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DePuy Knew of Metal-on-Metal Hip Implant Safety Risks

DePuy Knew of Metal-on-Metal Hip Implant Safety Risks

For more information, please contact The Ahearne Law Firm, PLLC for a free initial consultation and case evaluation. Call nationwide at (845) 986-2777.

DePuy’s metal-on-metal hip implant woes continue.

MDL 2197 (IN RE: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation) is still pending in the Northern District of Ohio before Judge Jeffrey J. Helmick notwithstanding settlement whereby DePuy agreed to pay $2.5 billion to settle approximately 8,000 lawsuits by United States patients who had hip revision surgery as of August 31, 2013.

A fourth bellwether trial in MDL 2244 (IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation) in the Northern District of Texas before Judge James Edgar Kinkeade, which will involve 10 patients, is scheduled for September 2017. On December 1, 2016, in the third set of bellwether trials, a Texas federal jury awarded $40 million in compensatory damages and more than $1 billion in punitive damages to six plaintiffs who alleged that DePuy Orthopaedics Inc.’s Pinnacle metal-on-metal hip implants were defectively designed and that the company failed to warn doctors and consumers about complications possible from the device, which included pain and subsequent revision surgeries. Johnson & Johnson prevailed in the first bellwether trial in 2014, and the second bellwether trial in March 2016 yielded a $500 million jury award to five plaintiffs. The court ordered that $140 million would be applied to collective compensatory damages with $360 million being awarded in punitive damages. DePuy Orthopaedics and Johnson & Johnson recently appealed the decision.

Making matters worse for the manufacturer, a Daily Telegraph investigation recently exposed a series of previously unseen memos, reports and emails, obtained from DePuy, that raised questions about the safety of metal-on-metal devices.

A senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted. Thousands of patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear, known as metallosis, and were forced to undergo painful revision surgeries.

Dr. Graham Isaac, a senior engineer based in DePuy’s Yorkshire, UK factory, and now a “distinguished engineering fellow” at DePuy, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris. In his 1995 memo, Dr. Isaac examined data on metal-on-metal hips produced by rival companies:

It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory. Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”

He also quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.

The Telegraph’s investigation also revealed:

  • In 1995, a surgeon advising DePuy told the firm that “we need to be cautious of the legal/litigation issues, lawyers etc … perception of metal debris and metal ion release.”
  • Senior company figures were told in 2003 that one surgeon had already collected “a lot of bad data about metal-on-metal debris” in patients who had received DePuy implants;
  •  A 2005 report warned that risks to patients of metal-on-metal were “as yet undetermined” but “the risk to DePuy may be major in terms of product liability or business impact”;
  • An internal email in September 2008 acknowledged there were “growing concerns over metal-on-metal hips”. Surgeons needed “a high stability non-metal option”;
  • Tony Nargol, a surgeon based in North Tees, UK, repeatedly told DePuy from around 2008 about problems with its implants but was labeled an “outlier” and told his patients may simply have high volumes of metal in their blood because of a local “water supply problem”;
  • A report commissioned by the company in 2008 about the use of one of DePuy’s first metal-on-metal implants found that tiny particles released from the devices “have killed the bone” and soft tissues around the hip and “resulted in the tendons ripping away”.

Another major bombshell included a 2010 e-mail from John Irving, a U.S. orthopaedic surgeon, forwarded internally to DePuy’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued. The e-mail was included in documents read out in the Pinnacle MDL court.

#DePuy #JNJ #Pinnacle #ASR #hip #implant

If you or a family member have a hip implant, or have had revision surgery to remove and replace a hip implant, you and/or your family member may be entitled to money damages.

For more information, please contact The Ahearne Law Firm, PLLC for a free initial consultation and case evaluation. Call nationwide at (845) 986-2777.

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