Depuy ASR Hip Replacement System Recall
DePuy Orthopaedics Inc., a unit of Johnson & Johnson, manufactures the ASR Acetabular System which was approved in August, 2005 by the Food and Drug Administration. Since then, it has been implanted in approximately 48,000 individuals in the United States.
The Depuy ARS hip replacement system is one of several models sold by DePuy and is known as a “metal-on-metal” implant. While hip implants typically last 15 years
or more, many doctors reported that ASR implants failed soon after implantation in many patients; often within two years. Approximately 13 percent of people who had an ASR total hip replacement have needed to undergo replacement surgery within five years.
On August 26, 2010, DePuy recalled ASR XL Acetabular System and ASR Hip Resurfacing System, due to early system failures. (Note that the DePuy ASR Hip Resurfacing System was not approved for sale in the U.S.) These recalls affected approximately 93,000 patients worldwide.
In response to the DePuy ASR hip recall, a US senate committee convened for a special hearing on the 510(k) premarket approval process on April 13. At the hearing, the committee heard evidence that devices approved through 510(k) are more likely to be recalled than products approved through more stringent regulatory pathways.
Since that meeting, the FDA has taken the unusual step of asking about 20 orthopedic manufacturers to undertake studies on patients implanted with metal-on-metal hip implants.
If you or a loved one has been injured as a result of a recalled Depuy ASR Hip Replacement System, you may be entitled to receive compensation for your pain and suffering. Medical device manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them for use. Failure to do so or failure to make consumers aware of any potential problems may be grounds for personal injury litigation.
BROADSPIRE HAS BEEN HIRED TO USE YOUR MEDICAL RECORDS AGAINST YOU. REMEMBER, BROADSPIRE PROTECTS DEPUY, NOT YOU. BEFORE YOU RELEASE RECORDS CONSULT WITH AN ATTORNEY.
Broadspires Relation to Recalled DePuy ASR Hip Implants
Broadspire is a company that DePuy and Johnson & Johnson have hired to help them with the defective DePuy ASR hip implant recall. The stated purpose of Broadspire is to allow patients implanted with the defective DePuy ASR to have their out-of-pocket expenses paid for by DePuy. But, there is considerable risk in speaking with Broadspire: it could damage your DePuy ASR hip implant lawsuit.
Broadspire, DePuy, and Johnson & Johnson are not offering to pay the complete expenses related to having a defective DePuy ASR hip implant. Rather, their offer is only to pay the out-of-pocket costs, meaning that the patient’s insurance company (whether private, Medicaid or Medicare) will have to pay most of the costs.
To arrange for Broadspire to pay for out-of-pocket costs, DePuy requires patients to sign a medical authorization enabling DePuy to get access to the patient’s medical records-without the patient being able to track which records DePuy retrieves. When represented by an attorney, DePuy may only access the client’s medical records under the attorney’s supervision, ensuring that the client’s right of privacy is protected.
The result of signing Broadspire’s authorization is that DePuy gets unsupervised access to a broad swath of a patient’s private medical information. One purpose DePuy has in gathering those records is to find ammunition allowing it to argue that a particular patient’s DePuy ASR hip implant failed due to the patient’s biology or anatomy-and not because the ASR was defective. This could obviously damage a patient’s DePuy ASR hip implant lawsuit.
The patient gets almost nothing in return for jeopardizing his or her case by providing this information. DePuy often requires the patient to pay her out-of-pocket costs to the doctor, then decides whether it will reimburse the patient at a later time.
If you or someone you love received a Depuy ASR hip implant, you may qualify for compensation for physical damage, additional surgeries and your pain and suffering. Do not contact DePuy Orthopaedics, Johnson & Johnson, or Broadspire without first talking to an experienced DePuy hip recall lawyer with experience handling defective medical device cases nationwide. You should contact the Plymale Law Firm for a free consultation by filling out the form on this page or by calling us at (877) 328-7670.