With one judge saying he found “troubling” the potential harm to patients from decreased incentives for drug makers to develop new breakthrough medications, a federal appellate panel in Chicago hashed out some of the legal questions surrounding the appeal of jury’s verdict ordering GlaxoSmithKline to pay $3 million to the widow of a Chicago lawyer who committed suicide, and whose family has accused the pharmaceutical company of failing to warn that a generic version of its drug Paxil could raise a patient’s risk of suicide.
On May 30, attorneys for both sides presented oral arguments before a three-judge panel at the U.S. Seventh Circuit Court of Appeals in Chicago.
The case, centering on the 2010 death of lawyer Stewart Dolin, 57, in Chicago, has been watched by many, because it has tested the limits of liability that can be imposed on makers of a name brand drug, for the alleged effects of a generic equivalent produced by another company.
Lisa Blatt
| Arnold & Porter LLP
United Kingdom-based GlaxoSmithKline, with American headquarters in Philadelphia, made and marketed Paxil from 1992-2014. Paxil is a brand-name medication prescribed to treat major depression and other psychiatric disorders. The U.S. Food and Drug Administration approved Paxil for use in the U.S., and regulated the text in the warning label available to consumers and doctors.
Stewart Dolin, of Glencoe, who practiced law with the Chicago firm of Reed Smith LLP, took paroxetine, a generic version of Paxil, for several days in July 2010, before killing himself by stepping into the path of a train in the Loop. Dolin’s widow, Wendy Dolin, sued GSK in Chicago federal district court, alleging the drug company was liable for her husband’s death.
Wendy Dolin argued the drug’s label did not adequately warn the drug could increase suicidal tendencies. GSK countered it did not make the actual drug Dolin had taken, noting paroxetine was made by the Mylan company. The company said U.S. law holds companies cannot be held liable for the effects of a product they did not make or sell. GSK further maintained the drug’s warning label’s text had passed muster with the FDA.
The case went to trial in March 2017, lasting almost five weeks, with the jury deliberating three days before finding GSK to blame. Jurors awarded $3 million to Dolin.
GSK appealed to the Seventh Circuit. In its written arguments, GSK reiterated points it made at trial, asserting the claims presented about the contents of its warning label should be preempted by the FDA’s regulation of its product and label. Two federal district judges had rejected those arguments before and during the Dolin case trial.
On Wednesday, lawyers for GSK and Dolin presented oral arguments, lasting about 50 minutes, before a panel including Seventh Circuit Chief Judge Diane Wood and judges David Hamilton and Diane Sykes. GSK was represented at the proceeding by Lisa Blatt, of Arnold & Porter Kaye Scholer LLP, of Washington, D.C. The company is also represented by Dentons US LLP, of Chicago and King & Spalding, of Atlanta, Ga.
Blatt argued finding for plaintiffs in the case would create an environment in which brand name drug manufacturers would be left to “insure the whole market,” leading to a reduction in innovation and harming patients by denying them new medications.
Judges peppered Blatt with questions about the responsibilities of GSK and the FDA in determining the proper label.
Judge Wood observed: “In the world of drugs, federal law places the labeling responsibility on the brand manufacturer.”
She later added, it seemed the FDA and GSK were “talking past each other” in communications concerning the content in the warning label pertaining to suicide risk.
Blatt denied that was the case, maintaining the FDA has the final say under federal law when it comes to the contents of a label. She said GSK would have “acted illegally” if it had unilaterally changed the label. Blatt asserted plaintiffs were attempting to use those communications between GSK and the FDA to “muddle” the issue.
Attorney R. Brent Wisner spoke for Dolin. Wisner is with Baum, Hedlund, Aristei & Goldman, of Los Angeles. Dolin is also represented by Rapoport Law Offices, of Chicago.
Wisner argued GSK carried the burden of showing “clear evidence that the FDA would have deemed Paxil misbranded” if GSK had added the information the plaintiffs believe the drugmaker should have.
Judge Wood questioned whether the court needed to determine whether “if there’s a bad label, the brand name manufacturer has the burden of addressing that problem, no matter who actually, in a sense, was its agent, manufacturing the product.”
Judge David Hamilton asserted that if Wisner’s arguments hold, the liability risk of brand name companies would increase “on average … 10-fold,” because generic equivalents account for 90 percent of U.S. drug sales.
“What marginal benefit for public safety do you see for that 10-fold (liability risk) increase?” Hamilton asked.
Wisner replied such companies could avoid such exposure by withdrawing from the market.
This response appeared to perplex Hamilton, who noted, while new drugs can often produce “dangerous side effects” and some may "suffer enormously who use them," "... they also produce some great benefits" for patients suffering from debilitating conditions.
“If your answer is, ‘Well, you should just withdraw from the market,’ that’s a pretty troubling answer," Hamilton said.
Wisner countered the increase in liability would not be that much, as a brand-name drugmaker would be only responsible for “their fault.”
He called the concern over decrease in innovation from drug companies and other effects on the market a “bogeyman.”
The appeals court will consider the oral and written arguments and announce a decision at a later date.
However, the judges also questioned whether the Illinois Supreme Court could also be pulled into the case, to help settle questions concerning how Illinois law may apply to the questions in the case.
The Illinois Trial Lawyers Association and American Association for Justice filed friend-of-the-court papers in support of Dolin's cause.
Friend-of-the-court papers supporting GSK were filed by: U.S. Chamber of Commerce; American Tort Reform Association; Product Liability Advisory Council, Inc.; National Association of Manufacturers; and Illinois Chamber of Commerce.
Jonathan Bilyk contributed to this report.