Patients at risk due to legal loophole for generic drugs
An investigation done by a CBS affiliate in Boston uncovered a legal loophole that may put millions of people who take generic drugs at risk. The investigation focuses on the Steele family. Alisa Steele was prescribed Ondansetron, the generic form of Zofran, to help with her morning sickness during pregnancy. The use of the drug for this purpose is still considered off-label by the FDA. Alisa gave birth to a daughter who suffered from congenital heart defects which are believed to be a side effect of the Ondansetron. However, current law does not allow generic drug manufacturers to be held liable when their product injures someone. Even though Ondansetron is identical to Zofran, which has been linked to birth defects, its maker cannot be sued for injuries caused by its use. Since they are unable to sue the maker of Ondansetron, the Steele’s are hoping that their story will convince a judge that brand manufacturers, like GlaxoSmithKline for Zofran, should be held responsible for their generic copies.