Thom v. Bristol-Myers Squibb Co.

• Citation: 353 F.3d 848
• Decision Date: 22 December 2003
• Docket Number: No. 02-8099.,02-8099.
• Parties: Steven THOM; Marcia Thom, Plaintiffs-Appellants, v. BRISTOL-MYERS SQUIBB COMPANY, a Delaware corporation, Defendant-Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals (10th Circuit)

353 F.3d 848

Steven THOM; Marcia Thom, Plaintiffs-Appellants, v. BRISTOL-MYERS SQUIBB COMPANY, a Delaware corporation, Defendant-Appellee.

No. 02-8099.

United States Court of Appeals, Tenth Circuit.

December 22, 2003.

Terence L. Moore, (R. Lanahan Goodman and Robert N. Williams, with him on the briefs), Meyer and Williams, Jackson, WY, for Plaintiffs-Appellants.

David M. Covey, (Kimberly S. Penner, Sedgwick, Detert, Moran & Arnold L.L.P., New York, New York and Thomas G. Gorman and Misha E. Westby, Hirst & Applegate, P.C., Cheyenne, Wyoming, with him on the brief), for Defendant-Appellee.

Before KELLY, HENRY, and LUCERO, Circuit Judges.

PAUL KELLY, JR., Circuit Judge.

Plaintiffs-Appellants Steven and Marcia Thom (the "Thoms") appeal from an order granting Defendant-Appellee Bristol-Myers Squibb's motion for summary judgment. We have jurisdiction over this diversity-based products liability action pursuant to 28 U.S.C. § 1291, and we reverse.

Background

The Thoms allege that Mr. Thom suffered personal injuries as a result of his use of Serzone (nefazodone), a prescription antidepressant medication manufactured by Bristol-Myers Squibb (BMS). According to the Thoms, Mr. Thom's use of Serzone caused him to develop priapism, a "[p]ersistent erection of the penis, accompanied by pain and tenderness, resulting from a pathologic condition rather than sexual desire." Stedman's Medical Dictionary 1425 (26th ed.1995). As a result of his priapism, Mr. Thom has permanent penile injury.

Mr. Thom was prescribed Serzone in August 1998 by his physician, Dr. Mark Schueler, to treat his sleep problems and depression. This was the first time that Dr. Schueler had prescribed Serzone. Dr. Schueler learned of Serzone at a hospital presentation that he believes was given by a representative of BMS. Aplt.App. at 324-25. However, he did not stay for the entire presentation. Id. at 325.

Serzone contains an FDA-approved package insert, which was reproduced in the Physician's Desk Reference (PDR), that discusses the possible complications of Serzone use, including priapism. At the time Serzone was prescribed to plaintiff, the package insert read:

PRECAUTIONS

....

Priapism

While priapism did not occur during pre-marketing experience with nefazodone, rare reports of priapism have been received since market introduction. A causal relationship to nefazodone has not been established (see ADVERSE REACTIONS Section). If patients present with prolonged or inappropriate erections, they should discontinue therapy immediately and consult their physicians. If the condition persists for more than 24 hours, a urologist should be consulted to determine appropriate management.

....

ADVERSE REACTIONS

....

Postintroduction Clinical Experience

Post marketing experience with SERZONE has shown an adverse experience profile similar to that seen during the premarketing evaluation of nefazodone. Voluntary reports of adverse events temporally associated with SERZONE have been received since market introduction that are not listed above and for which a causal relationship has not been established. These include:

Rare occurrences of ... priapism (see PRECAUTIONS Section).

As discussed in more detail below, the record is unclear as to whether Dr. Schueler read this package insert prior to prescribing Serzone to Mr. Thom. However, it is uncontested that Dr. Schueler did not discuss the possibility of priapism with Mr. Thom prior to prescribing it. Aplt.App. at 73, 357.

BMS argued it was entitled to summary judgment because (1) the Thoms could not establish that BMS failed to adequately warn that priapism was associated with Serzone use; and (2) the Thoms could not establish that any failure to warn was the proximate cause of their injuries.

Discussion

A. Summary Judgment Standard

We review a grant of summary judgment de novo, applying the same standard used by the district court under Federal Rule of Civil Procedure 56(c). Ashley Creek Phosphate Co. v. Chevron, USA, Inc., 315 F.3d 1245, 1253 (10th Cir.2003).

Summary judgment is proper if the movant demonstrates that there is "no genuine issue as to any material fact" and that it is "entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). In applying this standard, we view the factual record and draw all reasonable inferences therefrom in the light most favorable to the nonmovant. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Hirase-Doi v. U.S. West Communications, Inc., 61 F.3d 777, 781 (10th Cir.1995). An issue is "genuine" if there is sufficient evidence on each side so that a rational trier of fact could resolve the issue either way. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). An issue of fact is "material" if under the substantive law it is essential to the proper disposition of the claim. Id. In this diversity matter, we must apply the substantive law of the forum state. Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938).

The movant bears the initial burden of making a prima facie demonstration of the absence of a genuine issue of material fact and entitlement to judgment as a matter of law. See Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). In so doing, a movant that will not bear the burden of persuasion at trial need not negate the nonmovant's claim. Id. at 325, 106 S.Ct. 2548. Such a movant may make its prima facie demonstration simply by pointing out to the court a lack of evidence for the nonmovant on an essential element of the nonmovant's claim. Id.

If the movant carries this initial burden, the nonmovant that would bear the burden of persuasion at trial may not simply rest upon its pleadings; the burden shifts to the nonmovant to go beyond the pleadings and "set forth specific facts" that would be admissible in evidence in the event of trial from which a rational trier of fact could find for the nonmovant. Fed.R.Civ.P. 56(e).

B. The Learned Intermediary Doctrine in Wyoming

BMS contends, and the district court agreed, that as a drug manufacturer and distributor, its duty to warn extends only to physicians. In turn, physicians, based upon knowledge of their own patients, bear the final responsibility for the decision to prescribe medications and to warn the patient of possible side effects. Known as the "learned intermediary doctrine," this doctrine shields manufacturers of prescription drugs from liability where the manufacturer adequately warns a patient's prescribing physician of the potential risks inherent in the use of the product. Edwards v. Basel Pharms., 933 P.2d 298, 300 (Okla.1997). The district court predicted that the Wyoming Supreme Court would adopt the learned intermediary doctrine.

The learned intermediary doctrine derives from § 402A of the Restatement (Second) of Torts, see, e.g., Edwards, 933 P.2d at 300, which the Wyoming Supreme Court has adopted in its entirety. Ogle v. Caterpillar Tractor Co., 716 P.2d 334, 341-42 (Wyo.1986). Section 402A provides that a seller of a defective, unreasonably dangerous product is strictly liable for physical harm to a consumer. Comment k to § 402A establishes that this rule does not apply to "unavoidably unsafe products." These are

products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.... Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.

Restatement (Second) of Torts § 402A cmt. k.

Forty-four other jurisdictions have adopted the learned intermediary doctrine in prescription medicine cases, see Vitanza v. Upjohn Co., 257 Conn. 365, 778 A.2d 829, 838 n. 11 (2001) (collecting cases), and the District of Wyoming has predicted that Wyoming would follow suit. See Jacobs v. Dista Products Co., 693 F.Supp. 1029, 1036 (D.Wyo.1988) ("The drug manufacturer's liability to plaintiff ended when it imparted adequate warnings to the physician."). In addition, the Tenth Circuit has implied in an analogous case that Wyoming would adopt the doctrine. See Haste v. Am. Home Products Corp., 577 F.2d 1122, 1125 (10th Cir.1978) ("[T]he defendant discharged its duty to plaintiffs by the warnings to the veterinarians.").

The Thoms' main arguments against application of the learned intermediary doctrine are (1) the Wyoming Supreme Court and Legislature have not specifically adopted the doctrine, despite a Wyoming district court's prediction fourteen years ago that it would; (2) BMS's provision of a "Patient Information Sheet" to the plaintiff via Dr. Schueler constitutes a gratuitous undertaking, subjecting BMS to liability; and (3) the policy of Wyoming, in light of the Wyoming comparative fault statute, Wyo. Stat. Ann. § 1-1-109, would not immunize drug manufacturers.

First, silence on the part of the state means only that it has not had occasion to review the matter, not that it disagrees with the federal court's interpretation of state law. Although the Wyoming Supreme Court has not to date acknowledged the learned intermediary doctrine, "neither has it denied the [doctrine]; it simply has not ruled on the issue. We can and must safely assume that the delay, in the grandest traditions of all common-law courts, is due to the absence of a well presented and soundly argued case, rather than indicative of some invented implication" that the doctrine does not exist. Rawson v. Sears, Roebuck & Co., 822 F.2d 908, 927 (10th Cir.1987) (McKay, J., dissenting).

Second, the "voluntary duty" doctrine is exactly what the learned intermediary doctrine seeks to avoid. Thus, even if a drug manufacturer provides pamphlets for distribution to the ultimate drug user, "[t]he patient is expected to place primary reliance on the physician's judgment, and to...