Zofran Lawsuits Allege Heart Defects, Cleft Palate, Other Birth Defects. GlaxoSmithKline is facing lawsuits over its anti-nausea drug, Zofran. Plaintiffs in the litigation allege that the medication, which is not approved for morning sickness, caused birth defects such as heart abnormalities and cleft palate when taken by pregnant women. GSK has been accused of marketing Zofran off-label and failing to disclose the risks.
The personal injury attorneys at Parker Waichman LLP comment that Zofran is approved for treating nausea in patients undergoing cancer treatment or surgery. The firm is continuing to offer free legal consultations to individuals with questions about filing a Zofran birth defects lawsuit. Zofran is not approved to treat morning sickness in pregnant women.
Federal Zofran lawsuits have been consolidated into a multidistrict litigation in the U.S. District Court for the District of Massachusetts. The MDL contains some 300 lawsuits. The U.S. Judicial Panel on Multidistrict Litigation (JPML) creates MDLs to make complex litigation more efficient.
Lawsuits in an MDL are transferred to one court to eliminate duplicate discovery and streamline the legal process. MDL plaintiffs have similar allegations; Zofran lawsuits, for example, commonly allege that taking Zofran during pregnancy led to birth defects. GSK allegedly failed to warn patients or the medical community about this risk.
The Zofran litigation has been moving forward, as cases continue to be filed into the MDL. Two new cases were recently added to the litigation, one filed on behalf of a Mississippi woman who alleges that her child suffered 13 different birth defects due to Zofran exposure during pregnancy.
Another case represents a Texas plaintiff who alleges that Zofran caused cardiac septal defects, known as “hole in the heart” abnormalities in her child. Zofran side effects allegedly caused two holes, one located between the atria (upper chambers of the heart) and the other between the ventricles (lower chambers of the heart).
A Zofran birth defects lawsuit was also recently filed alleging cleft palate and cleft lip. The plaintiff is a New York woman who took a generic version of Zofran during her first and second trimesters.
Her child, now four years old, was born with “a cleft hard palate [and] unilateral right cleft lip,” the complaint states. She alleges that Zofran contributed to these defects, and seeks a total of $10 million in compensation for “severe and permanent pain and suffering mental anguish [and] medical expenses.”
Another Zofran injury claim alleges “hole in the heart” cardiac septal defects, low birthweight and developmental delays. The plaintiff is a New Jersey woman; she says her child requires special education services.
The suit also alleges the child suffers from a kidney condition known as hydronephrosis, a high palate, recessed chin, small jaw, and low set ears. She also has a condition since birth in which pinky fingers are bent inward from the topmost knuckle, called clinodactyly.
GSK has been accused of marketing Zofran “off-label”, or in a manner not approved by the U.S. Food and Drug Administration (FDA). Physicians can prescribe drugs off-label but pharmaceutical companies cannot promote their products for unapproved uses. In 2012, GSK agreed to a $3 billion healthcare fraud settlement that resolved government allegations of off-label marketing with Zofran, among other things.
FDA Warns of Electrical Heart Abnormalities with Zofran
In a 2011 safety communication, the FDA said that Zofran “may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.” The potentially life-threatening changes in electrical activity include Torsade de Pointes.
The agency issued an update in 2012, notifying the public and healthcare professionals about preliminary findings from a clinical study showing that “a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.”
The Zofran label was updated to remove the 32 mg single intravenous dose. Patients taking Zofran are advised to seek medical attention if they experience an irregular heartbeat, shortness of breath, dizziness or fainting.
The intravenous dose of 0.15 mg/kg can still be administered to adults and children with nausea associated with chemotherapy.
GSK Pays $3B to Settle Off-label Marketing Claims
In the past, GSK has faced federal government allegations of off-label marketing with Zofran, as well as other medications. The company agreed to resolve these allegations in July 2012, for $3 billion. According to a Department of Justice press release issued at the time, this settlement was the largest health care fraud settlement in U.S. history. The government alleged, among other things, that GSK marketed the drugs off-label and paid illegal kickbacks to healthcare professionals.
“Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” said James M. Cole, Deputy Attorney General, according to the release.
“At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.”
The government alleged that “GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs” the release states.
Various lawmakers commented on the importance of the settlement. Carmen Ortiz, U.S. Attorney for the District of Massachusetts, said “This case demonstrates our continuing commitment to ensuring that the messages provided by drug manufacturers to physicians and patients are true and accurate and that decisions as to what drugs are prescribed to sick patients are based on best medical judgments, not false and misleading claims or improper financial inducements,”
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