Johnson & Johnson (J&J) and its division DePuy Orthopaedics have agreed to pay $120m to settle unlawful marketing hip implant claims made by multiple US states regarding the ASR XL and Pinnacle Ultamet devices.
Attorneys General of 46 states claimed that DePuy carried out unfair and deceptive practices in promoting the longevity of the metal-on-metal hip implants.
Allegedly, patients implanted with these devices had to undergo a revision surgery prior to the company’s advertised timeframe, resulting in undesirable reactions such as pain, allergic reactions and tissue necrosis.
New York Attorney General Letitia James said: “Doctors and their patients need to have accurate and up to date information to ensure that patients are receiving appropriate healthcare.
“Companies should never be allowed to freely mislead the public, especially when there are health concerns involved. This settlement serves as an important message that deceptive and false medical practices will never be tolerated.”
DePuy issued a voluntary recall of the ASR XL and Pinnacle Ultamet in 2010 and 2013, respectively.
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According to Reuters, the company previously agreed to pay a minimum of $2.47bn to settle several lawsuits by patients who had to have the ASR implant removed.
In addition, DePuy is facing approximately 10,400 lawsuits in the US over the Pinnacle device. The company has reportedly denied these claims.
Commenting on the latest agreement, DePuy noted that the settlement does not involve an admission of liability or misconduct on its part.
The settlement requires DePuy to maintain a post-market surveillance programme and update internal product complaint handling operating procedures, among others.
J&J reported $27bn in worldwide sales of its medical devices during the full-year 2018, a 1.5% growth compared to the previous year.
The company said that the domestic medical device sales increased 0.1%, while international sales surged by 2.8%.
It attributed the impact on worldwide operational results to Interventional Solutions electrophysiology products, Acuvue contact lenses and surgical products, endocutters, biosurgicals and Acuvue contact lenses and surgical products.
Late last year a global investigation found that numerous unsafe medical devices have been implanted in patients and are already causing great harm. The investigation, which was carried out by the International Consortium of Investigative Journalists (ICIJ) in coordination with the British Medical Journal and various media outlets, found that pacemakers, artificial knees, hips and rods to support the spinal cord are among the faulty devices.
Additional reporting by Charlotte Edwards.