In coming weeks, the U.S. Supreme Court is expected to weigh in on the 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, particularly when those warning labels are closely controlled by federal regulators.
And the decision could have major implications for lawsuits against pharmaceutical companies, including a case decided last year by a federal appeals panel in Chicago, in a legal action brought by the widow of Chicago lawyer who committed suicide after taking the generic equivalent of the antidepressant, Paxil.
In recent weeks, attorneys for pharmaceutical company GlaxoSmithKline and for plaintiff Wendy Dolin filed competing briefs before the U.S. Supreme Court.
Dolin is asking the high court to toss out the decision of the U.S. Seventh Circuit Court of Appeals, which had, in turn, thrown out a jury verdict ordering GSK to pay Dolin $3 million.
In that decision, the Seventh Circuit judges had essentially found GSK could not be held liable for the content of the warning label on its medication, because those labels were controlled by the U.S. Food and Drug Administration.
Dolin had sued GSK in 2012, two years after her husband, Stewart Dolin, killed himself in a downtown Chicago transit station. Dolin alleged her husband was taking paroxetine, the generic version of GSK’s Paxil, at the time. She 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, however, said it tried several times to secure approval from the FDA to revise the label, but the FDA declined.
After years of proceedings in federal district court in Chicago, a jury found in favor of Dolin at trial. GSK appealed, and the Seventh Circuit overturned the verdict.
Dolin then appealed to the U.S. Supreme Court, arguing the Seventh Circuit got it wrong. Dolin’s lawyers particularly argued the Seventh Circuit’s ruling conflicted with 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.
Dolin’s attorneys also noted the decision conflicts with the decision of the U.S. Third Circuit Court of Appeals, which found in a similar case the FDA’s regulation of drug warning labels did not absolve pharmaceutical company Merck of liability for injuries allegedly suffered by patients who took Merck’s drug, Fosamax.
That case, docketed before the Supreme Court as Merck v. Albrecht, was argued before the Supreme Court in January. A decision could be forthcoming in the case in coming weeks.
No matter which way the court falls on the question, though, it may also decide the fate of the Seventh Circuit’s decision in the Dolin matter.
Dolin, in a brief filed April 11, asked the Supreme Court to hold off on deciding whether to take up her case until after it has decided the Albrecht case.
“At the heart of the pending Albrecht decision is an analysis of what was presented to the FDA, how the FDA responded, and what warning (if any) the FDA rejected…,” Dolin’s attorneys wrote.
“This is exactly the issue in this case, i.e., when the FDA through informal communications stated that GSK’s proposed Paxil-specific adult warning should not go in the middle of the class-labeling section (as that applied to the whole class of drugs), but that GSK should submit a formal (Changes Being Effect) supplement that the FDA could review independent of the class-labeling being implemented for over 30 different antidepressants, was the FDA rejecting a Paxil-specific adult warning? Every jury and virtually every jurist (with the exception of the Seventh Circuit panel …) has answered this question in the negative.”
GSK, however, in a brief filed in late March, asserted the Seventh Circuit’s decision is on firm legal footing, no matter the outcome in Albrecht.
“This Court’s resolution of that dispute, … will not affect the outcome here,” GSK argued in its brief. “The (Seventh Circuit) court of appeals here found that the ‘undisputed evidence’ regarding FDA’s decision-making was subject to only one reasonable interpretation: FDA, after exhaustively studying the issue for years, definitely and repeatedly rejected an adult-suicidality warning based on substance and science.”
GSK also asserted the decision was sound, even when posed against Wyeth, as the Seventh Circuit found “no reasonable jury could find that the FDA would have approved an adult-suicidality warning for Paxil … between 2007 and Stewart Dolin’s suicide in 2010.”
Aside from the Seventh Circuit’s findings, GSK also asked the Supreme Court to note Dolin’s lawyers were essentially attempting to use a warning label suit to hold GSK liable for the alleged effects of a generic medication it did not make, sell or distribute, under a theory called “innovator liability” – making the innovator of a product pay for the alleged damage caused by a copy of its original product, made and sold by someone else.
“But such a theory of liability is untenable,” GSK wrote. “Holding brand manufacturers liable for injuries allegedly caused by generic manufacturers would up-end tort principles, deter medical innovation, and require brand manufacturers to insure an entire industry when their patents have long since expired and they no longer profit from the drug.”
GSK asked the Supreme Court to reject the appeal, and not hear arguments in the case, allowing the Seventh Circuit decision to stand.
Supreme Court justices are scheduled to consider whether to hear arguments in the Dolin case at a conference April 26, according to the court’s docket.
Dolin is represented by attorneys with the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles, and the Rapoport Law Offices P.C., of Chicago.
GSK has been represented by the firms of Arnold & Porter Kaye Scholer, and and Williams & Connolly LLP, each of Washington, D.C., and by the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta.