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

INTRODUCTION

The basic purpose of the law of torts is to afford compensation for injuries sustained by one person as the result of the conduct of another. In Grover v. Eli Lilly & Co. , the Ohio Supreme Court acted to curtail this purpose. The Court held that the grandson of a woman who ingested the defective prescription drug, diethylstilbestrol, could not recover for injuries which were proximately caused by his mother’s in utero exposure to the drug. Although the Court did not accept an absolute rule precluding future actions based on preconception torts, the Court’s failure to allow such an action in the Grover case displayed a lack of foresight as to the evolving function of tort law.

GROVER V. ELI LILLY & CO., DES EXPOSURE: THE RIPPLING EFFECTS STOP HERE, AKRON LAW REVIEW, Vol. 26:2, 1992.

This Note first discusses the nature of DES, prenatal torts, and preconception torts. The Note then reviews product liability law in Ohio. The remainder of the Note analyzes the Grover decision and discusses its impact on public policy.

BACKGROUND

The Unique Nature of DES

DES is a synthetic estrogenic substance capable of producing the same effects as natural estrogens. It was first developed in England in 1938. DES was less expensive than natural estrogen and less painful to administer. Consequently, it became the preferred source of hormone therapy. In 1941, the FDA first approved the use of DES in the United States for a variety of medical problems but limited to uses unrelated to pregnancy. By 1947, the use of DES expanded to include the prevention of miscarriages. Between 1947 and 1971, DES was manufactured by several hundred companies and ingested by several million pregnant women.

The FDA contraindivated the drug’s use by pregnant women in 1971 after mounting evidence revealed that DES was ineffective at preventing miscarriages and increased the risk of vaginal and cervical cancer to females exposed to the drug in utero. Because this cancer may not develop in those women exposed in utero until well after they reach their late teens and early twenties, the victim may not realize the harm until decades after exposure. Due to the insidious  nature of DES and the latent manifestation of the injuries caused by exposure to the drug, legal debate abounds concerning liability.

Legal Liability Beyond the Traditional Tort

Prior to 1946, if a pregnant woman was injured, causing her child to be born in an injured or deformed state, the child was precluded from bringing any cause of action against the tortfeasor. Courts determined that a defendant had no legal duty to an individual who did not exist at the time of his tortious act, – and furthermore that allowing such causes of action would launch the law into “a boundless sea of speculation.”

As early as 1900, the judiciary realized that tort law needed to keep pace with medical science. This realization did not culminate into a legal cause of action for a child harmed in utero until 1946 when the United States District Court for the District of Columbia decided Bonbrest v. Kotz. However, the Bonbrest Court allowed recovery to a child only if there was a direct injury, the child survived the birth, and the child was viable at the time the injury took place.

The viability standard, however, remains a difficult one to distinguish and maintain. Hence, the modem trend of courts is to disregard the issue of viability and allow recovery for a child regardless of when the injury occurred provided that the child is subsequently born alive. Consequently, “once courts began to recognize a duty of care to a fetus before viability, no great intellectual leap was necessary to justify the imposition of liability for harm that occurred prior to conception.

The first case to allow a cause of action for a preconception tort was Jorgensen v. Meade Johnson Labs., Inc. The Jorgensen case was based on products liability law. The court, in allowing a cause of action based on wrongful conduct prior to the plaintiffs conception, focused upon causation, rather than upon traditional concepts of legal duty.

The first case to recognize a cause of action for a preconception tort based on a negligence theory was Renslow v. Mennonite Hosp. The Renslow Court directed its focus on the concept of legal duty and held that “there is a right to be born free from prenatal injuries foreseeably caused by a breach of duty to the child’s mother.”

To date, only a handful of courts has addressed the issue of legal liability to a child harmed by a preconception tort. Although only a small number of courts have confronted the issue of preconception torts, an abundance of authority on the topic exists.

Product Liability Law in Ohio

“In Ohio the law in the field of products liability has had a slow, orderly and evolutionary development.” In 1958, Ohio established an action in tort for the recovery of personal injuries based upon a manufacturer’s breach of an express warranty. The doctrine of strict liability in tort was adopted in Ohio in 1966. In order for a party to recover based upon a theory of strict liability in tort, it must be proven that:

  1. the product manufactured and sold by the defendant contained a defect;
  2. the defect existed when it left the hands of the defendant;
  3. and the defect was a direct and proximate cause of the plaintiff s injury.

In 1977, Ohio’s law of strict liability was expanded by the adoption of Section 402A of the Restatement (Second) of Torts which now governs strict liability for defective products in Ohio. In determining liability under a section 402A analysis, the focus should be on the product and the nature of the defect rather than the conduct of the manufacturer.

The theory of strict liability has been used as a basis for recovery for injury suffered as a result of a manufacturer’s failure to warn adequately of dangers associated with the use of the product. The claimant in such a case must prove that the manufacturer knew, or should have known, in the exercise of ordinary care, of the risk about which it failed to warn. Additionally, no liability will be found unless it can be shown that the manufacturer failed to take the same precautions as that of a reasonable person who was presenting a product to the public. Therefore, the standard imposed upon the defendant in a strict liability claim based upon an inadequate warning is the same as that imposed in a negligence claim based upon an inadequate warning. Due to the similarities, courts have encountered difficulty in distinguishing negligence claims from those founded on strict liability where the defect for section 402A purposes is asserted to be a lack of adequate warning.

STATEMENT OF THE CASE

Charles Grover was prematurely born on November 22, 1981. Charles suffers from cerebral palsy and other serious injuries. Plaintiffs allege that these injuries were the result of Charles’ premature birth and that such birth was proximately caused by Charles’ grandmother‘s ingestion of DES.

In 1952 and 1953, June Rose, grandmother of Charles Grover, was prescribed and ingested DES. During this time, June became pregnant and gave birth to Candace Grover, mother of Charles Grover. While in utero, Candace was exposed to the DES ingested by her mother, June Rose.

At the age of 22, Candace Grover discovered that she suffered from cervical abnormalities which were caused by her in utero exposure to DES. Six years later, Candace became pregnant and gave birth to her second son, Charles. Candace’s pregnancy with Charles remained uncomplicated until September, 1981 when a Shirodkar procedure was performed in an attempt to prevent a premature birth due to an incomplete cervix. Charles Grover was subsequently born 11 weeks premature.

On behalf of themselves and their two minor sons, Candace and Brent Grove filed suit against Cooper Laboratories, Inc. and Eli Lilly & Co.  in Federal District Court alleging strict liability, negligence and breach of warranty. The pharmaceutical companies filed several Motions for Summary Judgment, one of which stated that Charles Grover’s tort claims must be dismissed as Ohio does not recognize a cause of action on behalf of a child who was not concieved at the time of the alleged tort. The District Court certified a question of law to the Ohio Supreme Court, as this issue was one of first impression.

Certified Question of Law

The certified question presented to the Ohio Supreme Court stated: “Does Ohio recognize a cause of action on behalf of a child born prematurely, and with severe birth defects, if it can be established that such injuries were proximately caused by defects in the child’s mother’s reproductive system, those defects in turn being proximately caused by the child’s grandmother ingesting a defective drug (DES) during her pregnancy with the child’s mother?

The Supreme Court’s Answer to the Certified Question of Law

The Supreme Court of Ohio answered the certified question in the negative. Although the Court declined to adopt an “absolute no duty rule” as to a cause of action for preconception torts, the Court held that because of the remoteness in both time and causation, “a pharmaceutical company’s liability for the distribution or manufacture of a defective prescription drug does not extend to persons who were never exposed to the drug, either directly or in utero.” The Court noted that the pivotal question in ascertaining liability was “whether the drug companies should have known, at the time that it was prescribed, that DES could cause a birth defect that would result in the delivery of a premature child twenty or thirty years later.” Based upon the Court’s evaluation of that pivotal question, the Court determined as a matter of law that such a birth defect was not foreseeable.

In a strong dissent, Justice Resnick stated that “there can be no question that pharmaceutical companies should have known the dangers of [DES]. Justice Resnick, noting the “insidious nature” of DES,  stated that the majority, in its decision, failed to consider the uniqueness of the drug. “To hold under these circumstances that Charles Grover’s injuries were not foreseeable is to ignore an entire body of scientific information which was available or could have easily become available with a measure of care concerning the effects of DES on subsequent generations.”

ANALYSIS

For the purpose of evaluating the certified question before it, the Ohio Supreme Court assumed that Charles Grover was able to prove that his injuries were proximately caused by his mother’s in utero exposure to DES. In Therefore, although a direct causal link between the defective product and Charles’ injuries was deemed established, the Court concluded that “because of the remoteness of time and causation, . . . Charles Grover does not have an independent cause of action.” Due to this conflicting language regarding causation, the basis for the majority’s denial of a cause of action to Charles Grover remains unclear. Furthermore, because the Court addressed tort causes of action in general and interchanged language peculiar to negligence and strict liability, the specific impact of this decision is precarious at best.

Assessing the Manufacturers’ Knowledge

To find liability in a strict liability for failure to warn case, Ohio law requires that a plaintiff prove that the manufacturer “knew or should have known, in the exercise of ordinary care, of the risk or hazard about which it failed to warn.” The majority, in discussing the impact of such knowledge, found that “even if knowledge of DES’ dangerous propensities is sufficient to create liability to the women exposed to the drug in utero, this same knowledge does not automatically justify the extension of liability to those women’s children.” The Court precluded Charles Grover from pursuing his cause of action without analyzing the most crucial issue in this case: Whether knowledge of DES’ dangerous propensities extended to include harm to the offspring of females exposed to DES in utero.

The Court appears to be selecting an arbitrary cut-off point as to where foreseeability and causation will no longer allow a cause of action in tort. However, the Court gives little indication as to how it arrived at such a point. If DES manufacturers “knew or should have known” that females exposed to the drug in utero would be born with defective reproductive systems, then does it not follow that those same manufacturers “knew or should have known” that some of those females would choose to employ those reproductive systems in the future?

Where these women would not reach childbearing age until at least 16 years after their birth, could or should the manufacturers have known that DES could cause a birth defect in those women exposed in utero that would result in the delivery of an injured child twenty or thirty years later? The majority, with little justification for its position, decided that the answer to such a valid and pertinent question was no.

In reaching this decision, the majority engaged in a narrow analysis of what the manufacturer knew or should have known. Evidence exists indicating that in the 1930s and 1940s, the manufacturers of DES had available information which indicated that the drug caused reproductive tract abnormalities and cancer in exposed animal offspring. The duty of a drug manufacturer to warn of dangers associated with the drug extends beyond any actual knowledge the manufacturer gains from research it performs to include knowledge available to an expert through scientific literature. Where such knowledge is vital to establishing liability, the court’s indication that “this generalized knowledge” is not sufficient to impose liability for injuries to a third party that occur 28 years later is far too superficial of an analysis of what the manufacturer knew or should have known.

Determining Foreseeabiliy, or Lack Thereof

The Court, in analyzing the issue of foreseeability, did not adequately account for the unique nature of DES and the threat it poses to future generations. This nature was, however, addressed by the Ohio legislature. In an effort to deal with the latent hazards of DES, and to preserve a right to pursue a remedy, the legislature sought to protect those injured by allowing a suit to be advanced within two years of when the plaintiff reasonably discovered the existence of the injury incurred.

In discussing foreseeability, the Court notes that if an actor’s conduct creates a risk of harm to a certain class of plaintiffs, and such risk of harm actually injures a person of a different class to whom the actor could not reasonably have anticipated injury, then the actor is not liable to the party injured. However, this statement erroneously assumes that Charles Grover’s “class” could not be foreseeable.

Injuries to the reproductive organs of Charles Grover’s mother were deemed foreseeable. The harm to Charles was inextricably linked to those same foreseeable injuries in his mother’s reproductive organs. Therefore, although Charles may be in a different “class” than his mother, that “class” is not automatically unforeseeable merely because it may have been ignored or overlooked by the manufacturer.

Plaintiffs aver that scientific information regarding the risks of DES to reproductive organs of those exposed in utero was available to manufacturers as early as 1930. In light of this scientific information and the Ohio legislature’s special accommodation for actions brought pursuant to injury caused by DES, to hold that Charles was not foreseeable would be to ignore the “very fact of the insidious nature of DES.

A more thorough inquiry into what the manufacturer knew or should have known would have led the Court to a sound determination of foreseeability. Unfortunately, the Court chose a more cursory route on its way to precluding a cause of action for Charles as well as others in his “class.”

Public Policy and the Implications of the Grover Decision

The Court relied upon Enright v. Eli Lilly & Co., as persuasive authority. 101 As in Enright, the Ohio Supreme Court predicated its decision to preclude liability for Charles Grover’s claim on the basis of such a claim’s impact on public policy. The Court appears to be concerned that the “imposition of liability would invoke ‘staggering implications’ and ‘rippling effects,” upon the legal system.” However, as noted in an earlier decision by the Ohio Supreme Court, an increased possibility of litigation is not a valid reason for denying a judicial forum.

The same Court that denied a cause of action to Charles Grover once stated that it is the business of the law to remedy wrongs that deserve it, even at the expense of a ‘flood of litigation’; and it is a pitiful confession of incompetence on the part of any court of justice to deny relief upon the ground that it will give courts too much work to do. Furthermore, the general improbability of preconception torts’ resulting in actionable injuries as well as the practical problems associated with proof and causation will no doubt keep courts protected from the possibilities of a “floodgate of litigation.”

Although harmed irreparably by the tortious conduct of another, Charles Grover and others like him will have to go through life uncompensated. However, the cost of such tortious conduct will not go unpaid.

“Recognizing a cause of action for preconception torts serves a twofold purpose.” First, a deterrent force is added to tort law by requiring those responsible for inflicting debilitating physical injuries upon children to pay for the additional costs needed to enable the child to adapt to a society that is geared toward those without such injuries. 10 Such a requirement would prevent a windfall for the tortfeasor as well as help to alleviate from both society and the child’s family the enormous costs associated with raising a handicapped child. Second, it would keep with the traditional notion of compensation via the body of tort law. Therefore, the result of recognizing a cause of action for preconception torts would help to promote an accurate economic distribution of costs and permit an effective allocation of society’s resources. The Grover decision burdens the citizens of the State of Ohio by requiring them to pay for the tortious conduct of large drug manufacturers. By not allowing Charles Grover his day in court and his chance to prove his cause of action for the tort committed upon him, the burden will seem that much heavier.

CONCLUSION

“Any legal system, to remain viable over a span of time, must have the flexibility to admit change.” After the Grover decision, the viability of tort law in Ohio remains questionable. While the Court was required to assume that Charles could prove a direct causal link between the tortious conduct of the pharmaceutical companies and his injuries, the Court determined that too much time had passed to allow Charles a chance to advance his cause of action.

“To find solutions for a succession of differing problems in a continuously changing context the legal system must be creative.” By relying on traditional and stagnant concepts of duty and foreseeability, the Ohio Supreme Court has shown no creativity.

Although the Court did not accept a “blanket no-duty rule” regarding causes of action for preconception torts, their failure to provide guidelines as to when such causes of action may be advanced leaves potential litigants guessing, and the rest of us paying the bill.

LISA A. NAPOLI, 1992.

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