On June 24, 2013 the United States Supreme Court decided the case Mutual Pharmaceutical v. Bartlett, and held that the manufacturer of a generic version of a drug could not be held liable for injuries cause by the defective design of that drug. In 2011, the Court had also held that generic drug manufacturers could not be held liable for defective (incomplete) warning labels accompanying their products. The end result is that manufacturers of generic drugs are almost completely protected from liability for their defective products.
The FDA has been asked to step in and make changes to address the issue of generic drug makers’ accountability. Members of Congress have sent letters, and petitions have been filed by citizens’ groups. It may be up to Congress itself to make changes to the laws in order to make sure generic drug makers take responsibility for their products.
Meanwhile, victims of defective generic drugs have limited options for recovering for their injuries. Neither of the Supreme Court’s decisions dealt with the issue of whether a drug manufacturer should have changed a warning label after they received new information about their product. Generic drug makers are also required to make sure that their product labels match the brand name drug labels exactly, and can be held liable for failing to do so.
Some patients receive a mix of brand name and generic versions of drugs, leaving open the possibility of a suit against the brand name manufacturer. In other cases, such as in the case of Yaz, Yasmin and Ocella birth control, the brand name manufacturer will actually be hired by the company that sells the generic version to manufacture the generic alongside the brand name. The law firm of Lopez McHugh has recovered millions of dollars for women injured while taking Ocella and Gianvi, the generic versions of Yaz and Yasmin birth control pills.
Who Suffers If Nothing Is Done?
If changes are not made to the law, it is not just the individual drug user who is the victim. Society as a whole suffers.
When a person is injured, someone has to shoulder the burden of caring for them. In a perfect world, this would be the person or entity that was directly responsible for the injuries. Otherwise, costs of medical care typically fall on private insurance companies or public (state and federal) healthcare plans, which in turn cause higher premiums and taxes for everyone. Meanwhile, drug companies’ focus on profits without consequences leads to shortcuts in brining drugs to market and will only increase the chances that severe side-effects from the next “blockbuster” drug are not found.
Those who would argue in favor of protecting big pharmaceutical companies, claiming that lawsuits result in higher costs for products, often do not realize that the cost of injury gets passed on to the general public anyway, and these costs are often much higher than the alternative: given companies an incentive to ensure that their products are properly tested and with appropriate warnings about all side-effects. In any event, fairness dictates that these costs be paid by the wrongdoer, and the best way to meet that ideal in light of the recent Supreme Court decision, is with grassroots support for Congress to update the laws so that all drug companies are held responsible for wrongdoing.