Dunkin v. Syntex Laboratories, Inc., Civ. C-76-428.

• Decision Date: 14 October 1977
• Docket Number: No. Civ. C-76-428.,Civ. C-76-428.
• Parties: Gail Y. DUNKIN and husband, Russell L. Dunkin, Plaintiffs, v. SYNTEX LABORATORIES, INC., Syntex (FP), Inc. and Syntex Puerto Rico, Inc., Defendants.
• Court: U.S. District Court — Western District of Tennessee

443 F. Supp. 121

Gail Y. DUNKIN and husband, Russell L. Dunkin, Plaintiffs, v. SYNTEX LABORATORIES, INC., Syntex (FP), Inc. and Syntex Puerto Rico, Inc., Defendants.

No. Civ. C-76-428.

United States District Court, W. D. Tennessee, W. D.

October 14, 1977.

COPYRIGHT MATERIAL OMITTED

J. B. Cobb, Memphis, Tenn., for plaintiffs.

Henry H. Hancock, Farris, Hancock, Gilman, Branan & Lanier, Memphis, Tenn., for defendants.

MEMORANDUM DECISION AND ORDER GRANTING SUMMARY JUDGMENT

BAILEY BROWN, Chief Judge.

This cause comes before the court on the motion of defendants, Syntex Laboratories, Inc., Syntex (FP), Inc., and Syntex Puerto Rico, Inc., for summary judgment as to each cause of action stated against them in this case. This action was brought by Gail Y. Dunkin and her husband Russell L. Dunkin, who seek to recover for injuries and losses allegedly occasioned by a stroke suffered by Gail Dunkin as a result of her use of defendants' birth control pills. The pills were prescribed for her by her physician.

In considering this motion, the court is cognizant of the fact that summary judgment is appropriate only where there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law. F.R.Civ.P. Rule 56.

I BREACH OF DUTY TO WARN OF RISKS ASSOCIATED WITH USE OF A PRESCRIPTION DRUG

The Dunkins contend that defendants negligently breached a duty to adequately warn the prescribing physician, the general medical community, and Gail Dunkin herself of the risks inherent in the use of Norinyl 1 + 80, 28-day birth control pills, the type used by Dunkin.

The initial issue presented concerns the scope of the duty to warn imposed by law upon a drug manufacturer selling prescription drugs. Defendants contend that such a duty exists, but that it is limited to a duty to warn the prescribing physician of the risks inherent in the drugs he prescribes.

Counsel has advised the court that there is no Tennessee law directly controlling this issue, and the court is of the same opinion. In this situation, this being a diversity case, this court must make an educated guess as to the law the courts of Tennessee would apply if faced with the issue.

This court is of the opinion that the Tennessee courts would choose to apply the majority rule, that the manufacturer of a prescription drug has a duty to warn only physicians, and not the ultimate users, of risks associated with the use of that drug. This rule is based on a recognition that prescription drugs are sold on a prescription basis and not over-the-counter because the special expertise of a trained physician is necessary for their safe use. Thus, an effective warning could go only to the medical profession, and not to an untrained patient. Moreover, concern has been expressed that attempts to give detailed warnings to patients could mislead patients and might also tend to interfere with the physician/patient relationship. On the other hand, it has been recognized that an effective warning regarding a prescription drug must go to the medical profession generally, and not to the prescribing physician alone, since the patient may not return to the original prescribing physician when problems occur. See Hoffman v. Sterling Drug, Inc., 485 F.2d 132 (3rd Cir. 1973); Basko v. Sterling Drug, Inc., 416 F.2d 417 (2d Cir. 1969); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968); Stottlemire v. Cawood, 213 F.Supp. 897 (D.D.C.1973).

This is not to suggest that persons using prescription drugs should receive no warning of the dangers involved in the use of those drugs. Rather, it is this court's determination that the duty to warn the patient, if one exists, lies with the physician and not with the drug manufacturer.

Further, the rule stated above with regard to prescription drugs would not apply in a case involving over-the-counter drugs.

The affidavits and depositions now on file in this case establish without contradiction that the following warnings were provided by defendants concerning the possible side effects attending the use of Norinyl birth control pills:

(1) The Physicians' Desk Reference for 1973 and 1974, the years in question, warned of possible cerebral apoplexy, cerebral thrombosis, or cerebrovascular disorders, thus specifically alerting physicians to the danger of strokes.

(2) A package insert for all packages of Norinyl 1 + 80, 28-day, addressed to physicians, also warned of possible cerebral apoplexy, cerebral thrombosis, or cerebrovascular disorders.

(3) Additionally, a leaflet contained in each Norinyl 1 + 80, 28 day tablet dispenser, labeled "patient information," warned that safe use of the drug required "a careful discussion with your doctor" and that the most serious known side effect of the drug was "abnormal blood clotting, which can be fatal."¹

(4) The package insert for physicians, and the leaflet for patients, were in accordance with FDA regulations, and in fact the exact language contained in the insert and leaflet was required by those regulations.

With regard to the adequacy of the warnings given, it is difficult to see how they could have been more precise or more accessible to the medical profession. The package insert and the Physicians' Desk Reference entry warned specifically of the possibility of the adverse side effect which Gail Dunkin allegedly suffered. Physicians prescribing the drug would almost certainly be advised of the dangers inherent in its use by either the insert or the Physician's Desk Reference entry. The medical profession in general would be advised of the dangers involved by the Physician's Desk Reference, a standard reference work available throughout the medical community. Accordingly, this court holds that the warnings given by defendants regarding strokes as a possible side effect of Norinyl 1 + 80, 28-day were adequate as a matter of law in terms of the precision in which they pointed out the risk and in terms of their distribution within the medical profession.

Moreover, Dr. Wilson, who prescribed Norinyl for Dunkin, deposed that at the time he prescribed the pills for her he was aware of the risk of cerebral vascular accidents. He further stated that his sources of information were the package inserts and Physician's Desk Reference entry, as well as information provided by defendants' traveling "detail men." Wilson's familiarity with the risks associated with Norinyl buttresses our conclusion that adequate warnings were given. It also negates the proposition that any presumed breach of the duty to warn on the part of defendants herein could have been the proximate cause of Gail Dunkin's injury.

Accordingly, defendants are entitled to a summary judgment as to plaintiffs' negligent failure to warn claim.

II NEGLIGENT MARKETING, PROMOTION AND MISREPRESENTATION

The Dunkins also allege that defendants are liable for negligently marketing and promoting an inadequately tested drug with unknown side effects and for negligently misrepresenting Norinyl as safe when in fact inadequate testing had been conducted to support such a representation.

However, as noted above, there is no genuine issue of material fact regarding the warnings concerning possible cerebrovascular accidents which defendants provided to the medical community at the time Gail Dunkin received a prescription for Norinyl and used the drug. This is clearly not a case where a drug company marketed a drug with unknown deleterious side effects, but rather a case where defendants marketed a drug with known adverse consequences for a small but statistically significant percentage of users. Moreover, this court has already held that the risks associated with Norinyl were sufficiently communicated to the medical profession at large and to Dunkin's prescribing physician in particular, and that the warnings given made specific and unambiguous reference to the precise side effect allegedly suffered by Dunkin.

Accordingly, this court holds as a matter of law that at all times material to this lawsuit, defendants had conducted...