In light of the evidence revealed in the ongoing litigation surrounding the ASR hip and transvaginal mesh products marketed by Johnson & Johnson’s Ethicon unit, it’s not surprising that the company is coming under more scrutiny.
New York, NY (PRWEB) February 23, 2013
Johnson & Johnson has announced that is facing new investigations into the company’s 2010 DePuy ASR hip recall, as well as its marketing of surgical mesh products used in hernia and urogynecological procedures. According to Bernstein Liebhard LLP, the company is already facing hundreds of product liability claims stemming from its 2010 DePuy ASR hip recall, as well as mounting litigation involving Gynecare mesh products marketed by its Ethicon unit that are used in urogynecological surgeries. In a recent regulatory filing, Johnson & Johnson disclosed that the U.S. Department of Justice “is investigating whether any person or entity submitted or caused to be submitted false claims or false statements affecting federal health care programs in connection with the marketing and use of the ASR XL Hip device.” The filing also disclosed that the company was contacted by the California Attorney General's office last October regarding a multi-state Attorney General investigation into the marketing of surgical mesh products.*
“In light of the evidence revealed in the ongoing litigation surrounding the ASR hip and transvaginal mesh products marketed by Johnson & Johnson’s Ethicon unit, it’s not surprising that the company is coming under more scrutiny,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently representing hundreds of people in claims stemming from the DePuy ASR hip recall, as well as Ethicon transvaginal mesh lawsuits.
DePuy ASR Hip Lawsuits
According to court documents, Johnson & Johnson and its DePuy Orthopaedics unit are facing more than 10,000 claims stemming from the 2010 ASR hip recall. The metal-on-metal hip implants were recalled after they were found to have an unacceptably high failure rate. Plaintiffs in DePuy ASR hip lawsuits allege the device can shed dangerous levels of metal ions into surrounding tissue and bloodstream, leading to early failure of the device and other health problems. Bernstein Liebhard is actively filing claims on behalf of individuals affected by the DePuy ASR recall in a federal litigation now underway in U.S. District Court, Northern District of Ohio. Bellwether trials in that proceeding are scheduled to begin this spring. (In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197).
The nation’s first trial involving a DePuy ASR lawsuit is currently underway in Los Angeles Superior Court. According to a report from The New York Times, evidence disclosed in the course of the Los Angeles trial included a 2011 Johnson & Johnson estimate that almost 40% of the ASR hip implants will fail within five years of surgery that was never disclosed to the public. It was also revealed that DePuy received numerous complaints from doctors regarding early failure of the device in the years leading up to the recall.** (Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles))
The U.S. Food & Drug Administration (FDA) is currently reviewing the safety of metal-on-metal hip implants like the ASR, in which the ball and cup consist of a chromium-cobalt alloy. Last month, the agency proposed an order that would make these devices ineligible for 510(K) clearance, which allowed such implants to come to market with no human testing. The FDA has also recommended that doctors consider metal ion testing for all-metal hip replacement patients who are experiencing symptoms of a failing implant, including pain, swelling, loosening of the implant, or change in the ability to walk.***
Ethicon Mesh Lawsuits
Hundreds transvaginal mesh lawsuits involving Ethicon’s Gynecare products are currently pending in both state and federal court. Bernstein Liebhard Partner Jeffrey S. Grand is serving on the Plaintiffs Steering Committee in In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (“ MDL No. 2327”), now underway in U.S. District Court, Southern District of West Virginia. In addition, Mr. Grand is serving as Co-Liaison Counsel in a consolidated litigation established for Ethicon mesh lawsuits in New Jersey Superior Court. (In re Pelvic Mesh/Gynecare Litigation, No. 6341-10)
The FDA has been reviewing the safety of transvaginal mesh devices since 2008. In June 2012, the agency warned that there had been a five-fold increase in reports of serious complications associated with the use of pelvic mesh. The FDA also modified its previous position on the frequency of such complications, stating in the alert that vaginal mesh injuries associated with pelvic organ prolapse repair were not rare. *** Johnson & Johnson’s Ethicon unit announced in June 2012 that it would stop selling four Gynecare transvaginal mesh products, including Gynecare TVT Secur System, Gynecare Prosima Pelvic Floor Repair System, Gynecare Prolift Pelvic Floor Repair System, and Gynecare Prolift+M Pelvic Floor Repair System. The company stated that the action did not constitute a recall, and asserted that sales of the Ethicon mesh products were being ended for commercial reasons, and not due to safety concerns.****
Victims of complications stemming from DePuy ASR hips or Ethicon mesh devices may be entitled to compensation for their medical bills, lost wages, pain and suffering and other damages. For more information about these legal proceedings, please visit Bernstein Liebhard LLP’s website, http://www.consumerinjurylawyers.com/. Free consultations may be obtained by calling the Firm at 1-877-779-1414.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP