Zofran Birth Defect Lawsuits Allege The Anti-Nausea Drug Can Cause Babies To Develop Heart Murmur, Cleft Lip, Cleft Palate And Other Birth Defects.
As filings of Zofran birth defect lawsuits continue, Zofran’s maker, GlaxoSmithKline, wants plaintiffs to identify whether they use the Zofran brand name drug or a generic version of the anti-nausea drug Zofran made by another company. GlaxoSmithKline is a defendant in 223 Zofran birth defect lawsuits that allege the company’s antiemetic drug causes birth defects that include cleft lip and palate, atrial septal defect (hole in the heart), and heart murmur.
In a motion filed on February 22, GlaxoSmithKline said that some or all of claims may be dismissed because the plaintiffs never actually used the company’s Zofran brand name drug. The pharmaceutical giant purports that plaintiffs in at least 153 cases allege using generic ondansetron, while only 68 plaintiffs said they exclusively use brand-name Zofran. The remaining Zofran complaints do not specify whether the plaintiffs used Zofran or generic ondansetron. GlaxoSmithKline asked U.S. District Judge Dennis Saylor, who is presiding over the litigation in the District Court in Massachusetts, to require each plaintiff to identify the product they claim to have used. “Requiring disclosure of product information now—information that plaintiffs should already possess—is the most sensible and fair way to proceed with initial discovery in this litigation,” the company said in its motion. (In Re: Zofran Products Liability Litigation – MDL 2657)
Zofran (ondansetron) is used to treat nausea and vomiting associated with chemotherapy, radiation, and post-operative nausea. The drug was first approved by the U.S. Food and Drug Administration (FDA) in 1991; and 15 years later, approved the first generic version of ondansetron. After 2006, the market for generic versions of ondansetron rapidly increased and Zofran’s sales in the United States declined by 88 percent, GlaxoSmithKline said in its motion. Currently, Zofran’s generic version is among the most widely distributed generic drugs products available with at least 30 companies manufacturing different forms of generic ondansetron, according to GlaxoSmithKline.
Zofran faced federal criminal and civil charges over Zofran and its other drugs, according to Zofran complaints. In 2012, the U.S. Department of Justice (DOJ) maintained that Zofran was not approved by the FDA to treat morning sickness in pregnant women. GlaxoSmithKline was also accused of paying kickbacks to health care professionals as an incentive to promote and prescribe Zofran and its other drugs. The company agreed to pay $3 billion to resolve criminal charges of illegally promoting certain of its prescription drugs, failure to report certain safety data, and civil claims for alleged false price reporting practices. According to the DOJ, the resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, U.S. Department of Justice]
Court records show that this is the second time GlaxoSmithKline has tried to dismiss the Zofran birth defects complaints that allege that the company knew that its anti-nausea medication presented an “unreasonable risk of harm” to developing fetuses because the drug passes through the human placenta. In January, Judge Saylor denied the company’s request to dismiss 200 Zofran lawsuits that contain state law claims of the company failing to change Zofran’s label to warn that the drug may cause birth defects in newborns. The company contended federal “clear-evidence” law pre-empts those claims. Under the federal law, GlaxoSmithKline maintained it had “clear evidence” the FDA would not have approved the changes that plaintiffs asked the company to make to Zofran’s warning label. (In Re: Zofran Products Liability Litigation – MDL 2657)
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