The DePuy unit of Johnson & Johnson (J&J) has agreed to pay $2.5 billion to settle thousands of lawsuits from patients who were alleging injured by the company’s faulty hip replacement implants, the company announced Tuesday.
The settlement was announced during a hearing in U.S. District Court in Toledo, Ohio and is one of the largest settlements for the medical device industry. This would compensate approximately 8,000 patients who underwent surgery to have the company’s metal ball-and-socket hip implant removed or replaced.
J&J was defending more than 12,000 lawsuits in state and federal court regarding injuries allegedly caused by its metal-on-metal ASR hip replacement systems, according to regulatory filing.
J&J pulled the implants from the market in 2010 after data showed it failed much sooner than older implants.
The settlement provides about $250,000 per patient and covers those who had their implants removed or replaced before August 31, 2013. J&J expects to make most of the payments to patients in 2014.
“The U.S. settlement program provides compensation for eligible patients without the delay and uncertainty of protracted litigation,” said Andrew Ekdahl, president of DePuy Synthes Joint Reconstruction, in a statement.
The DePuy division of J&J said in a statement that the deal does not cover all lawsuits pending against the company.
“DePuy will continue to defend against remaining claims and believes its actions related to the ASR Hip System have been appropriate and responsible,” the company said.
The artificial hip, known as the Articular Surface Replacement, or ASR, was sold for eight years to some 35,000 people in the U.S. and more than 90,000 people worldwide. J&J stopped making the product in 2009 and the following year, recalled it.
Internal J&J documents were unsealed during the case revealing that company officials were aware of problems with the device as far back as 2008.
In addition, according to a deposition from a J&J official, a 2011 company review of a patient registry concluded that more than one-third of the implants were expected to fail within five years of their implantation. Orthopedic hips are generally supposed to last at least 10-20 years.
In past decades, almost all orthopedic hips were covered in plastic or ceramic. But approximately a decade ago, many orthopedic surgeons began favoring all-metal implants after laboratory tests suggested the devices would last longer and reduce the chances of dislocation.
Recent data from patient registries show the devices actually fail at a higher rate than older implants. Government advisers stated last year that in only a few, if any cases, should metal-on-metal hip implants be recommended.
If J&J was aware of problems with the device in 2008, why did they wait until 2009 to stop making this faulty product and why would they wait until 2010 to recall the implants? Thousands of patients suffered needlessly, requiring additional surgeries.