Earlier today, the United States Supreme Court issued its opinion in the case of Pliva, Inc. v. Mensing (5-4) that generic drug companies are not legally responsible and therefore will not be held liable for failing to warn consumers about the side effects of medications they sell, and of which they are well aware, if their packaging labels are identical to those of the original brand-name product.
The High Court ruled that federal law preempted any state law rulings that required these generic drug companies from letting people know about problems that these companies know about – by labels, or by writing letters to doctors, whatever. Seems that the generic drug companies are to coattail on the drug makers’ actions.
According to Justice Clarence Thomas (who wrote the majority opinion), it’s just too hard for drug manufacturers to have to deal with federal laws on consumer warnings along with state laws that might ask them to do more. So the generics aren’t going to have to do this, either. Preemption.
This will be a big problem for thousands of Americans who have sued for severe injuries resulting from taking the generic versions of drugs including Accutane, Darvocet, Reglan, and Zocor.
It is a big win for Big Pharma.
Once again, be careful out there. Don’t trust the product (including the drug) just because a doctor or pharmacist handed it over to you. Learn what it is, investigate for yourself, and trust your instincts. Get medical care and legal help when you think you may need it: don’t expect your health care professional to tell you to seek a second opinion or to find a lawyer.
To read the Supreme Court opinion, go here.
