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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Tuesday, November 4, 2014

Stryker: $1.43 BILLION Settlement Offer (Criminal ?!)

Stryker Settles Suits by Hip Implant Patients for $1 Billion
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.
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.

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 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 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 Follow me on Twitter at ajones5_al.