” This case was initiated in the United States District Court for the District of Rhode Island. The plaintiff, Marilyn Castrignano (Marilyn), sought to recover damages for injuries that she allegedly incurred in utero when her mother ingested diethylstilbestrol (DES), which the plaintiff claimed was manufactured by the defendant, E.R. Squibb & Sons, Inc. (Squibb).
CASTRIGNANO v. E.R. SQUIBB & SONS, INC, Leagle, 19881321546A2d775_11316, August 3, 1988.
The Federal District Court conducted a jury trial that held Squibb strictly liable in tort and liable for breach of implied warranty of merchantability. After the verdict the trial judge, Chief Judge Francis J. Boyle, acting pursuant to Rhode Island Supreme Court Rule 6, sua sponte certified three questions to this court concerning liability for injuries caused by prescription drugs. The certified questions are as follows:
- 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?
- 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 theory of strict liability in tort?
- 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?
Since Judge Boyle asked our court to consider the specific facts of this case when answering the certified questions, a discussion of the facts is necessary.
Marilyn’s complaint alleges she has suffered physical abnormalities of her reproductive system that have caused her to suffer miscarriages, infections, and other complications because of her exposure to DES in utero. The jury trial against Squibb began in 1986.
The facts elicited at trial are as follows. Susan Silvestri, Marilyn’s mother, conceived Marilyn on August 15, 1953. Doctor Thomas Fogarty was Mrs. Silvestri’s physician. In November 1953 Mrs. Silvestri experienced some cramping. The medical records that Dr. Fogarty kept indicated that on November 5 he prescribed progesterone for Mrs. Silvestri.
Another notation in the medical records indicated that Dr. Fogarty prescribed Stilbetin for Mrs. Silvestri. Stilbetin is Squibb’s trade name for DES. The date of the medical-record notation was somewhat illegible and seemed to indicate that Stilbetin was prescribed on either the 1st or the 10th of December. Considering both of these dates, calculations established that Mrs. Silvestri began taking DES between the sixteenth and eighteenth weeks of gestation. She continued to take DES each day throughout her pregnancy. Mrs. Silvestri testified that Dr. Fogarty told her that he prescribed DES to prevent her from having a spontaneous abortion or, in layman’s terms, a miscarriage.
Several of plaintiff’s doctors testified that Marilyn’s various physical problems were related to DES. They reached this conclusion because of the particular constellation of her symptoms. Although each symptom could occur in the general female population, when they occur in the same person they signal DES exposure. These doctors also testified that at the time Dr. Fogarty prescribed DES to Mrs. Silvestri, several studies were published that should have put Squibb on notice that DES injured the reproductive systems of fetuses exposed to the drug. Furthermore they noted that in 1971 the FDA banned the use of DES for the prevention of spontaneous abortions.
Squibb’s witnesses, on the other hand, testified that all the problems that Marilyn alleges were caused by DES can be found in women who were never exposed to DES. They also stated that Mrs. Silvestri took DES after the time when it could have adversely affected the development of Marilyn’s reproductive system. No damage could occur from DES exposure during the eighteenth and nineteenth weeks of gestation but rather only during the third through the fourteenth weeks of gestation. Squibb’s experts also insinuated that Mrs. Silvestri’s ingestion of the prescribed progesterone could have caused the abnormalities in Marilyn’s reproductive system.
Alternatively Squibb’s experts testified that regardless of whether Mrs. Silvestri ingested DES, Squibb cannot be held liable because in 1953 it had no reason to know of the drug’s alleged adverse effects. They noted that in 1947 the Federal Drug Administration (FDA) approved the use of DES for the prevention of miscarriages. Contradicting the publications cited by plaintiff, Squibb’s experts argued that none of the research available in 1953 reasonably established that a human female’s exposure to DES in utero could damage her reproductive system. Without any reason to know of any side effects, they argue, they cannot be held liable.
After plaintiff presented her case, the trial judge dismissed the claims based on res ipsa loquitur, breach of express warranty, and misrepresentation. Opting to let the case proceed to the jury before ruling on the motion for a directed verdict, the trial judge reserved ruling on the remaining counts of negligence, strict liability, implied warranty of merchantability, and implied warranty of fitness for a particular purpose.
The jury returned a verdict against Squibb on the strict-liability and implied-warranty-of-merchantability counts but ruled in Squibb’s favor on the remaining counts. Squibb immediately filed a motion for a new trial notwithstanding the verdict. Squibb argued that in the charge to the jury, the trial judge failed to exclude prescription drugs from strict-tort liability pursuant to the Restatement (Second) Torts, § 402A, comment k (1965). In the instructions the trial judge did not recognize a comment-k exception for prescription drugs but instead instructed the jury that Squibb would be strictly liable if the drug was defective and unreasonably dangerous according to an ordinary consumer’s expectations. He further instructed that in order to make this determination, the jury must employ a risk-benefit analysis in light of the information available at the time the drug was taken because drugs are by nature dangerous substances. Upon considering Squibb’s motion, the trial judge noted that the application of comment k to prescription-drug liability had not yet been addressed in Rhode Island. He therefore certified these questions to our court.
To summarize briefly this court’s answers to the certified questions, we rule:
- Based on the facts of this case Rhode Island law recognizes actions for damages for personal injury based on the theories of strict liability in tort and breach of the implied warranty of merchantability.
- In a tort action comment k is a defense to an allegation of design defect. Comment k, however, is not a defense to an allegation of failure to warn. Comment k also is a defense for liability under the contract theory of breach of implied warranty of merchantability.
- The application of comment k is a mixed question of law and fact. The defendant who uses comment k as a defense bears the burden of proving that the comment applies. If reasonable minds could only reach one conclusion, the judge may rule on comment k’s application. Otherwise, the question should be submitted to the jury.
The defendant correctly contends that Rule 6 of the Supreme Court Rules imposes no absolute duty on this court to answer the certified questions. Jefferson v. Moran. We, however, shall respond to the questions to clarify the law of Rhode Island on these issues. To analyze the issues at hand logically, we shall bifurcate the first question and address the strict-liability-in-tort issue in full. Second we shall address the issue of whether the breach of the implied warranty of merchantability is an appropriate theory of recovery for prescription-drug cases.” …
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