Supreme Court Ruling Protects Medical Device Manufacturers


By Lynn Fugaro, Staff Writer

The medical device industry is enormous. Everything from medical gloves and gauze to artificial hips, prosthetic devices, and pacemakers are all made by medical device manufacturers. It is the U.S. Food & Drug Administration’s (FDA) responsibility to ensure all devices are safe for use and to ensure compliance with the standards and laws in the Federal Food, Drug and Cosmetic Act (FD&C), which was first enacted in 1906 but has been amended numerous times.

For obvious reasons, some medical devices are more stringently overseen than others. Those devices that support human life directly are classified as Class III devices and are required to go through pre-market approval, which is the most rigorous testing required by the FDA. The rigorous testing may give you confidence in the devices on the market today, but the 510(k) exception may give you pause.

510(k): Substantial Equivalence

510(k) refers to the section of law that allows for the substantial equivalence exception and works like this: if a medical device manufacturer wants to introduce a new device into the market without going through the pre-market approval process, all they need to do is show that their new device is substantially equivalent to one that has already been approved to go to market. In order to obtain premarket approval, a device manufacturer would have to provide “scientific, regulatory documentation to the FDA to demonstrate the safety and effectiveness of the device.” In other words, it takes a lot of time, money, and scientific testing to obtain pre-market approval from the FDA. Thus, whenever possible, medical device manufacturers will seek to streamline the process by demonstrating that their device is substantially equivalent to a device that’s already on the market.

What it comes down to is that every medical device is not tested directly before it is used. So, if a medical device is implanted into your body and fails, you should have recourse, right? Well, the Supreme Court said “No,” at least for many defective medical device companies.

Riegel v. Medtronics

Charles Riegel had a blocked artery in his heart, so, his doctor scheduled him for an angioplasty. During an angioplasty, a doctor will insert a catheter in your arm or groin area and advance the catheter through the body and into your heart. Once the catheter reaches your blocked artery, a balloon on the end of the catheter is inflated, which pushes the blockage against the artery walls and opens it, allowing the blood to resume flowing through your artery.

The procedure is very common. On average, roughly 600,000 angioplasties are performed each year in the United States.

Charles Riegel had no reason to believe his wouldn’t be a standard, run-of-the-mill angioplasty. He was prepared for the recovery time and the chest pain sometimes associated with procedures of that type, but he was not prepared for the complications he soon faced.

When his doctor went to inflate the balloon in Mr. Riegel’s artery, the balloon burst, causing major complications. Charles was put on life support. He survived and sued Medtronics, the company who manufactured the balloon the doctor used in his procedure. Mr. Riegel asserted that Medtronics had negligently manufactured the balloon and also alleged negligence regarding its design, testing, inspection, and distribution. The District Court, however, ruled that an amendment in the Food, Drug, and Cosmetic Act prevented Riegel from holding Medtronics accountable. The Supreme Court agreed

The amendment referred to is known as the MDA, or the Medical Device Amendments. The Supreme Court held that “the MDA pre-empted state common law claims for defective devices such as this one.” The ruling hinged on the fact that Congress included in the MDA a provision that precludes states from holding medical devices to higher safety standards than those required in federal law, and because Mr. Riegel’s lawsuit was based on New York state law, the Supreme Court ruled in Medtronics’ favor.

State Court vs. Federal Court

This ruling by the Supreme Court makes it much more difficult (but not impossible) for those negatively affected by medical devices to hold the manufacturers responsible. So, while victims can still sue medical manufacturers in Federal court, those lawsuits will be more challenging and less likely to result in plaintiff victories, let alone large damage awards.

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