Goodson v. Searle Laboratories

Decision Date23 October 1978
Docket NumberCiv. No. N-76-376.
Citation471 F. Supp. 546
CourtU.S. District Court — District of Connecticut
PartiesGeorgia S. GOODSON v. SEARLE LABORATORIES.

Leander Gray, New Haven, Conn., for plaintiff.

Miles F. McDonald, Jr., Badger, Fisher, Cohen & Barnett, Greenwich, Conn., for defendant.

RULING ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

ELLEN B. BURNS, District Judge.

This is a products liability case involving the use of an oral contraceptive. On November 15, 1972, the plaintiff's physician issued to her a prescription for Demulen 21, a birth control pill, obtainable only by prescription. On November 19, 1973, she suffered a cerebrovascular accident which resulted in her partial blindness and some permanent loss of dexterity in her dominant hand. On November 18, 1976, the plaintiff filed the instant Complaint claiming that the defendant drug company's product was in a defective and unreasonably dangerous condition in that it contained an amount of estrogen sufficient to cause her stroke. She is asking one million dollars in damages, plus whatever other legal and equitable relief this Court may deem necessary and proper.

On June 22, 1978, the defendant drug company pursuant to Rule 56 of the F.R. C.P. filed the present Motion for Summary Judgment. The defendant contends there is no material issue of fact that it warned the medical profession prior to plaintiff's use of Demulen of the risk of cerebral thrombosis associated with the use of Demulen, and further argues that the manufacturer of a prescription drug has a legal duty only to warn the physician, not the patient, as to the risks associated with the use of the drug. The defendant thus maintains it is entitled to a summary judgment as a matter of law. The plaintiff argues, on the other hand, that the defendant had a duty to warn all foreseeable users of the drug rather than just the prescribing doctor, and that the defendant's failure to adequately warn the plaintiff of the allegedly defective condition of the drug raises issues of material fact which cannot be decided as a matter of law. For the reasons discussed below, the defendant's Motion for Summary Judgment must be granted.

Rule 56(c) of the F.R.C.P. provides that summary judgment shall be rendered in cases where there is no genuine issue as to any material fact and where the moving party is entitled to a judgment as a matter of law. In support of its Motion, the defendant has submitted a number of exhibits. These include extracts concerning Demulen from the Physician's Desk Reference supplement c/1970 (Ex. D),1 the defendant's directions for Demulen's use, warnings to physicians as to its side effects and adverse reactions and package inserts (Ex. E),2 and the affidavit of the prescribing physician stating that he was aware of the risk of cerebral thrombosis claimed to be associated with the use of all hormonal oral contraceptives, including Demulen, from his reading of medical journal articles, package inserts and the Physician's Desk Reference and discussions with colleagues (Ex. A). Nowhere in her Memorandum opposing the defendant's Motion does the plaintiff claim that the defendant did not in fact warn the medical profession and the prescribing physician. And, indeed, given the exhibits filed by the defendant, this Court is compelled to find there is no issue of material fact that the defendant warned the medical profession and the prescribing doctor prior to the plaintiff's use of the risk of cerebral thrombosis associated with the use of Demulen. Even were the warning found to be inadequate as to the medical profession as a whole, it is clear that the physician who prescribed Demulen for the plaintiff had been adequately warned of the increased risk of thromboembolic disease associated with its use.

Once the existence of this material fact has been established, the next question is whether the defendant is consequently entitled to a judgment as a matter of law. It is the position of the defendant that the manufacturer of a prescription drug has a duty to warn the physician, not the patient. The leading opinion in this Circuit in this area is that of Circuit Judge J. Joseph Smith in Basko v. Sterling Drug, Inc., 416 F.2d 417 (1969). There Judge Smith noted that the Connecticut Supreme Court has adopted the strict liability position taken by § 402A of the Restatement (Second) of Torts, and went on to reason:

While § 402A imposes strict liability on the seller who markets a product "in a defective condition unreasonably dangerous" to the consumer, comment k makes an exception to the strict liability rule in the case of products characterized as "unavoidably unsafe." These include "products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use," and they are "especially common in the field of drugs." . . .
Although the imposition of strict liability for the idiosyncratic side effects of a drug is certainly not unthinkable, comment k provides that such a drug is neither "defective" nor "unreasonably dangerous" in the § 402A sense if the manufacturer gives an adequate warning of the risks involved.
In this respect, comment k simply adopts the ordinary negligence concept of duty to warn. If proper warning is given "where the situation calls for it," the manufacturer is "not to be held to strict liability for unfortunate
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