Paxil Lawsuit Not Preempted. A lawsuit filed by the family of a young woman who committed suicide after taking Paxil will go forward, after an appeals court ruled that it is not preempted.
Paxil is one of a class of drugs called selective serotonin reuptake inhibitors (SSRIs), and has been approved to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was also the first antidepressant formally approved in the U.S. for the treatment of social anxiety disorder.
In 2005, the U.S., a Black Box Warning to the ‘Paxil’ label regarding its association with an increased risk of suicidal thoughts among adolescents. That warning was expanded to include young adults in 2007.
Paxil lawsuit was preempted because the FDA took no action
According to her parents lawsuit, Tricia Mason was only 23 when she took her own life just two days after taking Paxil. GlaxoSmithKline had argued, among other things, that the Paxil lawsuit was preempted because the FDA took no action to force a warning during the time period Tricia Mason took Paxil, thus, the Food & Drug Administration (FDA)would not have approved a label change.
The 7th Circuit found that GlaxoSmithKline didn’t meet its burden of showing with “clear evidence” that the FDA would have rejected a change in the Paxil’s labeling. Its ruling overturns a 2008 summary judgment for GlaxoSmithKline granted by the U.S. District Court for the Central District of Illinois.
In its unanimous ruling, the 7th Circuit cited the “clear evidence” standard set last year by the U.S. Supreme Court in Wyeth vs. Levine. In that case, the High Court decided to let stand a Vermont Supreme Court ruling that upheld a jury verdict against Wyeth over deficient labeling related to the IV push injection of Phenergan. In that case, the Court held that there could only be preemption if the manufacturer presented “clear evidence” that the FDA would have rejected the proposed additional warning.