After the recall of the
Stryker ABG II and Rejuvenate hip implants in July, 2012, lawsuits began
pouring in following the lead of the DePuy ASR hip implant recall. In January,
2013, a multi-county litigation was established for the suits against Stryker
in the Bergen County Superior Court under Judge Brian R. Martinotti. Three
months prior to the issuance of the Stryker recall, notice was sent to surgeons
and hospitals regarding the potential risks involved for those with an ABG II
or Rejuvenate implant. The specific risks included corrosion and fretting at
the metal neck junction which could lead to microscopic metal shards burrowing
into surrounding tissue or entering into the bloodstream.
Once corrosion and fretting
occurs, the implant recipient can suffer inflammation, chronic pain, loss of
tissue or bone, loosening of the implant or joint dislocation. Any of these
serious symptoms can result in the necessity of a revision surgery to replace
the defective hip implant device. Pseudo-tumors can also result from the cobalt
and chromium ions and, once formed, require surgery to remove. Symptoms of
metal toxicity such as cardiovascular, renal thyroid and gastrointestinal
disorders, disruption of DNA, vertigo, skin problems, memory loss, anxiety and
depression can all occur when cobalt and chromium have built up in the body to
a certain level. Some people are more vulnerable to metals in the body than
others, but there really are no safe levels of toxic metals in the body.
Stryker is expecting to pay
out almost $400 million dollars in legal fees, costs for revision surgeries,
blood tests, x-rays and MRIs for the 20,000 recalled hip devices implanted in
recipients. Following the recall Stryker advised those patients who were having
any type of trouble related to the implant to seek the advice of their
physician. Even those who are not currently experiencing problems with their
implant should undergo blood tests and image screening since a large percentage
of the implants experienced failure within 3-5 years following the initial
implant. Although 81 lawsuits have been filed against Stryker in this latest
New Jersey multi-county litigation, it is expected there will be many more to
come between now and the time the statute of limitations runs out. On March 19,
2013, a case-management conference regarding the multi-county litigation took
place.
Stryker is one of the largest
manufacturers of orthopedic devices, generating over $8 billion in annual sales
in 2012, and ranking at 308 on the Fortune 500. This is due in part to the fact
that when the companies who manufactured metal-on-metal hip implants began
having lawsuits filed against them Stryker picked up that share of the hip
implant market due to the fact that the company was offering an innovative
design which included several neck and stem components which gave surgeons
greater flexibility in custom fitting the implant to the specific patient. The
stems were manufactured using Stryker’s titanium alloy blend which they claimed
would resist the effects of corrosion and fretting.
Despite this claim,
post-market data revealed evidence of corrosion and fretting, serious side
effects including implant loosening and the release of toxic metals which
eventually led to the recall. The hip implants which were intended to last
considerably longer than ceramic or polyethylene implants began failing within
the first two, three and four years following the initial implant. The first
DePuy ASR lawsuit was recently settled for a staggering $8.3 million dollars;
many believe this is an indication of how the thousands of hip implant lawsuits
will continue to resolve, perhaps including the Stryker ABG II and Rejuvenatelawsuits as well.