received and argued for adoption of a market share liability theory. The court determined that to adopt market share liability in a DPT case “would frustrate overreaching public-policy and public-health considerations by threatening the continued availability of needed drugs and impairing the prospects of the development of safer vaccines. The fact that Congress had already established a fund and a mechanism to compensate plaintiffs the vaccine allegedly injured also influenced the court’s decision.

The largest area of cases in which plaintiffs have been largely unsuccessful in attempting to impose market share liability has been in asbestos litigation. The main factor prohibiting application of the theory to asbestos cases is that asbestos is not a fungible product. Asbestos is a generic term for a family of minerals. Asbestos products have wide variances in toxicity depending on the amount of asbestos contained in the product; the greater the toxicity, the greater the risk of harm.” Therefore, establishing market shares based on the amount of product a manufacturer supplied into the market would not accurately reflect the amount of harm its product caused.

In Goldman v. Johns-Manville Sales Corp., the Ohio Supreme Court clearly articulated the reasons for which market share liability theory is rejected in asbestos cases.’ 60 The Goldman court reasoned that market share liability is inappropriate “in an asbestos litigation case, especially where it cannot be shown that all the products to which the injured party was exposed are completely fungible. The risk that the manufacturer created, the Goldman court noted, is not accurately reflected in its market share because many products contain different degrees of asbestos. The court further reasoned that there would be difficulties with the theory as applied to asbestos cases because the largest asbestos supplier, Johns-Manville, was not amenable to suit. Instead of adopting a market share theory, the court concluded that the problem required legislative solution.

Plaintiffs in a less cohesive mixture of cases have likewise been unsuccessful in their attempts to expand the doctrine of market share liability. In one line of cases, courts have held that plaintiffs, injured by the explosion of multipiece truck wheels, could not use market share liability against the manufacturers. These courts generally reason that the plaintiff failed to prove that the product was defective. Additionally, courts have found no proof that each company’s product shared the same defect. Manufacturers of clothing alleged to be unreasonably flammable, were held not liable under the market share liability theory because the products were not sufficiently fungible. The market share liability theory also was rejected in actions against the manufacturers of a type of blood product from which plaintiff contracted AIDS, the manufacturers of benzidine congener dyes, the manufacturers of Salk polio vaccine,162 and the manufacturers of a breast prostheses.

V. ANALYSIS

As illustrated, a slim majority of state supreme courts have embraced the market share liability theory in DES cases. The market share liability theory, however, has been rejected in almost all other contexts. Furthermore, the five courts that adopted some form of market share liability have criticized and ultimately rejected, in whole or in part, the theory as developed in the other jurisdictions. Each adopting court has recognized that its version of the theory may be flawed, but adopted the market theory anyway, believing that subsequent opinions would refine the concept. Nevertheless, after a decade of refining, the courts recognize that they apparently have been unable to resolve many of the problems with the concept. Courts should not be swayed to adopt market share liability, or one of the slightly altered variations of it, based on the strong emotional appeal to provide injured plaintiffs with a remedy. The theory is not only infirm, it is also a marked deviation from useful tort principles.

A. Criticisms of the Procedures Adopted for Implementing Market Share Liability

Market share liability represents one of the most important, if not one of the most radical, developments in tort law in the past decade. It has understandably been the subject of criticism. Market share liability defendants and some commentators have argued that the whole concept is flawed. The flaws associated with the overall concept of market share liability will be addressed later in the Article. This section discusses the flaws associated with the procedural elements of market share liability.

The first procedural component in a market share liability case is the identification of defendants. The California market share liability theory requires the plaintiff to name defendants having a “substantial share” of the market,  while the market share liability theories of the three other states require the plaintiff to name only one defendant. One criticism specific to the California “substantial share” requirement is that the Sindell court failed to define what constitutes a “substantial share” of the market, such that the burden of proof shifts to the defendant. The law review article that the court relied upon suggested that the plaintiff join seventy-five to eighty percent of the manufacturers. The court, though, rejected this percentage as too high and held that only a substantial percentage share is required.

The three other state supreme courts only require the plaintiff to sue one defendant. However, without the requirement that a “substantial share” of the market be present, perhaps at least fifty percent of the market, there is the realistic potential of creating liability disproportionate to the amount of damage a manufacturer caused, especially if only a small manufacturer or a few small manufacturers are joined. If a substantial share is joined, there is at least a likelihood that one of the defendants before the court caused the injuries. Without the substantial share requirement, one manufacturer or a handful of manufacturers could continually be named defendants and be forced to pay damages. Consider what could happen if the sole defendant is a small contributor to the DES market. This manufacturer could possibly shoulder complete liability, without proof of it being the cause in fact of the injury; in fact, the great likelihood will be that the manufacturer did not cause the plaintiff’s injuries. For example, under the Washington procedure, a small company that no longer has records of its actual market share is given a presumptive share which equals the portion of the damages unattributed. Thus, that company could be responsible for seventy-five percent or more of the damages, when common sense dictates that a small company surely could not have distributed such a high percentage of the DES used in the market.

Defendants assigned presumptive shares are also held liable for the share of the market attributable to companies no longer in business or not otherwise amenable to suit. Defendants who are amenable to suit become insurers of the products that other manufacturers, not amenable to suit, made and marketed. Therefore, a market share liability theory that does not require the identification of a substantial number of defendants can be substantially unfair to any company that is unable to prove its market share, especially if that company is small.

Another criticism of the procedures developed is that each theory, other than New York’s, fails to identify the relevant market-the local area, the county, the state, or the nation-for purposes of determining a particular defendant’s market share. The relevant market area is important because a manufacturer’s liability will vary widely depending on which market is used. The courts adopting the theory claimed that market share liability approximates each defendant’s responsibility for the injuries its own product caused. However, these assertions are undermined by the fact that, depending on the chosen market, there is this potential for extreme variance in liability. Furthermore, each state’s theory fails to specify how the market for DES can be allocated fairly when DES was prescribed for uses other than as a miscarriage preventative. Failure to account for the diverse uses of DES exacerbates the improbability that the market share theory apportions liability in any way that approximates the injuries each defendant caused.

The Wisconsin provision that holds a single named defendant who can not prove market share 100% liable for a plaintiff’s injury, in particular, is subject to criticism. The Wisconsin Supreme Court emphasized that it was adopting the concept due, in part, to the fact that the defendant created a risk of harm. The other courts adopting market share liability did not go so far as to impose potentially total liability on a single defendant merely for creating a risk of harm. The Collins decision contravenes the principle that a mere possibility that a defendant is the responsible party is insufficient to satisfy causation. It is possible, therefore, under the Wisconsin theory that the defendant’s liability will far exceed the probability that it caused the injuries.

The Wisconsin court, in Collins, also rejected “unalloyed market share,”‘ 86 concluding that it “does not constitute the most desirable course to follow in DES cases because the theory, while conceptually attractive, is limited in practical applicability. The Collins court found that defining the market and apportioning the market share are almost impossible to accomplish fairly and accurately because of the insufficiency of the data on market shares, and because a second mini-trial to determine market share would waste judicial resources. While this observation may be true, it has been pointed out that the Collins single defendant method does not resolve the perceived errors in allocating market share. Moreover, under the court’s procedure, the errors are compounded by inundating a jury with a mass of information and by adding a trial on the separate issue of apportioning liability.

The New York Court of Appeals recently declined to accept Wisconsin’s risk contribution theory, believing that it would only be feasible on a limited scale. The New York court was wary “of setting loose, for application in the hundreds of cases pending in this State, a theory which requires the fact finder’s individualized and open-ended assessment of the relative liabilities of scores of defendants in every case. The court concluded that the injustice resulting from delays in recoveries and inconsistent results militated against adoption of the theory.

B. Inability to Reconstruct the Defendant’s Market Shares

There are numerous problems with the overall concept of market share liability aside from those concerning the procedures each court developed to impliment its theory. A major flaw with DES cases is that there is only a small amount of, or in some cases no reliable information available to establish the defendants’ percentages of the market. No party can be blamed for the lack of information. The lack of information is, in part, the result of the inadequacy of the laws in effect regarding maintenance of records. Other factors relate to the long lapse in time from the sale of the drug to the filing of the lawsuit. Besides the lack of records for existing manufacturers, many of those defendants named in the lawsuits are no longer in business. For these companies especially, it is unlikely that records are available to establish their share of any market. The lack of available records is evidenced by the fact that after extensive discovery, many plaintiffs are unable to identify the responsible manufacturer or even to narrow it to a likely group of defendants. Unfortunately, the courts that have adopted market share liability have done so while ruling on pretrial motions. These courts have not had the benefit of hearing evidence regarding the unavailability of market share data before ruling on whether or not to adopt the market share liability theory.

The experiences of trial courts in California, directed by the Sindell court to apply the market share liability theory, exemplify the problems courts will encounter in determining market shares. The Smith court noted that California trial judges, in In re Complex DES Litigation, attempted to define the relevant market as narrowly as possible. After extensive discovery proceedings, the parties were unable to present data on a narrow market. Therefore, the judge determined that the only practical relevant market was a national market. Likewise, the Smith court noted that another California court, in Stapp v. Abbott Laboratories, expressed exasperation with the task of attempting to formulate market shares after spending over four weeks examining the DES market. The Stapp court concluded that there simply was no such market share data. The Stapp court criticized the courts that developed the market share concept for adopting the theory despite their obvious lack of trial experience and lack of knowledge as to what would go into proving a case based on the theory.

Those who support the market share liability theory, and those courts that developed it, did so believing that attributing damages in proportion to the percentage of DES a manufacturer supplied in a narrow market would, over the run of cases, result in holding each defendant responsible for the amount of harm its own product caused. Thus, the causation in fact element was preserved as much as possible. It is highly unlikely, however, that market share liability can meet the goal of apportioning damages in the context of DES cases.

A truly reliable market share calculation must be limited to an accurate reflection of the amount of DES a manufacturer supplied into the market. Such an accurate determination of market share apparently cannot be achieved. Moreover, any market share determination must be limited to the amount of DES the manufacturer sold for use in preventing miscarriages. This narrow market is appropriate because the drug was, and is, safe for the other purposes for which it was sold. The task of determining market share is especially awesome in the case of DES sales because of its widespread use and because of the long period of time over which it was prescribed. To reconstruct the market and apportion liability accurately, evidence must be presented detailing each defendant’s percentage of the relevant market for a specific year, overlapping years, or span of years. For instance, if a plaintiff’s mother, for some reason, took DES intermittently over a period of three years before the plaintiff’s birth, the trial court will have to reconstruct the market shares of each defendant for each year. In addition, DES cases have generally been consolidated before a single trial judge for docket management purposes. The judge has the difficult task of developing the various market shares for the numerous defendants and years involved in the multitude of DES cases before the court. This can mean reconstructing the sales data for thirty or more manufacturers for any number of years between 1947 and 1971.

Unfortunately, reconstructing these narrow markets can be nearly impossible due to the scant amount of market data that remains available. If courts and juries are allowed to apportion damages when reliable information is not available, the clear result will be arbitrary determinations and wide variances between judgments, without sufficient explanation for these differences. This unpredictability makes it difficult for manufacturers to insure against liability and to reach reasoned settlements in pending suits. Additionally, states that adopt market share liability place a burden on their trial courts and the parties involved to determine market shares. This burden bogs down trial courts and creates for them an almost futile endeavor. The burden of establishing market shares based on unreliable or insufficient data also comes at a tremendous cost to the court system and to litigants, both monetarily and in terms of manpower.

Contributing to the misperception regarding the ability to reconstruct markets is the implicit contention that defendants amenable to suit can establish their true market shares. Throughout the history of the use of DES as a miscarriage preventative, hundreds of manufacturers produced the product. It is impossible to bring them all before a single court. The defendants who do appear in court face the difficult burden of proving their market share. Those who cannot meet this task, but who still desire to reduce their potential liability, will have the even more difficult burden of establishing market shares of codefendants or unnamed manufacturers. The likely result of the failure of market share proof will be that those companies that are amenable to suit, but unable to establish their market share, will be liable for a wholly speculative and disproportionate amount of the damages. Instead of having every DES manufacturer pay damages that, in the long run, approximate the harm the manufacturer caused, the market share theory places liability on only the small percentage of the many DES manufacturers that are still viable and amenable to suit.

One contention that may support adoption of market share and may overcome some of the problems discussed is, that after a number of jurisdictions have grappled with developing market shares, there will become a pool of generally accepted market share data for the various DES manufacturers. Such a proposition, however, is not accurate. Any generally accepted data that courts develop will likely be established for those few large companies that are still viable and amenable to suit. Also, any generally accepted data will most likely be only for large manufacturers’ national market shares. Under each adopted market share liability theory, except for New York’s, the trial court first attempts to determine the local market share-that is the market shares of the defendants who participated in a specific neighborhood, county, region of the state, or whole state. Thus, regardless of a manufacturer’s national market, if suits are brought throughout the country, the incentive and the burden will remain for a manufacturer to attempt to establish a more localized market share.

Even if the trial courts agree to accept only data on national market shares, inevitably disagreement will arise about these markets. For example, after extensive discovery and hearings, a San Francisco California court developed national market shares for the years involved in the cases before it. However, the litigants in a New York DES case declined to accept these figures. The New York court is now attempting to construct its own market share figures. Subsequently, the San Francisco court decided to relitigate the market share issue because of perceived errors in its calculation.

Last, the national market data will inevitably be flawed due to the lack of reliable information. Market share figures likely will not include all the companies brought before each court or will not include the many companies no longer amenable to suit.

C. Tort Principles Used to Justify Adoption of Market Share Liability

Irrespective of the lack of reliable market share data, the underlying policy goals of market share liability do not justify adoption of the theory. Proponents of the theory argue that certain policy considerations of negligence and strict liability law compel courts to adopt market share liability. Although tort law must remain viable to impose liability on the responsible manufacturer or manufacturers, market share liability either does not effectuate the principles and policy reasons offered as justification, or, to the extent market share theory achieves tort law goals, the proposed reasons are insufficient to warrant adoption of the concept.

The Sindell court relied upon two policy reasons for adopting market share liability: (1) as between an innocent plaintiff and a manufacturer of a defective product, the manufacturer should bear the cost of injury; and (2) as between the injured plaintiff and the possibly responsible manufacturer, the manufacturer is better able to absorb the cost of the injury. These two policy reasons are also cited to justify imposition of strict products liability. The courts that followed Sindell in adopting the market share liability also justified adoption of the theory based in part on these policy reasons.

However, eight years after Sindell, in Brown v. Superior Court, the California Supreme Court held that prescription drugs should be exempt from strict liability; in so holding, the Brown court adopted comment k of the Restatement (Second) of Torts section 402A for determining the liability of a pharmaceutical manufacturer. Brown held that, in general, “so long as the drug involved was properly prepared and accompanied by warnings of its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution,” a manufacturer is not strictly liable. As shown earlier, market share liability is a theory that has essentially been limited to actions against manufacturers of DES, a prescription drug. Interestingly, when California, the first state to adopt market share liability, explained its reasons for accepting market share, the court relied on policy reasons underlying strict liability. Nevertheless, in Brown, a later California case, the California Supreme Court held that in an action under market share liability, the plaintiff could not rely on an action sounding in strict liability. In California, a plaintiff can now recover under the market share liability theory only by proceeding under a negligence cause of action.

The California court’s legal reasoning is patently unsound. First, the court legitimized the adoption of market share liability based on the policy reasons supporting strict liability, and then the court later declared that the market share theory should not be used in a strict liability action. In the meantime, the subsequent courts that adopted market share liability unwisely accepted the underlying policy reasons for adopting market share without analyzing whether the policies support adoption of the concept. After scrutinizing the policy reasons, it appears doubtful that they do sufficiently support adoption of the market share liability theory.

As noted, one policy consideration relied upon in adopting the theory is that drug companies are better able to absorb the costs of the injury by insuring against liability and passing the costs on. Linked with this principle is the contention that the pharmaceutical drug companies are in solid financial condition and, therefore, are able to afford insurance to cover the costs. Manufacturers have strongly contested the figures and conclusions regarding their financial status, or any implication that one company’s solid position reflects the security of other participants in the drug manufacturing industry. The producers further contend that expansions in tort law, such as the adoption of market share liability, have the perverted result of eliminating production of certain useful and necessary drugs. Additionally, manufacturers contend that adoption of market share liability dramatically increases insurance costs to such an extent that some companies either can no longer obtain insurance or cannot pass the costs on to consumers, while other companies can no longer survive.

There are a number of examples of drugs that are no longer produced because of increased product costs related to potential liability. For example, Oculinum and Benedectin were considered safe and useful but are no longer available to the public because manufacturers cannot afford to insure their sale of the drugs. The federal government has interceded in some cases to protect companies from liability, in order to insure availability of a drug. For instance, the government intervened to insure availability of the swine flu and polio vaccines. The New Jersey Supreme Court voiced this same concern when it declined, on policy grounds, to impose market share liability on manufacturers of DPT because of the crippling effect potential liability would have on the availability of the vaccine.

Surely, broadening manufacturers liability exposure through market share liability will have the concomitant effect of negatively impacting drug availability. Manufacturers will need to insure against losses arising from the sale of their own products as well as the products of others in the industry, most of whom are no longer in existence. Even if a manufacturer decides not to insure against losses, it will still be obliged to cover the costs of any damage awards. This added potential for liability will likely contribute to a reduction of the number of participants in the market and the availability of drugs, as well as a decline in the amount of new drug research. It may be tempting to impose liability based on the fact that these manufacturers profited from the sale of a drug that may be responsible for the plaintiff’s injuries, regardless of their actual ability to cover these costs. However, this temptation alone is not a sufficiently compelling reason to adopt a theory that significantly alters a state’s tort law, while only providing a clearly flawed alternative. Likewise, the policy considerations regarding the ability of manufacturers to absorb costs is insufficient to justify adoption of market share liability given the unclear effect on future drug availability.

Another policy consideration supporting the development of products liability is that the production of safer goods will be promoted. Proponents of market share liability argue that adoption of the theory is also necessary to provide incentive to produce safer generic drugs. However, this argument is unconvincing. First, the industry arguably needs no additional encouragement above and beyond the incentives that strict liability and negligence laws provide to produce safer drugs. For years, the pharmaceutical industry has been the frequent target of litigation, facing large damage awards. This exposure has provided the industry with incentive to produce safe products. Before any drug is introduced to the public, extensive research and development costs are incurred to ensure that the product is safe. Furthermore, this country has established and yearly funds the Food and Drug Administration which is responsible for regulating the safety of pharmaceuticals. The FDA must first approve the use of any new drug before it is allowed on the market. After a drug is approved for sale, the FDA retains authority to remove the drug from the market if a problem later is discovered.

The likelihood of an incentive towards safety resulting from the imposition of market share liability in DES cases also is questionable for another reason: liability is not imposed until forty years after the undesirable behavior occurred and almost twenty years after the potential harm was discovered and the product removed from the market. Most of the defendants in current DES litigation had very little to do with the marketing of the drug when it was taken as a miscarriage preventative. Imposition of liability at this late date will have little deterrent effect. Today, drug manufacturers are guided in their safety incentive by medical and scientific research and FDA regulations not by this new concept for ensuring recovery. A third reason why market share liability does not provide a safety incentive stems from the fact that the theory imparts potential liability on all manufacturers in the particular industry. There cannot be an incentive to produce safer products if liability is still imposed as a result of the negligence of others in the industry. The incentive towards safety is also diminished if a manufacturer knows that others in the industry will absorb the damages resulting from its negligence.

The safety incentive rationale is questionable for a final reason: the theory has been adopted in only a limited number of jurisdictions, and thus far, market share liability is’only being applied to manufacturers of DES. Therefore, if a court adopts market share liability, the goal of warning manufacturers to produce safer products will not reach a wide array of drug manufacturers or other industries. The limited reach of the rule will produce little incentive for most manufacturers to produce safer goods since only one segment of the pharmaceutical industry is affected.

Similarly unavailing is the policy argument that adoption of market share liability encourages manufacturers to maintain more detailed records that will enable plaintiffs to identify the culpable party. Normally, when DES leaves a manufacturer’s plant, it is identifiable. Somewhere along the chain of distribution, however, the drug becomes commingled and less traceable. Due to the fungible nature of DES, drug manufacturers have very little ability to keep track of the ultimate market and user of the drug. Moreover, the drug industry did not violate any laws regarding the maintenance of sales records. With the adoption of market share liability, however, manufacturers nevertheless are punished for their failure to maintain better records.

Certainly, there are infirmities in the rationale offered to justify adoption of market share liability. Moreover, to the extent that these reasons and policy goals are met, they do not provide sufficient basis for judicial adoption of the theory.

D. Pharmaceutical Drug Manufacturers Should Not Become Insurers of Their Industry

Another justification offered for adoption of market share liability is that the DES manufacturers breached a duty to make a safe product and, therefore, liability should be imposed. First, one must note that in the cases adopting the theory no breach of duty had yet been established because the issue was decided on the basis of pretrial motions. Additionally, there is conflicting evidence as to whether DES is in fact an unreasonably dangerous product or whether it is especially harmful. Regardless, the concept that liability may be imposed based merely on a breach of duty or creation of risk, without causation established, has long been rejected in American tort law.

Courts should not easily discard historic tort law principles merely because the defendants are members of the drug industry or because a plaintiff has suffered an injury. Market share liability, however, does disregard tort law principals. As a result, manufacturers are insurers of not only their own products but also the products of other manufacturers in the industry. Additionally, market share liability in DES cases causes solvent defendants to become insurers of an industry that existed approximately twenty to forty years ago.

As Justice Richardson stated in his Sindell dissent:

The majority’s decision effectively makes the entire drug industry (or at least its California members) an insurer of all injuries attributable to defective drugs of an uncertain or unprovable origin, including those injuries manifesting themselves a generation later, and regardless of whether particular defendants had any part whatever in causing the claimed injury.

Such a result is unwarranted. The majority of plausible DES defendants have not been, or cannot be, brought before a court. Those defendants who are brought before courts bear the difficult burden of establishing their share of a relevant market. The companies that cannot prove their share will have to pay the unattributed portion of the damages, thus paying the damages that rightfully belong to companies that are insolvent, not amenable to suit in the jurisdiction, or for some other reason, are not before the court. The Sindell court justified its ruling in part on the belief that over the run of the cases, a company’s liability would approximate the harm it caused. However, this assumption is purely illusory, as recognized in Hymowitz. This type of judicial legislation is an unreasonable overreaction in an attempt to achieve what is perceived as a socially desirable result. A decision to adopt market share liability not only distorts a state’s common law but also is best decided by the legislature and not the courts.

VI. LEGISLATURES, NOT COURTS, SHOULD DETERMINE THE PUBLIC POLICY IN DES CASES

There is a strong appeal in compensating DES daughters for their injuries. However, in fashioning market share liability theories, the state supreme courts are, in essence, legislating. In fact, the courts that have adopted market share liability have expressly done so after determining what they perceive as public policy demands in the DES cases. The courts declining to adopt market share liability recognized that the issue demands a judgment on public policy; these courts then concluded that the legislatures could better address the issue. The Sindell court, however, rejected the dissent’s argument that the issue should be left to the legislature because the majority found no “justification for shifting the financial burden for such damages from drug manufacturers to the taxpayers of California.

The market share liability issue involves determinations of public policy. The various state legislatures are the appropriate forums for determining public policy in this instance. A legislature has the ability to hold hearings, listen to debate, receive data on the extent of the problem, and ultimately to determine what, if any, remedy the state should provide. In performing this function, legislatures face divergent interests when considering the adoption of market share liability. On the one hand, a state may strongly desire to ensure that its citizens are compensated for injuries and have access to courts to pursue their claims. On the other hand, a state legislature may recognize the strong public interest that the pharmaceutical industry continue its research and development of new and safe drugs. A legislature is equipped to determine what economic effect the imposition of market share liability will have on the industry. State lawmakers may determine that the laws should not sanction a tort theory which likely will apply to only a small group of defendants-pharmaceutical manufacturers-and which may have a disproportionately large economic impact. Or lawmakers may determine that the theory unreasonably expands the state’s laws to benefit a narrow class of plaintiffs. The legislature also may decide to fashion its own form of market share liability, or it may decide to remunerate the victims without assigning fault to any group of defendants.

Courts are not the proper forums for making these policy evaluations in DES cases because they do so without any concept of the extent of harm or even risk of injury involved by the maternal ingestion of the drug. Reliable evidence indicates that although hundreds of thousands of women took DES, the incidence of injury to their children is minimal. The courts are thus emasculating existing tort law for the benefit of a narrow group of people while the necessity of the action remains open to question. Such a determination could be addressed more intelligently and thoroughly in the legislative forum, where both sides of the issue would be analyzed appropriately.

Certainly one may argue against deferring to the legislature in this instance because the pharmaceutical industry and the insurance industry are influential and will be able to politically sway the issue their way. On the other side of this issue, however, are the powerful trial lawyers associations and other bar groups, both of which are coordinated on the state and national levels and which have also exhibited legislative persuasion. Moreover, in similar instances, legislatures have in fact determined that persons suffering’ injuries resulting from drugs or other products should be compensated, thus thwarting the desires of the insurance industry and drug manufacturers. The compensation such legislation provides is not awarded by courts. Instead, compensation comes from a specific fund established for the purpose.

Legislation which compensates victims for injuries resulting from defective products generally establishes a fund and a procedure people must follow in order to receive money. The recovery fund is established from revenue received by members of the industry producing the product or through tax revenue. A structured and predictable system for recovery is thereby created that operates at a lower monetary cost and in a more efficient and expeditious manner. Injured parties benefit by avoiding protracted and uncertain civil litigation. The legislation recovery system insures that there is a source from which to recover. Also, the manufacturers’ costs of defending suits and the necessity of insuring against unknowable damage awards are eliminated. A legislated recovery system is predictable in the sense that manufacturers know in advance what their costs of compensation will be. However, the public ultimately bears the costs for this either in its tax bill, if it is funded through tax revenue, or in the higher prices paid for the goods, if the manufacturers have to bear the cost and decide to pass it on in the form of higher prices.

VII. CONCLUSION

Courts in the past have not been hesitant to develop new tort concepts. Courts should, however, decline to adopt market share liability because of the theory’s infirmities. Market share liability is a flawed concept that likely will apply only to a narrow class of plaintiffs and defendants. Moreover, rejection of the market share liability concept will not leave DES daughters or other plaintiffs without a remedy. Some DES plaintiffs have been able to establish the identity of the specific manufacturer, while others will be able to establish enough evidence to proceed to trial on the issues of causation in fact or negligence. Adoption of the market share liability theory, though, contravenes existing tort principles. The theory deviates too greatly from a principle which serves a vital function in the law: causation in fact. In the final analysis, the legislature, and not the court, is the appropriate forum for determining whether to adopt or reject market share liability.

David M. Schultz, 1991.

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More DES DiEthylStilbestrol Resources

Preconception Tort Liability – The Duty to Third Generations

INTRODUCTION

Diethylstilbestrol (“DES”) is a synthetic estrogen hormone invented by British researchers in 1937. DES was used to treat a variety of health conditions, and beginning in 1947, was prescribed for the purpose of preventing miscarriages. Because DES was never patented, the approval of the Food and Drug Administration (“FDA”) was the only requirement needed by pharmaceutical drug manufacturers to produce the drug. By 1952, the FDA had declared DES to be generally recognized … as safe. However, in 1971, DES was discovered to be the specific cause of vaginal cancer in female offspring of women who had ingested DES (“DES daughters“) and was contraindicated by the FDA for use in pregnancy. By this time, DES had been taken by several million pregnant women. Consequently, four to six million mothers and their offspring were exposed to the drug. While a number of DES daughters have contracted vaginal and cervical cancer, the vast majority of injuries to DES daughters are pre-cancerous vaginal abnormalities. In most DES litigation, plaintiffs have encountered a number of legal problems such as the running of the statute of limitations, the absence of a cause of action for prenatal or preconception injury, and the inability to identify the manufacturer who produced the ingested drug. However, New York is one of several states that have taken steps to protect the rights of DES victims. For example, in 1978, the New York Legislature enacted Public Health Law section 2500-c which specifically recognized the link between prenatal exposure to DES and an unusual type of vaginal or cervical cancer in female offspring. This legislation was designed to locate, monitor and establish programs for DES daughters. In Enright v. Eli Lilly & Co., a case involving preconception tort liability, the New York Supreme Court, Third Department Appellate Division, confirmed New York’s truly agressive position toward recovery for those injured by DES. The court held that the plaintiff, Karen Enright, had a strict products liability cause of action against the drug manufacturer for birth defects resulting from her grandmother’s ingestion of DES while pregnant with the plaintiff’s mother. In reaching its decision, the court distinguished this case from prior New York cases denying preconception tort causes of action for the sole reason that this case involved DES. The court balanced the legislative policy favoring a remedy for DES injuries against the significant consequences of recognizing a novel cause of action for preconception tort liability. The court in Enright stressed the dictates of common-law justice and fairness along with the insidious nature and long dormancy period of DES injuries as a basis for favoring a remedy for DES injuries.

PRECONCEPTION TORT LIABILITY – THE DUTY TO THIRD GENERATIONS: ENRIGHT V. ELI LILLY & CO., CREIGHTON LAW REVIEW Vol. 24, 1991.

The Enright case is significant in that it is the first New York case to allow a preconception tort and is unique in that it involved DES and a third generation plaintiff. This Note discusses the evolution of prenatal torts as well as cases which have considered whether or not a cause of action exists for children conceived after tort injury to the parent. In addition, this Note examines the New York policy concerns regarding preconception liability both within the context of DES litigation as well as generally. Finally, this Note analyzes the implications of Enright to future New York preconception tort cases and concludes that the DES situation is an exceptional case and does not replace New York policy disfavoring preconception tort claims.

FACTS AND HOLDING

During 1959 and 1960, Rosemary Whitmore Hickson was prescribed and ingested diethylstilbestrol (“DES”) while pregnant with Patricia Enright. Although on January 29, 1960, Patricia Enright was born with a malformed uterus, uterine and cervical dysfunction, and squamous metaplasia as a result of her mother’s ingestion of DES, the implications of the injuries were not detected until she herself became pregnant. Patricia Enright was unable to maintain a full-term pregnancy, and on August 9, 1981, she prematurely gave birth to a daughter, Karen Enright, who has cerebral palsy and suffers from grand mal seizures and other congenital defects.

In 1988, Patricia Enright and her husband filed suit against various manufacturers of DES on behalf of themselves and their daughter, Karen. Damages were sought for the emotional and physical injuries which Patricia Enright suffers as a victim of DES as well as for the physical injuries, pain and suffering which her daughter suffers. Husband and father, Earl Enright, asserted both a derivative cause of action and a cause of action for the emotional damages associated with his inability to ever have a healthy child. Relying on New York’s nonrecognition of preconception tort liability, the defendants filed motions for summary judgment.

The New York Supreme Court, Chenango County, addressed several issues including:

  1. whether a third generation plaintiff could assert a cause of action against a drug manufacturer of DES;
  2. whether New York recognizes a shared theory of liability whereby all manufacturers of DES may be held jointly responsible for injuries suffered,
  3. and whether New York’s revival statute, which is a procedural device ‘that revives an otherwise time-barred remedy, is unconstitutional.

In response to the first- issue, the trial court held that New York does not recognize preconception tort liability. Relying on policy considerations articulated in Albala v. City of New York,  the court in Enright stated that expanding liability to include preconception torts would require the extension of traditional tort concepts beyond manageable bounds. Furthermore, the court declared that foreseeability alone can neither establish a legal duty nor has such a duty been mandated statutorily or at common-law. The court also stated that these policy considerations were considered applicable to strict liability causes of action as well. The Enrights argued that in a footnote in Albala, the court had recognized a preconception cause of action based in strict liability. However, the trial court relied on the holding in Catherwood v. American Sterilizer Co.  which held that the footnote in Albala only preserved the strict products liability issue for later cases, such as Catherwood, and that because of policy considerations surrounding ingestion and exposure cases, liability should be limited to situations in which a duty to the unconceived can be established. Finally, the court quoted portions of the revival statute along with its legislative history in support of its holding that the statute was specifically enacted to provide a remedy to a select group of plaintiffs which did not include the Enrights. Additionally, within the revival statute itself, a cause of action for personal injuries caused by exposure to DES “upon or within the body” was interpreted by the trial court as the legislature’s way of establishing some predictability as to those persons entitled to sue. Thus, both of Karen Enright’s claims were dismissed as were the claims of her parents which were posited upon Karen’s claims. Therefore, the issues remaining were applicable only to the claims filed by Karen Enright’s parents on behalf of themselves.

Turning to the second issue, the court discussed theories of liability utilized in other jurisdictions in similar situations in which identification of the manufacturer who produced the product is impossible to determine. Traditionally, in order to maintain a products liability cause of action, the plaintiff was required to prove that the defendant produced, manufactured, sold or was somehow responsible for the product which caused the injury. However, innovative counsel, as a way of imposing liability upon one or more of the manufacturers, have utilized alternative theories such as the concerted action theory which imposes joint and several liability upon all those who manufacturered the drug regardless of whether they manufactured the drug which the plaintiff ingested. Because the concerted action theory had been allowed in an earlier Appellate Division case, the court in Enright reluctantly allowed Patricia Enright and her husband to proceed on such a theory.

In addressing the constitutionality of New York’s revival statute, the court noted that “exceptional circumstances must be demonstrated to warrant legislative intervention in reviving a cause of action which is time barred. Relying on the legislative history of the statute, which stresses the nondetectability of DES injuries until years later, the court concluded that the requisite “exceptional circumstances” test was easily met.

In summary, the court granted the defendants’ motions for summary judgment dismissing Karen Enright’s preconception tort claim and all claims of Karen’s parents which were posited upon Karen’s claim.  Cross appeals were filed with the New York Supreme Court, Appellate Division, Third Department.

Because New York’s highest court had recently adopted a market share theory of liability in DES cases and had sustained the constitutionality of New York’s revival statute, the only disputed issue on appeal was whether Karen Enright’s preconception tort claim should be allowed. The appellate court’s analysis began with Albala which was a preconception tort action brought on behalf of an infant plaintiff who was born brain damaged four years after his mother’s uterus was perforated while undergoing an abortion. In Albala, the New York Court of Appeals held that the child’s cause of action against the doctors who damaged his mother’s uterus prior to the child’s conception was not cognizable under New York’s laws because of the potential for unlimited liability and the undesirable effect of encouraging the practice of defensive medicine. However, in reviewing the policy considerations which formed the basis of the Albala opinion and other New York preconception tort cases such as Catherwood, the appellate court in Enright reached a different conclusion. The court in Catherwood had stated that it would be inappropriate to allow a preconception tort action when a date-of-injury statute of limitations is used because expiration of the cause of action could occur prior to conception of the plaintiff. Because New York had replaced its date-of-injury statute of limitations with a date-ofdiscovery rule for almost all toxic torts, the policy consideration voiced in Catherwood was no longer applicable.

However, the court in Enright did not overturn Catherwood. Instead, the Enright case was distinguished from other preconception tort cases because it involved DES. The court in Enright stated that “products liability law cannot be expected to stand still where innocent victims face inordinately difficult problems of proof. The court also concluded that the enactment of the revival statute by New York’s legislature was further proof of the state’s commitment to furnish a remedy for DES victims. Finally, the court discussed the New York cases, Bichler v. Eli Lilly & Co. and Hymowitz v. Eli Lilly & Co., which involved DES. The court considered these cases to be indicative of New York’s policy favoring a remedy for DES victims. For example, like the court in Hymowitz, the court in Enright stated that the manufacturers should not be able to hide behind a curtain and expect innocent DES victims to bear the costs of a DES injury simply because of its long dormancy period, especially where the legislature has consciously created an expectation of recovery by reviving hundreds of DES cases. Thus, based upon New York’s policy favoring DES victims and the broad applicability of strict products liability theories, the appellate court granted Karen Enright’s cause of action in strict products liability for injuries sustained because of her mother’s exposure to DES in utero. Therefore, the defendants’ motions for summary judgment, which had previously been granted, were modified to allow Karen Enright’s cause of action. However, the court in Enright stressed that the DES situation is an exceptional case and that the preconception tort issue requires the striking of a delicate balance between competing policy considerations which arise when tort liability is extended beyond traditional bounds.

The dissent in Enright argued that the majority had engaged in “judicial overreaching” by allowing a preconception tort cause of action which conflicted with the established rule in New York denying preconception tort liability under common-law negligence principles. The dissent also stated that the cases cited by the majority in support of its decision were irrelevant because they did not involve preconception torts, but rather other issues pertaining to DES litigation. In addition, the dissent argued that the toxic tort revival statute should be interpreted literally and that direct contact between a plaintiff and DES should be a prerequisite to a strict products liability cause of action.

BACKGROUND

PRENATAL TORTS

Although the commmon-law had recognized that an unborn child was entitled to legal protection, this protection only existed within the context of criminal and property law, not tort law. This view was illustrated in 1884 by the first American case involving tort liability for prenatal injuries, Dietrich v. Northampton. In Dietrich, a pregnant woman fell on a road in Northampton which resulted in premature labor and the birth of a child who lived less than fifteen minutes. The child’s estate sued the city of Northampton for its negligent maintenance of the road. However, the Massachusetts Supreme Judicial Court upheld the common-law rule that there was no remedy for such injuries. The unborn child was part of the mother at the time of the injury, and no duty could be owed to one not yet in existence.

In 1891, an influential decision was handed down by an Irish court in Walker v. Great Northern Railway of Ireland. In Walker, a pregnant woman and her unborn child sustained injuries while passengers on a railway. The woman brought suit against the railway for the injuries to her child. The court discussed at great length the common-law rights of unborn children. However, the court held that because the unborn child’s existence was unknown to the railway at the time of the accident, there was no contract of carriage between the child and the railway and the railway owed no duty to the child. In addition, the court stated that allowing a cause of action for prenatal injuries would result in “a boundless sea of speculation.” Thus, the court relied on the principle that a child en ventre sa mere, that is, “in its mother’s womb,” was not an entity separate from its mother and, therefore, was not entitled to legal redress for tortious prenatal misconduct.

In Allaire v. St. Luke’s Hospital, a case decided in 1900, Ada Allaire went to St. Luke’s Hospital to give birth to her son. Ada Allaire was seriously injured and her unborn child was permanently disabled as a result of an elevator accident at the hospital. Ada settled with the hospital regarding her personal injuries and damages but brought a cause of action for injuries sustained by her son. In a per curiam opinion, the Illinois Supreme Court held that no cause of action for the child could be maintained. The court reasoned that:

a child before birth is, in fact, a part of the mother, and is only severed from her at birth, . . . that an unborn child may be regarded as in being for some purposes, when for its benefit, is a mere legal fiction, which, . . . has not been indulged in by the courts of common law to the extent of allowing an action by an infant for injuries occasioned before its birth.

In a powerful dissent, Justice Boggs challenged the Dietrich proposition that no duty of care could be owed to the infant which is “too little advanced in foetal life to survive its premature birth. Boggs argued that once a fetus reaches viability, that fetus should be considered a separate legal entity. His analysis was based on a number of theories.

First, he stated that common-law precedents are general principles which should be applied to the facts of each case and, because of the diversity of factual situations, these principles must continue to grow and expand.  In this case, the “governing principle” was that damages are awarded for personal injuries inflicted by the neglect or wrong of another. Therefore, he argued that this case was “embraced within the limits of the principle … and it is clear that recovery could have been maintained at commonlaw unless the fact the plaintiff was unborn when the alleged injuries were inflicted would have operated to deny a right of action. According to Justice Boggs, such a denial should not occur when the plaintiff is unborn but viable.

Second, Boggs discussed property and criminal law principles pertaining to the inherent rights of the unborn in both areas of law and questioned the court’s nonrecognition of these common-law principles in the area of tort law.  Boggs stated:

In the case at bar the infant, when the injury was inflicted, had, as the declaration alleged, reached that advanced stage of foetal life which would have, according to the experience of mankind, and according to the medical learning of the age, endowed it with such vitality and vigor, and with members and faculties so far complete and mature, that it could have maintained independent life, and the death of the mother would not have deprived it of life. It is but natural justice that such an infant, if born alive, should be allowed to maintain an action in the courts for injuries so wrongly committed upon its person while so in the womb of the mother.

Next, Boggs distinguished Dietrich on the basis of viability. While the child in Dietrich was born four to five months premature, the child in Allaire had been carried full-term and was within ten days of his anticipated birth date at the time of the accident. Therefore, Boggs argued that the infant was capable of existing separate from his mother at the time of the accident and should not have been denied a cause of action.

Finally, Boggs addressed the Walker “lack of duty” argument. In Walker, the railway did not know of the unborn child’s existence nor was any consideration given for the child’s transportation. However, in Allaire, St. Luke’s Hospital “knew of the condition of the mother, and of the existence of the plaintiff in her womb, contracted with direct reference to the safety and care of both mother and child and received compensation for the performance of a duty to both.” Boggs concluded that it would be “abhorent to every impulse of justice or reason to deny such a child a right of action against such physician to recover damages for the wrongs and injuries inflicted by such physician.”

Between 1900 and 1946, Boggs’s dissent was noted by some courts but never followed. Finally, in 1946, the landmark case of Bonbrest v. Kotz was decided by the United States District Court for the District of Columbia. The case of Bonbrest was a medical malpractice case initiated on behalf of an infant injured during delivery. The court relied on the logic of Montreal Tramways v. Leveille, a Canadian Supreme Court case which had stated:

If a child after birth has no right of action for pre-natal injuries, we have a wrong inflicted for which there is no remedy, for, although the father may be entitled to compensation for the loss he has incurred and the mother for what she has suffered, yet there is a residuum of injury for which compensation cannot be had save at suit of the child. If a right of action be denied to the child it will be compelled, without any fault on its part, to go through life carrying the seal of another’s fault and bearing a very heavy burden of infirmity and inconvenience without any compensation therefor. To my mind it is but natural justice that a child, if born alive and viable, should be allowed to maintain an action in the Courts for injuries wrongfully committed upon its person while in the womb of its mother.

The district court insisted that the recent developments in science and medicine regarding the unborn human fetus as an entity separate from its mother could not be ignored. Consequently, the court dismissed Dietrich on its face and called the Walker “difficulties of proof” argument no argument at all. A court, for the first time, had recognized that a viable fetus was not just a part of its mother, but a separate entity to whom the physician’s duty extended and in whom there existed the right to bring an action for negligently inflicted prenatal injuries.

The case of Bonbrest received virtually instant acceptance by courts in all jurisdictions. However, with the recognition of an unborn’s cause of action came two additional questions: first, whether a child must be born alive in order to maintain a cause of action or whether a cause of action can be maintained on the child’s behalf if an injury is inflicted upon the pregnant mother and the child is stillborn due to the injury; and, second, whether it is unjust to limit causes of action strictly to viable fetuses.

WRONGFUL DEATH

In order to answer the first question, courts have usually relied on an analysis of the applicable wrongful death statute to determine whether a viable fetus is recognized as a “person” by the legislature. The Minnesota Supreme Court, in Verkennes v. Corniea, allowed recovery for the death of a stillborn fetus which, prior to death, had reached viability. The court did not require a live birth because the stillborn fetus was considered a “person” within the meaning of the state’s wrongful death statute. The majority of courts have adopted this view and rejected a live-birth requirement. However, a number of jurisdictions have determined that their state wrongful death statute “does not include unborn fetuses within the statutory definition of persons.” These states have determined that according to property and criminal law, the rights of the unborn ripen at the child’s live birth. Jurisdictions denying application of wrongful death statutes to unborn fetuses have held that such an analogy should be extended to tort law.

VIABILITY REQUIREMENT

The pre-Bonbrest cases had denied a cause of action to an unborn child because it had been held that a duty of care could not be owed to someone who was not an independent “person” at the time of injury. The early post-Bonbrest cases considered a viable fetus to be an independent person because the fetus had the capacity to survive outside the womb; therefore, these courts were able to retain personhood as the basis for finding a duty. However, as medical knowledge continued to grow, the viability requirement fell under increasing criticism. Viability was considered a poor standard for justifying recovery because “it was difficult to assess, irrelevant to proof of causation, and an arbitrary bar to legal redress.”

In 1953, in Kelly v. Gregory, the New York Supreme Court, Appellate Division, rejected the “viability” requirement. In Kelly, the plaintiff’s mother was struck by a car while crossing the street; she was three months pregnant with the plaintiff who was born “weakened and debilitated and otherwise physically handicapped. The court took a biological approach in reaching its decision and stated:

While the point at which the foetus becomes viable has been of usefulness in drawing some legal distinctions, the underlying problem that has troubled the judges who have written on the subject of recovery for pre-natal injuries, has been in fixing the point of legal separability from the mother.

We ought to be safe in this respect in saying that legal separability should begin where there is biological separability. We know something more of the actual process of conception and foetal development now than when some of the common law cases were decided; and what we know makes it possible to demonstrate clearly that separability begins at conception.

Thus, the court held that injuries sustained by the unborn child “at any period of its prenatal life” due to the negligence of another are actionable by the surviving infant. Today, the majority of jurisdictions which allow prenatal tort actions permit recovery for injuries sustained at any stage of fetal development.

In 1965, one commentator stated that the battle in jurisprudence is almost over. He referred specifically to the twenty-year struggle which had ensued prior to the recognition of an unborn plaintiff’s right of action in tort law. However, during the brief history of prenatal law, the issues surrounding prenatal injuries have engendered significant controversy. The cases had raised an assortment of unique and difficult social and legal issues, such as the legal status to be afforded a fetus, the reasonableness of recognizing a duty to a person not yet in being, the scope of protection to be afforded a potential child and the difficulties of proof and causation. The development of preconception tort liability would raise still more issues.

PRECONCEPTION TORT LIABILITY

In 1973, the United States Court of Appeals for the Tenth Circuit, in Jorgensen v. Meade Johnson Laboratories, Inc., became the first American court to allow a cause of action for preconception negligence. The complaint alleged that birth control pills taken by the mother had caused chromosomal changes in her body which had led to the mongoloid condition of her twins. A suit was brought on behalf of the twins for the personal injuries which they had sustained due to their retardation, deformity, and for pain and suffering. The action had been dismissed by the United States District Court for the Western District of Oklahoma which had concluded that no cause of action for preconception injuries existed in Oklahoma, the source of the applicable substantive law, and that such a right could only be created by the legislature. The court of appeals reversed the lower court, reasoning that although the mother’s chromosome structure was injured prior to conception, the plaintiffs’ mongoloid deformities did not occur until after conception.  The court recognized that prior decisions had long accepted the theory that a duty may be owed to a fetus from the moment of conception. Therefore, the court stated that the pleading should be construed to include the effects of the defendant’s drug both before and after conception. In addition, the appellate court stated:

If the view prevailed that tortious conduct occurring prior to conception is not actionable in behalf of an infant ultimately injured by the wrong, then an infant suffering personal injury from a defective food product manufactured before his conception would be without remedy. Such reasoning runs counter to the various principles of recovery which [the law] recognizes for those ultimately suffering injuries proximately caused by a defective product or instrumentality manufactured and placed on the market by a defendant.

Therefore, the court of appeals reasoned that if causation and proximate cause could be proven, the majority view would support “an action.., for prenatal injuries negligently inflicted if the injured child is born alive.

In 1977, the Illinois Supreme Court in Renslow v. Mennonite Hospital became the first state court of last resort to grant a cause of action to an infant for preconception negligence. In Renslow, eight years prior to conception, the plaintiff’s mother had received the wrong blood type during a transfusion which had sensitized the mother’s immune system which then caused prenatal hemolysis of the plaintiff’s blood cells. The complaint alleged that the prenatal damage to the plaintiff’s red blood cells had endangered her life and had caused her premature birth. The plaintiff sought damages for injuries which included permanent damage to her brain and nervous system. The trial court dismissed the complaint because the defendants owed no duty of care to the child prior to conception.

However, the Appellate Court of Illinois reversed, stating that there was “no logical reason to deny recovery… simply because the plaintiff had not yet been conceived when the wrongful conduct took place.” Although the defendants argued that the plaintiff’s injuries were unforeseeable at the time of her mother’s blood transfusion, the appellate court disagreed. The court noted that the defendants were a doctor and a hospital and could have foreseen that a thirteen year-old patient – plaintiff’s mother-to-be – would at some point marry and have a child who could be harmed as a result of improper blood transfusions. In addition, the appellate court found that other areas of tort law did not bar recovery simply because the wrongful conduct occurred before the injury.

On appeal, the Illinois Supreme Court affirmed but disagreed with the appellate court’s conclusion that “duty and foreseeability are identical in scope.” Instead, the supreme court required a showing that the likelihood of harm due to the defendants’ negligence was foreseeable by the tortfeasors and also that their conduct had violated a duty which, had it been performed, would have precluded the harm. The court remarked that because the plaintiff was not in existence at the time of the defendants’ wrongful conduct, the traditional notions regarding duty of care would seem inapplicable. However, the court stated that “duty is not sancrosant in itself, but only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection.” Thus, because courts grant relief for injuries incurred prior to viability, the court found it illogical to bar relief for preconception liability since the defendant would be liable for the same offense had the child, even without defendant’s knowledge, been conceived prior to his act.

NEW YORK’S APPROACH TO PRECONCEPTION LIABILITY

Relatively few jurisdictions have granted recovery for preconception torts and, until recently, New York’s position has been that no cause of action may be sustained by a child for preconception injuries to the mother. In 1976, a New York trial court, in Park v. Chessin, allowed the wrongful life claim of an infant afflicted with polycystic kidney disease based upon the preconception malpractice of the two defendant obstetric specialists. The infant had died at the age of two and one-half years from the same congenital defects which had caused the death of the Park’s first child. Prior to the second child’s conception, the parents had sought the advice and medical care of the defendants regarding the possibility of having another child similarly afflicted. The complaint, brought by the parents on the child’s behalf, alleged that the risk of having another child born with the same congenital defects as their first child was never communicated to the parents by the doctors. The trial court had allowed the cause of action and stated that medical specialists may be held liable for preconception negligent acts. The court said that “it makes no difference how much time elapses between a wrongful act and a resulting injury if there is a causal relationship between them. The trial court noted that the causal link between the defendants’ malpractice and the child’s injuries had been established, and the doctors’ advice had influenced the mother’s decision to become pregnant. The court stated that the birth of the child was foreseeable to the doctors; however, foreseeability was not a “necessary ingredient” for sustaining liability. The court also stated that once causation was established, the infant should be compensated for the injuries if the infant is born alive. The fact that the infant was not in existence at the time of the malpractice was of no relevance to the court.

However, the New York Court of Appeals in Becker v. Swartz modified the Park decision by refusing to recognize a wrongful life claim. In Becker, the defendant physicians failed to inform the expectant parents about the availability of an amniocentesis test which could have detected that the fetus was afflicted with Down’s Syndrome and would have precipitated a decision on the parent’s part to end the pregnancy; the failure to terminate the pregnancy resulted in the live birth of a child afflicted with Down’s Syndrome. The court in Becker noted that there was no basis statutorily or at common-law for granting the impaired child a cause of action. The court also discussed the “staggering implications” of any law which would allow claims because the child was less than perfect. Finally, the court in Becker stated that sentiment should be put aside when faced with a novel cause of action.

Wrongful life cases are distinguishable from other preconception tort cases, such as those involving DES, in which the plaintiff claims that the alleged negligence caused life in an impaired state versus life in an unimpaired state. In wrongful life cases, the plaintiff asks the court to calculate damages dependant upon a comparison between life in an impaired state and nonexistence. Nevertheless, the arguments used in Becker have been applied to other preconception tort cases. For example, the New York Court of Appeals in Albala, expressed the same concerns as the court in Park regarding preconception tort liability. In Albala, the plaintiff’s mother suffered from a perforated uterus after a negligently performed abortion. Approximately four and one-half years later, the plaintiff was born brain damaged as a result of his mother’s perforated uterus.

The New York Court of Appeals discussed a variety of policy considerations in support of its holding that the child did not have a cause of action against the doctors who negligently performed his mother’s abortion. Such considerations included the possibility of unlimited liability. The court stated, for example, that if a negligent motorist hits another vehicle containing a female passenger whose uterus is punctured as a result of the accident and she later gives birth to an impaired child, the negligent motorist would be liable to the child.  The court agreed that imposing perimeters of liability is a proper legislative concern, but that in preconception tort cases, liability could not be judicially established in a practical and reasonable manner.  However, the court in Albala stated that this decision encompassed policy considerations which were unique to negligence actions and that the area of products liability may require a different analysis.

In Catherwood v. American Sterilizer CO., the plaintiff, who was conceived after her mother’s exposure to ethylene oxide, a chemical used to sterilize materials that cannot withstand steam or heat, argued that the Albala decision was not dispositive of her claim. However, the court in Catherwood interpreted Albala as neither disallowing a cause of action for preconception injuries based on a theory other than negligence nor allowing a cause of action based in strict products liability. Thus, the court assessed the policy considerations surrounding a preconception strict liability action. The court was concerned with the need for “limitation of liability in exposure and ingestion cases” and the “proliferation of frivolous claims and claims where proof presents a hardship to defendants”. In addition, the court found that no duty to the unconceived had been recognized in New York. Thus, the court dismissed the case.

PRODUCTS LIABILITY: DIETHYLSTILBETROL (DES)

DES plaintiffs must face a variety of legal hurdles including the identification of the drug manufacturer, the running of the statute of limitations, and the nonrecognition of prenatal and/or preconception torts. However, the applicability of preconception tort liability within the context of DES litigation has not been the focal point of these cases because the majority of plaintiffs were already conceived at the time of DES ingestion by their mothers. Thus, DES suits involving the extension of duty under tort law to someone not yet conceived, including claims brought by third generations, are just beginning to emerge.

Although New York is facing the issue of preconception torts within the context of DES for the first time, the state’s interest in providing relief for DES victims is apparent both legislatively and judicially. In 1978, the New York Legislature enacted legislation to assist DES victims because it considered “the effective identification, screening, diagnosis, care and treatment of persons who have taken DES, or who have been exposed to DES prenatally to be of paramount public importance. However, one of the principal problems facing DES plaintiffs was the inability to comply with the New York statute of limitations which was based on a date-of-injury rule. Therefore, in 1986, the New York Legislature enacted the Toxic Tort Revival Statute which abolished the “date-of-injury” rule and adopted a “discovery” statute of limitations. The statute applies to persons exposed to the latent effects of five substances, including diethylstilbestrol. By abandoning the date-of-injury rule and adopting a discovery statute of limitations, the New York Legislature intended to relieve the harsh consequences inflicted upon parties whose causes of action were time-barred before the injuries were even detected. In addition, a one-year window from the effective date of the act was opened. For one year, persons exposed to one of five substances were able to resurrect a cause of action which was previously dismissed because the statute of limitations had run or, if they had never filed but were now time-barred under the “date-ofinjury” rule, a claim could still be filed during this one-year period.

Another fundamental barrier which DES plaintiffs face is an inability to identify the exact manufacturer of the DES which caused the injuries, as is generally required in a products liability action. However, a variety of approaches have been adopted by courts, including those of New York, which aid plaintiffs in overcoming this causation problem. In Bichler v. Eli Lilly & Co., the New York Court of Appeals allowed a concerted action theory of liability which was later replaced by the market share theory. The concerted action theory makes those who take part in the wrongdoer’s act, in pursuance of a common design or plan to commit a tortious act, equally liable. The court assessed the challenge facing plaintiffs who are unable to identify the drug company that manufactured the DES which caused the injuries. The court in Bichler stated that because of the “unusual DES fact pattern,” its decision would entail more than just a straight application of products liability law. The court recognized that some DES cases could be “prosecuted within well-established principles of products liability as those principles have been adapted to the manufacturing and marketing of prescription drugs. However, the court in Bichler was concerned about the far more common DES case in which the identity of the drug manufacturer is unknown and undeterminable. The court insisted that “products liability law cannot be expected to stand still where innocent victims face ‘inordinately difficult problems of proof.

In Hymowitz v. Eli Lilly & Co., the New York Court of Appeals decided two issues pertaining to DES litigation – one involving the market share theory of liability and the other involving New York’s revival statute. The court in Hymowitz assessed the merits of the concerted action theory and the alternative liability approach, which imposes joint and several liability upon all defendants who acted tortiously without requiring a showing of express or tacit understanding. However, the court considered the market share concept to be the appropriate method for DES cases. The court stated that the market share approach apportions liability according to the overall culpability of each defendant, using a national market as the measuring device, and is not based on causation. Thus, recovery against a DES manufacturer became possible without identification of the specific drug producer that caused the injury. In reaching its decision, the court in Hymowitz noted New York’s policy toward DES litigation:

Indeed, it would be inconsistent with the reasonable expectations of a modern society to say to these plaintiffs that because of the insidious nature of an injury that long remains dormant, and because so many manufacturers, each behind a curtain, contributed to the devastation, the cost of injury should be borne by the innocent and not the wrongdoers. This is particularly so where the Legislature consciously created these expectations by reviving hundreds of DES cases. Consequently, the ever-evolving dictates of justice and fairness, which are the heart of our common-law system, require formation of a remedy for injuries caused by DES.

Once again, the state’s interest in providing relief to DES victims was readily apparent.

ANALYSIS

A New York Supreme Court, Appellate Division, Third Department, in Enright v. Eli Lilly & CO. granted the granddaughter of a woman who had ingested DES the right to proceed on a strict products liability theory against certain DES drug manufacturers. Relying on the New York policy favoring a remedy for DES victims, the appellate court held that the creation of arbitrary generational limits in the area of DES litigation would insulate drug manufacturers and “dilute the economic incentive to turn out safe products. Although the result in Enright is different from prior New York decisions denying preconception torts, the decision is nevertheless consistent with the analysis of the New York courts which have emphasized public policy considerations.

In Albala v. City of New York, the plaintiff was conceived and born after his mother underwent a negligently performed abortion which allegedly resulted in the plaintiff’s brain damage. Although the majority and dissent in Albala both noted that the injuries to the plaintiff were causally related, foreseeable and resulted in verifiable damages, the court still denied liability. Fearing undistinguishable parameters of liablity as well as encouraging defensive medicine, it denied the child a cause of action for the alleged preconception malpractice of the defendants. Thus, in Albala, the court left unresolved New York policy regarding preconception tort causes of action within the context of products liability. This issue was addressed five years later in Catherwood v. American Sterilizer Co.

In Catherwood, a New York trial court stated that had this been a negligence action, the decision in Albala would have been controlling and a determination in favor of defendants imminent. However, Catherwood was an exposure case based on strict products liability and, therefore, presented an issue of first impression. Although the court in Catherwood reached the same conclusion as in Albala and denied the plaintiff’s preconception tort cause of action, this decision was reached after careful assessment of the policy concerns unique to strict products liability litigation rather than a simple extension of Albala denying all preconception torts. The court in Catherwood agreed that there may not be many policy reasons for limiting liability in cases involving strict liability without fault. However, the court determined that ingestion or exposure cases should be an exception. Specifically, the court held that it seemed “incongruous to allow an action for preconception tort in an exposure case while applying a statute of limitations which accrues on date of last exposure. The end result would be accrual long before conception, and the court questioned how a plaintiff not in existence at the time could sustain a cause of action. Consequently, the plaintiff’s cause of action was denied.

Although Enright involved an ingestion case which, arguably, fits within the parameters of the Catherwood decision, there have been several responses to this comparison. For example, the dissent in Catherwood distinguished Albala not based on policy concerns but because Albala only applied to medical malpractice actions. Therefore, the dissent in Catherwood contended that preconception tort actions should be available in a products liability setting. Also, the court in Enright stated that the Catherwood statute of limitations policy concern was alleviated by New York’s subsequent abandonment of the date-of-injury rule and its replacement with a date-ofdiscovery rule.

In strict products liability cases, once a causal relationship has been established, the liability of the manufacturer is extended to all persons affected, regardless of foreseeability, privity or due care.  Thus, the court in Enright stated that it was not faced with the same policy concerns as in Catherwood and was able to recognize a strict products liability cause of action due to the conspicuous absence of the necessity of establishing manageable bounds as espoused in Albala and affirmed in Catherwood.

However, the court in Enright was emphatic about the fact that the overriding policy concern in this case was DES. In this regard, the court stated that New York’s interest in protecting the rights of DES victims is supported both by case law and legislation. In Bichler v. Lilly & Co., the New York Court of Appeals allowed a DES daughter to pursue any joint tortfeasor. The court recognized the difficulties which threaten recovery for the majority of victims, such as the inability to pinpoint the manufacturer directly responsible, and, therefore, extended the application of concerted action liability to include DES victims. The court stated that DES litigation was an area of law in which products liability could not be expected to stand still.263 In addition, the court in Hymowitz v. Lilly & Co. modified the personal injury rules because “the present circumstances call for recognition of a realistic avenue of relief for plaintiffs injured by DES. Although a preconception tort was not involved in either the Bichler or Hymowitz case, the court in Enright stated that both cases declared New York’s policy favoring relief for DES victims.

In addition to New York case law supporting the state’s position regarding DES victims, the New York Legislature has also displayed considerable flexibility in allowing DES victims a remedy. For example, in 1986, a date-of-discovery rule was adopted in place of the old date-of-injury rule for essentially all toxic torts. The new statute of limitations allows an injured party to assert a cause of action within three years from the date of discovery of the injury regardless of the date of exposure. Additionally, in order to eliminate the unfairness of the date-of-injury rule, a one-year window was opened which allowed DES victims the opportunity to bring a cause of action where previously barred by the old date-of-injury rule.

The dissent in Enright argued that this decision involved considerable judicial overreaching because New York had never recognized preconception tort liability. While preconception torts were denied in both Albala and Catherwood, these decisions were not reached simply because they involved preconception torts. Rather, the decisions were made after each court carefully analyzed the policy concerns pertaining to the specific case. Therefore, Enright cannot be assessed strictly in terms of New York’s prior decisions denying preconception tort liability, but must also incorporate New York’s policies regarding assistance for DES victims.

A very narrow reading of the Enright decision would allow future preconception tort causes of action where the injuries were caused by DES and thus grounded in strict products liability. The Enright court “neither fashioned a new remedy out of sympathy nor overturned established legal principles.” Instead, it adhered to New York’s policy favoring a remedy for DES victims and concluded that Karen Enright’s allegations adequately met the requirements of a strict products liability cause of action. Although recognition of a preconception tort was considered to be the main issue on this appeal, the court shifted its focus to the fact that DES was involved, and it is from this standpoint that the case was resolved. However, according to the dissent, the only way to resolve this case was by application of New York precedent regarding preconception torts. The dissent argued that Albala is the law in New York with respect to medical malpractice and common-law negligence cases. The dissent noted that a preconception tort was denied in Albala because to allow it would “require the extension of traditional tort concepts beyond manageable bounds.” In addition, the dissent stated that no reliance should be placed on the footnote in Albala which suggests that preconception tort litigation in strict products liability may be allowed.

The dissent also distinguished Bichler and Hymowitz because neither of these cases involved preconception plaintiffs but rather DES victims injured in utero. The dissent was not influenced by the fact that the plaintiff’s injuries were caused by DES but rather considered the Enright decision to be in direct conflict with New York’s policy regarding preconception torts.

However, the Enright decision cannot be so broadly construed as to suggest that New York has opened the door for all preconception tort cases. In allowing the plaintiff a cause of action in strict products liability, the court reasoned that:

although plaintiff is not a “DES daughter” – one who was exposed to DES while in utero – she may be no less a victim of the devastation wrought by DES than her mother, who is a DES daughter, and we see no sound basis for denying plaintiff her day in court along with her mother.

Thus, the court’s decision was based entirely on the DES factor and should not be considered a new policy favoring all preconception tort plaintiffs.

In terms of legislation, the dissent cited Besser v. Squibb & Sons  as support for the contention that New York’s toxic tort revival statute applies only to DES users and persons in utero. However, Besser did not involve a preconception tort but involved a statutory interpretation of New York’s revival statute. As stated by the dissent, the literal language of the statute applies to every action for personal injury or injury to property caused by “the latent effects of exposure to DES upon or within the body.”‘ 91 Yet, this was not interpreted by the court in Besser to mean that no duty to unconceived generations exists. The court was concerned instead with ascertaining the legislature’s intent rather than adhering “slavishly to the statute’s literal language.” It held that the “primary impetus behind enactment of the revival statute was to relieve the harsh results of New York’s exposure-based statute of limitations, which, due to the latent effects of exposure to some toxic substances, might have expired before the injured party even knew of his injuries.” Thus, the dissent’s reliance on this case within the context of preconception torts was misplaced.

Furthermore, the future impact of the Enright decision is unlikely to reach “beyond manageable bounds” as suggested by the dissent. It is true that the traditional fault concept is premised upon foreseeability and duty, and causation cannot be the single determinative factor. However, in determining to whom a duty is owed, the court must consider not only foreseeability of harm but social policy as well. According to Dean Prosser, “in the end the court will decide whether there is a duty on the basis of the mores of the community, ‘always keeping in mind the fact that we endeavor to make a rule in each case that will be practical and in keeping with the general understanding of mankind.’- The court in Enright made it clear that this case was distinguishable on its facts from other New York cases regarding preconception torts because of DES; therefore, the result was clearly a social policy decision. As a result, its usefulness in preconception tort cases involving something other than DES should be minimal.

If the Enright decision is broadly construed in subsequent cases as precedent favoring all preconception torts, the legislature has the authority to limit both the Enright type cause of action and other preconception claims. This can be accomplished by expressly restricting the potential plaintiffs and defendants and by striking a balance between the rights of preconception plaintiffs and the public’s interest in minimizing stale claims. First, the statute could exclude the natural parents as potential defendants, thus preventing disruption of the public’s interest in family harmony. Second, a statute of limitations could be set barring claims against nonmedical persons or places if not commenced within a certain number of years from the date of the negligent conduct. Members of the medical profession could be excluded since they are better prepared to bear the burdens of large recoveries. Finally, in terms of Enright type cases, the statute could limit recovery to plaintiffs from certain generations; for example, “the first generation to follow the preconception negligent act. Such restrictions are for the legislatures and courts to consider; however, limitations are possible.

Considering the vast changes which have occurred in the area of prenatal injury law, the Enright decision is a natural development. In Kelly v. Gregory, New York became the first state to expand the right of action for injuries incurred prior to viability, which reflects its willingness to extend the duty of care to protect persons whose existence is not readily apparent. In addition, the New York Supreme Court in Park v. Chessin became the first state court to allow a child a cause of action for conscious pain and suffering based upon a preconception tort. Although Park was later modified, given the present trends in the law, the timing of a tortfeasor’s negligence may soon become irrelevant.

CONCLUSION

In its decision to allow Karen Enright a preconception tort cause of action in strict products liability, the New York Supreme Court, Appellate Division, used the same analysis as applied in prior New York cases involving DES, and demonstrated the state’s flexibility in affording a remedy to DES victims. The court in Enright v. Eli Lilly & Co.  balanced the concerns associated with preconception tort causes of action against the devastating effects of DES and considered its decision to have struck a delicate balance. The Enright decision is also compatible with the underlying purpose of New York legislation, such as the Toxic Tort Revival Statute, which was enacted to assist DES victims who had been shut out by the “date-ofexposure” rule. Thus, the State of New York has made its position quite clear, both legislatively and judicially, in favoring a remedy for DES victims. The decision in Enright simply extends this logic and demonstrates the willingness of the state of New York to enforce this policy.

EPILOGUE

Subsequent to the completion of this Note, the New York Court of Appeals reversed the Supreme Court, Appellate Division and dismissed Karen Enright’s preconception tort cause of action. The court stated that a DES cause of action does not present any unique features which would justify the extension of liability to third generation plaintiffs. The court admitted that both the New York Legis lature and New York courts have removed legal barriers to tort recovery in the past simply because of the “peculiar injustice” which DES litigation worked. According to the court, the enactment of these “special rules” was justified because of the “insurmountable barriers” facing DES victims. However, the court characterized Karen Enright’s preconception tort claim as something “significantly different” than the removal of a legal barrier unique to DES victims. According to the court, the policy concerns espoused in Albala v. City of New York,  an earlier preconception tort case in which the court refused to recognize a cause of action on behalf of the child, were equally applicable to the present case regardless of the fact that DES was involved.

The court refuted the plaintiff’s second argument, that because Enright was a strict products liability cause of action, it involved different policy considerations than those addressed in Albala which was a negligence action. The court refused to extend a strict products liability cause of action to Karen Enright because of several countervailing policy concerns. First, the court noted the “staggering implications” which could result if DES exposure has a “rippling effect” which extends for generations. The court stated that in order to confine liability within manageable limits, a cause of action should only be allowed to those who were exposed to DES in utero or who ingested DES. Second, the majority stated that because manufacturers were still amenable to suit by those persons injured by exposure to DES, limiting their liability would not impair the deterrent purposes of tort liability. In addition, the need for the tort system to provide a deterrent effect is somewhat diminished because the Food and Drug Administration exercises primary responsibility for prescription drug safety. Finally, the court stated that because of the dangers of overdeterrence and “the possibility that research will be discouraged or beneficial drugs withheld from the market”, public policy endorses the availability of prescription drugs despite their risks.

In a lengthy dissent, Justice Hancock characterized the court’s decision to be “an abrupt change in the course of New York strict products liability jurisprudence, a cut-back on recent precedent and a rejection of policy established by the Legislature and accepted by our court.”

First, Justice Hancock argued that the 1986 Toxic Tort Revival Statute had been enacted for the express purpose of remedying a fundamental injustice in New York law which had denied relief to persons suffering injuries from the latent effects of DES and other substances. Second, Justice Hancock stated that the New York Court of Appeals in Hymowitz v. Eli Lilly and Co. had created a means for a DES victim to recover precisely because of the unique characteristics of DES and the underlying policy of the Toxic Tort Statute. Justice Hancock contended that the sole remaining question was “whether the remedy for DES victims made possible by the Legislature in the Toxic Tort Revival Statute and given effect by our court in Hymowitz should be withheld from a granddaughter who suffers injuries from this wrong. According to Justice Hancock, if social and economic considerations exist which warrant an arbitrary cut-off point in these kinds of cases, such a statute of repose could be engrafted on the Toxic Torts legislation. However, Justice Hancock noted that New York Legislature has not chosen to do this.

Additionally, Justice Hancock discussed what he considered to be two fundamental principles of justice which mandated that Karen Enright be permitted to prove her case, even if no clearly discernible legal or policy guidelines existed. First, he stated that because Karen Enright is a victim whose injuries could reach enormous proportions, she should be properly compensated pursuant to the judicial system. Second, relying on the basic principle that “like cases should be treated alike”, Justice Hancock stated that Karen Enright was damaged no less than other DES victims and if they are permitted to recover for their injuries, then Karen Enright should also be permitted to recover. In summary, Justice Hancock stated that:

Our established strict products liability jurisprudence mandated by considerations of “justice and common sense”, the compelling social policies prompting the adoption of the Toxic Torts bill, decisions in other jurisdictions allowing recovery for preconception torts and the legal commentary all call for a decision permitting Karen Enright to prove her claim. Yet the majority denies her this right. This decision … amounts to an exercise in discretion and line drawing reflecting social and economic policy choices which should be made not by judges but by legislators.

CONCLUSION

The New York Court of Appeals could have affirmed the decision of the Supreme Court, Appellate Division and allowed Karen Enright a strict products liability claim without eviscerating New York’s traditional limitations on preconception liability. Both the majority and the dissent agree that New York has shown legislative and judicial solicitude for DES victims. The special policies pertaining to DES victims which the Legislature has adopted and which New York courts have implemented should apply equally to Karen Enright’s claim because she is no less a victim of DES than was her mother or grandmother. Instead of adhering to these special policies, the New York Court of Appeals has contrived its own policy considerations and arbitrarily determined where the risk and, therefore, the liability stops.

The Enrights’ lawyer, Leonard Finz, may request that the New York Legislature respond to this issue. He is also considering asking the United States Supreme Court to review the case. According to Mr. Finz:

“this decision has left thousands of “victims of a calamity of overwhelming proportions without a legal remedy.”

Margaret M, Hershise, 1991.

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More DES DiEthylStilbestrol Resources

The Indeterminate Defendant in Products Liability Litigation

I. INTRODUCTION

The problems created by mass marketing, unequal bargaining power, and hidden product hazards have necessitated major changes in products liability law during the past thirty years. Correspondingly, considerations of cost reduction, injury avoidance, and fair risk distribution are generally advanced as the policies behind the widespread acceptance gained by strict liability in the 1960’s.

The Indeterminate Defendant in Products Liability Litigation and a Suggested Approach for Ohio, Cleveland State Law Review, Law Journals, 1991.

A decade later, these considerations were applied to the problem of proof of causation faced by plaintiffs who could not identify the specific defendant who caused their injuries. A limited version of this problem had been considered earlier in the seminal case of Summers v. Tice, giving rise to the theory of alternative liability. However, the large volume of litigation surrounding the drug diethylstilbestrol (DES) gave the issue new prominence and led to a variety of theories relaxing the plaintiffs burden of proof of causation in fact. Although considerations of cost reduction and fair distribution of risk provide a common theoretical ground, no one rule has found consistent acceptance.

This Note will examine the causation problem raised by the plaintiff who cannot identify one among two or more possible manufacturer-defendants and will analyze the various approaches advanced to deal with the issue. It will then focus on the treatment of these issues in the Ohio courts. Finally, the Note will discuss the appropriateness of the Ohio approach as it relates to the goals of fair risk distribution and cost reduction.

II. CAUSATION AND THE UNIDENTIFIED DEFENDANT

Causation is a critical element in products liability actions. The plaintiff must be able to establish a sufficient nexus between his injury and the defendant’s product.  When a products action is brought under either strict liability or negligence theories, causation is broken down as in other tort applications. The plaintiff traditionally bears the full burden of proof in establishing both causation in fact and proximate cause.

Causation in fact, as used in this Note, refers to the question of whether the defendant actually manufactured or supplied the product that injured the plaintiff. Alternately, cause-in-fact answers the question: But for the defendant’s supply or manufacture of the product, would the plaintiff have been injured? Difficulties arise when the plaintiff can satisfactorily establish proximate cause, including proof of injury by the product in question, but finds it difficult to meet the burden of proof necessary to show causation in fact.

This difficulty with defendant identification may occur when the product in question is destroyed, or when functionally identical products are manufactured by more than one source. As mass marketing of generic or substantially similar products continues, defendant identification issues will continue to arise. The question gains unique proportions when the plaintiff cannot offer circumstantial evidence of distinctive product characteristics.

In many states other than Ohio the litigation surrounding DES and asbestos related injuries brought this causation issue into focus. In either the instance of the destroyed product or the multiple manufacturer situation, adherence to the traditional burden of proof of causation results in the plaintiff being denied all compensation. Judicial dissatisfaction with this outcome has led to the development of various means of altering the plaintiff’s burden of proof with respect to the identity of the defendants.

III. APPROACHES TO ALTERING THE BURDEN OF PROOF

A. Alternative Liability and Concerted Action

Two tort theories, alternative liability and concerted action, have been considered as a basis for recovery by the plaintiff who cannot specify which of a number of tortious actors actually caused his injury. In many jurisdictions, alternative liability is the accepted doctrine when this situation arises in a simple negligence action. Because elements of both theories have been used in many later formulations of causation rules in products liability actions, they merit a discussion here.

The theory of alternative liability was specifically developed as a solution to the causation in fact problem raised by the indeterminate defendant. The California Supreme Court is credited with first stating this theory in Summers v. Tice. In that case, the plaintiff was injured in a hunting accident when he was struck in the eye by birdshot. Both of the plaintiff’s companions had fired at the same time, using the same size birdshot, and both had negligently fired in the plaintiff’s direction. Although the plaintiff could not prove which of the two had fired the shot that hit his eye, the court held both defendants jointly and severally liable. Because proximate cause was established and the conduct of both defendants was tortious, each had the burden of absolving himself.

The alternative liability theory was later adopted as Section 433(B)(3) of the Restatement (Second) of Torts:

Where the conduct of two or more actors is tortious, and it is proved that the harm has been caused to the plaintiff by only one of them, but there is uncertainty as to which one has caused it, the burden is upon each such actor to prove that he has not caused the harm.

The Restatement explained the rationale for shifting the burden of proof to the defendants:

The reason for the exception is the injustice of permitting proved wrongdoers, who among them have inflicted an injury upon the entirely innocent plaintiff, to escape liability merely because the nature of their conduct and the resulting harm has made it difficult or impossible to prove which of them has caused the harm.

The fairness of this rationale, as it relates to the original facts on which alternative liability was modeled, has been attributed to several factors. First, all of the defendants must be shown to have acted tortiously, under either strict liability or negligence principles. This requirement removes the possibility of a defendant whose behavior could not have proximately caused the harm being held liable. Second, it is often stated that all possible tortfeasors must be joined as defendants. While the Restatement does not refer to this conclusively, the purpose is to ensure that the actual tortfeasor does not escape liability while others bear the burden of paying damages. A third factor, often cited as a requirement for the application of alternative liability, is that the defendants must be in a better position than the plaintiff to identify the actual tortfeasor. The validity of this requirement is questionable, and it is not entirely consistent with the rationale advanced for shifting the burden of proof to the defendants.

Although the stated rationale for the imposition of alternative liability stresses fairness to the innocent plaintiff, the factors advanced as requirements for the theory emphasize that it is a causation rule. Thus, alternative liability provides for the situation in which causation in fact truly cannot be determined. The doctrine also has a secondary function, facilitating the identification of the actual tortfeasor.

Alternative liability was conceived as a solution to a limited fact pattern, and was put forth as a theory which might need later revision . When it has been considered as a theory for products liability cases involving large industries, factors such as joinder of all possible tortfeasors have proved impractical or impossible. Although a comment to Section 433(B)(3) of the Restatement suggests that alternative liability may be applied to multi-defendant litigation, courts have been hesitant to use the theory in these situations. A possible reason for this is that as the number of potential defendants grows, the probability that any one defendant is the actual causation in fact of the plaintiff’s injury tends to decrease.

Pure alternative liability is best applied to those situations similar to the facts of Summers v. Tice. Products liability actions involving relatively few tortious actors and comparatively uncommon events fit into this category. Complications occur where the products of one industry, with multiple participants, repeatedly cause harm. In these situations, both the size of the potential defendant class and considerations of loss spreading and risk apportionment warrant an adapted theory. As a result, variations of alternative liability that depart from the original joint and several damage apportionment, or which otherwise explain the causation element, have been developed.

Concerted action, or concert-of-action, was not developed as a rule of causation or a solution to the problem of the unidentified defendant. The theory originated to provide a form of vicarious liability. Thus, it imposes joint and several liability upon actors whose harmful conduct is shown by the plaintiff to be linked by an element of agreement or conscious cooperation. Although concerted action can be applied to extend liability to other members of a group when the identity of the party actually causing the harm is known, this identification is not necessary to the final formulation of liability. The imposition of joint and several liability has been explained on the theory that each defendant becomes a causation in fact of the plaintiffs injury because of his contribution to the action of the group as a whole.

Because the application of concerted action obviates the requirement of proof of causation by each individual in the group, the plaintiffs proof of the element of agreement is especially critical. Section 876 of the Restatement (Second) of Torts sets out three situations in which joint and several liability will be imposed on the theory of concerted action:

For harm resulting to a third person from the tortious conduct of another, one is subject to liability if he (a) does a tortious act in concert with the other or pursuant to a common design with him, or (b) knows that the other’s conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself, or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person.

Many courts have rejected the concert-of-action theory in products cases involving unidentified defendants because proof of this agreement element is thought to be too speculative. The fact that proof of an improper agreement can be implied through circumstantial evidence has created difficulty. The circumstantial evidence to support implied agreement is usually found in the parallel behavior of the parties. It has been argued that such behavior does not sufficiently establish the required element of agreement or action in concert. Imitative practices among suppliers of a given product are a common feature of a competitive industry. Thus, it is reasoned that a concert-of-action theory would often result in joint and several liability among defendants who had no express or even tacit agreement. Such a result would be unfair as each actor wrongfully found to be in concert would be held to be a causation in fact of the plaintiff’s injury. Even a defendant who could prove that it had not supplied the actual product that caused the plaintiffs harm could not escape liability. This has led courts to fear that one supplier could be held liable for the acts of an entire industry.

The rejection of parallel business practices as an indicator of concerted action can be explained in terms of unfair distribution of financial burden. This would be evident, for example, if a small manufacturer who had received little benefit from its supply of the product was the only solvent defendant. The cost reduction policies prevalent in products liability law may also be relevant to the rejection of concerted action theories. Inadequate evidence of an agreement or cooperation between defendants may indicate that the parties have little control or influence over others in the industry, and thus will not be able to effect widespread changes. Also, because liability will not attach without an agreement, manufacturers may determine that it is more advantageous to make their own safety related errors than to join with others to address safety issues. Furthermore, as with alternative liability, the imposition of joint and several liability may ultimately have a detrimental effect on plaintiffs’ recoveries, because even solvent suppliers will eventually be financially overburdened.

Finally, concerted action has been deemed inappropriate in defendant identification cases due to its origin. The theory was developed to extend liability to a group as a means of deterrence, and was not intended to be used in proving causation. An application different than that originally intended should not, in itself, be a basis for the rejection of a theory. The goal of deterrence of hazardous activities, to a limited extent, is consistent with many of the policies behind products liability innovations. However, when the agreement element is tenuous, the application of a concerted action theory will result in a fictional determination of causation in fact. Imposition of liability without regard for causation would violate tort principles, chill productivity among suppliers, and would permit a direct form of virtually absolute, insurer liability upon an industry and its individual members.

Both alternative liability and concerted action are traditional tort theories which have been considered in light of the issue of causation in fact in multi-defendant litigation. However, these theories were developed in response to factual settings vastly different from the problem raised by the indeterminate defendant. Both theories have shortcomings when applied to the products liability area and, perhaps for that reason, neither theory in its pure form has had significant acceptance in the field. However, elements of both concerted action and alternative liability appear in many of the approaches taken to the problem of the indeterminate defendant in products liability actions.

B. Theories Developed for Products Liability Cases

Both courts and commentators have recognized that alternative liability and concert-of-action theories are inadequate when applied to multi-party product liability actions. The inadequacies of these theories have left the courts with two options. The first possibility is to reject both theories, leaving many innocent consumers without compensation because they cannot prove causation. A second option is to readdress the issue of causation in fact by limiting or eliminating the plaintiff’s burden of proof. Courts have taken various paths, and have both adapted old theories and formulated new approaches. The courts which have opted for recovery turned first to the concept of enterprise liability. The general concept of “enterprise liability” is the idea that an enterprise should bear the cost of the losses it causes. In other words, the parties who market a defective product can best control the associated risks, and should be held liable. In Hall v. E.L DuPont De Nemours & Co., the applicability of this concept to a products liability action involving indeterminate defendants was considered. In one of the cases consolidated in Hall, the plaintiffs were injured in twelve unrelated accidents involving dynamite blasting caps. Because all identifying features on the caps had been destroyed, the plaintiffs sued six manufacturers and their trade association. These manufacturers represented most of the United States explosives industry. The gravamen of the complaint was a theory of concerted action, and the court utilized concerted action terminology. Nevertheless, the actual basis for the imposition of liability was distinct from its purported source. As courts often do, old language was used to create new law.

As one theory available to the plaintiffs, the court stated that if the manufacturers had worked through the trade association to determine precautionary measures, such as warnings on the blasting caps, then the enterprise as a whole could be said to control the risk, and the explosives industry could be held jointly liable.  The court reasoned that precautions should be taken and liability imposed… at an industrywide level.  The court went on to explain the necessity for joint liability:

The point is not only that the damage is caused by multiple actors, but that the sole feasible way of anticipating costs or damages and devising practical remedies is to consider the activities of a group. We do not… suggest that private actions are the best way to meet these problems but only that in the absence of preemptive legislation, tort principals will support a remedy.

Although Hall made reference to both concerted action and enterprise liability, the court went on to set out a modified version of alternative liability which would operate as a corollary theory of causation. Thus, although alternative liability had previously been applied where all possible tortfeasors had been joined as defendants, here the plaintiffs needed only to prove by a preponderance of the evidence that the products had not come from a different source. After this, each defendant could escape liability by proving that it had not manufactured the blasting caps involved in the accidents.  This possibility of exculpation is contrary to the theory of concerted action, where the defendants’ participation in group activity, rather than the supply of a specific product, is treated as the causation in fact of the plaintiffs injury.

While Hall has been the subject of a variety of interpretations, and has been the basis for other proposed theories, two aspects of the case are particularly notable.  First, although a showing of concerted group activity by an industry does not provide a basis for unconditional liability under Hall, it does allow for the preliminary identification of an entire industry as a suitable defendant group. Because it need only be “more probable than not” that the actual tortfeasor is before the court, the focus is shifted away from determining causation in fact, and toward the goals of risk allocation and cost reduction.

A second notable aspect of Hall is the unexplained combination of theories. This points up a fundamental conflict created by the indeterminate defendant in a products liability case. While the Hall court cites strict liability commentary in its argument for risk allocation, it also indicates that a legislative solution is more appropriate. The addition of an alternative liability qualifier may indicate the court’s uneasiness with its role. While strict liability removed the requirements of intent or negligence to meet society’s needs, deemphasizing causation may leave the courts little on which to efficiently and consistently base decisions.

A related issue concerns the extent to which courts can ignore the conduct of a party when imposing liability. At a certain point the actual, rather than theoretical, status of insurer becomes operative. If fault plays no role in imposing strict liability and conduct plays no role in establishing causation in fact, there is little protection for an innocent manufacturer whose product happens to fall within a generic class. The Hall court appears to have recognized at least some of this danger. The same may not be true of courts taking even greater steps to protect injured consumers.

Many of the more recent approaches to altering the burden of proof for the plaintiff who cannot identify one defendant have been developed in cases involving the drug diethylstilbestrol (DES). DES, a drug which had been commonly prescribed to pregnant women, was subsequently shown to have a significant correlation to the development of cancer in the adult female offspring of those women. Because of the time lapse between the mothers’ ingestion of the drug and the onset of the plaintiffs’ injuries, and because a functionally identical product was sold by hundreds of manufacturers, plaintiffs have had difficulty identifying one defendant.

Although DES litigation is characterized by many unique factors, the large number of manufacturers and the generic nature of the drug have had the greatest effect on the methods used to prove causation in fact. For example, several courts, faced with litigation related to DES, have considered and rejected the application of enterprise liability. Because DES was manufactured by hundreds of companies, rather than the six involved in Hall, the presumption of joint control of risk is considered to be weak.

In Sindell v. Abbott Laboratories the California Supreme Court declined to apply enterprise liability, and instead outlined a new theory of market share liability. First, it was presumed that the DES manufacturers had acted tortiously toward the plaintiff, and that DES was the proximate cause of the plaintiff’s injury. Next, the DES plaintiff was required to join as defendants an undefined “substantial share” of the manufacturers of the particular pills her mother may have taken. Then, unless a defendant could prove that it did not produce the pills actually taken by the plaintiffs mother, it would be liable for a percentage of the total damages proportional to its share of the market, with the market defined as that relevant to the plaintiff’s mother.

In explaining its reasons for applying market share liability, the Sindell court adopted the rationale of fairness to the innocent plaintiff set out in Summers v. Tice. However, the Sindell court went further, and cited rationale borrowed from arguments for the imposition of strict liability. Here, as in Hall, the manufacturers were said not only to be better able to bear the loss, but to be in the best position to take preventative measures, and were therefore the best target for incentives to increase product safety. The market share apportionment among defendants was thought to be fair because it would approximate each defendant’s share of responsibility for the injuries of the relevant group of plaintiffs.

The market share approach is generally thought to be an improvement over the pure forms of either alternative liability or concerted action in DES cases.  Under market share, the plaintiff need not prove concerted activity or an industry-wide standard allowing unsafe products, and does not have to join all possible tortfeasors, as often required in alternative liability. Also, it has been argued that liability will closely approximate actual causation if each defendant is held liable for its market share of damages in all cases. With no complications, the burden on each defendant would be the same as if it could always be identified and had to pay the entire amount in a number of cases proportional to its market share.

Like enterprise liability, market share recognizes the applicability of the strict liability goals of fair risk allocation and safety incentives, which would lead to an overall reduction in the costs of injuries. However, market share liability is also similar to the theory suggested in Hall in that it is directed toward a goal of determining or approximating actual causation.

The Sindell court’s approach to balancing broad policy goals with the need to link liability to causation might not promote both objectives to the extent intended.

First, allowing a reduction in necessary parties by permitting joinder of less than all of the possible tortfeasors obviously reduces the possibility of the actual actor being found. This is, however, a necessary compromise when complicating factors preclude joinder of all manufacturers.” The apportionment by market share seeks to temper this by allocating damages to each defendant in a proportion which “would approximate its responsibility for the injuries caused by its own products . . .” over time. Allowing each defendant to escape liability by proving that it had not manufactured the pills in question could negate this effect. It is possible, for example, that the manufacturer of a pill with an unusual appearance could escape liability in many of the cases in which it was not the actual tortfeasor, while similarly innocent manufacturers of plain pills could not. This would occur if plaintiffs were able to exclude the unusual pill from the field of similar products more often than they were able to identify it specifically as the medication taken. Thus, some manufacturers could be liable for substantially less than the injuries caused by their own products.

Second, the market share theory may also fail to fully promote the goals of risk allocation and cost reduction. The determination of market share in Sindell proved to be very difficult and time consuming. The transaction costs involved in this procedure could easily outweigh any benefit that would result.

Third, if the necessary percentage of manufacturers to be joined is inconsistent, or if the market share could not be determined accurately, the theory would impose liability in a manner that could not be anticipated and insured against by manufacturers.

Finally, Sindell did not address the question of whether joint and several liability would be applicable. This determination is significant in evaluating whether the theory is effective in promoting the policies of strict liability. Those suppliers held jointly liable could be exposed to costs disproportionate to their market share, and thus disproportionate to their fair allocation of risk. However, the application of several liability would prevent many plaintiffs, who are the least able to bear the costs of their injuries, from obtaining full recovery. The California Supreme Court resolved the issue in Brown v. Superior Court, holding that the liability of DES manufacturers under the market share theory was several only. By choosing this approach, the California court implicitly attacked the policies of fairness to the innocent plaintiff and shifting loss to the party best able to pay. As these were key policies underlying Sindell, Brown has also drawn the acceptance of market share liability in its progenitor court into question.

Several courts, also in the context of DES litigation, have formulated liability theories that are designed to avoid some of the weaker elements of market share liability. In Collins v. Eli Lilly Co., the Supreme Court of Wisconsin recognized the difficulty of determining the appropriate market share and declined to apply the theory on that ground. Instead of basing liability on the proportion of harm caused by a manufacturer’s product, the Collins court considered the contribution that each manufacturer had made to the plaintiff’s risk of injury by marketing its product.

The theory of “risk share liability” defined in Collins was not conceived as a variant of alternative liability, and thus involves a different procedure. To avoid the difficulty of determining a suitable group of defendants, the court required the plaintiff to bring an action in negligence or strict liability against only one defendant. Equitable distribution of liability was said to be attained by allowing the defendant to implead other manufacturers as third party defendants. The plaintiff then had the burden of proving, by a preponderance of evidence, that the defendant had supplied a product with the same physical characteristics as that responsible for her injury. As in alternative liability, the burden then shifted to the defendants to prove, by time or geographical location, that they could not have supplied the specific product in question.

Under the risk share theory, if more than one defendant is found to be liable, the damages are apportioned by a jury under the state’s comparative fault statute. Percentages of liability are assigned according to the risk imposed on the plaintiff by each manufacturer. This risk is determined by considering a number of factors, including the general size of each defendant’s relevant market share.

In Hymowitz v. Eli Lilly & Co.  New York also adopted a theory which apportions liability among defendants according to the risk imposed. Here, the court was concerned not with the individual plaintiffs risk of injury, but with the risk imposed on the public in general. The difficulty encountered by the Sindell court in determining market shares at an individualized level was noted. Allowing a jury to determine liabilities according to personal risk was also rejected as time consuming and inconsistent. Conceding that it could make no connection between liability and causation in fact in an individual case, the Hymowitz court chose to apportion liability according to national market share. Under the “national market share” theory, a defendant cannot escape liability by showing that it did not manufacture the product which caused the plaintiff’s injury. The theory simply abolishes all need for causation in fact.  However, liability is several only, resulting in a less than 100% recovery for the plaintiff if the manufacturers joined as defendants represent less than 100% of the market. The Hymowitz approach is easily applied and highly supportive of consumer protection. Under this theory, any manufacturer who contributed to any individual’s risk of harm becomes severally liable for all resultant injuries. The limitation on liability is provided by the portion of the market controlled by each individual defendant. Although the wisdom of the Hymowitz approach may be questioned, its simplicity of application and direct approach to the policy promoted have merit.

Both Hymowitz and Collins, in making a conceptual shift from actual injury to creation of a risk, explicitly recognize the goals of effective spreading of losses and cost reduction through safety incentives. However, in application and effect the two theories differ. The risk share theory espoused in Collins maintains a substantial connection with causation in-fact through a focus on individual risk. Although this causal link provides a sense of fairness under traditional tort principles, the jury apportionment process may actually be time consuming, expensive and unpredictable. In addition, the liability of a defendant under the risk share theory is apparently joint and several. Joint and several liability allows the plaintiff to obtain full recovery when some defendants are judgment proof, beyond the court’s jurisdiction, or no longer subject to process for any reason. This furthers the policy of allocating costs to the manufacturers, who may be better able to pay. However, this theory also removes the focus from an imposition of liability that is proportional to individual risk. In addition to weakening the link between the risk share theory and causation in fact, this undermines the policy of fair risk allocation, and may have a negative impact on safety incentives.

In contrast to the risk share theory, the national market share theory utilized in Hymowitz makes a complete departure from traditional causation principals in favor of optimizing risk allocation and cost reduction. National market share liability operates as a judicially administered insurance system. A manufacturer who creates greater risks makes larger payments on a regular basis. Whether a particular injury is attributable to that manufacturer’s products is rendered academic.

Difficulties in the application of national market share liability may arise for at least three reasons. The first problem arises because the plaintiff may recover less than 100% of her damages if less than the entire national market is joined.  When a consumer, for reasons of time and expense, can join only a limited number of defendants, there will be an incentive to sue only the largest manufacturers. These manufacturers, although limited in number, would provide near to 100% of the national market. A consistent focus on the largest manufacturers would result in a windfall to the manufacturers who controlled a smaller proportion of the market, because they, in effect, would be imposing risks on the public without liability for the accompanying losses.

The second problem associated with the national market share theory may arise not from the theory itself, but from its application at only a statewide level. Manufacturers who did not contribute to the actual risk to the plaintiff in a given New York case may nonetheless be liable in proportion to their national market share. However, when these manufacturers are found liable in a state which operates under a different theory, they may have to pay damages exceeding their market share. Thus, in the aggregate, these manufacturers would pay more than a sum proportional to the risk they imposed. Simultaneously, those who distributed their products primarily in the New York area would pay less as they would not be subject to liability in other states.

Finally, because the national market share theory is extremely favorable to plaintiffs, there is a substantial possibility that New York will become a haven for suits in which the plaintiff cannot prove causation in fact. Most major manufacturers do business in New York, and the fairly liberal jurisdiction and venue rules would probably allow such suits. This influx of litigation would place an additional burden on the already overloaded New York civil justice system. It is quite possible that the resultant cost increases, lengthy delays and concomitant problems would substantially outweigh the benefits to the plaintiffs involved in products liability actions.

Overall, no one theory of liability has found consistent acceptance for proving causation in fact in products liability actions. The theories of concerted action and alternative liability originated in simple negligence contexts and have not been widely applied in their pure form. Market share theory, although conceptually more appropriate, has proved difficult to apply, and may now be disfavored in even its progenitor court. Some states have used the earlier approaches as springboards to develop tailored theories. Finally, a number of states, including Ohio, have not taken a definite stance or have rejected any expansion of liability.

IV. THE INDETERMINATE DEFENDANT IN OHIO PRODUCTS LIABILITY

A. Ohio’s Approach to Causation In Fact

In many respects, shifts in Ohio products liability law have paralleled those of the rest of the country. Significantly, Ohio applied the principles of strict products liability soon after precedent was set by California.11 In 1977, strict liability was expressly recognized as a valid doctrine through the adoption of section 402(A) of the Restatement (Second) of Torts. The adoption of strict liability brought with it a recognition of the underlying policies of allocating risks fairly and reducing the costs of accidents. These same policies have played an important role in the courts’ approaches to causation in fact problems.

Ohio, by its adherence to more traditional tort principles, has been slower than some states to adopt a solution to the causation problem created by the indeterminate defendant. This adherence may reflect a variety of factors, including the nature of the cases which have arisen in Ohio, observation of the difficulties encountered by other states, and an awareness of functions more appropriate to the legislature.

In 1984, several years after California, New York and other states had developed theories in response to DES litigation, the Ohio Supreme Court stated its position in Minnich v. Ashland Oil Co. Inc. . In that case the plaintiff was severely injured when a solvent he was using to clean a printing press exploded. Because Minnich’s employer purchased chemically identical solvent, ethyl acetate, from two chemical companies, Minnich was unable to determine which company had produced the particular batch involved in the explosion.

The court, in allowing the plaintiff to proceed against both suppliers, adopted the theory of alternative liability as it is expressed in Section 433(B)(3) of the Restatement (Second) of Torts. The Minnich court stressed that before the burden of proof would be shifted to the defendants, the plaintiff would initially have to prove that two or more defendants had acted tortiously, and that the plaintiff’s injury was proximately caused by one of the defendants.

It is notable that Minnich is a very brief opinion, in which the majority cites only the Restatement on the issue of alternative liability. Although market share liability had been created and other theories were being developed, the problems inherent in altering the plaintiff’s burden of proof regarding causation in fact were not addressed.

The court’s lack of discussion may have been a conscious omission, made for tactical reasons. However, alternative liability was completely appropriate to the simple tort situation presented in Minnich. First, the alleged tortious act was committed by only one of two possible parties. 118 In addition to placing no hardship on the plaintiff with respect to joinder, there was no doubt that one of the two suppliers was the actual tortfeasor. Furthermore, there was no indication that the alleged failure to warn was an industry-wide practice, or that it had caused a number of injuries. Because of this, the issues of fair risk allocation within the chemical industry and promotion of safety procedures were absent.

Minnich, which presented a fact situation very similar to that of Summers v. Tice, was a model case for the application of alternative liability. However, alternative liability will not always be the most appropriate solution to the problem faced by the plaintiff who cannot identify one defendant from a group of tortious actors. In particular, situations involving many defendants have been deemed inappropriate for the application of alternative liability in many jurisdictions.

Since the adoption of alternative liability in Minnich, the Ohio Supreme Court has reviewed only one products liability case involving an indeterminate defendant. In that case, the court recognized the limitations of alternative liability in a situation where not only many defendants, but the special problems presented by asbestos were involved. In Goldman v. Johns-Manville Sales Corp., the plaintiff sued eleven asbestos sup- pliers, alleging that her husband had developed cancer due to his exposure to asbestos products at the bakery where he had worked. Because the bakery had burned down, the plaintiff could identify neither the specific products nor the suppliers.

In affirming a summary judgment in favor of the defendants, the court first determined that the plaintiff could not prove proximate causation with respect to most of the products, because she had presented insufficient evidence as to their existence. The court did find that one product, asbestos tape, had been used at the bakery, but declined to apply alternative liability to shift the burden of proving causation in fact to the remaining defendants.

One of the grounds for the Goldman court’s rejection of alternative liability was that all of the companies that had produced asbestos tape were not before the court. The court found support for this requirement in a comment to Section 433(B)(3) of the Restatement (Second) of Torts, because the cases thus far decided in which alternative liability has been applied have all been cases in which all of the actors involved have been joined as defendants. Similarly, a second basis for rejecting alternative liability was also found in this comment. Here, the court noted that the theory was traditionally applied in situations where all of the defendants created similar risks of harm to the plaintiff. Because asbestos products that appear to be similar may contain different types and varying quantities of the substance, asbestos suppliers do not meet this criterion. Interestingly, like most other courts that have considered this problem, the Goldman court did not apply the remainder of the Restatement comment upon which it had relied. The comment to Section 433(B)(3) continues:

It is possible that cases may arise in which some modification of the rule stated may be necessary because of complications arising from the fact that one of the actors involved is not or cannot be joined as a defendant, or because of the effect of lapse of time, or because of substantial differences in the character of the conduct of the actors or the risks which they have created.

The Goldman court noted that alternative liability, in its original form, imposes joint and several liability, which would be inequitable if either all of the possible defendants were not present, or if the defendants had posed varying degrees of risk.  A modification of the joinder or fungibility requirements of alternative liability theory without an accompanying adjustment of liability allocation would impose a burden unrelated to causation in fact. This substantial departure from traditional tort principles would lead to the problem of judicial imposition of absolute, insurer liability on the members of an industry.

Market share liability, which does modify the allocation of liability, was rejected by the Goldman court, primarily on the grounds that DES, for which the theory was developed, is fungible, while asbestos is not. Recognizing that the application of the market share theory to an asbestos case would result in the imposition of liability without regard for the risk imposed by each defendant, the court rejected the theory as a court constructed insurance plan. On a policy basis, the court explained that a device that places liability on manufacturers who were not proved to have caused the injury involves social engineering more appropriately within the legislative domain.

The Ohio Supreme Court, in Goldman, recognized the limitations of the market share theory as a method of liability apportionment in asbestos litigation. Specifically, market share liability will not fairly allocate liability among manufacturers unless their different shares of the relevant market represent the only variable in the determination of the amount of risk each has imposed upon the public. Asbestos litigation, with its unique complications, presents an exceptional number of such variables, including a product that is not truly generic. However, the court specifically recognized the need for a solution to the problem posed by the indeterminate defendant, and noted the possibility of adopting a theory in a future case.

Other than the two cases considered by the Ohio Supreme Court, there is very little Ohio law addressing the topic of the indeterminate defendant. Since Ohio’s adoption of alternative liability, the topic has been considered in only four products actions. Three other cases have discussed alternative liability in relation to simple tort claims. In general, the courts have worked within the parameters set in Minnich. Indeed, none of the cases have presented fact patterns which required a more liberal or imaginative approach.

Similarly, the Ohio legislature has been silent on the issue of proof of causation in fact by a plaintiff who cannot identify one of many possible defendants. The Ohio Tort Reform Act, which took effect in 1988, codified extensive areas of products liability law. Included in the Act are the standards for a manufacturer’s liability for compensatory damages, with specifications as to proximate causation and proof of defect in a destroyed product. The absence of a causation in fact provision, in light of the decision in Goldman and the litigation occurring in other jurisdictions, may indicate the legislature’s intent to leave the area open for judicial resolution. Regardless of whether the legislature’s omission was intentional, for the present it has left the formulation of an approach to the issue of causation in fact to the Ohio courts. Although the Supreme Court has rejected market share liability within the narrow ambit of asbestos litigation in Goldman, it has left open the possibility of adopting a modified theory for the proof of causation in fact in other situations. As the legislature has effectively rejected the court’s plea for a legislative solution, the likelihood of judicial alternatives is enhanced.

Although Ohio has not experienced the large scale problems with DES litigation that some other states have faced, it is clear that similar issues will arise in the future. Mass marketing, the public’s need for new products, competition among suppliers and economically reasonable limitations on quality control will all contribute to other situations where injuries are caused by the substantially similar products of a number of suppliers. Adherence to only the conceptually limited theory of alternative liability in these situations will place an unfair burden on plaintiffs, who are least able to pay the costs of their injuries. Furthermore, because Ohio residents will have no recourse in their own state, an additional caseload is likely to be placed on more favorable forums, such as New York and California. To avoid this result, either the legislature, or the courts, if the appropriate case arises before the legislature has acted, will need to adopt a theory that strikes a balance between protecting consumers and placing reasonable burdens on industry.

B. A Suggested Approach for Ohio

A proper approach to proof of causation in fact combines elements of risk share theory and alternative liability with the concept of apportionment of damages found in Ohio’s comparative fault statute.  This theory would be available only to those plaintiffs who were unable to identify one defendant from a number of manufacturers of substantially similar products. It follows that this theory would supplement rather than replace alternative liability. If adopted by the Ohio Supreme Court, this theory would be available only in limited product liability fact patterns.

Under the suggested theory, the plaintiff may initiate an action by suing only one supplier of the type of product that caused his injury. However, the plaintiff has the option of suing more than one defendant, and is actually encouraged to do so to avoid other possible actions being barred by the statute of limitations. After the plaintiff has initiated the action, the defendants may implead other manufacturers of the product as third party defendants.

Allowing the plaintiff to proceed in this manner has several advantages. First, the plaintiff is relieved of the necessity of joining all possible manufacturers, as currently required under Ohio’s pure alternative liability theory. This avoids denying compensation to injured parties in those instances where more than a few manufacturers have acted tortiously. Second, the court is relieved of the costs and potential inaccuracies of determining the appropriate defendant group. A third advantage is obtained by the plaintiff’s incentives to make every effort to join as many suppliers as he reasonably can. Finally, the defendants are prompted to use their superior knowledge of the industry to implead other manufacturers. Utilizing this industry knowledge decreases the likelihood of the actual tortfeasor escaping liability, and thus helps to maintain a substantial link to causation in fact.

The plaintiff, or the third party plaintiffs, must establish a prima facie case against each defendant by establishing two factors by a preponderance of the evidence. First, the plaintiff must establish that the defendant made the type of product in question, and that the product was defective. The plaintiff then must show that his injury was proximately caused by the product defect. Consistent with the alternative liability theory, each defendant may exculpate itself by showing either that it did not produce the product at all, that it did not produce the product at the time relevant to the plaintiff, or that it did not supply the product in the geographical area relevant to the plaintiff.

Allowing defendants to escape liability in this manner avoids the insurance approach taken by the New York courts, and maintains a focus on causation in fact. The fairness of allocating risk for only those activities which actually benefited the manufacturer is coupled with a practical consideration. The opportunity for exculpation tends to make manufacturers liable only for the risks imposed upon a known market. Because a known risk can be anticipated, industry is then able to provide for its liability through insurance and by passing the costs on to consumers through product prices.

Finally, damages are apportioned by importing the distinction between economic and noneconomic loss expressed in Ohio’s comparative fault statute. In this application, the trier of fact separates the plaintiffs total damages into categories of economic loss, including lost wages, medical expenses and other special damages, and noneconomic loss, including pain and suffering and other intangible damages. All of the remaining defendants are jointly and severally liable for the plaintiff’s economic harm, but are only severally liable for the noneconomic harm. The trier of fact apportions liability for noneconomic harm among the defendants by considering a number of factors including relative market share, participation in industry-wide standards, role in determining such standards, and individual marketing techniques.

This method of damage apportionment is critical to the balance achieved by the proposed method of altering the burden of causation in fact. By providing the injured plaintiff with assured complete recovery of actual monetary loss, the problems of inadequate compensation that may be encountered in market share or national market share liability are avoided. At the same time, limiting joint and several liability to this liquidated amount minimizes the departure from causation in fact and goals of fair risk apportionment. Finally, imposing only several liability for noneconomic loss will not substantially detract from the goals of strict liability. Maintenance of joint and several liability for economic loss should adequately serve as a safety incentive, and thus reduce the costs associated with injuries.

V. CONCLUSION

Fungible products have created substantial difficulties for injured consumers who cannot identify their source. At this time, the problem has been highlighted primarily by litigation involving diethylstilbestrol, other drugs and workplace hazards. The realities of mass production in competitive industries, and society’s need for reasonably priced products ensure that the issue will continue to arise in the future.

The problem posed by the indeterminate defendant has required courts to juxtapose two distinct concepts. Traditional tort principles, perceptions of fairness and the necessity of reasonable limits on industry’s obligations require that liability be strongly linked to causation. The policies of reducing injury costs and protection of the consumer, which fostered the development of strict liability, must also be considered.

Several modified causation theories have been developed and tested in other jurisdictions. The experiences of those jurisdictions provide a background against which a balanced and effective approach can be applied when the causation in fact issue next arises. The theory proposed for Ohio seeks to strike a balance between the two fundamental policy considerations, and to provide a flexible framework for achieving equitable results.

Rebecca J. Greenberg, 1991.

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1982 DES Case: O’Brien v. Eli Lilly & Co.

Abstracts

The question for decision in this appeal from a summary judgment in favor of four defendant pharmaceutical manufacturers in a diversity action is whether the district court properly applied the Pennsylvania “discovery rule,” which modifies the personal injury statute of limitations. The district court determined that, if she had exercised due diligence, appellant Ann O’Brien reasonably could have discovered in February 1976 that her mother had taken Diethylstilbestrol (commonly known as Stilbestrol or DES) during her 1956 pregnancy and that the drug arguably caused appellant’s subsequent cancer. She did not file her complaint until December 31, 1979; accordingly, the district court concluded that the suit was barred by the two-year statute of limitations. Appellant contends that whether she possessed the knowledge necessary in 1976 to start the running of the statute was a jury question. Conceding that this is a close case, we nevertheless find no genuine issue of material fact and affirm the grant of summary judgment.” …

O’BRIEN v. ELI LILLY & CO., Leagle, 19811372668F2d704_11255, January 21, 1982.

… “Having been a trial judge for more than thirteen years, I am keenly aware of the inordinate pressure which trial judges have in trying to dispose of their heavy caseloads efficiently and fairly. But summary judgments were never intended to decrease basic fairness for litigants in order to increase a court’s pace in the disposition of cases. From my view Ann O’Brien has already suffered the tragedy of cancer; her plight should not have been compounded by depriving her of the opportunity to present her case to the jury. I dissent because there is a genuine disputed and material issue of fact as to whether she was sufficiently diligent in ascertaining the etiology of her cancer. Under the facts of this case, a rational jury could find that there was no lack of diligence when a teenager accepted as true the statements of her mother and surgeon.”…

… read the full paper O’BRIEN v. ELI LILLY & CO., on Leagle.

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1982 DES Case: Dawson v. Eli Lilly & Co.

Abstracts

Defendants Eli Lilly and Company, Abbott Laboratories, E.R. Squibb & Sons, Inc., and Upjohn Company have moved for summary judgment and to dismiss the complaint on the basis of the statute of limitations. The undisputed facts are as follows. In 1973, when plaintiff was seventeen years old, her mother read an article in the newspaper about diethylstilbestrol (DES) and its effects on the daughters of women who took the drug during pregnancy. She then ascertained from her obstetrician that she had taken DES during her pregnancy with the plaintiff. That same day, she discussed these matters with her daughter, and about two weeks later, plaintiff was taken to a Dr. Marlow for a gynecological examination. Dr. Marlow diagnosed plaintiff’s condition as cervical adenosis. At that time, plaintiff took a pamphlet on DES from a table in the doctor’s office. Dr. Marlow also told plaintiff at the first visit that there are cases where cancer has developed from taking DES. Since that time, plaintiff has continued to visit Dr. Marlow two to four times a year for check-ups related to her adenosis and to determine whether any cancer cells have developed.

DAWSON v. ELI LILLY & CO., Leagle, 19821873543FSupp1330_11679, July 28, 1982.

Thus, although the record does not reveal directly that plaintiff was informed that her condition was or might be a result of her mother’s ingestion of DES, it is clear from the circumstances surrounding the diagnosis of her adenosis that she was aware at that time of a possible connection between her condition and DES. She was taken to the doctor precisely because her mother had discovered that she had taken DES during her pregnancy with plaintiff, she picked up DES pamphlets in the doctor’s office, and the doctor told her that cancer had been known to develop “from taking DES.” She was subsequently checked regularly for the possible development of cancer. Plaintiff admits that she knew, as early as 1973, “of the possibility of a causal nexus” between DES and her condition, but states that she was not told of a “clear and certain causal relationship” at that time.”  …

… “Plaintiff makes two arguments in opposition to defendants’ motions.

  1. First, she did not know of a “clear and certain causal relationship” between DES and her condition. Defendants’ representatives have testified as recently as 1981 in various depositions to the effect that there is no certain relationship between ingestion of DES by pregnant women and adenosis or malformation of the sexual organs of their offspring, or that their companies take no position on the question. Plaintiff argues that if defendants’ experts in 1981 did not know of a causal link, it cannot be decided as a matter of law that she should have known of the causal link before June 5, 1978.
  2. Secondly, plaintiff argues that District of Columbia law requires not only a knowledge of the injury and its cause, but also knowledge of some wrongful conduct on the part of the defendant, to begin the running of the statute of limitations. Plaintiff has submitted an affidavit to the effect that she was unaware until November, 1980 that at the time of her gestational period, DES was marketed without adequate testing as to its safety nor efficacy (to prevent abortion) .” …

… “In general, discovery rules are adopted to avoid the unfairness of interpreting a statute of limitations to accrue when the injury first occurs, if at that time plaintiff does not have enough information to bring suit. This policy is applied to different factual situations as they arise. Where the injury is latent, the claim is held not to accrue until the plaintiff discovers the injury. Where causation of an injury is unknown, the action accrues when both the injury and its cause have been (or should have been) discovered. Where the injury and causation are known, but not that there has been any wrongdoing, the action is held to accrue when the plaintiff discovered, or by due diligence should have discovered, the wrongdoing. We believe the District of Columbia courts would follow this progression. While a few courts have forthrightly rejected some or all of these interpretations of the discovery rule, most have at least phrased their discovery rules in a manner that could allow such interpretations should an appropriate case arise. In the majority of cases, injury, causation and fault are apparent at the time of the occurrence. Cases in which one or more of these elements are not evident simultaneously are rare, and become more so as more of these elements are discovered separately. Therefore it is not surprising that many jurisdictions, including the District of Columbia, have not reached the precise issue before us. ” ...

… read the full paper DAWSON v. ELI LILLY & CO., on Leagle.

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1990 DES Case: Bowen v. Eli Lilly & Co.

Abstract

… “We summarize the undisputed record facts. During her pregnancy with the plaintiff, the plaintiff’s mother took the prescription drug diethylstilbestrol (DES) to prevent a threatened miscarriage. The plaintiff was born on April 14, 1948. In 1969 the plaintiff underwent an operation for a malignant vaginal tumor, during which a colostomy was performed as well as a radical hysterectomy. The complaint in this action was filed approximately fourteen years later on March 23, 1983. The question is whether, on the summary judgment record, there is a dispute of material fact as to whether the three-year statute of limitations had run before this action was commenced.

BOWEN v. ELI LILLY & CO., Leagle, 1990612408Mass204_1595, August 6, 1990.

This court has recognized the unfairness of a rule that holds that the statute of limitations has run even before a plaintiff knew or reasonably should have known that she may have been harmed by the conduct of another. We, therefore, have developed (in the absence of a governing statute) a discovery rule for the purpose of determining when a cause of action accrues, and thus when the statute of limitations starts to run. This rule prescribes as crucial the date when a plaintiff discovers, or any earlier date when she should reasonably have discovered, that she has been harmed or may have been harmed by the defendant’s conduct.”  …

… continue reading the full paper BOWEN v. ELI LILLY & CO., on Leagle.

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1992 DES Case: Moll v. Abbott Lab.

Abstract

… “In this pharmaceutical products liability action, plaintiff Jean Moll alleges that as a result of her in utero exposure to the prescription drug diethylstilbestrol (DES) she suffers from an incompetent cervix, resulting in a probable inability to carry a fetus to term. Michael Moll alleges a loss of consortium. Defendants are manufacturers and distributors of DES.

MOLL v. ABBOTT LAB., Leagle, 1992916192MichApp724_1830, February 3, 1992.

Plaintiff testified at deposition that in 1975 she consulted a gynecologist, Dr. Ulmer, regarding birth control. Because of the way her cervix appeared, she was asked if she had undergone any abortions. Plaintiff told the doctor that she had not, and there was no further discussion at that time about the condition of her cervix. In 1976, Dr. O’Campo told plaintiff that she had a “hood over her cervix.” Dr. O’Campo asked plaintiff if her mother had taken DES and requested the medical records from when plaintiff’s mother was pregnant. Plaintiff had been told by her mother, Shirley Petroff, that she was hospitalized during her pregnancy because she was “losing” plaintiff. Mrs. Petroff told plaintiff that she remembered receiving medication to prevent her from “losing” plaintiff, but did not know what she was given.

In 1977, plaintiff was told by her doctor that the cervix “didn’t look good” and that the condition might be attributable to DES that her mother had taken. The doctor was still trying to locate the mother’s medical records at that time. When plaintiff was having difficulty getting pregnant in 1979, her doctor indicated that her difficulty might be related to the hood over her cervix. The doctor stated that it was possible that plaintiff’s condition was caused by exposure to DES.

The medical records from the pregnancy were still unavailable in 1979. Apparently, plaintiff’s mother had contacted the physician who had treated her during her pregnancy, but was unable to locate the records. In her deposition, plaintiff stated that in the late 1970s she tried to call the hospital where she was born in order to obtain the records, but was told that the hospital had either burned down or closed. Plaintiff also remembered discussing articles relating to DES and DES-related injuries with her mother. The record does not disclose the content of these articles or the information plaintiff gained from discussing them. According to plaintiff, these discussions could have occurred as far back as 1978 or 1980.

On December 30, 1986, plaintiff and her husband filed a complaint that sought damages for injuries arising from in utero exposure to DES.1 In June 1988, defendants filed a motion for summary disposition pursuant to MCR 2.116(C)(10), alleging that there was no genuine issue of material fact because plaintiff had failed to produce evidence that her mother had ingested DES. The motion was apparently granted, but the entry of the order was delayed so that plaintiff could complete her investigation regarding her mother’s hospital records. In October 1988, plaintiff located records that indicated that her mother had ingested DES.

In December 1988, defendants again moved for summary disposition, this time under MCR 2.116(C)(7). Defendants alleged that plaintiff’s complaint was filed more than three years after she learned that her injuries might be related to in utero exposure to DES and was therefore barred under MCL 600.5805(9); MSA 27A.5805(9). In her response, plaintiff argued that her cause of action had not accrued until 1988, when she located the medical records that established that her mother had ingested DES. The trial court denied defendants’ motion, noting that plaintiff’s cause of action did not exist more than three years before the filing of the complaint because plaintiff did not have evidence that her mother had ingested DES.”  …

… continue reading the full paper MOLL v. ABBOTT LAB., on Leagle.

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1989 DES Case: Murphy v. Eli Lilly & Co.

Abstract

The defendants, Lilly, Abbott, Upjohn, Vale, Merck, and Squibb, seek an order granting partial summary judgment dismissing the derivative claim of plaintiff Kevin Murphy for loss of consortium on the ground that the alleged tortious conduct which gave rise to his wife’s claim for personal injury occurred prior to the marriage.

MURPHY v. ELI LILLY & CO., Leagle, 1989169146Misc2d23_1166, December 1, 1989.

The defendants’ motions for partial summary judgment must be granted. Damages for loss of consortium are not recoverable where, as here, the alleged wrongful conduct preceded the marriage. (Clark v Lilly & Co.)

The policy behind this rule is that a third party should not be able to “create an ex post facto liability for loss of consortium where none existed before” simply by marrying an injured person. The plaintiff Kevin Murphy’s reliance on Enright v Lilly & Co. is misplaced.

The latter case cited Piccirelli v Johns-Manville Sales Corp. as authority for the proposition that where a personal injury action is revived, the derivative loss of consortium claim is also revived. In Piccirelli, an asbestos case, the parties were married on the date of the alleged tortious conduct and, thus, the derivative cause of action was revived, as well. Such is not the case here.”  …

… continue reading the full paper MURPHY v. ELI LILLY & CO., on Leagle.

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