DES Cases and Identification of Parties

ABSTRACT

One of the most interesting legal issues in connection with identifying the potential parties to a toxic substances occurs when a plaintiff is aware of the particular agent that caused harm, but cannot establish a causal connection between that agent and a specific defendant In Ryan v. Eli Lilly & Co., the plaintiff alleged that she suffered a pre-cancerous condition caused by prenatal exposure to diethylstilbestrol taken by her mother during pregnancy. She could not however, identify the specific drug company that manufactured and sold the drug ingested by her mother. She sought to maintain suit against various manufacturers of DES under theories of alternative liability and market share liability. Although the court granted the defendants’ motion for summary judgment based upon her failure to identify the manufacturer of the drug taken by her mother, each of these theories may have potential application in other toxic substances cases where a plaintiff has similar problems in identifying a defendant.

Toxic Substances Litigation in the Fourth Circuit, University of Richmond, Law Review Volume 16, Winter 1982.

There are any number of techniques for establishing join torts and several liability including; vicarious liability, common duty; concurrent causation of a single, indivisible result which neither cause would have accomplished alone; concurrent causation of a single, indivisible result which either would have caused alone; damage of the same kind which is difficult to apportion; and acts innocent in themselves that together cause damage. Alternative liability is a common approach. The typical application of this theory occurs in the context of two or more tortfeasors who combine to bring about harm to a plaintiff such as two hunters who fire rifles at the same time, one of whom shoots at plaintiff. The alternative liability doctrine allows the plaintiff to shift the burden of proof to the defendants to establish which one caused the alleged harm. If the burden is not met both defendants will be jointly liable. The application of this theory to DES cases has generally been limited because of the following arguments: there are a large number of potential defendants and not all of them are brought into the lawsuit; the defendants do not have any greater access to information concerning who sold the drug and are dealing with the same level of uncertainty as the plaintiff; there is no specific information that any one of the name defendants sold the drug that allegedly caused the harm; and the activities of the defendants are different in time and place.

Concert of action is another theory that may be used t solve a plaintiff’s identification problem. Under this approach a group of defendants may be liable if they act in concert pursuant to a common design, knowingly give substantial assistance to others engaged in breaching a duty to give substantial assistance while breaching a separate duty to a plaintiff. The typically cited example of concert of action involves a suit brought by an innocent person who is injured as a result of a drag race. The specific facts connected with defendants’ actions are usually controlling and courts have been inconsistent in applying this theory in DES cases. Reasons cited for not applying this theory have included lack of evidence of anti-social behavior, passage of time between conduct complained of and subsequent activities, lack of tacit understanding or a common plan, joinder of fewer than all potential defendants, large numbers of defendants and evidence only of mere manufacturing activities with similar economic results. On the other hand, one jury has found that there was sufficient evidence of concerted action to hold the defendant manufacturers liable for failing to make sufficient tests and for marketing DES without adequate warnings.

Closely related to concert of action is a theory of civil conspiracy also considered in Ryan v. Eli Lilly & Co. Plaintiffs alleged that the named manufacturers of DES conspired to fraudulently misrepresent the benefits of DES or acquiesed in such misrepresentation. On motion for summary judgment the court found that there was no evidence of an agreement by the named defendants to commit a criminal act or intentional tort pursuant to a common scheme.

Other plaintiffs have suggested that there is a concept of “enterprise liability” that should be appropriate for assisting plaintiffs to identify defendants in these kinds of cases. This type of enterprise liability should be distinguished from the larger social theory that enterprises should bear the risk of loss for all harm caused by that enterprise. This theory proposes that various overwhelming social policies would be better served by shifting the risk of loss to an offending industry as a whole rather than maintaining the risk of loss on injured consumers. In the DES cases there has been no support for this approach for a number of reasons including the large number of defendants, the presence of pervasive governmental regulation, and a dearth of legal precedent.

The most recent suggestion by plaintiffs to surmount the difficulties of identifying defendants has been for “market share liability”. According to this theory, if a plaintiff suffered harm caused by a toxic substance but cannot identify the manufacturer of that substance, then the plaintiff may sue a substantial portion of the entire industry producing the substance and recover damages to be paid by each manufacturer in proportion to respective shares of the market for that substance. This doctrine is based upon the express social policies of providing the most appropriate incentives for product safety and of placing liability on the parties most capable of bearing compensation costs. Objections to this theory have included the lack of precedent, unfairness to some defendants and plaintiffs, and that it is counter to such social policies as the encouragement of medical research.

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1981 DES Case: Needham v. White Laboratories, Inc.

ABSTRACT

In 1946 the Food and Drug Administration (“FDA”) authorized defendant-appellant White Laboratories, Inc. (“White”), to market dienestrol, a synthetic estrogen, for the treatment of menopausal symptoms and suppression of lactation In 1950 the FDA authorized White to market dienestrol for treatment of threatened and habitual miscarriages.

Mary Needham, plaintiff-appellee Anne Needham’s mother, took dienestrol in 1952 during her pregnancy with plaintiff. In early 1974 Dr. Jerome Warren informed Anne Needham that she had clear cell adenocarcinoma, a rare form of vaginal cancer. Needham claims that the dienestrol her mother took in 1952 is the proximate cause of her cancer.

NEEDHAM v. WHITE LABORATORIES, INC., Leagle, decision/19811033639F2d394_1963, April 27, 1981.

The trial of this cause was trifurcated. A jury was impaneled to determine whether the Illinois statute of limitations barred this suit. The jury found that the Illinois two-year statute of limitations did not bar plaintiff’s cause of action. A new jury was impaneled to decide the liability and damages issues. That jury returned a verdict for plaintiff and, after the subsequent damages trial, awarded the plaintiff $800,000. White appeals. We reverse and remand.  …  …

The limitations period does not commence when the plaintiff learns of his injury, but only after the plaintiff knows or has reason to know that he or she has a physical problem and also that someone is or may be responsible for it.

White claims that the jury finding that Needham did not know of the connection between her injury and the dienestrol her mother took before March 22, 1974, is not supported by the record. We disagree.

Needham testified that she first learned of the possible connection between her injury and the dienestrol in May 1974. Her mother testified that neither she nor plaintiff knew of the relationship between the cancer and the dienestrol before May 1974. The only evidence tending to prove that Needham knew or should have known of the connection between her injury and dienestrol before March 22, 1974, was the testimony of her father and her gynecologist, Dr. Jerome Warren. Needham’s father testified that he knew of the connection between Needham’s injury and the dienestrol on March 1, 1974, but that he did not discuss the possible connection with his daughter before March 22, 1974. Dr. Warren testified that he discussed the connection between the cancer and dienestrol with plaintiff and her mother at a meeting on March 2, 1974. Plaintiff and her mother, however, testified that no meeting occurred on March 2, 1974, and Dennis Rauen testified that he was with Needham all day March 2, 1974.

The jury’s function is to resolve the conflicts in the testimony and weigh the credibility of the witnesses. Legally sufficient evidence in the record supports the jury’s resolution of the conflicts in favor of the plaintiff, and we affirm its finding that this suit is not time-barred.

White claims that the district court erred in permitting Needham to introduce evidence that dienestrol was not effective in preventing miscarriages. We agree with defendant and reverse and remand. In ruling that inefficacy evidence was admissible, the district court erroneously interpreted Illinois case law and the comments to section 402A of the Restatement (Second) of Torts. …

…  Second, the manufacturer will be strictly liable if it fails to warn of a known risk inherent in the product. Comment j of section 402A explains that a product may be unreasonably dangerous if the manufacturer fails to warn of an inherent danger.

The seller is required to warn [of a danger], if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of … the danger. Likewise in the case of poisonous drugs, or those unduly dangerous for other reasons, warning as to use may be required.

… Third, a court will impose strict product liability even if a warning is given if the product remains unsafe when the warning is followed and the risk of danger outweighs any apparent usefulness of the product.

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. ” … …

… continue reading NEEDHAM v. WHITE LABORATORIES, INC. on Leagle.

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Daughters at Risk : a Personal DES History

image of daughters-at-risk book
Anne Needham, who as a young DES Daughter had a hysterectomy for cancer, sued White Laboratories, makers of a DES drug. Lawrence S. Charfoos – an attorney in the litigation – and Stephen Fenichell detail the case and provide a history of DES development, research linking it early to cancer, the FDA’s approval, the pharmaceutical company promotion, and the medical community’s involvement.

This is the legal story of one of the first DES cases to go to trial, as told by the plaintiff’s lawyer and a journalist covering the case; and it conveys neither the victim’s feelings nor the drama of the experience.

Anne Needham was 20 when operations for the rare vaginal cancer now appearing in DES daughters left her unable to bear children, partially incontinent, and emotionally in turmoil. Six years later an Illinois court awarded her $80,000 in damages ; a decision that was reversed on appeal and remanded for trial; and there the story ends.

The authors competently recount the development of DES in England; its popularization by the Smiths of Harvard as a drug to ward off miscarriage; how the first cases of vaginal cancer were connected to DES; and the role of the FDA.

It seems however that “the particulars of Anne Needham’s personal ordeal and of the trial are vague and incomplete” and that “at the trial, the importance of the legal maneuvering is never quite established“.

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1981 DES Case: Mizell v. Eli Lilly & Co.

ABSTRACT

These actions arise out of the alleged use of the drug diethylstilbestrol (hereinafter DES) by Virginia McGuire while pregnant with Stacey McGuire Mizell in 1954. DES is a synthetic non-steroidal estrogen which was prescribed for use by pregnant women who had a history of miscarriages. At the time that she took this medication in 1954, Virginia McGuire was a resident of Santa Clara, California.

MIZELL v. ELI LILLY & CO., Leagle, decision/19811115526FSupp589_11020, February 5, 1981.

The plaintiffs, Carl E. Mizell and Stacey McGuire Mizell, were married in 1975 in California.

In 1976, twenty years after her birth, plaintiff Stacey Mizell allegedly learned that she had developed cancer. The alleged cancerous condition of Stacey Mizell was first diagnosed in February 1976 by Dr. William Singleton at Travis Air Force Base in California. On June 9, 1980, the plaintiffs filed this action in federal district court in Charleston, South Carolina.

The plaintiffs have failed to identify the manufacturer of the particular brand of DES taken by Mrs. McGuire. Rather, the action is brought against the six named pharmaceutical corporations which allegedly manufactured and distributed DES in California during this period. ” …

… continue reading MIZELL v. ELI LILLY & CO. on Leagle.

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1981 DES Case: Namm v. Charles E. Frosst & Co.

ABSTRACTS

This is a pharmaceutical products liability case wherein plaintiffs appeal from a summary judgment dismissing their complaint against approximately 44 drug manufacturing and distributing companies. The compliant charges defendants with liability based upon principles of negligence, breach of warranties and strict liability.

NAMM v. CHARLES E. FROSST & CO., Leagle, decision/1981197178NJSuper19_1195, February 5, 1981.

Plaintiffs Gail Namm and Paul Namm, are husband and wife and in their complaint they allege that prior to February 15, 1949 all of the defendants named “manufactured, compounded, tested, sold and marketed” large quantities of synthetic estrogen known as “diethylstilbestrol“, “stilbestrol” and “dienestrol” (hereinafter referred to collectively as DES) in prescription drug form. The drug was promoted for use by pregnant women to prevent loss of the fetus by spontaneous abortion. Plaintiff Gail Namm was born February 15, 1949. Prior thereto her mother had ingested DES obtained by prescription from her obstetrician to prevent termination of her pregnancy by spontaneous abortion. Plaintiffs allege that Gail Namm developed adenocarcinoma of the vagina and “underwent a total abdominal hysterectomy” in August 1975, and that the adenocarcinoma Gail developed was caused by the DES ingested by her mother.

The complaint was filed August 1, 1977. Although more than 300 companies have manufactured or sold DES since 1941, the complaint names only 74 companies as defendant-manufacturers; 44 were served and answered the complaint. On June 22, 1977 an order was entered fixing dates for service of the complaint and for the filing of answers. The order postponed indefinitely the assertion of crossclaims and third-party claims and provided for orderly discovery as to the identification of the pharmaceutical and the identification of the manufacturer. Discovery as to identification was obtained from plaintiffs, Gail Namm’s parents, their doctor and pharmacist, hospital records and representatives of defendant drug companies. The primary source of information as to identification of both the drug and the manufacturer was obtained from Mrs. Vernick, Gail’s mother.

She recalled that she obtained pills (as opposed to capsules or other forms of oral medication) during her pregnancy. The original prescription came from Dr. Bogen, her obstetrician, and the medication was obtained from Elks Drug Store in Brooklyn. While she did not recall what the pill container looked like, she did recall there were several different pill sizes but none smaller than five milligrams. They were white or light in color and contrasted with the dark surface of her kitchen counter. She was unable to provide any other details concerning the appearance or physical characteristics of the pills.

The owner of the pharmacy obtained drug supplies from wholesalers, cash peddlers, manufacturers and other local drug stores. He had no recollection or records which shed any light on either the source of his supply of DES or purchases by the Vernicks. Nor was he able to state when he first began to supply DES, where he obtained it or the physical characteristics of the DES he did supply.

Other discovery did not provide any information whatsoever as to the identification of the manufacturer or distributor or as to the nature or appearance of the pharmaceutical.

All defendants thereafter moved for summary judgment, primarily on the grounds that plaintiff had failed to identify the manufacturer or to produce any evidence linking any individual defendant with the drugs which allegedly caused plaintiff’s injuries (the defendants have many other defenses which are all reserved and are not involved in this appeal). It was for this reason that the trial judge granted the summary judgment as to all 44 defendants.

Plaintiffs conceded at oral argument in the trial court and before us that they were unable to identify the manufacturer or distributor of the drug allegedly causing plaintiff’s injury and that it was unlikely that they would be able to do so. However, for reasons to be considered below, plaintiffs argue it is not necessary that they do so in order to maintain this action. 

… In an attempt to circumvent this general principle plaintiffs place reliance upon two theories of liability which have been described as “alternative liability” and “enterprise liability.” Plaintiffs contend that the application of either or both of these theories establishes that the grant of summary judgment was improper.

Alternative Liability

This theory is said to evolve from those cases which hold that if a party cannot identify which of two or more defendants caused an injury, the burden of proof may shift to the defendants to show that they were not responsible for the harm. This theory does not apply where a joint tort is involved, but rather where independent acts by two or more joint tortfeasors are alleged to have occurred, with all the tortfeasors having acted wrongfully, but only one having injured plaintiff.

Plaintiffs argue that where, as here, “the presumption of liability verging toward a certainty is against one or more of the defendants” the theory of alternative liability shifts the burden to each defendant in turn to come forward with proof of its particular activity as it relates to the supply and distribution of its output of DES in explanation or exoneration of its conduct, and that if any named defendant feels additional manufacturers of DES are needed to complete the roster of named defendants, it is free to bring them into the litigation as added defendants. Plaintiffs continue to argue that not only does the burden of proof shift to each defendant becoming one of exculpation but that plaintiffs are entitled to a charge that requires a jury to render a verdict in favor of plaintiffs against at least one defendant.

Plaintiffs further argue that they are entitled to proceed to trial where each defendant will be motivated to fix responsibility upon others as part of the incentive to accomplish their own exculpation. …. …. …

Enterprise Liability

Plaintiffs argue that liability should be imposed upon defendants collectively because “the acceptance of DES by the medical profession and the unsuspecting public was the consequence of a cumulative effort by all who entered the market as manufacturers … and of immense promotion and advertising to which defendant’s contributed a mite, or a treasure or something in between.”

Plaintiffs conceded in the trial court and at least tacitly in this court that this theory is contrary to the established law of this State, but claimed that the traditional requirement of manufacturer identification in a product liability case should be discarded here because each defendant participated in an “industry enterprise” and a “pervasive and cumulative market effort.” This theory referred to as “enterprise liability” or “industry wide liability,” if adopted, would impose liability upon each member of an industry who manufactures or produces a product which causes injury or harm to a consumer. The share of liability of each member of the industry would be measured by reference to that defendant’s share of the market for the product.

The adoption of this theory of liability was urged in the DES cases of Lyons v. Premo Pharmaceutical Labs Inc. ; Ferrigno v. Eli Lilly & Co. and Abel v. Eli Lilly & Co.. However it was unnecessary for the courts to rule on the issue in those cases and they did not do so. The theory was specifically rejected in Sindell v. Abbott Laboratories.

Adoption of this legal theory would, of necessity, result in total abandonment of the well settled principle that manufacturers are only responsible for damages caused by a defective product upon proof that the product was defective and that the defect arose while the product was in the control of defendant. And traditional methods of assessing and apportioning damages among defendants would also, of necessity, have to be abandoned and new ones fashioned. ” … …

… read the complete report NAMM v. CHARLES E. FROSST & CO. on Leagle.

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1979 DES Case: Lyons v. Premo Pharmaceutical Labs, Inc.

ABSTRACT

” This is an appeal from two judgments, both resulting from the same cause of action. It presents questions relating to liability for injuries caused by the taking of a drug during pregnancy.

On September 26, 1956, near the end of her first trimester of pregnancy, plaintiff Claire Lyons notified her obstetrician that she was experiencing some bleeding. To prevent spontaneous abortion, he prescribed a drug generically known as stilbestrol or diethylstilbestrol (DES). The prescription, which specified no particular brand, was phoned in to a local pharmacy and filled with stilbestrol tablets manufactured by Premo Pharmaceutical Labs, Inc. Mrs. Lyons took four of the 25 milligram pills daily for 12 days, after which the medication was discontinued because the bleeding had stopped. On April 20, 1957 after an otherwise normal pregnancy, she gave birth to a girl, Joan.

LYONS v. PREMO PHARMACEUTICAL LABS, INC., Leagle, decision/1979353170NJSuper183_1340, August 8, 1979.

In the fall of 1973, when Joan was a junior in high school, it was discovered that she was suffering from clear cell adenocarcinoma of the cervix. Surgery was performed at that time to correct the condition. Although it appeared initially that the doctors had succeeded in arresting the spread of the malignancy, Joan died on November 3, 1977 of “widespread metastasis of clear cell adenocarcinoma and bronchopneumonia.”

Clear cell adenocarcinoma of the cervix, a rare form of malignancy in Joan’s age group, has been observed in recent years in girls of 14-22 and related to in utero exposure to DES.

The present case began with the filing of a complaint by Joan Lyons, her mother Claire and her father Thomas, on September 29, 1975. The complaint identified Premo as the manufacturer of the medication taken by Claire during her pregnancy with Joan and alleged, against that defendant, negligence, breach of warranty, strict liability in tort and false representation. Merck & Co. was charged also with essentially the same acts and theories on the assertion that it had licensed Premo to produce stilbestrol. Eleven other drug companies were joined as defendants, the allegation against them being that it was through their joint efforts that DES was placed on the market. Compensatory and punitive damages were demanded.

Plaintiffs requested that the court relax R. 4:14-1 to allow for the early taking of depositions so that “we can determine whether or not we have all the defendants” and “the proper defendants.” The motion was granted by the assignment judge.

A second order issued in January 1976 allowed plaintiffs to proceed with taking depositions from representatives of Premo, but limited them “to the discovery of such facts as may be necessary to permit plaintiff to make a determination as to the joinder of additional parties.”

The discovery pursuant to these orders revealed that the DES used by Premo in the tablets taken by Claire Lyons was purchased from the manufacturer, Specific Pharmaceutical Labs, Inc., through a brokerage firm, R.W. Greeff & Co., Inc. As a result, the complaint was amended to add these two parties and Chemetron Corp., which since had acquired Specific.

All defendants but Premo moved for summary judgment. Judgment was granted on May 23, 1977 for all those not within this particular chain of distribution. The motions of Greeff and Chemetron were denied without prejudice.

On June 9, 1977 the trial judge denied plaintiffs’ motion to pursue discovery against all defendants, with the exception of Specific, Chemetron, Premo and Greeff.

In October 1977 plaintiffs agreed to a settlement with both Premo and Chemetron (for Specific). The following month Joan died.

The case continued against Greeff on the basis of strict liability in tort. For the purposes of a motion by Greeff for summary judgment, both parties stipulated to a series of facts. Essentially, it was agreed that the sale of DES from Specific to Premo had been arranged by Greeff and that the drug was shipped directly from Specific to Premo, with Greeff never having physical control of the product.

Finding that the drug did not become dangerous until Premo obtained it, added to it other ingredients and packaged it for sale, the trial judge dismissed the complaint against Greeff.

This appeal from both judgments followed. “…

… continue reading LYONS v. PREMO PHARMACEUTICAL LABS, INC, on Leagle.

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1978 DES Case: Gray v. Eli Lilly & Co. and the United States

ABSTRACT

This is a civil damage suit brought by the plaintiff, Beverly Ann Gray (Gray), against a drug company, Eli Lilly and Company (Lilly), and the United States. Plaintiff alleges that she has been harmed by a drug diethylstilbestrol (DES), taken by her mother during Gray’s period of gestation. The pleadings and affidavits indicate that DES was dispensed by physicians in the early 1950’s to pregnant women with histories of miscarriages in order to avoid problem pregnancies. It was not until 1971 that the medical community recognized that DES caused cancer in women whose mothers took the drug. This is the basis of Gray’s complaint. In essence this is a products liability case. Gray sues Lilly as the manufacturer of the drug and the United States for its approval, through the Food and Drug Administration (FDA), of the sale of DES without warning of its adverse effects. The case is now before the court on motions for summary judgment by Lilly and the United States.

GRAY v. UNITED STATES, Leagle, decision/1978782445FSupp337_1743, February 2, 1978.

Lilly contends that the plaintiff has failed to identify it as the particular manufacturer of the drug, DES, which caused her injury. It is a fundamental principle of products liability law that a plaintiff must prove, as an essential element of his case, that a defendant manufacturer actually made the particular product which caused injury. In Wetzel v. Eaton Corporation, the plaintiff sued two corporations which were the only suppliers of a defective tractor part prior to the injury in question. The plaintiff, however, could not produce any evidence identifying the particular defendant that supplied the defective tractor part. The court held that summary judgment was appropriate for the moving defendant since it would be only speculation and conjecture that might link any one of the two defendants to the defective part.

It is apparent that Gray is unable to identify Lilly as the particular manufacturer of the DES taken by her mother. In 1953 and 1954 there were at least one hundred separate companies offering to sell some form of DES. Gray, of course, cannot of her own knowledge identify which of these one hundred companies manufactured the drug taken by her pregnant mother. Gray’s mother has testified that she cannot identify what brand of DES she took, nor can she remember the shape, color or dosage of the DES ingested. Dr. Charles F. Beckert who treated Mrs. Gray during her pregnancy and who prescribed DES for her use from October 19, 1953 to April 26, 1954 cannot identify the manufacturer of the DES taken by Mrs. Gray. Mr. Charles Wesley Gray, plaintiff’s father, does not remember the size, shape, color or manufacturer of the DES taken by Mrs. Gray. Mr. Vernon C. Thompson, former co-owner of the drug store where Mrs. Gray’s DES prescriptions were filled, cannot identify which manufacturer’s DES was used to fill Mrs. Gray’s prescriptions. The present owner of such drug store, Hugh Allen Johnson, destroyed all prescription records for the years prior to 1956 due to insufficient storage space, and cannot identify the manufacturer of the DES taken by Mrs. Gray. It has been over three years since Gray filed her original complaint, and well over a year since the critical issue of the manufacturer’s identity was raised by Lilly’s amended motion for summary judgment. Gray has had ample time for discovery, but has failed to provide any proof on this essential element of her case. Lilly’s motion for summary judgment must be granted.

The United States has moved for summary judgment on the basis of a statutory exception to the Federal Tort Claims Act. The exception relied upon is in 28 U.S.C. § 2680(a) which states:

The provisions of this chapter and section 1346 of this title shall not apply to . . . Any claim based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused.

It is clear that this statutory exception from the Federal Tort Claims Act bars recovery for acts which constitute discretionary functions of government officials. In her original complaint, plaintiff alleges that the United States government, through its agent, the Food and Drug Administration (FDA), was negligent in failing properly to test DES, in failing to warn of the adverse effects of DES, and in approving DES and representing that it was safe. The new drug provisions of the Federal Food, Drug and Cosmetic Act state that a drug which is not generally recognized by qualified experts as safe and effective under the conditions for which it is prescribed, recommended or suggested, may be shipped in interstate commerce only if an approval of a new drug application is effective for that drug. The function of the Food and Drug Administration was to approve the new drug application for DES pursuant to 21 U.S.C. § 355(d). That section required the Secretary to determine whether:

  1. the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;
  2. the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;
  3. the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity;
  4. or upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; . . . he shall issue an order refusing to permit the application to become effective. ” …

… continue reading GRAY v. UNITED STATES. on Leagle.

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1981 DES Case: Ryan v. Eli Lilly & Co.

ABSTRACT

This is a pharmaceutical product liability action. The plaintiff, Nancy Ryan, alleges she has developed a pre-cancerous condition as a result of her prenatal exposure to diethyestilbestrol (hereinafter “DES”), a synthetic estrogen taken by her mother during 1952 and 1953. This drug was promoted in the late 1940’s and early 1950’s for use by pregnant women to prevent loss of the fetus by spontaneous abortion. Nancy Ryan was born May 1, 1953. Prior to that time her mother had ingested DES obtained by prescription from her doctor to prevent possible miscarriage. The complaint was filed on February 8, 1977. Although 118 companies were manufacturing and marketing DES in the dosage taken by plaintiff’s mother in 1952 and in 1953, the complaint named only eight companies as defendants. Plaintiff alleges that the DES ingested by her mother was manufactured by Eli Lilly & Company, or by E. R. Squibb and Sons. In addition to Lilly and Squibb, the plaintiff joined Rexall Drug Company, Upjohn Company, Blue Line Chemical Company, Abbott Laboratories, and McNeil Laboratories as party defendants, alleging a conspiracy in their production of synthetic estrogens. The plaintiff seeks legal as well as equitable relief, and claims numerous causes of action: negligence, breach of warranty and implied warranty, strict liability, civil conspiracy, fraud, and violation of the Federal Drug and Cosmetic Act of 1938.

RYAN v. ELI LILLY & CO, Leagle, decision/19811518514FSupp1004_11365, May 14, 1981.

The major weakness in plaintiff’s case, and one issue upon which defendants’ motion is based, is her inability to identify the manufacturer of the DES tablets taken by her mother nearly 28 years ago. Three and a half years of discovery have revealed nothing that would indicate which, if any, of the defendants is the culpable party.

It is elementary that in any action claiming injury from a product, the plaintiff must show causal connection between the defendant manufacturer and that product. The defendant manufacturer must be identified with the specific instrumentality that allegedly caused the injury, and this is the law of both North and South Carolina.

It goes without saying that if a drug manufacturer … is to be held liable for harm caused by a product, it is necessary to show that the drug or medicine was one with which the defendant is identified in the respect asserted — that is, it must be shown that the defendant actually manufactured, compounded, or sold the drug or medicine in question.

Proof connecting the defendant with the instrumentality of the alleged defect is necessary regardless of the theory upon which plaintiff relies.

The plaintiff cannot show who manufactured the DES ingested by her mother, but contends it was one of two defendants, Lilly or Squibb. Discovery as to identification was obtained from the plaintiff, her parents, their doctor, a pharmacist, representatives of defendant drug companies, and others. These efforts have not, however, been successful in uncovering any evidence connecting any of these defendants with the drug taken by Mrs. Ryan.

William Ryan, plaintiff’s father, testified that the prescription was filled at a certain Eckerd’s Drug Store in Charlotte, North Carolina. The primary source of identification of the drug, and its manufacture by Lilly or Squibb, is a statement alleged to have been made by an Eckerd’s Drug Store pharmacist, which statement has been denied by the pharmacist. Plaintiff’s mother claims that she was told by this pharmacist that the DES bought by Eckerd’s in 1952 was supplied by either Lilly or Squibb, or both. This statement is not only denied by the man who supposedly made it, but it is hearsay because it is offered to prove that Lilly or Squibb was the manufacturer. Furthermore, the pharmacist alleged to have made the statement did not even work for Eckerd’s until 1956; Eckerd’s has retained no prescription records from this 1952-53 period.

Plaintiff, of course, is unable to identify the particular manufacturer of the DES taken by her mother before she was born. Nor can Margaret C. Ryan, plaintiff’s mother, identify the manufacturer. Mrs. Ryan remembers only that the drug came from Eckerd’s; she did not know what it was when it was prescribed, she remembers none of the markings on the bottle, nor can she remember the size or the shape of the pill. She remembers only that she thinks the pill was red or white. Nor can Mr. Ryan remember the size, shape, color or manufacturer of the DES taken by his wife. Neither the attending physician nor his records specify the manufacturer of the DES he prescribed. The drug store records were destroyed years ago, and there is no one now employed by Eckerd’s Drug Company who can state which manufacturer’s product would have been used to fill a prescription for DES in 1952 or 1953. 

The defendants are merely seven of the one hundred eighteen companies manufacturing or distributing DES or its cogeners in 1952 and 1953. The plaintiff has offered nothing to show that one of these seven, and not one of the other one hundred eleven, manufacturers produced the drug in question. While the culpable manufacturer may be before the Court as a defendant, it is just as likely that it is not. The plaintiff is therefore unable to meet the threshold burden of maintaining this action — i. e., identifying the manufacturer of the drug taken and thereby establishing causation in fact. 

The applicable principle is summarized in Annot., “Products Liability: Necessity and Sufficiency of Identification of Defendant as Manufacturer or Seller of Products Alleged to Have Caused Injury”:

Regardless of the theory which liability is predicated upon … it is obvious that to hold a producer, manufacturer, or seller liable for injury caused by a particular product, there must first be proof that the defendant produced, manufactured, sold or was in some way responsible for the product, and this rule is supported in all of the cases examined in this annotation.

This fatal flaw in plaintiff’s case is nothing new in DES litigation. A number of courts have dismissed actions in which a plaintiff was unable to connect her injuries to a particular manufacturer. In Gray v. U. S. and Eli Lilly & Company, a case remarkably similar to the one here, the Court summarily granted the defendant drug manufacturer’s motion for summary judgment. After extensive discovery, the plaintiff still could not identify the defendant Lilly as the particular manufacturer of the drug which caused her injury. The Court found that summary judgment was appropriate for the moving defendant because it would be “only speculation and conjecture” that might link the defendant to the injury.

In a very recent decision, a New Jersey Appellate Court affirmed a lower court’s granting of summary judgment on the same grounds. Namm v. Eli Lilly & Company. The Court affirmed summary judgment finding that it was “a fundamental principle of products liability law” that a plaintiff must prove that the defendant manufacturer actually made the product which caused the injury.

The rule has been aptly stated by Dean Prosser:

Plaintiff still has the burden of establishing that the particular defendant has sold a product which he should not have sold, and that it has caused his injury. This means that he must prove, first of all, not only that he has been injured, but that he has been injured by the product. The mere possibility that this may have occurred is not enough, and there must be evidence from which the jury may reasonably conclude that it is more probable than not. 

Plaintiff cannot supply any direct evidence identifying the manufacturer of the drug taken by her mother. The claim that either Lilly or Squibb is the manufacturer is unsupported and unsupportable on the record. That one of these two defendants manufactured the DES at issue here is at best a guess. At the time Mrs. Ryan was prescribed DES, a number of companies marketed the product in the dosage she took. Lacking any basis for this essential element of proof, defendants Lilly and Squibb are entitled to summary judgment on all claims made solely against them.

In an attempt to circumvent the requirement that she causally connect her injuries to a particular DES manufacturer, plaintiff has placed additional reliance on claims of conspiracy among all these defendants in the licensing, manufacture, promotion and sale of DES. In her complaint, plaintiff alleges “the collective efforts of all defendants resulted in a conspiracy to defraud and deceive by virtue of their active agreement to fraudulently and deceptively misrepresent the alleged benefits of DES or the acquiescence to such misrepresentations ….” In considering this claim, an examination of the events surrounding the development and marketing of DES is therefore necessary. These facts have been revealed through extensive discovery, and have not been controverted by plaintiff in her opposition to this motion.

Crucial to an understanding of this conspiracy claim is some knowledge of the history of the development and marketing of DES. Much of this history is developed in the record here, and has been set forth in detail in several reported cases. Plaintiff alleges a long list of “collective efforts” made by these defendants in connection with DES since the early 1940s; these efforts she would have the Court call a “conspiracy.” This Court, however, is convinced that the facts in the record establish neither the claimed “collective efforts” nor the elements of civil conspiracy.

A review of the facts relating to the plaintiff’s conspiracy allegations is necessary to understand the second shortcoming of plaintiff’s case. “

… continue reading RYAN v. ELI LILLY & CO. on Leagle.

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1980 DES Case: Ferrigno v. Eli Lilly & Co.

ABSTRACT

These are actions by eight female offspring for personal injuries they allegedly sustained because each of their mothers took a drug during pregnancy to prevent miscarriage. In the popular press, they have been denominated “the DES cases.”

The first legal complication arises because plaintiffs-mothers and daughters alike-are unable to link the pills used about a quarter of a century ago to a particular drug company. Plaintiff daughters were in utero when their mothers ingested the drug; a generation has passed, and because the need to identify was not and could not have been anticipated, no records have been maintained.

FERRIGNO v. ELI LILLY AND CO., Leagle, decision/1980726175NJSuper551_1669, July 2, 1980.

Although these are complex multi-party cases with forecasts of protracted trials involving novel legal issues of major import, the parties declined the court’s invitation to address some of the issues in advance of trial.

What I view as two of the most important issues shall be dealt with:

  1. the question of nonidentification
  2. and the legal principles that are to govern the trials.
Procedural History

Plaintiff Linda Ferrigno and her mother Marilyn instituted the first of the two actions involved here in June 1976. The complaint sought relief on their behalf and on behalf of a proposed class.

The would-be class was generally described as

… all those females born to mothers who consumed DES manufactured by the defendants, and were either born in this state or reside now in this state, and either:

  • developed cancer of their genital organs;
  • or developed structural changes of their genital organs not amounting to cancer;
  • or who have been exposed, but are yet to manifest any change or disease.

The Ferrigno complaint alleged that Marilyn took the drugs in 1952 and 1953 during the gestation period of Linda who was born on July 1, 1953. As a consequence, plaintiffs contended Linda developed cancer in or about 1970.

In November 1976 the Ferrignos filed a motion, in what was then the only pending action, to file an amended complaint. The amendment sought to add 19 additional plaintiffs and several additional defendants.

A month later, before a ruling had been rendered on the motion to amend, the same plaintiffs named in the proposed amendment commenced a second suit against the same defendants named in the proposed amendment. Further, plaintiffs for the first time sought to name a defendant class consisting of all manufacturers, processors, packagers and distributors in the United States dealing in DES, prescribed by physicians to New Jersey women “to prevent so-called accidents of pregnancy.”

In May 1977 an order was entered permitting plaintiffs to file the amended complaint in the first action and consolidating it with the second for purposes of discovery. At the same time, another order was entered staying without date the assertion of crossclaims and third-party claims.

Plaintiff class certification was denied in March 1979 and defendant class certification was likewise denied in April 1980.

Because of their scope, the actions were assigned to one trial judge who handled all phases of the litigation until March 1980, when they were reassigned to me.

In the interim, the individual claims of Linda and Marilyn Ferrigno were settled for an undisclosed amount and a dismissal was filed in March 1980. All other claims remain.

The Pleadings

Eight of the plaintiffs, including Linda Ferrigno, named in the amended complaint in the first action and in the complaint in the second suit (hereafter “the complaint”), are daughters whose mothers when pregnant with each took a synthetic estrogen prescribed by their doctors to prevent miscarriage. The remaining plaintiffs are either parents or spouses of those daughters.

The complaint alleges that as a direct consequence of the mothers taking the drugs their daughters developed a variety of serious ailments, including cancer of the vagina and cervix, adenosis and certain structural changes.

From 1946 to 1972, the complaint says, the 22 defendants manufactured, distributed and sold large quantities of the kind of prescription drugs ingested by the mothers. Collectively denominated as DES by plaintiffs, the drugs are alleged to have been diethylstilbestrol, stilbestrol and dienestrol.

According to the complaint, 12 of the defendants, at an unspecified time, joined together to form an organization known as the American Drug Manufacturers Association and also formed a “Small Committee for Stilbestrol” to develop DES. These 12 companies, acting together, were responsible for getting the drug on the market.

The complaint sounds in strict liability, negligence, misrepresentation and breach of warranties.

Negligence is charged in the design, testing, investigation, experimenting with, manufacturing, packaging, marketing, distributing, inspecting, promoting and labeling of the drugs. As to misrepresentation, the complaint asserts that defendants misstated to plaintiffs and to the medical profession that the said products were adequately and fully tested, that they were safe for use as directed and that they would cause no serious or deadly long-range side effects, which was untrue, and that defendants marketed the drugs after knowing they were ineffective.

Plaintiffs also allege that defendants knew, or in the exercise of reasonable care should have known, that the drugs were capable of causing cancerous and precancerous growths and were nevertheless promoted by the defendants for prescription by doctors to pregnant women to prevent loss of the fetus by spontaneous abortion.

Plaintiffs further maintain that defendants prospered from the many sales of the DES before 1972 when the Federal Food and Drug Administration (hereafter the FDA) “banned” its further sale and use for the prevention of miscarriages.

Plaintiffs acknowledge in the complaint that they are unable to determine in any of the cases, except for the Ferrignos, which of the defendants manufactured, distributed and sold the DES involved.1 However, they allege that where the particular manufacturer of DES cannot be established, liability should be borne by members of the industry in proportion to the amount of DES each sold during the periods of time the product was marketed as an anti-miscarriage drug.

The answers of defendants generally deny the significant allegations of the complaint; they assert plaintiffs were negligent and invoke the statute of limitations as an affirmative defense. “

… continue reading FERRIGNO v. ELI LILLY AND CO. on Leagle.

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1980 DES Case: Sindell v. Abbott Laboratories

ABSTRACT

This case involves a complex problem both timely and significant: may a plaintiff, injured as the result of a drug administered to her mother during pregnancy, who knows the type of drug involved but cannot identify the manufacturer of the precise product, hold liable for her injuries a maker of a drug produced from an identical formula?

Plaintiff Judith Sindell brought an action against eleven drug companies and Does 1 through 100, on behalf of herself and other women similarly situated. The complaint alleges as follows:

SINDELL v. ABBOTT LABORATORIES, Leagle, decision/198061426Cal3d588_1587, March 20, 1980.

Between 1941 and 1971, defendants were engaged in the business of manufacturing, promoting, and marketing diethylstilbesterol (DES), a drug which is a synthetic compound of the female hormone estrogen. The drug was administered to plaintiff’s mother and the mothers of the class she represents, for the purpose of preventing miscarriage. In 1947, the Food and Drug Administration authorized the marketing of DES as a miscarriage preventative, but only on an experimental basis, with a requirement that the drug contain a warning label to that effect.

DES may cause cancerous vaginal and cervical growths in the daughters exposed to it before birth, because their mothers took the drug during pregnancy. The form of cancer from which these daughters suffer is known as adenocarcinoma, and it manifests itself after a minimum latent period of 10 or 12 years. It is a fast-spreading and deadly disease, and radical surgery is required to prevent it from spreading. DES also causes adenosis, precancerous vaginal and cervical growths which may spread to other areas of the body. The treatment for adenosis is cauterization, surgery, or cryosurgery. Women who suffer from this condition must be monitored by biopsy or colposcopic examination twice a year, a painful and expensive procedure. Thousands of women whose mothers received DES during pregnancy are unaware of the effects of the drug.

In 1971, the Food and Drug Administration ordered defendants to cease marketing and promoting DES for the purpose of preventing miscarriages, and to warn physicians and the public that the drug should not be used by pregnant women because of the danger to their unborn children.

During the period defendants marketed DES, they knew or should have known that it was a carcinogenic substance, that there was a grave danger after varying periods of latency it would cause cancerous and precancerous growths in the daughters of the mothers who took it, and that it was ineffective to prevent miscarriage. Nevertheless, defendants continued to advertise and market the drug as a miscarriage preventative. They failed to test DES for efficacy and safety; the tests performed by others, upon which they relied, indicated that it was not safe or effective. In violation of the authorization of the Food and Drug Administration, defendants marketed DES on an unlimited basis rather than as an experimental drug, and they failed to warn of its potential danger.

Because of defendants’ advertised assurances that DES was safe and effective to prevent miscarriage, plaintiff was exposed to the drug prior to her birth. She became aware of the danger from such exposure within one year of the time she filed her complaint. As a result of the DES ingested by her mother, plaintiff developed a malignant bladder tumor which was removed by surgery. She suffers from adenosis and must constantly be monitored by biopsy or colposcopy to insure early warning of further malignancy.

The first cause of action alleges that defendants were jointly and individually negligent in that they manufactured, marketed and promoted DES as a safe and efficacious drug to prevent miscarriage, without adequate testing or warning, and without monitoring or reporting its effects.

A separate cause of action alleges that defendants are jointly liable regardless of which particular brand of DES was ingested by plaintiff’s mother because defendants collaborated in marketing, promoting and testing the drug, relied upon each other’s tests, and adhered to an industry-wide safety standard. DES was produced from a common and mutually agreed upon formula as a fungible drug interchangeable with other brands of the same product; defendants knew or should have known that it was customary for doctors to prescribe the drug by its generic rather than its brand name and that pharmacists filled prescriptions from whatever brand of the drug happened to be in stock.

Other causes of action are based upon theories of strict liability, violation of express and implied warranties, false and fraudulent representations, misbranding of drugs in violation of federal law, conspiracy and “lack of consent.”

Each cause of action alleges that defendants are jointly liable because they acted in concert, on the basis of express and implied agreements, and in reliance upon and ratification and exploitation of each other’s testing and marketing methods.

Plaintiff seeks compensatory damages of $1 million and punitive damages of $10 million for herself. For the members of her class, she prays for equitable relief in the form of an order that defendants warn physicians and others of the danger of DES and the necessity of performing certain tests to determine the presence of disease caused by the drug, and that they establish free clinics in California to perform such tests. “

… continue reading SINDELL v. ABBOTT LABORATORIES on Leagle.

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