GlaxoSmithKline LLC, the makers of Zofran, have been sued in federal court by a couple claiming that taking Zofran during pregnancy caused birth defects in their son.
Sicily Lafleur and Justin Lee Thibodeaux, both individually and as parents and natural tutors of their son, Kaden L. Lafleur, a minor, filed suit against GlaxoSmithKline LLC on February 23 in the U.S. District Court for the the Western District of Louisiana, Lafayette Division. The claims cited are negligence, misrepresentation, fraud, and breach of implied and express warranty.
According to the suit, Lafleur was prescribed Zofran in the beginning of her first trimester to alleviate morning sickness by her health care provider in Lafayette. The product of that pregnancy, Kaden L. Lafleur, was born on November 7, 2012, with congenital heart defects. The plaintiffs allege that these defects are a direct and proximate result of Kaden’s prenatal exposure to Zofran. As a result of these defects, Kaden purportedly required surgery immediately after birth as well as extensive follow-up treatments.
The suit states that there is no history of birth defects in either Lafleur or Thibodeaux’s families, and Kaden’s state is a result of Zofran and the defendant’s negligent actions. According to the suit, the FDA has never approved Zofran for the treatment of morning sickness or any other condition in pregnant women. Further, GlaxoSmithKline allegedly never performed any clinical studies of Zofran use in pregnant women.
The suit maintains the defendant marketed Zofran “off-label” as a safe and effective treatment of morning sickness. In addition, the plaintiffs claim that the defendant continued to negligently and illegally misrepresent the product as safe for pregnant women, despite being aware of the potential harm.
The complaint states that neither Lafleur nor the unnamed Lafayette health care provider were aware of the dangerous effects of Zofran or GlaxoKlineSmith’s fraudulent marketing of the drug.
As a direct and proximate result of defendant’s actions, plaintiffs have allegedly been subjected to severe and permanent pain and suffering, mental anguish, emotional distress, past and future medical expenses, and other economic loss. As a result, the suit seeks: general damages; medical, incidental, and hospital expenses; pre- and post-judgement interest; a full refund on all purchases of Zofran; damages consequential, compensatory, and punitive; cost of suit and attorney fees.