In recent weeks, we have written extensively on the issues surrounding the DePuy Orthopaedics articular surface replacement (ASR) metal-on-metal hip replacement joints. Essentially, these faulty medical products have caused thousands of people in New Jersey and throughout the country to suffer debilitating pain and lasting injury as a result of friction in the joint's metal components.
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.
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.
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 new studies, those defective products may continue to cause harm long after they are removed from the body.
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.
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 vaginal mesh suits are not the only litigation facing Johnson & Johnson at this time. The company is also defending itself against a growing class action products liability lawsuit after "mechanical failure" forced the recall of hundreds of artificial joints.
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 after receiving multiple reports of injuries and fatalities caused by the defective products, an agency spokesman said.