O'Neal v. Smithkline Beecham Corp.

• Decision Date: 30 January 2008
• Docket Number: No. CIV S-06-1063 FCD/DAD.,CIV S-06-1063 FCD/DAD.
• Parties: Terri S. O'NEAL, individually and as successor-in-interest to the Estate of Benjamin L. Bratt; Barry M. Bratt, individually, Plaintiffs, v. SMITHKLINE BEECHAM CORPORATION d/b/a Glaxosmithkline, a Pennsylvania Corporation; and Does 1-50, Defendants.
• Court: U.S. District Court — Eastern District of California

551 F.Supp.2d 993

Terri S. O'NEAL, individually and as successor-in-interest to the Estate of Benjamin L. Bratt; Barry M. Bratt, individually, Plaintiffs, v. SMITHKLINE BEECHAM CORPORATION d/b/a Glaxosmithkline, a Pennsylvania Corporation; and Does 1-50, Defendants.

No. CIV S-06-1063 FCD/DAD.

United States District Court, E.D. California.

January 30, 2008.

Bijan Esfandiari, Robert M. Brava-Partain, George William Murgatroyd, III, Karen Barth Menzies, Baum Hedlund Aristie Goldman & Menzies, P.C, Los Angeles, CA, Frances M. Phares, PHV, Baum Hedlund, PC, Covington, LA, for Plaintiffs.

Andrew T. Bayman, PHV, Chilton D. Varner, PHV, Halli D. Cohn, PHV, S. Samuel Griffin, PHV, Sarah T. Sloan, PHV, King and Spalding LLP, Atlanta, GA, Halli D. Cohn, PHV, King & Spalding, LLP, Washington, DC, Martha M. Harris, PHV, Robert E. Glanville, PHV, Thomas S. Wiswall, PHV, Phillips Lytle LLP, Buffalo, NY, Michelle Ann Childers, Thomas W. Pulliam, Jr., Drinker Biddle and Reath LLP, San Francisco, CA, for Defendants.

MEMORANDUM AND ORDER

FRANK C. DAMRELL, JR., District Judge.

This matter is before the court on defendant SmithKline Beecham Corporation, d/b/a GlaxoSmithKline's ("GSK") motion for summary judgment on the ground plaintiffs Terri O'Neal and Barry Bratt's ("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, because they require warnings that directly conflict with federal law governing the labeling and warnings for Paxil® ("Paxil"). Plaintiffs bring this action for the wrongful death of their son, Benjamin Bratt ("Benjamin"), who attempted suicide, on February 14, 1997, at the age of 13, while being treated with Paxil, an antidepressant medication manufactured and sold by GSK. Benjamin died on February 15, 1997 from injuries sustained from his suicide attempt.

The gravamen of plaintiffs' claims is that GSK should have provided, at the time of Benjamin's death, a warning that Paxil is associated with suicidality¹ in pediatric patients. GSK contends, however, that plaintiffs' state tort claims directly conflict with the FDA's-mandated labeling for Paxil in February 1997, and implementation of the warning urged by plaintiffs would have rendered Paxil's prescribing information false and misleading under federal law, as no reasonable evidence existed, at the time, to support implementation of the warning. As such, because there is a direct and actual conflict between plaintiffs' state law claims and federal law, GSK asserts plaintiffs' claims are preempted and must be dismissed.

The court heard oral argument on the motion on January 18, 2008. By this order, the court now renders its decision, granting GSK's motion in its entirety. For the reasons set forth below, the court finds that federal law preempts plaintiffs' instant action against GSK.

BACKGROUND

A. FDA Regulation of Drug Labeling Generally

The Federal Drug Administration ("FDA") is responsible for enforcing the FDCA. In the FDCA, Congress broadly charged the FDA with promoting "the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products," 21 U.S.C. § 393(b)(1), and with ensuring that "drugs are safe and effective," 21 U.S.C. § 393(b) (2)(B). Congress also provided the FDA with exclusive authority to enforce the FDCA, and litigants cannot enforce the FDCA through private actions. 21 U.S.C. § 337(a); Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n. 4, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001).

As part of its regulatory mission, the FDA undertakes an extensive review of new drugs before they are allowed on the market. See 21 U.S.C. § 355 (outlining the New Drug Application ["NDA"], which requires, among many other things, evidence establishing whether the drug is safe and effective in its use and proposed labeling). Most prescription drugs, including Paxil, begin the regulatory approval process as a "new drug." 21 U.S.C. § 321(p). The FDA carefully reviews the NDA and identifies the actual and potential safety risks the drug poses and decides how these risks should be disclosed in the prescribing information. The FDA approves the NDA only after it concludes that a prescription drug is both "safe" and "effective" under the conditions of use specified in the proposed prescribing information. 21 C.F.R. §§ 201.56(d), 201.57 (FDA must be satisfied that the drug's labeling accurately describes its indications, dosages, administration, contraindications, warnings and precausations, adverse reactions, interactions, and use in specific populations). The FDA must disapprove a NDA if it finds that: (1) investigations conducted to establish safety and effectiveness were not adequate; (2) the prescription drug is not safe for use under the conditions provided in the proposed labeling; or (3) the proposed labeling is false and misleading. 21 U.S.C. § 355(d); 21 C.F.R. § 314.125(b)(2), (3), (6).

As part of the approval process, manufacturers of new drugs submit to the FDA "specimens of the labeling proposed to be used for such drug." 21 U.S.C. § 355(b)(1). While there are several mandatory aspects of included drug information (see 21 C.F.R. § 201.56-57), the aspect relevant to the present case involves the "warnings" section. This section must describe "clinically significant adverse reactions (including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the drug)." 21 C.F.R. § 201.57(c)(6)(I). Under the FDA's regulations, warnings must be included on a label "as soon as there is reasonable evidence of a casual association [of a serious hazard] with a drug." Id.²

The FDA communicates its decision to approve the NDA through an approval letter that sets out FDA's terms for approving both the drug and its labeling. FDA approval of a NDA is expressly conditioned on the development and use of "final printed labeling" (prescribing information) that is identical, in every material respect, to the labeling that accompanies the approval letter. 21 C.F.R. § 314.105(b). Use of the FDA-approved prescribing information is mandatory and failure to comply may lead to civil and criminal enforcement. The FDCA envisions a number of remedies against violators, including in rem forfeiture, injunction, and/or criminal prosecution against the manufacturer or responsible person if a "misbranded" drug is distributed. 21 U.S.C. §§ 332(a), 333, 334(a), and 337(a). The FDA may also seek to withdraw approval of a NDA. 21 C.F.R. § 314.150(b).

A prescription drug is misbranded if its labeling is false or misleading, lacks "adequate information for use," or omits material facts. 21 U.S.C. §§ 352(a), (f)(1), 321(n); 21 C.F.R. § 201.100(c)(1). Therefore, departing from the FDA-approved prescribing information, failing to include a scientifically valid warning FDA believes is necessary, or including warning information not based on scientific evidence of known risks, causes the drug labeling to be "false and misleading" and lacking "adequate directions for use" and misbranded, in violation of the FDCA. 21 U.S.C. § 352(a), (f)(1).

After approval of a NDA, the FDA continues to exercise extensive control over the safety of prescription drugs and the content of their labeling. The FDA can move to withdraw its approval of a drug if it finds that scientific data shows that the drug is unsafe for use under the conditions set forth when the application was approved. 21 U.S.C. § 355(e). Additionally, the FDA imposes comprehensive post-approval reporting requirements on manufacturers, including reports of adverse events and all published and unpublished clinical trials on the drug. 21 C.F.R. § 314.80-81. If a manufacturer seeks NDA approval for additional indications or dosage forms (as was done for Paxil more than ten times between 1992 and 2004), then it must provide new supporting data to the FDA, including updated integrated summary of safety ("ISS") and effectiveness ("ISE"). 21 C.F.R. § 314.50(d)(5)(vi)(a). If the FDA finds that any information from a post-approval report or a new ISS report merits a change in the drug's labeling, it will request that the company make the change. If the company refuses to do so, the FDA may pursue the administrative and enforcement actions described above to secure the change.

FDA regulations also allow manufacturers to make certain changes to their drug labels. With the exception of minor editorial changes, a manufacturer must formally file a "supplement" to the NDA to effect any change in a drug's prescribing information. Two types of supplements are used for labeling changes. The first, a "Prior Approval Supplement," requires FDA's prior approval before implementation. 21 C.F.R. § 314.70(b)(2)(v). The second, a "Changes Being Effected" supplement ("CBE"), does not require prior approval but must nonetheless be submitted to the FDA for its review and final approval.³ 21 C.F.R. § 314.70(c)(6)(iii). Among the changes that can be unilaterally made by the manufacturer using a CBE supplement are changes to "add or strengthen a contraindication, warning, precaution or adverse reaction." 21 C.F.R. § 314.70(c)(6)(iii)(A). These changes, like all warnings, remain subject to Section 201.57(c)(6)(I) and may only be added when there is reasonable evidence of an association of a serious hazard with the drug.

B. Pertinent Aspects⁴ of Paxil's Regulatory History

1. FDA Review & Approval of Original Paxil NDA (1989-1992)

On November 20, 1989, SmithKline Beecham Pharmaceuticals ("SB")⁵ filed a NDA for paroxetine (Paxil) seeking FDA approval for the treatment of depression in adults.⁶ (Pls.' Opp'n to GSK's Stmt, of Undisputed Facts [Docket # 142-2], filed Nov. 14, 2007 ["UF"], ¶ 7.)⁷ SB submitted extensive data and information in this initial submission and in numerous amendments to the NDA...