The birth injury lawyers at Pintas & Mullins have written extensively on the risks of birth defects in children born to mothers who took certain drugs. It has recently come to light that Zofran, a drug marketed to pregnant women to treat nausea, may also be causing birth injuries.
Zofran was approved by the FDA to treat nausea in cancer patients undergoing chemotherapy or surgery. In recent years, doctors have also prescribed the drug to expectant mothers who suffer nausea and vomiting during pregnancy, although the FDA never approved it for this use.
Prescribing a drug "off-label," or for uses not approved by the FDA, is not illegal for doctors to do; it is illegal, however, for drug companies to market their drugs for off-label uses, or to recommend doctors prescribe drugs for off-label treatments. Big Pharma by and large ignores these laws through various channels, spending large sums of money and time marketing drugs to doctors, so they will prescribe them for all kinds of treatments that have not been proven safe or effective.
Zofran's manufacturer, GlaxoSmithKline (GSK), saw the potential market for expectant mothers suffering from morning sickness. Getting a drug approved by the FDA for a specific treatment is a very long, very expensive process. Years of studies must be done in patients to prove the drug is safe and effective for long-term use, before it can be an official treatment for that purpose.
Big Pharma companies like GSK do not adhere to these guidelines, preferring to merely pay the million-dollar federal fines for illegal marketing. This is because drugs profit in the billions of dollars - a few million dollars in fines is a drop in the bucket compared to how much money they can and do make from off-label marketing.
In 2012, GSK plead guilty to federal charges of illegally marketing several drugs, including Zofran. It was the largest health care fraud settlement in U.S. history, ending in a $3 billion payment by GSK to the Department of Justice. The case was unprecedented in size and scope, and involved claims that GSK paid doctors to promote and prescribe Zofran to pregnant women. GSK ultimately pled guilty to three charges of criminal behavior.
The public is taking particular notice of the birth injury lawsuits because GSK knew there was a risk to infants from the beginning. Court documents prove that GSK knew that Zofran posed an unreasonable risk of harm to developing babies in the womb as early as 1992. The company continued to market it to expecting mothers and their physicians anyway.
About one million pregnant women take Zofran or its generic every year. Birth injuries named in Zofran lawsuits include:
• Club foot
• Cleft lip or palate
• Heart defects, such as holes in the heart
• Skull deformities, such as craniosynostosis
One of the most recent suits was filed in February 2015 by a mother who was told Zofran was safe to take while pregnant. Unfortunately, her daughter was born with various birth defects, including facial dysmorphia, hearing loss, ingueno hernia, and several heart deformities. The child endured ten surgeries in her first 12 years of life to correct the defects.