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The following are questions that are frequently asked by patients and families concerning the recalled DePuy ASR XL Acetubular Hip System.
Belt & Bruner presents these FAQs for general informational purposes only. If you have specific questions about your case, please contact us right away to speak directly with a lawyer and receive a free review of your case.
What is the DePuy ASR XL Acetabular System?
The ASR XL Acetabular System is a three-component hip replacement system. It comprises the:
- Femoral stem, which is inserted inside the femur
- Femoral head (or ball), which connects to the stem and fits inside the third component
- Acetabulum (cup).
A unique characteristic of the ASR XL Acetabular system is that it is a metal-on-metal device. This means that both the ball and cup portions of the implant are metal (cobalt and chromium).
What are common problems or symptoms associated with the DePuy ASR XL Acetabular System?
There are many complications that have been reported to arise from these recalled DePuy hip implants, including:
- Component loosening
- Component misalignment
- Bone fractures,
- Loss of muscle mass
- Hip, thigh and groin pain
- Difficulty walking or rising from a seated position
- Clicking sounds.
X-rays, MRIs and CT scans may also reveal the presence of metal debris, which can ultimately lead to inflammation of the surrounding tissue.
Who discovered problems with the DePuy hip implants?
Suspected defects in the ASR XL Acetabular System were first documented by the Australian National Joint Replacement Registry in early 2008. The evidence indicated a very high rate of failure concerning this device. Australia withdrew this device from the market in December 2009.
Researchers from a British study also reported problems with the metal-on-metal implants causing adverse soft tissue reactions resulting from the friction of the metal-on-metal surfaces. Patients in the study showed higher rates of wear and tear and soft tissue damage.
The U.S. Food and Drug Administration did not participate in a recall despite this information. Hospitals and hip surgeons in the U.S. had been warned about the defects of this device, but continued to use it until DePuy voluntarily recalled the product in August 2010.
Should I return to my physician if they contacted me about this DePuy hip implant?
In our experience, most doctors have been very supportive of their patients. They are ordering X-rays, MRIs, blood tests and bone density tests. These tests are important. However, we have also received several reports that certain physicians have only ordered X-rays, told their patients they were fine, and in at least one case, stated that the patient’s pain onset of complications occurred only when they received the recall letter. If you are unable to locate a physician who will listen to you, please let us know.
Should I sign the documents my doctor gave me?
If you are referring to a document prepared by DePuy, the answer is, “absolutely not!” There are different versions of this document, but they allow DePuy to obtain your medical records. In some cases, the document allows DePuy to obtain your defective device if it is removed. Your information will also be provided to DePuy’s adjusters handling hip implant claims.
Do I have to go back to my doctor for follow-up treatment to be covered?
No. In fact, a class action lawsuit has been filed against DePuy claiming that the company is misleading consumers in its correspondence with them on this issue and related issues. In that complaint, it is alleged:
“In our opinion, DePuy’s ‘offer’ may deceive potential claimants into believing that the company has actually agreed to advance or reimburse their costs for medical monitoring or revision surgery. In fact, no specific offer to pay medical costs has been made and no specific plan for reimbursement has been announced. Moreover, DePuy has stated that before reimbursement of expenses will be provided, it will review the patient’s medical records to determine if the patient meets DePuy’s criteria for payment. According to DePuy, the medical records must confirm that the revision is related to the ASR recall and ‘not some other type of cause, such as a traumatic fall.’ Blaming the device failure on a fall, or another cause, such as physician error, patient misuse, pre-existing condition or underlying diseases is a standard litigation defense in these types of cases. Thus a patient who releases medical records to DePuy may do nothing but provide DePuy with a jump start on litigation defenses.”
Letting DePuy dictate your care may cost you in the future.
In previous medical implant litigation handled by our firm, patients were offered free medical care. What they were not told was that the manufacturer paid the doctors the billing rate as opposed to the insurance, Medicare or Medicaid reimbursement rate, which is much lower. When it came time to settle their claims, the manufacturer demanded credit from the settlement for what they paid, which was three or four times what the insurance carrier would have paid. This is essentially a “carrot” used to keep some physicians happy.
What else do I need to know about the recalled DePuy ASR XL Acetabular System?
First, there is often a very close relationship between the makers of medical devices and the physicians who install them. Trips, seminars and catered lunches are not uncommon. Often, the physicians and their orthopedic reps, as they are called, have close personal relationships. There is no doubt that DePuy will seek to exploit this relationship (if it can be exploited) to obtain releases and medical records (to prepare its defense that the failure is unrelated). On the other hand, many physicians are patient advocates. Some have even advised clients to seek legal representation.
What should I do if I received a recalled DePuy ASR XL Hip Replacement?
Always consult your doctor regarding health-related issues that you have suffered after you received one of the recalled DePuy metal-on-metal hip implants. If you believe that you or someone you care about received a defective joint replacement component, the Belt & Bruner would like to speak with you right away.
DO NOT SIGN A RELEASE FROM YOUR SURGEON OR DePUY.
These releases could allow DePuy complete access to your medical records and allow them to obtain possession of the defective implant in the event it is removed.
So, what do I need to be doing after discovering that I have a recalled DePuy hip implant?
First and foremost, continue your treatment regimen. Additionally, consider keeping a journal. We have found this to be extremely helpful in representing clients. It will assist us in personalizing your claims when we ultimately present them for settlement or trial.
For More Information
- Metal-on-Metal Hip Implants, U.S. Food and Drug Administration
- J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say, Bloomberg News
- F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants, The New York Times
- J.&J. Unit Phasing Out All-Metal Hip Devices, The New York Times
- DePuy ASR Hip Replacement Recall Guide, DePuy Synthes