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Supreme Court Grants Immunity for FDA Approved Medical Devices
In a landmark decision this week, the Supreme Court of the United States granted tort immunity to manufacturers of medical devices that have recieved FDA pre-market approval.
In Riegal v. Medtronic, the plaintiff had filed a lawsuit after a Medtronic catheter ruptured in Mr. Riegal's coronary artery during a heart surgery. Even though the catheter's labeling specifically warns against use for patients with diffuse or calcified stenoses, the doctor choose to use it in Mr. Riegal's heavily calcified artery. As the heart surgeon was inflating the catheter, it ruptured, leaving Mr. Riegal on life support and requiring emergency coronary bypass surgery.
The catheter had recieved FDA pre-market approval. Any medical device must undergo extensive screening by the FDA before it can be sold (hence the name "pre-market approval"). This screening includes an average of 1,200 hours of FDA review per application to ensure that each device has a "reasonable assurance" of the device's "safety and effectiveness," as weighed against hte probable risk of injury or illness resulting from use.
The result of this decision is to make it virtually impossible to sue manufacturers of medical devices - like pacemakers or catheters - as long as they have been pre-approved by the FDA. While the FDA does a great job in screening out medical devices not ready for the mass market, their screening process does not warrant giving blanket immunity to the makers of medical devices.
Even scarier? The Supreme Court will hear a case next term regarding the exact same issue - but with prescription drugs. This could be the end of manufacturer liability in the medical industry.
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