Is the FDA Helping Companies Hide Medical Device Injuries?

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The US Food & Drug Administration (FDA) is generally thought to be there to protect people from the negligence of manufacturers. However, per a recent report in the Minnesota Star Tribune, the FDA may be helping medical device manufacturers hide the fact that their products could injure patients, or may have already. Reportedly, the FDA is allowing companies to sidestep the requirement to report medical device injuries as soon as they find out about them. Instead, according to data obtained by the Star Tribune, companies have been allowed to report product-related injuries late. In some cases, manufacturers have not reported injuries until years after the fact. In addition, the Star Tribune reports that the FDA is allowing medical device manufacturers to keep the details of these incidents confidential even after they do finally report them.

How Could FDA Rules Help Companies Cover Up Medical Device Injuries?

An example cited in the Star Tribune report involved Baxter International, a medical product maker based in Illinois. Allegedly, Baxter’s Colleague drug pump suffered around 75,000 malfunctions. Per the Star Tribune, the FDA let Baxter put the malfunctions in a confidential report and only required them to publicly disclose the issue through a summary, which failed to mention the number of malfunctions that had occurred. This is just one of many incidents that the FDA has enabled medical device makers to cover up.

People shouldn’t have to worry about the products they use, especially medical devices, hurting them. When this happens, in some cases, victims and their families can fight back by filing a product liability claim. Call our experienced Southern Illinois personal injury attorneys today for help with your claim.

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