Southern Med Law Discusses Off-Label Marketing Issues at Center of 2012 GlaxoSmithKline Settlement, New Zofran Lawsuit claims Pending in U.S. Courts
A number of Zofran birth defects lawsuits currently pending in U.S. courts put forth claims regarding GlaxoSmithKline’s alleged off-label marketing of the medication as a treatment for morning sickness. According to Southern Med Law, court records indicate that these complaints echo allegations cited in a massive, $3 billion settlement the pharmaceutical company reached with the U.S. Department of Justice (DOJ) in 2012.
“While Zofran has never been approved to treat nausea and vomiting related to pregnancy, doctors may prescribe prescription drugs for any purpose they deem appropriate. Drug makers, however, are legally barred from promoting their products based on this type of ‘off-label’ use,” says Dr. François Blaudeau, the founder of Southern Med Law. Dr. Blaudeau is both an attorney and a practicing obstetrician/gynecologist. As such, he possesses unique insight into the tactics used by pharmaceutical companies to market their products to physicians.
The $3 billion settlement reached between the DOJ and Glaxo in 2012 revolved around the marketing of a number of medications, including Zofran, Paxil, Wellbutrin, Avandia, Advair and Lamictal. In addition to alleging that Zofran had been illegally promoted as a treatment for morning sickness, the federal government also charged that the company had paid doctors kickbacks to induce them to prescribe the medication to pregnant women. Glaxo pled guilty to promoting off-label use of Paxil and Wellbutrin, and to concealing safety data involving its diabetes drug, Avandia. However, it did not admit wrongdoing in resolving any of the other charges, including those that involved Zofran.
Court records indicate that a number of Zofran lawsuits have been filed in recent months on behalf of children who were allegedly born with serious birth defects due to pre-natal Zofran exposure. The first such complaint was filed in U.S. District Court, Eastern District of Pennsylvania on February 12, 2015. (Case 2:15-cv-00709-PDC) The most recent lawsuit involving the drug was filed in April 17, 2015 in the U.S. District Court, Eastern District of Texas. (Case No. DRU-1505-14). Both of these complaints accuse Glaxo of wrongly promoting Zofran as a safe and effective treatment for morning sickness, even though the medication had never been studied for this use. The lawsuits cite the 2012 settlement between Glaxo and the federal government as evidence of the company’s alleged misconduct in regards to the promotion of Zofran for this purpose.
Southern Med Law is currently evaluating potential Zofran lawsuits on behalf of families who believe their child was born with a birth defect due to this medication. To learn more about the litigation involving Zofran and birth defects, please contact the Firm as soon as possible. You can arrange for a free, no obligation Zofran lawsuit review by calling Southern Med Law today, at 205-547-5525.
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526