Nearly 200 lawsuits have been filed this year alone against GlaxoSmithKline (GSK) for birth defects caused by a chemotherapy drug prescribed to expecting mothers suffering from morning sickness.
Made by GSK, Zofran’s only approved use was to prevent nausea and vomiting brought about by chemotherapy and radiation; however, it was illegally pushed by the drug maker onto pregnant women suffering from nausea-induced morning sickness.
While doctors are allowed to prescribe drugs for off-label uses, drug companies are prohibited from pushing drugs to doctors or patients for uses not approved by the U.S. Food and Drug Administration (FDA).
GSK is being accused of trying to capitalize on the fact that there are no FDA approved drugs for treating morning sickness, which led them to encourage doctors to prescribe Zofran despite failing to test its safety among pregnant women.
Zofran alters brain chemistry by modifying serotonin levels and has been linked to the following birth defects and side-effects in non-expecting women:
- Heart malformations (non-expecting women)
- Club feet
- Cleft palates
- Craniosynostosis — a condition in which the skull is abnormally shaped and may not have enough space for the brain, causing problems with vision, eating, and mental impairment
GSK knew Zofran probably caused harm to unborn babies but pushed it any way for profits
According to Courthouse News Service:
“GlaxoSmithKline pushed its chemotherapy drug Zofran for morning sickness, an off-label use that causes birth defects, ‘experimenting with the lives of unsuspecting mothers-to-be and their babies,’ with a ‘profit maximization’ slogan for doctors, a mother claims in Federal Court.”
Despite pleading guilty to pushing the chemotherapy drug for non-FDA approved uses in 2012, and agreeing to pay $3 billion in criminal and civil fraud charges, GSK turned Zofran into a “blockbuster” drug through a “fraudulent marketing campaign,” earning the drug maker $1 billion in annual sales.
Like most big pharmaceutical companies, GSK thought it was above the law and ignored the FDA’s warning in 1999 to “immediately cease distribution” of ads that promoted Zofran in a light that was “false or misleading.”
Mother prescribed Zofran during pregnancy gave birth to deformed infant
The warning GSK received in 1999 was cited by plaintiff Deana Brown in her October 29 lawsuit against the company. Brown was prescribed Zofran during her first trimester of pregnancy and ended up giving birth to a baby with congenital band syndrome and teratologic clubfoot.
Also known as amniotic band syndrome, congenital band syndrome is when the baby becomes entangled in “fibrous, stringlike amniotic bands in the womb that can wrap around fingers, toes and limbs, restricting blood flow and normal development, and cause complete amputation.”
Teratologic clubfoot is when a baby’s feet rotate inward. The condition is often severe and requires surgery to correct.
Brown has no family history of either of these deformities.
In her lawsuit, Brown alleges that GSK knew the drug was not tested for safety on pregnant women, yet bribed doctors with financial motives to push the drug on unsuspecting patients, blatantly violating the law by instructing GSK drug salesmen to “emphasize to medical providers not only the benefits of Zofran but also the financial benefits to the providers by prescribing Zofran” in the early 1990s.
GSK offers doctors cash in exchange for prescribing birth defect-causing Zofran
GSK told doctors that by using a 32 mg bag of Zofran, they’d be offering patients the most effective dose while increasing his or her profits by x amount of dollars in reimbursements.
“GlaxoSmithKline even developed a catchy motto for its sales staff to pitch to doctors about its premixed Zofran bag: ‘Profit Maximization – It’s in the Bag,’” reports Courthouse News Service.
According to Brown, GSK carried out this misconduct until the Department of Justice began investigating them in the early 2000s.
Brown sued GSK after learning about its twisted history surrounding Zofran.
She is seeking “damages for negligence, product liability, fraudulent misrepresentation and concealment, breach of express warranty, breach of implied warranty, loss of consortium and violations of Idaho’s Consumer Protection Act, plus medical expenses and attorneys’ fees,” according to Courthouse News Service.
193 lawsuits have been filed against GSK this year, all regarding Zofran, with 16 of them being filed Friday in Alabama and 11 more the same day in Boston.
A 2014 study found that Zofran “increases the risk of severe birth defects and injury to the mother,” according to Drug Watch.
In 2013, a study of nearly a million Danish women showed that those taking Zofran experienced a “two-fold increased risk of cardiac malformations… leading to an overall 30 percent increased risk of major congenital malformations.”