Indiana District Court Vacates Prior Preemption Ruling Concerning PAXIL After Gaining a Better Appreciation of FDA’s Labeling Requirements

July 22, 2008

On July 18, 2008, in a rare “win” (depending on which side you are on) on a motion for reconsideration, the U.S. District Court for the Southern District of Indiana (Indianapolis Division), vacated the court’s September 2007 decision in Tucker v. SmithKline Beecham Corp., in which Chief Judge David F. Hamilton had earlier dismissed, on federal preemption grounds, a wrongful death/failure-to-warn lawsuit brought under Indiana state law against GlaxoSmithKline (“GSK”) concerning the company’s antidepressant drug PAXIL (paroxetine HCl).  The recent decision, in which the court found no implied conflict preemption and declined to rely on FDA’s “preemption preamble” (see pages 3933-36) changes the Drug Preemption Scorecard kept by the folks at Drug and Device Law Blog.  The case is now reopened for adjudication on the merits, which the court promised to address in the “near future.”

The case concerns the death of Father Rick Tucker, a Roman Catholic priest who allegedly committed suicide in September 2002 after being prescribed PAXIL in August 2002.  Plaintiff Debra Tucker, Father Tucker’s younger sister, brought a wrongful death suit under Indiana state law against GSK claiming that her brother committed suicide as a result of taking PAXIL. Ms. Tucker contends that GSK breached its duty to warn of an increased suicide risk in adults taking PAXIL. GSK argued that the company could not be held liable for the alleged inadequacy of the PAXIL labeling because the United States Constitution’s Supremacy Clause mandates that the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and FDA labeling requirements preempt Ms. Tucker’s state law claims.  In September 2007, the district court granted GSK’s motion for summary judgment because Ms. Tucker’s “state law claims stand in direct conflict with the FDA’s labeling requirements for Paxil issued pursuant to federal law. . . .” (i.e., conflict preemption).

Fast-forward 10 months and the district court has reversed course.  After the September  2007 decision, Ms. Tucker filed a Rule 59 motion asking the court to reconsider its decision.  Ms. Tucker argued that no conflict exists between Indiana state law and federal law because “FDA has not, in fact, precluded GSK from including in its current label Paxil-specific warning language,” and that even if there is a conflict as a result of class-wide antidepressant labeling changes implemented in 2007 concerning suicide, “no conflict existed in 2002 when GSK could have warned Father Tucker or his physician about Paxil’s alleged association with suicidality.”

GSK countered that although FDA’s labeling regulations give the company the right to adopt proper labeling, and that the company had the ability to change PAXIL’s labeling if there was a “reasonable association” between a serious adverse event and the drug, FDA retains exclusive regulatory authority over prescription drug labeling.  GSK also argued that the conflict between state and federal law that favors preemption is the risk that “drug manufacturers will be forced to walk a tightrope between being sanctioned by the FDA for ‘overwarning’ and sanctioned by the courts for ‘underwarning.’”  That is, there is a Catch-22 – a company could misbrand a drug by adding warnings against non-existent risks to avoid tort liability, or adhere to FDA labeling requirements and risk failure-to-warn tort liability.

In his latest ruling, Judge Hamilton was unconvinced by GSK’s arguments.  “In [earlier] finding conflict preemption, the court failed to appreciate the significance of the fact that the FDA regulations allow a manufacturer to modify pharmaceutical labels unilaterally and immediately, without prior FDA approval, when the manufacturer has reasonable evidence of a serious hazard.”  With respect to GSK’s argument that FDA retains exclusive authority over prescription drug labeling, the court stated that:

This argument fails to appreciate, as the court failed to appreciate, the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer.  Although the FDA might later disapprove of a label strengthened pursuant to 21 C.F.R. § 314.70(c) and § 201.80, the FDA’s power to disapprove does not make the manufacturer’s voluntarily strengthened label a violation of federal law, which is what it would take to establish an actual conflict between state tort law and federal law. 

With respect to GSK’s Catch-22 argument, the court found this position flawed in one key respect:

[I]n spite of the FDA’s direction regarding Paxil’s label in May 2007, GSK still had (and has) the obligation to revise its label to strengthen a warning upon reasonable evidence of an association of a serious hazard, particularly with respect to this individual drug. If GSK were to receive such evidence, it would be obligated to revise its label in spite of the FDA’s directive in May 2007. In fact, when it issued its instruction that GSK revise Paxil’s label, the FDA advised GSK that if GSK disagreed with the FDA’s belief that Paxil-specific analysis should be included in the SSRI labeling revisions, GSK could request a meeting with the FDA. The FDA’s offer, upon which GSK did not act, is consistent with GSK’s ongoing obligations under the regulations. In other words, the FDA’s revisions were not necessarily the final word on Paxil’s label and did not put GSK into a position where it was impossible for GSK to comply with both state and federal law.

Judge Hamilton also took the opportunity to take issue with FDA’s “preemption preamble” in the Agency’s January 2006 final rule on prescription drug labeling.  There, FDA asserted that “FDA approval of labeling under the [FDC Act] . . . preempts conflicting or contrary State law,” that the Agency’s labeling requirements are not minimum standards but establish both a “floor and a ceiling,” that this preemption position was “long standing,” and that state failure-to-warn lawsuits have “directly threatened the agency’s ability to regulate manufacturer dissemination of risk information for prescription drugs.” 

Citing a recent essay authored by former FDA Commissioner Dr. David Kessler and Georgetown University Law Professor David Vladeck, Judge Hamilton states that “FDA’s current position on preemption is not ‘long standing’ but is in fact a ‘180-degree reversal’ from its earlier stance.”  Thus, “[t]he court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations.” Moreover, Judge Hamilton opined that “failure to warn litigation can serve to reinforce the FDA’s regulations, which already place the obligation to strengthen the warnings on a drug’s label squarely on the shoulders of the drug’s manufacturer.”

By Kurt R. Karst 

Categories: Drug Development