In a much-anticipated ruling on the appeal of a $3 million verdict against GlaxoSmithKline (GSK) in a wrongful death case involving the Paxil generic, paroxetine, the U.S. Court of Appeals for the Seventh Circuit reversed on Wednesday and held that the plaintiff’s claims were preempted under Wyeth v. Levine, 555 U.S. 555 (2009). Dolin v. GlaxoSmithKline LLC, No. 17-3030, slip op. at 25 (7th Cir. August 22, 2018). The appellate court’s decision was also notable in that the court ruled on the preemption issues without addressing whether Illinois law would permit a claim of “innovator liability” against brand manufacturer GSK when the plaintiff had only taken generic paroxetine manufactured by a different company. Id.

The plaintiff’s husband had taken paroxetine for six days prior to his suicide in 2010. After extensive motion practice, her case went to verdict against GSK in 2017. Id. at 2. GSK argued that it should not be liable under Illinois law because the decedent had not taken a drug it manufactured, and also that federal law preempted any suicidality warning requested by plaintiff “because the FDA had rejected GSK’s attempts to add just such a warning.” Id. at 3.

GSK changed its Paxil label in April 2006 under the “changes being effected” (CBE) regulation, 21 C.F.R. § 314.70(c), to add information about adult suicidality data after an internal analysis. The FDA completed its own meta-analysis in November 2006 and, in May 2007, ordered GSK and the manufacturers of all SSRI antidepressants to adopt class labeling on adult suicidality. Id. at 9-11. “This action had the effect of rejecting GSK’s unilateral change to the paroxetine label in 2006 using the CBE regulation to warn of increased risk among older adults.” Id. After this class label change, GSK asked the FDA on several occasions for permission to use paroxetine-specific adult suicidality warnings, but this was repeatedly rejected by the agency in 2007. Id. at 13. GSK continued to market Paxil with this class labeling through 2014, when it sold Paxil to another manufacturer. Id.

The Seventh Circuit’s opinion largely focused on the “clear evidence” presented by GSK of impossibility preemption: (1) that the FDA had rejected paroxetine-specific suicidality warnings in 2007 and (2) that GSK lacked new information after 2007 that would have allowed it to add an adult suicidality warning under the CBE regulation. Id. at 16-17.

The Seventh Circuit noted that in Levine, the Supreme Court found “four key facts” when it found no preemption, but all of those “evidentiary gaps in Levine were filled here.” Id. at 19. First, GSK had studied the risk at issue; second, GSK had made a CBE change and supplied the FDA its data about the risk that supported the change; third, GSK had made four requests for permission to make this change after the class labeling was directed by the FDA; and fourth, “(e)ach time, the FDA told GSK not to add the paroxetine-specific warning.” Id. at 20. The Seventh Circuit stated that this was clear evidence that, as of 2007, the FDA rejected an adult suicidality warning for paroxetine. Id.

The court of appeals rejected the plaintiff’s “unreasonable” argument that the FDA had only rejected GSK’s proposal to add its language in the middle of the class warning, and not in any other section of the label. Id. at 21. The court also rejected the plaintiff’s argument that GSK lacked clear evidence that the FDA would have rejected an adult suicidality warning after a formal meeting. The Seventh Circuit held that the Levine preemption argument rests on whether the manufacturer could not change its label through the CBE regulation, not on whether it could have persuaded the agency “to change its mind in a formal meeting.” Id. at 22.

The Seventh Circuit also held that the plaintiff failed to offer evidence at trial that GSK had new information after 2007 on suicidality that would justify a CBE label change before 2010. Id. at 23. The plaintiff argued that GSK had “withheld or manipulated data” submitted to the FDA, but the appellate court found that the “undisputed evidence shows that the FDA was aware of the nature of the data it received from GSK.” Id. Plaintiff also argued that a 2011 article showed that GSK did a re-analysis in 2008 with relevant data, but the court noted that the plaintiff’s expert had testified at trial that this was not a new analysis, but based on data from GSK’s own 2006 analysis. Id. at 24. Thus the Seventh Circuit held that the plaintiff’s Illinois law claim that GSK should have warned of a risk of adult suicidality on the paroxetine label in 2010 was preempted under Levine, given the clear evidence that the FDA would have rejected the warning—namely its rejection of such a warning in 2007 and the lack of newly acquired information before 2010.

Given its preemption holding, the Seventh Circuit did not need to consider the innovator liability theory advanced by the plaintiff (although it noted that the Illinois state courts have not yet considered “the new theory of liability that plaintiff advances.”) Id. at 25.

The Seventh Circuit also found it unnecessary to decide whether pre-emption under Levine is a question of law or fact, a question pending in the Supreme Court on certiorari to the Third Circuit in In re Fosamax (Alendronate Sodium) Products Liability Litig., 852 F.3d 268 (3d Cir. 2017). According to the court, regardless of the standard, “no reasonable jury could find that the FDA would have approved an adult suicidality warning for Paxil under the CBE regulation between 2007 and Stewart Dolin’s suicide in 2010.” Id. at 18.