Pseudotumor and Johnson & Johnson DePuy Pinnacle Hips

Elevated metal levels may better indicate pseudotumor after MoM THA than symptoms

November 6, 2017

DALLAS — Pseudotumor formation occurred in 52% of patients who underwent metal-on-metal total hip arthroplasty performed with two different designs of prostheses and later underwent metal artifact reduction sequence MRI or MARS MRI of the hip, a presenter said at the American Association of Hip and Knee Surgeons Annual Meeting

“So overall prevalence and severity, over half of our patients had a pseudotumor and nearly 40% either had a type 2 or type 3 lesion,” Daniel E. Goltz, BS, said.

The 207 hips that underwent MARS MRI received an ASR THA prosthesis or a Pinnacle prosthesis with Ultamet liner (both DePuy) metal-on-metal (MoM) hip implant. The patients represented just the patients who had MARS MRI and had any pseudotumors graded among 178 patients with ASR prostheses and 788 patients with Pinnacle prostheses who were operated on between 2002 and 2013 and had a minimum 2-year follow-up and average 8-year follow-up.

Goltz and colleagues analyzed the factors associated with a pseudotumor and found those patients were significantly more likely to have higher cobalt levels, a higher cobalt-chrome ratio, a high-offset femoral stem and a larger size acetabular cup.

“Patients with thick-walled cystic or solid masses were more likely to be revised than those with thin-walled cystic masses (P < .001),” the investigators wrote in the study abstract.

In his presentation, Goltz said, “Interestingly, we found that symptoms may not be the best reliable indicator of whether or not a patient has a pseudotumor or its severity.”

The study definition of being symptomatic after MoM THA was pain, weakness or a limp, he noted.

“Sixty percent of our cohort actually ended up having symptoms,” Goltz said. However, among the asymptomatic patients, 47% had a pseudotumor, he said.

“It is our hope that this work will be able to guide all of you as clinicians as you make what may come to be a challenging decision in terms of which patients to revise and the timing for that revision,” Goltz said. – by Susan M. Rapp

Reference:

Kleeman L, et al. Paper #39. Presented at: American Association of Hip and Knee Surgeons Annual Meeting; Nov. 2-5, 2017; Dallas.

Disclosure: Goltz reports no relevant financial disclosures.

PROPOSED Australia Settlement $250M: Defective J&J ASR hip

• 
  

Johnson & Johnson to pay $250 million in class action settlement

Sydney bus driver Joseph Pereira was a lead plaintiff in the case against Johnson & Johnson over faulty hip joints. Steven Siewert

by Marianna Papadakis

• Mar 31 2016 at 4:40 PM Updated Mar 31 2016 at 4:40 PM

Pharmaceutical and medical devices giant Johnson & Johnson will pay $250 million for faulty hip replacements in the second-biggest class action settlement in Australia over the past decade.

The conditional agreement between Johnson & Johnson and its British subsidiary DePuy International and lawyers for 1700 Australians was lodged at a short hearing at Sydney's Federal Court on Thursday and must be approved by a judge.

The companies were sued by Shine Lawyers and Maurice Blackburn five years ago. There was a 17-week trial last year. The biggest class action settlement was $800 million for the Victorian bushfires cases.

Lead plaintiff Sydney bus driver Joseph Pereira claimed the implants left him in constant pain and with elevated levels of heavy metals in his bloodstream.

The DePuy ASR resurfacing hip implant has led to a compensation package of $250 million from Johnson &amp; Johnson. " 

The DePuy ASR resurfacing hip implant has led to a compensation package of $250 million from Johnson & Johnson. Supplied

Johnson & Johnson withdrew the DePuy ASR hip implants from sale in Australia in December 2009 and issued a formal hazard alert for the products in August 2010.

Maurice Blackburn Lawyers senior associate Julian Schimmel said the settlement, following the court's approval, meant patients could be compensated if they had or still needed corrective surgery because of problems with hip implants.

PARTS 'DEFECTIVE'

The law firms alleged the ASR hip implants, which provided a total hip replacement, were defective, not fit for their purpose and not of merchantable quality.

Mr Schimmel said the case was settled on a "no admissions" basis.

Shine Lawyers partner Rebecca Jancauskas said a compensation scheme to distribute the money would be devised to ensure compensation paid to each group member reflected their individual circumstances and losses.

"We estimate there are still hundreds of Australians who are yet to have hip revision surgery and the settlement scheme will remain open for these people to access the compensation they are entitled to," Ms Jancauskas said.

A Johnson & Johnson spokeswoman said the company still used the ASR devices and they performed well in some patients.

"The respondents' priority is, and always has been, patient safety," the spokeswoman said. "Since the recall decision was made, the respondents have worked to provide patients and surgeons directly with the information and support they need.

"They have continued to focus on the care and wellbeing of all ASR patients, their family members and surgeons."

Johnson & Johnson is appealing a separate case in the United States concerning different Pinnacle metal-on-metal hip implants after the company was ordered by a Texas federal jury to pay about $US500 million ($650 million) to five plaintiffs who claimed they were injured by the devices.

Read more: http://www.afr.com/business/legal/johnson--johnson-to-pay-250-million-in-class-action-settlement-20160331-gnv15d#ixzz44Ww36I2x 

Follow us: @FinancialReview on Twitter | financialreview on Facebook

The FDA's Medical Device Problem

The F.D.A.’s Medical Device Problem

By RITA F. REDBERG and SANKET S. DHRUVA              JULY 17, 2015

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).

As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.

Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.

The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.

In general, the proposed law is likely to shift the burden of evidence to clinical studies that are conducted only after the devices have been put on the market. Unfortunately, such studies are often delayed months to years after a device is approved. Many are never completed (and even when they are, their findings are often not publicly available). Although the proposed law alludes to “timely postmarket data collection,” that vague directive needs to be clearly defined — and more important, enforced — by the F.D.A. In fact, according to a 2014 journal article co-written by one of us, the F.D.A. has never issued a warning letter or penalty for a postmarket study delay.

Even if a postmarket clinical study deems a medical device dangerous, it still can be difficult to remove it from the marketplace. In 2005, for example, an intracranial stent called the Wingspan was approved on an expedited basis to prevent recurrent strokes. When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.

Once a medical device is developed and approved, its manufacturer often makes small changes intended as enhancements (such as using a different size wire or new material). Currently, the F.D.A. is the arbiter responsible for ensuring that these changes result in a safe and effective device. But alarmingly, the 21st Century Cures Act would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.

The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health.

Rita F. Redberg is a cardiologist at the University of California, San Francisco, Medical Center. Sanket S. Dhruva, a cardiologist, is a clinical scholar at Yale University.

http://www.nytimes.com/2015/07/17/opinion/the-fdas-medical-device-problem.html?emc=edit_tnt_20150717&nlid=50639700&tntemail0=y&_r=0

Billion: That is $2.5 billion !!! Settlement is not justice for harmed patients!

DePuy to pay $2.5 billion for hips

Warsaw firm to settle thousands of implant lawsuits

Paul Wyche | The Journal Gazette  Published: May 31, 2014 3:00 a.m.

DePuy Orthopaedics, a unit of Johnson & Johnson, has waived its “walk-away rights,” which means the Warsaw company agrees to pay more than $2.5 billion to settle thousands of hip implant lawsuits, court documents show.

Officials at the medical device company have decided that enough plaintiffs exist to proceed with the settlement, according to paperwork filed last week with the U.S. District Court for the Northern District of Ohio in Toledo.

“While Settlement Program enrollment forms are still being processed, most (eligible) patients have opted into the program,” court documents stated.

“The company is, therefore, moving forward before the June 1 decision deadline provided for in the Agreement. The exact timing and amount of compensation will depend on a number of factors and circumstances specific to each claim,” the documents continued.

“However, eligible patients with allowed claims can expect payment now that there is certainty the program is moving forward,” the court papers said.

In November, the parent company agreed to pay plaintiffs who received the DePuy-made ASR hip implants.

The settlement gives money to patients based on several factors, including age, extent of injuries and whether they had to replace the defective implant. That agreement set the base rate at $250,000 per patient.

The DePuy ASR recall was announced in August 2010 after post-market data indicated that 12 percent to 13 percent of recipients required revision surgery within five years, according to Bernstein Liebhard, a New York law firm offering free legal evaluations to patients.

Attorneys with Bernstein Liebhard said that by the time the recall was announced, nearly 100,000 people worldwide had received the devices. Evidence revealed during DePuy ASR lawsuit trials indicated that the implant’s actual failure rate may be closer to 5 percent.

Other circumstances could entitle plaintiffs to a supplemental award if, for example, they required multiple revision surgeries, or if they experience “certain extraordinary injuries” in the future, attorneys said.

“DePuy remains committed to the well-being of ASR patients, as demonstrated by the worldwide voluntary recall and the global Broadspire program providing support for recall-related care,” said Mindy Tinsley, a DePuy spokeswoman, in an email Friday.

Broadspire is an independent, third-party claims processor available to patients not eligible for the U.S. Settlement Program, DePuy said.

pwyche@jg.net

NPR: Johnson and Johnson $2 Billion Settlement for failed hip (metal toxicity)

http://www.npr.org/2014/01/07/260409045/patients-consumer-advocates-question-hip-implant-settlement

Patients, Consumer Advocates Question Hip Implant Settlement

by ROB STEIN


January 07, 2014 4:29 AM

Lawyers for thousands of patients who had to have their defective hip replacements removed have reached a settlement with the company that made the faulty device. Many patients, however, aren't satisfied, and consumer advocates say the case illustrates what's wrong with how the government regulates implantable medical devices.

Listen to the Story  5 min 54 sec

Morning Edition

RENEE MONTAGNE, HOST:


The company that made a defective artificial hip has agreed to pay more than $2 billion to thousands of patients who had to have those implants replaced. But some patients are questioning whether the settlement is enough. Consumer advocates say the deal with Johnson & Johnson does nothing to prevent faulty medical implants from getting on the market in the future.


NPR's Rob Stein reports.


ROB STEIN, BYLINE: Mary Schrag is 69 and lives outside Seattle. Life has been a struggle since she got the defective metal joint implanted in her hip.


MARY SCHRAG: I'm still in a lot of pain in my back and my hips because I'm not really able to walk steadily. And I do feel very depressed because I - it's just trying to get through another day.


STEIN: And that's even after Schrag went through a complicated operation to have the implant replaced. She used to work, travel and hike. Now she has a hard time just standing up and can barely walk with a cane. She needs a wheelchair to go shopping.


SCHRAG: All I know is I'm just - I feel like I've been living in a hell for many, many years. My life just will never be the same.


STEIN: Schrag is one if about 8,000 patients who are candidates for compensation through the settlement with Johnson & Johnson, which owns the company that made the defective hip. Steven Skikos is a San Francisco attorney who helped negotiate the deal for the patients.


STEVEN SKIKOS: Those patients who had the implant taken out are eligible to participate in a settlement that amounts to two and a half billion dollars. And those patients are available to receive compensation, which is essentially around $250,000.


STEIN: The deal also pays patients' bills for getting their implants replaced and sets up a $475 million pool for those who suffered the worst complications. But the exact amount each patient gets could end up being higher or lower, depending on things like how long they had the bad hips, their age, their weight. Many patients would probably get about $160,000.


SKIKOS: There's no amount of money that, for a lot of these patients, will compensate for what they've been through. But the truth is, is that in terms of the negotiation of this particular agreement, there was no penny left on the table.


STEIN: Some patients are happy with the deal. Jeanette Trout is 66 and lives in Manchester, Pennsylvania. She's expecting about $165,000.


JEANETTE TROUT: I'm tickled to death with the money I'm getting. It's going to help me tremendously. I mean this - this is God-sent. This is God-sent.


STEIN: But some patients feel betrayed. Some are angry that lawyers are getting about $800 million. Others say the amount of money it looks like they'd get won't come close to making up for their suffering and any future medical bills they may have. Mary Schrag.


SCHRAG: I really do not think it's fair. I truly, truly don't. This has jeopardized my life and my health indefinitely.


STEIN: And patients aren't the only ones who aren't satisfied. Lisa McGiffert is with the Consumer's Union Safe Patient Project. She says the settlement does nothing for thousands of other people who also got the defective joints.


LISA MCGIFFERT: There are about 27,000 other people who got this particular brand of hip who are not included in this settlement.


STEIN: Not included because they haven't had their hips replaced yet or filed lawsuits, and there are thousands more who got similar devices. And, McGiffert says, the settlement does nothing to prevent another defective medical implant from destroying more lives in the future.


MCGIFFERT: I think the settlement is inadequate to address the fundamental flaws in this market.


STEIN: McGiffert says implants like artificial hips and knees can get approval without thorough safety studies if they are similar to other products already on the market.


MCGIFFERT: We think that all medical devices that are implanted in the body - that is, it takes surgery to put them in, it takes surgery to take them out - that those devices should have to go through rigorous testing that requires some clinical evidence that they are safe.


STEIN: And that every device should come with a warranty and be tracked closely to catch any problems more quickly. But the medical implant industry disputes all of this. David Nexon of the Advanced Medical Technology Association says the current system insures safety without stifling innovation.


DAVID NEXON: No process is perfect and sometimes things turn up that weren't detected when FDA reviewed it or when the manufacturer developed it. But by and large, patients can be very confident that the medical devices that are used in their procedures are very safe products.


STEIN: Johnson & Johnson would not make anyone available for an interview. In a statement, the company said the settlement was fair. Steven Skikos, the attorney who negotiated the deal, said the lawyers got patients the most they could.


SKIKOS: Every element of this was very hard fought, so I can say with confidence that the lawyers who put this together put together the best deal possible under these circumstances.


STEIN: Skikos says the lawyers will help any patients who need to have their hips replaced in the future get compensated. In the meantime, those who are eligible for this settlement have until April to decide whether to accept it or keep fighting for more. Rob Stein, NPR News.


Copyright © 2014 NPR. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to NPR. This transcript is provided for personal, noncommercial use only, pursuant to our Terms of Use. Any other use requires NPR's prior permission. Visit our permissions page for further information.


NPR transcripts are created on a rush deadline by a contractor for NPR, and accuracy and availability may vary. This text may not be in its final form and may be updated or revised in the future. Please be aware that the authoritative record of NPR's programming is the audio.

“You get a better chance of getting a letter from your car manufacturer if your car is recalled than you do if your hip has been recalled.”  Stanford University Chairman of Orthopedic Surgery

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.
___________________________________
More information:

___________________________________

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.

###

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

Mindy Tinsley
574-372-7136
mtinsley@its.jnj.com

Investor Contacts:
Louise Mehrotra
732-524-6491
LMehrot@its.jnj.com

Lesley Fishman

732-524-3922

LFishma@its.jnj.com

___________________________________________________________________

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

__________________________________________________________________________________

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

Read More
_____________________________________________

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

J&J Patient Harm: Too Big To Fail / Jail ?

New York Times FULL ARTICLE and trial video

During Trial, New Details Emerge About Hip Maker

By BARRY MEIER

Published: January 30, 2013

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

Multimedia

Andrew Ekdahl Testifies

CLOSE VIDEO

 

See More Videos »

But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.

In addition, the executive also held a senior marketing position at a time when Johnson & Johnson decided not to tell officials outside the United States that American regulators had refused to allow sale of a version of the artificial hip in this country.

The details about the involvement of the executive, Andrew Ekdahl, with the all-metal hip implant emerged Wednesday in Los Angeles Superior Court during the trial of a patient lawsuit against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 lawsuits have been filed against DePuy in connection with the device — the Articular Surface Replacement, or A.S.R. — and the Los Angeles case is the first to go to trial.

The information about the depth of Mr. Ekdahl’s involvement with the implant may raise questions about DePuy’s ability to put the A.S.R. episode behind it.

Asked in an e-mail why the company had promoted Mr. Ekdahl, a DePuy spokeswoman, Lorie Gawreluk, said the company “seeks the most accomplished and competent people for the job.”

On Wednesday, portions of Mr. Ekdahl’s videotaped testimony were shown to jurors in the Los Angeles case. Other top DePuy marketing executives who played roles in the A.S.R. development are expected to testify in coming days. Mr. Ekdahl, when pressed in the taped questioning on whether DePuy had recalled the A.S.R. because it was unsafe, repeatedly responded that the company had recalled it “because it did not meet the clinical standards we wanted in the marketplace.”

Before the device’s recall in mid-2010, Mr. Ekdahl and those executives all publicly asserted that the device was performing extremely well. But internal documents that have become public as a result of litigation conflict with such statements.

In late 2008, for example, a surgeon who served as one of DePuy’s top consultants told Mr. Ekdahl and two other DePuy marketing officials that he was concerned about the cup component of the A.S.R. and believed it should be “redesigned.” At the time, DePuy was aggressively promoting the device in the United States as a breakthrough and it was being implanted into thousands of patients.

“My thoughts would be that DePuy should at least de-emphasize the A.S.R. cup while the clinical results are studied,” that consultant, Dr. William Griffin, wrote.

A spokesman for Dr. Griffin said he was not available for comment.

The A.S.R., whose cup and ball components were both made of metal, was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version of the A.S.R. for use here in standard hip replacement that used the same cup component as the resurfacing device. Only the standard A.S.R. was sold in the United States; both versions were sold outside the country.

Before the device recall in mid-2010, about 93,000 patients worldwide received an A.S.R., about a third of them in this country. Internal DePuy projections estimate that it will fail in 40 percent of those patients within five years; a rate eight times higher than for many other hip devices.

Mr. Ekdahl testified via tape Wednesday that he had been placed in charge of the 2005 introduction of the standard version of the A.S.R. in this country. Within three years, he and other DePuy executives were receiving reports that the device was failing prematurely at higher than expected rates, apparently because of problems related to the cup’s design, documents disclosed during the trial indicate.

Along with other DePuy executives, he also participated in a meeting that resulted in a proposal to redesign the A.S.R. cup. But that plan was dropped, apparently because sales of the implant had not justified the expense, DePuy documents indicate.

In the face of growing complaints from surgeons about the A.S.R., DePuy officials maintained that the problems were related to how surgeons were implanting the cup, not from any design flaw. But in early 2009, a DePuy executive wrote to Mr. Ekdahl and other marketing officials that the early failures of the A.S.R. resurfacing device and the A.S.R. traditional implant, known as the XL, were most likely design-related.

“The issue seen with A.S.R. and XL today, over five years post-launch, are most likely linked to the inherent design of the product and that is something we should recognize,” that executive, Raphael Pascaud wrote in March 2009.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The F.D.A. also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant.

During a part of that period, Mr. Ekdahl was overseeing sales in Europe and other regions for DePuy. When The Times article appeared last year, he issued a statement, saying that any implication that the F.D.A. had determined there were safety issues with the A.S.R. was “simply untrue.” “This was purely a business decision,” Mr. Ekdahl stated at that time.

This article has been revised to reflect the following correction:

Correction: February 1, 2013

A headline on Thursday about a patient lawsuit against DePuy Orthopaedics, a unit of Johnson & Johnson, misstated the start of the trial in some copies. It began last week, not on Wednesday.

original post - During Trial, New Details Emerge About Hip Make
r

By BARRY MEIER

Published: January 30, 2013

When Johnson & Johnson announced the appointment in 2011 of an executive to head the troubled orthopedics division whose badly flawed artificial hip had been recalled, the company billed the move as a fresh start.

But that same executive, it turns out, had supervised the implant’s introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.