Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand drug manufacturers. Judge Zagel found that GSK had not shown “clear evidence” that the FDA would have rejected the heightened warning label sought by plaintiff. Therefore, plaintiff’s claims were not preempted.

This ruling comes from the same court that held in 2014 that GSK, the brand drug manufacturer, owed a duty of care to a patient who took only the generic version of its drug. Dolin v. SmithKline Beecham Corp., No. 1:12-cv-06403 (N.D. Ill. Feb 28, 2014).

Background

Plaintiff Wendy Dolin sued GSK for her husband’s death. Mr. Dolin was a prominent attorney in Chicago who died in an apparent suicide six days after he began taking paroxetine, a generic form of Paxil, to treat work-related anxiety.

The complaint alleged that paroxetine caused akathisia, a condition characterized by agitation and restlessness, and that akathisia is associated with suicidal behavior. Plaintiff alleged that GSK failed to warn that paroxetine was associated with an increased risk of suicide in adults.

GSK had previously moved for summary judgment on product liability and negligence claims on the grounds that it did not manufacture the product that Mr. Dolin ingested. In denying GSK’s motion, Judge Zagel reasoned that GSK owed Mr. Dolin a duty of care because “it was well understood that any generic manufacturer would be required by law to use GSK’s design and warning label.”

Preempting Failure-to-warn Claims

After discovery, GSK renewed its motion for summary judgment on the grounds that the plaintiff’s failure-to-warn claims were preempted. In the renewed motion, GSK attacked the negligence claim, which alleged that GSK failed to effectively warn consumers of the risk of Paxil-specific adult suicide. GSK argued that the failure-to-warn claim was preempted by FDA regulations governing drug labels.

Judge Zagel denied the motion, finding that the claims were not preempted because GSK had failed to demonstrate with “clear evidence” that the FDA would not have approved a Paxil-specific adult warning regarding the risk of suicide. The court began its preemption analysis by recognizing that preemption in this context is a demanding defense. Citing Wyeth v. Levine, the court found that “[t]o meet this demanding burden, GSK is required to produce ‘clear evidence’ that, had it added a Paxil-specific adult suicidality warning, that change would have been rejected by the FDA or deemed a misbranding of the drug.”

“Clear Evidence”

Front and center in this dispute was the issue of what such “clear evidence” might be. GSK had put forth substantial evidence regarding the FDA’s own studies of suicide risks for the entire class of selective serotonin reuptake inhibitor (SSRI) drugs. GSK also cited its extensive correspondence with the FDA on what changes should be made to the Paxil label in light of the FDA’s changes to all SSRI drugs. But the court focused only on one transaction: on June 22, 2007, the FDA invited GSK to discuss the option of altering the language on its warning label. According to GSK’s brief, the letter stated:

As for your first question, the Agency has reviewed your proposed changes, and we do not believe that your product specific analysis should be included in class labeling revisions since the labeling is targeted at the class of drugs. If you would like to discuss this matter further, please submit a formal meeting request.

Despite the vast record showing the FDA’s heavy hand in shaping SSRI labeling in general, and Paxil labeling in particular, the court simply noted that GSK did not follow up to discuss the matter further and sought no further labeling changes. This factual record, the court found, was insufficient to support GSK’s assertion “that the FDA has considered and rejected an adult suicide warning during the relevant period.”

Judge Zagel’s ruling departs from the Wyeth standard, as it potentially requires a defendant to demonstrate by clear evidence not that the FDA would have rejected a proposed warning label, but instead that the FDA actually did reject the label.

Implications

The ruling leaves open questions as to the defendant’s burden of proof in establishing a preemption defense. Rather than adding clarity to pharmaceutical labeling requirements, this opinion muddies the water. It brings defendants closer to having to disprove that an entire chain of events would have occurred leading to the FDA’s rejection of a strengthened warning—precisely the type of “Mouse Trap game” that Justice Thomas found should not be within the purview of the courts.PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2578 (2011).

Should plaintiff prevail at trial, we expect and hope that this opinion would be reversed on appeal based on the clear evidence that the FDA took control over the content of the label.