Forst v. Smithkline Beecham Corp., Case No. 07-CV-612.

• Decision Date: 29 July 2009
• Docket Number: Case No. 07-CV-612.
• Citation: 639 F.Supp.2d 948
• Parties: Gary A. FORST and Bonita A. Forst, Plaintiffs, v. SMITHKLINE BEECHAM CORP. d/b/a GlaxoSmithKline, Defendant.
• Court: U.S. District Court — Eastern District of Wisconsin

639 F.Supp.2d 948

Gary A. FORST and Bonita A. Forst, Plaintiffs, v. SMITHKLINE BEECHAM CORP. d/b/a GlaxoSmithKline, Defendant.

Case No. 07-CV-612.

United States District Court, E.D. Wisconsin.

July 29, 2009.

COPYRIGHT MATERIAL OMITTED

Timothy J. Andringa, Cramer Multhauf & Hammes LLP, Waukesha, WI, Bijan Esfandiari, Frances M. Phares, Kate E. Gillespie, Nicole KH. Maldonado, Baum Hedlund Aristei & Goldman PC, Los Angeles, CA, for Plaintiffs.

Andrew T. Bayman, Geoffrey M. Drake, Robert B. Friedman, Mark S. Brown, King & Spalding LLP, Atlanta, GA, John T. Bode, Nicole C. Maher, Murn & Martin SC, Waukesha, WI, for Defendant.

ORDER

J.P. STADTMUELLER, District Judge.

Plaintiffs Gary and Bonita Forst ("the Forsts") bring this products liability and personal injury action against Defendant Smithkline Beecham Corporation d/b/a GlaxoSmithKline ("GSK"), the manufacturer of the drug Paxil CR® ("Paxil"). Their claims arise from Gary Forst's attempted suicide after beginning use of the prescription antidepressant. GSK has filed a motion seeking summary judgment based on federal preemption of the Forsts' state law tort claims. For the reasons set forth below, the court will deny the motion. The court will also address several pending motions regarding documents filed in connection with the motion for summary judgment.

BACKGROUND

Gary Forst ("Mr. Forst") began taking a prescription for the antidepressant medication Paxil in 2004. (Defendant's Proposed Findings of Fact, "DFOF" ¶ 1). Paxil is part of a wider class of antidepressants referred to as selective serotonin reuptake inhibitors, or "SSRI's." (Id. at ¶ 3). Shortly after beginning his prescription for Paxil, Mr. Forst attempted suicide. (Id. at ¶ 2).

The Federal Food and Drug Administration (FDA) originally approved Paxil in 1992. Since that time, the agency has also approved a number of supplemental New Drug Applications (NDA's) for new therapeutic indications, as well as two additional NDA's. (DFOF at ¶ 21). As part of its submissions to the FDA, GSK included safety and efficacy information regarding Paxil. The agency's approvals involved review of this information and were also contingent upon FDA acceptance of Paxil's labeling and warnings. (Id. at ¶¶ 22-24). However, the FDA never required revisions to Paxil's labeling to include warnings about an increased risk of suicidality as part of its consideration or approval of the submissions. (Id. at ¶ 28).

In March and April 2006, two years after Mr. Forst's suicide attempt, GSK submitted additional information to the FDA that included the results of metaanalyses of Paxil studies in adults. (DFOF ¶ 49). Based on these analyses, GSK consulted with the FDA and proposed changes to Paxil's labeling. (Id. at ¶ 51). GSK submitted a Changes Being Effected (CBE) supplement, which proposed a label change stating, among other things, that a statistically significant increase in the frequency of suicidal behavior in adults with Major Depressive Disorder was shown in placebo-controlled trials of Paxil. (Id. at ¶ 52). The FDA reviewed the CBE supplement and notified GSK that the supplement was approvable. (Id. at ¶ 57). However, the FDA directed that instead of including Paxil-specific language changes to its labeling, GSK should employ standardized, class-wide labeling applicable to all SSRI medications. (Id. at ¶¶ 58-59, 63).

STANDARD

Summary judgment is appropriate where the moving party establishes that there is no genuine issue of material fact and that the 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). "Material facts" are those facts which "might affect the outcome of the suit," and a dispute about a material fact is "genuine" if a reasonable finder of fact could find in favor of the nonmoving party. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The party opposing summary judgment cannot simply rest on allegations or denials in its pleadings, but rather, it must also introduce affidavits or other evidence setting forth specific facts showing a genuine issue for trial. Anders v. Waste Mgmt. of Wis., 463 F.3d 670, 675 (7th Cir.2006). Finally, in conducting its review, the court views all facts and draws all reasonable inferences in favor of the nonmoving party. Tanner v. Jupiter Realty Corp., 433 F.3d 913, 915 (7th Cir. 2006).

ANALYSIS

Three motions remain pending before the court, one for summary judgment and two regarding related filings. The court will address each motion in turn.

I. Summary Judgment Motion

GSK urges this court to enter summary judgment in its favor because federal law, in the form of the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301, et seq., preempts the Forsts' state law claims. Specifically, GSK asserts Paxil would have been misbranded under FDA rules 21 U.S.C. § 352(a) and § 352(f)(1) if it had provided the enhanced warnings that the Forsts claim were required. Therefore, GSK concludes, federal and state law applies conflicting duties and trigger preemption of the state tort claims. However, since the time GSK filed its motion for summary judgment, the United States Supreme Court has addressed the precise preemption issue currently before this court. The Supreme Court decided Wyeth v. Levine, 555 U.S. ___, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), a case involving state law failure-to-warn claims against a drug manufacturer. The defendant drug manufacturer in Levine raised the same arguments for preemption of state law claims arising from prescription drug labeling that GSK argues in its summary judgment brief. Thus, the Levine decision informs this court's resolution of the preemption issue and compels a denial of summary judgment.

In Levine, the plaintiff brought state law claims against the defendant drug manufacturer alleging that the company failed to provide an adequate warning about the risks of administering a particular drug, Phenergan, through an "IV push" method after she developed gangrene that required amputation of her forearm. Id. at 1189. Like GSK in the instant case, the defendant in Levine argued that the plaintiff's state law failure-to-warn claims were preempted because the manufacturer could not simultaneously comply with both state-law duties required by tort claims and federal labeling duties. Id. The drug manufacturer also argued that requiring it to comply with state law duties to provide stronger warnings would interfere with Congress' purpose of entrusting an expert agency with drug labeling decisions. Id. at 1190. However, the Court rejected these arguments and held that the plaintiff's state law failure-to-warn claims were not pre-empted by federal law. Id. at 1189-90. Relying on the Supreme Court's holdings in Levine, this court similarly rejects GSK's preemption arguments.

When addressing preemption, the court starts with two guiding principles: 1) that the "purpose of Congress is the ultimate touchstone"; and 2) that a preemption analysis starts with the "assumption that the historic police powers of the States were not superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Levine, 129 S.Ct. at 1194 (citations omitted). The court applies these principles to GSK's pre-Levine arguments that the Forsts' state law claims conflict directly with FDA-mandated labeling, that the state law claims interfere with Congress' purposes in regulating drugs, and that the FDA's position on preemption requires deference. However, the court's job is simplified because the Supreme Court directly addressed and rejected each of GSK's arguments.

GSK first argues that preemption applies because the company cannot simultaneously comply with its duties under both state and federal law. The Supreme Court found, however, that state law failure-to-warn claims do not directly conflict with FDA-mandated labeling because a drug manufacturer has both the ability and duty to update its warnings. Levine, 129 S.Ct. at 1198 (citing 21 CFR § 201.80(e); § 314.80(b); 73 Fed.Reg. 49605). Federal law does not prohibit drug manufacturers from updating their labels to warn of known risks when the FDA-approved labeling did not include the updated language. Instead, a drug manufacturer has a duty to advise consumers of risks because it "bears responsibility for the content of its label at all times." Id. at 1197. Thus, a drug is not misbranded under the FDCA simply because a drug manufacturer modifies a previously-approved label by including enhanced warnings. Id. at 1197. Even if the addition of enhanced warnings did constitute "misbranding," drug manufacturers are not forced to choose between state tort liability or FDA enforcement action, as GSK implies. The Supreme Court dismissed possible agency enforcement against stronger drug warnings as a non-existent threat. Id. ("And the very idea that the FDA would bring an enforcement action against a manufacturer for strengthening a warning pursuant to the CBE regulation is difficult to accept."). State failure-to-warn claims do not subject GSK to conflicting state and federal duties requiring preemption.

GSK next argues that state law failure-to-warn claims create an impermissible obstacle to the accomplishment and execution of Congress' objectives in regulating drugs. This argument is similarly dispatched by Levine. Instead of hindering congressional objectives, the Supreme Court concluded that state law claims promote Congress' objectives in regulating drugs by serving as an additional oversight on safety and effectiveness. Levine, 129 S.Ct. at 1200. Further, Congress' decision not to enact an express preemption of state claims is an acknowledgment of the important role played by these claims. Id. ("If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point...