Pharmaceutical manufacturer GlaxoSmithKline paid over one billion dollars in 2012 in a settlement with the federal government over the sale and use an anti-nausea drug, Zofran. That has not, however, stopped the filing of at least one new lawsuit over damages from its use. A Billings couple has filed suit claiming that use of the drug during pregnancy caused the couple’s child to be born with cleft lip and palate.
The Billings couple’s child was born in 1998, but they were unaware of any link between the drug and cleft lip and palate until 2015. The baby was diagnosed with the abnormality at the time of birth. She had 10 corrective surgeries over the course of her young life, and at the time of the lawsuit filing she was facing additional surgeries.
The drug was first developed to treat nausea in patients undergoing chemotherapy. It was never intended or tested for treatment of nausea in pregnant women. Unfortunately, that had not stopped physicians from prescribing the drug for such use. Apparently, there was a reason that occurred. In 2012, GSK entered into a settlement with the United States Department of Justice, resolving allegations that the company had:
- promoted Zofran for non-covered uses and paid kickbacks to doctors for prescribing the medicine;
- made false statements concerning the drug’s safety; and
- committed irregularities under the Medicaid Drug Rebate Program.
The drug had been approved in 1991, but not for pregnancy-related nausea. Within nine years, GSK had received as many as 32 reports of birth defects after use by pregnant women. Defects included heart defects, stillbirth, kidney malformation, and cleft palate. The billion dollar settlement with the Department of Justice consisted mostly of a criminal fine of over 950 million dollars.
If you took Zofran, also known as odansetron, during pregnancy and believe your child may have been born with a defect, please call us. We have extensive experience in personal injury claims and can evaluate your case and provide you with meaningful, expert advice. To schedule a one-on-one consultation with one of our experienced lawyers, please contact our firm online or call our office at 406-812-7634.
