DePuy ASR Hip Implant Failures Mount, with Devastating Effects
Posted November 15, 2011 in Products Liability by Arthur Buono
DePuy Hip Replacement Helpline Moniters The DePuy Recalls
DePuy ASR hip implants continue to fail at an alarming rate. Patients who’ve received these systems are presenting about 20 new claims per week on average. About 4,000 cases already have been filed against DePuy and its parent company, Johnson & Johnson, and it seems there’s no end in sight to the trouble.
DePuy ASR hip implants continue to fail, cases continue to mount
Metal-on-metal design implicated in failure
Victims face revision surgeries, uncertain complications from metals exposure
Victims Face Painful "Revision" Surgery
To get an update on the problem and the litigation, I spoke with Felecia Stern of the Bernstein Liebhard law firm. Stern’s firm has a substantial number of cases pending in the sprawling complex of lawsuits this defective medical device has spawned.
Felecia L. Stern
First some background. The DePuy ASR artificial hip was approved by the FDA in 2005. More on that in a moment. It’s a so-called metal-on-metal (MOM) design, meaning both the cup of the pelvic component and the ball or head of the femur component are made of metal. When the joint moves, the metal cup and ball are in contact.
As these parts rub together, bits of the metal shear off. As this happens, patients who have these systems begin to suffer from what’s commonly referred to as metallosis. At the site, patients begin to experience pain in their groin and hip. This is caused by necrosis – death – of the surrounding tissue.
Metallosis Toxicity, Cancer Risk Eyed
But that’s not all. These patients also begin to show elevated levels of cobalt and chromium in their blood. No one is sure exactly what effect this will have on patients, but between this and the physical injury to the hip, patients must have "revision" surgery to remove the DePuy system and replace it with another.
As Stern points out, "The revision surgery is much more complicated" than an initial hip replacement. "The necrosis of adjacent tissue caused by the metallosis means the patient has a lot less of everything to which the replacement system can be attached."
The sad irony behind the physical tragedies these patients endure is that J&J aggressively marketed the ASR as a superior design that would last far longer than existing hip replacement systems. "It was aimed at younger, more active people as something that would last for 15 years," Stern says. This was very appealing to people who wanted to continue an active, healthy lifestyle, to play tennis, golf and other active pursuits. Instead, what they got was a physical nightmare and medical uncertainty.
The cases keep mounting. The DePuy ASR system shows a failure rate of 12-13 percent, which, according to Stern, is two-to-three times higher than other systems. And that’s just based on the data available today. The system was only approved for five years in the US, slightly longer elsewhere. As time passes, it’s expected the failure rate will increase.
Stern says 37,000 systems were implanted in patients in the US, and 93,000 worldwide. So as I said at the top, it only seems as though there’s no end in sight to this disaster. But since we know the total number of systems implanted, we also know the ultimate potential number of failures.
What we don’t know, Stern says, are the long-term effects of metallosis on the person as a whole. Now that the barn door’s been closed on new ASR implants by DePuy’s August, 2010 voluntary recall, those patients who’ve received them, their doctors, lawyers and epidemiologists are wondering if they’ll experience any toxicity or perhaps even cancers as a result of this exposure.
Another "Fast-Track" Device Approval Disaster
And the barn door is just the right metaphor for what the FDA and Johnson & Johnson have done in this case. The DePuy ASR system was approved via the FDA’s section 510(k) "fast-track" process. It was not clinically tested in humans prior to approval. The patients who received these implants were the ultimate crash test dummies.
The 510(k) process is under fire and will likely be overhauled. It allows a medical device to be approved based on its "substantial similarity" to an existing, approved device. The existing, approved device, called the "predicate," itself may have been approved by this process without clinical testing, and so on, without limitation, back to an initially approved device which was clinically tested for safety.
Now it appears that the predicate device for the ASR was DePuy’s own "Pinnacle" MOM hip replacement system. And the Pinnacle is now also subject to its own complex of lawsuits in federal court.
These hip systems are not the only devices to bring disrepute to the 510(k) process currently – or to bring disrepute to Johnson & Johnson. As we wrote last week, transvaginal surgical mesh marketed by another J&J subsidiary and rubber-stamped by the FDA under 510(k) is now going to pieces in women who’ve received it.
Complex Litigation to Determine Compensation
As claims mount, the earliest cases are proceeding in a complex process of "multi-district litigation." It’s not a class action but a process in which numerous individual cases are filed and consolidated for certain purposes, like discovery of certain issues and the winnowing of issues for trial. Stern says that certain cases are then agreed upon as "bellwether" claims and trial proceeds as to them. As the results of these trials appear, the plaintiffs and defendants can then come to agreement on the settlement of further claims. The process typically takes from two to six years, and since, as Stern notes, the initial claims are nearing the two-year mark, we could begin to have a clearer picture of what the victims of this mass tort can expect the outcome to be in the no-so-distant future.
DePuy Hip Replacement Helpline counselors are concerned about the mounting DePuy Hip failures. This has had a huge effect on our over 55 population. DePuy Hip Recall lawyers are accepting cases for victims of thge failed DePuy who hace been informed they need revision surgery. Lawyers are also accepting cases for Metal toxicity form chromium and coblt in huge toxic levels in the blood stream.