At least 151 Alabama families have filed Zofran lawsuits against GlaxoSmithKline for birth defects they claim were caused by generic brands of ondansetron. However, others in the state are now barred from pursuing similar lawsuits, thanks to a law enacted by the Alabama legislature last year.
“I just trusted my doctor,” Clara Rickman recently told Al.com “Maybe it was my fault that I didn’t ask her more questions.
Clara was prescribed Zofran in 2014 to control severe morning sickness associated with her pregnancy. When she had the prescription filled, the pharmacist substituted a less expensive, generic version of ondansetron. Neither name-brand Zofran nor ondansetron have been approved to teat pregnancy-related nausea and vomiting. However, the drugs have long been prescribed off-label for this purpose.
Today the Rickman’s believe ondansetron caused a cardiac birth defect that forced their newborn son to undergo open heart surgery when he was just four days old. He’s since had one additional procedure, and continues to see a cardiologist regularly, as well as a nephrologist and urologist.
Even though generic drugs pose the same risks as their brand name counterparts, consumers have been prohibited from bringing state law failure to warn claims against generic drug manufacturers since 2011. That year, the U.S. Supreme Court determined that such lawsuits were barred because generic drug makers had no control over their products’ labels.
In most states, it’s now impossible to file suit for generic drug injuries. But in 2014, the Alabama Supreme Court ruled that patients who use generics can sue the manufacturer of the brand-name drug, since that company actually controls what safety information is included on the labels for both brand-name and generic versions. But in 2015, the Alabama legislature gave in to tremendous industry pressure and passed a law reversing the Court’s decision. The law went into effect on October 30, 2015.
The Rickmans and 150 other ondansetron plaintiffs were able file birth defects lawsuits against GlaxoSmithKline – the manufacturer of name-brand Zofran — before the October 2015 deadline. Many other families were not as fortunate.
“It’s so arbitrary to tell them that if you gotten to me by October 30 we could have done something, but now we can’t,” one plaintiffs’ attorney told AL.com.
More than 260 Zofran lawsuits, including the cases filed by the Rickmans and other Alabama generic drug plaintiffs, have been centralized in the U.S. District Court, District of Massachusetts. All of the plaintiffs claim that GlaxoSmithKline failed to provide adequate warnings regarding the alleged association between Zofran and birth defects.