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FDA PLANS TO INCREASE SAFETY OF MEDICAL DEVICES AND IMPLANTS

Posted on November 27, 2018
by David P. McCormack

David P. McCormack
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Every year, defective medical devices are implanted into patients in Massachusetts and across the United States. A disproportionately large number of such medical products enter the marketplace with FDA approval based upon what is known as a Premarket Notification 510(k). Through this approval process, products that have a “substantial equivalence” to pre-existing products are not subjected to extensive clinical testing, but are given an expedited path to use in patients. Unlike new pharmaceutical drugs and completely new medical devices which are subjected to strict scrutiny by the FDA, components brought to market through the 510(k) process undergo only limited checks without the need for extensive pre-market testing or clinical observation. Often (in as much as 20% of applications), new devices are introduced based on “substantial equivalence” to predicate devices introduced to the market more than 10 years before the new product’s 510(k) Premarket Notification. Some products entering the market (and being implanted in patients) are based on outdated designs or even products that were previously found to be defective and recalled from the market. As you can imagine, the 510(k) process has resulted in a flood of unsafe implants and medical devices being implanted and causing severe and lifelong damage to patients.

As reported today by the Associated Press, health officials in Washington plan to overhaul the existing 510(k) procedure to increase the safety of products available to U.S. consumers. The planned overhaul could have a major impact on the healthcare industry and greatly improve patient safety. Though proposed changes could take years to implement and might require Congressional approval, an overhaul is called for. Class action and multi-district litigations (MDLs) based upon defective medical devices, many of which were introduced to the market under Premarket Notification 510(k) processes, have cost billions of dollars in recent years. These cases, which are common in Massachusetts, have been handled by SUGARMAN attorneys and include defective hip claims against Stryker Corporation and DePuy Orthopedics and transvaginal mesh cases brought against Boston Scientific Corporation, Johnson & Johnson/Ethicon, Inc., Coloplast and American Medical Systems. Pending defective hip claims against Stryker Corporation have been consolidated in a Massachusetts MDL. These claims, and others, which have been brought against medical device manufacturers by patients who have suffered serious injuries – often requiring surgical revision or re-implantation – allege avoidable injuries, the frequency of which could be decreased by a more careful pre-market review of products by the FDA. Hopefully the new procedure will accomplish this goal and improve the safety of implants.

SUGARMAN attorneys have decades of experience dealing with claims related to defective medical devices. If you or someone you know has been injured by a medical implant, you may have a case. Contact a SUGARMAN personal injury lawyer today by filling out a Contact Form, calling us at 617-542-1000 or emailing info@sugarman.com.