U.S. District Court Potentially Expands The Reach Of Prenatal Tort Liability

On August 12, 2015, the United States District Court for the Southern District of New York potentially expanded the reach of tort liability against the manufacturer of a prenatal drug. In Sullivan v. Aventis, Inc., 2015 U.S. Dist. LEXIS 107360 (S.D.N.Y. 2015), U.S. District Court Judge Nelson Roman determined that the plaintiff had adequately pled a prenatal tort claim, as opposed to a claim for "wrongful life," in connection with birth defects allegedly sustained from her mother's use of a well-known fertility drug.

The decision in Sullivan focuses on the drug Clomid. Clomid was prescribed to the plaintiff's mother in 1992 "with the intent that it [would] help her conceive." Plaintiff was born in 1993, but was diagnosed with significant birth defects several months later.

Plaintiff alleged that Clomid remained present in her mother's "maternal circulation" during plaintiff's gestation. Relying on "studies, papers, and actions by the FDA from the 1960s through the present" purporting to show that Clomid may cause birth defects, plaintiff asserted that the defendant knew or should have known of these risks but failed to warn physicians and consumers about them. The complaint alleged causes of action for design and manufacturing defect, misrepresentation, and failure to warn.

Defendant moved to dismiss the complaint on several grounds. Most notably, defendant argued that the plaintiff's claims were virtually indistinguishable from those sounding in "wrongful life." In Becker v. Schwartz, the Court of Appeals rejected wrongful life as a viable cause of action under New York law on the grounds that recognizing such an injury would require courts to resolve the philosophical and theoretical "mystery" of whether "nonexistence" is preferable to impaired existence. In that same vein, the Court felt that such claims presented the "hurdle" of calculating damages based on a comparison of impaired existence versus nonexistence.

Unlike wrongful life claims, prenatal torts are recognized causes of action under New York law. Thus, "where a pregnant woman is injured through negligence and the child subsequently born suffers deformity or other injury as a result, recovery therefore may be allowed to the child, provided the causal relation between the negligence and the damage to the child be established by competent medical evidence." New York courts have distinguished prenatal torts from wrongful life claims "on the basis of whether the relevant counterfactual is 'nonexistence' or a healthy child."

In Sullivan, the plaintiff requested that Judge Roman simplify this dichotomy by applying the test adopted in Morgan v. Christman. In that case, a Kansas court distinguished wrongful life claims from prenatal torts on the basis of whether the defendant's negligence caused the birth defect. Although Judge Roman found this distinction to be somewhat "attractive," persuasive New York authority prevented him from applying that test.

Nevertheless, he concluded that plaintiff's claims were grounded in prenatal tort because they did not "raise the nonexistence problem" that confronted the parties in Becker, thus distinguishing plaintiff's claims from those of wrongful life. Under plaintiff's design defect theory, "Clomid could feasibly have been designed such that it would have helped [her] mother conceive with a substantially smaller risk of harm to plaintiff." In other words, "if Clomid had not been defectively designed, plaintiff would have been born healthy notwithstanding her mother's use of [the drug]."

The Sullivan decision is significant insofar as it avoids the philosophical inquiry raised in Becker (i.e., the "nonexistence problem") by "comparing plaintiff to a healthy child – a task that courts routinely entertain." Although this decision is only persuasive authority, the reasoning applied by the District Court has the potential to expand the scope of tort liability against pharmaceutical manufacturers, and perhaps to other areas where the distinction between prenatal tort and wrongful life claims is narrow.