Devices

J&J, DePuy Settle with 46 States on Hip Devices

Attorneys general in 46 states have reached a $120 million settlement with Johnson & Johnson and DePuy to resolve allegations that the medical device company unlawfully promoted two metal-on-metal hip implant devices—the ASR XL and the Pinnacle Ultamet. An announcement by New York State attorney general Letitia James said the states alleged that DePuy made misleading claims as to the longevity (survivorship) of the metal-on-metal hip implants.

James says that some patients who required hip implant revision surgery to replace a failed ASR XL or Pinnacle Ultamet 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 and DePuy discontinued sale of the Pinnacle Ultamet in 2013.

Under a consent decree reached by the states with the company, DePuy is to reform how it markets and promotes its hip implants. The company is to:

base claims of survivorship, stability, or dislocations on scientific information and the most recent dataset available from a registry for any DePuy hip implant device;
maintain postmarket surveillance and complaint handling programs;
· 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; and
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.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome