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.
Friday, March 7, 2014
Friday, February 28, 2014
Thursday, February 27, 2014
Posted by Daniela Nuñez, Consumers Union FiDA highlight
Since last September, Consumers Union’s Safe Patient Project has been calling on the top hip and knee manufacturers to warranty their products. A warranty would cover revision surgery for patients if their implant is defective –for example, if the implant breaks, fails to adhere to the patient’s body or emits metal particles into tissue or blood. Shockingly, only one hip and knee implant part comes with a warranty, yet more and more patients are getting these implants installed in their bodies.
To help us understand what patients really need, we’ve asked thousands of people with artificial hips and knees to tell us what they expect from a good warranty. Now, we’ve started asking orthopedic surgeons who implant these hip and knee devices what they think about our warranty idea. As experts in their field, we think they’d give us some good input. A surgeon in Florida shared his thoughts on warranties in a guest blog post. Some orthopedic surgeons in Washington state had helpful comments, with several stating an interest in the idea. And a researcher who has analyzed hip and knee implants retrieved from patients over the past 30 years reached out to us with a very useful perspective on the issue.
In our newest effort to get more feedback from surgeons, our Safe Patient Project team will head to the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans March 10-14, 2014. We tried to pay the registration fee for us and several patient safety activists, but an AAOS representative told us that this is a “private meeting and not open to those outside the medical field or official exhibitors.” So, we will be outside the meeting and around New Orleans ready to talk to surgeons about why we think hip and knee manufacturers should back their products with a warranty and identifying supporters.
Unfortunately, many patients are left in the dark on how long their hip or knee implant will last — even though most people are given an estimate, there is not a solid guarantee to back that up. Patients also need a clear process to follow if their device fails unexpectedly, something that is routinely offered with warranties. And when a hip or knee implant fails, insurance companies, Medicare and patients are forced to foot the bill while the implant maker doesn’t have to pay a dime. That should change.
Surgeons play an important role in the success of a patient’s hip or knee replacement. We look forward to getting their feedback! And we hope we can enlist their support for warranties.
(If you are an orthopedic surgeon, please email us your thoughts on a warranty at email@example.com. If you’ll be at the AAOS conference, let us know!)
Tuesday, February 18, 2014
Read the ruling here.
NewJersey.com ruling article here.
NewJersey.com ruling article here.
Wednesday February 12, 2014
Trial against pelvic mesh manufacturers ongoing
Daily Mail Staff
CHARLESTON, W.Va. -- A Johnson & Johnson president of North American businesses was the latest to testify in one of several cases against the manufacturers of pelvic mesh.
Trial began Monday in the case brought by women who say the mesh used to treat stress urinary incontinence led to pain and permanent injury because of its defective design.
Carolyn Lewis, Kenneth Lewis, Augistina Brown-Singletary, Andre Singletary-Smith, Karin Harrison, Robert Harrison, Patricia Headrick, Darrell Headrick, Katie Uszler, Nick Uszler, Kelly Young and Kenneth Young originally filed the lawsuit in July 2012 in the Northern District of Texas.
Lewis received surgery in 2009, where doctors implanted the TVT, or transvaginal tape. The lawsuit alleges because of the defective design of the product, Lewis experienced pain when she emptied her bladder and during sex.
Defendants in the case are Johnson & Johnson, Ethicon Inc., Ethicon Women's Health and Urology, Gynecare and American Medical Systems Inc. This is the first case against Ethicon.
Attorneys for the companies said the plaintiffs never complained about problems from the mesh until after they filed the lawsuit and said the product was not defective.
U.S. District Judge Joseph Goodwin is overseeing the consolidation of more than 26,000 similar cases alleging injury from plastic mesh devices used to treat bladder and other organ weaknesses.
Laura Angelini, who has served in several marketing positions at Johnson & Johnson and Ethicon, appeared in a pre-recorded video deposition.
In her video testimony, Angelini agreed with the attorney, saying a Swedish company and the inventor of the TVT signed an agreement that later led to the company being the exclusive supplier of the tape. She said the inventor was a 20 percent shareholder in the company.
Angelini said the TVT initially was launched in Europe and was launched in the U.S. in late 1998. She agreed the type of mesh was used in hernia repair.
In Monday's opening statements, Lewis' attorney, Thomas Cartmell, alleged Ethicon used mesh to treat hernias but problems caused by the heavy nature of the product and small pores required surgeries to remove it.
Cartmell said a Swedish inventor later contacted Ethicon saying he used the old mesh to treat stress urinary incontinence and experienced no complications.
In her video testimony, Angelini said the Swedish company and the inventor signed an agreement where his company would be the exclusive supplier of the TVT.
Under the agreement, Agenlini agreed Johnson & Johnson would pay $400,000 to the company if it received acceptable clinical trial results.
In her opening statements, Christy Jones, an attorney representing the mesh manufacturers, said there were several studies on the transvaginal tape, not just those conducted by the inventor.
She said those studies have shown the tape is effective to treat stress urinary incontinence and said it was deemed the gold standard to treat this condition.
In the video, the attorney read off the agreement, saying Johnson & Johnson would pay $20 million for the TVT and a second installment of $2 million. If 140,000 units of TVT were sold, then Johnson & Johnson would pay another $2 million to the seller.
Angelini agreed that if all payments were made, that would total more than $24 million for the TVT device.
The video also showed an email from Angelini in response to her colleagues in the U.S. The attorney asked if she wrote they should spin it to more of a safety aspect than the complications and asked if she had influenced the title of a medical presentation.
Angelini responded that she provided her perspective to provide a more balanced position to show the safety data they had.
Goodwin dismissed the jury early Wednesday and told them to come back at 9 a.m. today. According to the court calendar, the trial is scheduled to last through Feb. 25.
Contact writer Andrea Lannom at Andrea.Lan...@dailymailwv.com or 304-348-5148. Follow her at www.twitter.com/AndreaLannom.
Monday, February 17, 2014
February 17, 2014 FiDA highlight added The Gazette
A 2005 surgery meant to correct Frances Schulte’s (from Coralville, Iowa) urinary incontinence brought her pain and further embarrassment rather than relief.
Doctors implanted a medical device known as surgical mesh, which has since eroded — which means her mesh sling is poking and irritating nearby organs.
“I get stabbed thousands of times a day,” Schulte said. “People don’t understand that I’m in pain every day.”
Schulte, whose surgery was done in Illinois, said that the pain prevents her from comfortably moving around and going to the bathroom.
Surgical mesh, which is generally used to repair weakened or damaged tissue, is made from synthetic material. It is permanently implanted to reinforce a weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, which can commonly occur in older women, women who have had children and women who are obese.
However, more than 1,000 adverse events were reported to the U.S. Federal Drug Administration between 2005 and 2007, which caused the agency to issue a Public Health Notification in 2008. Since then, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse.
The most common complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, organ perforation and urinary problems.
“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” the FDA states on its website.
The FDA has stated that complications associated with the use of surgical mesh have not been linked to a single brand. But Schulte, along with thousands of other women nationwide, opted to seek legal action.
Multiple class-action lawsuits have been filed against various makers of the mesh. Cases against Johnson & Johnson, C.R. Bard, Endo Health Solutions Inc. and Boston Scientific Corp. are all winding their way through federal court in the Southern District of West Virginia.
“I don’t like that they’re still putting it (the mesh) into people,” Schulte said.
Less risky alternatives
Dr. Catherine Bradley, an OB/GYN and division director of urogynecology and reconstructive pelvic surgery at the University of Iowa Hospitals and Clinics, said that a polypropylene mesh sling was first introduced to the United States in 1998. It was developed by Scandinavian researchers and was tested with promising results.
As the medical device became more popular, other companies began developing similar products, Bradley said.
“I don’t think these were tested as much as they should have been, and the FDA approval was probably inadequate,” she said.
She added that she never used transvaginal mesh for her patients because she was uncomfortable with the studies that had been completed.
Bradley noted that the FDA since has required companies making these products to do more rigorous testing, which can be expensive — this, combined with the class-action lawsuits, has led to some companies to no longer sell the product.
Instead, she opts to treat women suffering from pelvic organ prolapse through surgery without mesh in less severe cases and, when necessary by sacral colpopexy, a less-invasive surgery in which mesh is added through an incision made in the abdomen.
Bradley said there is only about a 5 percent risk of erosion when mesh is implanted this way, compared with a 10 percent and sometimes higher risk of erosion when mesh is applied transvaginally. Removing eroded mesh is difficult, but the removal can help with the pain.
“With abdominal surgery, you are also less likely to have pain than a transvaginal surgery, even one without mesh,” she said.
“As a surgeon who treats women and uses mesh, we complain about how much time we spend talking about it,” she said. “But it’s better that we’re spending more time talking with patients and counseling patients that we can’t always cure (their problems) without complications arising.”
Sunday, February 16, 2014
by Marshall Allen ProPublica, Feb. 12, 2014, 1:34 p.m.
The top executive at the country’s pre-eminent health care quality organization is being paid hundreds of thousands of dollars by two large medical companies that have a stake in the group’s work.
The payments to Dr. Christine Cassel raise new conflict-of-interest concerns at the National Quality Forum, which endorses benchmarks that Medicare uses to compensate hospitals based on performance.
As ProPublica recently reported, the Quality Forum is reviewing its conflict-of-interest policies after being stung by allegations that the former co-chair of one of its endorsement committees had accepted kickbacks to help a drugmaker win favorable treatment.
Cassel received about $235,000 in compensation and stock last year as a board member for Premier Inc., a North Carolina company that says it provides group purchasing and performance improvement consulting for an alliance of 2,900 hospitals and thousands of nursing facilities and other providers.
Cassel also was paid $189,000 as a board member for the Kaiser Foundation Health Plans and Hospitals in 2012, Quality Forum officials confirmed to ProPublica. Kaiser’s tax forms are not available for 2013, but they show that in 2010 and 2011 Cassel received a total of $357,125.
Cassel, who declined to be interviewed, took over as chief executive officer last summer after a decade as president and CEO of the American Board of Internal Medicine. She also sits on the President’s Council of Advisors on Science and Technology and has been active with the Institute of Medicine.
Quality Forum officials would not say how much Cassel receives to run the Quality Forum, but her predecessor was paid about $525,000 in salary and other compensation in 2011, tax documents show.
The group's chairwoman, Helen Darling, said in an email that the board was “fully aware” of Cassel’s outside compensation when she was hired in December 2012. Darling, president of the National Business Group on Health, initially agreed to an interview but did not respond to follow-up contacts.
Spokeswoman Ann Greiner said the board got a legal opinion and discussed it in depth before agreeing that Cassel could recuse herself “where her outside board service would be construed as an actual or perceived conflict of interest.” So far that hasn’t happened, Greiner said.
Two ethics experts interviewed by ProPublica said Cassel’s relationships with Kaiser and Premier present obvious conflicts given the Quality Forum’s broad involvement in health care.
The Quality Forum maintains a clearinghouse of more than 700 quality measures — covering everything from tracking hospital readmissions to setting information technology standards — that are established by expert committees and widely adopted by U.S. hospitals and other providers.
The ethics experts said they were uncertain how Cassel could recuse herself to anything related to Kaiser and Premier and still do her job.
“Would that mean every time somebody said the word ‘hospital’ she would have to say, ‘I can’t be in this conversation?’” said Eric Campbell, a Harvard School of Medicine professor who has published extensively on conflicts of interest.
“Conflict of interest is as much an appearance as it is an effect,” added Sheldon Krimsky, a medical ethics expert at Tufts University. He called Cassel’s conflicts “absolutely egregious.”
Campbell and Krimsky said the cleanest way to eliminate potential conflicts would be for Cassel to resign from the outside boards. Campbell also said Cassel could continue serve but without pay, which would at least remove possible concerns about the influence of money.
No one has suggested that Cassel has used her post to benefit Kaiser or Premier. But the disclosure of her outside compensation comes as quality is increasingly becoming a bottom-line issue for the industry.
Not so long ago, hospitals and other medical providers were paid the same fees by Medicare and other payers based on services they provided, regardless of whether outcomes were good or bad for patients. But as medical errors continued to cause harm and drive up costs, the federal government and others began experimenting with ways to link payments to performance.
That’s where the Quality Forum’s endorsements come in.
Established in 1999, the Washington, D.C., nonprofit invites hundreds of participants from across the health care spectrum — insurers, practitioners, researchers, health care systems and consumer groups — to become members and help pick the best quality benchmarks for endorsement by consensus.
Kaiser and Premier are among the group’s 375 dues-paying member organizations.
In 2009, Medicare awarded a $40 million contract to the Quality Forum to recommend measures it could adopt. President Obama’s health care reform law accelerated the move to pay-for-performance. Medicare already has begun penalizing and rewarding hospitals based on readmission rates, mortality and patient satisfaction measures. By 2017, it’s expected that 9 percent of Medicare payments will be based on performance.
Much of the Quality Forum’s work has been behind the scenes. But that changed last month when allegations arose that questioned the group’s vulnerability to commercial influence.
In settling federal whistleblower lawsuit, the Justice Department accused a well-known patient safety leader, Dr. Chuck Denham, of accepting $11.6 million in kickbacks from a drug company while he co-chaired a Quality Forum committee to endorse patient safety measures.
Denham said he had legitimate contracts with the drug company, but the payments were not disclosed to the Quality Forum. ProPublica found that the group’s final 2010 Safe Practices report endorsed the company’s surgical antiseptic, a decision that other committee members said was unintended.
In response to the Denham case, the Quality Forum launched a review of the committee’s work and the organization’s conflict-of-interest policies. The review is expected to be complete by Feb. 25.
The Quality Forum’s policy for committee members defines a “conflict of interest” as any financial or other interest that could actually, or be perceived to, impede a person’s objectivity or “create an unfair competitive advantage for you or an organization associated with you.”
Cassel’s outside board positions create conflicts, according to ethics experts, because Kaiser and Premier could be affected by Quality Forum endorsements.
Kaiser, an integrated system that’s been touted as modeling the future of health care, had hospital revenue of $18 billion and health insurance plan revenue of $37 billion in 2011. The organization operates in eight states and the District of Columbia at 37 hospitals and hundreds of medical buildings.
Kaiser spent $1.6 million lobbying Congress, the Department of Health & Human Services and other agencies last year, according to the website OpenSecrets.org. A Kaiser executive, Jack Cochran, sits on the Quality Forum’s board.
In an email, Kaiser spokesman John Nelson said the health system was “incredibly fortunate” to have Cassel on its board for the past decade and that “any organization smart enough to engage with her will receive wise counsel and honorable service."
Premier reported revenues of $869 million in the fiscal year ending last June. It spent more than $1 million on lobbying in 2013, according to OpenSecrets.org. In August and November, the company urged members of Congress to instruct Medicare to run any quality measures through the Quality Forum.
Premier featured Cassel’s status as a board member and future top executive of the Quality Forum in documents last May describing its initial public stock offering. In September Cassel acquired 3,704 shares of Premier stock that were then worth about $100,000.
The company’s business involves group purchasing and a consulting arm that uses data analysis to help providers perform better on various quality metrics. In October, a measure sponsored by Premier to track hospital care by the average length of stay was up for renewal by the Quality Forum.
Blair Childs, Premier’s spokesman, said the company is still evaluating the average length of stay metric and that it could be submitted for consideration as a Medicare pay-for-performance measure.
Childs said Cassel’s role on the Premier board doesn’t pose any conflict of interest, and that her relationship with Premier was vetted carefully by the Quality Forum’s board. Cassel was a good addition to the Premier board because of her commitment to improved care and lower costs, he said.
Defining the Strike Zone
Harvard’s Campbell said Cassel’s dual roles aren’t necessarily a problem if disclosed and carefully managed. But he offered a baseball analogy to show why they present a risk for the Quality Forum.
Imagine, Campbell said, training umpires to call balls and strikes — except the person doing the training is also being paid by the New York Yankees, and the strike zone favors the swing of Derek Jeter.
Campbell said he wasn’t being judgmental about Cassel’s conflicts of interest. But the Quality Forum is paid taxpayer dollars by Medicare to perform a public service in a quasi-regulatory role, he said. When the Quality Forum’s leader is paid hundreds of thousands of dollars by hospital companies, Campbell said, it creates a potential incentive to shape the rules in their favor.
Krimsky, the Tufts ethics expert, was more critical of the arrangement. He said it’s not enough for Cassel to recuse herself from decisions or discussions related directly to Kaiser and Premier. She still could be involved in choosing who sits at the table to have discussions or make decisions, he said.
“When there’s a conflict of interest in the management group, that’s a serious problem,” Krimsky said.
Dr. Peter Pronovost, a well-known patient safety leader from Johns Hopkins Medicine, said he did not see how Cassel’s outside board roles would present a direct advantage for Kaiser and Premier. But he said conflicts of interest in the world of quality improvement are often indirect, and the industry hasn’t clearly defined how to navigate them.
“That doesn’t mean (the conflicts) are not real,” Pronovost said. “But they’re less risky. The field does need to articulate the boundaries for these indirect conflicts.”
Although Cassel’s relationships were known to the board, it does not appear that they were widely shared with the Quality Forum’s membership. Cassel’s biography on the Quality Forum website mentions about a dozen other affiliations but not Kaiser and Premier.
Some who are active on Quality Forum committees also said they were unaware.
Leah Binder, president and CEO of The Leapfrog Group, a coalition of employers that advocates for quality and transparency in health care, said she respects Cassel but would have liked to have known about her outside board roles.
“Maybe we need to understand from Chris how she recuses herself from any kind of decision making that might have an impact on those two organizations,” Binder said. “I think she would owe us an explanation of that.”
Lisa McGiffert, director of the Consumers Union Safe Patient Project, sits on a committee that’s recommending possible pay-for-performance metrics to Medicare. Recently a debate about a proposed hospital readmission measure pitted the consumer-minded members, who favored it, against the providers, who were against it. In the end, the consumer side didn’t get its way, she said.
“All of this is about relationships, and (Cassel) has a relationship with that hospital system,” she said. “That relationship means that Kaiser might weigh in with her on those hospital measures.”
McGiffert said all Quality Forum conflict-of-interest disclosure forms should be posted online so anyone can easily see various allegiances.
Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.
“The insiders don’t see it,” Gibson said. “It’s like a fish in water.”
ProPublica is investigating health care quality and welcomes your input. Medical providers – help us by completing a brief Provider Questionnaire. Patients can complete ProPublica’s Patient Harm Questionnaire.
Comment: Joleen Chambers
At the FDA, trained patient representatives are eliminated because OSHI (Office of Special Health Issues) must 'vet' the participants in medical device advisory panels. Harmed patients are often not selected because of their 'bias' (real-life experience!), but industry insider financial conflicts-of-interest are not an issue that interferes with their full participation. When the established standard is engaged patient advocates having access to define and populate panel discussions at FDA, NQF, IOM, TMIT, PCORI, (etc.) and have equal time at the microphone on webinars with all compensation (and non-compensation) listed in the program, the shame of the disparity will highlight the good medical leaders from the profiteers. For me, a bell weather will be seeing Regina Holliday properly compensated for her leadership and accomplishments! Google her.
Friday, February 14, 2014
Out of the Dark Ages! FDA requires medical device manufacturers to report adverse events on a computer!
Posted: February 13, 2014 - 3:30 pm ET
Hospitals, physicians and their patients soon may know if a medical device is faulty more quickly than in the past thanks to a Food and Drug Administration final rule issued Thursday. The rule requires manufacturers to submit reports of injuries or deaths associated with their products electronically to the FDA instead of via a paper report as is currently done.
Electronic submissions will make it easier for the FDA to review adverse events and rapidly communicate information about suspected problems to the medical-device industry, healthcare providers, consumers and other government agencies, it said in the rule.
For decades, the FDA has received these reports in a paper format through the mail. In 2009, the agency released a proposed rule that called for electronic reports on a voluntary basis. The final rule makes it mandatory to do so starting Aug. 14, 2015.
The FDA on average receives roughly 200,000 adverse events annually and can take anywhere from three days to six to properly analyze a report received by mail, according to the FDA. Others argue it could be even longer in some instances.
“It is no secret that, for years, paper medical-device reports were mostly warehoused,” said Jeffrey Shapiro, an attorney at Hyman, Phelps & McNamara.
The FDA estimates it oversees more than 20,000 device manufacturers and importers. The industry will face one-time costs of $40 million in training and IT changes to make the switch, the FDA estimated. However, device makers will save about $9.2 million annually because electronic submission should reduce the time needed to submit documents and reduce delivery costs.
A major change between the proposed and final rule: user facilities such as hospitals will not be required to comply with the e-filing requirement.
“This change from the proposed rule was obviously in response to comments concerning the increased costs for electronic submissions by entities that file a small number of reports each year,” said William Kitchens, a partner at the law firm Arnall Golden Gregory.
Small devicemakers are not exempt from the new requirement, however.
“There are many very small device manufacturers and I believe that this is going to be a burden for them,” said Wally Pellerite, an industry consultant and former FDA compliance official, adding that it makes the agency appear inconsistent to exempt hospitals but not small devicemakers. “Small device firms with few medical-device reports should be allowed to submit paper reports.”
Follow Virgil Dickson on Twitter: @MHvdickson