The U.S. Supreme Court has refused to hear a case on whether GlaxoSmithKline can be held responsible for failing to warn about the risk of suicide following use of generic versions of Paxil, allowing a lower court’s decision to dismiss the litigation to stand.
According to an order list (PDF) this week, the high court indicated that it would not consider an appeal filed on behalf of consumers, who argued that the name-brand drug maker should be held liable for failing to warn, since generic equivalents are required to carry the same warning label as the product they are copying.
As a result, the court will not review a prior decision by the 7th U.S. Circuit Court of Appeals, which dismissed a Paxil suicide case filed by the family of a man who committed suicide after using a generic drug containing the same active ingredient developed by GlaxoSmithKline, paroxetine.
The appeal stems from a lawsuit filed by the widow of Stuart Dolin, who began taking the generic Paxil in 2010, and committed suicide six days later. The plaintiff presented claims against GlaxoSmithKline for failing to add proper warnings to the Paxil label, which would have then been duplicated on the labels of the generic versions as well. However, the manufacturer indicated that it tried several times to add suicide warnings to Paxil, but its efforts were rejected by the FDA, which must approve of all label warnings, arguing that the state law failure to warn claims were pre-empted by federal law.
At trial, Wendy Dolin originally won the case and obtained a $3 million award. However, GlaxoSmithKline successfully appealed the verdict before the 7th Circuit, which ruled in favor of the manufacturer. The refusal by the high court to hear the case means that decision stands.
The refusal comes following a recent opinion which better defined when cases can be pre-empted by federal law. That case, involving bone fractures linked to Fosamax, resulted in an unanimous Supreme Court ruling that a judge, not a jury, must determine whether a drug maker established that there was “clear evidence” that the FDA refused a request to update a drug’s label warning.
As a result of that ruling, the nation’s highest court remanded hundreds of Fosamax lawsuits over failure to warn about the risk of atypical bone fractures, which have been sent back to a lower appeals court to determine whether Merck, the manufacturer of Fosamax, can establish the preemption defense under the newly articulated standards.
Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.
In 2009, GlaxoSmithKline reportedly paid about $1 billion to settle hundreds of Paxil lawsuits, including nearly $400 million to settle Paxil suicide claims.
Side effects of Paxil have been linked to an increased risk of suicidal tendencies in some users, including a risk of death or severe injuries from attempted suicides.