Recently, it was reported that five people close to the DePuy ASR MDL 2197 litigation confirmed settlement discussions. The leadership of the Executive Committee emailed the following statement to reporters: "The lawyers and leadership in the cooperating jurisdictions are working for the benefit of the 35,000 United States patients who have this recalled medical device. We have reviewed some 50 million pages of documents that have been produced and have taken over 50 depositions. At this time we have a significant number of trials set with the company and we are primarily focusing our efforts on trial preparation. Any comment relating to settlement that does not come from leadership, the Court, or from the company itself, is and uninformed."
The first case will start in Los Angeles on Tuesday, January 22, 2013. While it is part of the California proceedings, California leadership and the MDL leadership have been working cooperatively to develop evidence, witnesses and experts for this case as well as all cases across the country. Next month, another trial is set to start in Illinois which is also part of the cooperating jurisdictions. Judge Katz, who presides over the MDL, selected two plaintiffs' cases for trial. The first will occur in May in Toledo and the second will be in July.
Most of the ASR and Pinnacle hip cases have been filed in court and thousands are now pending in both large federal court actions in Ohio and Texas in many state court actions. No cases have gone to trial and the first of many trials is set for 2013.
We currently represent clients with products cases which involve two different types of metal-on-metal hips manufactured by DePuy, a subsidiary of Johnson & Johnson. The ASR model hip device has been recalled and the Pinnacle metal-on-metal hip also demonstrates similar problems of early failure and development of elevated heavy metals in the blood, called metallosis. We are pursuing metal-on-metal claims for clients who are having problems with either of these two metal-on-metal hips by DePuy.
ASR Hip Replacement Recall Background
In August 2010, DePuy Orthopaedics issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. These products were first available in July 2003 (for the Pinnacle), and 2005 (for the ASR). Any hip surgery performed prior to this date is not subject to a recall.
These recalled products are constructed entirely of metal. The metal-on-metal construction may result in metal debris flaking off and damaging the surrounding tissue. The presence of this metal may also cause increased cobalt or chromium levels in the joint, the kidneys and in the blood. Elevations of these elements can cause a variety of medical problems including necrosis or death of muscle and soft tissue plus neurologic and dermatologic issues.
1. What should I do if I’ve had a total hip replacement surgery since July 2003?
You should contact your doctor and find out whether your artificial hip was manufactured by DePuy, and, if so, if it is the kind that has been recalled. This information will be in your medical records, and your health care provider will let you know. It is wise to obtain copies of these medical records to confirm which implants you have and meet with an attorney to discuss your options. When you request this information also be aware that the important question to be answered is the model name of the specific acetabulum or cup and femoral component. A variety of different types of stems, including but not limited to Summit or Corail stems as examples, have been used with the ASR cup and Pinnacle.
2. What symptoms should I be concerned about?
Some symptoms that may indicate a problem include unexplained hip pain, difficulty walking, swelling or inflammation of the tissue surrounding the implant, or loosening or fracturing of the hip.
3. So what happens if my artificial hip is the DePuy product that was recalled?
If you do have the recalled DePuy hip, schedule an appointment with your doctor. Your doctor will want to examine you to determine if the implant is functioning properly. Some patients, the majority, in fact, seem to do well no matter what kind of artificial hip was used. You may need to have another surgery using a different artificial hip. Your doctor will probably want to continue to monitor you over time.
4. What kind of monitoring will my doctor do?
Your doctor may evaluate the level of cobalt and chromium ion levels in your blood or urine, as well as order x-rays, an MRI, ACT, or ultrasound scan. He may wish to draw some synovial fluid from your hip to determine if it has evidence of metal debris. If cobalt or chromium levels in your blood or urine exceed a predetermined amount, a second test may be scheduled three months after the first. If the other tests reveal soft tissue reactions, fluid collections, or tissue masses, your doctor may suggest a second surgery to replace the ball and socket or cup portion of the hip, the acetabulum, if not the whole unit. A normal x-ray may not rule out significant problems with this device so further testing is generally warranted.
5. I received a letter from DePuy asking me to sign a form allowing the release of my medical records to “service providers” – what should I do?
Do not sign this release form. You don’t want your medical information or your artificial hip device itself to be available to all different people and companies. In the wrong hands, your medical information may very well be used against you at some point. DePuy wants to lead you down a path to settle for the least amount of money possible. Don’t sign the form!
6. How many artificial hips has DePuy recalled?
The company has recalled 93,000 defective ASR hips.
7. Why is this product being recalled?
DePuy has acknowledged that the metal-on-metal ASR hip replacement system may fail within a few years after the surgery. Hip implants typically last 10-15 years.
These devices have an increased risk of problems. Research by various medical groups in Britain have determined these are failing within the first 60 months at rates any where from 12% to nearly 60% of the time. Fractured bones around the implant or dislocations are also possible. Additionally, with the metal-on-metal construction, it is possible that cobalt and chromium could flake off and get into your blood, kidneys, bones, and tissue. Elevations of these metals may cause a number of medical problems. It appears that patients with pre-existing kidney and diabetes problems may be at somewhat higher risk.
What if your hip is a metal-on-metal Pinnacle hip, not an ASR hip by DePuy?
The metal-on-metal Pinnacle hips manufactured by DePuy also appear to be failing at a higher rate than expected and these patients have similar problems with elevations of chromium and cobalt and require more early revision of their hips.
While these hips have not been recalled, there are hundreds of reports to the FDA indicating problems with the devices and there is a slight possibility they will be recalled in the future.
Given the widespread difficulties so many patients have experienced, you may wish to speak with an attorney about your Pinnacle hip if you are having increased pain, or such problems as dislocation. You may want to consult with your physician and have the same sort of monitoring described above, including blood tests for elevations of the heavy metals, cobalt and chromium, and such studies as x-rays, ultrasound and MRI. Again, a normal x-ray may not rule out a significant problem.
New literature is just coming out which shows the seriousness of health problems that can result from these metal-on-metal hips:
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