2010 DePuy Hip Recall

Recall of hip replacement implants The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010.Barry Meier With Warning, a Hip Device Is Withdrawn https://www.nytimes.com/2010/03/10/business/10device.html?fta=y A unit of Johnson & Johnson, just months after saying it was phasing out an artificial hip implant because of slowing sales, has warned doctors that the device appears to have a high early failure rate in some patients. The New York Times March 9, 2010 2010-12-17 Barry Meier The Implants Loophole https://www.nytimes.com/2010/12/17/business/17hip.html?scp=1&sq=hip%20j&J&st=cse A recently recalled artificial hip made by a unit of Johnson & Johnson, designed to last 15 years or more, is failing worldwide at unusually high rates after just a few years. The New York Times December 15, 2010 2010-12-17 Background The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients.Farrell Greg J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say Bloomberg.com 9 March 2011 https://www.bloomberg.com/news/2011-03-09/j-j-hip-replacement-failure-rate-may-be-49-u-k-orthopedists-group-says.html Bloomberg 24 February 2012 May 2024 Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.January 2022 At the beginning of 2011, DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2011, The New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However, at this point, they still had not issued a recall of the product. In fact, they claimed any statements referencing a recall were false.Re: DuPay ASR Hip Cup (Cease and Desist Letter) https://www.scribd.com/doc/36534618/Cease-and-Desist-Recall-letter-ASR-DePuy-Hip-Replacement Kramer Levin Naftalis & Frankel LLP April 1, 2010 12 November 2013 Lawsuits About 93,000 persons worldwide received an ASR implant.https://www.reuters.com/article/us-johnson-johnson-india/jj-to-work-with-india-on-compensation-for-recalled-hip-implants-idUSKCN1LN0HI J&J to work with India on compensation for recalled hip implants Kalra Aditya 7 September 2018 8 September 2018 Reuters Shine Lawyers commenced an Australian class action in the Federal Court of Australia on September 27, 2011, against DePuy International Pty Ltd and Johnson and Johnson Medical Pty Ltd. Both lawsuits claimed that the DePuy ASR hip replacement was defectively designed, that DePuy knew that there were problems with the implant early on but did not do anything to let patients or their surgeons know about the possible problems.May 2024 United States The first lawsuit in the United States against DePuy Orthopaedics was filed on June 15, 2010.May 2024 Through the multidistrict litigation process, the cases were centralized in different courts depending on the exact implant at issue. The United States Judicial Panel on Multidistrict Litigation (JPML) issued a ruling on December 7, 2010Hansen David IN RE: DePUY ORTHOPAEDICS, INC., ASR HIP IMPLANT PRODUCTS LIABILITY LITIGATION http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197/10md2197TransferOrder.pdf Panel on Multidistrict Litigation 2011-03-04 https://web.archive.org/web/20110721065829/http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197/10md2197TransferOrder.pdf 2011-07-21 dead that determined the fate of the United States lawsuits relating to the ASR XL Acetabular Hip System implants. Its ruling stated that all cases filed across the country "are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings." On January 26, 2011, Judge Katz entered an order in the multidistrict litigation naming the leadership counsel for both the plaintiffs and the defendants. Ben Gordon, Eric Kennedy, Ellen Relkin, Mark Robinson, Christopher Seeger, and Steven Skikos were named on the plaintiffs' Executive Committee. Robert Tucker and Susan Sharko were named as defendants' Co-Lead Counsel. January 2022 In 2013, Johnson & Johnson announced that it would pay $2.5 billion to settle claims related to the ASR XL implants globally. Johnson & Johnson retained an option to withdraw the settlement if too few claimants signed up, but in May 2014 it announced it would not withdraw the global settlement. Settlements began at a base of $250,000. Johnson & Johnson continued to deny culpability.Saunders Joseph DePuy ASR Total Hip Replacement Settlement Update https://www.saunderslawyers.com/depuy-asr-total-hip-replacement-settlement-update/ Saunders & Walker, P.A. July 17, 2014 June 1, 2014 Pinnacle implant litigation On May 24, 2011, the JPML centralized all cases relating to the Pinnacle Acetabular Cup System in the Northern District of Texas before judge James E. Kinkeade. Transfer Order https://www.txnd.uscourts.gov/sites/default/files/documents/311-md-2244_1.pdf May 24, 2011 United States Judicial Panel on Multidistrict Litigation John G. Heyburn II The Pinnacle litigation centralized in the Northern District of Texas proceeded to a series of bellwether trials for selected plaintiffs from different states. In a first trial with a single Montana plaintiff, the jury found for DePuy. https://web.archive.org/web/20160625191302/http://www.bloomberg.com/news/articles/2014-10-23/johnson-johnson-wins-first-pinnacle-hip-implant-trial https://www.bloomberg.com/news/articles/2014-10-23/johnson-johnson-wins-first-pinnacle-hip-implant-trial Johnson & Johnson Wins First Pinnacle Hip Implant Trial Bloomberg News 2014-10-23 2016-06-25 Jef Feeley In a second trial with five Texas plaintiffs, the jury awarded $502 million to the plaintiffs, consisting of $142 million in actual damages and $360 million in punitive damages. https://www.bloomberg.com/news/articles/2016-03-17/j-j-ordered-to-pay-502-million-over-pinnacle-hip-failures-ilwk16v4 https://web.archive.org/web/20160709162851/https://www.bloomberg.com/news/articles/2016-03-17/j-j-ordered-to-pay-502-million-over-pinnacle-hip-failures-ilwk16v4 2016-07-09 J&J Ordered to Pay $502 Million Over Pinnacle Hip Failures Tom Korosec Jef Feeley March 17, 2016 The judge reduced this to a total judgment of $151 million based on the Texas limitation on punitive damages. https://www.reuters.com/article/idUSKBN13Q5XE/ Reuters.com Johnson & Johnson hit with over $1 billion verdict on hip implants Erica Teichert December 1, 2016 In a third trial with six California plaintiffs, the jury awarded $1.04 billion to the plaintiffs, consisting of $30 million in actual damages and over $1 billion in punitive damages. https://web.archive.org/web/20161202124013/https://www.bloomberg.com/news/articles/2016-12-01/j-j-ordered-to-pay-more-than-1-billion-for-pinnacle-hip-device 2016-12-02 https://www.bloomberg.com/news/articles/2016-12-01/j-j-ordered-to-pay-more-than-1-billion-for-pinnacle-hip-device J&J; Ordered to Pay Record $1 Billion for Faulty Hip Implants 2016-12-01 Jef Feeley Tom Korosec India Of the total number of people receiving the implants, about 4,700 were in India. As of 2018, J&J committed to working with the Indian government to support all Indian ASR patients. In late 2018, an Indian government report, the accuracy of which has been disputed by J&J, proposed that each patient who had a faulty implant should receive a lump sum payment of 2 million (27,812). J&J had previously provided 2.25 million to cover diagnostic and surgical costs to patients with defective implants, but the Indian government was concerned that these monies included no compensatory funds. References Further reading Medical Device Alert: DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty and total hip replacement, Medicines and Healthcare products Regulatory Agency, MDA/2010/044, 25 May 2010 Medical Device Alert: All metal-on-metal (MoM) hip replacements, Medicines and Healthcare products Regulatory Agency, MDA/2012/008, 28 February 2012 4 Corners Investigative Journalism report into ASR Hip Replacements, Quentin McDermott, 16 May 2011, Australian Broadcasting Corporation 4 Corners Follow Up Report on ASR Hip Replacements, Quentin McDermott and Peter Cronau, 26 May 2014, Australian Broadcasting Corporation External links ASR Hip Replacement Recall site DePuy Hip Recall Category:Product recalls Category:Johnson & Johnson Category:Multidistrict litigation Category:United States District Court for the Northern District of Ohio cases