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Will One Woman's Amputation Change the Future of Medical Device Lawsuits?

Mellino Law Firm

The House and Senate have proposed legislation to make it easier for injured patients to sue medical device manufacturers. If passed, the Medical Device Safety Act of 2009 would overturn the Supreme Court’s 2008 ruling in Riegel v. Medtronic.

That case held that a medical device manufacturer usually cannot be sued by injured patients if the Food and Drug Administration approved the device for marketing through its premarket approval (PMA) process, said consumer advocacy organization Public Citizen. The FDA’s website states that PMA is “the most stringent” marketing application. The Riegel ruling essentially protected makers of defective devices from product liability lawsuits.

Or so they thought until musician Diana Levine filed a defective drug injury lawsuit that forced legislators to rethink preemption.

Levine, a musician, went to the emergency room for a migraine. There, she was injected with Wyeth drug Phenergan to alleviate nausea. According to the Wall Street Journal, the physician assistant who administered the drug missed Levine’s vein, and she developed gangrene and had to have part of her arm amputated.

“The problem wasn’t with the drug itself, but with the way it was administered,” wrote Jacob Goldstein. “Levine argues the label, which did warn about the risks of inadvertent intra-arterial injection, should also have clearly warned against IV push.”

Per Cornell University Law School, “Wyeth … argued that federal law preempted Levine’s state law claims, as state law directly conflicted with the requirements of the Federal Food, Drug and Cosmetic Act.”

Levine was awarded $6.7 million in damages.

Only time will tell whether the Medical Device Safety Act of 2009 will pass, but one thing is certain: Given the number of defective medical devices making the news, something needs to change.


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