When consumer health issues
such as metal poisoning and metallosis are potential consequences of a recalled
metal hip implant, the costs to the manufacturer can be substantial. Stryker
Corp, the manufacturer of the recalled Stryker ABGII and Rejuvenate hip implant
devices, has increased the original estimates of $190-$390 million to over $1.1
billion for expenses related to the July, 2012 recall. Of course the ultimate
cost will depend on a variety of factors, including the number of Stryker
lawsuits, the amount of the settlements and the costs of revision surgery and
other treatment for victims of the recalled hip implants.
Over 400 lawsuits are pending
in a Minnesota Court under U.S. District Judge Donavan Frank, with over 600
more pending in state court in New Jersey. Consolidation of product liability
cases is common in order to avoid conflicting pretrial rulings from many
different judges as well as to allow sharing of discovery. Johnson &
Johnson is estimating over $3 billion in settlement costs for the DePuy ASR
metal hip device for the over 10,000 lawsuits filed in response to the recall. With
time left for most states under the statute of limitations, it is likely many
more Stryker lawsuits will be filed.
Metal poisoning symptoms occur
when the hip device suffers corrosion, leading to the generation of microscopic
metal ions which enter the bloodstream. Such serious health issues as loss of
hearing and vision, memory loss, vertigo, neurological disorders, changes to
DNA, the development of pseudo-tumors, cardiovascular problems, renal and
thyroid issues, reproductive disorders, gastrointestinal issues and chronic
headaches can result. Should the cobalt and chromium ions enter the hip tissue,
inflammation, chronic pain and the deterioration of bone and tissue can occur,
leading to hip failure and the necessity of revision surgery. At the time of
the ABGII and Rejuvenate recall, Stryker stated the risk of fretting, corrosion
and the release of metal ion debris at the neck-stem taper junction.
Unlike the traditional
one-piece neck and stem, Stryker offered surgeons a variety of neck and stem
components of varying angles and lengths which allowed the surgeon to
custom-fit the device to the individual patient. Unfortunately, the innovative
design which was meant to offer longer implant life and greater freedom of
motion failed to live up to expectations. The neck-stem taper junction created
friction during periods of activity, and that friction led to dangerous and
premature levels of corrosion, despite the use of a ceramic ball rather than a
metal ball.
While there is no United
States database which comprehensively tracks hip implants, it is estimated that
over 20,000 of the devices were implanted into consumers between FDA approval
in 2009 and the time of the recall. Revision surgery, should it become
necessary, is considered riskier and more expensive than the original implant
surgery, with a considerably longer recovery time. Patients harmed by the
recalled Stryker Rejuvenate or ABGII should undergo the necessary testing to
determine whether they have dangerous levels of cobalt and chromium in their
bloodstream. Legal representation may also be beneficial for those seeking to
recover expenses associated with the recalled implants.
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