The U.S. Supreme Court has decided to wade into the contentious question over whether a pharmaceutical company can be held liable, potentially costing many millions of dollars, for failing to warn consumers and doctors of a drug’s potential effects, when federal regulators prohibited them from adding such warning language to the drug’s label.
And that decision could have significant implications for a $3 million verdict a jury awarded to the widow of a Chicago lawyer who committed suicide in the Loop after taking the generic version of antidepressant drug Paxil.
On July 2, attorneys for pharmaceutical company GlaxoSmithKline asked judges from the U.S. Seventh Circuit Court of Appeals to take note of the Supreme Court’s decision to follow the recommendation of the U.S. Solicitor General’s office to take up an appeal from drugmaker Merck & Co. GSK said that move bolsters its contention federal judges erred when they allowed plaintiff Wendy Dolin to take to a jury her claims over GSK’s alleged failure to warn of suicide risk, when GSK said the U.S. Food and Drug Administration had not allowed the company to add that information to the warning label that accompanies Paxil and its generic equivalent, paroxetine.
Lisa Blatt
| Arnold & Porter LLP
“As noted in GSK’s letter, and as discussed at oral argument in this case, the Solicitor General’s Brief supports GSK’s argument here that preemption … is a legal question for the court, not a factual question for a jury,” wrote GSK’s attorneys in their citation of supplemental authority. “The Solicitor General’s Brief - whose recommendation the Supreme Court has now followed - also supports GSK’s argument that plaintiff’s claims here are preempted because FDA’s 2007 decision mandating class-wide adult suicidality warnings for all antidepressants prohibited GSK from providing a Paxil-specific warning.”
In late May, a three-judge panel for the Seventh Circuit heard oral arguments between attorneys for Dolin and GSK over whether a jury’s verdict awarding Dolin $3 million should be allowed to stand.
The case landed in federal court in 2012, about two years after 57-year-old lawyer Stewart Dolin committed suicide by stepping in front of an L train in the Loop. Dolin sued GSK, asserting the company bore responsibility for her husband’s death, because the drugmaker allegedly had not adequately warned of the suicide risk arising from the use of paroxetine. Stewart Dolin’s doctor had prescribed paroxetine, and Dolin had taken the drug for several days before he died.
GSK had made and distributed brand-name Paxil from 1992-2014. However, the medication taken by Dolin was made by generic drugmaker Mylan.
GSK asserted the lawsuit should be disallowed because it could not be held liable for harm allegedly caused by a medication manufactured and sold by someone else. It further asserted the law and legal precedent should protect it against the plaintiffs’ failure to warn claims, because the FDA controls the contents of the warning labels at the heart of the case.
GSK’s reasoning, however, was rejected by two federal judges, and a jury awarded Dolin’s widow $3 million after a five-week trial in 2017.
GSK then appealed, reiterating its assertion the failure to warn claims should be preempted by the FDA’s preeminence in regulating the warning labels.
GSK argued any court finding otherwise is essentially asking name-brand manufacturers to “insure the whole market,” creating an unfair regime in which name-brand drugmakers who research and innovate new medications, treatments and therapies, must submit to extensive regulation, yet are not shielded by that regulation from lawsuits brought years later by plaintiffs asserting they should be held liable for a product made and sold by someone else.
Attorneys for Dolin, however, asserted drugmakers like GSK have never demonstrated conclusively that the FDA actually ever barred them from including specific warning language on their labels. Rather, plaintiffs have argued the drug company didn’t push hard enough to persuade the FDA to add the language.
GSK is represented by attorney Lisa Blatt and others with the firm Arnold & Porter Kaye Scholer LLP, of Washington, D.C., and the firms of Dentons US LLP, of Chicago, and King & Spalding, of Atlanta, Ga.
Dolin is represented by attorneys with the firm of Baum, Hedlund, Aristei & Goldman, of Los Angeles, and by the Rapoport Law Offices, of Chicago.
Such questions over so-called “innovator liability” are pending in lawsuits against pharmaceutical companies across the country, where courts have divided on the topics, as attorneys for plaintiffs like Dolin have pushed theories related to the failure to warn.
Those theories could face a crucial test before the Supreme Court during its 2018-19 calendar, as justices granted the petition from Merck to hear its appeal of a decision from the U.S. Third Circuit Court of Appeals. In that case, the Philadelphia-based Third Circuit overturned a lower court’s finding that failure to warn claims against Merck were preempted because the FDA controlled the content of the warning label for Merck’s osteoporosis drug, Fosamax.
Plaintiffs have alleged Merck did not include a warning concerning the risk of thigh fractures elevated by the drug. Merck asserted the FDA initially refused to allow Merck to add that language to the warning label. Merck currently faces more than 1,000 lawsuits over the question.
In a friend-of-the-court brief filed in May, the U.S. Solicitor General’s office, along with counsel from the U.S. Department of Justice and others in the Trump administration, asked the Supreme Court to take up the Merck appeal, saying the case and others like it grappling over the question of federal regulatory preemption should be a question left to the Supreme Court, and not judges and juries in thousands of lawsuits across the country.
“On balance … the government concludes that review is warranted at this time,” the Solicitor General wrote. “The legal question, although narrow in the context of this case (the Merck lawsuit) involving an FDA decision rejecting a proposed labeling change, is important and cleanly presented.
“Its practical implications are starkly illustrated by the volume of tort claims asserted against petitioner in this case. And the Court’s consideration of the proper method for resolving the preemption issue in this case may inform the proper analytical framework for resolving FDA preemption … more generally.”