A federal appeals court in Chicago could be tasked with taking another look at its previous decision undoing a jury verdict ordering one of the world’s biggest pharmaceutical companies to pay $3 million to the widow of a Chicago lawyer who committed suicide after taking the generic equivalent of a widely prescribed antidepressant drug.
Earlier this week, the U.S. Supreme Court weighed in on a similar case, lending new legal illumination to the murky question of how much liability drug companies should face over the warning they give to doctors and patients of certain allegedly harmful side effects from their medications.
In a unanimous decision, the nation’s high court instructed the U.S. Third Circuit Court of Appeals in Philadelphia to revisit its decision last year allowing people to sue drug makers over the content of their medications’ warning labels, even if the U.S. Food and Drug Administration rejected a company’s attempt to revise the warning label to include more warnings about more potential side effects.
In that case, docketed as Merck v Albrecht, a group of more than 500 plaintiffs had sued pharmaceutical company Merck, asserting the FDA’s regulation of drug warning labels did not absolve Merck of liability for bone fractures suffered by patients who took Merck’s osteoporosis drug, Fosamax.
Merck, however, asserted the FDA regulation meant federal law should trump state law, and Merck should not be penalized for failing to issue a warning that the FDA had blocked them from including in the Fosamax warning label.
According to court documents, Merck warned the FDA in 2008 that Fosamax could be tied to the increased risk of fractures. The FDA ultimately allowed them to do so in 2011. The plaintiffs asserted they took Fosamax from 1999-2010.
A federal judge had ruled in favor of Merck, but that decision was overturned on appeal by the Third Circuit. Merck then appealed to the Supreme Court.
There, all nine justices agreed to vacate the Third Circuit’s decision. However, the Supreme Court used its opinion to further clarify the standards by which federal courts should decide the question. The case largely centered on the Supreme Court’s 2009 ruling in Wyeth v Levine, which held drug companies with “clear evidence” of problems can revise labels to enhance warnings, without FDA approval.
In the Fosamax case, the Supreme Court sought to further define the term “clear evidence.” In this case, the Supreme Court said “clear evidence” must include “evidence that shows the court that the drug manufacturer fully informed the FDA” of the potential dangers of its medication, and why the label should be revised to include that additional warning language. Further, the high court said, they must show judges “the FDA … informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.”
Further, the Supreme Court said the question of whether the FDA had been “fully informed” should be left to a judge, not a jury.
While the decision could lead to a different result in the Fosamax case, it could also lead to new hearings and potentially different results in a similar case that made its way through the Chicago courts.
In that case, plaintiff Wendy Dolin sued pharmaceutical company GlaxoSmithKline over the death of her husband, Stewart Dolin, who had committed suicide in a downtown Chicago transit station in 2010. Dolin alleged her husband’s suicidal behavior was caused by the drug paroxetine, the generic version of GSK’s Paxil.
Dolin asserted the warning label for paroxetine, which was written by GSK and is identical to the warning label for Paxil, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the alleged increased risk, yet chose not to revise the warning label.
GSK has asserted it tried several times to secure approval from the FDA to revise the label, but the FDA declined.
Two federal district judges presiding over the case rejected GSK’s arguments concerning the FDA regulation, allowing the case to go trial. There, a jury awarded Dolin $3 million.
GSK appealed, and the U.S. Seventh Circuit Court of Appeals overturned the verdict.
Dolin then appealed to the Supreme Court, asserting the Seventh Circuit got the facts of the case wrong, particularly arguing GSK never presented “clear evidence” it had pressed the FDA to allow it to change the Paxil warning label.
Representatives of GSK did not reply to repeated questions from The Cook County Record concerning the impact of the Fosamax decision on their defense, asserting the FDA regulation preempted Dolin’s claims under Illinois state law for failure to warn.
However, an attorney for Dolin said the plaintiffs believe the Fosamax decision will result in the Supreme Court ordering the Seventh Circuit to also take another look at its earlier decision, just as the justices ordered the Third Circuit.
Attorney Bijan Esfandiari, a partner at the firm of Baum, Hedlund, Aristei & Goldman in Los Angeles, who authored the appellate briefs filed on behalf of Dolin at the Supreme Court, said the facts in the Dolin case are opposite those in the Fosamax case.
He said plaintiffs have long maintained “GSK never fully informed the FDA” of Paxil’s potential to increase suicide risk.
He said they maintain the “FDA never rejected or prohibited GSK from issuing a warning.”
“We believe the Seventh Circuit misapplied (Wyeth v Levine), and we’ll be able to demonstrate there is no (federal) preemption,” Esfandiari said, meaning Dolin’s claims under state law should be allowed to proceed.
The Supreme Court is scheduled to take up the Dolin appeal at a conference on May 23. From there, the high court would decide whether to hear arguments in the case, or to deny Dolin’s appeal, allowing the Seventh Circuit decision to stand, or to send the matter back to the Seventh Circuit court for a new hearing.
This article was first published by Cook County Record.