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Monday, October 14, 2019

ARKANSAS ATTORNEY GENERAL: Rutledge Reaches Settlement Over Illegal Promotion Of Hip Implants

By Press release submission | Jan 29, 2019

Arkansas Attorney General issued the following announcement on Jan. 22.

Arkansas Attorney General Leslie Rutledge announced she has joined 45 attorneys general to reach a $120 million settlement with Johnson & Johnson and its wholly-owned subsidiary DePuy Orthopaedics, Inc. to settle allegations that DePuy unlawfully promoted its metal-on-metal hip implant devices. Arkansas will receive $1.7 million in the settlement.

“The settlement helps to ensure that doctors and patients have necessary and accurate information when considering implant options,” said Attorney General Rutledge. “Surgeons who implant devices like these metal-on-metal hip replacement systems need to have the most up-to-date information concerning patient outcomes.”

The Attorneys General allege that DePuy engaged in deceptive practices in its promotion of the ASR XL and Pinnacle Ultamet hip implant devices by making misleading claims as to the longevity, also known as survivorship, of metal-on-metal hip implants. DePuy advertised that the ASR XL hip implant had a survivorship of 99.2% at three years when the National Joint Registry of England and Wales reported a 7% revision rate at three years. Similarly, DePuy promoted the Pinnacle Ultamet as having a survivorship of 99.8% and 99.9% survivorship at five years when the National Joint Registry of England and Wales reported a 2.2% three year revision rate in 2009 increasing to a 4.28% five year revision rate in 2012.

Some patients who required hip implant revision surgery to replace a failed implant experienced persistent groin pain, allergic reactions, tissue necrosis, as well as a build-up of metal ions in the blood. The ASR XL was recalled from the market in 2010. DePuy discontinued its sale of the Pinnacle Ultamet in 2013.

As part of the settlement, DePuy has agreed to reform how it markets and promotes its hip implants, including:

- Advertised claims of survivorship, stability or dislocations will be based on scientific information and the most recent dataset available from a registry for any DePuy hip implant device.

- Maintain a post market surveillance program and complaint handling program.

- Update and maintain internal product complaint handling operating procedures including training of complaint reviewers.

- Update and maintain processes and procedures to track and analyze product complaints that do not meet the definition of medical device reportable events.

- Maintain a quality assurance program that includes an audit procedure for tracking complaints regarding DePuy products that do not rise to the level of a medical device reportable event but that may indicate a device-related serious injury or malfunction.

Perform quarterly reviews of complaints and if a subgroup of patients is identified that has a higher incidence of adverse events than the full patient population, determine the cause and alter promotional practices as appropriate.

Original source can be found here.

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