The
DePuy ASR metal-on-metal hip implant was approved in 2005 by the FDA, but soon
thereafter both DePuy and the FDA began receiving reports of adverse health
events. Some believe that the much less rigorous 510(k) approval process which
allows manufacturers to skip clinical trials could be at least partially
responsible for the adverse health effects in the thousands of ASR recipients.
Following a flurry of complaints, DePuy voluntarily recalled the ASR on August
26, 2010. At present there are approximately 4000 DePuy ASR lawsuits
consolidated into an MDL in Ohio as well as a smaller mini-state consolidation
in Chicago with approximately 600 plaintiffs and another in California
containing 1500 or so plaintiffs. Since California is experiencing so many
financial problems, the plaintiffs and their attorneys are expected to face
problems in getting a trial setting.
The
MDL, or multi-district litigation system is meant to streamline the litigation
process, taking advantage of the fact that there are similar allegations from
all plaintiffs made against the defendants—in this case DePuy and Johnson and
Johnson. The first trial regarding the ASR was scheduled to begin in state
court in Las Vegas in mid-December although it has been rumored the case
settled prior to trial. Should this be true, it would be a positive precedent
for all other ASR lawsuits to follow. The metal-on-metal design came about due
to its ability to last significantly longer than the metal-on-ceramic or
metal-on-plastic hip implants. Unfortunately, the metal-on-metal design allowed
the cobalt and chromium ball and cup to shave off microscopic metal ions into
the body, entering the surrounding tissues or even the bloodstream. The FDA
recently held a two-day panel to discuss the safety of the metal hip implant.
Soon
after the metal-on-metal ASR hip implant was FDA approved, as many as 40% of
surgeons were using it in their patients who required hip implants. Once the
adverse reports began coming in only about 16% of surgeons were implementing
the all metal hip implant in 2010 and the recent numbers show that fewer than
10% of surgeons are choosing to use the metal-on-metal hip implant model even
though there are many brands out there other than the ASR. While the final
failure rate of the ASR has not yet been established, it is believed that half
of all the implants will fail within the first six years—a number that is
easily four times the rate stated by DePuy at the time of the recall. One
well-known orthopedic surgeon puts the numbers even higher—80% failure rate at
eight years following the initial hip implant surgery.
There
are an estimated 93,000 recipients of the ASR worldwide with 43,000 of those in
the United States alone so the problem is a staggering one. Corporate e-mails
which came to light during the discovery process strongly suggest that DePuy
held off recalling the ASR for several months in order to sell as many of the
defective implants as possible. While the ASR hip replacement system was
initially discontinued, there were still significant amounts of inventory on
medical shelves around the world. A recall is implemented so this unused
inventory can be retrieved, barring it from implantation but the prolonged
period of time DePuy waited between the discontinuation and the actual recall
leads one to wonder whether they were hoping the problem would simply go away
quietly.
Of
the 43,000 United States recipients of the ASR hip implant approximately 6,000
have come forward to join in the lawsuit against DePuy and Johnson and Johnson.
You may wonder about the other 37,000 ASR patients. It is believed that some of
these people simply have not heard about the recall while others are elderly
and believe their symptoms are related to aging rather than metal toxicity or
failure of the implant. Still others may feel they cannot enter into a lawsuit
against DePuy unless they are currently having medical issues related to the
implant.
Andrew
Sullo, Class Action Lead Counsel & Managing Partner at Sullo & Sullo wants
to reach out to those 37,000 people and let them know how vitally important it
is that they speak to an attorney quickly before the statute of limitations
runs out on August 26th. Those people may find to their dismay that
a year from now or even two, three or five years from now when their ASR
implant fails or they develop severe metal toxicity they are left with
absolutely no legal recourse because they have neglected to maintain and
protect their rights. They may be left with astronomical medical bills, lost
wages during the six weeks to six months of recovery time, and could also end
up partially or totally disabled.
Sullo
calls this group “question mark clients” because they are currently experiencing
no adverse symptoms from the metal implant. He stresses however that, “What this group of clients does have is that
after the Statute of Limitations expires and they begin to have a problem with
their hip they need to be protected. They need financial protection, they need
medical protection, they need pain and suffering protection.” The Sullo & Sullo Law Firm has the
expertise and the knowledge to provide that level of protection. Don’t
wait—call today.
