Parents Allege Defective Drug Resulted in Son’s Birth Defect

A California couple is suing drug manufacturing giant GlaxoSmithKline (GSK) after they allege a medication the mother took has resulted in birth defects in their young son, according to a report in The Legal Examiner.

The lawsuit alleges that the anti-nausea medication, Zofran, caused a serious heart defect in their son, who was born in 2009, according to the report. The woman suing GSK says she took Zofran early in her first trimester of pregnancy to help relieve issues related to morning sickness.

After giving birth to her son in 2009, the woman stated he was soon diagnosed with bicuspid aortic stenosis, a condition wherein the aortic valve is malformed and does not function correctly, according to the report.

The lawsuit states that the son’s life will be forever altered due to the condition, including monitoring and costly future surgeries to repair and/or replace the damaged valve, according to the report. With no history of heart defects in the family, the couple claims that if she had been aware of the risks and side effects associated with Zofran she would have never considered taking it during her pregnancy.

In the lawsuit, the parents also go after GSK for allegedly misleading the public about Zofran’s connection to birth defects.

Indeed, GSK’s marketing of Zofran to pregnant women was never approved by the Federal Drug Administration. The FDA approved the prescription anti-nausea medication in 1991 for cancer patients who were suffering from nausea and vomiting as a result of chemotherapy. However, GSK began encouraging doctors to prescribe the medication for nausea pregnant mothers, the report states.

The drug manufacturer never conducted clinical trials of the drug in pregnant women before encouraging doctors to market it to them as an “off-label” use..

GSK received more than 30 reports of birth defects as a result of Zofran by 2000. To date, there have been more than 200 reports of birth defects.

The U.S. Justice Department opened an investigation of GSK in connection with several claims — including GSK’s encouragement of Zofran for off-label use never approved by the FDA — which the two parties settled in 2012, with GSK paying out more than $3 million, according to the report.

As part of the settlement, GSK admitted in a written agreement that it had promoted the use of Zofran for conditions not approved by the FDA. It also stated that GSK offered and illegally paid doctors and other healthcare professionals to use and prescribe Zofran for uses than than those approved by the FDA.

Have you or a loved one been affected by a defective drug?

If you believe you or a loved one has been injured by a defective drug, contact the attorneys at Boone & Davis in Fort Lauderdale, Florida today. We have more than 40 years of experience helping victims of defective drugs and are prepared to begin working on your case immediately.