Thom v. Bristol-Myers Squibb Co.

353 F.3d 848, 2003 U.S. App. LEXIS 26105, 2003 WL 22995555
CourtCourt of Appeals for the Tenth Circuit
DecidedDecember 22, 2003
Docket02-8099
StatusPublished
Cited by383 cases

This text of 353 F.3d 848 (Thom v. Bristol-Myers Squibb Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Tenth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 2003 U.S. App. LEXIS 26105, 2003 WL 22995555 (10th Cir. 2003).

Opinion

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 Ser-zone caused him to develop priapism, a “[pjersistent 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
Postintroduetion Clinical Experience
Post marketing experience with SER-ZONE 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.

*851 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.

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Bluebook (online)
353 F.3d 848, 2003 U.S. App. LEXIS 26105, 2003 WL 22995555, Counsel Stack Legal Research, https://law.counselstack.com/opinion/thom-v-bristol-myers-squibb-co-ca10-2003.