Gender targeting by (sometimes criminal) medical device industry? Breast implants, birth control, transvaginal surgical mesh?

Maker of faulty French breast implants given fouryears in jail

BY JEAN-FRANCOIS ROSNOBLET AND ALEXANDRIA SAGE

MARSEILLE/PARIS Tue Dec 10, 2013 8:00am EST Reuters FiDA highlight

(Reuters) - The founder of a French breast implant company was sentenced to four years in prison on Tuesday for hiding the true nature of the sub-standard silicone used in implants sold to 300,000 women around the world.

Jean-Claude Mas, 74, founder and long-time chief executive of Poly Implant Prothese (PIP), was prosecuted after a worldwide panic in 2011 when France recommended that women with such implants should have them removed due to an abnormally high rupture rate.

Worries about the implants launched a flurry of international lawsuits and prompted calls for Europe to toughen controls on medical devices and fix its fractured oversight system.

Once the third-largest global supplier of breast implants, the company was shut in 2010 and its implants ordered off the market after inspectors pursuing a tip-off discovered vats of industrial-grade silicone outside the PIP factory in the southern town of La-Seyne-sur-Mer.

A Marseille criminal court also ordered Mas, who had been pursued for aggravated fraud, to pay a 75,000-euro ($103,000) fine. His lawyer, Yves Haddad, said he would appeal.

Four other executives, including the chief financial officer, were sentenced to between one-and-a-half and three years in prison, some of it suspended, and fined.

"It's a strong signal. This decision is what victims were waiting for," said one of their lawyers, Philippe Courtois.

The president of a PIP victims group, Alexandra Blachere, called it a "symbolic sentence" that challenged any prejudice that there was "a ditzy bimbo behind every pair of silicone breasts."

The two-month trial in April and May was held in an exhibition center to accommodate the 7,400 civil plaintiffs and 300 lawyers. Jeers from the crowd greeted Mas' appearance in the makeshift courtroom.

For less serious felonies in France, the criminal court hands down a sentence without pronouncing a guilty or not guilty verdict, which is implicit.

HIDDEN EVIDENCE

Mas admitted using silicone created by trial and error that was never approved by regulators and which cost a seventh of the price of silicone approved for use in medical devices.

He has insisted the gel he had relied on since the founding of the company in 1991 was non-toxic and has said women who complain about their PIP implants are "fragile people, or people who are doing it for the money."

A police investigation revealed a sophisticated fraud at PIP, which managed to conceal the implants' ingredients from regulators, thereby allowing them to be sold on international markets.

Before annual audits to the PIP factory by private certification company TUV Rheinland, employees would clear away evidence of the cheaper gel it used to fill implants.

For a special report on the PIP scandal, click here:

TUV sued PIP for fraud, but a French court ruled last month the German company had failed in its obligations of "vigilance and caution" and ordered it to pay 3,000 euros to each of the 1,600 plaintiffs, women wearing PIP implants who had sued.

Health experts insist that no link has been established between PIP implants and breast cancer.

Still, women around the world with PIP implants, whether in Venezuela, France or Britain, have rushed to their surgeons to have them removed, fearing health complications.

Since France recommended removal, some 14,729 women in France - nearly half of all French women with PIP implants - have chosen this option, according to French regulators.

Regulators say a quarter of PIP implants removed were found to be faulty, most having ruptured.

Only one case of anaplastic large cell lymphoma, a rare type of cancer originating in the lymphatic system, has been documented in France from a women wearing PIP implants.

National health agencies have given differing advice. While France and Venezuela offered to reimburse women who have their PIP implants removed, other countries, such as Britain, recommended that women merely have them checked.

Other legal cases related to PIP are still pending in France, including one related to the 2010 death of a woman wearing PIP implants. Another relates to tax fraud by Mas, his former girlfriend and Chief Executive Claude Couty.

(Writing By Alexandria Sage; Editing by Mark John and Ruth Pitchford)

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.

Huzzah! Canadian Patient Outcomes Research on Joint Replacement: U.S. PCORI=none?

New Hips More Troublesome in RA ThanOA

 Published: Nov 21, 2013

 By Nancy Walsh, Staff Writer, MedPage Today

Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania

 Action Points

         Note that this large cohort study of Canadian recipients of hip or knee replacements demonstrated higher complication rates among those with rheumatoid arthritis compared with those with osteoarthritis.

         Be aware that there may be unmeasured confounders that could affect the interpretation of these results -- for example the degree of immunomodulatory therapy received by the RA group.

Patients with rheumatoid arthritis were at higher risk than those with osteoarthritis for adverse outcomes following joint replacement surgery, a Canadian study found.

After adjustment for potential confounders, having a diagnosis of rheumatoid arthritis was a significant and independent predictor of dislocation following total hip arthroplasty, with a risk almost double that for osteoarthritis (HR 1.91, 95% CI 1.29-2.82, P=0.001), according to Bheeshma Ravi, MD, of the University of Toronto, and colleagues.

Patients with rheumatoid arthritis also were at greater risk for developing an infection after total knee arthroplasty (HR 1.52, 95% CI 1.11-2.09, P=0.03), the researchers reported online in Arthritis & Rheumatism.

"Over the last decade, the age-sex standardized rates of total hip arthroplasty and total knee arthroplasty have increased in North America by approximately 25% and 65%, respectively," wrote Ravi and colleagues.

These surgeries have been linked with a risk -- albeit small -- for serious complications including dislocation, infection, venous thromboembolism, and even death.

However, most data on these complications have been drawn from the patient population with osteoarthritis, and little is known about risks for those with rheumatoid arthritis, a much different disease in its causes, prognosis, and treatment.

The researchers previously conducted a systematic review and meta-analysis in an effort to fill this knowledge gap, but were hampered by limitations in many studies such as the possibility of diagnostic misclassification and lack of adjustment for confounders.

Therefore, they undertook a study in which they analyzed data from the Canadian Institute for Health Information Discharge Abstract Database, identifying patients with a primary elective hip or knee replacement between April 2002 and March 2009.

The diagnosis of rheumatoid arthritis was confirmed using an algorithm that necessitated hospitalization with a diagnostic code specifically for rheumatoid arthritis or three physician claims, at least one being from a specialist such as a rheumatologist or orthopedic surgeon, within the previous 2 years.

This validated algorithm has a specificity of 100% and a sensitivity of 78%.

The researchers adjusted for patient age, gender, income, residence, and comorbidities such as congestive heart failure and diabetes.

They also controlled for frailty, which has been linked with loss of muscle strength and immune system abnormalities and therefore could contribute to dislocation and infection.

During the study period, there were 89,713 knee and 60,305 hip arthroplasties performed in Ontario. A total of 3% of the hip replacements and 4% of the knee surgeries were in patients with rheumatoid arthritis.

Compared with recipients with osteoarthritis, those with rheumatoid arthritis were younger, more often women and frail, and had more comorbidities.

They also were more likely to have any type of complication following surgery (5.7% versus 4.7%, P=0.01), but less likely to develop venous thromboembolism (HR 0.35, 95% CI 0.15-0.82, P=0.02).

The lower risk for venous thromboembolism was unexpected, according to the researchers, and may reflect selection bias.

Among all patients experiencing a dislocation within 2 years, the median time to the event was 211 days for rheumatoid arthritis compared with 263 days for osteoarthritis.

And among those who developed articular infections, the median time to the event was 196 days for rheumatoid arthritis compared with 468 days for osteoarthritis.

The researchers noted that dislocation within a short time of total hip arthroplasty is a "serious complication."

"In addition to being very painful and necessitating revision arthroplasty and/or aggressive rehabilitation following closed reduction, it is estimated that dislocations increase the hospital costs of a primary total hip arthroplasty by over 300%," they observed.

Possible reasons why patients with rheumatoid arthritis were more likely to experience this complication were the use of smaller implants and different surgical techniques, along with disease-related factors such as acetabular protrusion and soft tissue problems.

Explanations for why infections were more common in the rheumatoid group included the use of immunomodulatory treatments, but it wasn't clear why the increased risk was only for knee replacement and not also for the hip.

Strengths of the study included the specificity of the algorithm used for diagnosis and large patient population, while limitations were the lack of information about the specific implants used and the possibility of unmeasured confounders.

"As both dislocation and infection lead to significant morbidity and drastically increase healthcare costs, research is warranted to elucidate explanations for this increased risk among patients with rheumatoid arthritis. This information will be valuable to inform patient management decisions, including the development and implementation of strategies designed to target modifiable risk factors," Ravi and colleagues concluded.

The study was supported by the Canadian Institutes of Health Research.

The authors reported no conflicts of interest.

Primary source: Arthritis & Rheumatism
Source reference: Ravi B, et al "Patients with rheumatoid arthritis are at increased risk for complications following total joint arthroplasty" Arthritis Rheum 2013; DOIi: 10.1002/art.38231.

Essure: Hazardous Birth Control Implant?

Warning: This Birth Control ProductMay Be Hazardous to Your Health

Posted: 11/19/2013 1:36 pm

 by guest blogger Diana Zuckerman, PhD, president of the National Research Center for Women & Families

"Was I just unlucky, or is this medical product not really safe?" That's a question I get asked often, and was recently asked about Essure, a "permanent birth control" device made by Bayer.

At first it seemed these women were just unlucky. But after gathering more information, it now looks like there could be much greater risks than patients are being advised of.

In case you're wondering, permanent birth control means sterilization. The purpose of Essure is to prevent a woman from ever getting pregnant again. For some women, preventing any future pregnancies could save their lives. So it is obviously a problem when Essure doesn't work and women get pregnant, which was one of the problems I heard about. But I also heard from women who were in terrible, unrelenting pain, feeling that their lives had been ruined by this product.

Since National Research Center for Women and Families is known as an objective source of medical information and isn't on the payroll of any companies, the women asked, "What do you know?" and "Is this product really safe, or are there a lot of other women like me?" And also, "Can you warn other women?"

The Food and Drug Administration (FDA) has much lower standards for medical implants than it does for prescription drugs, so I checked out Essure on the FDA website and was pleasantly surprised to see that the FDA had required clinical trials, which the agency often doesn't require for implants. These studies of women with Essure implants showed that Essure patients had a rather low rate of complications.

The studies showed that the main problem was that sometimes the device fell out. If the woman didn't realize it, she could get pregnant. If she did realize it, she'd need to get a replacement implant or use another type of birth control.

There was about a 5 percent rate of serious complications reported--not great (especially if a complication happens to somebody we care about), but not a bad rate, either. Since all birth control has some risks (such as potentially fatal blood clots), and since pregnancy has rather substantial health risks (an even greater risk of potentially fatal blood clots), the studies of Essure seemed reassuring (no pun intended).

Sometimes studies can be deceiving, however, especially when conducted by the company trying to sell you the product. An NBC news investigative team interviewed Kim Hudak, one of the women in the study who has had terrible pain in the years since she got Essure. The reporters found that the telephone surveys and medical visits that were used to provide data for the company's study had yielded information about her terrible health problems after Essure but hadn't counted them as complications. The health professionals conducting the study had made very subjective decisions: for example, that excruciating pain in the same part of her body as the Essure device somehow was unrelated to Essure and therefore needn't be counted as a complication. Instead, they reported Kim's experience with Essure as "excellent" and Kim as "very satisfied." Meanwhile, Kim was in excruciating pain--and had gained 100 pounds from the medications she was given as doctors tried to figure out what was wrong. Kim told me that she thought her health problems might possibly be caused by Essure but believed the doctor when he told her they weren't.

Eventually, Kim was in so much pain that she ignored the doctor's advice and had her Essure implant removed. Kim told me that her health has dramatically improved ever since, and she has lost most of the weight she had gained.

This is not the story of one woman. It's a story about how poorly conducted research provides inaccurate information that can potentially harm thousands if not millions of patients. Whether the study was intentionally fraudulent or just badly conducted by some of the medical professionals involved, the results are the same for Kim and anyone misled by the completely inaccurate reporting of her terrible medical problems. The fact that Bayer was accused just two years ago of covering up deaths from Yasmin, another one of its birth control products, does add extra drama. Can the company's studies be trusted? And should the FDA do a better job of scrutinizing them?

It doesn't take much to monitor these studies. For example, you can see in Kim's study survey where her health problems were clearly written and then somebody crossed them out, added his or her initials to show this was an official revision, and changed the answer from "Yes" (I have health problems since getting Essure) to "No." The woman interviewing Kim also checked "excellent" and "very satisfied."

If that had only happened to Kim and nobody else, then perhaps Essure could be almost as safe as the company reported. But the same people who collected data on Kim also "studied" other women, so it's likely that such changes and inaccuracies happened numerous times. That would mean that FDA's decision to approve Essure was based on inaccurate information.

Instead of monitoring the company's studies, unfortunately, the FDA has defended them. While the NBC investigative reporters were gathering information, the FDA wrote a new article for its website defending the safety of Essure.

As a person who uses medical products, what can you do to make sure you aren't harmed by implants or medications that aren't really safe? There is no easy answer. But there are a few things you can do:

.                Before starting a new medication or agreeing to a new medical implant or device, go online. Go to your favorite search engine and type in the name of the product and the word "problems" or "risks" or "complications." That will usually take you to web pages that list the possible problems with the product. You can even go to the official website for the product. Although a company's website will advertise how great the product is, by law the company is also required to list all the possible complications that the FDA has found. This isn't a perfect source of information (as my Essure example shows), but it will provide some warnings of what the risks are.

.                For prescription drugs, you can also go the ConsumerReport.org's Best Buy Drugs website to get information that compares the drug you are considering with other drugs that can be used for the same purpose. The site doesn't have information about all drugs, but it does have good comparison information about many widely used drugs.

.                Check out www.center4research.org and www.stopcancerfund.org for information about many drugs and devices. And, if you are having trouble finding the information you're looking for, you can contact our Center's free hotline at info@center4research.org to ask us. You'll receive a free, personal response within days.

One more thing to remember: The newest medical products are often not the best, even though they're the most expensive. FDA approves new medical products on the basis of information that is provided by the company making the product. It isn't until the product has been used by many thousands of patients in the real world that it's possible to learn what all the risks are and how it compares to other treatments.

Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals as well as in newspapers across the country.

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

Mindy Tinsley
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Lesley Fishman

732-524-3922

LFishma@its.jnj.com

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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

Read More
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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