[1] Reuters, "Biomet reaches $56 million settlement over faulty hip replacements" (February 3, 2014).
Biomet Inc. has agreed to settle a multidistrict lawsuit over its metal-on-metal hip replacement device M2a Magnum. The multi district litigation began in 2012 when hundreds of cases from courts across the country were consolidated at the federal court of Indiana, Biomet's home state. As part of the $56 million settlement, each qualifying plaintiff will receive a base award of $200,000. The agreement extends to all pending cases and any future lawsuit filed in a federal court on or before April 15, 2014.
[1] Reuters, "Biomet reaches $56 million settlement over faulty hip replacements" (February 3, 2014).
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As DePuy Pinnacle's metal-on-metal hip design is being phased out, lawsuits continue to be filed claiming that the grinding of metal components in the implant sheds metallic debris into the patient's blood stream, causing swelling, pain, metallosis, and other complications that require surgery to correct. Plaintiffs' attorneys argue that the DePuy Pinnacle model shares defective design qualities with the discontinued DePuy ASR hip implant. In 2013, a $2.5 billion dollar settlement deal was reached to settle claims arising from the DePuy ASR hip implant.
[1] Emison, Brett A. "DePuy Just Can't Shake Those Hip Replacement Lawsuits", Law360 (Jan. 27, 2014). [2] Meier, Barry "Johnson & Johnson in Deal to Settle Hip Implant Lawsuits", NY Times (Nov. 19, 2013). According to a Case Management Order issued on December 17th, Stryker Corp. has settled four lawsuits in New Jersey state court, where more than 500 lawsuits have been consolidated for pretrial proceedings. The settlements were made for an undisclosed amount of money. A recall on Stryker Rejuvenate and ABG II hip implants was announced in July 2012, affecting 20,000 patients worldwide. In addition to the 500+ lawsuits in New Jersey, Stryker faces an additional 400+ lawsuits in federal multi district litigation in U.S. District Court, District of Minnesota.
[1] In Re Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem Litigation, No. 296 (Bergen County Superior Court, New Jersey) [2] In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, MDL No. 2441 (U.S. District Court, District of Minnesota) Earlier this week Johnson & Johnson agreed to pay a $2.5 billion settlement to an estimated 8,000 patients who needed to have their defective DePuy ASR hip implants replaced. The typical payment for pain and suffering would be about $250,000 per patient. In addition, J&J has agreed to pay all medical costs related to the replacement of the implants. Typically, metal and plastic artificial hips are expected to last 15 years or more, but an internal J&J document estimated that the DePuy ASR model would fail within 5 years in 40% of patients who received it. The DePuy ASR metal-on-metal hip implants are no longer installed in patients, but J&J will likely have to make an additional settlement as the device fails in more patients.
[1] In re: ASR Hip Implant Products Liability Litigation, case number 1:10-md-02197 (N.D. Ohio). [2] Meir, B. "Johnson & Johnson to offer $2.5 billion hip device settlement," NY Times (Nov. 19, 2013). On July 6, 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems. "While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action," said Stuart Simpson, Vice President and General Manager, Hip Reconstruction. According to Stryker, these risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reaction, as well as possible pain and swelling. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records.
[1] FDA.gov, "Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems" (July 9, 2012). [2] Stryker "Modular Neck Stem Voluntary Recall Information" at www.AboutStryker.com/ModularNeckStems. On June 1, 2012 Smith & Nephew Orthopaedics initiated a market withdrawal for metal liners of the R3 acetabular system due to a higher than expected number of revision surgeries associated with the use of the device in total hip replacements outside the U.S. Smith & Nephew is recommending that physicians maintain their usual follow-up protocol for patients who have undergone total hip replacement or resurfacing surgery.
[1] FDA.gov, "Recalls Specific to Metal-on-Metal Hip Implants" Legal News: Wright Medical's CONSERVE® Hip Implant Cases Consolidated in Multidistrict Litigation3/1/2012 The federal judicial panel on multidistrict litigation issued an order consolidating cases against Wright Medical involving alleged defects of its CONSERVE® line of hip implant products. Most of the claims in the five consolidated actions focus on the metal-on-metal design of the CONSERVE® products and the alleged propensity of the devices to generate high levels of metal debris, cause metallosis, and/or fail early. The specific devices at issue include Wright's CONSERVE® Total Implant System, CONSERVE® Total A-Class Advanced Metal Hip Implant System, and CONSERVE ® Resurfacing System. The cases will be heard in the Northern District of Georgia by federal district court judge Hon. William S. Duffey, Jr.
[1] Order, In Re: Wright Medical Technology, Inc., CONSERVE Hip Implant Products Liability Litigation (MDL No. 2329) (February 27, 2012). [2] MDL Case Listings, U.S. District Court of the Northern District of Georgia, In Re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (1:12-me-2329-WSD). On Aug. 24, 2010, there was a voluntary recall of the DePuy ASR TM total hip system because of new, unpublished data from the UK joint registry indicating the revision rates within 5 years were approximately 13 percent.
[1] FDA.gov, "Recalls Specific to Metal-on-Metal Hip Implants" On July 22, 2008, there was a voluntary recall of the Zimmer Durom® Acetabular Component (“Durom Cup”) because the instructions for use/surgical technique instructions were inadequate.
[1] FDA.gov "Recalls Specific to Metal-on-Metal Hip Implants" |
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