Cartwright v. Pfizer, Inc.

• Decision Date: 31 March 2005
• Docket Number: No. 6:04CV292.,6:04CV292.
• Citation: 369 F.Supp.2d 876
• Parties: Matthew D. CARTWRIGHT, Individually and as Administrator of the Estate of Bethany J. Cartwright, and as Next Friend of Blake Nicholas Cartwright and Kristan Allyssa Cartwright Plaintiffs, v. PFIZER, INC. Defendant.
• Court: U.S. District Court — Eastern District of Texas

369 F.Supp.2d 876

Matthew D. CARTWRIGHT, Individually and as Administrator of the Estate of Bethany J. Cartwright, and as Next Friend of Blake Nicholas Cartwright and Kristan Allyssa Cartwright Plaintiffs, v. PFIZER, INC. Defendant.

No. 6:04CV292.

United States District Court, E.D. Texas, Tyler Division.

March 31, 2005.

Craig May, Denver, CO, Dan J. Anderson, Canton, TX, George W. Murgatroyd, III, Jessica R. Dart, Karen Barth Menzies, Robert M. Brava-Partain, Los Angeles, CA, for Plaintiffs.

Amy Padden, James E. Hooper, Denver, CO, Jack Edward Urquhart, Laura E. Desantos, Houston, TX, for Defendant.

ORDER ON SUMMARY JUDGMENT

STEGER, District Judge.

Came on this day for consideration the Defendant Pfizer Inc's Motion for Summary Judgment (Federal Preemption) and Memorandum in Support (Docket No. 13). After careful consideration, the Court is of the opinion that the following order should issue.

BACKGROUND AND PROCEDURAL HISTORY

This is a products liability case arising from the suicide death of Bethany Cartwright. According to the Plaintiffs' Complaint, two weeks prior to her death, Mrs. Cartwright was prescribed Zoloft by a local physician's assistant. She had taken Zoloft before, but was unable to remain on it consistently due to the side effects as well as the high cost of the drug. Plaintiffs' Complaint, ¶ 13. Zoloft is a member of the class of drugs referred to as "selective serotonin reuptake inhibitors" ("SSRI"). SSRIs are used to treat major depressive disorder, from which Mrs. Cartwright suffered, as well as obsessive compulsive disorder, panic disorder, premenstrual dysphoric disorder, and social anxiety disorder.

After filling the prescription, her side effects became even more pronounced than before, including: "akathisia, insomnia, mania, agitation, emergent suicidality, emotional blunting and paradoxical worsening of depression." Id., ¶ 14. On May 30, 2002, Mrs. Cartwright, apparently while folding laundry, put the laundry aside, brought the family's 22-caliber rifle into the bathroom, got into the bathtub, wrapped a towel around her head, placed the rifle in her mouth, and tragically, pulled the trigger.

The Plaintiffs, Mrs. Cartwright's estate and heirs, argue that Zoloft, a drug manufactured by the Defendant Pfizer, Inc., which Mrs. Cartwright began taking before her death, was a cause of her suicide. The Plaintiffs further contend that Pfizer had sufficient knowledge of the association between Zoloft and acts of self-harm to warn of this association prior to Bethany Cartwright's death and yet failed to warn of this association. The Defendant argues that the Plaintiffs' state law tort claims are preempted by federal law and must, therefore, be dismissed.

The Court believes that analysis of the instant motion requires a summary of the federal Food and Drug Administration's ("FDA") drug approval process. The federal Food, Drug, and Cosmetic Act ("FDCA") requires FDA approval of prescription medicines as "safe and effective" before they may be sold in this country. 21 U.S.C. §§ 355(d), 393(b)(2)(B). To obtain approval, a manufacturer must submit a new drug application ("NDA") containing test results, results of clinical studies, and other information. Id., § 355(b), (d). The FDCA requires the FDA to disapprove an NDA if the agency finds that

(1) the investigations, reports of which are required to be submitted to the Secretary ..., 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; ... (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, 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 (7) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular[.]

Id., § 355(d).

After approving an NDA, the FDA continues to monitor the drug's safety. The agency must withdraw its prior approval if at any time it finds that "clinical or other experience, tests, or other scientific data show that such drug is unsafe for use" or, "on the basis of new information," that the labeling "is false or misleading in any particular." Id., § 355(e). An element the FDA considers crucial in determining whether a drug is safe is the labeling used to inform physicians about the drug's uses and risks. 50 Fed.Reg. 7452-01, 7470 (Feb. 22, 1985) ("Drug labeling serves as the standard under which FDA determines whether a product is safe and effective."). The FDA regulates all such labeling, including "all written, printed, or graphic matter" used in marketing the drug. 21 C.F.R. § 1.3(a).

The FDA approves an NDA only if the agency "determines that the drug meets the statutory standards for safety ... and labeling." Id., § 314.105(c). The FDA refuses approval if test results "show that the drug is unsafe for use under the conditions prescribed, recommended, or suggested in its proposed labeling or the results do not show that the drug product is safe for use under those conditions," or if "[t]here is insufficient information about the drug to determine whether the product is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling." Id., § 314.125(a), (b)(3)-(4).

FDA regulations mandate the format and content of all the labeling sections — "Contraindications," "Warnings," "Precautions," and "Adverse Reactions" — and the risk information each section must contain. Id., §§ 201.56, 201.57. The FDA states its product-specific labeling requirements in an "approvable" letter to the manufacturer. Id., § 314.110(a) ("FDA will send the applicant an approvable letter if the application ... substantially meets the requirements of this part and the agency believes that it can approve the application ... if ... specific conditions (for example, certain changes in labeling) are agreed to by the applicant. The approvable letter will describe ... the conditions the applicant is asked to meet."). Approval of the NDA is "conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed labeling prior to marketing." Id., § 314.105(b).

On April 13, 1988, Pfizer submitted to the FDA an NDA seeking approval to market Zoloft to treat depression in adults. The NDA comprised 117 volumes of safety and efficacy data. The information in it and in supplemental submissions included detailed information about suicidality in patients given placebo, Zoloft, and active control drugs during clinical studies. See Defendant's Motion for Summary Judgment, Exhibit C.

On November 19, 1990, the FDA convened its Psychopharmacological Drugs Advisory Committee ("PDAC") to review the NDA and advise the FDA regarding the medicine's safety and efficacy. The PDAC consisted of psychiatrists, statisticians, and other experts chosen by the FDA from academic and research institutions throughout the nation. The PDAC voted unanimously that the evidence had shown that Zoloft "is safe when used in the treatment of depression." Defendant's Motion for Summary Judgment, Exhibit E.

The FDA issued its "approvable" letter on September 30, 1991. See Defendant's Motion for Summary Judgment, Exhibit F. Attaching proposed required labeling, the FDA stated, "We believe it presents a fair summary of the information available on the benefits and risks of [Zoloft]," and directed Pfizer to "use the proposed text verbatim." Id. at 1. The "Precautions" section of the labeling stated:

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.

Id. at 5-6.

In addition, the "Adverse Reactions" section of the FDA's proposed required labeling listed "suicide attempt" as an "Infrequent" occurrence, explained that "infrequent adverse events are those occurring in 1/100 to 1/1000 patients," and stated, "It is important to emphasize that although the events reported occurred during treatment with Zoloft (sertraline), they were not necessarily caused by it." Id. at 14-15.

The FDA granted final approval on December 30, 1991. See Defendant's Motion for Summary Judgment, Exhibit G. It also prepared a final report summarizing the bases for its conclusion that Zoloft, with the required labeling, was safe and effective for treating depression. See Defendant's Motion for Summary Judgment, Exhibit H.

FDA's ongoing study of Zoloft and other SSRIs during the ensuing decade continued to find no causal relationship to suicide. Indeed, the FDA made six more explicit determinations that Zoloft was "safe and effective" with the FDA-required labeling. In 1996, the FDA approved Zoloft, as labeled, as safe and effective for treatment of adult obsessive compulsive disorder ("OCD"). See Defendant's Motion for Summary Judgment, Exhibit P. In 1997, FDA approved Zoloft, as labeled, as safe and effective for treatment of panic disorder and of pediatric OCD. See Defendant's ...