Medical device giant Johnson & Johnson has reportedly negotiated a settlement that will bring an end to over 7,500 lawsuits from patients who received the company’s all-metal hip implants. For many of these patients, complications from the all-metal hip implants required corrective surgery or removal of the device. According to the New York Times, the total value of the settlement could exceed $4 billion.
Under the deal, patients who were forced to undergo hip implant removal / replacement will receive an average payment of $300,000. The hip implants at fault were manufactured by the company’s DePuy division. While this settlement will protect the company from patients who have had an ASR implant removed, the company could still face legal action from patients who still have the all-metal hip implants. As of now, the settlement still has to be approved by the court.
For J&J / Depuy, all-metal hip implants have been a significant issue. In 2010, the company recalled 93,000 ASR all-metal hip implants after it was revealed that the devices caused patient injuries and suffered from high failure rates. Out of these recalls, 37,000 took place in the United States.
In October of this year, J&J settled two all-metal hip implant lawsuits. However, the latest settlement will be the company’s biggest one to date.
A federal trial against the company over the fall hip implants was pushed back several months due to issues with expert witnesses. However, if the settlement goes through, the federal case (slated for trial in the U.S. District Court of Ohio) could be cancelled.
Several months ago, J&J is alleged to have started talks on the multi-billion-dollar settlement. News of the settlement first broke in August of this year. While the alleged settlement figure at that time was $3 billion, that figure has grown to an estimated $4 billion. As of August, J&J has almost $1 billion set aside to cover settlement and recall costs.
For the time-being, there are many questions that don’t have answers. According to the New York Times, the settlement will be announced by the company in the coming week. However, this settlement is unlikely to wipe up the company’s all-metal hip implant troubles. In total, the company may face up to 11,500 lawsuits in the United States alone. In addition, J&J global lawsuits could weigh on the company’s finances as more patients around the world experience issues with ASR all-metal hip implants.
That said, J&J isn’t the only all-metal hip implant manufacturer facing recalls and lawsuits. Other companies like Biomet and Stryker face a mounting number of lawsuits of their own. Assuming that J&J’s settlement goes well, other companies facing legal wrangles may pursue a similar course.
J&J has said it will exit the ceramic-on-metal and metal-on-metal hip implant markets by 2014.
- 3 Tips for Successfully Launching an Outsourced Medical Device - Webcast
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast
- Rapid Prototyping for Medical Devices - Webcast
- New Approaches to Assessing Biocompatibility for Medical Devices - Webcast
- Five Mistakes That Can Derail Your Product Development Effort - Webcast
- How to Manage Risk Throughout Medical Device Product Development Cycle and Beyond - Webcast