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With some medical devices, you don’t know what you don’t know

On behalf of Cohn Lifland Pearlman Herrmann & Knopf LLP | Aug 22, 2018 |

There are regulatory protocols to follow for getting the government’s OK to market most medical products in the U.S. Prescription drugs need to prove their effectiveness and safety through human trials. Manufacturers must provide data showing study results, side effects and more. Final approval only comes after a review by a panel of Food and Drug Administration scientists.

You might expect something close to the same level of oversight for medical devices. However, that is not the case. Those with experience in personal injury law know there is a loophole in the regulatory net that has allowed myriad products to reach the market over the past decade without any significant review. The result is that a growing number of unsuspecting consumers have either already suffered injury, or face the risk of injury from device defects.

Such stories have been around for a long time, but now a Netflix documentary tries to put a spotlight on the issue. At the center of the bull’s eye, The Bleeding Edge takes aim at the so-called 510(K) pathway. This is a provision in FDA controls that allows a medical device maker to get around the usual Pre-Market Approval (PMA) process by showing that the product is “substantially equivalent” to one that is already on the market. The work-around can applied even if the existing product was recalled for safety issues.

The result, as one health advocate notes, is that most moderate and high-risk devices have not been subjected to testing for safety or efficacy. One graphic used in the movie indicates only 2 percent of devices have gone through PMA, while 98 percent have used the 510(K) provision.

The documentary looks at five devices, from metal-on-metal joint replacements to the Essure device for female sterilization, offering up disturbing statistics. The film’s producers welcome the early attention it is getting, but say true success will be gauged by whether it brings about regulatory changes.

Shy of that happening, the only remedy many victims of defective products may have is through direct claims against manufacturers. Consulting skilled legal counsel is the way to determine if a viable case exists.