Johnson & Johnson DePuy ASR Hip Replacement Implant Lawsuit Settlement Signup Information
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Johnson & Johnson will pay more than $4 billion to resolve more than 12,000
lawsuits in federal and state courts over defective DePuy ASR hip implants. Once
approved, this settlement will be the largest US settlement of legal claims for a
medical device, dwarfing the 2001 settlement of claims involving defective Sulzer
hip and knee implants that cost $1 billion.
We expect the announcement will be made next week in federal court in Toledo,
Ohio, where U.S. District Judge David Katz coordinates federal litigation. Judge
Katz must approve the settlement.
DePuy recalled 93,000 ASR hip implants worldwide in August 2010, citing a 12
percent failure rate in the first five years. However, internal J&J documents show
37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia
rose to 44 percent within seven years. Unfortunately this is a poor prognosis for
any recipient of a DePuy ASR hip system.
We expect that Judge Katz will approve the settlement and that 94 percent of
eligible claimants will sign up warding off a DePuy withdrawal from the deal.
There will be a timeframe within which clients will decide whether or not to
participate in the settlement. Clients will have the opportunity to "opt out" and
continue their litigation in court. It is expected that payments to individuals with
one revised hip will be between $300,000 and $350,000. Individuals with bilateral
revisions or those who suffered complications during revision or re-revisions will
receive more money. The settlement will probably be scaled based upon age so a
person with a revision who is 40 years old will receive more than someone who is
80 years old. We expect that those who have an ASR hip that has not been revised
will not receive a substantial amount but that the settlement will remain open to
pay them if their hip fails in the future and a revision is needed.
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Recently the Daily Telegraph reported that National Health Service Hospitals in Great Britain are to be banned from fitting most metal-on-metal hip replacements after a study found unacceptably high failure rates among implants in 17,000 patients.
The National Institute for Health and Care Excellence (NICE) has issued a warning that high failure rates in metal-on-metal joints were discovered, as high as 43 percent in some of the implants. This came after an audit of all hip surgery in England, Wales, and Northern Ireland was conducted with alarming results.
In particular it was found that The DePuy ASR, which had already been withdrawn when the manufacturers admitted to a failure rate of 13 percent within five years, had an astonishing estimated failure rate of 43 percent at nine years.
These findings resulted in regulators drawing up new guidelines recommending that the NHS stop using any hip implant with a failure rate higher than five percent at five years. This means that every type of metal-on-metal hip replacement joint, including five still in use, will no longer be implanted in patients. Among the metal-on-metal devices listed in the ban include DePuy ASR and Pinnacle implants, Zurom Durom Cup devices, and the Biomet Recap-Magnum.
The study also included models used in hip resurfacing procedure, usually used in younger more active patients. Failure rates in this category were 14 percent after five years and as high as 36 percent after nine years. The metal-on-metal resurfacing models found to have such high failure rates are: the Adept; Cormet 2000; Durom; Recap Magnum; and Conserve Plus.
I applaud the steps taken by NICE. Metal-on-metal hip joints represent the largest medical device failure in history. The pain and suffering endured by patients who have received these joints will go on for years. In the United States earlier this year The FDA issued new safety guidelines regarding metal-on-metal hip problems that recommends continued monitoring of implant patients for possible metal poisoning. The agency also warns physicians to be on the lookout for symptoms of metal, which might include pain or swelling near the hip joint, reduced mobility, and noise from the joint.
The Telegraph report indicates that the scope of the problem is only now becoming clear and the full scale of the failings has yet to be realized. Dr. Martyn Porter, past president of the British Orthopedic Association said surgeons first started becoming aware of the problem about three years ago, "We were starting to see high revision rates but this is like watching a car crash in slow motion - at first, you just don't know how bad it is going to be.
The tragedy is that much of it could have been avoided. Many of the manufacturers knew early on of problems with metal-on-metal joints yet ignored reports from doctors and continued to let profits, not patient safety, guide their decision-making. In a lawsuit earlier this year against Johnson & Johnson, parent company of DePuy Orthopedics, it was revealed that internal documents showed the company aggressively kept marketing the ASR replacement joint after it learned of high failure rates. Most disturbing was the revelation that after the ASR was denied approval by the FDA in the United States in 2009, DePuy continued to market the ASR overseas for almost another year.
Great Britain is taking the correct steps to protect patients by banning the use of metal-on-metal implants. In the United States - even as thousands of hip replacement lawsuits are being filed against manufacturers such as DePuy, Stryker, and Zimmer - metal-on-metal implants continue to be used.
How many revision surgeries will it take here before we decide enough is enough?