GlaxoSmithKline Zofran’s Warning Label. Zofran Anti-nausea Medication Was Approved by The U.S. Food and Drug Administration (FDA) specifically for the treatment of vomiting and nausea as a side effect from chemotherapy, radiation, and for surgery patients after taking post-operative medications. GlaxoSmithKline (GSK), makers of Zofran (ondansetron), however, marketed the drug for nausea in pregnant women even though the drug was not FDA approved for expectant mothers’ use.
As lawsuits emerged due to cardiovascular and cleft-palate birth defects, families affected by the side-effects of this drug maintained that the drug manufacturer did not warn about these risks as soon as the drug company was aware of the potential damage. A new label alerts consumers of the Zofran link to serious birth defects for the first time.
When another company, Novartis, acquired the rights to sell ‘Zofran’ in 2015, the new warnings were placed on the drug’s label. The new label was submitted to the court as evidence by GSK, without saying if it had been aware of the birth defect risks, according to the plaintiffs.
Birth Defects Linked to Zofran
Birth defects associated with Zofran include mental problems, cleft palate and lip, heart defects, club foot, stomach issues, hearing problems, and skull deformities.
“Moreover, GSK’s filing blatantly sidesteps the actual risk information in the 2016 Novartis, label,” the families said according to a Law360 report.
“Conspicuously absent from the GSK summary are the two facts identified in the label acknowledging that a doubling of the risk for cardiac septal defects and cleft palate defects was revealed in separate studies.”
Lawsuits Involving Zofran. As early as 1992, court documents show that GlaxoSmithKline knew that Zofran presented “unreasonable risk of harm” to developing babies as the medication passes through the human placenta. Despite this knowledge, GSK continued to promote Zofran to expectant mothers and advertised the drug as a safe treatment for morning sickness and hyperemesis gravidarum, although it was not officially approved for this use.
Hyperemesis gravidarum is extreme, excessive and persistent vomiting in early pregnancy that may lead to dehydration and malnutrition, according to MedicineNet.com.
Although the FDA had approved Zofran only to help cancer or surgery patients with nausea, GSK saw the drug could be used in the treatment of morning sickness. The lawsuits filed alleged that GSK illegally marketed Zofran to pregnant women.
It was important for the plaintiffs in the Zofran birth defect cases to determine when and if GSK was aware of the risks associated with the anti-nausea drug.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals and families who have been injured by pharmaceuticals.
GSK pled guilty to federal charges of illegal marketing and fraud for some of its medications, including Zofran. GSK was accused by the U.S. Department of Justice (DOJ) specifically for promoting Zofran off-label for morning sickness from 2002 to 2004.
Off-label means that a drug or medical device is being used in a manner not approved by the FDA. Physicians can prescribe drugs off label, but it is illegal for companies to market their drugs for unapproved uses.
The pharmaceutical giant paid $3 billion to settle the charges in 2012. According to a DOJ press release, the company pleaded guilty and paid “to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.”
New York filed a lawsuit alleging that Zofran led to her son’s birth defects
A woman from Oneida, New York filed a lawsuit alleging that Zofran led to her son’s birth defects. The suit claims that GSK neglected to disclose the risks, and illegally promoted Zofran to treat morning sickness in pregnant women.
According to the lawsuit, the plaintiff used the generic form of Zofran in her first and second trimester. Her son was born with “a cleft hard palate [and] unilateral right cleft lip,” allegedly due to Zofran.
The plaintiff alleges that these birth defects caused “severe and permanent pain and suffering, mental anguish [and] medical expenses.” The plaintiff seeks $10 million in compensation.
The lawsuit is one of more than 280 consolidated in the federal multidistrict litigation (MDL) in Massachusetts. An MDL is established to expedite complex litigation and consolidates cases that have similar allegations in one court. This practice helps eliminate duplicate discovery, saves resources and can be more efficient.
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