The
DePuy metal-on-metal hip implant, approved by the FDA a mere seven years
ago—has been inundated with over 8,000 lawsuits claiming the implant is
inherently defective and can lead to costly and painful revision surgery as
well as a myriad of other serious health issues. DePuy initially claimed the
failure rate of the ASR metal hip implant to be between 4-5%. When DePuy
voluntarily recalled the implant in 2010, they upgraded the failure rate to
approximately 12% within the first five years. Studies independent of DePuy or
Johnson & Johnson place the failure rate of the ASR metal implant at 50%
within six years and 80% within eight years. These staggering numbers almost
guarantee that this particular metal-on-metal hip implant will fail at some
point in the majority of recipients.
Nearly
a hundred thousand ASR devices were implanted worldwide prior to the recall
with nearly forty thousand in the United States alone. The propensity of the
implant to loosen and detach as well as the thousands of reports regarding
adverse health effects from high levels of chromium and cobalt have led to over
6,000 lawsuits filed in federal court an another 2,000 filed at the state level
in Maryland, California, Nevada and other states. Johnson & Johnson
recently settled three Nevada cases for $600,000—an amount considered to be at
the low end of the expected $200,000-$500,000 to settle each case.
These
three lawsuits were expected to go to trial in late 2012 and came from three
women, all over the age of sixty, whose surgeries were performed by the same
surgeon. Each woman had no choice but to undergo revision surgery—a procedure
which is not only extremely painful, but can require months of recuperation and
time away from work. One of the women reported excessive amounts of damage to
the surrounding hip bone as a direct result of the implant yet Johnson &
Johnson countered that the implants were not responsible for any of the
developing life-threatening illnesses. The research regarding the potential of
chromium and cobalt in the bloodstream to cause serious and life-threatening
illnesses is sadly lacking at this point in time.
It
is expected that when all DePuy cases are fully resolved the amount Johnson
& Johnson will be liable for will exceed $2 billion dollars although the
company has set aside approximately three billion in anticipation of additional
lawsuits. Three state trials coming from Maryland will be the first to see the
inside of a courtroom this January should they not reach a settlement agreement
prior to that date. The first consolidated federal trials are expected to begin
in March or April of 2013. A representative for Johnson & Johnson stated in
January that they have spent over $800 million dollars on the recall for the
ASR during the past two years. The representative declined to estimate the
current product liability costs.
DePuy’s
metal-on-metal hip implant has dealt with multiple design flaws in addition to
its potential to cause metal toxicity health problems when the metal ball and
cup rub against one another during normal everyday activity. This friction
causes small metal ions to shear off, lodging in the surrounding tissues or
entering the bloodstream. Those metal shavings often lead to serious infection,
inflammation of the joints and metal poisoning. Neurological, kidney, cardiovascular and
thyroid problems have been seen in those patients with the all-metal hip
implant as well as destruction of the soft tissue surrounding the implant. When
the implant fails, it can be very difficult to obtain a successful revision
surgery due to the dead tissue. This
leaves patients who believed their implant was safe with multiple physical
problems. While not medically documented, many recipients of the metal implant
have reported such symptoms as dizziness, the inability to distinguish between
sweet and salty foods, memory loss, skin disorders, gastrointestinal problems,
loss of balance, nerve damage and impaired liver function.
Although
the metal-on-metal hip implants are considered much more durable than the
metal-on-ceramic or metal-on-polyethylene implants fewer surgeons are choosing
to use the all-metal implants due to the surrounding controversy. In fact, the
use of metal-on-metal implants has dropped from an all-time high of about 40%
to less than 10% since the recall and subsequent FDA warnings. Many of the
lawsuits currently filed against DePuy and Johnson & Johnson claim there
was little or no warning regarding the potential dangers of the implant. The
total lack of adequate warning and concern for the health of implant patients
will likely end up costing Johnson & Johnson several billion dollars--yet
the health cost to recipients cannot be quantified in dollars.
