Last month, the U.S. Food and Drug Administration (FDA) proposed a policy which, if adopted, could significantly increase the oversight and safety of the medical device industry. Under the proposal, each individual device would receive its own identification number, allowing medical professionals and manufacturers to better track defective products, determine the cause of the problems and alert other patients who are using the same device.
Earlier this week, the U.S. House of Representatives approved a bill that secures the funding for the Food and Drug Administration (FDA) for the next several years. Last week, the U.S. Senate passed a similar version of the bill, and leaders from the chambers will now work to come to a consensus, reportedly aiming for July 4 as a deadline to finalize the bill.
Earlier this week, we began a look at common issues with the FDA's approval process which have resulted in unsafe medical devices being approved for sale and use by patients in New Jersey and throughout the country and world. As a result, many patients who have received these medical products have reported adverse side effects including debilitating pain, injury and even death.
According to a 2011 report from the U.S. Food and Drug Administration (FDA), the number of "adverse event" reports for medical devices has increased by about 15 percent every year for the last 10 years. If you are a regular reader of our New Jersey personal injury blog, you are likely not surprised by this increase.
As we previously discussed, several members of Congress are working to close a loophole in the U.S. Food and Drug Administration's approval process. Currently, the 501(k) process requires the FDA to approve medical devices if a manufacturer can show that the device is similar to one that has already been approved for sale.
Earlier this week, we talked about the loophole in the U.S. Food and Drug Administration's 510(k) medical device approval process which reportedly allowed for the approval of a vaginal mesh product manufactured by New Jersey-based Johnson & Johnson. Recently, members of the U.S. House of Representatives proposed a bill which, if passed, would close that loophole, effectively preventing devices based on dangerous, previously-recalled medical products from being approved by the FDA.
Last month, we wrote about federal legislators' efforts to close the loophole in the U.S. Food and Drug Administration's medical device approval process. Now, it appears that a top official with the device division of the FDA agrees that such a change should be made. Hopefully, this will spur the legislation and prevent dangerous or defective products from making it to the marketplace in the future.
Earlier this week, we began an in-depth look into the convoluted process by which Johnson & Johnson and its unit DePuy Orthopaedics sought FDA approval for its articular surface replacement devices, or ASRs. Initially, the FDA rejected the medical product, stating that additional clinical study was necessary to determine whether the product was safe.
New documents have revealed that DePuy Orthopaedics, a unit of New Jersey-based Johnson & Johnson, continued to sell faulty hip replacement joints internationally after they were rejected for sale by the U.S. Food and Drug Administration. At the same time, DePuy sold a similar defective product in the U.S. after was approved through the FDA's 501(k) loophole, which we detailed extensively in a previous product liability blog post.
Last week, we wrote that the U.S. Food and Drug Administration had ordered additional research into the vaginal mesh products that have caused injury and even death to women throughout the country.