Birth Defect Lawsuits Over Zofran Dismissed After Summary Judgment Granted on Federal Preemption

The U.S. District judge presiding over pretrial proceedings in all federal Zofran birth defect lawsuits granted a motion for summary judgment filed by the drug maker last week, determining the failure to warn claims are preempted by federal law, resulting in the dismissal of several hundred lawsuits brought by families nationwide.

Since late 2015, the litigation has been centralized in the U.S. District Court for the District of Massachusetts, where U.S. District Dennis Saylor has presided over discovery and pretrial proceedings in claims brought by more than 400 families of children born with severe birth defects or congenital malformations following exposure to Zofran during pregnancy, including cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other life-long health problems.

Each of the complaints raise similar allegations, indicating GlaxoSmithKline withheld important warnings about the pregnancy risks with Zofran, an anti-nausea medication which has commonly been marketed for “off-label” use to treat morning sickness.

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While the first “bellwether” trials were expected to begin later this year, to help gauge how juries may respond to certain evidence and testimony that would be repeated throughout the claims, the litigation came to an abrupt end last week, when Judge Saylor granted a renewed motion for summary judgment brought by the drug makers.

A a similar motion was rejected in February 2019, after the Court found there was not clear evidence the FDA would have rejected an attempt by the drug makers to add new pregnancy warnings to the drug label. However, Judge Sayler agreed to reconsider the decision after a U.S. Supreme Court decision issued a few months later clarified that a judge, not a jury, must determine whether there is clear evidence a drug maker fully informed the FDA about the justifications for adding such warnings, and that such warnings were rejected.

In a 68-page memorandum and order (PDF) issued on June 1, Judge Saylor determined the state-law based claims for failure to warn were preempted by federal law, after finding the FDA had ample opportunity to change Zofran’s warning label, and has refused to do so. Therefore, since the FDA’s judgment has priority, the Court determined GlaxoSmithKline cannot face failure to warn claims regarding Zofran, regardless of whether it provided the agency with all the necessary information to make that decision.

“In short, even assuming that GSK did, in fact, fail to make complete disclosures to the FDA in 1991, and at various later points, there is no question that the FDA is now fully informed of all relevant information concerning the safety of the drug. And the FDA has made the determination that a label change is not warranted,” Judge Saylor wrote. “Thus, the FDA, acting pursuant to the duty imposed on it by federal law, has rejected the pregnancy warning label that plaintiffs insist was required by state law at the time of the alleged injuries.”

Judge Saylor issued an official judgment (PDF) in favor of GlaxoSmithKline on June 2. resulting in the dismissal of all claims, which is likely to be appealed by plaintiffs’ lawyers.


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