In a lawsuit brought by 46 U.S. states, Johnson & Johnson (J&J) has agreed to pay $120 Million to resolve claims that it used “unfair and deceptive” practices to market its metal-on-metal hip-implant devices.
New York Attorney General Letitia James, along with 45 other attorneys general, alleged that J&J and its subsidiary, DePuy Synthes, made misleading claims about how long the implants would last. Though the companies advertised a 5-year survival rate of more than 90%, European health regulators found the actual rate to be closer to 5%. Well within that 5-year timeframe, many patients have undergone revision surgeries.
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J&J’s metal-on-metal hip implants have been under scrutiny since before 2012, when the first of 6,000 product liability lawsuits over the devices went to trial.
Each lawsuit claimed that 1 or both of DePuy’s hip implant products caused a build-up of metal ions in the blood. Plaintiffs have also reported hip replacement injuries like groin pain, allergic reactions, and tissue necrosis. All such adverse events could have been avoided if the companies hadn’t led vulnerable patients to believe their products were safe, the latest lawsuit alleged.
“Doctors and their patients need to have accurate and up-to-date information to ensure that patients are receiving appropriate healthcare,” James said in a statement. “Companies should never be allowed to freely mislead the public, especially when there are health concerns involved.”
The settlement, announced Tuesday, is the largest J&J has made with attorneys general over hip replacement complications. As part of the agreement, J&J and DePuy are required to regularly monitor product performance and customer complaints, while grounding any further claims in the latest available data.
Yet neither company admits accountability for any hip replacement injuries. Both say they acted appropriately and responsibly throughout development, testing, and marketing of the devices.
“The settlement involves no admission of liability or misconduct on the part of the companies,” said Mindy Tinsley, spokeswoman for DePuy. “DePuy Synthes remains committed to meeting the current and future needs of orthopedic surgeons and patients.”
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It was 2010, a year after the Food and Drug Administration (FDA) refused to approve a version of the product for sale in the U.S., when DePuy finally pulled the devices off the market. Following a worldwide voluntary recall of 93,000 devices, the company said it would set aside at least $2.47 Billion to end lawsuits over the product.
As for the devices, DePuy halted sales in 2013 after the FDA strengthened its artificial hip regulations.
Since, the company has settled thousands of lawsuits brought by patients who have suffered through pain and injury after receiving hip replacements. In 2016, Johnson & Johnson paid $500 Million – then another $1 Billion – in bellwether trials that found the company guilty of negligent design, failure to warn the public about its dangers, and fraudulent concealment of potential risks with the device. In 2017, a Dallas jury delivered a third straight victory of $247 Million.
And Tuesday’s settlement came as J&J announced yet another blow to its growth: that its fourth-quarter litigation expenses had doubled to $1.29 Billion, in part because of settlements over its hip implants but also because of links between its talc products and cancer.
Johnson & Johnson and DePuy still face some 10,400 lawsuits in the U.S. over its device alone. In the meantime, says James:
“This settlement serves as an important message that deceptive and false medical practices will never be tolerated.”