Kransky v. DePuy—the first ASR
metal-on-metal hip implant trial-began on January 25th in Los
Angeles County. Loren Kransky received an ASR hip implant in 2007 and due to
severe adverse health effects underwent revision surgery in 2012. Revision
surgery is widely considered to be riskier than the original surgery and has a
longer recovery time as well. At this time there are over 10,000 lawsuits from
recipients of the ASR. On the first morning of the trial Co-Counsel Michael
Kelly walked the jury through the original ASR design, the lack of testing
prior to marketing and the extreme levels of harm suffered by the Plaintiff as
a result.
Risks of the ASR
Kelly referenced documents
which clearly reflected DePuy’s knowledge of the potential risks of the ASR—and
their lack of action or further studies regarding the implant. Graham Isaac, a
DePuy scientist sent an e-mail to other employees which in essence stated that
under certain conditions the ASR is susceptible to extreme metal ion levels.
Isaac stated in the e-mail “The concern, it has the potential to seriously
affect our business.” In other words, while there was concern that the
defective product could affect the financial bottom line, there was no evidence
of concern for the people who would be receiving the implants.
DePuy’s Counterclaims
DePuy and Johnson &
Johnson maintain that Mr. Kransky had an infection—unrelated to the ASR implant—and
that the infection was the only
reason for the revision surgery. The attorney for DePuy and Johnson &
Johnson stated that the cobalt and chromium in the ASR were not responsible for Mr. Kransky’s
problems. He further stated that the ASR was thoroughly tested and researched
and that Mr. Kransky’s illnesses and adverse medical conditions were due to a
history of smoking as well as kidney and heart disease and diabetes.
Safety Improvements Not Implemented
Kransky’s attorney then
introduced an e-mail from bioengineer Chris Hunt regarding the health hazards
of the ASR as well as introducing a deposition by Mr. Flett regarding Project
ALPHA. ALPHA was the code name for a re-design of the ASR which would make
certain changes which would increase the safety of the implant. One letter was
introduced which stated “a small improvement to geometry could represent a
large improvement for many patients.” Removing the groove on the ASR cup would
greatly reduce the friction experienced by ASR recipients to approximately
three times less than the original design yet these simple design changes were
not implemented, presumably because of financial considerations. Plaintiff’s attorney also introduced an
exhibit which clearly showed that the DePuy ASR failed its own safety test and
rather than make alterations to the device DePuy simply altered the test.
Metal Ion Backlash
In the early days of the
trial, a DePuy marketing executive, Randall Kilburn, testified regarding a marketing
team meeting in July of 2007 in Chicago. During this meeting a Power Point
presentation was show with a title of “What Scares us the Most in the Year
Ahead?” Of the nine items listed, “Metal ion backlash” was number one. Kilburn was asked if he was aware of the fact
that surgeons were complaining about excessive ion debris shedding from the
ASR. Kilburn answered, “When it was malpositioned, yes.” During the second week of the trial jurors
heard that a 2011 internal DePuy study showed that 35.8% of ASR hips failed
within four and a half years, requiring revision surgery for the recipient.
Testimony from Kransky’s Daughter
Despite the claims of Johnson
& Johnson and DePuy regarding other causes of his illnesses, Kransky’s
daughter, Jennifer Flynn gave a moving description of her father as a once
self-sufficient man whose health deteriorated rapidly after receiving a DePuyASR hip implant. Within three years of the implant, Flynn stated, her father
needed help bathing and using the bathroom and was soon in a wheelchair, living
in a nursing home with round-the-clock medical attention. When her father
initially complained of a metallic taste in his mouth Flynn’s first reaction
was that he was being poisoned. In response to DePuy’s defense that Kransky’s
other illnesses were the direct cause of the implant failure Dr. Robert
Harrison testified that the cobalt and chromium ions released into Kransky’s
body and bloodstream were the cause of the failure of the implant.
Harrison further stated that
Kransky’s normal white blood cell count and lack of fever during his surgery
clearly showed that it was not an infection nor underlying health problems
which necessitated the revision surgery rather the toxic metals. Graham Isaac,
the engineer for DePuy was asked whether he considered 50 plus micrograms of
cobalt to be a safe level he answered “that would be high.” According to the
California Poison Control any level of cobalt above 7 micrograms per liter are
considered harmful—Mr. Kransky’s levels were 53.6 on September 1, 2011—almost
eight times the “acceptable” level.
Managing Perceptions
Further into the trial, Plaintiff’s
counsel introduced an e-mail message dated May 2, 2008 from Paul Berman, head
of DePuy Marketing Department. The e-mail stated that while a cup redesign
would ultimately be required, the “short-term action is to manage perceptions.”
This same e-mail detailed the multiple
safety concerns regarding the ASR and noted that as an employee of Johnson
& Johnson & DePuy he did not feel comfortable with marketing the ASR.
The Kransky v. DePuy trial is
currently in its fourth week and on February 19th Loren Kransky
testified that he dreaded the revision surgery he had a year ago, however he
was in constant pain, unable to walk and believed he was being systematically poisoned
from the chromium and cobalt ions shearing away from the ASR metal hip implant.
Kransky-who had undergone 25 prior surgical procedures-believed the revision
surgery could kill him. Kransky stated “I’m going to die either way. One would
be slow and one would be fast. I took the lesser of two evils.” During cross
examination of Kransky, J & J attorney, Michael Zellers suggested that a
fall Kransky allegedly took prior to having the ASR implanted suggested balance
problems caused by Kransky’s other medical conditions. It is expected that this
trial may well set the tone for the thousands to follow. The MDL consolidated
Federal trials are set to begin in May, 2013 and July, 2013.
