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Depuy Failed Hip Surgery
Lawsuits
In August, 2010, DePuy Orthopaedics Inc.
announced that it would be recalling two hip replacement
products, the ASR Hip Resurfacing System and the ASR XL
Acetabular System, after receiving new data which indicated that
more patients than expected experienced pain and other symptoms
which required a revision surgery following the initial hip
replacement procedure. The patients with DePuy ASR and ASR XL
metal-on-metal hip implants have experienced loosening and
dislocation of the device resulting in the need for early
revision surgery and/or the release of metal debris causing
muscle and soft tissue damage.
If you or a
family member have been the victim of a failed hip replacement
surgery including a defective hip replacement cup implant or hip
replacement system, please feel free to
submit an inquiry or
click here to send an e-mail with any questions about a failed hip replacement surgery and
defective hip implant lawsuit.
Johnson and Johnson's failed Depuy hip
implants
DePuy’s problems started in 2005 when it
introduced the implant device without clinical trials,
with legal clearance from the U.S. Food and Drug Administration.
But in three years, the FDA has received more than 300
complaints about early failure of the ASR hip device.
On August 24, 2010, Johnson & Johnson, and
its wholly owned subsidiary DePuy Orthopedics, Inc. announced
that it would be recalling 93,000 hip implant products
including: The ASR XL Acetabular System (Total Hip Replacement)
and The ASR Hip Resurfacing System. Both have an unreasonably
high failure rate.
The decision to recall the two products was
mostly based on the findings from a recent study conducted in
the UK that showed a five-year rate of revision surgery of 12
percent for the ASR Resurfacing System and about 13 percent for
the ASR XL system. The double digit rates are uncommon and
higher than expected.
The study showed that the faulty hip
replacement may cause serious injuries including but not limited
to: 1) severe pain, swelling and inflammation leading to damage
to surrounding bone and tissue, partial or complete lack of
mobility and 2) Genotoxicity and potential cancer causing
injury: One of the primary functions of the immune system
is to fight imortalized cancer cells within the body itself. A
diminished capacity of immune system not only increases the rate
and severity of infection, it also becomes less effective in
holding the cancer cells in check.
As a result of the study, the British
Orthopedic Association advised the Medicines and Healthcare
products Regulatory Agency (MHRA) of the UK, that over time
metal debris may affect the performance of a hip implant and
cause painful complications. The same expert group links metal
hip implants, such as DePuy AST to genotoxicity. The local
exposure to metal debris causes the chromosomes of bone marrow
or white blood cells to breakdown.
Depuy
Recall was Long Overdue
Some experts feel that this recall was long
overdue, and wonder why it took same devices were withdrawn from
the market in Australia in December with The Health Report
(Australia), Dr. Stephen Graves, director of the Association’s
National Joint Replacement Registry, said that the registry knew
for
years that the ASR device had a higher rate of failure. He said:
In our 2007 annual report we identified the resurfacing part of
as having at least twice the risk of revision compared to other
resurfacing devices….after three years [there] was four to five
times the risk revised compared to other devices.
Orthopedic surgeons around the US noticed
defects associated with DePuy ASR XL Acetabular hip implants
long before official products recall. According to Dr. Joshua J.
Jacobs from the Rush University Medical Center, ―Most major
medical centers have seen issues with this device. This does not
come as a surprise. Defects Associated with DePuy ASR XL
Acetabular Hip Implant System According to Dr. Kevin J. Bozic,
MD, an orthopedic surgeon at San Francisco Medical Center, in
reference to DePuy hip implants recall: ―It was a design failure
that frankly was not picked up until they were implanted in
thousands of patients.‖ The DePuy ASR Surgeon Recall Pack
contains a detailed listing of defects associated with the ASR
XL Acetabular hip implants. These defects include component
loosing and malalignment, dislocation of the elements,
infection, fracture of the bone, metal sensitivity, and pain.
Current Litigation environment on DePuy: As of beginning of
September a handful of class action lawsuits have already been
filed in U.S. District courts, with an strong appeal by
plaintiffs seeking an order from Judicial Panel on Multidistrict
Litigation pursuant to 28 U.S.C. § 1407 to enter an order
transferring cases to the District of New Jersey and assigned to
the Honorable Judge Susan D. Wigenton for coordination. As of
September 3 the MDL designation of MDL 2197 has been assigned,
although these cases have not been transferred yet, pending a
hearing in late October. Lanier Law Firm is actively advertising
these cases, and has filed 2 cases in Northern District of
California San Francisco Division. There is also a growing
nationally media and web campaign by various plaintiffs’ firms
gathering these cases. Allegation in Original Petition filed in
US Dist. Court, Northern Dist. Of Cal. San Francisco Div.: 1.
Negligence 2. Strict Product Liability (Manufacturing Defect);
Depuy Failed Implant Lawsuits are expected to
include the following allegations including Design Defect;
Inadequate Warning; Failure to Conform to Representation;
Failure to Adequately Test; Breach of Express Warranty; Breach
of Implied Warranty of Merchantability; Fraudulent Concealment;
Intentional Misrepresentation; Negligent Misrepresentation; and
Unlawful, Unfair and Fraudulent Business Practices in Violation
of CAL. BUS. & PROF. CODE § 17200, et seq
Defective Hip
Implant Devices Lead to Suffering, Pain, Impairment, and Mental Anguish as well
as having to have Second Hip Replacement Surgery to Repair the
Problem
Revision Surgery: one of the most serious and
prolonged injuries resulting from DePuy defective hip
replacement systems, is the need for surgical extraction of the
faulty ASR Hip Implant Device and often replacement with another
defect-free Hip Replacement System of proper design by other
orthopedic device manufacturer. The Hip replacement by its very
nature of necessity is often surgically performed in middle-aged
and elderly population. And recovery from the second hip
replacement is often more difficult than after the first. A
second surgery of this nature could and often does increase the
risk of complications, severe infections, prolonged recovery
time, and death. In some patients the infection resulting from
defective ASR system, is so advanced and systemic that a
revision surgery is not possible. In this group of patients the
only option is a surgical extraction of defected device without
any corrective hip replacement to restore the lost mobility
function patients experienced in first place.
After a person has gone through an extensive
hip surgery including the lengthy recovery and process, it can
be very upsetting to learn that the manufacturer incorrectly
made the implant so that it will have to removed and the person
will have to undergo the hip replacement surgery again requiring
more recovery, missed time from work, and missed time from
family and normal functioning.
In reviewing a potential failed hip
replacement surgery medical negligence lawsuits and failed hip
replacement defective hip implant lawsuits, it is extremely
helpful to know what type of hip implant was implanted into the
patient, when the hip implant occurred, if a second hip
replacement surgery was needed or will be needed, when the hip
implant began to malfunction, and what problems the defective
hip implant caused. It is also helpful to be able to review the
medical records of the surgery. For more information on
potential defective hip implant lawsuits or failed hip
replacement surgery medical negligence lawsuits, feel free to
submit an inquiry or
e-mail failedhipreplacementsurgerylawsuit@texaslawyers.com.
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