Plaintiff Claims Zofran Maker Uses Expectant Mothers and Unborn Children as Human Guinea Pigs

San Francisco, CAAccusing GlaxoSmithKline (GSK), the Zofran maker, of using expectant mothers and unborn children as human guinea pigs sounds like something the National Enquirer would dream up. In GSK’s defense, using pregnant women in clinical trials would be tantamount to such an accusation. But if GSK hid the risks of Zofran birth defects, that’s another story.

Several Zofran lawsuits have been filed in the past few months. In February 2015, the plaintiff with the “guinea pig” accusation, which refers to the company’s alleged “off label” promotion, also says that GSK has “never once undertaken a single study on the effects of this powerful drug on a pregnant mother or growing child in utero.” For obvious reasons a drug company would never study its drug in pregnant women. The plaintiff further says that she “had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.” Did she actually inquire about such studies before taking the anti-nausea drug? This case, number 1:15-cv-10429, was filed in the United States District Court of the District of Massachusetts.

To support her claims, the lawsuit refers to the federal government’s charges in 2012 that cost GSK more than $1 billion in payments to the feds for illegally marketing a number of its drugs, including Zofran. The US Department of Justice charged GSK with:

• promoting the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea)

• making and/or disseminating unsubstantiated and false representations about the safety and efficacy of Zofran concerning [the drug’s use for] pregnancy-related nausea

• offering and paying illegal remuneration to health care professionals to induce them to promote and prescribe Zofran

Two more Zofran lawsuits were filed in California in March 2015, both claiming that Zofran causes heart defects. Parents from San Francisco allege that Zofran caused their child’s heart defect. The mother was prescribed Zofran “off label” during the first trimester. Their child, who was born in 2009, has a serious congenital heart defect called bicuspid aortic stenosis, which is potentially life-threatening.

An Oakland mother’s claim made it the fourth lawsuit in the US to allege that Zofran increases risks for major birth defects. Her complaint, case number RG15761042, was filed in the Superior Court for the State of California, County of Alameda.

All plaintiffs claim that GSK knew about the risk of Zofran birth defects for more than two decades.