Glaxo prevails in Paxil preemption case as Supreme Court refuses review

A long-running case over an attorney’s suicide while taking generic versions of GlaxoSmithKline’s Paxil has ended in the drugmaker’s favor, as the U.S. Supreme Court refused to review a lower court’s ruling.

With the decision, the 7th U.S. Circuit Court of Appeals’ prior dismissal will stand, handing GSK a victory. Previously, a jury had awarded the widow of deceased Chicago attorney Stewart Dolin $3 million after he committed suicide while taking generic copies of the GSK antidepressant.

Stuart Dolin started taking Paxil—known generically as paroxetine—in 2010 to treat depression and anxiety. Six days later, he committed suicide. Dolin was a partner at the international law firm Reed Smith.

After the original jury decision, the 7th U.S. Circuit Court of Appeals threw out the verdict on grounds that federal law—or the FDA’s authority—prevented GSK from adding a warning about possible suicides to the drug’s label. The company tried several times to add the warning and the FDA wouldn’t allow it, the appeals court said in its opinion. Generics simply copy the branded label, so the warning didn’t appear on the medicine Dolin took, either.

Dolin’s widow, Wendy, took her appeal to the Supreme Court, but the high court on Tuesday denied hearing the case.

The Supreme Court decision follows a ruling on a similar issue for Merck and its Fosamax drug. In that review, the justices ruled that the issue of whether an FDA labeling decision preempts liability claims should be decided by a judge, not a jury.

In hundreds of Fosamax cases, plaintiffs argue Merck failed to warn about serious bone breaks linked to long-term use of the osteoporosis med. Originally, the district court agreed with Merck and said the plaintiffs’ claims were preempted by FDA regulations. The appeals court then rejected the decision and revived the litigation.

Product liability cases in pharma have long wrestled with preemption, and the latest Supreme Court decision further irons out the issue. The justices sent the Merck cases back down to the appeals court with further clarification on the High Court’s view, allowing Merck another chance to get the lawsuits thrown out.

https://www.fiercepharma.com/pharma/gsk-prevails-paxil-preemption-case-as-supreme-court-denies-taking-up-review