Dobbs v. Wyeth Pharmaceuticals

• Decision Date: 17 January 2008
• Docket Number: No. CIV-04-1762-D.,CIV-04-1762-D.
• Parties: Annabel DOBBS, individually and as Personal Representative of the Estate of Terry Dobbs, Deceased, Plaintiff, v. WYETH PHARMACEUTICALS, Defendant.
• Court: U.S. District Court — Western District of Oklahoma

530 F.Supp.2d 1275

Annabel DOBBS, individually and as Personal Representative of the Estate of Terry Dobbs, Deceased, Plaintiff, v. WYETH PHARMACEUTICALS, Defendant.

No. CIV-04-1762-D.

United States District Court, W.D. Oklahoma.

January 17, 2008.

Arnold Anderson Vickery, Paul F. Waldner, III, Vickery & Waldner LLP, Houston, TX, Tia J. Goodman, Law Office of Tia J. Goodman PLLC, Oklahoma City, OK, for Plaintiff.

Amber B. Shushan, Jones Day, Atlanta, GA, David B. Alden, Jones Day, Cleveland, OH, Douglas M. Todd, Thomas G. Wolfe, Phillips McFall McCaffrey McVay Murrah, Oklahoma City, OK, Junius C. McElveen, Jones Day, Washington, DC, Mark Herrmann, Jones Day, Chicago, IL, Terence M. Murphy, Jones Day, Dallas, TX, for Defendant.

ORDER

TIMOTHY D. DEGIUSTI, District Judge.

Before the Court is Defendant Wyeth Pharmaceuticals' Motion for Partial Summary Judgment Based on Federal Preemption or, in the Alternative, Based on State Law [Doc. No. 113]. Plaintiff Annabel Dobbs has timely responded to the motion, and Wyeth has filed a reply in support of the motion. The parties have also filed supplemental briefs in support of their respective arguments, and have submitted extensive exhibits.

I. Introduction:

In this action, Plaintiff seeks damages resulting from the tragic death of her husband, Terry Dobbs, who committed suicide in December, 2002. Plaintiff alleges that Mr. Dobbs, who had been diagnosed with depression, committed suicide as a result of taking Effexor, a prescription antidepressant drug manufactured by Defendant. Plaintiff contends that Defendant is liable under Oklahoma common law for failing to adequately warn that Effexor could cause suicide; she asserts tort claims based on strict liability for failure to warn, negligent failure to warn, and misrepresentation.

In its motion for partial summary judgment, Defendant argues that it is entitled to judgment as a matter of law on the failure to warn claims because such claims are preempted by federal law consisting of United States Food and Drug Administration ("FDA") regulations regarding the content of warnings contained in labeling accompanying prescription drugs. In summary, Defendant contends that it was required to comply with the FDA regulations regarding the content of Effexor's labeling and that the FDA had concluded, as of the time of Mr. Dobbs' death in 2002, that the warning now sought by Plaintiff in this case was not supported by scientific evidence. Defendant further argues that the FDA at that time would not have approved the warning sought by Plaintiff and that Defendant could have been subjected to regulatory action for unlawful misbranding if it had altered its labeling to include that warning. As a result, Defendant argues, the FDA regulations preempt Oklahoma's tort law regarding failure to warn. Defendant further argues that, if the Court concludes that the state tort claims are not preempted, it is entitled to judgment because the undisputed facts establish Plaintiff cannot, as a matter of law, prove the requisite element of causation in this case.

Plaintiff argues that the FDA regulations do not preempt state law because Defendant faced no conflict in complying with those regulations and its common-law duty to warn. According to Plaintiff, the FDA regulations authorized Defendant to alter its labeling for Effexor prior to Mr. Dobbs' suicide and the regulations, in fact, acknowledge a drug manufacturer's obligation to make such changes when the manufacturer obtains evidence of a previously unknown risk after the drug is approved. With respect to Defendant's alternative causation argument, Plaintiff contends that material factual disputes preclude summary judgment on that issue.

II. Summary judgment Standard:

Summary judgment is proper where the undisputed material facts establish that a party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A material fact is one which may affect the outcome of the suit under the governing law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). To dispute a material fact, a plaintiff must offer more than a "mere scintilla" of evidence; the evidence must be such that "a reasonable jury could return a verdict" for her. Id. The facts and reasonable inferences therefrom must be viewed in the light most favorable to the plaintiff. MacKenzie v. City & County of Denver, 414 F.3d 1266, 1273 (10th Cir.2005). Where the summary judgment movant argues that a state law claim is preempted by federal law, determination of material facts is not necessary, as the motion presents only a legal question. Watters v. Wachovia Bank, N.A., ___ U.S. ___, 127 S.Ct. 1559, 1566, 167 L.Ed.2d 389(2007); Dobbs v. Anthem Blue Cross & Blue Shield, 475 F.3d 1176, 1177 (10th Cir.2007). Thus, summary judgment is appropriate as to a claim which a court determines is preempted. Id.

In this case, the parties do not dispute that Mr. Dobbs committed suicide in December 2002 after having taken Effexor for several days; at the time of his death, he was 53 years old. It is also not disputed that Mr. Dobbs had seen a physician in December 2002 to inquire about medication for anxiety. At the time, Mr. Dobbs had encountered both health and financial problems; he told the physician, Douglas Brandt, D.O., that he was experiencing serious anxiety and depression. Dr. Brandt diagnosed Mr. Dobbs as "fairly severely depressed," and he prescribed Lexapro, an antidepressant. Because Mr. Dobbs' condition did not improve, he again sought treatment. A different physician, Martha Speed, D.O., examined him and confirmed the diagnosis of depression. Dr. Speed told Mr. Dobbs to stop taking Lexapro, wait one day, and then begin taking Effexor. A few days after he began taking Effexor, Mr. Dobbs committed suicide. Plaintiff contends that Mr. Dobbs committed suicide because he took Effexor¹.

III. Preemption:

Because the Court's ruling on preemption may render Defendant's alternative argument moot, the Court will first consider Defendant's contention that FDA regulations preempt Plaintiff's state law tort claims.

Federal preemption of state laws is derived from the Supremacy Clause of the United States Constitution; if federal and state laws conflict, the federal law preempts the state law. U.S. Const, art. VI, cl. 2. The Supreme Court has recognized three types of preemption: 1) "express preemption," which exists when Congress has expressly stated that a federal law will preempt state law, see English v. General Electric Co., 496 U.S. 72, 78-79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990); 2) "field preemption," which occurs when Congress has expressed its intent that federal law will exclusively occupy an entire field of regulation, Id.; and 3) "conflict preemption," which arises when "it is either impossible for a private party to comply with both state and federal requirements, or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Sprietsma v. Mercury Marine, 537 U.S. 51, 64, 123 S.Ct. 518, 154 L.Ed.2d 466 (2002). See also Crosby v. National Foreign Trade Council, 530 U.S. 363, 372, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000). In this case, the parties agree that the only potentially applicable basis for preemption is conflict preemption.

Conflict preemption can apply to both state statutes and common law tort obligations. Geier v. American Honda Motor Co. Inc., 529 U.S. 861, 873, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992). The conflict is not required to stem directly, from the language of a federal statute, as agency regulations promulgated pursuant to federal statutory authority "have no less pre-emptive effect than federal statutes." Fidelity Federal Sav. and Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982). Furthermore, a federal agency "acting within the scope of its congressionally delegated authority may pre-empt state regulation." Louisiana Public Serv. Comm'n v. FCC, 476 U.S. 355, 369, 106 S.Ct. 1890, 90 L.Ed.2d 369 (1986). There is, however, a general presumption that Congress does not intend to displace state law; thus, conflict preemption applies only if the need for it is clear. Geier, 529 U.S. at 885, 120 S.Ct. 1913. "[B]ecause the States are independent, sovereigns in our federal system, we have long presumed that Congress does not cavalierly preempt state-law causes of action." Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700(1996). Therefore, conflict preemption will be found only if the need for it is clear, as "[c]onsideration under the Supremacy Clause starts with the basic assumption that Congress did not intend to displace state law." Bldg. & Constr. Trades Council of Metro. Dist. v. Associated Builders & Contractors of Mass./R.I., Inc., 507 U.S. 218, 224, 113 S.Ct. 1190, 122 L.Ed.2d 565(1993). However, the Supreme Court has also held that a "preemptive regulation's force does not depend on express congressional intent to displace state law" and that a "narrow focus" on Congress's intent to supersede, state law is "misdirected." Fidelity Fed. Say., 458 U.S. at 154, 102 S.Ct. 3014.

The degree of deference to be afforded an agency's interpretation of the preemptive effect of its own regulations has been the subject of numerous Supreme Court decisions. An agency's interpretation is entitled to "substantial deference," commonly known as "Chevron deference," only where Congress has delegated authority to the agency generally to make rules carrying the force of law, and the agency interpretation claiming deference was promulgated in the exercise of that authority. United States v. Mead Corp., 533 U.S. 218, 226-27, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001): Chevron USA, Inc. v....