Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, October 3, 2017

Could One Company Be . . . Medtronic? St. Jude?

By FRED SCHULTE and CHRISTINA JEWETT   OCT. 2, 2017  The New York Times
WASHINGTON — Medicare paid at least $1.5 billion over a decade to replace seven types of defective heart devices, a government watchdog says. The devices apparently failed for thousands of patients.
A report released on Monday by the inspector general’s office for Health and Human Services said officials needed to do a better job tracking these costly product failures to protect patients from harm. More detailed reporting could lead to earlier recognition of serious problems with medical devices and faster recalls of all types of “poorly performing” ones, the inspector general’s office said.
The report marks the first effort by anyone in government to assess the losses to taxpayers and patients 65 and older from medical gear that proves faulty.
Officials said the $1.5 billion lost from the seven devices from 2005 through 2014 was a “conservative estimate.” Patients also paid $140 million in out-of-pocket costs for this care, the report noted.
The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections. It did not outline specific injuries that patients suffered as a result.

The inspector general did not identify the manufacturers of the seven devices, but officials said they included implanted cardio defibrillators and a pacemaker that had either been recalled because of flaws or had “prematurely failed.” Pacemakers and implantable defibrillators are small devices placed under the skin to help treat irregular heartbeats.
How best to identify these defects and cut Medicare spending associated with fixing them has been under consideration at various times since 2007, according to the report. But it remains a contentious issue.
The inspector general recommended that hospitals and doctors be required to submit detailed information identifying failed devices, like serial and batch numbers, during the billing process.
“This could help reduce Medicare costs by identifying poorly performing devices more quickly, which could also protect beneficiaries from unnecessary costs and improve their chances of receiving appropriate follow-up care more quickly,” the report said.
David Lamir, an official in the inspector general’s Boston office, said the $1.5 billion figure represented a “drop in the bucket” of the true costs to Medicare from medical products that malfunction. He said device failures not only waste money, but also can expose patients to a “high risk of illness,” including needless surgeries.

The report said that medical device recalls nearly doubled from 2003 through 2012 and noted that they have probably cost Medicare billions of dollars. In the past five to six years, more than 200 cardiac devices have been recalled, according to the inspector general’s office. In most cases, manufacturers withdrew their products voluntarily after reports surfaced of injuries or malfunctions. Device makers are required to report problems they learn of, often from doctors and hospitals, to a database run by the Food and Drug Administration.
Diana Zuckerman, president of the National Center for Health Research who has testified before Congress on device safety, said her organization supports making hospitals report malfunctioning devices when they seek Medicare payments to cover an implant surgery. She said the change would help officials pinpoint faulty devices before issuing a recall for tens of thousands of products in patients.
“It would be much more obvious much more quickly which implanted devices were causing problems,” she said.
Ms. Zuckerman noted that the report did not touch on other high-profile device failures, like metal-on-metal hip implants or vaginal mesh.
Medical device companies and some doctors have opposed tighter reporting, arguing that it would be costly and difficult to integrate with existing payment claim forms and might not yield useful information.
“It is abundantly clear that data collected in electronic health records is a far superior and more cost-effective method for monitoring the performance of medical devices,” said Mark Leahey, who heads the Medical Device Manufacturers Association. The trade group represents nearly 300 device companies.
Mr. Leahey said that the electronic health record “captures the full clinical history of the patient, their changing health status and detailed information on their medical treatments,” including any surgically implanted devices.
A spokesman for the Centers for Medicare and Medicaid Services said the agency had not seen the report and would have no comment.
But in written remarks included in the report, Seema Verma, the agency’s administrator, said the tighter reporting requirement was “under consideration” and that the agency would “carefully evaluate the potential that this policy would impose a burden on physicians unnecessarily.”
This article was produced in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation. 

Sunday, October 1, 2017

Surgical Mesh Scandal: Worse Than Thalidomide. Truth.

Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history.
16:40, UK,
Saturday 30 September 2017

The vaginal mesh that was fitted to tens of thousands of women, leading some to suffer pain
By Charlotte Lomas, Sky News Correspondent and Aubrey Allegretti, News Reporter

An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.
Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".
Speaking about the scale of the scandal, he said: "I think this is the worst one that we'll ever see in my lifetime because of the scale of the number of women affected."
More than 75,000 women in England had the procedure - known as TVT - between 2006 and 2016, according to NHS data.
One in 15 have had the implant removed.
The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.

While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.
The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.
Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.
She is now registered disabled, is in chronic pain and survives on benefits.

Lesley Elder has had 13 operations to repair damage caused by the fitting of the mesh
"I'm not the woman I used to be," she told Sky News. "I feel like a helpless no-hoper. I think I'd be better off dead; I don't want to live like this. I want my old life back."
Professor Heneghan, from the University of Oxford, said Lesley's case is not unique, and warned that the UK is heading for a "major disaster".
"Every young woman I have talked to has not been told about the adverse consequences," he told Sky News.
Professor Heneghan said the NHS was not offering the operation to patients based on "need" but on what manufacturers with a commercial interest wanted.
The mentality, he said, was: "Get people through the system - in and out."

Ms Elder says she has to take a cocktail of drugs after having the procedure
One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.
Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.
David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a "significant" medical case.
Total compensation, he claimed, could "run into the billions of pounds, which would make it the largest medical case in UK history".
A spokesperson for Johnson & Johnson told Sky News implantable mesh was "backed by years of clinical research" and that "Ethicon is confident in its products".
They said the use of pelvic mesh devices is "supported by medical experts around the world".
The spokesperson added: "Ethicon is defending lawsuits concerning the use of our pelvic mesh products.

"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."

Mission Accomplished!

Wednesday, September 27, 2017

Get an Unsafe, Ineffective Medical Implant & Lose Your Civil Rights!

September 26, 2017 Press Release
WASHINGTON, DC (September 26, 2017) Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).
”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.

“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”
“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”

DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.

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Saturday, September 23, 2017

Definition of a Guinea Pig: Ask the FDA!

FDA fails to enforce requirements
  • by Larry Husten, CardioBrief September 20, 2017 

Pharmaceutical and device companies are often taking advantage of a lenient (or, some would say, negligent) FDA to shirk their obligation to perform timely post-approval studies, a new Perspective published in the New England Journal of Medicine shows.
The topic has gained increasing  visibility and importance as the FDA has granted approval to many new drugs and devices without all the evidence that might ideally be required.For safety as well as efficacy, the FDA has allowed much of the burden of proof to shift from pre-approval to the post-approval period.

But in an analysis of 614 post-approval requirements and commitments imposed by the FDA in 2009 and 2010 (the first full years after the FDA gained the power to require these studies), Steven Woloshin at Dartmouth Institute for Health Policy and Clinical Practice and colleagues showed that only 54% of these studies were completed after 5-6 years. They found that 20% of "required" studies had not been started and 25% were delayed or ongoing as of September 2015.
"It's not a secret that we need a better post-market system," said former FDA Commissioner Robert Califf, now at Duke University. "The good news is that technology is no longer the limiting factor -- it's all about culture, organization and priority setting by policy makers, clinicians and patients and their 'carers' (families and loved ones)."
The authors observed that in many cases there didn't appear to be any good reason for the delays. For instance, more than 5 years after approval of buprenorphine/naloxone film (Suboxone), no protocol had been submitted for assessing the risk of QT-interval prolongation, "even though the design of such studies is highly standardized and participants are observed for a limited period."
"The slow, irregular pace of post-approval studies contrasts starkly with the short, rigid deadlines and other shortcuts used to speed marketing approval," the authors wrote.

The FDA should "do more to ensure that sponsors meet post-approval deadlines," the authors urged. Although the FDA has the power to impose fines or other penalties on companies that fail to live up to their obligations, "to our knowledge, it has never imposed such fines." They also recommend that the FDA set shorter deadlines for post-approval studies.

"Woloshin and colleagues offer some useful insights into the FDA's use of post-approval studies to confirm and further evaluate drugs' safety and efficacy at the time of approval," said Joe Ross of Yale University. "While more than half were completed, many were not. This study is only made possible by the efforts at FDA to provide public transparency of the post-approval requirements, but more information could help the public and the profession understand why certain requirements were not fulfilled, whether these studies were intended to provide key clinical information to inform practice (as opposed to safety info that instead came from another clinical study), and even for those studies that were completed, whether the results were published and made available."
Sanjay Kaul of Cedars-Sinai Medical Center said that it is not unreasonable to shift "the regulatory burden from the pre-approval phase to a life cycle-based approach. However, the success of such an approach is predicated on a rigorous and timely post-approval phase. That 1 in 5 post approval studies had not even been started after 5 to 6 years calls into question the degree to which the changes in the FDA's regulatory authority in 2007 have resolved the challenge of reducing the number of unfulfilled post-approval requirements. This can hardly be reassuring given the 21st Century Cures Act which calls for faster marketing of drugs and devices at the cost of stringent evidentiary standards! Even though the FDA has congress-legislated authority to revoke approval of drugs and devices that failed to confirm clinical benefit on post approval studies, it rarely does so! It is difficult to put the genie back into the bottle."

The "bottom line," said Kaul, is that "marketing drugs and devices faster can only be justified if there are much better post-market data to reliably support efficacy and safety."

Friday, September 22, 2017

J&J ASR Hip Defense Verdict is Overturned in Chicago

Amanda Bronstad, The National Law Journal
September 21, 2017  
A Chicago judge has granted a new trial in one of the only verdicts involving DePuy Orthopaedics Inc.’s ASR XL hip implants.
Tuesday’s ruling by Cook County Circuit Court Judge Deborah Mary Dooling reversed a 2013 defense verdict that came out just before DePuy reached a $2.5 billion global settlement resolving about 8,000 cases. The judge found that a key scientific expert for plaintiff Carol Strum should have been allowed to testify at the trial about the wear on the hip implants. The lawsuits claimed the devices caused pain, grinding or clicking in the hips and high metal content in blood tests.
“He was going to provide objective proof of the amount of metal loss on the device versus the amount that should be lost,” Strum’s lawyer, Peter Flowers, said of the expert, Dr. David Langston. “The lack of objective proof of that certainly played a large role in the ultimate outcome.”
On Thursday, Dooling told both sides to return next week with possible trial dates.

“We believe the verdict arrived at by the jury in 2013 was consistent with the facts in this case,” wrote Stela Meirelles, a spokeswoman for DePuy, which is a subsidiary of New Jersey’s Johnson & Johnson. “DePuy’s actions concerning the product were appropriate and responsible."
The ruling is a big win for the plaintiffs bar, whose scientific evidence and experts at several mass tort trials have been criticized as “junk science.” It has come up in litigation involving Johnson & Johnson’s baby powder, acne drug Accutane and cholesterol drug Lipitor
In her ruling, Dooling relied on a scientific evidentiary test established in Illinois called the Frye standard, named for the U.S. Court of Appeals for the District of Columbia Circuit’s 1923 holding in Frye v. United States. Under the standard, evidence can be admitted that is “generally accepted” in the scientific community. Dooling concluded that her original definition of that field was “too restrictive” and that Langton’s methodologies were generally recognized, even by scientists at the U.S. Food and Drug Administration.
“Surely the FDA, the agency responsible for ensuring safety for patients who have medical devices implanted, would not request a device manufacturer to perform testing that was not generally accepted in the scientific community,” she wrote. 
Strum had the device implanted in 2008 due to arthritis in her left hip. Two years later, DePuy recalled the ASR. After suffering pain, Strum had another surgery in 2011 to replace the implant.
Her case wasn’t the first to go to trial over the ASR hip implant. Months earlier, a jury in Los Angeles awarded $8.3 million to Loren Kransky after finding the ASR was defectively designed. But many lawyers considered that case, which was bumped up for trial due to Kransky’s poor health, to be an outlier. DePuy reached its global settlement before the first bellwether trial in the federal cases began.
But thousands of plaintiffs have been excluded from the deal, which limited payouts to those who had revision surgeries as of Aug. 31, 2013.
As of Sept. 15, there were more than 1,600 cases still pending over ASR hip implants in the federal multidistrict litigation in Ohio, according to the U.S. Judicial Panel on Multidistrict Litigation. Flowers, of Chicago’s Meyers &  Flowers, said dozens of ASR lawsuits remain in Illinois, including Strum’s case, which was excluded from the settlement because it went to trial.
That doesn’t mean it couldn’t settle, rather than go to trial.
“It very well could,” Flowers said. “That remains to be seen.”

Contact Amanda Bronstad at