US Supreme Court's generic drug decision

Benjamin C. Zipursky in Bloomberg Law, July 08, 2011

Bloomberg Law interviews Fordham Law Professor Benjamin Zipursky in its coverage on the United States Supreme Court’s generic drug liability decision.

The impact, legally of this case is quite broad because it covers all generic pharmaceuticals and 70 – 75 percent of prescriptions today are for generics rather than brand-name drugs. And what it says is that what is far in a way the most important basis for liability in personal injury cases for such generic drugs have now been removed by the United States Supreme Court. You can no longer sue generics on a failure-to-warn claim assuming they are FDA approved and as complied as what the labeling requirements of the FDA. So, that is a pretty significant ruling, and in defense of what the court did in this case, I would say most Americans are probably far more worried about the cost of their drugs than they are about whether they are going to be able to sue if they are injured by the drug. Undoubtedly, that is part of what the US Supreme Court Justices, at least some of them, might have been thinking. If there is too much liability for these generic companies they are not going to remain as low cost as we want them to be. Of course, that is not the basis the court used, but it is important to bear in mind that one of the idea that Congress had when it passed Hatch Waxman statute, which is an issue here, creating a regulatory framework for generic drugs, was that this is going to become important to Americans as an inexpensive way to buy pharmaceuticals. And it has, that’s why a majority of prescription drugs today are generics.