Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims. The ruling created a legal injustice for those injured by generic drugs.
While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough to know that this polarized and partisan Congress would never do so. And honestly, I’m not even sure if Obama would sign it – screeds from the right notwithstanding, Obama has not been a friend of lawyers or the injured.
But there is hope! Pharmalot noted that the U.S. Department of Justice filed a court brief that indicates that the FDA is considering changing the very rule that the Supreme Court based its ruling on. If the FDA does change the rule, generic drug manufacturers will once again be held accountable for the same conduct brand-name manufacturers are held accountable for:
“This is what the footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers“ (see page 15 of this brief).
To short, if the FDA were to make such a change in regulations, generic drugmakers could be sued in state courts if they become aware of evidence of serious side effects but do not take action to update the product labeling. We were alerted to this by Bob Pollock, a senior advisor at Lachman Consultants, and a former acting deputy director of the FDA Office of Generic Drugs.”
Source: FDA May Change Warning Regs For Generic Labels // Pharmalot