1990 DES Case: Castrignano v. E.R. Squibb & Sons, Inc.


Marilyn Castrignano brought a diversity suit against, inter alia, Squibb & Sons, Inc. (“Squibb”) for damages allegedly caused in utero by exposure to diethylstylbestrol (“DES”) in 1953. She claimed to have suffered congenital gynecological abnormalities which caused miscarriages and other medical problems. The case ultimately went to trial against Squibb alone on four theories of Rhode Island law: negligence, strict liability in tort and breaches of implied warranties of merchantability and fitness.

CASTRIGNANO v. E.R. SQUIBB & SONS, INC., Leagle, 19901355900F2d455_11266, May 3, 1990.

In trying the case and instructing the jury, the district court was required to determine whether the design defect theory of strict liability was applicable on the facts of this case under Rhode Island law. The district court decided that Rhode Island would allow the action but would exempt manufacturers from strict liability under the Restatement (Second) of Torts, comment k, if the product satisfied a risk-benefit balancing test. It rejected the argument that comment k exempted prescription drugs from strict liability as a matter of law where proper warnings were given. The court instructed the jury to apply a risk-benefit analysis to determine whether the product was unreasonably dangerous, and thus, whether Squibb was subject to strict liability. The jury found Squibb strictly liable and in breach of the implied warranty of merchantability. Damages were awarded in the amount of $400,000.

After the verdict, the district court reserved judgment on the defendant’s motions for new trial and judgment n.o.v., certifying the following three questions to the Rhode Island Supreme Court concerning the applicability of comment k:

  1. Does the State of Rhode Island recognize an action for damages for personal injuries in the circumstances presented in this action based on theories of strict liability in tort and breach of warranty of merchantability?
  2. Does comment (k) to § 402A, Restatement of Torts apply in Rhode Island to an action for damages for personal injuries in the circumstances presented in this action in an action based upon the theory of strict liability in tort?
  3. If comment (k) applies to this type of action, is its application to the prescription drug DES a matter of law or a question of fact, and, if a question of fact, which party has the burden of proof?

The Rhode Island Supreme Court answered the certified questions in an opinion reported as Castrignano v. E.R. Squibb & Sons, Inc., (R.I.1988). On the first question, the court held that the facts of this case could support an action based on the theories of strict liability (both design defect and failure to warn) and implied warranty of merchantability. Second, in strict liability, comment k is a defense to an allegation of design defect, but not to an allegation of failure to warn, which continues to be governed by comment j, adopted in an earlier case. It is also a defense to an implied warranty of merchantability claim. Finally, the application of comment k is a mixed question of law and fact to be decided by the judge only if reasonable minds could not differ, but otherwise by the jury. If the benefits of the drug are determined to outweigh the risks, the manufacturer is exempt from strict liability. The defendant has the burden of proving the defense.

Following the Castrignano decision, the district court ruled on its reserved motions for new trial and judgment notwithstanding the verdict. Squibb argued a number of inadequacies in the jury instructions in light of the Rhode Island Supreme Court’s decision regarding comment k. The district court decided that whatever deficiencies may have been present, Squibb had received the benefit of a balancing test instruction despite the fact that it had failed to introduce any evidence that entitled it to the comment k defense. The court therefore denied the motions.

On appeal, the defendant challenges only the denial of a new trial, arguing that the Rhode Island Supreme Court’s decision amounts to a change in the law that requires the grant of a new trial. Castrignano cross-appeals the date from which prejudgment interest was calculated. Having reviewed carefully the substantial record in this case and the governing law, we affirm the district court’s decision. We affirm, too, the award of prejudgment interest.” …

… continue reading the full paper CASTRIGNANO v. E.R. SQUIBB & SONS, INC., on Leagle.

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