No doubt the Plaintiff’s attorneys in Tucker v. SmithKline Beecham, d/b/a GlaxoSmithKline, 04-cv-01748 (DFH/WTL), S.D. Ind. (Indianapolis Division) are breathing a huge sigh of relief. On July 18, 2008, Chief Judge David Hamilton reopened the case by granting the Plaintiff’s motion for reconsideration, effectively reversing the court’s prior grant of summary judgment on preemption grounds. Perhaps even more remarkable than the 180-degree-turn of events is the depth of this particular jurist’s understanding of the preemption issue in the context of SSRI litigation – specifically, in the context of Paxil suicide cases – and the utter frankness of the opinion. Tucker v. GSK, Slip opinion (S.D. Ind. July 18, 2008) At last, someone gets it.
By way of background, Tucker involves a wrongful death suit against GlaxoSmithKline (GSK) brought by Debra Tucker, arising from the suicide of her older brother, Father Rick Tucker (a priest). Father Tucker committed suicide after only 3 weeks of taking GSK’s Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant, Paxil.
At the outset of its discussion explaining the reasoning for its about-face, the court recognized that the core theory of GSK’s argument is that the FDA has “exclusive authority” over labeling of prescription drugs. Id. at Slip op. 6-7. The court then candidly admitted:
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 ….
Id. at Slip op. 7 (emphasis added).
Later in the opinion, the court reiterated the specific facts of the history of Paxil’s suicidality labeling that had originally swayed the court to espouse preemption:
In particular, the court was swayed by the fact that, in May 2006, GSK revised Paxil’s label to include the following warning:
‘In adults with [major depressive disorder] (all ages), there was a statistically significant increase in the frequency of suicidal behavior in patients treated with [Paxil] compared to placebo …. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.’
In the meantime, the FDA engaged in its own evaluation of whether all antidepressants, as a class of drugs, were associated with an increased risk of suicidality in adults. … [T]he FDA contacted GSK in May 2007 and required GSK to revise the label for Paxil to include a class-wide warning that included the following language: ‘Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.’ The court found that this FDA-mandated warning ‘confirms the risk of suicidality in pediatric patients, but affirmatively rejects the hypothesis that there is any such association in adults,’ and that this revised labeling ‘stands in clear and undeniable conflict with Tucker’s state law causes of action’.
Id. at Slip op. 20-21. Essentially, the court had been convinced that the regulatory history demonstrated (1) an attempt by GSK to strengthen its adult suicidality warning, and (2) a rejection of that warning by the FDA, which essentially signaled a conflict sufficient to warrant preemption of Ms. Tucker’s failure to warn claim.
However, citing to a document that is not available to the public and was filed under seal, the court undid its prior reasoning and explained at length why no implied conflict exists:
On reconsideration, the court finds that this position is flawed in one key respect: in 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 FDA [cite to Sealed Document.] 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.
Id. at Slip op. 21-22 (emphasis added).
If you are a plaintiff’s attorney battling preemption in the prescription drug arena, we urge you to read this opinion today. And then read it again. The judge’s reasoning is in line with every argument that we and others have repeatedly raised in SSRI cases for the past five years. Kudos to our friends at Baum, Hedlund, Aristei & Goldman on their hard work and in achieving this great victory for the plaintiff’s bar.