DePuy, a subsidiary of Johnson & Johnson, in August of 2010 issued a worldwide hip replacement recall for two of its devices. The ASR Hip Resurfacing System and ASR XL Acetabular System—the complementary ball and socket devices, respectively—have been determined to be defective and can “fail catastrophically.” Many recipients of an ASR device need to have a “revision” surgery to replace the implant.

With the recall, DePuy had seemingly accepted responsibility for the defects of its products, even promising to “cover reasonable and customary costs of testing and… including revision surgery if it is necessary.” Now, however, it appears that DePuy intends to blame the victims, possibly using information gathered by way of a “help line” to do so. In papers recently filed in California Supreme Court, DePuy asserts that recipients of the recalled ASR devices have been “negligent, careless, and at fault and conducted themselves so as to contribute substantially to their alleged injuries and damages.”

DePuy is asking recipients of a recalled ASR device to call its “ASR Help Line,” ostensibly so that a victim can be “assigned a claim number” and so that DePuy will be able to “process… reasonable out-of-pocket costs.” Yet, according to Rochelle Rottenstein of the Rottenstein Law Group, claimants should be wary of divulging any information on any such help line operated or sanctioned by DePuy. “Victims of DePuy’s malfeasance might find their candid communications to the ‘help line’ being used as admissions against them in court,” says Rottenstein. She notes that DePuy has no duty of confidentiality to people who call the help line and is free to use the information for the company’s benefit in litigation.

Letters sent by DePuy (or by doctors, at DePuy’s suggestion) to recipients of the recalled devices urge the recipients to call the toll-free help line. A caller to the help line is instructed to send certain documentation to Broadspire Services, a New Jersey-based insurance company. Rottenstein cautions potential claimants against calling the DePuy help line or sending documentation to Broadspire before speaking with a lawyer.

How do I know if my replacement hip has been recalled?

Here are additional resources you may be interested in:

• DePuy ASR Hip Replacement Lawsuit Information Center

• Why You Need a DePuy ASR Lawyer Now

• Five Things to Do Before Making a DePuy ASR Hip Replacement Claim

• Five Things to Know Before Suing DePuy/Johnson & Johnson

• What if my doctor hasn’t called me?

• Do I have a case if my replacement hip was recalled?

• Case Snapshot

• What if I’ve suffered no pain or discomfort?

• How did this happen?

• Rottenstein Law Group Heeds Latest Order in DePuy ASR Multidistrict Litigation

• Rottenstein Law Group Fears Many Recipients of Faulty DePuy Implant Still Unaware of Hip Replacement Recall

• Rottenstein Law Group Learns of DePuy ASR Hip Implant Failure Rate Much Higher Than Previously Reported

• Rottenstein Law Group Encouraged by DePuy/J&J Position, Admissions at Hip Recall Litigation Conference

• View all DePuy ASR Hip Replacement updates

Rottenstein Law Group Learns of DePuy ASR Hip Implant Failure Rate Much Higher Than Previously Reported

Posted on March 21, 2011 Source – click here

The Rottenstein Law Group has learned that DePuy’s ASR systems fail nearly half the time, a frequency much greater than previously publicized.

According to a recent Bloomberg article, “The British Orthopaedic Association and the British Hip Society said in a statement this week that data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.”

The orthopedic surgeon who serves as chairman of the groups’ expert advisory group on metal bearing hips told Bloomberg that “about 10,000 of the hips were implanted in the U.K., including 5,000 or so resurfacing devices and 5,000 of the ASR XL prostheses, also known as total-hip replacements.”

“Based on the results presented, the use of large diameter metal-on-metal bearings in primary total hip replacement should be carefully considered and possibly avoided,” the U.K. group wrote, as quoted by Bloomberg.
DePuy, a Johnson & Johnson company, recalled its ASR devices globally after the National Joint Registry of England and Wales made public data showing that, within five years, about 12% of recipients of the hip resurfacing system and about 13% of recipients of the acetabular system needed corrective surgery—data that now appears to be out of date.

Two weeks ago, DePuy announced that David Floyd, president of DePuy since 2007, had resigned his position “to pursue outside interests.” Floyd will leave after a short transition period. No replacement for Floyd has yet been named.

The DePuy ASR Hip Replacement Device’s Badly Designed Components

Posted on June 27, 2011 by Rottenstein Law GrouP, Source – click here

The August 2010 DePuy ASR recall came after the company reported 12-13% of patients receiving the product required a revision surgery to correct a failure of the device. These failures caused serious disruptions in the lives of the patients, as they result in an inability to carry on everyday activities without serious pain. The statistics have been talked about at length and the people who suffered due to the product’s bad design are well documented, but what is it exactly about the components of DePuy’s ASR that caused its repeated failure?

A hip replacement device is a complex mechanism but boiled down, there are two large components: the acetabular cup component, which replicates the “socket” part of the hip and the femoral component, which is attached to the end of the femur and fits into the acetabular cup while allowing for a fluid range of motion. Together the two components work together to synthesize a hip joint and if designed properly, hip replacement devices can be expected to last over 15 years.

The problem with the ASR starts with the acetabular cup component. Reportedly, the cup is too shallow, allowing for insufficient coverage of the ball at the end of the femoral component. In a typical hip replacement device, the ball fits deep into the socket, ensuring that it is firmly held in place. The shallow design of the ASR Acetabular Cup causes the ball to come loose much easier than if it were designed with the appropriate depth. This is allegedly the biggest reason for the high rate of failures in the device.

The ASR’s femoral component is not without fault in the product’s failure. Reportedly, the ball was designed to be too large given the size of the socket, which is essentially the same issue as the one previously discussed, just in the context of the head of the femoral component. An additional problem with the poor fitting of the ball and socket is that with more of the head exposed, it has reportedly caused corrosion to develop at the neck of the device which leads to metal particles to flake off and potentially causing the patient metal toxicity.

The ASR hip replacement parts recall that occurred in August 2010 has given those who have been harmed by the product’s failure an avenue for legal recourse. If you have suffered pain, loosening, or required revision surgery of your ASR device, fill out this contact form for a free consultation with a Rottenstein Law Group attorney regarding a potential ASR compensation lawsuit.

DePuy May Have Known About ASR’s Problems In 2007

Posted on June 6, 2011 by Rottenstein Law Group, Source – click here

It appears that DePuy could foresee the problems that were going to occur with regard to its ASR acetabular cup system long before the August 2010 recall of the device. On October 29, 2007, DePuy presented a slight change to its ASR system, which had initially been approved by the U.S. Food and Drug Administration (FDA) two years prior. Three spikes were added to the outer surface of the cup component of the hip replacement system for the purpose of “adjunct fixation.” This modification, much like the original ASR design, was granted FDA approval through the controversial 510(k) approval process, which requires no pre-market testing.According to the Section 510(k) summary, the new design is “identical in design to the acetabular cups cleared as part of the DePuy ASR Modular Acetabular Cup System in K040627 on August 5, 2005 with the addition of spikes on the outer surface of the cup.”

This indicates that for whatever reason, two years after the product was approved and released for sale, DePuy felt it necessary to add an additional measure to help the product fix itself to the bone. Given the high rate of failure that would come to light just a couple years later, one cannot help but question whether the company went far enough in remedying the problems with the device that were likely apparent at the time.

This is yet another condemnation of the Section 510(k) approval process. Companies like DePuy who release badly designed or harmful products have an avenue to make an attempt to put a band-aid on a product that should really be recalled. It is the near 50% of patients that received the ASR hip replacement device and suffered a failure within just a few years that have to suffer as a result.

Johnson & Johnson Reserves Almost $1 Billion for DePuy Victims

Posted on January 31, 2011

The Rottenstein Law Group has learned that Johnson & Johnson has set aside an amount close to one billion dollars to cover the costs, including compensation in the forms of litigation awards and settlements, stemming from the recall of defective hip replacement devices manufactured and sold by its subsidiary DePuy Orthopaedics.According to an announcement made this week by Johnson & Johnson, the company had sales of $15.64 billion for the fourth quarter of 2010. Worldwide sales for 2010 were reported at $61.6 billion.

Fourth-quarter 2010 net earnings included after-tax charges of $922 million representing money set aside to cover litigation settlements and awards and other costs associated with the DePuy ASR Hip recall.In August of 2010, DePuy announced a global hip replacement recall of two devices: the ASR Hip Resurfacing System and the ASR XL Acetabular System. Each unit replaces a worn or weakened part of the hip. Many orthopedic doctors believe that the units were poorly designed.

The implants can generate debris from wear, causing inflammation and tissue damage in recipients. 93,000 persons worldwide had an ASR device implanted.DePuy, a Johnson & Johnson company, recalled its ASR devices globally after the National Joint Registry of England and Wales made public data showing that, within five years, about 12% of recipients of the hip resurfacing system and about 13% of recipients of the acetabular system needed corrective surgery.In addition, it appears that DePuy’s other metal-on-metal implant line might also have significant design defects. Hundreds of lawsuits have been started by recipients of ASR devices; so far only a small number of suits allege fault with DePuy’s Pinnacle system, however.

Nonetheless, the United States Food and Drug Administration has received more than 500 negative reports about Pinnacle devices, most of them involving severe pain and/or doctors’ findings of metal ions shed by the devices into patients’ bloodstreams and surrounding tissue, according to data available at the FDA’s Web site.

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