Polley v. Ciba-Geigy Corp.

658 F. Supp. 420, 1987 U.S. Dist. LEXIS 3431
CourtDistrict Court, D. Alaska
DecidedFebruary 11, 1987
DocketA86-327 Civ
StatusPublished
Cited by8 cases

This text of 658 F. Supp. 420 (Polley v. Ciba-Geigy Corp.) is published on Counsel Stack Legal Research, covering District Court, D. Alaska primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 1987 U.S. Dist. LEXIS 3431 (D. Alaska 1987).

Opinion

ORDER

HOLLAND, District Judge.

Ruling on Motion for Summary Judgment

The Court now has before it Defendant Upjohn’s motion for partial summary judgment.

Upjohn seeks a determination, as the law of the case, that drug manufacturers have a duty to provide physicians with reasonable warnings of the risks inherent in the use of prescription medicines which they manufacture and that drug manufacturers have no duty to advise patients directly, or to use physicians as mere conduits for specific patient instructions generated by the manufacturers.

Upjohn requests a ruling that evidence of “patient brochures”, or other materials designed by a manufacturer of prescription medicines for ultimate distribution to patients, is irrelevant to a manufacturer’s duty to warn. Upjohn contends that such evidence should not be admissible since the manufacturer’s duty to warn the physician is satisfied by the provision to physicians of warnings which reasonably disclose all risks inherent in the use of the drug which the manufacturer knew or should have known to exist.

Prior to removal of this action, Upjohn moved in state court for summary judgment. Upjohn sought a determination that a drug manufacturer has no legal duty to provide information directly to the consumer of a prescription drug. The motion was grounded on the “learned intermediary” rule, by which the manufacturer satisfies its duty to warn of risks inherent in its product by providing adequate information to prescribing physicians, who in turn pass on to their patients whatever information, in whatever form, they believe best for each patient’s individual medical circumstances.

The learned intermediary rule carefully allocates the duties of educating physicians, on the one hand, and warning patients, on the other, of the risks inherent in prescription medicines. The drug manufacturer has a duty to warn physicians, but has no duty to assist physicians in communicating with their patients. The rule requires manufacturers to provide physicians with warnings which give “adequate notice of possible complications”, Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir.1984); which are “sufficient to put the physician on notice” of possible dangers, Kinney v. Hutchinson, 468 So.2d 714, 718 (La.App.1985); which “disclose the nature and extent of the danger”, Perfetti v. McGhan Medical, 662 P.2d 646, 650 (N.M.App.1983); and which “reasonably discloses to the medical profession all risks inherent in the use of the drug which the manufacturer knew or should have known to exist”, Williams v. Lederle Laboratories, 591 F.Supp. 381, 384 (S.D.Ohio 1984), quoting Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831 (1981). By so doing, the cases unanimously hold, the manufacturer satisfies its duty. How the physician communicates the medicine’s dangers to the patient is the physician’s own decision, and his or her independent duty. There is no legal support for imposing upon a drug manufacturer an “advisory” role in that decision. Education of the physician, on the one hand, and communication to the patient, on the other, are distinct processes, and the manufacturer’s duty involves only the former. As explained by the court in Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir.1974), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974):

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. ... The choice he makes is an informed one, an individualized medical *422 judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.

On May 30, 1986, Superior Court Judge Brian Shortell granted Upjohn’s motion for summary judgment. Judge Shortell ruled that:

The plaintiff shall be precluded from arguing or presenting evidence in support of the proposition that the defendants had a duty to warn Polley directly of the dangers associated with using their products.
This ruling shall not preclude plaintiff from contending that the defendants’ duty to warn Polley’s physician was violated because they did not provide adequate materials to the physician to aid him in his duty to advise his patient.... It is possible that the patient brochures evidence available to plaintiff may be admissible on the issue whether the manufacturers’ duty to warn, advise, and assist the physician has been breached. My ruling that the defendants have no duty to warn the patient directly does not categorically preclude such evidence if it is relevant to issues relating to duty to warn the “learned intermediary”.

Emphasis in original.

Upjohn correctly concludes that Judge Shortell’s ruling did not decide the admissibility of “patient brochures” as evidence, but rather left the issue open for later decision. Upjohn, however, misinterprets Judge Shortell’s ruling by concluding that the ruling creates a “patient brochures loophole”.

The plain language of Judge Shortell’s ruling does not indicate an effort to extend the manufacturer’s duty under the learned intermediary rule. Rather, the ruling simply leaves open the possibility that patient brochures evidence may be admissible on the issue of whether the manufacturer has breached its duty to warn the physician if such patient brochures evidence “is relevant to issues relating to duty to warn the ‘learned intermediary’.”

Hence, if other evidence is inconclusive as to whether the manufacturer adequately warned the physician under the learned intermediary rule, then the patient brochures evidence would be admissible. On the other hand, if other documents and/or testimony of the physician and the manufacturer’s detailmen establish that the manufacturer’s duty has been met, then the patient brochures evidence might indeed be irrelevant.

In short, such patient brochures evidence will be relevant only when it sheds light on whether or not the manufacturer fulfilled its duty under the learned intermediary rule to warn physicians of possible dangers and complications. Judge Shortell’s ruling creates no specific duty to provide patient brochures to physicians. It merely indicates that evidence of such patient brochures might be relevant in some circumstances.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Harwell v. American Medical Systems, Inc.
803 F. Supp. 1287 (M.D. Tennessee, 1992)
Shanks v. Upjohn Co.
835 P.2d 1189 (Alaska Supreme Court, 1992)
Humes v. Clinton
792 P.2d 1032 (Supreme Court of Kansas, 1990)
Spychala v. G.D. Searle & Co.
705 F. Supp. 1024 (D. New Jersey, 1988)
Jacobs v. Dista Products Co.
693 F. Supp. 1029 (D. Wyoming, 1988)
Kociemba v. G.D. Searle & Co.
680 F. Supp. 1293 (D. Minnesota, 1988)

Cite This Page — Counsel Stack

Bluebook (online)
658 F. Supp. 420, 1987 U.S. Dist. LEXIS 3431, Counsel Stack Legal Research, https://law.counselstack.com/opinion/polley-v-ciba-geigy-corp-akd-1987.