Zofran Bellwether Trial Over Pregnancy Risks Postponed Following GSK Petition to FDA

The U.S. District Judge presiding over all federal Zofran birth defect lawsuits has decided to delay the start of the first bellwether trial, as GlaxoSmithKline is petitioning the FDA regarding the drug’s warning label.

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 throughout the federal court system 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.

As part of the coordinated proceedings before Judge Saylor, a small group of representative cases have been prepared for a series of Zofran “bellwether” trials, which were expected to begin in January 2020, to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.

On November 13, GlaxoSmithKline filed a memorandum (PDF) with the court, indicating that a citizen’s petition was filed with the FDA on November 1, seeking a change to the drug’s warning label.

An issue in the litigation is whether the Zofran claims are preempted by federal law, and the drug manufacturer is asking the FDA to make a ruling about whether studies show a link between side effects of Zofran and birth defects, which would require a warning label update.

The drug maker asked the court to delay the start of first bellwether trial, which was set to begin January 13, until the agency responds to the petition.

In a memorandum (PDF) submitted the same day in response to the request, Plaintiffs questioned the request, noting that it is unlike most petitions submitted to the FDA, because it does not request the agency alter or revoke a current regulation or agency order. The memorandum also points out that GlaxoSmithKline is also not asking the FDA to consider the most recent scientific developments, or any regulations related to the drug.

“Rather, GSK’s petition merely asks the agency to opine on the relevance of ‘four other categories of information’ to ‘Zofran’s pregnancy-related labeling’ – specifically, the four categories of information Plaintiffs have identified as withheld from the agency in its prior reviews of Zofran’s pregnancy-related labeling,” plaintiffs note. “GSK’s Petition represents a blatant misuse of the Citizen Petition process and Plaintiffs will shortly be filing comments with the FDA seeking dismissal of the petition.”

Instead, Plaintiffs characterize the company’s request to take whatever action the FDA deems appropriate and to inform the public whether there is the need for a label change is inappropriate. The Plaintiffs’ memorandum notes the petition was filed the day before oral arguments on a pending motion on whether families pursuing Zofran lawsuits should be barred from pursuing a recovery under the legal theory known as preemption.

Plaintiffs also note that the petition makes it clear there have been undisclosed communications between the FDA and the manufacturer on this issue, which should have been revealed to the plaintiffs during the discovery process.

Following a status conference held on November 20, the Court issued a docket entry, which indicates that the first Zofran trial will be delayed until May 4, to provide the FDA time to respond to the petition. The hearing on the request for summary judgment filed by the drug maker based on preemption, as well as Daubert motions challenging the admissibility of expert witness testimony, has also been pushed back, and will now be considered on January 15, 2020.

Judge Saylor also indicates that the Court intends to send a letter to the FDA asking about the citizen’s petition, and has called for parties to submit any proposals regarding the content of that letter to the court by December 2.

Zofran Birth Defect Risks

According to allegations raised in complaints filed by families nationwide, GlaxoSmithKline knew or should have known about the birth defect risks associated with Zofran, yet withheld critical safety information and failed to warn doctors and consumers against use of the drug to treat morning sickness. Although the FDA never approved Zofran for use to combat pregnancy-associated nausea, plaintiffs allege that the drug maker actively promoted this “off label” use.

As early as 2006, plaintiffs note studies have found Zofran crosses the placenta in significant amounts when taken by pregnant women, with Hong Kong researchers concluding that the “developmental significance of this drug exposure requires further investigation.”

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

In August 2013, another study highlighted a potential risk of heart defects with Zofran, following a review of data involving more than 900,000 pregnancies in the Danish Medical Birth Registry. Researchers found that children may be two to four times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

According to a study published by the medical journal Reproductive Toxicology in October 2014, there there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

GlaxoSmithKline has attempted to defend against the lawsuits by arguing that the plaintiff’s failure to warn claims should be preempted by federal law. However, Judge Saylor has previously rejected this argument, finding there was no clear evidence the drug maker was prevented from strengthening the Zofran warnings. In addition, the court found there was not clear evidence the FDA would have rejected such efforts.

While the outcomes of any early “bellwether” trials will not be binding on other claims, 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, if the drug maker is unable to otherwise bar the claims.


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