The Pinnacle Ultamet is a metal-on-metal hip implant manufactured by DePuy Synthes, a medical device division of Johnson & Johnson.
In 2013, after hundreds of thousands of patients reported premature failure of various makes and models of hip implants, the FDA finally proposed a strengthening of its artificial hip regulations. A new rule required that makers of metal-on-metal hips must prove the devices were safe and effective before they could sell existing devices or get approval for new all-metal implants. DePuy subsequently stopped selling the Pinnacle devices in that same year. The “new” FDA order became effective in May of 2016.
Metal-on-metal hip implants came under scrutiny over allegations that they caused a build-up of metal ions in the blood, resulting in groin pain, allergic reactions, bone erosion and tissue death. Risks specific to metal-on-metal implants are described on the FDA website. DePuy faces over 10,400 U.S. lawsuits over its Pinnacle device in connection with those claims.
Patients suffering from a defective hip implant often remain on pain medication, sometimes for years, and will eventually need revision surgery to replace the defective hip implant. As time goes on, the faulty device can shed tiny metallic particles, and some patients may become permanently disabled due to bone, muscle or nerve damage.
DePuy/J&J denies consumer claims related to its Pinnacle products, and stated they acted appropriately and responsibly in the development, testing, and marketing of the devices, which did not undergo clinical trials on humans.
This is not DePuy’s first large scale lawsuit over defective hip replacement systems. Thousands of U.S. lawsuits were filed by patients injured by their ASR metal-on-metal hip implant. The ASR implants failed at a much higher rate than the industry standard, with patients having to undergo painful and costly revision surgery. Many of these plaintiffs suffered irreversible injuries and crippling disabilities even after the ASR implants were removed and replaced with new devices. In November of 2013, DePuy agreed to pay $2.5 billion to resolve 8,000 patient lawsuits. It was one of the largest product liability payouts at that time.
Patient complaints of premature failures of the Pinnacle Hip Replacement device and/or metal poisoning resulted in a 7-year legal battle against DePuy and Johnson & Johnson. In New York, over 9,000 patients filed suit and six patients won a $247 million trial verdict.
On February 4, 2019, Bloomberg reported that Johnson & Johnson agreed to settle the bulk of consumer lawsuits alleging the product is defective and the company misled patients about the dangers of the Pinnacle hip device. Details were not provided.
In a separate matter, DePuy and Johnson & Johnson agreed to pay $129 million to settle multistate lawsuits for deceptive marketing and false claims relative to the Pinnacle hip implant.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.
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