SACRAMENTO — California Attorney General Xavier Becerra has announced a $120 million settlement with Johnson & Johnson and its subsidiaries Medical Device Business Services, DePuy Products, DePuy Synthes, and DePuy Synthes Sales for unlawful promotion of hip replacement devices.
As stated in a press release issued on Jan. 21, "The settlement—of which California will receive $8 million— resolves allegations that the company violated state consumer protection laws by misrepresenting the effectiveness and safety of its hip implant devices," with agreement alleging that "Johnson & Johnson conducted unfair and deceptive marketing practices by making misleading claims on the longevity—also known as survivorship—of its metal-on-metal hip implant devices. Johnson & Johnson has also agreed to injunctive terms to reform how it markets and promotes its hip implant products."
The settlement resolves questions such as "allegations that Johnson & Johnson violated state law by misleading consumers in the marketing of metal-on-metal hip implant devices used for hip replacement surgeries. In 2005, Johnson & Johnson began marketing its ASR XL device to doctors seeking to provide longer-lasting hip replacement surgery in younger, more active patients," the release said.
Some consumers who had the implant experienced groin pain, allergy, tissue necrosis, build-up of metal in the blood, as well as other painful side effects.
There were some requirements in the settlement that DePuy will have to comply with.
"As part of the settlement, Johnson & Johnson will pay $120 million in penalties, and comply with a set of important injunctive terms that are enforceable by the California Attorney General in the event of future misconduct. Under the consent judgement, the Johnson & Johnson subsidiary companies that market these devices will:
- 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 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; 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," the release said.
The attorneys general of Florida, Indiana, North Carolina, Ohio, Pennsylvania and Washington were part of the executive committee of the settlement, as well as Texas and South Carolina leading the investigation.