Colacicco v. Apotex Inc.

521 F.3d 253

Joseph C. COLACICCO, Individually and as Executor of the Estate of Lois Ann Colacicco, Deceased, Appellant v. APOTEX INC.; Apotex Corp., as Subsidiary of Apotex, Inc.; Smithkline Beecham, d/b/a GlaxoSmithKline

Beth Ann McNellis, on Behalf of the Estate of Theodore DeAngelis, Deceased and in Her Own Right v. Pfizer Inc.; John Does 1-5; ABC Doe Corp.; DEF Doe Corp.; GHI Doe Corp.

Pfizer Inc., Appellant.

No. 06-3107.

No. 06-5148.

United States Court of Appeals, Third Circuit.

Argued December 10, 2007.

Filed April 8, 2008.

Harris L. Pogust, Derek T. Braslow (Argued), T. Matthew Leckman, Pogust & Braslow, Conshohocken, PA, Attorneys for Appellant, No. 06-3107.

M. Karen Thompson, Norris, McLaughlin & Marcus, Sommerville, NJ, Malcolm E. Wheeler (Argued), Wheeler, Trigg & Kennedy Denver, CO, Attorneys for Appellant, No. 06-5148.

Charles A. Fitzpatrick, III, Arthur B. Keppel (Argued), Rawle & Henderson, Philadelphia, PA, Attorneys for Appellee Apotex Corp., Apotex Corp. as Subsidiary of Apotex, No. 06-3107.

Chilton D. Varner (Argued), Andrew T. Bayman, Erica M. Long, S. Samuel Griffin, King & Spalding, Atlanta, GA, Joseph E. O'Neil, Lavin, O'Neil, Ricci, Cedrone & DiSipio, Philadelphia, PA, Attorneys for Appellee Smithkline Beecham, d/b/a GlaxoSmithKline, No. 06-3107.

Gregory S. Spizer, Sol H. Weiss (Argued), Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, Philadelphia, PA, Attorneys for Appellee Beth Ann McNellis, No. 06-5148.

Allison Zieve, Public Citizen Litigation Group Washington, DC, Attorney for Amicus-Appellants Public Citizens Litigation Group, Trial Lawyers for Public Justice and Association of Trial Lawyers of America, No. 06-3107.

Shanin Specter, David J. Caputo, Charles L. Becker (Argued), Kline & Specter, Philadelphia, PA, Attorneys for Amicus-Appellant Pennsylvania Trial Lawyers Association, No. 06-3107.

Frederick S. Longer, Arnold Levin, Matthew C. Gaughan, Levin, Fishbein, Sedran & Berman, Philadelphia, PA, Attorneys for Amicus-Appellants Michael H. Alderman, Jerry Avorn, Lisa Bero, Elizabeth A. Boyd, Adriane Fugh-Berman, and Curt D. Furberg, No. 06-3107.

Arnold A. Vickery, Vickery & Waldner, Houston, TX, Attorney for Amicus-Appellants Steve Hulley, Richard A. Kronmal, Kirby Lee, Arthur A. Levin, Bruce M. Psaty, Wayne Ray, Jacquelyn Giles and Annabel Dobbs, No. 06-3107.

Michael A. Galpern, Law Offices of Gene Locks, Cherry Hill, NJ, Attorney for Amicus-Appellees Association of Trial Lawyers of America-New Jersey, No. 06-5148.

Kenneth S. Geller, Mayer, Brown, Rowe & Maw, Washington, DC, Attorney for Amicus-Appellees Product Liability Advisory Council, Inc., No. 06-3107.

Robert N. Weiner, Jeffrey L. Handwerker, Arnold & Porter, Washington, DC, Attorneys for Amicus-Appellees Pharmaceutical Research and Manufacturers of America, No. 06-3107.

Michael X. Imbroscio, Covington & Burling Washington, DC, Attorney for Amicus-Appellees American Tort Reform Association, No. 06-3107.

Douglas N. Letter, Sharon Swingle (Argued), United States Department of Justice, Washington, DC, Attorneys for Amicus-Appellee United States, No. 06-3107.

Before: SLOVITER, AMBRO, Circuit Judges, and RESTANI^*, Judge.

OPINION OF THE COURT

SLOVITER, Circuit Judge.

The issue before us is one of preemption, an area of the law that need delicately balance federal interests and those of the states. It harks back to the very beginning of our republic, and has continued to occupy us ever since. Preemption is not a doctrine that lends itself to a black-letter rule. One size does not fit all. The decision must be based on the circumstances presented in the particular situation.

The plaintiffs in these consolidated cases are the husband and daughter, respectively, of two adults who committed suicide after taking medication from the class of antidepressants known as selective serotonin reuptake inhibitors ("SSRIs"). The common question presented by the cases is whether the plaintiffs may maintain their state-law tort actions against the manufacturers of two such drugs on the theory that the drugs' labeling failed to warn of their association with an increased risk of suicidality. The central issue is whether actions taken by the Food and Drug Administration ("FDA") pursuant to its authority under the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-397, and the corresponding regulatory scheme preempt the plaintiffs' state-law failure-to-warn claims.

I.

SmithKline Beecham, d/b/a GlaxoSmithKline ("GSK"), manufactures Paxil, an SSRI that is used to treat depression. On October 6, 2003, Lois Colacicco's physician prescribed Paxil for her depression. After her prescription was filled with a generic version of Paxil, Lois Colacicco began taking that medication. Less than a month later, on October 28, 2003, at the age of fifty-five, she committed suicide in her New York home.

At the time of Lois Colacicco's death, the labeling for Paxil included the following language in its "Precautions" section:

Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for PAXIL should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose....

Colacicco App. at 436. Apotex, Inc. and Apotex Corp. (together, "Apotex") manufacture and distribute the generic version of paroxetine hydrochloride (the active ingredient in Paxil) ingested by Lois Colacicco. The labeling for Apotex's generic paroxetine was identical to GSK's labeling for Paxil.

After Lois Colacicco's death, her husband, Joseph C. Colacicco, filed suit against Apotex and GSK in the United States District Court, for the Eastern District of Pennsylvania, alleging that those companies violated state common-law tort rules and New York state consumer protection laws by selling their products with labels that failed to warn consumers of the increased risk of emergent suicidality and worsening depression in adults taking paroxetine. On May 26, 2006, Apotex and GSK moved to have Colacicco's complaint dismissed on the ground that it was preempted by federal law and, alternatively, that GSK did not owe a duty of care to the consumers of generic paroxetine, such as Lois Colacicco. The District Court dismissed the complaint on the basis of preemption. Colacicco v. Apotex, Inc., 432 F.Supp.2d 514, 537-39 (E.D.Pa.2006).

Pfizer is the manufacturer of Zoloft, another SSRI that is used to treat depression. On January 22, 2003, sixty-four-year old Theodore DeAngelis was prescribed Zoloft for anxiety and depression. DeAngelis ingested that drug in the days leading up to his death by suicide on January 30, 2003. At the time of his death, the suicide precaution on Zoloft's labeling read as follows:

Suicide — The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for Zoloft (sertraline) should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.

McNellis App. 499-500.

Following DeAngelis' death, Beth Ann McNellis, his daughter and the executrix of his estate, filed suit in New Jersey state court, alleging that Pfizer violated various New Jersey products liability and consumer fraud statutes by selling Zoloft without warning consumers that it increased the risk of suicidality in those ingesting the drug. Pfizer removed the action to the United States District Court for the District of New Jersey and moved for summary judgment on the ground that McNellis' claim was preempted by federal law. The Court denied that motion on December 29, 2005. McNellis ex rel. DeAngelis v. Pfizer, Inc. ("McNellis I"), No. Civ. 05-1286(JBS), 2005 WL. 3752269, at *18 (D.N.J. Dec.29, 2005). On September 29, 2006, following the dismissal of Colacicco's complaint in the Pennsylvania District Court, the New Jersey District Court denied Pfizer's motion to vacate its denial of the summary judgment motion, but certified its order for interlocutory appeal. The District Court framed the question for appeal as follows:

Whether ... the United States Food and Drug Administration's requirements for the form and content of the labeling for the prescription antidepressant Zoloft preempted New Jersey's failure-towarn law, under the doctrine of conflict preemption, where the FDA's regulations at 21 C.F.R. 201.57(e) [(2003)] and 314.70(c)(6)(iii) [(2007)] permit a manufacturer to unilaterally enhance its warning when the manufacturer has reasonable evidence of an association of a serious hazard with a drug.

McNellis ex rel DeAngelis v. Pfizer, Inc. ("McNellis II"), No. Civ. 05-1286(JBS), 2006 WL 2819046, at *13 n. 9 (D.N.J. Sept.29, 2006). We must decide which of the two fine opinions authored by two of the ablest district judges in this circuit most closely expresses our view of the difficult issue presented.

II.

The FDA is charged with "promot[ing] the public health by promptly and efficiently reviewing [drug manufacturers'] clinical research and taking appropriate action on the marketing of regulated products in a timely manner" and "protect[ing] the public health by ensuring that ... drugs are safe and effective." 21 U.S.C. § 393(b)(1), (b)(2)(B). In this capacity, the FDA regulates the introduction of all new drugs. Id. § 355(a). Persons intending to market a drug must first file a new drug application ("NDA") with the FDA. Id. § 355(b). An NDA must include, inter alia, full reports of investigations into the drug's safety and effectiveness, the components and production methods used to manufacture the drug, and "specimens of the labeling proposed to be used for such drug." Id. § 355(b)(1); see also 21 C.F.R. § 314.50(c)(2)(i) (...