Johnson & Johnson has announced a multi-billion-dollar agreement reached with lawyers representing thousands of defective hip implant recipients, as reported in the 11/19/13 New York Times article.

A Los Angeles jury has returned a $8,338,000 verdict for the plaintiff in a closely watched personal injury product liability trial involving the defective Johnson & Johnson Depuy ASR metal on metal hip implants (see previous blogs and my defective implant web page re the nature of the defects and the litigation). Although the verdict did not include punitive damages, the jury sent a clear message to Johnson & Johnson by awarding the plaintiff Loren Kransky, a retired prison guard who had terminal cancer unrelated to the hip replacement, as well as a history of smoking, vascular disease and diabetes, $8 million in pain and suffering. While Johnson & Johnson is now facing nearly 11,000 lawsuits over the implants, this was the first one to reach a verdict.

As reported today in the New York Times, court documents newly disclosed in pre-trial proceedings in the first California Depuy ASR hip implant case set to go to trial, reveal that Johnson & Johnson predicted in 2011 that 37% of its Depuy ASR metal hip implants would eventually fail, indicating that potentially thousands of additional patients will eventually require surgical replacement of their implants.

Additional court documents released last week reveal that the company was aware in 2008, from European reports, that a similar version of its device was releasing high levels of dangerous metallic particles, especially in women.

Lawyers In California handling Depuy hip implant injury cases will be closely watching this first California trial brought by implant recipient Loren Kransky.

Johnson & Johnson, the maker of the recalled defective metal on metal Depuy ASR hip implants, has reportedly offered more than $2 billion to settle more than 10,000 claims filed against it by individuals who have the implants. This averages approximately $200,000 per claimant. The amount of that offer is expected to rise in the future as negotiations continue with lawyers representing hip implant claimants in California and around the country.

The $200,000 amount, while it may adequately compensate some claimants, would be woefully inadequate to compensate a huge number of claimants. Regardless of the total amount of the ultimate settlement reached, the way any settlement scheme would work is that a claims system would be set up with tiered settlement amounts depending upon the extent of a claimant’s injuries and whether the claimant had, or will have, surgery to replace the implant. Similar schemes have resulted from pharmaceutical defect mass tort acions in the past.

Johnson & Johnson’s offer comes on the eve of the first California case scheduled to go to trial in Los Angeles this week, a trial which will be closely watched.

Following the wide-spread failures of all-metal hip implants such as the failures of the Johnson & Johnson Depuy ASR hip implants (see Johnson Depuy hip implant defect lawyers), the Food and Drug Administration is set to propose rules to more tightly regulate the all-metal hip implant industry.

As reported in today’s New York Times, the FDA’s proposed rules would require the manufacturers of artificial hips and all-metal components to prove the devices were safe before they can continue selling existing ones or obtain approval for new all-metal designs. Under current rules, manufacturers merely have to show that their hip devices resemble ones already on the market, and they are not required to conduct clinical studies before marketing them. The result of the current rules has been that implant manufacturers were able to start selling a new generation of all-metal hips approximately ten years ago without running clinical tests.

The FDA’s proposed rules arise amid one of the largest ever medical device failures. Hip implants have been failing early at an alarming rate, and have caused severe tissue and bone damage caused by the release of tiny particles of harmful metal debris as the implant components grind against each other as the patients walk normally. Thousands of patients with such implants have been forced to undergo revision surgery to replace the failing implants, and many have become disabled from tissue and bone damage. Thousands of lawsuits by hip implant recipients have been filed and court trials in these lawsuits are beginning.