McNeil v. Wyeth

• Decision Date: 22 August 2006
• Docket Number: No. 05-10509.,05-10509.
• Citation: 462 F.3d 364
• Court: U.S. Court of Appeals — Fifth Circuit
• Parties: Sue C. McNEIL, Plaintiff-Appellant, v. WYETH, Formerly Known as American Home Products Corporation, Doing Business as A.H. Robins Company, Inc., Defendant-Appellee.

Page 364

462 F.3d 364

Sue C. McNEIL, Plaintiff-Appellant, v. WYETH, Formerly Known as American Home Products Corporation, Doing Business as A.H. Robins Company, Inc., Defendant-Appellee.

No. 05-10509.

United States Court of Appeals, Fifth Circuit.

August 22, 2006.

COPYRIGHT MATERIAL OMITTED

John Alan Jones, Coleman M. Cowan, George Christopher Olson (argued), Martin & Jones, Raleigh, NC, for Plaintiff-Appellant.

Michael Randolph Klatt, Susan Elizabeth Burnett (argued), Kelly R. Kimbrough, Clark, Thomas & Winters, Austin, TX, Jeffrey R. Pilkington, Davis, Graham & Stubbs, Denver, CO, for Defendant-Appellee.

Appeal from the United States District Court for the Northern District of Texas.

Before KING, SMITH and BENAVIDES, Circuit Judges.

JERRY E. SMITH, Circuit Judge:

Sue McNeil appeals a summary judgment for defendant Wyeth, a pharmaceutical company. We reverse and remand.

I.

In August 2000, Dr. Eduardo Wilkinson prescribed Reglan, whose generic name is metoclopramide, manufactured by Wyeth, to treat McNeil's symptoms of gastroesophageal reflux disease ("GERD"). The prescription was for six months, though the Food and Drug Administration had approved the drug only for use of no more than twelve weeks. Thereafter, McNeil's prescription was continued by Dr. Roy Ragsdale for six months and then by Dr. William Mania for two months.

GERD is a disease whose expression ranges from infrequent heartburn to frequent heartburn accompanied by regurgitation. In severe cases it can lead to a narrowing of the esophagus by scarring.

Reglan is a "prokinetic" drug that helps control GERD by blocking dopamine receptors in the brain and throughout the body, thus enhancing movement or contractions of the esophagus, stomach, and intestines. Dopamine is a chemical produced naturally by the human body that sends signals from one nerve to the next. Simple movements of muscles, such as moving a finger, are controlled by what is known as the pyramidal system. More coordinated muscle movements, such as dancing or talking, require fine motor control from the extrapyramidal system.

By blocking dopamine receptors, Reglan can affect the extrapyramidal system by causing extrapyramidal symptoms ("EPS"), which "are a group of adverse drug reactions referred to generally as extrapyramidal symptoms because of the involvement of the extrapyramidal nervous system."¹ The clinical pharmacology section of Reglan's FDA-approved label explains that, like other "dopamine antagonists" such as phenothiazines, Reglan "may produce extrapyramidal reactions, although these are comparatively rare."

Tardive dyskinesia is a particularly severe form of EPS characterized by grotesque involuntary movements of the mouth, tongue, lips, and extremities, involuntary chewing movements, and a general sense of agitation. Reglan's label warned that Reglan may produce tardive dyskinesia.

In October 2001, about fourteen months after she started taking Reglan, McNeil was admitted to an emergency room complaining of shortness of breath, anxiety, and an involuntary "chewing motion" of her mouth. The nurse who first treated McNeil noted that she was also fidgeting, appeared nervous, and had an unsteady gait. The emergency room physician who later examined McNeil confirmed these observations and diagnosed EPS, likely occasioned by exposure to Reglan.

McNeil's primary care physician confirmed this diagnosis, discontinued Reglan, and prescribed a replacement drug. When McNeil's EPS symptoms failed to improve with time, she consulted a neurologist and two medical specialists in movement disorder; all three concluded that McNeil suffers from Reglan-induced tardive dyskinesia in addition to Reglan-induced EPS.

II.

McNeil sued Wyeth in state court. Her complaint alleged that Wyeth had failed adequately to warn physicians and consumers of the increased risk of tardive dyskinesia that accompanies long-term use of Reglan. McNeil argued that Wyeth's failure to warn rendered the inherently unsafe product unreasonably dangerous. Further, McNeil alleged that the Reglan label was misleading as to the risk of tardive dyskinesia and failed adequately to warn about the increase in risk associated with exposure to the drug for more than twelve weeks.

Wyeth removed to federal court pursuant to 28 U.S.C. § 1332(a)(1). Both parties consented to decision by a magistrate judge, whom we therefore refer to as the "district court."

Wyeth moved for summary judgment, which the court granted, concluding that the Reglan label was "adequate as a matter of law" because it "specifically mentions the circumstances complained of . . . ." More specifically, the court noted that the label

specifies that the drug is intended for short-term use of 12 weeks or less, warns against the potential risk of tardive dyskinesia and other movement disorders, and discloses that the risk of developing tardive dyskinesia is highest among elderly women and increases with the duration of treatment and the total cumulative dose. The label also describes the possible symptoms associated with movement disorders caused by the drug—the very symptoms of which plaintiff complains.

Therefore, the court concluded that Wyeth was entitled to summary judgment on McNeil's marketing defect claims. In an additional paragraph, the court stated that "Wyeth is entitled to summary judgment on plaintiff's design defect claims." McNeil appeals only the failure-to-warn claims.

III.

Summary judgment is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." FED.R.CIV.P. 56(c). Disputes about material facts are genuine "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). We review the district court's decision de novo. Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 (5th Cir.1992). The evidence and inferences from the summary judgment record must be viewed in the light most favorable to the nonmovant. Minter v. Great Am. Ins. Co., 423 F.3d 460, 465 (5th Cir.2005).

IV.

Texas, like most jurisdictions, has adopted section 402A of the Restatement of Torts for product liability claims. Nobility Homes, Inc. v. Shivers, 557 S.W.2d 77, 79-80 (Tex.1977). Under that section, "[i]f a product is unreasonably or inherently dangerous, a warning is required." Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.—Corpus Christi 1973, writ ref'd n.r.e.) (citing RESTATEMENT (SECOND) OF TORTS § 402A (1965)).

Texas law generally holds that the adequacy of a product's warning is a question of fact to be determined by the jury. Williams v. Upjohn Co., 153 F.R.D. 110, 114 (S.D.Tex.1994); Alm v. Aluminum Co. of Am., 717 S.W.2d 588, 591-92 (Tex.1986). In prescription drug cases involving the learned intermediary doctrine, however, when "a warning specifically mentions the circumstances complained of, the warning is adequate as a matter of law." Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex.App.—Waco 1993, writ denied).²

McNeil argues that the district court's reliance on Rolen to find adequacy as a matter of law is inapposite. We agree. Although Reglan's label mentions the conditions of which McNeil complains, McNeil's claim, unlike the claim of the plaintiff in Rolen, is not that the warning is inadequate because her condition was not mentioned. Rather, her argument is that the label is misleading as to the risk level for developing the condition.

We are aware of no Texas case allowing adequacy as a matter of law in such situations, and therefore we apply the default Texas rule that adequacy questions go to the jury. Our position is consistent with Texas law and the Restatement of Torts, which Texas courts follow, because, as the district court recognized, even in the context of a learned intermediary, "`if the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user.'"³

Warning the learned intermediary of a much lower risk than the actual risk could render the warning not just misleading, but ineffective. When the risk described on the label is so low as to induce a doctor to undertake the risk, had he not done so if he were warned of the real risk, we cannot say that no reasonable jury could conclude that a warning was inadequate. Thus, if the manufacturer decides to label a risk as "comparatively rare" and also to provide a numerical quantification of that risk, that number must be within a certain degree of accuracy.⁴

V.

The issue therefore is whether there is a genuine issue of material fact as to whether the label was misleading. This must be viewed in terms of significant differences between the disclosed risk and the actual risk of developing EPS and tardive dyskinesia, with use longer than twelve weeks.

A.

Wyeth argues that it does not have a duty to warn about risks of use longer than twelve weeks because the label clearly states that the drug is indicated for treatment for no more than that duration. Thus, not only would such a warning be superfluous, but it would also be improper, because Wyeth allegedly cannot tell a medical professional how to exercise professional judgment on whether a drug should be used longer than the period approved by the FDA. We disagree.

Wyeth was, or should have been, aware that Reglan was prescribed routinely for long-term use. Plaintiff's expert, Dr. Thompson, testified that by 1988 Wyeth had its "own market data that 84 percent of people" were using Reglan long-term. In 1992, an article by Dr. Ron Stewart and others drew attention to the common practice of long-term treatment with metoclopramide. The study involved 4,515 elderly patients at the Florida Geriatric Research...