J&J Finalizes Largest Medical Device Settlement in US History for DePuy ASR Hip Replacement Devices
On Tuesday, November 12th, Johnson & Johnson finalized the largest medical device settlement agreement in US history. The pharmaceutical company and their subsidiary, DePuy, agreed to pay $4 billion to settle thousands of personal injury lawsuits involving their all-metal hip replacement device, the Articular Surface Replacement, or DePuy ASR device.
After some of the bellwether cases in a multidistrict litigation (MDL) were decided in favor of the plaintiff, J&J started making moves to settle cases. In October, a bellwether trial for plaintiff Robert Ottman was settled before it went to trial. The first DePuy ASR bellwether case, involving plaintiff Loren Kransky, was decided in favor of the plaintiff, and Kransky received $8.3 million due to his personal injury.
J&J and DePuy Orthopedics have been considering a larger settlement for about a month, but the final settlement amount was larger than predicted. Initially, the medical device manufacturer considered $3 billion, or about $300,000 per plaintiff. The higher amount of $4 billion would equate to about $350,000 per plaintiff.
The settlement will most likely include a provision that J&J can withdraw from the agreement unless 94% of the plaintiffs agree to the terms, and a medical definition of the DePuy ASR device’s failure in the body. Hip implants fail for a variety of other reasons, including infection contracted during implant surgery.
This is the second large personal injury settlement that Johnson & Johnson has finalized this month. Earlier, the pharmaceutical company agreed to pay $2.2 billion to settle claims about misuse of its antipsychotic drug, Risperdal.
History of DePuy ASR Device Failure
J&J introduced the DePuy ASR all-metal hip replacement device to the United States in 2005, after the DePuy ASR received FDA approval in 2003. However, in 2010, the company recalled 93,000 units worldwide, including 37,000 in the US alone. The company claimed initially that the recall was due to low sales figures, making the continued manufacture of the all-metal hip devices unappealing, but it turned out that 12% of the devices failed within the first five years after hip replacement surgery. The failure rate is much higher than other hip replacement devices, at double the industry standard, which can be a combination of metal and plastic, ceramic, or entirely plastic.
According to the New York Times, DePuy Orthopedics launched their metal-on-metal hip implant without thoroughly testing and researching it. It became cleared through a narrow pathway called the 510(k) approval process, which did not require it to undergo clinical trials.
J&J had marketed the devices as safer and sturdier than their plastic counterparts, which last over five years. The FDA has, so far, received over 300 complaints of device failure and personal injury directly related to receiving a DePuy ASR implant.
Side effects of DePuy ASR device failure include:
- Pseudotumors from metal debris
- Allergic reactions
- Permanent muscle and tissue damage
- Loose hip cups
- Hip dislocations
- Bone fractures
The Strom Law Firm Can Help with DePuy ASR Personal Injury Cases
If you or a loved one has received a metal hip replacement device, specifically from DePuy Orthopedics, and have since suffered painful side effects, you may be entitled to compensation. The attorneys at the Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800.