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Why is the FDA hiding data on defective medical devices?

Do you trust the Food and Drug Administration (FDA) to keep you informed about the dangers that crop up with medical devices, products and drugs?

You probably shouldn’t.

It’s no secret that medical product manufacturers don’t like recalls on their products. They’re public relations nightmares. They’re expensive. They can deeply damage a company’s stock prices and cut into corporate profits. When given the discretion to make a recall or even an announcement to warn consumers, most companies would prefer to sit on their proverbial hands — even as reports of complications keep rolling in.

And, unfortunately, the FDA may be helping them do just that. A recent investigation by Kaiser Health News showed that the FDA gave out numerous exemptions to medical device manufacturers that allowed them to avoid public disclosure of complications with their products. In fact, a program that started almost two decades ago allowed medical manufacturing companies to file mere summary reports about their products’ malfunctions in a database that couldn’t be accessed by either medical researchers or doctors — let alone the public!

While many of those “alternative summary” exemptions were revoked in 2017, most of the hidden reports remain hidden. Some of the devices that have hidden reports, including implantable defibrillators and medical staplers. While about 100 reports of patient injuries were publicly linked to these devices in 2016 alone, nearly 10,000 reports of malfunctions were actually quietly filed with the FDA that didn’t become public.

If you ask the FDA for more information, most likely you’ll be told to make a request under the Freedom of Information Act — which can take almost two years to process.

Issues like these are why it is so important to have an attorney who is experienced with litigation over defective medical devices on your side if you or a loved one suffered an injury. Find out more today about your rights.


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