Free Zofran Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Zofran and our lawyers can help.
Montana Couple Alleges Zofran Caused Daughter’s Cleft Palate
The lawsuit, which was filed April 3 in the U.S. District Court, Billings Division, accuses GSK of failing to conduct appropriate safety tests to ensure Zofran was safe for use by pregnant women.
According to the complaint, Pam Marlenee was prescribed Zofran for morning sickness during her first trimester of pregnancy. She gave birth to a daughter, M.M., in 1998, who was immediately diagnosed with a cleft palate. The girl has since had to undergo 10 surgeries “to try and correct her cleft lip and palate,” and is expected to need additional treatment in the future as she continues to grow.
Pam and her husband claim there is no history of oral cleft defects in their family, and were surprised to learn this past February that their daughter’s defect may have been caused by her exposure to Zofran. They had no idea at the time Pam was taking the drug that it could cause harm to an unborn child. She states in the lawsuit that had she been aware that Zofran could increase risk of birth defects, she never would have taken it.
‘Off-Label’ Morning Sickness Treatment
The U.S. Food & Drug Administration (FDA) approved Zofran in 1991 as a treatment for cancer patients with severe nausea from chemotherapy and radiation treatment. The medication was never approved for use in pregnant women; however, GSK marketed Zofran “off-label” to doctors as a treatment for morning sickness. The company had never performed studies to determine the drug’s effectiveness for this purpose, but later studies indicated that it could be harmful to a fetus.
GSK Fined for Illegal Marketing
In 2012, GSK pled guilty to:
• Promoting the sale and use of Zofran for conditions other than those for which it was approved;
• Making false representations about the safety of the drug, and
• Offering and paying illegal remuneration to doctors to encouraging them to prescribe Zofran.
The drug maker agreed to a settlement with the federal government that included over $1 billion in payments.
Zofran Birth Defect Studies
In 2006, a Hong Kong-based study found that Zofran could cross the placental barrier to infect embryonic compartments. In 2012, researchers found that when taken during the first trimester, Zofran increased the risk of cleft palate, and the next year, that it increased the risk of heart defects.
The Marlenee’s contend that GSK should have warned pregnant women about the risks of using Zofran, and that the company had an obligation to be more forthcoming in their marketing materials about the drug’s potential to cause harm to unborn children. They are seeking compensation for:
- Strict products liability
- Breach of warranties
- Fraudulent concealment
- Negligent misrepresentation
- Negligent infliction of emotional distress
- Punitive damages
The case number is: 1:15-cv-00026-SPW-CSO.
Do I Have a Zofran Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.
Free Zofran Lawsuit Evaluation: Again, if your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.