J&J Sold Pelvic Mesh While Concealing Risks: Washington State Attorney General

• AG FILES MAJOR LAWSUIT AGAINST JOHNSON & JOHNSON OVER CONCEALED RISKS OF PELVIC MESH

• FOR IMMEDIATE RELEASE: 

May 24 2016  FiDA highlight

Complications left women permanently disabled, in chronic pain

SEATTLE — Attorney General Bob Ferguson filed a consumer protection lawsuit today against Johnson & Johnson, accusing the company of knowingly concealing the risks associated with a surgical mesh designed to treat pelvic floor conditions in women. As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.

These complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible.

“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”

The lawsuit alleges thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors. The attorney general will ask the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.

The state alleges tens of thousands of violations of the CPA, potentially placing penalties well into the millions of dollars.

Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.

The mesh is made of woven polypropylene threads, and is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.

The mesh is inserted surgically, and is put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and finally permanently anchoring it in the body to hold up falling organs.

The mesh, its construction and infection-ridden insertion through the vagina have caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The mesh can shift position and cut through the vaginal wall or into other organs.

One patient shared this about her ordeal:

“I experienced excruciating pain from day one. I felt as though my urethra was being strangled, I couldn’t pee, walking was out of the question, sitting was agony, & I couldn’t lie on my left side due to severe pain and numbness at my left groin area.  Over the course of the next 14 weeks I visited/was admitted to the [hospital] 10 times. … I had no quality of life.  My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’  … I still suffer left side groin pain and numbness, buttock pain, sharp pains in my lower stomach and I am less continent now than I was pre-op.” 

A doctor described in a 2009 email to Johnson & Johnson: “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician.  She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere. … This patient will have a permanently destroyed vagina.”  

The company never told consumers that the mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material.

The company never told consumers that mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.

The company never told consumers that severe erosion — or a complication where the mesh moves and protrudes into an organ or through the vaginal wall — causing chronic pain and dyspareunia, or painful intercourse, is a common complication.

One patient said, “[I] had all kinds of problems with chronic pain, bleeding, dyspareunia (even my husband complained of scraping and poking)…The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent and miserable sex, and marital problems was almost more than I could bear.”

And the company never told consumers that this risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.

Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.

This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.

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The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Attorney General Bob Ferguson is working hard to protect consumers and seniors against fraud, keep our communities safe, protect our environment and stand up for our veterans. Visit www.atg.wa.gov to learn more.

- See more at: http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh#sthash.V0tz1X8g.Myhh7sWx.dpuf

http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh

Peter Lavallee, Communications Director, (360) 586-0725; PeterL@atg.wa.gov

AU "living nightmare" with J&J Prolift pelvic mesh!

'We've lost so much': Senate urged to act on failures over mesh device implants

April 13, 2016 - 8:15PM

Joanne McCarthy (FiDA highlights)

EXCLUSIVE

Five years ago Gai Thompson warned Australia's peak health bodies of a looming disaster involving women receiving mesh device implants to treat common problems after pregnancy, birth and hysterectomies.

This week Mrs Thompson and others are speaking publicly for the first time as they plan a rally in Canberra and call for a formal inquiry into the health regulators and medical bodies they say have failed them.

They are the women who, in many cases, can no longer have sex, have lost their jobs, have had to mortgage or sell their homes, have travelled overseas for surgery to remove the mesh, have suffered excruciating chronic pain, are resistant to some antibiotics because of chronic infections, and have suffered in isolation and silence – often for years.

"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson said.

In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of up to $12.5 million. In Australia the response from women has been slower because of fewer numbers and isolation, but it is growing, says Australian Pelvic Mesh Support Group founder Caz Chisholm.

A planned rally by her group in Canberra in late May will target one of Australia's peak health regulators, the Therapeutic Goods Administration (TGA), which approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. Prolapse is where pelvic muscles and ligaments are weakened after pregnancy, birth or hysterectomy.

The TGA approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.

Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been "mature" and lacked "rigour". The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.

Mrs Thompson's life after mesh surgery in February, 2008, is reduced to a one-page incident report on the TGA website.

She is the woman whose adverse event report to the TGA in October, 2011 about the Johnson & Johnson Prolift mesh device, noted she could no longer have sex and her life after February, 2008 had become "a living nightmare".

The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.

She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.

It took almost exactly three years for the TGA to complete its investigation of Mrs Thompson's October, 2011 complaint, until it placed her adverse event report on its website in October, 2014.

This week she said she first contacted the TGA by phone in 2010, after two years of seeing different medical specialists to deal with the consequences of the surgery.

"You don't know where to complain when something like this happens. When I first phoned the TGA they said they'd had no other complaints. I kept ringing them. I kept saying to them 'What else have I got to do to get you to do something'?" she said.

"They just kept saying sorry, but I was the only complaint they had."

A Senate inquiry into Australia's health care complaints processes will consider a submission by a patient advocate arguing the complaints process has spectacularly failed women given transvaginal mesh devices to treat prolapse surgery.

While it is mandatory for manufacturers to report adverse events to the TGA, they have to be made aware of any adverse events experienced by women. The TGA has confirmed it is not mandatory for doctors to report adverse events experienced by patients.

Ms Chisholm and Mrs Thompson say the majority of women were completely unaware they could complain to the TGA, or even that mesh was classed as a "device" that came under the TGA.

When Mrs Thompson was told three or four years ago that she had irreversible nerve damage in her pelvis because of the mesh, she was advised she could try morphine patches to cope with the pain.

She rejected the idea. Her life is about managing pain and the stress that flows from it.

"I can't get up and down steps. I can't go out for a walk. I feel like I have barbed wire in my pelvis and every time I move it causes me pain," she said.

"To have one day pain free, when you've had years and years of chronic pain, is something I can't even imagine now."

The Therapeutic Goods Administration said it started monitoring urogynaecological meshes in 2008, with a review in 2010 that found complications were closely linked to the skill and training of surgeons.

By August 2014 after a clinical review it reassessed the clinical evidence for devices and took action against some manufacturers, including the cancellation of devices.

In a statement to the Newcastle Herald the TGA said it had strengthened its oversight of new applications for mesh approvals, including conducting its own clinical assessment of the evidence rather than relying solely on European approvals as the basis for approval in Australia.

Johnson & Johnson was contacted for comment.

Newcastle Herald

http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html

Read more: http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html#ixzz45hzjwkUb 

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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 & 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 

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FDA Commissioner Dr. Califf: The Fox is in the Henhouse!

F.D.A. Asks If Faulty Blood Monitor Tainted Xarelto Approval

By KATIE THOMAS FEB. 22, 2016

The Food and Drug Administration is investigating whether a faulty blood-testing device may have compromised the results of a clinical trial that led to the approval of Xarelto, a blockbuster anticlotting drug that has been prescribed to millions of Americans since it arrived on the market in 2011.

The agency has asked the drug’s manufacturer, Johnson & Johnson, detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.

The clinical trial, known as Rocket AF, was led by Dr. Robert M. Califf, currently President Obama’s nominee for head of the Food and Drug Administration. It involved more than 14,000 patients worldwide and took place from 2006 to 2010.

Xarelto, which is also known by its scientific name, rivaroxaban, is one of a new class of drugs that are seen as a replacement for warfarin, a cumbersome 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation. Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that is working. If patients receive too little of the drug, they could experience a stroke. But if they receive too much, their lives could be threatened by catastrophic bleeding.

Questions about the trial have been stirring since last fall, when Johnson & Johnson and Bayer, which sells Xarelto overseas, notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding. The device, the INRatio sold by Alere, was used in the trial to help doctors gauge whether patients were getting the right dose of warfarin. The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto to those of patients who were given warfarin.

Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.

This month, researchers with the Duke Clinical Research Institute, which oversaw the trial, published their own analysis in the New England Journal of Medicine and concluded that the faulty device did not affect the trial’s outcome. A few days later, an analysis by the European Medicines Agency, the F.D.A.’s European counterpart, came to the same conclusion.

But rather than settling the matter, the analyses have raised additional questions and have come under harsh criticism from some medical experts. The Duke researchers, for example, never mentioned the existence of central laboratory tests — taken at two points during the trial — that could have been used to assess whether the device’s readings were accurate. And the analysis released by the European drug agency, while it did include those readings, was done by the companies themselves and not by independent statisticians.

“There are so many questions that are yet unaddressed,” said Dr. Harlan M. Krumholz, a cardiologist and director of the Yale University Open Data Access Project, which has an agreement with Johnson & Johnson to make the company’s data from clinical trials available to outside researchers. He has asked the company for access to the trial data, he said, and the company has agreed — but Bayer has refused.

Dr. Krumholz called on Alere to release more information about its device. “We do not know why the device did not work well,” he said.

In a statement, a spokeswoman for the F.D.A. said that while the agency was looking into the issue, it had not changed its recommendations for the drug, which “provides an important health benefit when used as directed.”

A spokeswoman for Alere declined to comment, and a representative for Duke referred to an earlier statement detailing the results of its reanalysis.

Johnson & Johnson said the INRatio device was selected because it was F.D.A.-approved and easy to use. It said it was not informed of the device recall until last September, when it and Bayer “acted with urgency, diligence and in the best interests of patients and prescribers.” The company said that it has provided answers to the questions the F.D.A. asked and that the analysis published in the New England Journal of Medicine confirmed the safety and efficacy of the drug.

A spokesman for Bayer said the company was confident in the results of the trial and dismissed the issue as being driven by plaintiffs’ lawyers, saying, “They have cherry-picked testimony and documents divorced from any context.”

Dr. Califf is the former director of the Duke Clinical Research Institute, which conducted the trial, and served as the study’s co-chairman. He has since left Duke and is now a deputy commissioner of the F.D.A. Dr. Califf, who did not respond to an email, has no role in the inquiry into the Rocket AF trial, the F.D.A. has said. The Senate was expected to vote Tuesday on whether to confirm his nomination as head of the agency.

Just as the trial was getting underway in 2006, the INRatio was facing scrutiny by the F.D.A. In 2005 and 2006, the agency sent warning letters to HemoSense, then the manufacturer of INRatio, claiming that the devices were generating “clinically significant” erroneous values and that the company, which was later acquired by Alere, was not properly investigating the complaints.

In 2014, Alere recalled the INRatio monitors, saying that they might provide inaccurate results.

However, the connection to the Rocket trial was not made public until this past fall, when a journalist for the British Medical Journal began asking the companies about it. A spokesman for Johnson & Johnson told the journal that the company had been unaware of the recall. The revelation led to the reanalysis by the Duke researchers as well as inquiries by the European Medicines Agency and the F.D.A.

But while the European agency concluded that the trial outcome was not affected by problems with the device, the F.D.A. appears to be taking a closer look, asking pointed questions about whether the company had evidence that the device was malfunctioning during the trial and what actions it took, according to the legal document, which was filed with Judge Eldon E. Fallon in the Eastern District of Louisiana.

The legal motion filed on Monday also cited internal emails that, the lawyers said, showed that some doctors were questioning the accuracy of the device while the trial was underway. The lawyers said so many concerns were raised about the device that a special program was set up to investigate the malfunctions, but none of these details were provided to the F.D.A. when Johnson & Johnson responded to the agency this month.

The Rocket trial has previously come under criticism. In 2011, the F.D.A.’s medical reviewers recommended against approval of Xarelto, citing concerns that the patients receiving warfarin during the trial were being poorly managed, which could give an unfair advantage to Xarelto.

An outside advisory committee later voted to approve the drug — although several members cited reservations — and the agency allowed it to go on the market. It has since become the best-selling drug in its class, bringing in $1.9 billion in the United States in 2015, according to Johnson & Johnson.

Some said the fact that Xarelto has been on the market since 2011 gave them faith in the safety of the product. “The real world has already made the case for this drug,” said Dr. Jürgen vom Dahl, a German cardiologist who served as an investigator in the trial, who said he did not recall encountering any problems with the device.

Dr. vom Dahl also said that he and his German colleagues have wondered whether Dr. Califf’s F.D.A. nomination was playing a role in the renewed questions about the trial. “We don’t know what is real science, and what is more politics,” he said.

But others say that plenty of questions remain, and that they are disheartened by a seeming reluctance by Duke, Johnson & Johnson and Bayer to be forthright about the problem.

“It depends on where you put the flashlight,” said Robert Powell, a clinical pharmacologist who has worked in the drug industry, as well as for six years at the F.D.A. “I think they were directing people away from the problem.”

Sabrina Tavernise contributed reporting.

Any COI? Dr. Robert Califf: FDA Commissioner and former Duke University researcher.

Document Claims Drug Makers Deceived a Top Medical Journal

By KATIE THOMAS MARCH 1, 2016

It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?

Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.

Duke and Johnson & Johnson contend that they worked independently of each other. Bayer declined to comment. And top editors at The New England Journal of Medicine said they did not know that separate laboratory data existed until a reporter contacted them last week, but they dismissed its relevance and said they stood by the article’s analysis.

But the claim — that industry influence led to the concealing of data — carries echoes, some experts said, of an earlier era of drug marketing, when crucial clinical data went missing from journal articles, leading to high-profile corrections and a wave of ethics policies to limit the influence of drug companies on medical literature.

“It just feels like it’s a real ethical breach,” said Dr. Lisa Schwartz, a professor of medicine at Dartmouth, of the failure to include the lab data in the letter. “If you know the direct answer to this question, then how can you not provide it to be able to give insight?”

Xarelto, which is sold in the United States by Johnson & Johnson and overseas by Bayer, had nearly $2 billion in United States sales last year and is the best seller in a new category of drugs seeking to replace warfarin, an older blood thinner. The two companies hired the Duke Clinical Research Institute to run a three-year clinical trial involving more than 14,000 patients that led to Xarelto’s approval by regulators. But those results have come under scrutiny since September, when the companies notified regulators that a blood-testing device used in the study had malfunctioned.

The trial compared the number of strokes and bleeding events experienced by patients taking Xarelto with those of patients using warfarin. The concern is that the faulty results may have led doctors to give patients the wrong dose of warfarin, which could have favored Xarelto.

Last month the Duke researchers published an analysis in The New England Journal of Medicine and concluded that the problems with the device did not change the trial’s results.

But some in the medical community questioned their findings because their method required them to essentially guess which groups of patients were more likely to be affected by the malfunctioning device.

A better way to evaluate the device, other researchers said, would be to compare the device readings with test results that were done at a central laboratory. Investigators did that at two points in the trial, drawing blood from more than 5,000 of the patients who took warfarin and sending the samples for testing. The blood was taken 12 and 24 weeks after patients enrolled in the trial.

But the Duke researchers made no mention of the lab data in their letter. In an interview, journal editors said they did not know about the lab data until last Tuesday, when a reporter for The New York Times asked them about it.

“At the time we published the letter, we didn’t know that it existed,” said Dr. Jeffrey M. Drazen, editor in chief of The New England Journal of Medicine.

Dr. Drazen disputed the lawyers’ claim that the editors had been misled about the data, and said it was not relevant to the letter that was published.

Last week, lawyers in the case against Johnson & Johnson and Bayer filed a legal brief in federal court in New Orleans, asking a judge to unseal documents in the case, which involves more than 5,000 lawsuits filed by patients and their families who claim they were harmed by Xarelto. Of those, 500 involve patient deaths.

In a footnote, the lawyers said that during the process of vetting the Duke researchers’ letter, a peer reviewer asked about the existence of lab data that would allow a comparison with the device’s readings.

“Despite being provided this opportunity to respond to the peer reviewers,” the lawyers said, the “defendants remained silent on this point, thereby misleading the NEJM.”

Dr. Drazen confirmed that a peer reviewer, whose identities are kept confidential, had asked about such data, but said the editors had rephrased the question to ask whether such data was available throughout the course of the trial. Duke then answered no, he said.

The letter’s three authors, two from Duke and one affiliated with the University of Edinburgh in Scotland, declined to comment, as did a spokesman for Duke.

Dr. Drazen questioned the value of comparing lab results taken at only two points during the trial, noting that people’s blood-clotting levels can vary greatly over time. “There’s so much variation among people that it probably wouldn’t be clinically informative,” he said.

However, he said, the Duke researchers had since agreed to conduct an analysis of the lab data.

Dr. Drazen also said that the editors had not been in contact with either Johnson & Johnson or Bayer. A spokeswoman for Johnson & Johnson said the analysis by Duke was conducted independently of the company. Although a company employee serves on the trial’s executive committee, she said he recused himself “from the conduct of the reanalysis, the drafting of the research letter, and provided no feedback before it was submitted.” Bayer declined to comment.

In a previous statement, Duke said it had conducted its research separately from the two companies. But this fall, Bayer submitted an analysis to the European Medicines Agency that was nearly identical to the approach used by the Duke researchers, comparing the outcomes of patients who had specific medical conditions with outcomes of those who did not. And the legal document filed last week cites a document obtained from one of the companies that describes the peer-review process.

Some experts say this case is reminiscent of other instances in which drug companies concealed or altered drug-trial data in medical journals. In 2005, for example, The New England Journal of Medicine published a rare Expression of Concern after it learned that researchers had failed to include three heart attacks in a study of the painkiller Vioxx, made by Merck, which has since been withdrawn from the market. In that case, editors learned that data had been deleted from the trial manuscript two days before it was submitted to the journal.

Such controversies led to changes in the way that journal articles are published. Authors are now required to disclose their outside financial interests and the role that drug companies played in articles’ publication.

Several researchers said they were surprised that Duke and the editors at the journal did not see value in comparing the lab data, especially since Bayer and Johnson & Johnson have submitted such information to regulators in Europe and the United States.

“I think it’s always important to make sure that you have all the information to answer the scientific question before publication,” said Dr. Rita F. Redberg, a cardiologist who is also editor of the medical journal JAMA Internal Medicine.

Less than a week after the Duke letter was published, the European Medicines Agency released its own report, which contained analyses using the independent lab comparisons. The agency concluded the device most likely did not affect the trial’s outcome, but it did find that the device was highly inaccurate.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, served on the Food and Drug Administration advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He expressed doubt that any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial,” he said.

J&J Tylenol product: 38 years of harm-for-profit?

How Much Acetaminophen a Day is Safe? Canada May Decide It’s Less

After an investigation by the Toronto Star, Canada’s top health agency considers whether to lower the maximum recommended daily dose of the active ingredient in Tylenol and other painkillers.

by T. Christian Miller and Jeff Gerth

ProPublica, July 15, 2015, 12:08 p.m.

Canada’s top health agency is considering lowering the maximum recommended daily dose of acetaminophen, the active ingredient in Tylenol and other pain relievers.

Citing the risk of liver damage from overdosing on the popular pain medication, Health Canada announced it will review changes to labels, the creation of an educational awareness campaign and possible revisions to dosage recommendations.

Acetaminophen is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. In severe cases, acetaminophen overdose can cause death.

“Our goal is that we will have fewer effects on liver, less hospitalization, less instances of unintentional overdose, and we have more people that are informing themselves about all the products that they use, not just acetaminophen,” Supriya Sharma, senior medical adviser for Health Canada’s Health Product and Food Branch, told the Toronto Star, in an interview.

The announcement comes after the Star published a lengthy investigation last year on the potential dangers of acetaminophen. The Star, which was assisted in its reporting by ProPublica, found that acetaminophen use in Canada had been responsible for hundreds of deaths, tens of thousands of hospitalizations and tens of millions of Canadian dollars in health-care system costs over the last decade.

An earlier ProPublica investigation done in collaboration with This American Life examined the toll of acetaminophen in the United States. The investigation found that 1,500 people in the U.S. had died and tens of thousands more had been hospitalized as a result of overdosing on acetaminophen over the past 10 years.

ProPublica and This American Life also found that the Food and Drug Administration had delayed implementing safety measures for decades. McNeil Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol, had worked to repeatedly block tougher safety warnings on its billion-dollar product.

Both investigations found a common problem known as “double dipping.” Acetaminophen is present in hundreds of over-the-counter medicines. Thus, people may take several medicines containing acetaminophen — say Tylenol and Theraflu — and not realize that they have exceeded the maximum recommended daily dose of acetaminophen, which is four grams, or eight 500-mg pills.

Another problem with acetaminophen: While generally recognized as safe and effective, the drug has a narrow safety margin — the dosage that can help is relatively close to the dosage that can begin to affect liver function. Some studies have suggested that liver damage can result from taking a few additional pills over the recommended daily dose for several days.

Canada and the United States are among the few industrialized nations in the world to allow unlimited access to acetaminophen. Countries such as Britain, France and Germany restrict access to the amount of acetaminophen that can be purchased, as well as the amount of medicine in an individual pill.

In response to the ProPublica story, McNeil said the company has always put consumer health first and that Tylenol is safe as long as it is used as directed.

After a 2009 FDA hearing in which experts raised new concerns about acetaminophen safety, McNeil changed the label on its Tylenol product to recommend no more than 3 grams, or six extra-strength tablets, per day.

The company maintains that acetaminophen’s safety compares favorably with other over-the-counter pain medications. (The FDA recently announced additional warnings about the risk of heart attacks of taking non-steroidal anti-inflammatory drugs, or NSAIDs, found in popular brands such as Advil.)

“McNeil takes acetaminophen overdose very seriously, which is why we have taken significant steps over the years to mitigate the risk,” the company wrote in an emailed statement.

“We will continue to work hard to educate and warn consumers of the dangers of acetaminophen overdose, reminding them to read the labels on all medicines before taking them, to take medicines only as directed and to be aware that any medicine they take has risks.”

The FDA did not respond to a request for comment on Friday. The agency has previously acknowledged that its procedure for regulating over-the-counter drugs, known as the monograph process, is cumbersome and slow. More than 38 years have passed since the FDA first began hearings on acetaminophen, and the FDA has yet to issue final guidelines on the safe use of the drug.

Last year, the agency announced that it would begin to review the monograph process in order to improve it.

It has yet to take any action.

http://www.propublica.org/article/how-much-acetaminophen-a-day-is-safe-canada-may-decide-its-less?utm_source=et&utm_medium=email&utm_campaign=dailynewsletter&utm_content=&utm_name=

F.B.I. Investigates: Are Medical Device Adverse Events Reported?

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

By DENISE GRADY and KATIE THOMAS MAY 27, 2015

The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.

The tool, called a morcellator, has rapidly spinning blades that cut tissue into pieces that can be removed from the body through the tiny slits made during minimally invasive surgery. Morcellators have often been used in surgery to remove the uterus, but in some women with undetected cancers they have sprayed malignant cells around inside the abdomen like seeds, speeding the progression of the disease.

The inquiries were first reported on Wednesday by The Wall Street Journal, which said the agents worked out of the F.B.I. office in Newark, N.J.

Celeste Danzi, a spokeswoman for the F.B.I.’s Newark office, declined to confirm the inquiry. “We just don’t comment on the existence or nonexistence of any investigation,” she said.

In an interview with The New York Times, Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed that they had spoken a number of times to an F.B.I. agent from Newark. A retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men declined to name the agent, saying they had been warned that disclosing too much information could interfere with the investigation.

Dr. Reed, 42, an anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston. Fibroids are benign, but they sometimes hide cancer. A biopsy after Dr. Reed’s surgery found a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and radical surgery, but the cancer recurred in March of this year, near her spine, requiring still more surgery.

The couple, who have six children, have conducted a ceaseless nationwide campaign to ban morcellation. Gynecology groups have resisted, saying that sarcomas are uncommon and that morcellation makes surgery less invasive and safer for the majority of women.

In November, the Food and Drug Administration said that morcellators should no longer be used in “the vast majority” of women. But the agency did not take the devices off the market or ban their use.

Dr. Noorchashm said he contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A. He said that he and his wife spoke with the agent a number of times over a few months, and that the F.B.I. seemed increasingly interested.

Dr. Lamparter said that he had also recently spoken to the F.B.I., and that the conversation had focused on his 2006 correspondence with Ethicon, the unit of Johnson & Johnson that sold power morcellators. At that time, he warned Ethicon of the potential for the morcellators to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Johnson & Johnson withdrew its morcellators from the market last July.

Johnson & Johnson has said that after Dr. Lamparter raised his concerns, it added new language to the instructions for use of the device, and that the company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue.

In a telephone interview Wednesday, Dr. Lamparter said that he considered the change a “legal fig leaf” and that the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Penn., reported that the training they received from the company in using the device did not substantially change after he raised his alarm.

Dr. Lamparter said he initially believed that the morcellator could still be used, but not on women at high risk for cancer. However, he added, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”

Ernie Knewitz, a Johnson & Johnson spokesman, said it was unaware of any investigation.

Kate Zernike contributed reporting.

http://www.nytimes.com/2015/05/28/business/fbi-investigates-whether-harm-from-surgical-power-tool-was-ignored.html?emc=edit_tnt_20150527&nlid=50639700&tntemail0=y&_r=0

Jury Verdict: Johnson and Johnson to pay for 'malice' toward patient.

UPDATE 2-Johnson & Johnson ordered to pay $5.7M in California mesh trial

Thu Mar 5, 2015 4:04pm EST

By Jessica Dye

(Reuters) - A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to "malice," her lawyer said.

The verdict is the fourth win for plaintiffs suing Ethicon over transvaginal mesh. More than 36,000 lawsuits have been filed against Ethicon in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.

The Abbrevo, one of Ethicon's newer models of mesh products, was cleared for sale by the U.S. Food and Drug Administration in 2010 to treat stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.

Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network.

Ethicon's lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment.

Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."

Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, he added.

Ethicon won one trial over mesh in federal court in West Virginia, where another trial over its mesh products started on Monday.

Ethicon, Boston Scientific Corp and C.R. Bard are among seven companies facing more than 70,000 mesh injury lawsuits in federal court and thousands of additional cases in state courts.

The case is Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123. (Reporting by Jessica Dye in New York; editing by Chris Reese, Alexia Garamfalvi and Lisa Von Ahn)

http://www.reuters.com/article/2015/03/05/johnson-johnson-mesh-verdict-idUSL1N0W728U20150305

Sign this petition to have all surgical mesh reclassified to high risk!

https://actionnetwork.org/forms/tell-the-fda-reclassify-all-mesh-as-high-risk


Many thanks!

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.


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“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

Boston Scientific follows product failure with belated $1 million clinical study

Vaginal Mesh Effectiveness Target of New Boston Scientific Study

By: Austin Kirk | Published: June 10th, 2013  (FiDA highlight)

Boston Scientific announced last week that it is working with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness of treating uterine prolapse with vaginal mesh compared to traditional surgery.  

The company is contributing more than $1 million to the study, which will look at one form of pelvic organ prolapse (POP) and the available treatment options.

The announcement comes two years after the FDA found that there was no evidence that transvaginal mesh provides any additional benefits when compared to traditional surgery, yet it appears to carry a risk of serious complications.

Concerns about the safety of surgical mesh for treatment of pelvic organ prolapse and female stress urinary incontinence gained widespread attention in July 2011, when the FDA indicated that nearly 3,000 reports of problems with vaginal mesh were received by the agency between January 2008 and December 2010, including cases where the mesh eroded through the vagina, caused infections and other debilitating injuries.

In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, looking for additional information to establish whether they pose an unreasonable risk of injury for women.

Concerns Over Safety and Effectiveness of Vaginal Mesh

The main manufacturers of vaginal mesh products sold in the United States are Boston Scientific, American Medical Systems (AMS), C.R. Bard, Johnson & Johnson’s Ethicon and Gynecare subsidiaries, Coloplast Corp. and Cook Medical.

Many of these products were approved through the FDA’s controversial 510(k) system, which allowed the manufacturers to begin selling the devices without conducting rigorous pre-market studies. Products were approved by the agency as long as the manufacturer could indicate that it was “substantially equivalent” to other products on the market.

As concerns have surfaced over the safety and effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing their products in an effort to avoid conducting the required studies.

The new study announced last week by Boston Scientific, the SUPeR clinical trial, is expected to enroll 180 women considering surgery to treat uterine prolapse who do not plan to have any more children. The women will either be implanted with the Boston Scientific Uphold LITE Vaginal Support System or they will be treated with more traditional surgery, including a vaginal hysterectomy.

The test subjects will be evaluated every six months for up to five years. Researchers will look at the safety, success, cost-effectiveness and other factors resulting from the surgery. The final results are expected in 2018.

Vaginal Mesh Lawsuits

About 20,000 women throughout the U.S. are currently pursuing a vaginal mesh lawsuit against the makers of these products, alleging that transvaginal surgical mesh is unreasonably dangerous and defective, carrying a severe risk of painful and debilitating health problems for women that outweighs any potential benefits.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for cases involving different manufacturers, with five Multidistrict Litigations (MDLs) centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

According to an updated case list (PDF) released on May 15, Judge Goodwin is currently presiding over at least 2,938 Bard Avaulta lawsuits, 6,028 AMS vaginal mesh lawsuits, 3,557 Boston Scientific pelvic mesh lawsuits, 5,763 Ethicon Gynecare mesh lawsuits and 320 Coloplast bladder slings lawsuits.

Several cases pending in state courts throughout the country have already gone to trial, with a California court awarding $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh in July 2012, and a New Jersey state court jury awarded $11.1 million in damages in February, including both compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.

In the federal court system, the first vaginal mesh trials are scheduled to begin next month, with a series of lawsuits involving the Bard Avaulta mesh set to begin on July 6. Later this year and early next year, a series of at least three additional trials will be held involving AMS mesh, Boston Scientific mesh and Ethicon mesh.

These early trial dates are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be offered throughout the vaginal mesh litigation. The preparation and any outcomes may help facilitate negotiations to reach vaginal mesh settlements in other cases.