Grover v. Eli Lilly & Co.

The United States District Court for the Northern District of Ohio has certified the following question to us:

“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?”

For purposes of this question, we are required to assume that Charles Grover can prove that his injuries were proximately caused by his mother’s *758exposure to DES. We are not evaluating the facts of this case, but determining, as a matter of law, whether Charles Grover has a legally cognizable cause of action.

DES was prescribed to pregnant women during the 1940s, 1950s and 1960s to prevent miscarriage. The FDA banned its use by pregnant women in 1971 after medical studies discovered that female children exposed to the drug in útero had a high incidence of a rare type of vaginal cancer. See 36 Fed.Reg. 21,537 (1971). Candy Grover was exposed to DES as a fetus. Her son, Charles Grover, claims that his mother’s DES-induced injuries were the cause of his premature birth and resulting injuries.

Because the mother and the child whose injury results from her injury are uniquely interrelated, and because it is possible that the mother may not discover the extent of her own injury until she experiences difficulties during pregnancy, the facts of this case pose a novel issue. Courts and commentators refer to the child’s potential cause of action in such cases as a “preconception tort.” See, e.g., Note, Preconception Torts: Foreseeing the Unconceived (1977), 48 U.Colo.L.Rev. 621. The terminology stems from the fact that a child is pursuing liability against a party for a second injury that flows from an initial injury to the mother that occurred before the child was conceived.

Only a handful of courts have addressed whether a child has a cause of action for a preconception tort. One recurring issue is whether a child has a cause of action if a physician negligently performs a surgical procedure on the mother, such as an abortion or a Caesarean section, and the negligently performed procedure causes complications during childbirth several years later that injure the infant. See Albala v. New York (1981), 54 N.Y.2d 269, 445 N.Y.S.2d 108, 429 N.E.2d 786 (child has no cause of action for doctor’s negligence during abortion performed four years prior to his conception); Bergstreser v. Mitchell (C.A.8, 1978), 577 F.2d 22 (construing Missouri law) (child has a cause of action against a doctor based on the doctor’s negligence during a Caesarean section performed two years prior to the child’s conception). In another malpractice suit, the Illinois Supreme Court recognized that a child had a cause of action against a hospital that negligently transfused her mother with Rh-positive blood eight years prior to the child’s conception. Renslow v. Mennonite Hospital (1977), 67 Ill.2d 348, 10 Ill.Dec. 484, 367 N.E.2d 1250. As a result, the mother’s body produced antibodies to the Rh-positive blood that later injured her fetus during pregnancy. See, also, Monusko v. Postle (1989), 175 Mich.App. 269, 437 N.W.2d 367 (allowing cause of action by child against her mother’s physicians for failure to inoculate the mother with rubella vaccine prior to the child’s conception).

*759In McAuley v. Wills (1983), 251 Ga. 3, 303 S.E.2d 258, the Supreme Court of Georgia evaluated a wrongful death action brought on behalf of an infant who died during childbirth due to the mother’s paralysis. The suit was brought against the driver who had originally caused the mother’s paralysis in an automobile accident. The court held that a person may owe a duty of care to a child conceived in the future, but also held that the injury in that case was too remote as a matter of law to support recovery. Id. at 6-7, 303 S.E.2d at 260-261. The driver could not reasonably foresee, as a matter of law, that his lack of care in driving a motor vehicle would result in complications during the delivery of a child who was not yet conceived at the time of the accident. Id.1

The facts of these cases are significantly different from those of the case before us. The cause of action certified to us involves the scope of liability for the manufacture of a prescription drug that allegedly had devastating side effects on the original patient’s female fetus. However, this case is not about the devastating side effects of DES on the women who were exposed to it, which have indeed been well documented in medical studies and court opinions. See authorities cited infra at 763-764 (Resnick, J., dissenting) and the discussion of the state of medical research at 765-766 (Resnick, J., dissenting). This case is concerned with the rippling effects of that exposure on yet another generation, when that female child reaches sexual maturity and bears a child. Because a plaintiff in Charles Grover’s position cannot be injured until the original patient’s child bears children, the second injury will typically have occurred more than sixteen years after the ingestion of the drug.

Several courts have addressed a fact pattern virtually identical to the facts of the case currently before this court. The New York Court of Appeals held that a child does not have a cause of action, in negligence or strict liability, against a prescription drug company based on the manufacture of DES if the *760child was never exposed to the drug in útero. Enright v. Eli Lilly & Co. (1991), 77 N.Y.2d 377, 568 N.Y.S.2d 550, 570 N.E.2d 198, certiorari denied (1991), 502 U.S. -, 112 S.Ct. 197, 116 L.Ed.2d 157. The court relied in part on its earlier opinion in Albala v. New York, supra. In both cases, the court was concerned with the “staggering implications of any proposition which would honor claims assuming the breach of an identifiable duty for less than a perfect birth and by what standard and the difficulty in establishing a standard or definition of perfection. * * *” Id., 54 N.Y.2d at 273, 445 N.Y.S.2d at 109, 429 N.E.2d at 788. See Enright v. Eli Lilly & Co., supra, 77 N.Y.2d at 384, 568 N.Y.S.2d at 553, 570 N.E.2d at 201. The court was troubled by the possibility that doctors would forgo certain treatments of great benefit to persons already in existence out of fear of possible effects on future children. Albala, supra, 54 N.Y.2d at 274, 445 N.Y.S.2d at 110, 429 N.E.2d at 788-789. In Enright, the court noted that “the cause of action plaintiffs ask us to recognize here could not be confined without the drawing of artificial and arbitrary boundaries. For all we know, the rippling effects of DES exposure may extend for generations. It is our duty to confine liability within manageable limits * * *. Limiting liability to those who ingested the drug or were exposed to it in útero serves this purpose.” Id., 77 N.Y.2d at 387, 568 N.Y.S.2d at 555, 570 N.E.2d at 203. See, also, Loerch v. Eli Lilly & Co. (Minn.1989), 445 N.W.2d 560 (the evenly divided Supreme Court of Minnesota affirmed, without opinion, a lower court’s decision that a child who was not exposed to DES has no cause of action).

One court has held that a plaintiff situated similarly to Charles Grover has a cause of action. The United States Court of Appeals for the Seventh District reversed a lower court’s directed verdict on the issue of a pharmaceutical company’s liability to a child for injuries caused by a premature birth. McMahon v. Eli Lilly & Co. (C.A.7,1985), 774 F.2d 830. The court concluded that under Illinois law the company could be liable for failing to warn of the dangerous propensities of the drug, and need not have anticipated a particular side effect. Id. at 834-835.

We find the reasoning applied by the New York Court of Appeals persuasive on the issue currently before us. As an initial matter, we note that the pharmaceutical companies’ conduct must be evaluated based on whether they knew or should have known of a particular risk through the exercise of ordinary care. The marketing of prescription drugs differs significantly from other consumer goods. Each drug is tested and approved for use by the Food and Drug Administration and is selected for use by a physician, who then prescribes the drug to the ultimate user. As a result, the drug manufacturer’s primary responsibility is to provide adequate warnings to the physician. Prosser & Keeton, Law of Torts (5 Ed.1984) 688, Section 96. The manufactur*761er does not breach its duty to warn — in negligence, in strict liability for breach of warranty, or in strict liability in tort — until the company knew or should have known of a particular risk through the exercise of ordinary care. Id.; Crislip v. TCH Liquidating Co. (1990), 52 Ohio St.3d 251, 257, 556 N.E.2d 1177, 1182-1183, fn. 1.

It is on this point that Ohio law differs from Illinois law as construed in McMahon v. Eli Lilly & Co., supra, 774 F.2d at 834-835. The Seventh Circuit held that knowledge of the general dangerous propensities of the drug was sufficient to subject the company to liability for failure to warn. This court has stated that “[i]n a products liability case where a claimant seeks recovery for failure to warn or warn adequately, it must be proven 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.” (Footnote omitted.) Crislip v. TCH Liquidating Co., supra, 52 Ohio St.3d at 257, 556 N.E.2d at 1182-1183. Even if knowledge of the drug’s “dangerous propensities” is sufficient to create liability to the women exposed to the drug in útero, this same knowledge does not automatically justify the extension of liability to those women’s children. It is one thing to say that knowledge of a propensity to harm the reproductive organs is sufficient to impose liability for a variety of different injuries to the reproductive organs. It is yet another thing to say that this generalized knowledge is sufficient to impose liability for injuries to a third party that occur twenty-eight years later.2

Knowledge of a risk to one class of plaintiffs does not necessarily extend an actor’s liability to every potential plaintiff. While we must assume that DES was the proximate cause of Charles Grover’s injuries, an actor is not liable for every harm that may result from his actions. “ * * * The plaintiff sues in her own right for a wrong personal to her, and not as the vicarious beneficiary of a breach of duty to another.” Palsgraf v. Long Island RR. Co. (1928), 248 N.Y. 339, 342, 162 N.E. 99, 100. An actor does not have a duty to a particular plaintiff unless the risk to that plaintiff is within the actor’s “range of apprehension.” Id. at 344, 162 N.E. at 100. “* * * If the actor’s conduct creates such a recognizable risk of harm only to a particular class of persons, the fact that it in fact causes harm to a person of a different class, to whom *762the actor could not reasonably have anticipated injury, does not make the actor liable to the persons so injured.” 2 Restatement of the Law 2d, Torts (1965), Section 281, Comment c; Jeffers v. Olexo (1989), 43 Ohio St.3d 140, 142-143, 539 N.E.2d 614, 616-617. The existence of a legal duty is a question for the court, unless alternate inferences are feasible based on the facts. Palsgraf supra, 248 N.Y. at 345, 162 N.E. at 101.

When a pharmaceutical company prescribes drugs to a woman, the company, under ordinary circumstances, does not have a duty to her daughter’s infant who will be conceived twenty-eight years later. Charles Grover’s injuries are not the result of his own exposure to the drug, but are allegedly caused by his mother’s injuries from her in útero exposure to the drug. Because of the remoteness in time and causation, we hold that Charles Grover does not have an independent cause of action, and answer the district court’s question in the negative. 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 útero.

Judgment accordingly.