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Ruling makes it harder to sue for defective medical devices

What happens if your pacemaker is defective? What if your insulin pump doesn't properly kick in when you reach a dangerous low? What if your pain pump causes an overdose?

You might think that the manufacturers of such devices would bear some responsibility if their products fail. Unfortunately, the Supreme Court just made it harder to hold those manufacturers responsible for their defective products -- even when the quality of those products is a matter of life and death.

The United States Supreme Court recently ruled that any medical devices that have gone through the Food and Drug Administration's pre-market approval process are protected from lawsuits -- even when there are clearly problems that put patients in danger.

It's important to understand that the Food and Drug Administration (FDA) does not do independent tests on medical devices before they are approved for use on consumers. Instead, the FDA relies on the information provided by a product's own manufacturer about the safety testing that the manufacturer completed. The FDA has to simply hope that the information they receive is honest and transparent.

It's a bit like putting the fox in charge of the hen house. The manufacturers of any given medical device stand to make a small fortune from their products if they gain FDA approval. The FDA relies on what the manufacturer says about its own devices in order to grant that approval. If a device is defective and injures anyone, victims can't sue because the FDA gave the product a green light.

Any checks or balances that are supposed to protect consumers are merely illusory at this point. There's almost no way to effectively hold the manufacturer responsible once that FDA approval is granted.

An attorney can give you more information about product liability laws and your rights after a product-related injury.

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DelVecchio & Miller, LLC

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