GSK birth defect suits preempted by federal labeling law

June 2, 2021

GlaxoSmithKline will not have to face more than 420 lawsuits alleging that its anti-nausea drug caused birth defects after a Massachusetts federal court said a federal drug labeling law preempts the claims.

Chief Judge F. Dennis Saylor IV of the U.S. District Court for the District of Massachusetts ruled that GSK met its burden on its preemption defense, presenting “clear evidence” that the FDA would have rejected the warning the families sought.

In 1991, the FDA approved Zofran to help cancer patients with nausea and vomiting after chemotherapy or radiotherapy treatments or surgery. Some doctors began prescribing Zofran to treat pregnant women with morning sickness, even though it lacked FDA approval for that use. In 2010, after the FDA became aware that Zofran was being prescribed to pregnant women in significant numbers, the agency requested that GSK provide supplemental information concerning the safety of Zofran when used during pregnancy. GSK provided an analysis of the then-available safety data, and the FDA did not require a labeling change.

In 2015, GlaxoSmithKline sold the rights to Zofran, along with the rest of its oncology portfolio of medications, to Novartis. Last year, Novartis also asked the FDA to add the pregnancy warning. Again, the FDA refused the request.

Now, because the plaintiffs are suing GSK under state law, claiming the drugmaker failed to warn them about the risks of using Zofran during pregnancy, their arguments are undermined by the FDA’s decision against adding the warning.

 Read the Bloomberg law coverage