View source for Medicine:2010 DePuy Hip Recall

The '''2010 DePuy Hip Replacement Recall''' was instituted when DePuy Orthopaedics, Inc., a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal [[Medicine:Hip replacement|hip replacement]] system on August 24, 2010.<ref name=withdraw>{{cite news |author=Barry Meier |title=With Warning, a Hip Device Is Withdrawn |url=https://www.nytimes.com/2010/03/10/business/10device.html?fta=y |quote=A unit of Johnson & Johnson, just months after saying it was phasing out an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. |newspaper={{wipe|The New York Times}} |date=March 9, 2010 |accessdate=2010-12-17 }}</ref><ref>{{cite news |author=Barry Meier |title=The Implants Loophole |url=https://www.nytimes.com/2010/12/17/business/17hip.html?scp=1&sq=hip%20j&J&st=cse |quote=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. |newspaper={{wipe|The New York Times}} |date=December 15, 2010 |accessdate=2010-12-17 }}</ref>
==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.<ref name=bberg>{{cite news|last=Farrell|first=Greg|title=J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say|newspaper=Bloomberg.com |date=9 March 2011 |url=https://www.bloomberg.com/news/2011-03-09/j-j-hip-replacement-failure-rate-may-be-49-u-k-orthopedists-group-says.html|publisher=Bloomberg|accessdate=24 February 2012}}</ref>  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, [[Medicine:Infection|infection]], [[Medicine:Bone fracture|fracture of the bone]], dislocation, metal sensitivity and [[Medicine:Pain|pain]]. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, [[Biology:Necrosis|necrosis]], [[Medicine:Swelling (medical)|swelling]], nerve damage, tissue damage and/or muscle damage.{{cn|date=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 {{wipe|Australia}}n implant registry.  In March 2011, ''{{wipe|The New York Times}}'' reported that DePuy issued its first warning to doctors and patients about the high early failure rate.<ref name=withdraw/>  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.<ref>{{cite web |title=Re: DuPay ASR Hip Cup (Cease and Desist Letter) |url=https://www.scribd.com/doc/36534618/Cease-and-Desist-Recall-letter-ASR-DePuy-Hip-Replacement |publisher=Kramer Levin Naftalis & Frankel LLP |date=April 1, 2010 |accessdate=12 November 2013}}</ref>
<!---Johnson and Johnson has experienced other recall issues this year and DePuy Orthopaedics was barely three years removed from a scandal that involved undisclosed payments to doctors.{{citation needed|date=February 2012}} --->

===Lawsuits===
About 93,000 persons worldwide received an ASR implant.<ref name=":0">{{Cite news|url=https://www.reuters.com/article/us-johnson-johnson-india/jj-to-work-with-india-on-compensation-for-recalled-hip-implants-idUSKCN1LN0HI|title=J&J to work with India on compensation for recalled hip implants|last=Kalra|first=Aditya|date=7 September 2018|access-date=8 September 2018|publisher=Reuters}}</ref> The first [[Social:Lawsuit|lawsuit]] in the United States against DePuy Orthopaedics was filed on June 15, 2010. 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 [[Medicine:Implant|implant]] early on but did not do anything to let patients or their surgeons know about the possible problems. The United States Judicial Panel on Multidistrict Litigation filed a ruling on December 7, 2010<ref>{{cite web|last=Hansen|first=David|title=IN RE: DePUY ORTHOPAEDICS, INC., ASR HIP IMPLANT PRODUCTS LIABILITY LITIGATION|url=http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197/10md2197TransferOrder.pdf|publisher=Panel on Multidistrict Litigation|access-date=2011-03-04|archive-url=https://web.archive.org/web/20110721065829/http://www.ohnd.uscourts.gov/assets/Clerks_Office_and_Court_Records/MDL/2197/10md2197TransferOrder.pdf|archive-date=2011-07-21|url-status=dead}}</ref> that determined the fate of the thousands of lawsuits regarding DePuy Hip Recalls in the United States. 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.  Discovery of documents from Johnson & Johnson and DePuy Orthopaedics has commenced.{{cn|date=January 2022}}

In 2014, Johnson & Johnson announced it would not withdraw a $2.5 billion global settlement. Settlements began at a base of $250,000. Johnson & Johnson continued to deny culpability. <ref>{{cite web |last1=Saunders |first1=Joseph |title=DePuy ASR Total Hip Replacement Settlement Update|url=http://www.saunderslawyers.com/depuy-asr-total-hip-replacement-settlement-update/|publisher=Saunders & Walker, P.A.|accessdate=17 July 2014|date=June 2014 }}</ref>

On March 17, 2016, United States District Judge Ed Kinkeade, after receiving the juries verdict, signed final judgment for Case# MDL Docket No. 3:11-MD-2244-K.  The  jury awarded five plaintiffs (3:13-cv-1071, 3:14-cv-1994,3:12-cv-1672,3:11-cv-2800, & 3:11-cv-1941) a combined award of $120 million against DePuy Orthorpaedics Inc, and a combined award $240 million against Johnson & Johnson.<ref>United States District Court Northern District of Texas Dallas Division Web-Site</ref>

== 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 {{Indian Rupee|2 million}} ({{US$|27,812}}).  J&J had previously provided {{US$|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.<ref name=":0" />
==References==
{{Reflist}}

== Further reading ==
* [https://web.archive.org/web/20100927181013/http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON082089 Medical Device Alert: DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty and total hip replacement], [[Organization:Medicines and Healthcare products Regulatory Agency|Medicines and Healthcare products Regulatory Agency]], MDA/2010/044, 25 May 2010
* [https://web.archive.org/web/20120510171315/http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON143782 Medical Device Alert: All metal-on-metal (MoM) hip replacements], [[Organization:Medicines and Healthcare products Regulatory Agency|Medicines and Healthcare products Regulatory Agency]], MDA/2012/008, 28 February 2012
* [https://web.archive.org/web/20110518152447/http://www.abc.net.au/4corners/content/2011/s3215297.htm 4 Corners Investigative Journalism report into ASR Hip Replacements], Quentin McDermott, 16 May 2011, Australian Broadcasting Corporation
* [http://www.abc.net.au/4corners/stories/2014/05/26/4010089.htm 4 Corners Follow Up Report on ASR Hip Replacements], Quentin McDermott and Peter Cronau, 26 May 2014, Australian Broadcasting Corporation

==External links==
* [https://web.archive.org/web/20120215175658/http://www.depuy.com/asr-hip-replacement-recall ASR Hip Replacement Recall site]

[[Category:Orthopedic surgical procedures|DePuy Hip Recall]]

{{Sourceattribution|2010 DePuy Hip Recall}}