Pfizer Cites New FDA Preemption Language, Asks Court to Vacate Denial of Judgment — (U.S. District Court for the District of New Jersey)

SSRI Ed note: Man is given Lexapro, reacts badly, switched to Zoloft, dose increased, he kills himself.

Original Article no longer available

U.S. District Court for the District of New Jersey

Jan 30, 2003

Citing a new Food and Drug Administration rule that supports federal preemption, Zoloft manufacturer Pfizer Inc. asked a federal trial court Jan. 30 to vacate an order denying summary judgment on preemption grounds Alternatively, Pfizer asked the U.S. District Court for the District of New Jersey to certify the matter for interlocutory appeal.

Certification is appropriate because the preemption issue involves a controlling question of law, and there is substantial ground for difference of opinion. Two other federal district courts have granted summary judgment for Pfizer on this issue, the defendant’s motion said.

Decedent Used Drug for a Short Time

Theodore DeAngelis, 64, said he began to feel depressed in late 2002. His family doctor prescribed Lexapro, an anti-depressant. DeAngelis disliked Lexapro and was switched to Zoloft on Jan. 22, 2003. Six days later, he consulted a psychiatrist, who prescribed a higher dose of Zoloft. DeAngelis was found dead on Jan. 30, 2003, having taken his own life. According to the opinion, he had no history of depression or suicidal tendencies, and had not used antidepressants before Lexapro.

DeAngelis’ daughter, Beth Ann McNellis, sued Pfizer. She asserted that Zoloft can and does “drive some people to their death by suicide” and that Pfizer failed to adequately warn her father’s physician of that risk.

Pfizer sought summary judgment on preemption grounds. Denying the motion, the U.S. District Court for the District of New Jersey explained that the Food and Drug Administration’s approval of a proposed label creates only minimum standards. A manufacturer may unilaterally strengthen adverse reaction warnings as long as the new warning is not false or misleading, the court said in its Jan. 29 ruling.

The court reasoned that if the plaintiff can demonstrate that Pfizer had knowledge of a heightened risk of suicidality, which should have resulted in a stronger label warning than initially approved, then the Food, Drug, and Cosmetic Act does not preempt the plaintiff’s claim.

New FDA Labeling Rule

On Jan. 24, the FDA published a prescription drug labeling rule, with a preamble containing preemptive language. The rule says, “under existing preemption principles, FDA approval of labeling … preempts conflicting or contrary state law,” Pfizer said. According to the drug manufacturer, the agency’s statements explain why two arguments raised by the plaintiff and made the basis of the court’s order misinterpret the regulations.

Pfizer said, “First, FDA states that its labeling requirements are not ‘minimum standards’ and that, instead, those requirements establish both a ‘floor’ and a ‘ceiling.'” Pfizer argued that the agency said its interpretation must be true, because state-law imposition of additional warning requirements “can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use.”

Second, Pfizer said, quoting from the rule, the FDA states that the conclusion, reached by some courts, that Section 314.70 negates the preemptive effect of FDA’s labeling requirements “conflict[s] with the agency’s own interpretations” of its own regulation and “frustrate[s] the agency’s implementation of its statutory mandate.”

According to Pfizer, the FDA stressed that it is the final arbiter of labeling form and content, pointing out that “the determination whether labeling revisions are necessary is, in the end, squarely and solely FDA’s under the act.”

Judicial Notice, Substantial Deference

Under 44 U.S.C. Section 1507, the FDA’s conclusions set forth in the Federal Register are entitled to judicial notice, Pfizer argued.

FDA’s assessment of the preemptive effect of its actions also is entitled to substantial deference, Pfizer said, citing Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), in which the manufacturer argued the U.S. Supreme Court not only has given weight to FDA’s conclusions regarding preemption of state-law claims, but has noted that the agency “is uniquely qualified to determine whether a particular form of state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress, and, therefore, whether it should be preempted.”

And in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), the court deferred to the Department of Transportation’s interpretation of its enabling statute, because Congress delegated to DOT the authority to implement the statute, the subject matter is complex, and DOT is uniquely qualified to comprehend the impact of state requirements.

Interlocutory Appeal Requested

Alternatively, Pfizer asked the court to allow interlocutory appeal of the summary judgment denial, as well as any order denying this motion to vacate.

Interlocutory review under 28 U.S.C. Section 1292 is appropriate because this appeal involves a controlling question of law and there is a substantial ground for difference of opinion, and an immediate appeal may materially advance the ultimate termination of the litigation, Pfizer said.

The preemption issue would be dispositive of these claims if decided in Pfizer’s favor, the drug company explained.

As for the existence of substantial grounds for difference of opinion, Pfizer cited the FDA’s disagreement with the conclusions on which the Dec. 29, 2005, order is based. Additionally, the court’s order conflicts with decisions in Dusek v. Pfizer Inc. (S.D. Texas, No. H-02-3559) and Needleman v. Pfizer Inc. (N.D. Texas, No. 3:03-CV-3074-N), in which the U.S. District Courts for the Northern District of Texas and the Southern District of Texas, respectively, found preemption of state-law warning claims in connection with the same antidepressant, the same warnings, and the same regulatory process by which the medicine is labeled. The decisions were consolidated for appeal to the U.S. Court of Appeals for the Fifth Circuit, but settled before the preemption issue was decided.

Unlike this court, the Dusek and Needleman courts also found that the FDA’s statements, expressed in an amicus brief to the U.S. Court of Appeals for the Ninth Circuit in Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004), another Zoloft case, were entitled to deference, Pfizer said. Motus was resolved on other grounds and the court did not reach preemption.

The third requirement for interlocutory appeal is that the resolution of the issue to be appealed will materially advance the termination of the litigation, Pfizer said. Resolution of the preemption issue would terminate this litigation and avoid the needless expenditure or a costly trial.

Because the same issue is before the court in another Zoloft case, Postigo v. Pfizer Inc., No. 05-CV-3414 (D. N.J.), immediate resolution by the Third Circuit can avoid the same waste of resources in that case as well, Pfizer asserted.

The plaintiff is represented by Steven A. Karg and M. Karen Thompson of Norris, McLaughlin & Marcus in Somerville, N.J.

Pfizer is represented by Malcolm E. Wheeler, James E. Hooper, and Andrew H. Myers, of Wheeler Trigg Kennedy in Denver.