A jury in California has ordered DePuy to pay the sum of $8.3 million dollars in compensation to Loren Kransky after finding that the company defectively designed his ASR XL hip replacement device. Mr. Kransky was one of the thousands of people around the world who had received a DePuy ASR hip replacement system.
In August 2010 DePuy Orthopaedics Incorporated, a Johnson & Johnson subsidiary, issued a global recall of their ASR hip replacement systems. Prior to the recall an estimated 93,000 of these hip replacement devices had been implanted in patients worldwide. Augustus Cullen Law are currently acting for a number of clients who have experienced adverse outcomes following the use of the DePuy ASR systems in their hip replacement surgery and we have a number of cases which are now at an advanced stage before the Irish Courts.
It is estimated that DePuy are facing over 10,000 claims as a result of defects in its ASR hips. The focus in this litigation to date has been in the United States where over 7,000 cases have been consolidated for trial in federal court in Toledo, Ohio. The first of the Ohio trials is listed to commence in May 2013. However, Mr. Kransky’s trial, which took place in Los Angeles, California, is the first to have come before the courts.
In this case Mr. Kransky sued DePuy in relation to an ASR XL Acetabular System which he had implanted in 2007. He claimed that DePuy were negligent in their design and manufacturing of the implant and in their failure to warn of the risks associated with it. He stated that debris from the metal components of the implant caused metal ions to enter his bloodstream and that these metal ions effectively poisoned him. He underwent revision surgery in February 2012 to have the DePuy implant removed and replaced.
DePuy staunchly defended this claim and as a result Mr. Kransky’s legal team called extensive evidence over the course of the trial which ran for some five weeks. Much of this evidence was garnered from DePuy’s own internal documentation which they had to disclose pre-trial. The evidence indicated that DePuy were aware from as early as 2005 that there were problems with the ASR devices. In fact, an e-mail from an Irish marketing official in June 2005 was specifically referred to in the course of the trail. It stated that the marketing official was even at that early stage “quite concerned about our failure rate”. Further emails show that a prominent Dutch surgeon decided in 2006 that he would not use the ASR devices anymore due to significant failures.
In e-mails in 2008 Mr. Paul Berman, DePuy’s head of U.S. Marketing, stated that “We will ultimately need a cup redesign but the short-term action is to manage perceptions”. In March 2010 Mr. Berman wrote an e-mail to a colleague which stated “I want to reiterate my concerns with the safety of the ASR platform…I still remain concerned with the safety of this product…As a marketing professional, I do not make product safety decisions, but I do have an obligation as an employee of J&J and DePuy to make known when I do not feel comfortable”.
DePuy employees also gave evidence regarding the design and manufacture of the implants as well as in relation to safety concerns. Mr. Jimmy Smith, who in 2011 oversaw a review of the design team’s safety standards for the ASR hip cup, gave evidence that his audit found that a DePuy group used irrelevant controls in a failure mode and effect analysis before the ASR was sold in the US in 2005. Mr. Graham Isaac, an engineer with DePuy in Leeds, was questioned as to why testing of the device was only carried out at one optimum angle of implant and confirmed that he believed the testing carried out was adequate.
Mr. Isaac was also questioned on internal DePuy e-mails regarding the decision of another Dutch surgeon to stop using the ASR systems due to significant failure rates. The internal DePuy e-mails stated that this doctor’s statement “is a huge problem for us as all other ASR users will listen to him”. Mr. Isaac could not recall whether DePuy’s vigilance and compliance committee was ever informed of these concerns. Similar internal emails were referred to in relation to concerns raised by a number of other surgeons who had been using the ASR systems. One 2009 e-mail from a surgeon in Northern Ireland stated “This ASR problem has to date been the worst problem I have had in my surgical career –it has been a real nightmare – I am still seeing at least one patient for revision at every problem clinic”.
It is certain that the outcome in this trial and in the Ohio trials which are due to commence shortly, will have a major bearing on how DePuy will deal with the thousands of other outstanding cases against them.
If you have been suffering as a result of receiving a DePuy hip implant please contact any of the following solicitors in our medical negligence group:
13 March 2013