Late last year, the DePuy ASR XL Acetabular hip device claim was consolidated for pre-trial purposes in the northern district of Ohio before an experienced judge. Shortly afterward, the court picked a leadership group counsel and plaintiffs' steering committee to assist in the prosecution of the case. "Since that time litigation has moved forward in a systematic way to uncover facts of the case and prepare the facts for trial," says Becker.
Becker says that the entire DePuy ASR case—or for that matter any metal-on-metal case—is really about evaluating and trying to figure out what is causing cobalt and chromium to be released into the bloodstream. Some experts theorize, as do many ASR recipients—that the cause is a wear issue, i.e., the metal ball and the metal cup slide against each other during movement, which can cause minute metal particles to wear off of the device and enter into the space around the implant. "These metal ions in the body can accumulate in the bloodstream and attack the muscle, effectively eating the muscle from the inside out," adds Becker. This condition is known as metalosis, which causes severe pain and damage to the surrounding tissue.
What degree of severity warrants a claim against DePuy—must you be diagnosed with metalosis to file a lawsuit? Becker is working with clients who have a broad range of complaints, ranging from pain to catastrophic failure that has resulted in metalosis. "If my clients are having problems with their ASR device, I tell them they may have a claim," explains Becker. "Certainly if you are contemplating revision surgery (particularly if your doctor recommends it), or your blood tests indicate high levels of cobalt and chromium, in my view you have a claim. And you have a good opportunity to pursue a recovery.
"The first thing I tell people who contact us is to make sure they are in communication with their doctor. Most orthopedic surgeons are aware of the problems associated with ASRs and are extremely sympathetic with their clients." Some doctors, however, are not so familiar with these problems and could tend to dismiss their patients, possibly interpreting their patient's complaints of hip failure as a potential medical malpractice suit. Becker says this is not typically the case.
"We don't view these cases as medical malpractice at all," he says. Peer-reviewed literature suggests that the ASR is a design problem on a few levels. First, it is a very hard device to implant; evidence suggests that even DePuy's consultants were having problems implanting correctly, which leaves a very small window for error. "Frankly, I think DePuy, to its credit, notified doctors of this problem early on and I think most doctors in these cases are willing to work with their patients because they also have issues," says Becker.
Second, Becker does exhaustive workup of the client's current medical condition. "We find out where they are on the pain scale and whether they have had blood work," he explains. " We ask if they have had, or have scheduled, a revision, and that is very important: We want to see clients—whenever possible—before their revision surgery because it gives us time to obtain the device that is being removed; we can then communicate with the surgeon and defense counsel so that evidence is not contaminated, and make sure it is removed properly."
Some people may have had revision surgery and didn't keep their original device. Perhaps they didn't ask their doctor to keep it. Are patients entitled to ask for their hip replacement device? Becker says that isn't an easy question but "retaining the devices in these cases are important and that we try to obtain them where possible.
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"If you had a revision a few years ago, it is a tougher call; the device may or may not be around. But we can still identify your device. When you go into surgery there is an ID badge or sticker that goes into your medical record on the surgical notes report. We can review and determine devices based on patients' medical records."
"We need to be careful with the metal-on-metal hips that are failing because when you start releasing these ions into the body, you can get nasty results—it is something we want to be mindful of. And we are actively working to push the cases to trial."