Zofran Lawsuit Claims Cleft Palate

Zofran Lawsuit Claims Cleft Palate

Posted By Golomb & Honik, P.C. || 14-Dec-2015

A mother in Arkansas filed suit against GlaxoSmithKline on September 14, 2015, alleging that the drug company’s anti-nausea drug, Zofran, was responsible for her child’s congenital birth defects. The Arkansas mother joins more than sixty other parents who are currently seeking damages in similar Zofran claims. All the current Zofran claims allege GSK concealed evidence of the link to Zofran birth defects to doctors and patients. Although this latest plaintiff resides in Cabot, AR, she has chosen to file her Zofran lawsuit in the U.S. District Court for the Eastern District of Louisiana. A Boston MDL is also currently in the works.

The story of this Arkansas mother appears to be all-too-familiar, as the allegations against GSK continue to mount. Zofran is a powerful anti-nausea drug, which has been prescribed for off label use to mothers in their first trimester to combat severe morning sickness. The Arkansas mother claims she was prescribed Zofran, then her baby was born in 2007 with a cleft palate, apnea, respiratory distress syndrome and bilateral clubfeet. The child, now eight years old, has undergone two surgical procedures and it is expected he will undergo more surgeries in the future. The drug was never intended for “morning sickness” in pregnant women.

Dangers of Zofran and Studies Associated with Zofran

Cleft palate, which is essentially a hole in the roof of the infant’s mouth, has been identified as an injury in at least a dozen Zofran lawsuits and was linked to Zofran use by a Boston University study reported in 2012. The Boston study concluded infants exposed to Zofran during the first trimester were more than twice as likely to be born with a cleft palate. Two large European studies reported in 2013 and 2014, found significant evidence that Zofran, when taken in the first trimester, increased the risk of congenital heart defects, including ventricular septal defect, atrial septal defect and atrioventricular septal defects.

A more recent investigation by the Toronto Star, reviewed medical records from Canadian mothers who submitted adverse event reports to the U.S. FDA. It was discovered in this investigation that at least 20 Canadian women who were treated for morning sickness with Zofran, delivered babies with various birth defects. The Star also reported two cases of infant death after Zofran exposure, however those deaths have not been definitively tied to the drug.

Did GSK Illegally Promote Zofran for Off-Label Use?

Zofran was approved in 1991 as an anti-nausea drug, primarily to treat patients undergoing chemotherapy or radiation treatment for cancer. Zofran has never been approved by the FDA for use as a “morning sickness” treatment among pregnant women. There have, however, been allegations against GSK for years that the company promoted the drug for off-label use. In 2012, the U.S. Justice Department filed a lawsuit against GSK, alleging the pharmaceutical giant had unlawfully marketed Zofran directly to OB/GYNs. GSK pled guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, paying out a staggering $3 billion as part of the settlement.

Was GSK Aware of the Potential Dangers of Zofran to Pregnant Women?

Certain court documents appear to indicate GSK was aware—as early as 1992—Zofran could present unreasonable harm to fetuses, as the drug was known to pass through the placenta. Despite this knowledge, GSK continued to promote Zofran for off-label use among pregnant women with severe “morning sickness.” In addition to alleging GSK concealed evidence of the dangers associated with Zofran, there are additional allegations that GSK failed to warn the public about potentially dangerous side effects, failed to determine safety risks prior to selling Zofran, promoted Zofran as being a safe treatment for morning sickness, misrepresented animal studies which showed signs of abnormal bone growth and toxicity, and produced a defective drug.

As many as 80 percent of all pregnant women suffer some form of nausea or vomiting during the first trimester. In addition to cleft palate and heart defects, lawsuits have alleged cleft lip, club foot, kidney malformations and skull deformations

Contact Our National Dangerous Drug Lawyers

If you took Zofran during pregnancy and your baby was born with a congenital defect, it is important to speak one of the experienced national dangerous drug attorneys at Golomb & Honik, P.C. immediately. Our lawyers can answer all your questions regarding the current Zofran litigation and determine if you are eligible to file a lawsuit against the manufacturers of Zofran.

To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb & Honik, P.C. today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik, P.C. have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

Blog Home