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Product Recalls DePuy Orthopedics designed its ASR Hip Resurfacing System with a metal device as a substitution for

the human hip while its ASR XL Acetabular System was intended to address pelvic problems. Of the 93,000 implanted devices, 37,000 were used in the United States and have become the subject of litigation since the August 2010 recall.

DePuy ASR Hip Resurfacing System

In announcing the recall, Johnson & Johnson officials stated that U.K. researchers discovered that after five years, 13 percent of patients with complete hip replacements and 12 percent with resurfacing devices required a second operation. The company also noted that DePuys previous analyses of post-market data, which includes national joint registries, company-sponsored clinical trials, and internal complaints data, have shown lower revision rates. DePuy spokeswoman Mindy Tinsley says, DePuy remains committed to covering reasonable and customary costs of testing and treatment for patients who need services, including revision surgery if it is necessary, associated with the ASR recall. Tinsley also affirms that the company is satisfied that the process to address the issues raised by this litigation is moving forward. Plaintiff Executive Committee Based in New Jersey, Johnson & Johnson is the worlds largest health-care product company, but its Indiana-based unit of DePuy Orthopedics has recalled its hip replacement devices. This recall resulted from the findings of researchers, who discovered that some patients needed a second operation, or revision surgery, after five years. The rates of these revision surgeries were higher than the company had anticipated. Lawyers of patients expect thousands of claims over the ASR XL Acetabular System, recalled on 26th August 2010. A team of plaintiff lawyers will lead the federal litigation against Johnson & Johnson over these devices, and U.S. District Judge David A. Katz of Ohio appointed the plaintiffs executive committee on 26th January 2011 after dozens of lawyers vied for the positions. This committee will make the major decisions of the litigation, and all pretrial proceedings will appear before Judge Katz. The Judicial Panel on Multidistrict Litigation notes

that pretrial proceedings have been consolidated under Judge Katz in order to serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. Bay Area Litigation A construction worker in the San Francisco area brought a case against Johnson & Johnson and DePuy Orthopedics over his two Acetabular hip replacements. The retained counsel, based in Los Angeles, asserted, 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. The suit contends that the plaintiff suffered pain, swelling, inflammation, infection, and damage to surrounding bone and tissue, which resulted from defects with the hip replacement mechanisms. The claimant removed one of the devices a month before filing suit, leaving him unable to walk. This case belongs to the first wave of litigation over the hip products, which Johnson & Johnson recalled on 26th August 2010. This recall occurred merely two days after the U.S. Food and Drug Administration warned DePuy about selling two other hip replacement systems for unapproved uses. Brief Notes on Other DePuy Cases Court filings indicate that Johnson & Johnson and DePuy face similar suits in the state court in Los Angeles and the federal court in New Jersey. In Los Angeles, a plaintiff filed a claim, asserting that his body rejected the Acetabular hip replacement due to a design flaw that allowed metal to grind on metal. A woman from Roanoke, Virginia also filed suit against DePuy in the federal court of Newark, New Jersey, claiming that by the end of 2008, DePuy had received over 300 reports of ASR hip failures and were therefore fully aware that the product was defective. Sulzer AG Settlement In 2001, Switzerland-based Sulzer AG, the worlds second-largest maker of pumps, agreed to a $1 billion settlement of suits. These claims alleged that the hip and knee implants made by the companys former Sulzer Medica unit were defective.

Sulzer Medica Hip Implant

Sulzer Medica, a unit based in Austin, Texas, began recalling hip implants in January 2001, noting that the implants may loosen. Of the 31,000 patients who received implants, more than 2,700 have had them replaced while over 560 patients have had their knee implants replaced.

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