GlaxoSmithKline Urges MDL Judge To Revisit Pre-Emption in Zofran Lawsuits Over Pregnancy Risks

Following a recent ruling by the U.S. Supreme Court, GlaxoSmithKline is asking the federal judge presiding over all federal Zofran birth defect lawsuits to reconsider a prior motion to dismiss the litigation, indicating that the determination about whether the FDA would have allowed the drug maker to update pregnancy warnings would have been permitted.

GlaxoSmithKline currently faces more than 400 product liability lawsuits brought by families nationwide, each involving allegations that consumers and the medical community were not adequately warned about the potential Zofran pregnancy risks, including claims that use of the anti-nausea drug caused children to develop severe birth defects, such as cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other congenital malformations.

Zofran has been commonly prescribed “off-label” for symptoms of morning sickness, and plaintiffs claim GlaxoSmithKline failed to provide sufficient pregnancy warnings. However, the drug maker has previously sought to dismiss the cases, arguing that the claims are pre-empted by federal law, since the FDA would not have allowed a pregnancy warning.

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Given the similar questions of fact and law presented in the litigation, cases filed in U.S. District Courts nationwide have been centralized for coordinated pretrial proceedings before U.S. District Judge Dennis Saylor in the District of Massachusetts, to reduce duplicative discovery, avoid conflicting pretrial rulings from different courts, and to serve the convenience of the parties, witnesses and the judicial system.

In February, Judge Saylor denied a motion for summary judgment, clearing the way for the first cases to go before a jury as part of a “bellwether” trial in September 2019, which was designed to help gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.

However, last month the U.S. Supreme Court issued an opinion on a case involving the osteoporosis drug Fosamax, which clarified the standard that drug makers must establish to maintain a pre-emption defense. In that case, Merck & Co. claimed it was exempt from charges of failure to warn, because the FDA allegedly rejected its efforts to add new label warnings to Fosamax.

In the decision, the Supreme Court justices unanimously determined that to maintain a pre-emption defense 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.

On May 20, Judge Saylor asked both parties in Zofran litigation to submit memorandum on how the court should proceed in light of the recent ruling, as the prior motion for summary judgment filed by GlaxoSmithKline argued that the FDA previously rejected warnings that plaintiffs now argue should have been provided. However, the Court previously determined that it was a jury question whether the drug maker failed to provide complete information, and whether that was material in the prior regulatory decision.

In a memorandum (PDF) filed on June 3, GlaxoSmithKline renews the request for summary judgment in light of the standard recently articulated by the U.S. Supreme Court.

“Plaintiffs acknowledge that the FDA repeatedly rejected their proposed labeling change but claim that the FDA lacked four categories of information. This Court held that the materiality of those four categories was a question for the jury at trial,” the memorandum states. “The Supreme Court has now made clear that this Court, not the jury, must resolve the materiality of such information.”

A separate memorandum (PDF) submitted on behalf of plaintiffs urged the Court to reject GlaxoSmithKline’s reasoning and proceed with the scheduled jury trials later this year.

“(T)here is no dispute in this MDL that the FDA never considered—let alone rejected—a birth defect warning for Zofran with full knowledge of all of the material scientific information that would have supported such a warning,” the plaintiffs wrote. “GSK did not dispute that it had failed to disclose full information concerning at least the three Japanese animal studies and certain adverse event data to the FDA.”

Since it is not disputed that the company failed to fully inform the FDA all of available data needed to make a regulatory decision on the label warnings, then there is no need to revisit the summary judgment issue in light of the Supreme Court ruling, plaintiffs argue.

If Judge Saylor decides to proceed with the bellwether trials, the outcomes will not be binding on other claims. However, they may greatly influence any Zofran settlement negotiations that would be necessary to avoid the need for hundreds of individual cases to go to trial in courts nationwide.


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