Many Georgia consumers have been impacted by a recent Supreme Court ruling granting immunity from lawsuits to medical device makers for products approved by the Food and Drug Administration (FDA). Our Atlanta Georgia lawyers have previously written about this decision.
\nSince that ruling judges in Georgia and across the United States have used it as a basis to dismiss cases against a wide range of manufacturers, including Medtronic. The most recent dismissal was this past Tuesday, by the Wisconsin Supreme Court.
\nThe New York Times reports that on the same day last month that a federal judge in Minnesota dismissed hundreds of lawsuits against the maker of a faulty heart device, a man entered a nearby hospital to have one of the flawed products surgically removed. The risky surgeryhad a tragic result. As doctors removed the device, a vessel was punctured, causing extensive bleeding. The 33-year-old patient died two days later, leaving behind a wife and two young sons.
\nHis widow and children are left without a remedy due to the Supreme Court decision. This is especially appalling in light of the fact that numerous reports show the FDA has not been adequately testing these products before granting approval.
\nBut now, some members of Congress want to give potential plaintiffs a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision. A similar Senate bill is expected to be reintroduced.
\nNot surprisingly, medical device manufactures and some conservative legal groups have begun to gear up campaigns to oppose the legislation.
\nThis situation was perhaps best summed up by David C. Vladeck, a professor at Georgetown University Law Center. He was quoted as follows: \u201cThe F.D.A. has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can\u2019t sue companies for redress.\u201d<\/p>\n