Question on drug’s label goes to trial
A federal judge has again declined to throw out a lawsuit accusing the maker of the anti-depressant Paxil of liability in the suicide of a Chicago lawyer who took a generic version of the drug.
In a written opinion last week, U.S. District Judge James B. Zagel rejected the argument that the negligence claims brought under Illinois law by Stewart Dolin’s wife are pre-empted by federal law.
Wendy Dolin filed the suit in Cook County Circuit Court, and GlaxoSmithKline (GSK) removed it to federal court under diversity jurisdiction.
The suit maintains the labels on Paxil and its generic version are false and misleading because they failed to warn of an increased risk of suicide in adults over the age of 24.
In a motion for summary judgment, GSK argued such a warning is pre-empted by the Federal Food, Drug and Cosmetic Act.
Zagel didn’t see it that way.
A failure-to-warn claim is preempted by federal law, he wrote, citing Wyeth v. Levine, 555 U.S. 555 (2009), only if there is “clear evidence” the U.S. Food and Drug Administration would not have approved the warning the plaintiff alleges is required by state law.
GSK presented no such evidence, Zagel wrote.
In 2007, he wrote, the FDA invited GSK to discuss the option of keeping language on Paxil’s label warning of the possibility of an increased risk of suicide or suicidal thoughts in adults.
GSK didn’t take the FDA up on that invitation, Zagel wrote.
GSK, he wrote, did not ask for a formal meeting with the FDA and did not ask to include additional language on the label concerning Paxil’s possible effect on adults.
Under those circumstances, GSK failed to meet the “demanding burden” of showing it would have been futile to seek permission from the FDA to add an adult suicide warning on Paxil’s label, Zagel held.
Wendy Dolin is represented by attorneys who include R. Brent Wisner of Baum, Hedlund, Aristei & Goldman P.C. in Los Angeles.
The lead attorney for GSK is Alan S. Gilbert of Dentons U.S. LLP.
Neither attorney could be reached for comment.
In 2010, Stewart Dolin killed himself by leaping in front of a Chicago Transit Authority train at the Blue Line station at Washington and Dearborn streets in the Loop.
Dolin, 57, was a partner in Reed, Smith LLP.
He had started taking a generic version of Paxil, the brand-name version of paroxetine hydrochloride, six days before he committed suicide.
In addition to alleging the warning on the paroxentine label was inadequate, Wendy Dolin contends GSK concealed and manipulated data concerning the drug.
GSK wanted to obscure the fact that paroxetine carries a 6.7 times higher risk of suicide in adults who take the drug compared to those who take a placebo, Dolin contends.
In 2014, Zagel dismissed all claims against Mylan Inc., which made the paroxetine taken by Dolin.
But he held GSK must face claims under Illinois law of common-law negligence, negligent misrepresentation and product liability based on a negligence theory.
In the 2014 opinion, Zagel conceded GSK did not manufacture the paroxetine taken by Dolin.
But the federal Hatch-Waxman Act requires that a generic drug’s design and warning label must match those of the name-brand drug, Zagel wrote.
Therefore, he held, the brand-name maker must in some circumstances face claims based on the warnings on the generic version’s label.
In last week’s opinion, Zagel declined to reverse his 2014 ruling.
Noting that GSK and Wendy Dolin plan to call expert witnesses to the stand during the trial, Zagel also declined to hold that the Paxil’s label is adequate as a matter of law.
And Zagel rejected arguments that the doctor who prescribed Paxil for Stewart Dolin knew of the drug’s risk and, therefore, GSK could not be liable in Dolin’s suicide.
The doctor’s testimony suggests he didn’t know of the increased risk of suicide in adults over 24, Zagel wrote, and he relied on the 2010 Paxil label before prescribing the drug.
The suit is to go to trial on Sept. 19.
Zagel issued the opinion Thursday in Wendy B. Dolin v. SmithKline Beecham Corp., No. 12 C 6403.