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Home/Legal & Regulatory and Reimbursement/DePuy Settles Hip Implant Suit for $120 Million
Legal & Regulatory and Reimbursement

DePuy Settles Hip Implant Suit for $120 Million

January 29, 2019 1 min read Premium comments

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DePuy Settles Hip Implant Suit for $120 Million
Source: Wikimedia Commons
Secondary#depuyorthopaedics#hipimplant

DePuy Synthes has agreed to pay $120 million to settle the multistate lawsuits that allege that the company made false claims and engaged in deceptive marketing for its metal-on-metal hip implant devices.

The attorneys general of 46 states sued DePuy Synthes and its parent company, Johnson & Johnson, claiming that DePuy engaged in unfair and deceptive practices in marketing its ASR XL and Pinnacle Ultamet hip implant devices. The investigation was led by South Carolina and Texas. The 46 states that brought the suits will share the settlement.

This settlement is in addition to the $2.5 billion that Johnson & Johnson paid in 2014 to settle thousands of lawsuits brought by hip replacement patients that accused the company of selling defective implants that cause injuries and the need for additional surgeries. Similar lawsuits have been filed against Johnson & Johnson and DePuy in the United Kingdom, Canada, Australia, Ireland, Germany, and Italy.

DePuy voluntarily recalled 93,000 of its ASR hip implants in 2010, saying that 12% of them failed within five years. DePuy took its Pinnacle devices off the market in 2013, after the U.S. Food and Drug Administration strengthened its artificial hip regulations. Metal-on-metal hip implants have been linked to build-up of metal ions in the blood, groin pain, allergic reactions, bone erosion, and tissue death.

According to the settlement agreement, DePuy is required to maintain a post-market surveillance program and update procedures to track complaints over hip implants. The company must also reevaluate, and revise is marketing and promotion strategies for hip implants. DePuy must now base its claims about the longevity of its hip implants on the latest available data.

DePuy and Johnson & Johnson have denied any wrongdoing or liability. In a prepared statement, the company said, “DePuy Synthes remains committed to meeting the current and future needs of orthopedic surgeons and patients.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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