What is a Defective Medical Device?
The U.S. Food & Drug Administration (FDA) has updated its approval guidelines after medical device lobbyists criticized the organization for delays in medical device approvals. Despite the fact that more defective medical device lawsuit are being filed, the agency recently announced changes that could make it easier for manufacturers to get new devices into the marketplace.
United States Falling Behind
Manufacturers argue that the United States is falling behind other countries whose approval rules are less stringent. However, patient safety advocates say that European guidelines only have one less requirement than that of the United States, and that other countries have significantly higher defective medical device recall rates. Even with the current guidelines in place, defective medical devices are recalled regularly in the United States after patients report problems, some of which can lead to death.
Some argue that the changes proposed fail to address many issues with the approval process that the FDA was made aware of before passing the Food and Drug Administration Safety and Innovation Act in 2012. The changes, in direct conflict with patient safety advocate advice, are designed to speed up the release of medical devices. The FDA reportedly still allows the use of medical devices that have been recalled in the past to be used as new devices under the guidelines. This has led many patient advocates to worry that a device, which has known problems that led to a recall in the past, can be approved by the FDA with little or no testing requirements simply because it will be used for another test or condition.
The current system relies on demonstrations by manufacturers showing that the device is the same, or at least similar, to one that is already on the market, even if the first device is used for something completely unrelated to what the new device will be used for. Critics say that the testing for medical devices, even those considered high-risk that must undergo more stringent testing, is still much less strict than the process for prescription drugs.
A couple in Hopkinsville, Kansas, filed a lawsuit against DePuy Orthopaedics, along with their parent company, Johnson & Johnson, due to an allegedly defective ASR metal hip implant. Women throughout country have filed lawsuits against the manufacturers of transvaginal mesh. All of these products were approved by the FDA as safe for use, yet all of them have been reported to cause injury and sometimes death.
With the new updates to approval guidelines, more people may be injured by defective medical devices. If you or a loved one have been injured by a defective medical device, or if a loved one has died due to complications from a medical device, contact Attorney Group for Kansas for a free, no-obligation consultation regarding a personal injury or wrongful death case. We can help you understand your options in a free consultation, and connect you with an affiliated attorney if you decide to pursue a claim. Contact us today for more information.