A Chicago federal appellate court has refused to reexamine its decision last month that reversed a $3 million verdict against drugmaker GlaxoSmithKline, on grounds the company was not responsible for the labeling of the generic version of its product Paxil, despite plaintiff’s urging a rehearing was needed, because she said the appeals panel set a “dangerous precedent.”
The Sept. 20 refusal was signed off by Chief Judge Diane Wood and Circuit Judges Hamilton and Diane Sykes of U.S. Court of Appeals for the Seventh Circuit.
Plaintiff Wendy Dolin had asked Sept. 5 for a rehearing before the three judges or all 14 judges of the Seventh Circuit. Wood, Hamilton and Sykes voted against the request without comment and none of the other 11 judges asked for a vote on the question of a rehearing by all 14.
On Aug. 22, the three judges tossed the $3 million verdict that favored Dolin, widow of lawyer Stewart Dolin, who killed himself in 2010 in a transit station in Chicago’s Loop. Wendy Dolin alleged her husband was taking paroxetine, the generic version of GSK’s antidepressant Paxil. She alleged the drug’s label, which is identical for both Paxil and paroxetine and was written by GSK, did not adequately warn the drug could increase the risk of suicide. Dolin alleged GSK knew of the increased risk.
The drug maker countered it repeatedly tried to persuade the U.S. Food and Drug Administration, which oversees labeling, to allow it to upgrade the suicide warnings on the labels, but the FDA declined. In response, Dolin contended GSK didn’t try hard enough.
At trial, a jury found for Dolin, awarding her $3 million.
The Seventh Circuit, led by Judge Hamilton, overturned the verdict. The judges found GSK pressed the FDA four times to change the labels, but to no avail, with the FDA ordering GSK to use standard language the FDA had approved for paroxetine and other antidepressants. All this showed Hamilton that GSK made a determined effort, but ultimately had no control over labels.
Dolin argued in her rehearing request the Seventh Circuit got it wrong on several counts, including that it blew off the U.S. Supreme Court’s 2009 ruling in Wyeth v. Levine.
According to Dolin, the Supreme Court held in Levine that federal law allows drug companies, without FDA approval, to revise labels to enhance warnings. As a consequence, a company that does not make such unilateral revisions is open to liability, unless it can show the FDA would not have approved proposed revisions if the proposals had first been submitted to the agency.
Dolin further maintained the “central premise” of FDA regulations, as the Supreme Court put it, is “the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”
Dolin claimed the Seventh Circuit’s decision is at “serious odds with Levine” and implies federal law prohibited GSK from revising the labels on its own, an “extraordinary conclusion.” Dolin added it would have been “unprecedented” for the FDA to have taken action against GSK for changing the labels.
“The Food, Drug and Cosmetics Act regulations, which were designed to be a weapon of the public against drug manufacturers to ensure they deliver unadulterated drugs and appropriate warnings concerning the risks and benefits of their drugs, have now been turned into a weapon against the public. The panel’s ruling sets a dangerous precedent that should be corrected,” Dolin asserted.
GSK is represented in the case by attorney Lisa Blatt, of Arnold & Porter Kaye Scholer, of Washington, D.C. The company is also represented by attorneys with the firms of Dentons US LLP, of Chicago and King & Spalding, of Atlanta, Ga.
Dolin is represented by attorneys with the firms of Baum, Hedlund, Aristei & Goldman, of Los Angeles, and Rapoport Law Offices, of Chicago.