A judge recently granted summary judgment in over 420 lawsuits to drugmaker GlaxoSmithKline (GSK) in the ongoing Zofran multidistrict litigation (MDL). The case is addressing the plaintiffs’ claims that the anti-nausea medication Zofran caused birth defects. This summary judgment order comes on the heels of a new Supreme Court ruling that changes the framework for analysis of preemption motions.
Product Liability Claims Against Zofran
The Food and Drug Administration (FDA) approved Zofran in 1991. The FDA approved Zofran for “the prevention of nausea and vomiting induced by chemotherapy or radiation therapy and post-operative nausea and vomiting.” GSK was the manufacturer of the drug at the time of its FDA approval. However, the company sold the rights to the drug to Novartis in 2015.
Zofran is not explicitly approved for pregnancy nausea. But doctors prescribed it off-label to pregnant women for many years. The plaintiffs in this MDL are mostly women who took Zofran during pregnancy. They say their children suffered from birth defects such as orofacial defects and cardiac ventricular and/or septal defects. Each plaintiff in the consolidated MDL essentially argues that Zofran caused childbirth defect injuries. Further, the plaintiff class claims that GSK labeling did not provide an adequate warning to pregnant women.
GSK’s Motions for Summary Judgment
GSK’s recent motion for summary judgment claimed that federal preemption shielded liability for any inadequate warning labeling. But the motion was a renewed one. In early 2019, F. Dennis Saylor IV, Chief Judge for the Massachusetts District Court, denied a similar GSK motion. The court found that the preemption issue presented disputed issues of material fact for a jury to decide rather than a judge.
Later in 2019, the Supreme Court ruled that preemption presents issues of law for a judge to decide, not a jury (Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668). Based on this new Supreme Court preemption ruling, GSK renewed its motion with a supplemented factual record. This time, the court granted the motion in alignment with the new high court ruling.
The Preemption Issue
The preemption doctrine stands for the proposition that when there is a conflict, federal law preempts state law. Here, the FDA, a federal regulatory agency, determines drug labeling requirements. Its governance includes warning labels. The plaintiffs, however, are suing GSK under state law. Before the recent Supreme Court ruling, juries would have owned factual determinations concerning preemption. But the high court’s ruling now says the courts will decide preemption issues as a matter of law.
In the ruling on GSK’s renewed summary judgment, motion Judge Saylor found that in carrying out its federal law duties, the FDA had “rejected the pregnancy warning label that plaintiffs insist was required by state law at the time of the alleged injuries.” Accordingly, he ruled that federal law preempts plaintiffs’ state-law claims of failure to warn. Thus, he granted summary judgment based on federal preemption.
Inside the Court’s Ruling
Let’s take a look at the court’s reasoning in this summary judgment ruling. It focuses on how the FDA made a clear determination on Zofran labeling. Further, the decision outlines how federal law, as applied by the FDA, took precedence over state law.
Judge Saylor discusses how the FDA repeatedly rejected requests for Zofran labeling changes concerning any pregnancy use risks. In 2010, the FDA asked GSK to submit supplemental information on Zofran’s safety during pregnancy. Based on the analysis of the then-available safety data, the FDA did not require GSK to change the labeling.
Again in 2013, the FDA rejected a citizen petition for a revised Zofran label. The proposal requested warning labels indicating an increased risk to fetal safety if ingested during pregnancy. And again in 2015, the FDA turned down a proposed change from Novartis. This label change would have “included a warning that use in pregnancy could cause harm to the fetus and is not recommended.”
In 2019, GSK asked the FDA to review Zofran safety information that the plaintiffs alleged hadn’t been provided to the agency. The FDA rejected that petition and did not require a label change. In early 2021, the FDA again rejected the proposed pregnancy warning based on recent GSK-provided epidemiological studies and data.
The New Albrecht Standard Applied
Judge Saylor used the preemption inquiry framework set out in the recent Supreme Court Albrecht decision. That framework establishes when a manufacturer may avail itself of the FDA changes being effected (CBE) process. First, the manufacturer must show “that it fully informed the FDA of the justifications for the warning required by state law.” Second, it must show that, “that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
Here, the court assumed (but did not decide) that “GSK had the ability to change the Zofran label unilaterally through the CBE process prior to the time it sold the rights to the drug to Novartis.” The court found that the FDA was fully informed of the plaintiffs’ justifications for the warning. Thus, there “is no basis at this point for concluding that any relevant information had been withheld from the FDA.” The court further found “that there is no doubt that the FDA would not approve the changes to the warning label proposed by plaintiffs since it had repeatedly rejected such calls and had approved contrary language.” Judge Saylor also said there was no reasonable basis to treat GSK and Novartis differently in the preemption analysis.
For GSK, this decision is a victory after many years of MDL involvement. The decision also removes the company from an upcoming bellwether in October 2021.