Knipe v. Smithkline Beecham

Decision Date28 August 2008
Docket NumberCivil Action No. 06-3024.
Citation583 F.Supp.2d 553
PartiesMarion L. KNIPE, Individually and as Administratrix and Administratrix Ad Prosequendum of the Estate of Harold Stanley Jake Garrison, Deceased, and Harold L. Garrison, Jr., Individually, Plaintiffs, v. SMITHKLINE BEECHAM d/b/a GlaxoSmithKline, Defendant.
CourtU.S. District Court — Eastern District of Pennsylvania

Bijan Esfandiari, Frances M. Phares, George W. Murgatroyd, III, Kate E. Gillespie, Baum, Hedlund, Aristei & Goldman, PC, Los Angeles, CA, Cara Luther, Baum, Hedlund, Aristei, Goldman & Menzies, PC, Washington, DC, for Plaintiffs.

Andrew Thomas Bayman, Franklin P. Brannen, Jr., Heather M. Howard, Robert B. Friedman, S. Samuel Griffin, Todd P. Davis, King and Spalding, LLP., Atlanta, GA, Cindy K. Bennes, Peter D. Braun, Phillips Lytle, LLP, Robert E. Glanville, Phillips, Lytle, Hitchcock, Blaine & Huber, Thomas S. Wiswall, Buffalo, NY, Mark S. Brown, Washington, DC, Joseph E. O'Neil, Hing, Wilson, Adler & Cheng, P.C., Melissa R. Margulies, Lavin, O'Neil, Ricci, Cedrone & Disipio, Philadelphia, PA, for Defendant.


BUCKWALTER, Senior District Judge.

Currently pending before the Court is (1) Defendant GlaxoSmithKline's ("GSK"'s) Motion for Summary Judgment on the Grounds of Federal Preemption (Docket No. 60), (2) the Response of Plaintiffs Harold L. Garrison, Jr., individually, and Marion Knipe, individually and as administratrix and administratrix ad prosequendum of the Estate of Harold Stanley Jake Garrison (Doc. No. 98), (3) Defendant's Reply Brief (Doc. No. 120), and (4) Plaintiff's Sur-reply Brief (Doc. No. 137). In addition, the Court jointly considers Plaintiffs' Motion to Strike Evidence Submitted by GSK in Support of Its Motion for Summary Judgment (Federal Preemption) (Doc. No. 107) and Defendant's Response thereto (Doc. No. 117).

This litigation commenced on July 10, 2006, when Plaintiffs sued Defendant for the wrongful death of sixteen-year old Harold Stanley Jake Garrison ("Jake"), who committed suicide after taking Paxil, an antidepressant medication manufactured and sold by GSK. The core of Plaintiffs' claims alleges that GSK breached its state law duty to warn of the increased risk of suicide in pediatric patients as a result of taking the drug. Defendant now contends that Plaintiffs' state tort claims are preempted by federal law, i.e. the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. and its implementing regulations, due to a direct and actual conflict between state and federal law. For the following reasons, the Court denies the motion in its entirety.

A. Jake Garrison's Suicide

In February 2001, deceased Plaintiff Jake Garrison ("Jake") was referred to dermatologist Booth Durham, M.D., for the treatment of acne. (Pls.' Ex. 153, Durham Dep. 11:8-17:8, Sep. 5, 2007.) Originally, Dr. Durham treated Jake with Accutane. Id. In light of the drug's labeling, the doctor informed Jake and his mother that the drug could cause suicidal behavior, and required them to sign a consent form. (Id.) The Accutane course of treatment was completed in August or September of 2001. (Id. at 21:13-22:2.)

On January 10, 2002, Jake, who was fifteen years old at the time, returned to Dr. Durham as a result of redness and irritation on his face. (Id. at 22:3-23:12.) Dr. Durham prescribed to Jake a fifteen-day supply of Paxil ten milligrams for treatment of his body dysmorphic disorder.2 (Id. at 23:12-25:21.) The dosage was increased to twenty milligrams after two weeks. (Id. at 25:16-25:21.) At that time, the label for Paxil contained the following statement in the "PRECAUTIONS" section:

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. Precautions for Paxil should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

(Plaintiffs' Statement of Undisputed Facts ("PSUF") ¶ 23, Ex. 35 at 1610.) The 2002 label also included, in a section entitled "Other events Observed During the Pre-marketing Evaluation of Paxil" (under the sub-heading "Nervous System"), the adverse reaction of "emotional lability," which was identified as a "frequent event." (Id. ¶ 24, Ex. 35 at 1614.) Under the section entitled "Pediatric Use," the label stated, "Safety and effectiveness in the pediatric population have not been established." (Id. ¶ 25, Ex. 25 at 1611.)

Jake refilled a thirty-day prescription for Paxil twenty milligrams, on January 27, 2002, and another thirty-day supply for Paxil twenty milligrams on April 8, 2002. (Pls' Resp., Objections and Evid. in Response to GSK's "Statement of Undisputed Facts" in Support of Mot. Summ. J. on Fed. Preemp. ("Plaintiffs' Objections") ¶ 1, Exs. 146, 147.) Thereafter, for unknown reasons, Jake stopped taking Paxil. (Id.) On September 11, 2002, Jake refilled another Paxil twenty milligram prescription and took the medication for three days. (Id.) On September 14, 2002, Jake committed suicide by gunshot. (PSUF ¶ 27, Ex. 38.)

B. FDA Regulation of New Drugs and Drug Labeling Generally

In the FDCA, Congress charged the Food and Drug Administration ("FDA") with the duty to "promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products" and to "protect the public health by ensuring that . . . drugs are safe and effective." 21 U.S.C. § 393(b)(1), (b)(2)(B) (1997). To satisfy its regulatory mission, the FDA engages in a thorough review of any proposed new drugs prior to their entry in the market. See 21 U.S.C. § 355. Under this procedure, a person or company that wishes to market a new drug3 must initially file a new drug application ("NDA") with the FDA. Id. at § 355(b). This NDA requires, among many other things, (a) full reports of investigations which have been made into the safety and effectiveness of the drug; (b) a list of all articles used as components of such drug; (c) a full statement of the composition of such drug; (d) a complete description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (e) samples of such drug and of the articles used as components thereof as the Secretary may require; and (f) specimens of the labeling proposed to be used for such drug. 21 U.S.C. § 355(b)(1); see also 21 C.F.R. § 314.50 (setting forth a complete list of requirements for an NDA).

The "labeling" requirement for a drug refers not simply to the label attached to the drug, but rather "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." 21 U.S.C. § 321(m). By regulation, "[t]he labeling shall contain a summary of the essential scientific information needed for the safe and effective use of the drug." 21 C.F.R. § 201.56(a).4 Drug labeling must include specific information under prescribed section headings, including, inter alia, contraindications, warnings and precautions, adverse reactions and use in particular populations, including pediatrics. Id. § 201.56(d)(1). Under the "Warnings" section, "the labeling shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur." 21 C.F.R. § 201.57(e). In addition,

Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. If a boxed warning is required, its location will be specified by the Food and Drug Administration. The frequency of these serious adverse reactions and, if known, the approximate mortality and morbidity rates for patients sustaining the reaction, which are important to safe and effective use of the drug, shall be expressed as provided under the "Adverse Reactions" section of the labeling.

Id. Notably, "[t]he labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Id.

The FDA must disapprove an NDA if, among other reasons, it finds that (1) the investigations submitted to the FDA "do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;" (2) "the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;" (3) the FDA has insufficient information to determine the drug is safe for use under such conditions; (4) "there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;" or (5) "based on a fair evaluation of all material facts, such labeling is false or misleading in any particular." 21 U.S.C. § 355(d); 21 C.F.R. § 314.125. Further, the FDA "will approve an application and send the applicant an approval letter if none of the[se] reasons ... for refusing to approve the application applies." 21 C.F.R. § 314.105(a). The FDA "will approve an application and issue the applicant an approval letter ... on the basis of draft labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft labeling." Id. § 314.105(b)....

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