DePuy Hip Implant Lawsuits
I’ve seen the ravages brought about by the DePuy hip replacement devices. Successful lawsuits have been filed, and a Texas court recently awarded a $1 billion verdict to compensate victims. To understand how this could happen, you need to know the history of the DePuy hip implant.
Who Is DePuy?
DePuy Manufacturing was begun in 1895 by Revra DePuy, a pharmaceutical salesman in Warsaw, Indiana. He started with a fiber splint for fractures, replacing wooden ones. Johnson & Johnson acquired the company in 1998, and today it is part of J&J Medical with 200 orthopedic products, including hip and other joint implants.
Understanding the Depuy Hip Implant Debacle
There are three DePuy hip implant devices:
- ASR XL (acetabular system total hip replacement)
- ASR Hip Resurfacing System
- Pinnacle
The FDA approved the use of the DePuy ASR™ XL device in 2005 using a 501(k) clearance. A medical device manufacturer must submit plans to the FDA that a device is about to be marketed. The premarketing timeline is 90 days. If the manufacturer indicates, and the FDA agrees, that the device is as effective and safe as a device that was previously marketed, no new clinical trials are needed. This type of approval allowed the DePuy ASR™ XL to be sold without extensive testing.
DePuy was unable to use 501(k) clearance for the ASR Hip Resurfacing System. Clinical trials for this device ran into problems. Johnson & Johnson responded by dropping the FDA application for approval. The devices could not be sold in the United States; however, they were sold outside the country. In addition, surgeons had a choice to use the ASR Hip Resurfacing System “off-label.” This means that FDA approval is not necessary for its use.
The Pinnacle comes with choices. Unlike the other two devices, the materials used for the ball and cup surfaces are not always metal. The surfaces can be:
- Metal-on-metal
- Ceramic on polyethylene
- Ceramic-on-metal
- Ceramic-on-ceramic
- Metal-on-polyethylene
This diversity gives an orthopedic surgeon a choice based on the needs of the patient. The MoM version was FDA approved using a previously approved device, The Ultima Mom Acetabular Cup and was often chosen to withstand a more active lifestyle. Patients with both the Ultima and the MoM Pinnacle devices experienced symptoms resulting from the friction of metal on metal.
Complaints and Recalls
Complaints, including pain, instability, fractures, infection, inability to walk and metallosis grew, and both the ASR XL and the Hip Resurfacing System were recalled in 2010. Over 93,000 were used worldwide before the recall. The British Hip Society and the British Orthopaedic Association cited a failure rate of 21 percent to 49 percent over a six-year span.
The Pinnacle hip implant has not been recalled as of 2016, despite numerous complaints and lawsuits with one verdict totaling more than $1 billion. The charges included negligence, fraudulent concealment, conspiracy, and intentional misrepresentation. Patients who develop problems due to metallosis and other issues are forced to pay for additional surgery costing thousands of dollars.
What Should You Do?
If you were injured by a DePuy implant, contacting an MoM implant lawyer may help you receive the compensation you deserve. In addition, the lawsuits will prevent others from suffering the same fate needlessly. Medical device companies, such as DePuy, are held to a standard of excellence, and when that obligation is breached, they are guilty and their liability cannot be ignored.
Metal-on-Metal Hip Implant Injury Lawyers
I’m Ed Smith, a metal-on-metal (MoM) hip implant lawyer. I believe in the duty physicians and medical device companies have to patients. While each case is different, the overriding concern is that DePuy ignored the problems associated with these devices and continued to supply them long after problems were apparent. In fact, the Pinnacle hip implant remains on the market.
Call me at (800) 404-5400 if you live outside of Sacramento, California, or locally. If you have questions, I’ll answer them. If you want me to review your case, I’ll do so free of charge. I promise you will always get free, friendly advice.
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Source of DePuy Metal-on-Metal Hip Implants ~
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