Having hip replacement surgery is not an easy surgery to endure or recover from, and requires months of rehab afterward for the patient to have a chance to return to normalcy. So can you imagine what it would be like to be told the hip replacement surgery must be repeated because of a hip replacement recall? I can’t!
But shockingly one out of 10 of the 93,000 patients worldwide (40,000 in the U.S.) implanted with the DuPuy ASR Hip Implant have had to have the hip replacement surgery repeated because the implant failed. And other studies suggest up to 30 percent will experience hip implant failure that will require revision surgery.
More recent data suggests that up to 50 percent of patients implanted with the ASR device in the United Kingdom may require hip replacement surgery. But it gets even worse. What shocks me even more is DePuy’s cavalier attitude toward its errors and the impact on patients implanted with its device.
After receiving findings that its ASR hip implant was faulty, DuPuy actually waited a year before sending out a warning on March 5, 2010 to American surgeons that its implant had a higher than expected failure rate.
Worse yet, the warning letters were not sent to American surgeons until three months after DePuy voluntarily withdrew its hip implant from the Australian market in December 2009. DePuy continued to promote and sell its faulty hip implant in America for six months after the Australian withdrawal before finally recalling the ASR hip implant in the U.S. in August 2010. What’s with that? You can easily see that DuPuy values its profits more than it is concerned over patients’ pain. http://www.cochranfoley.com/hip_replacement_recall.html
Most hip replacement surgeries are performed on elderly patients who are susceptible to deep vein thrombosis, implant dislocation, shortening of the leg, systemic infection, injury to the arteries or nerves of the leg, intractable pain, and permanent loss of range of motion.
DePuy Orthopedics, a division of Johnson & Johnson, obtained FDA approval in 2005 for its ASR hip implant, choosing to use a shortcut process that does not require clinical trials to be held. And even though the ASR hip implant was said to last 15 years or more it was recalled in only five years after being introduced on the U.S. market.
Not only were clinical trials of the ASR device not required but current FDA rules allow companies like DuPuy to determine when safety alerts about implants are issued or when bad products are withdrawn from the market. Clearly, implant devices should be held to the same requirements to obtain approval as prescription drugs are but the FDA does not see things as clearly as you and I and the common man does.
Anyone who has had a hip replacement in the past six years should contact their doctor to see if the DuPuy ASR device was used. If so, the doctor may want to order blood tests to see if metal breakdown has started and to determine chromium and cobalt levels. Common indications that the replaced hip may be faulty include: pain in the groin, hip or leg; a limp or change in walking ability; swelling at or near the hip joint.
Anyone who has been notified that they need revision surgery because their DuPuy ASR replacement has failed should absolutely not have the surgery done without first consulting an attorney who specializes in medical malpractice and medical product liability. Do not sign a consent form for surgery to remove and replace a DuPuy device without legal advice.
A lawyer specializing in medical malpractice or medical product failure, such as the lawyers on my staff, will strongly advise that our client provide the surgeon with written instructions about saving tissue samples and keeping the ASR devise after it is removed. It is critical that the surgeon receive these instructions before surgery.
There also are risks associated with surgery to replace a failed device. A 56-year-old former IBM employee from Illinois remains on disability and still must walk with a cane a year after having her ASR hip replaced. Tragically, this lady received her hip replacement surgery in 2007 ‘” the same year that ASR failures in Great Britain were reported to DuPuy who then kept the information from American surgeons.
Companies that manufacture medical products and devices, such as DuPuy, are expected to exercise the same standard of care that we expect from our surgeons, physicians and drug makers. When medical manufactures do not exercise due care and fail to take reasonable actions to prevent harm, they can and should be held liable.
Patients who are suffering from a failed hip replacement need to send a clear and strong message to DePuy that they will pay dearly for continuing to sell and promote on the American market a product they clearly knew was defective. That kind of arrogance should not be tolerated and is a justifiable reason to seek justice from the courts.
For more information about legal representation contact the law office of Cochran, Foley & Associates at 800-322-5543 or http://www.cochranfoley.com/hip_replacement_recall.html
About Terry Cochran:
Terry Cochran is senior partner in Cochran, Foley & Associates, P.C., a Michigan law firm specializing in personal liability, medical malpractice, and SSD/SSI appeals. Cochran, who is licensed in Michigan and Texas, does not represent insurance companies or corporations but instead bases his practice upon representing individuals and families. http://www.CochranFoley.com 800-322-5543 or visit: http://www.cochranfoley.com/hip_replacement_recall.html