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.
Bergen County residents who have suffered injuries from faulty DePuy hip replacements or other defective Johnson & Johnson products will likely be interested to learn that J&J recently set aside $600 million in preparation for a potential settlement over kickbacks allegations. This is in addition to the $5.3 billion that has reportedly already been reserved for potential products liability and kickback claims in relation to other J&J medications and medical devices.
After a rigorous series of tests performed by the Insurance Institute for Highway Safety, an independent analysis has created a list of the seven most dangerous motor vehicles sold in the U.S. Topping the list is the Dodge Ram, which earned the dubious honor through its low crash test scores and low JD Power Initial Quality rating.
Earlier this week, a unit of New Jersey-based Johnson & Johnson announced that it planned to discontinue sales of its vaginal mesh implants. The company denies that the decision was made in response to the product liability lawsuits that have been filed in connection with the mesh, but that the "negative overall publicity about vaginal mesh devices" motivated the discontinuation.
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.
Slow and steady seems to be the name of the game in the main personal injury lawsuit against DePuy Orthopaedics, a division of New Jersey company Johnson & Johnson, over its faulty artificial hip replacement products.
According to a recently released document, New Jersey company Johnson & Johnson began taking action to phase out the use of its metal-on-metal artificial hips just weeks after the receiving a letter from U.S. Food and Drug Administration. In that letter, the agency reportedly turned down Johnson's application to sell the medical product in the United States, and told the company to submit additional safety data if it wanted to pursue the application.
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.