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:

http://atlanta.legalexaminer.com/wp-content/uploads/sites/5/2014/04/Stryker-Rejuvenate-Hip-Replacement-Recall-.jpg

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.

Questionable Benefit of Implanted Heart Device: Patient Outcomes Tracked by Registry!

 Clots Tied to Heart Pump Open Debate on RisksPatients Face in Trials

By BARRY MEIER

Published: December 9, 2013 The New York Times

                         

A new report showing an increase in blood clots associated with a popular heart device is dividing experts over whether a clinical trial of the implant is potentially too risky for patients.

The debate, which involves a heart pump called the HeartMate II, sheds light on how researchers calculate whether to expose patients to a trial’s risks.

Medical researchers say such decisions are based on objective evidence. But a look at their decisions about HeartMate II trial shows how subjective those choices can be.

The trial, which has already faced delays, is set to start soon, if it receives a final go-ahead. But at least two hospitals that originally agreed to recruit patients for the trial have now withdrawn because of the new findings, while others have decided to stay in.

Some experts contend other factors might also be in play in those decisions, including an investment of years by some researchers to set up the study. In addition, more than $13 million has been earmarked for the trial by the HeartMate II’s maker, Thoratec, and the federal National Heart Lung and Blood Institute.

“You could argue it both ways,” said Dr. Carmelo A. Milano, a cardiologist at Duke University, which has decided not to participate, as has the Cleveland Clinic. “It certainly would be better if we didn’t have this problem.

The HeartMate II is a small pump that continuously pushes blood through the heart. Patients who get the device now are those facing imminent death from heart failure. Even the researchers who put together the new report said they would continue to use the pump in those cases.

The trial, called Revive-It, is intended to determine whether a HeartMate II can also benefit patients who have not quite reached that stage of heart failure. Such patients, who take drugs for their condition, typically struggle to perform physical activities, like walking short distances.

Because heart failure is a progressive condition, the new blood clot study has complicated the question of how to weigh the device’s risks and benefits to less sick patients.

“I would not embark on a clinical study until this problem is understood and mitigated,” said Dr. Robert G. Hauser of the Minneapolis Heart Institute Foundation, who is not involved in the trial.

In the new study, three big hospitals, the Cleveland Clinic, Duke and Washington University in St. Louis, jointly reported that the rate of HeartMate II-related blood clots had increased by nearly fourfold in devices implanted after early 2011.

Some patients died and others underwent emergency operations to get new pumps or transplanted hearts, according to a report in The New England Journal of Medicine.

Experts have yet to find a reason for the increase. But they say it most likely involves factors like changes in the device and changes in how doctors use anti-clotting drugs with such patients.

Long before the new report, however, word of a growing problem with the HeartMate II had been circulating among device experts. And researchers involved with Revive-It had already begun scrambling to understand its potential impact on the trial.

The issue began to take shape in March, when the Cleveland Clinic reported to the Food and Drug Administration and Thoratec that it was seeing a rise in pump-related clots. Physicians at other hospitals were also seeing an increase and were discussing the problem with colleagues at medical meetings or privately.

“There is an incestuous nature to our field,” said Dr. Scott Silvestry, a cardiologist at Washington University

In May, the principal investigators leading the trial — Dr. Keith Aaronson and Dr. Frank D. Pagani of the University of Michigan and Dr. Robert Kormos of the University of Pittsburgh — decided to delay the start of patient recruitment to examine the problem.

At that time, doctors at the Cleveland Clinic were keeping their findings confidential because they hoped to publish them in a medical journal.

But another source of data was available. In recent years, a federally funded registry at the University of Alabama at Birmingham has been tracking the safety of heart pumps like the HeartMate II. Known as Intermacs, the registry was showing that pump-related blood clots associated with the HeartMate II had risen to about 5 percent since early 2011, compared with about 2 percent in previous years.

But the registry also showed a variation in clot rates at differing hospitals, raising the possibility that facilities such as the Cleveland Clinic were outliers.

The trial’s lead investigators, Dr. Aronson, Dr. Pagani and Dr. Kormos, declined to be interviewed. But in a statement, they said the added risk detected by Intermacs was “small” and did not alter the trial’s balance of benefits and risks.

Based on the Intermacs data, officials at the F.D.A. and the National Heart Lung and Blood Institute and a panel of experts appointed by the institute to monitor the study’s safety came to the same conclusion.

“F.D.A. reviewed the Intermacs data and supported the Revive-It team’s decision to move forward,” the three researchers said a statement.

As a result, about 18 major hospitals nationwide again prepared to enroll patients. But now, the recent New England Journal of Medicine study published late last month has raised questions about which blood clot data is more reliable.

In their study, the Cleveland Clinic, Duke and Washington University reported a pump-related clot rate of 8.4 percent, compared with 2.2 percent in earlier years. The increase was significantly higher than the 5 percent rate reported by Intermacs.

Dr. Randall Starling of the Cleveland Clinic said he thought that Intermacs’ data was understating the problem’s scope.

“We believe our data is more accurate,” Dr. Starling said.

However, the import of new report was quickly disputed by the three investigators heading Revive-It. In a statement, they described the hospitals as outliers and said the Intermacs data was more reliable.

Dr. Milano, the cardiologist at Duke, said he thought that the reaction of researchers, who have spent years setting up the Revive-It study, was understandable.

“They are more apt to look at the data that suggests there is less of a problem,” Dr. Milano said. Still, at this point, he cannot see asking less-sick patients to get a device. “Knowing what I know, I probably won’t sign up,” he said. The three researchers leading the trial said it was imperative, given the shortage of donor hearts to know whether the device worked in earlier stage patients.

Whatever the case, the National Heart Lung and Blood Institute said in a statement that the study’s safety panel would soon review the new journal report and its implication, if any, for the trial.

In the meantime, specialists are going their separate ways. For example, while Dr. Hauser, the device expert in Minneapolis, says he thinks that the trial should be delayed, cardiologists at the hospital where he works are going forward. And unlike Duke and the Cleveland Clinic, Dr. Silvestry said Washington University hospital was also staying in the trial because it thought that the device’s potential benefits still outweighed its risks.

“We feel our patients will be served by a possibility of enrollment,” Dr. Silvestry said.

Lawyers win on $2.5B J&J hip settlement

Johnson & Johnson Offers $2.5 Billion HipDevice Settlement

By BARRY MEIER  The New York Times

Published: November 19, 2013

                                     

Johnson & Johnson and lawyers for patients injured by a flawed hip implant announced a multibillion-dollar deal Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants.

Under the agreement, the medical products giant will pay some $2.475 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device.

Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to some $3 billion, said people familiar with the proposal.

The typical patient payment for pain and suffering caused by the device will be about $250,000 before legal fees, under the plan. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners.

The settlement plan, which was submitted to a federal judge in Toledo, Ohio, on Tuesday, must receive the support of 94 percent of eligible claimants to go forward. Whether it will reach that goal is unclear. Under the deal, some patients will receive relatively small payouts and others will see payments reduced because the plan imposes a user’s fee on awards based on how long a patient had the implant.

Some patients, many of whom who suffered severe pain and injury from metallic debris generated by the debris, spent years trying to convince doctors there was a problem while Johnson & Johnson was denying one.

The now-recalled device, known as the Articular Surface Replacement, or A.S.R., ranks as one of the most-flawed medical implants sold in recent decades. The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 percent of the patients who received it.

Traditional artificial hips, which are made of metal and plastic, typically last 15 years or more before requiring replacement. DePuy recalled its device in mid-2010 amid rising failure rates.

The A.S.R. was sold in two versions, one for use in traditional hip replacement and the other for use in an alternative procedure known as hip resurfacing. Beginning in 2003, it was implanted in about 93,000 patients, about one-third of them in the United States.

The A.S.R., which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.

The precise value of the settlement is not known because it will vary based on the number of plaintiffs who qualify for it.

DePuy faces some 12,000 A.S. R-related legal claims in the United States. Lawyers estimate that about 8,000 of those claims involve patients who underwent operations to have an A.S.R. removed and replaced.

The remaining plaintiffs, about 4,000 patients, will not receive any compensation, though there is a provision to add $250,000 to the deal for each patient who undergoes a replacement procedure before the plan is finalized. The lawyers believe that Johnson & Johnson will probably have to make a subsequent settlement with added patients as the device fails in them.

Thus far, only two A.S.R. lawsuits have gone to trial. In March, a Los Angeles jury ordered DePuy to pay $8 million in damages to a Montana man after finding that the A.S.R. was defectively designed. Then in August, a Chicago jury sided with DePuy and rejected claims that it had inappropriately marketed the implant.

Under the plan announced Tuesday, the $2.475 billion payment by Johnson & Johnson would be divided into two pots.

The deal would create a $2 billion pool to cover basic awards and a separate $475 million pool to cover additional payments to compensate those patients who sustained more significant injuries related to the device or its removal and replacement.

The average basic award of $250,000 will be affected by a variety of factors. Under the plan, plaintiffs who smoke, are overweight or are older will see their payments reduced.

In addition, patients who had the device longer will also see reductions. For example, the average payment to a patient who had the device for five to six years would fall to $225,000 and be reduced to $200,000 for a patient who had the device six to seven years.

For patients who qualify for the special pool, their payouts would increase based on the severity of their injuries. Lawyers do not know what the number of patients would be to qualify for the pool but they estimate that the figure might be about 10 percent of claimants.

Some of the patients included in the pool would be individuals who had A.S.R.'s on both hips or who had a hip so badly damaged by the device that a procedure to replace it was not completely successful.

Johnson & Johnson’s decision to separately pay all medical costs related to a device replacement is unusual, lawyers said. Typically, such costs are part of a settlement award and a claimant is then liable for paying back an insurer or Medicare for their medical costs.

If the deal is approved, the biggest single payment will probably go to a group of lawyers who negotiated the plan. Under the plan they could receive a 6 percent fee, or about $150 million.
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More information:

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http://www.jnj.com/news/all/DePuy-Announces-US-Settlement-Agreement-to-Compensate-ASR-Hip-System-Patients-Who-Had-Surgery-to-Replace-Their-ASR-Hip

DePuy Announces U.S. Settlement Agreement to Compensate ASR™ Hip System Patients Who Had Surgery to Replace Their ASR Hip

WARSAW, IN, November 19, 2013 – DePuy Orthopaedics, Inc. (DePuy) and the Court-appointed committee of lawyers representing ASR™ Hip System plaintiffs today announced a settlement agreement to compensate eligible ASR patients in the United States who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013.

“We are committed to the well-being of ASR patients, as demonstrated by the voluntary recall and the program providing support for recall-related care,” said Andrew Ekdahl, Worldwide President, DePuy Synthes Joint Reconstruction. “The U.S. settlement program provides compensation for eligible patients without the delay and uncertainty of protracted litigation.  DePuy remains committed to our purpose of advancing innovative treatment options to serve those who need joint replacement surgery.”

The U.S. settlement is valued at approximately $2.5 billion, based on an estimate of 8,000 patients participating in the program.  The amount of the settlement program has been included as part of previously accrued amounts, and no additional charge to the company’s earnings is being recorded in connection with this settlement.  Any remaining related established product liability reserve is based on currently available information and changes to the reserve may be required in the future as additional information becomes available.  The majority of the payments related to this settlement are projected to occur during 2014 from currently available cash.

U.S. Settlement Program

For U.S. ASR Patients Who Had Surgery to Remove Their ASR Hip As of August 31, 2013

The U.S. settlement program is available for U.S. ASR patients who had revision surgery for reasons related to the recall as of August 31, 2013.  Patients eligible for this program can speak with their lawyer, if they have one, or contact the U.S. settlement program claims processor at www.USASRHipSettlement.com or (877) 391-3169.  ASR patients do not need a lawyer to participate in the program. 

For U.S. ASR Patients Who Have Surgery to Remove Their ASR Hip After August 31, 2013

For U.S. patients who have revision surgery after August 31, 2013, the existing Broadspire program providing support for recall-related care is available.  U.S. patients are encouraged to call 1-888-627-2677 for more information. 

For more information about the U.S. settlement program, please visit www.ASRHipInfo.com.

Status of Litigation

Judge David Katz of the U.S. District Court of the Northern District of Ohio is presiding over the federal multidistrict litigation.  The consolidated state litigations are presided over by: Judge Brian Martinotti of the Superior Court of New Jersey, Bergen County; Judge Deborah Mary Dooling of the Circuit Court of Cook County, Illinois; and Judge Richard Kramer of the San Francisco County Superior Court, California.  The settlement agreement was presented to these judges and Maryland State Court Judge, the Honorable Crystal Dixon Mittelstaedt, at a court hearing today. 

The settlement agreement will help bring to a close significant ASR litigation activity in the U.S.  However, some lawsuits in the U.S. will remain. DePuy will continue to defend against remaining claims and believes its actions related to the ASR Hip System have been appropriate and responsible. 

Recall Background

In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System, which showed a revision rate that was not in line with data previously reported in that registry.  The product continues to perform well in some patients.  Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need, including the global program providing support for recall-related care, which has thus far resulted in thousands of payments to patients.

DePuy Orthopaedics, Inc. is part of DePuy Synthes Companies of Johnson & Johnson.

(This release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements.  These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Orthopaedics, Inc. and Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; complex global supply chains with increasing regulatory requirements; and product efficacy or safety concerns resulting in product recalls or regulatory action.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.investor.jnj.com or on request from Johnson & Johnson.  Neither DePuy Orthopaedics, Inc. nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.)

Visit www.ASRHipInfo.com for more information.

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Press Contacts:
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732-524-1413
lgawrel1@its.jnj.com

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574-372-7136
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732-524-6491
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732-524-3922

LFishma@its.jnj.com

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https://www.usasrhipsettlement.com/Un-Secure/Documents.aspx

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http://www.asrhipinfo.com

DePuy Announces U.S. Settlement Agreement to Compensate ASR™ Hip System Patients Who Had Surgery to Replace Their ASR Hip

November 19, 2013
DePuy Orthopaedics, Inc. (DePuy) and the Court-appointed committee of lawyers representing ASR™ Hip System plaintiffs today announced a settlement agreement to compensate eligible ASR patients in the United States who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013.

U.S. Settlement Program Information Sheet for Patients

Contact Information - U.S. Settlement Program Claims Processor
www.USASRHipSettlement.com
(877) 391-3169
claimsprocessor@usasrhipsettlement.com

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http://www.modernhealthcare.com/article/20131119/NEWS/311199950?AllowView=VDl3UXpKSzRDLzJCbkJiYkY0M3hla0tvaGtVZEQrWT0=&utm_source=link-20131119-NEWS-311199950&utm_medium=email&utm_campaign=mh-alert J&J to pay $2.5B to settle hip-replacement lawsuits By Jaimy Lee  Modern Healthcare Posted: November 19, 2013 - 5:30 pm ET Johnson & Johnson will pay about $2.5 billion to settle thousands of lawsuits filed by patients who already underwent surgery to replace the company's faulty metal-on-metal hip implants, which failed at higher rates than traditional hip implants and were eventually recalled. About 8,000 patients who had revision surgery before Aug. 31 are part of the settlement, the New Brunswick, N.J.-based healthcare company said. More patients who received Johnson & Johnson's metal-on-metal hip implants are expected to undergo revision surgeries in the future. "The U.S. settlement program provides compensation for eligible patients without the delay and uncertainty of protracted litigation,” said Andrew Ekdahl, worldwide president of the DePuy Synthes Joint Reconstruction business unit, which is part of Johnson & Johnson. The settlement was announced Tuesday after the agreement was presented to the judge overseeing the federal multidistrict litigation consolidated in U.S. District Court in Toledo, Ohio. The settlement comes just weeks after Johnson & Johnson agreed to pay $2.2 billion to settle allegations that it illegally marketed the antipsychotic drug Risperdal and two other medications. Johnson & Johnson, which noted that there are still some ongoing lawsuits in the U.S., said that no additional charge to the company's earnings will be recorded as a result of the settlement. The standard payment for patients who claim a share of the settlement is $250,000. The award may be reduced based on age, smoking status, and the length the device was implanted. Patients may get more than $250,000 if they needed multiple revisions or experienced complications such as a heart attack or pulmonary embolism associated with the revision. They must register their claims by Jan. 6. About 93,000 people, including roughly 12,000 in the U.S., received the ASR XL Acetabular hip implant or the ASR hip resurfacing system, according to Johnson & Johnson's most recent financial filing. DePuy Orthopaedics, a Warsaw, Ind.-based subsidiary of Johnson & Johnson, recalled the metal-on-metal systems in August 2010. It is also facing lawsuits from patients in the United Kingdom, Canada and Australia. Metal-on-metal hip implants have failed at higher rates than traditional implants with plastic bearings, prompting the Food and Drug Administration this year to propose regulations that would require manufacturers of market metal-on-metal hip implants test to provide more information about the safety and effectiveness of these devices. Patients who received the metal-on-metal implants have reported a number of injuries, including adverse local tissue reactions and high ion concentrations of cobalt and chromium. The revision surgeries typically cost about $100,000. Dr. Geoffrey Westrich, director of research for the adult reconstruction and joint replacement division at the Hospital for Special Surgery in New York, said patients having problems with the implants generally experience three types of responses. Some clearly need revision surgery. Others are not symptomatic or suffering any pain, but MRIs indicate that they have adverse tissue reactions and elevated metal ion levels. Those patients may also need revision surgery, Westrich said. A third group of patients may have slightly elevated ion levels and need to be monitored. “There is no definitive answer what to do,” Westrich said. “Without regular follow-ups, we're not going to know who needs a revision.” About 400,000 people received hip implants in 2011, including the roughly 50,000 people who have revision surgeries each year, said Dr. Josh Jacobs, president of American Academy of Orthopaedic Surgeons. While the revision procedures are fairly common, they are often not as successful as primary implants, he said. Follow Jaimy Lee on Twitter: @MHjlee