Ackermann v. Wyeth Pharmaceuticals

• Decision Date: 24 April 2008
• Docket Number: No. 06-41774.,06-41774.
• Citation: 526 F.3d 203
• Parties: Rozlyn ACKERMANN, Individually and as Personal Representative of Martin Lindsey Ackermann, Deceased, Plaintiff-Appellant v. WYETH PHARMACEUTICALS, Defendant-Appellee.
• Court: U.S. Court of Appeals — Fifth Circuit

526 F.3d 203

Rozlyn ACKERMANN, Individually and as Personal Representative of Martin Lindsey Ackermann, Deceased, Plaintiff-Appellant v. WYETH PHARMACEUTICALS, Defendant-Appellee.

No. 06-41774.

United States Court of Appeals, Fifth Circuit.

April 24, 2008.

Arnold Anderson Vickery (argued), Vickery, Waldner & Mallia, Houston, TX, for Plaintiff-Appellant.

Mark Herrmann (argued), Jones Day, Chicago, IL, Edward J. Sebold, David Booth Alden, Jones Day, Cleveland, OH, Terence M. Murphy, Jones Day, Dallas, TX, Michael Randolph Klatt, Clark, Thomas & Winters, Austin, TX, for Defendant-Appellee.

Arnon D. Siegel, Dechert LLP, Washington, DC, for Product Liability Advisory Council, Inc., Amicus Curiae.

Allison M. Zieve, Public Citizen Litigation Group, Leslie A. Brueckner, Public Justice PC, Washington, DC, for Public Citizen, Inc. and Public Justice, Amici Curiae.

Russ M. Herman, Herman, Herman, Katz & Cotlar, New Orleans, LA, for Curt D. Furberg, Amicus Curiae.

Collyn Ann Peddie, Williams Kherkher, Houston, TX, for Texas Trial Lawyers Ass'n, Amicus Curiae.

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

Before JONES, Chief Judge, and WIENER and CLEMENT, Circuit Judges.

EDITH H. JONES, Chief Judge:

Appellant Rozlyn Ackermann ("Ackermann") challenges the district court's grant of summary judgment dismissing her claim that Wyeth Pharmaceuticals ("Wyeth") failed adequately to warn about the drug-induced risk of suicide from its drug Effexor, and this deficiency led to her husband's suicide. Because Ackermann has failed to demonstrate causation under the learned-intermediary doctrine, we affirm.

I. BACKGROUND

In November 2001, Martin Ackermann ("Martin"), a 53-year-old businessman, suffered from clinical depression brought on by severe business and family problems. Martin initially sought treatment from his personal physicians and began taking the prescription antidepressant drug Celexa.

Acting on a friend's advice, Martin sought treatment from psychiatrist Dr. Thomas Sonn on January 4, 2002. Martin saw Dr. Sonn four times in the following eight days. During that time, Dr. Sonn changed Martin's medication and gave him a sample trial pack¹ of another antidepressant, Effexor XR.² Sonn instructed Martin to take one low-dose 37.5-milligram pill each day as he monitored him. Martin took one 37.5-milligram pill for three days, then took one therapeutic-dose 75-milligram pill each day from January 9 to January 12.

On January 12, Martin complained to Dr. Sonn of various side effects he attributed to Effexor, including akathisia³ and anxiety. Martin announced he would no longer take the medication and terminated his relationship with Dr. Sonn. Nevertheless, Dr. Sonn changed Martin's medication from Effexor to Celexa because of the side effects. Martin continued to take Celexa for five days until January 17, 2002, when he committed suicide with a revolver. At the time of his death, Martin had detectable levels of Celexa, but not Effexor, in his bloodstream.

Rozlyn Ackermann, his widow, sued Wyeth, the manufacturer of Effexor, in July 2004, pleading causes of action under strict liability, negligence (including failure to warn), and implied warranty theories under common law and the TEXAS DECEPTIVE TRADE PRACTICES-CONSUMER PROTECTION ACT ("DTPA").⁴ She also pleaded breach of express warranty, fraud, and misrepresentation.

Wyeth initially moved for partial summary judgment, arguing that Ackermann's failure-to-warn claims conflicted with and were preempted by federal law. Dr. Sonn then testified at deposition that he believed the package insert for Effexor as it existed in January 2002 adequately warned him of the risks of suicide and that he would continue to prescribe the drug to depressed patients. In June 2006, Wyeth filed a separate motion for summary judgment on all claims. Regarding the warnings-based claims, Wyeth asserted a defense based on the learned-intermediary doctrine and, alternatively, on the statutory presumption of non-liability created by section 82.007(a) of the TEXAS CIVIL PRACTICE & REMEDIES CODE. Wyeth argued that summary judgment was appropriate for Ackermann's implied and express warranty claims under common law and the DTPA because no sale of the product had occurred, and because she had failed to identify an express warranty that had been breached. Finally, Wyeth argued that summary judgment was appropriate regarding her fraud and misrepresentation claims because she had failed to identify specific misrepresentations.

The magistrate judge first recommended that the district court grant Wyeth's motion for partial summary judgment based on preemption. Subsequently, the magistrate judge recommended that the district court grant Wyeth's June 2006 motion for summary judgment on all claims, adopting, inter alia, Wyeth's learned-intermediary doctrine theory for the failure-to-warn claims. Ackermann filed various objections. The district court overruled her objections, adopted the magistrate judge's recommendation to grant summary judgment for all claims — including the failure-to-warn claims based on the learned-intermediary doctrine — and dismissed the lawsuit. The magistrate judge, in turn, vacated as moot his report recommending partial summary judgment based on preemption.

Ackermann timely appealed. The only issue before this court is whether the learned-intermediary doctrine bars her strict-liability and failure-to-warn claims. She does not challenge the district court's conclusions regarding her express and implied warranty, fraud, and misrepresentation claims. Wyeth responds that the district court correctly applied the learned-intermediary doctrine, but it alternatively requests that this court affirm the district court on preemption grounds, should we hold that the learned-intermediary doctrine is inapplicable.

II. DISCUSSION

We review a grant of summary judgment de novo. Ford Motor Co. v. Tex. Dep't of Transp., 264 F.3d 493, 498 (5th Cir.2001). "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.'" McNeil v. Wyeth, 462 F.3d 364, 367 (5th Cir.2006) (quoting FED.R.CIV.P. 56(c)). "The evidence and inferences from the summary judgment record are viewed in the light most favorable to the nonmovant." Minter v. Great Am. Ins. Co. of N.Y., 423 F.3d 460, 465 (5th Cir.2005). But "[w]here the non-moving party fails to establish `the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial,' no genuine issue of material fact can exist." Whiting v. Univ. of S. Miss., 451 F.3d 339, 344 (5th Cir.2006) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)).

The learned-intermediary doctrine states that, in some situations, a warning to an intermediary fulfills a supplier's duty to warn consumers. See Alm v. Aluminum Co. of Am., 717 S.W.2d 588, 591-92 (Tex.1986). "In Texas, the most common use of this doctrine is in prescription drug cases." Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex.App.-Texarkana 2000, no writ) (citations omitted). Under the doctrine, a patient-purchaser's doctor stands between the patient and the manufacturer, professionally evaluating the patient's needs, assessing the risks and benefits of available drugs, prescribing one, and supervising its use. Id. If the doctor is properly warned of the possibility of a side effect and is advised of the symptoms normally accompanying the side effect, it is anticipated that injury to the patient will be avoided. Accordingly, the doctrine excuses a drug manufacturer "from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product's dangers." Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999).

The learned-intermediary doctrine is not an affirmative defense. Under Texas law, it delineates to whom a defendant — usually a prescription drug manufacturer — owes the duty to warn, but it is not used to show that the plaintiff has no valid case. Medrano, 28 S.W.3d at 94; see also Harrison v. Am. Home Prods. Corp. (In re Norplant Contraceptive Prods. Liab. Litig.), 165 F.3d 374, 378 (5th Cir. 1999) (making an Erie guess that the Texas Supreme Court would hold that the learned-intermediary doctrine is a common-law doctrine rather than a common-law defense). Thus, "when the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user." Alm, 717 S.W.2d at 592.

To recover for failure to warn under this doctrine, a plaintiff must show that (1) the warning was defective, and (2) the failure to warn was a producing cause of the injury. Porterfield, 183 F.3d at 468.⁵ In other words, "[u]nder Texas law, a plaintiff who complains that a prescription drug warning is inadequate must also show that the alleged inadequacy caused her doctor to prescribe the drug for her." McNeil, 462 F.3d at 372 (internal quotations omitted). If, however, "the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury" and the plaintiff's recovery must be denied. Porterfield, 183 F.3d at 468. "Even if the physician is not aware of a risk, `the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product.'" Dyer v. Danek Med., Inc., 115 F.Supp.2d 732, 741 (N.D.Tex.2000) (quoting Willett v. Baxter Int'l, Inc., 929 F.2d 1094, 1099 (5th Cir.1991)); see also Burton v. Am. Home Prods. Corp. (In re...