About two years ago, New Jersey company Johnson & Johnson made the widely-publicized decision to recall the ASR artificial hip manufactured and sold by DePuy Orthopaedics, a unit of J&J. The company set aside $3 billion to compensate people who had filed personal injury lawsuits in connection with the defective products, and seemed to acknowledge the danger of metal-on-metal artificial hips.
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.
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.
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.
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.
After a string of product recalls and products liability lawsuits, the chief executive officer of Johnson & Johnson is reportedly stepping down from his position later this spring. Although the New Jersey company's revenue has doubled in the past decade, the many product recalls in recent years have reportedly cost Johnson & Johnson more than $1 billion, as well as the serious hits to its public image and consumers' trust.
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.