A recent CBS Investigative Report found that a "majority of medical implants are not [sufficiently] tested" before they are implanted. In fact, many devices are allowed onto the consumer market after some minimal testing, routine paperwork, and a paid fee of about $4,000 to the Food and Drug Administration (FDA).
One of the products streamlined by the "fast-tracked" FDA approval process : metal-on-metal hip implants. According to the report, these metal-on-metal hip implants were one of many medical products approved after minimal clinical trials, then tested on unsuspecting patients before health risks were known. Michael Carome, deputy director of the patient advocacy organization, Public Citizen's Health Research Group, said in a statement that, "This is one very large uncontrolled experiment exposing millions of patients to an unknown risk."
Last Updated (Tuesday, 17 July 2012 02:53)
Depuy advises that approximately 93,000 patients worldwide have received Depuy ASR Hip System components. Depuy has stated it "intends to cover reasonable and customary costs of testing and treatment for patients who need services, including revision surgery, associated with the ASR recall. DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs."
Depuy Communicating with Doctors
Depuy is actively communicating with surgeons using the ASR hip device and has hosted surgeon-focused webcasts and distributed ASR recall information, including letters Depuy has asked surgeons to send to their patients.
Depuy ASR Reimbursement Process
DePuy hired several law firms and a third party reimbursement company to defend and assist the company in legal claims and reimbursement requests. The third party reimbursement company evaluates ASR recipient claims and considers whether to reimburse ASR patients for certain costs or expenses incurred in the event or revision surgery and treatment. In the case of Insured ASR Patients, DePuy has directed patients "to submit the costs of their testing and treatment to their insurer for coverage as they normally would. DePuy will then work with the insurer through established channels to handle reimbursement." In the case of Uninsured ASR Patients, DePuy has directed patients to collect surgeon or doctor bills and "submit claims for reimbursement of medical services."
Our Office Successfully Assisting Clients With Reimbursement
Our office has successfully helped numerous insured and uninsured clients secure payments, reimbursement, and revisions surgery costs. If you are in need of assistance concerning reimbursement, promptly contact our Depuy reimbursement coordinator to quickly assist you in initiating your reimbursement or payment for revision surgery.
Last Updated (Tuesday, 17 July 2012 03:05)
A motion was filed in the federal courts for national coordination of all DePuy hip implant lawsuits after the filing of the country's first hip implant claim in California. The lawsuit followed the recall of the DePuy ASR hip implant device. Johnson & Johnson recalled the two implants last year after many patients required a second surgery to correct problems. The recalled units, manufactured by Johnson & Johnson's DePuy Orthopaedics unit, include the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. More than 93,000 patients purchased the implants before the recall. Lawsuits have been filed in nearly every state, claiming that DePuy and Johnson & Johnson have known since 2007 that the hip implants were prone to fail based on a faulty design that causes metal-on-metal contact. Initial studies have shown that more than 10 percent of DePuy implant recipients required corrective surgery within five years.
UP TO 50% OF DEPUY ASR HIP DEVICES MAY FAIL IN NEXT SIX YEARS, ACCORDING TO RESEARCHERS
New evidence presented this month by a British researcher indicates that the DePuy hip implants could have a failure rate as high as 50 percent within the first six years. Consolidating this massive litigation allows thousands of faulty hip implant victims to have their cases handled more quickly and efficiently. The judge ordered this step in the proceedings, and many consumers hope to move toward resolving claims involving faulty or fractured devices, revision surgery, loss of income and other injuries.
To speak directly with one of the lawyers who filed the first case in the United States following the recall of the DePuy hip device, please call us at (866) 875-2262 or contact us using our online form.
Unlike new drugs that must go through clinical trials before getting FDA approval, some implants can be sold without the tests if it resembles an implant already in use, the story says.
Enter the Articular Surface Replacement, a hip replacement device made by DePuy Orthopaedics, a unit of Johnson & Johnson.
Many patients who have received the implant claim to have developed curious pain, and surgeons who have replaced the implant say they have found mysterious masses of dead tissue near patients' thighs. Some patients allege that they have high levels of cobalt ions in their blood, prompting them to fear they risk poisoning themselves.
Predictably, the lawsuits are lining up. Recently, the U.S. Judicial Panel on Multidistrict Litigation consolidated the suits and shipped them off to the Northern District of Ohio.
One suit, filed by California attorney Dana Taschner, alleges DePuy should have known its hip replacement devices fail in a high percentage of patients.
"Such failures have been shown to give rise to symptoms such as severe pain, inflammation and death to surrounding tissue and bone, a partial or complete lack of mobility, and the need for revision surgery to remove and replace the device giving rise to even more debilitation, a prolonged recovery time, and an increased risk of complications and death from further surgery," the suit says.
Did you know that every year there are 200,000 to 300,000 U.S. citizens (primarily over the age of 60) who undergo hip replacement surgery? Usually, the people who decide to undergo the operation have been dealing with severe joint pain for years. This chronic pain can destroy a person's way of life by preventing them from enjoying what they used to enjoy most – morning walks with their spouse, playing in the backyard with their grandchildren, fishing, golfing, etc.
Although surgery is difficult, many times it is the only option. Hopefully, after the 1 ½ - 3 hr surgery, 5-10 days in the hospital after the operation, and up to ten weeks of intense physical therapy and rehabilitation, the patient may be able to walk again without pain. Patients have enough to worry about between the surgery, recovery, and possible long-term and short-term risks associated with the operation (such as blood clots, infections, dislocation of the prosthesis, change of leg length, etc.), to worry about another complicated surgery afterwards if the hip replacement doesn't properly take or deteriorates.
Unfortunately, close to 93,000 individuals who have received a hip prosthesis from DePuy Orthopedics Inc., a subsidiary of Johnson & Johnson, may be in need of revision surgery. Two of DePuy's orthopedic products, the ASR Hip Resurfacing System and the ASR XL Acetabular System, were recalled on August 26, 2010, after data from the National Joint Registry revealed that one in every eight people with these systems required a follow-up revision surgery.
If you or a loved one has received a hip implant recently, or within the last 5 years, and have experienced pain, swelling, or problems walking, you may want to consult your doctor to verify the prosthesis used.
Last Updated (Tuesday, 17 July 2012 03:23)
On Thursday, August 26, DePuy Orthopaedics Inc., part of Johnson & Johnson, announced that it would be initiating a recall on two hip-replacement products, the ASR Hip Resurfacing System and the ASR XL Acetabular System, due to new data from the National Joint Registry (NJR) of England and Wales which shows higher-than-expected rates of a patients need for a second hip replacement, also known as a revision surgery, following use of their product.
In addition, the data from the National Joint Registry (NJR) also states that within five years, one in eight patients needed a revision surgery, which translates to a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System.
Johnson & Johnson was sued by a California construction worker over an implanted hip-replacement device that the drugmaker stopped selling last month after defect reports surfaced.
Officials of J&J's DePuy Orthopaedics unit knew for years many of the 93,000 patients with ASR hip implants required corrective surgeries due to the mechanisms' defects, lawyers for Maurice Brigham said in their lawsuit. Brigham, a heavy- equipment operator, received two implants in 2007, the suit said.
"For more than two years, defendants have known the ASR Hip Implant Devices were failing early and causing harm in a high number of patients," Brigham's attorneys said in the suit, filed earlier this week in federal court in San Francisco.
The recall last week came just two days after U.S. Food and Drug Administration officials warned DePuy about selling two other hip-replacement systems for unapproved uses. DePuy generated more than $5.4 billion in sales last year, according to court filings.
DePuy Hip Recall Legal Conference Announced
Leading lawyers and experts from around the country will gather on November 3, 2010 in Miami to discuss the Depuy Hip Recall Litigation ramifications and the medical issues surrounding the DePuy hip implant recall.
Topics to be discussed at the conference, relating to the recall, include an overview of DePuy - its place within the corporate structure of Johnson & Johnson, its own management structure, and its recalled product– as well as the damages incurred by the faulty hip implant, and possible settlements. The defective hip implant's impact upon individuals worldwide, the response litigation attorneys should have in handling such medical claims, and strategies for improving government response to these issues will also be topics of discussion.
Last Updated (Tuesday, 17 July 2012 03:21)
A growing number of lawsuits are being filed in response to the DePuy hip recall issued in August 2010 for thousands of defective metal hip implants. Lawyers representing individuals throughout the United States are planning to meet in Durham, North Carolina on November 17th to discuss issues that are likely to arise in the DePuy ASR hip litigation.
DePuy Orthopaedics recalled approximately 93,000 ASR XL Acetabular System and ASR Hip Resurfacing System implants in August, after data confirmed that about one in every eight people who received the DePuy metal-on-metal hip implant are experiencing problems within five years. Unfortunately, the true failure rate with DePuy ASR hip implants may be substantially higher as individuals have their artificial hips examined following the recall.
While a handful of DePuy ASR hip replacement lawsuits were filed prior to the recall, the litigation is increasing dramatically as more and more hip patients learn about the recall and hire a DePuy hip recall lawyer to represent them.
The U.S. Judicial Panel on Multidistrict Litigation will take oral arguments on a motion to centralize all federal DePuy ASR recall lawsuits before one judge for pretrial proceedings on November 18. At that time, the MDL Panel will hear from plaintiffs' attorneys and lawyers for DePuy and decide whether the cases should be coordinated as part of an MDL, and which judge should be assigned to preside over the DePuy recall lawsuits.
Last Updated (Tuesday, 17 July 2012 03:21)