Breslin & Breslin, P.A.
201.546.5881
medical malpractice & personal injurySuper-Lawyers

Posts tagged "product liability"

DePuy hip replacement trial progresses, slowly

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.

J&J began phasing out hip implant after FDA safety data request

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.

New Jersey company sold dangerous product without FDA approval

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.

Faulty hip replacement products could increase cancer risk

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.

FDA device director supports closing approval loophole (2)

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.

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. Hopefully, this will spur the legislation and prevent dangerous or defective products from making it to the marketplace in the future.

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 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.

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 that additional clinical study was necessary to determine whether the product was safe.

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 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.

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 new studies, those defective products may continue to cause harm long after they are removed from the body.