Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, November 13, 2014
Tuesday, November 4, 2014
Stryker: $1.43 BILLION Settlement Offer (Criminal ?!)
http://www.nytimes.com/2014/11/04/business/stryker-settles-suits-by-hip-implant-patients-for-dollar1-billion.html?emc=edit_tnt_20141103&nlid=50639700&tntemail0=y&_r=0
Stryker Settles Suits by Hip Implant
Patients for $1 Billion
By BARRY MEIER
NOV. 3, 2014
Stryker, the major producer of artificial
hip implants, said on Monday that it had reached a settlement of
thousands of patient lawsuits involving now-recalled all-metal devices that is
expected to cost the company about $1 billion.
The Stryker deal, negotiated with
lawyers representing the patients, would be one of the highest amounts paid in
the last year by an implant manufacturer to resolve claims by patients who said
they were injured by a hip replacement in which a device’s ball and cup
components were both made from metal.
Last November, the DePuy division
of Johnson & Johnson agreed to pay about $2.5
billion to resolve lawsuits filed by 8,000 patients who said they were injured
by an all-metal implant that it once sold, known as the Articular Surface
Replacement or A.S.R.
All-metal implants once accounted for about one of every three devices used in the estimated 250,000 hip replacement procedures that
are performed annually in this country. The devices have been largely abandoned
after evidence emerged several years ago that the metal components could rub
together, creating tiny particles of metallic debris that could severely damage a patient’s tissue and
muscle.
In announcing the settlement,
Stryker, which is based in Kalamazoo, Mich., said that it covered patients who
had received the Rejuvenate
Modular-Neck or the ABG II Modular-Neck and who underwent operations to
have the implant replaced. Stryker recalled both models in 2012 as complaints increased.
Stryker said that it had set aside
$1.45 billion to settle the claims but that it expected the eventual expenses to be higher.
“This settlement program provides
patients compensation in a fair, timely and efficient manner,” said William J.
Huffnagle, the president of Stryker Orthopaedics.
Since abandoning all-metal implants,
surgeons have returned to devices made of a mix of materials, such as
plastic and metal.
http://atlanta.legalexaminer.com/defective-dangerous-products/hip-implant-settlement-proposal-announced-on-stryker-rejuvenate-and-abgii-cases/
Hip Implant Settlement
Proposal Announced On Stryker Rejuvenate and ABGII Cases
Posted by Richard R.
Schlueter
November 3, 2014 4:00 PM
Just over two years since
the Stryker
Rejuvenate and ABGII hip implant products were recalled from the
market in June 2012, national leadership in the multi-district litigation (MDL) today announced a global settlement proposal
for all Stryker Rejuvenate and ABGII hip implant victims who have undergone revision surgery to remove and
replace their recalled Stryker hip implant on or before November 2, 2014.
The settlement proposal includes a base award amount of $300,000.00 to each claimant
who has undergone revision surgery on or before to November 2, 2014, and
otherwise qualifies for the settlement. There are certain limited potential
reductions to the base award for age, prior hip revisions, and other relevant
factors. Claimants may also receive additional compensation, referred to
in the proposed settlement as “Enhancements,” at a later date if they can
demonstrate that they meet the eligibility requirements for the categories set
forth in the settlement agreement.
Although participation is
voluntary, it is expected that many of those that qualify (those who have had
their recalled Stryker hip removed and replaced on or before November 2, 2014)
will benefit from the settlement program, and may ultimately decide to
participate in the settlement. Any such decision should be made on an
individual, case-by-case basis.
The following is a basic
summary highlighting key aspects of the Master Settlement Agreement:
Stryker
Hip Settlement
The settlement program applies to patients who are U.S.
citizens and residents who had either an ABG II Modular Neck System or a
Rejuvenate Modular Neck System implanted in their bodies in the United States,
and who had a qualified surgery to remove and replace the recalled device on or
before November 2, 2014. The settlement program is also open to certain patients who
have been deemed to be too sick or medically unstable to undergo a necessary
revision surgery.
At Childers, Schlueter &
Smith, our attorneys will immediately undertake to determine how the proposed
settlement will affect each of our clients, and will work with each client
individually to carefully consider the benefits of the proposed settlement so
that they can make an informed
personal decision on whether or not to participate. As a
nationally appointed leader in this litigation, founding partner Richard R.
Schlueter will ensure each and every one of our clients has all of
the information he/she needs to make the best choice for his/her unique
situation. Richard
Schlueter has been involved in the various hip implant litigations
(including DePuy ASR/Pinnacle, Zimmer Durom Cups, Biomet M2a Magnum and Wright
Conserve Plus among many others) for several years, and has unique knowledge
relating to hip implant failures and the injuries caused by those failures. Our
current and future clients will be continue to be very well represented and
informed during the entire process.
Attorneys representing those interested in participating in the Stryker
hip implant settlement will have to register their clients in the program on or
before the initial reporting deadline of December 14, 2014. After that, the next deadline will be the formal
enrollment of each individual patient who chooses to participate into the
Settlement Program. Those
qualified claimants who would like to participate in the settlement program
must enroll by March 2, 2015. If less than 95% of the qualified claimants
elect to participate in the settlement, Stryker has the ability to walk away
and cancel the settlement program. Stryker must make that decision on or
before June 15, 2015. Assuming the participation threshold is met
and the settlement continues after June 15, 2015, the deadline to file claims
for Enhanced benefits is September 30, 2015. Additional compensation
through the Enhanced benefits portion of the settlement will relate to damage
to the femur, soft tissue damage, additional procedures and infection.
There is a cap on the Enhanced damages so that most total claims (Base award
and Enhanced benefits) will be no more than $550,000.00 per claimant.
Based on the timing of the
deadlines in the proposed settlement, it is unlikely that any settlement
payments will be made prior to late summer or early fall 2015.
For patients who are not
eligible for the settlement program, Stryker’s existing program for
reimbursement of eligible out of
pocket costs, administered
by Broadspire, remains available. The decision to undergo a revision
surgery is a medical decision, not a legal decision, and should be made only by
patients in consultation with their surgeons. If you were implanted with
a recalled Stryker Rejuvenate or ABGII hip implant product but are not eligible
for the settlement program, all of your legal rights and claims are preserved
and you will not be affected so long as you have a filed legal claim with the
Court. Patients who have been implanted with a recalled Stryker hip in
both hips (referred to as “bilateral” hip implants), in whom only one hip has
been revised, will retain all of their claims and legal rights in regard to the
unrevised hip, even if they participate in the settlement for their revised
hip.
Childers,
Schlueter & Smith is committed to
continue litigating all claims for our clients who don’t qualify, who are
arbitrarily penalized so as to not receive an offer under this proposal, who
have not had revision surgery by today’s date, and those who choose not to
participate in the proposed settlement. If you have a recalled Stryker
Rejuvenate or ABGII, please call us for a free consultation regarding your
legal options.
For those looking for
answers and guidance on these and/or any other Stryker hip
implant related issues, we welcome you to contact our office for
more information.
Tags: chromium
toxicity, cobalt toxicity,
Product
Liability Lawsuits, recalled hip
implant, Rejuvenate and
ABG II modular-neck stems, Stryker, Stryker Hip
Implant, Stryker Hip
Implant Settlement, Stryker Hip
Implants, stryker Hip
Recall, Stryker Hip
Recall Trials, Stryker Hip
Settlement, Stryker MDL,
Stryker
Mediation, Stryker recall
http://abcnews.go.com/Business/wireStory/stryker-pay-143b-settle-hip-implant-cases-26664666
Stryker to Pay $1.43B to Settle Hip
Implant Cases
ST.
PAUL, Minn. — Nov 3, 2014, 9:04 PM ET
Medical implant maker Stryker will
pay at least $1.43 billion to settle thousands of lawsuits from patients who had to have surgery to
remove problematic hip implants, under a deal announced Monday.
The agreement, brokered by a New Jersey Superior Court
judge, resolves state and federal lawsuits against the maker of
orthopedics. It was announced Monday in U.S. District Court in St. Paul, Minnesota.
Stryker said the $1.43 billion figure
represents the "low end of the range of probable loss to resolve these
matters."
The lawsuits stem from two hip
implants that Stryker recalled due to corrosion and other problems in 2012. One
year ago Johnson & Johnson paid $2.5 billion to settle 8,000 lawsuits from
patients who had to have the company's metal ball-and-socket hip implant removed
or replaced.
Plaintiffs in 39 states alleged
Kalamazoo-based Stryker sold defective
hips that corroded
while in patients' bodies and caused illness, including pain and swelling in
the tissue around the implant.
"The settlement represents one
of the largest medical device settlements with an unlimited compensation fund," said
Minneapolis lawyer Charles Zimmerman, who helped negotiate the deal as part of
the lead-counsel committee for the case. "We are pleased that we were able
to reach a settlement with such meaningful relief."
Stryker Corp. expects to make most of
the payments by the end of 2015.
Thousands of cases
from patients across the country have been consolidated under a single federal
judge in Minnesota in a "multi-district litigation," a common type of
mass lawsuit filed against health care companies, the Star Tribune of
Minneapolis reported.
Stryker Corp. to pay at least $1.4 billion to
settle hip replacement lawsuits
Stryker Corp., whose Kalamazoo headquarters is shown here, has entered
an agreement intended to resolve a wave of state and federal lawsuits related
to two hip replacement products that it recalled in July of 2012.
Al Jones on November 03, 2014 at 6:39 PM, updated November 03, 2014 at 7:22 PM
KALAMAZOO, MI – Stryker Corp. has agreed to pay at least $1.4 billion to settle
thousands of lawsuits by U.S. patients who had surgeries to revise problematic
Stryker hip replacements.
The settlement in New Jersey's Bergen County Superior Court is
intended to compensate individuals who had to have surgery to replace either of
two Stryker products -- the Rejuvenate Modular-Neck hip stem and/or ABG II
Modular-Neck hip stem.
Following complaints by patients of pain and swelling that were
attributed to fretting and corrosion of the metal-on-metal hip implants,
Stryker voluntarily conducted a worldwide recall of the products in July of
2012.
The company did not provide an
estimate of how many people may have been effected or how many may be
compensated. It also did not offer a representation of how much individuals
stand to receive.
"The ultimate cost to entirely resolve these matters will depend
on many factors that are difficult to predict and may be materially different
than the amounts accrued to date," the company stated in a press release.
"Further charges to earnings may need to be recorded in the future as
additional information related to patient enrollment in the Settlement Program
becomes available."
The company stated that it expects to make the majority of the
payments under the settlement agreement by the end of 2015. The agreement,
which is intended to resolve a wave of state and federal lawsuits, was brokered by New Jersey Superior
Court Judge Brian R. Martinotti with the help of former United States
Magistrate Judge Diane M. Welsh, acting as chief mediator.
It covers individuals who have already had surgery to replace the
Stryker products. It also covers those who are already party to a lawsuit as
well as those who are not.
In a June report, MT
Services LLC reported that some cases involving revisions of Stryker
Rejuvenate and ABG II hips could be worth more than $500,000.
According to Stryker, patients eligible for compensation should
talk with their attorneys, if they have one, or contact the Settlement Program
claims administrator at www.strykermodularhipsettlement.com or
1-855-382-6404. Patients do not need an attorney to participate in the
Settlement Program.
A program called Broadspire, being done in partnership with
third-party claims administrator Broadspire Services Inc., offers support for recall-related care
among U.S. patients who have not had surgey to remove the recalled products.
In its press release, Stryker advised those patients to visit http://www.aboutstryker.com/modularneckstems/or
call 1-888-317-0200 for more information. It stated that patients do not need
an attorney to participate in the Broadspire program.
Kalamazoo-based Stryker produces a wide range of medical technologies
including surgical devices, patient-handling devices, hospital beds and
orthopedic implants such as replacement hips and joints.
MLive business writer Al Jones may be contacted at ajones5@mlive.com. Follow me on Twitter
at ajones5_al.
Labels:
ABC News,
Al Jones,
Atlanta Legal Examiner,
Barry Meier,
Broadspire Services,
Judge Diane Welsh,
Judge Martinotti,
Mlive,
MT Services LLC,
New York Times,
Richard Schlueter,
Stryker
Dallas, TX, USA
Kalamazoo, MI, USA
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