In the wake of Monday’s Supreme Court decision that blocked the ability of patients to sue generic drugmakers for design flaws in their medicine because it would conflict with Food and Drug Administration rules, members of Congress and consumer groups renewed their plea to the FDA to change those rules. A link to Tuesday’s Inquirer story is here.
Three senators and four representatives – all Democrats – sent a letter to FDA Commissioner Margaret Hamburg, urging her to make the changes happen so that patients who think they are harmed can seek redress in state courts.
Karen Bartlett was the plaintiff in the case that was decided Monday. The New Hampshire woman took a generic painkiller made by Philadelphia’s Mutual Pharmaceutical Co., which is now part of Sun Pharmaceutical Industries, Ltd. Her adverse reaction included terrible skin reactions, near blindness, 12 operations and the need for a medically-induced coma.