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,...
Product Liability
FDA device director supports closing approval loophole (1)
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....
Johnson & Johnson CEO to step down in April
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...
DePuy sold hip replacements overseas after FDA rejection (2)
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...
DePuy sold hip replacements overseas after FDA rejection (1)
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...
Faulty hip replacements can cause long-term injuries
Recently, the faulty metal-on-metal hip replacement joints manufactured by DePuy Orthopaedics, a unit of New Jersey-based Johnson & Johnson, have become the subject of scrutiny and debate after causing pain and injury to thousands of patients. According to a few...
Federal lawmakers seek to close FDA approval loophole
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.Vaginal mesh, which is manufactured primarily by two New Jersey...
New Jersey company faces growing product liability suit
Earlier this week, we wrote about the recent influx of product liability lawsuits against New Jersey-based Johnson & Johnson regarding its vaginal mesh implant products, which have resulted in injury and death in hundreds of women throughout the country. The...
FDA orders NJ companies to study safety of vaginal mesh implants
Two New Jersey-based companies are among the more than 30 businesses that must conduct studies and clinical trials on the safety and effectiveness of vaginal mesh implants, according to recent media reports. The U.S. Food and Drug Administration ordered the studies...
Federal officials can’t link defective drywall to injuries
The United States Consumer Product Safety Commission was not able to collect sufficient evidence proving that faulty drywall is a dangerous product capable of inflicting homeowners with illness or other ailments. The organization will therefore not ask the...
