Sacrificial lambs! U.S. Senate: AMEND 21st Century Cures Act

• OpEd by 
Dr. Kevin Kavanagh of Somerset,KY & board chairman of Health Watch USA.
•    

A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices?

I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use.
In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits.
When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
Just look at the morcellation debacle. A device intended to grind tissue into little pieces, thus allowing hysterectomies to be performed through a small incision, was found after 20 years of use to be spreading cancer. High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.
That's right, untold numbers. No one in the United States is effectively watching what happens to these devices after they are implanted in patients. The safety feedback loop, which helps spur device improvement and safeguards patients, is all but lacking.
The problems with metal-on-metal hip implants were first systematically detected in England, which has an effective reporting registry.
Problems with retrograde medical endoscopes spreading untreatable bacteria were known in Europe two years before the United States, and morcellators posed an unacceptable risk of spreading cancer for many years before anyone noticed.
Some have stated it is not practical to test all medical devices. This may be true, but I want any device implanted in me to be thoroughly tested.
The U.S. House of Representatives passed the 21st Century Cures Act but instead of strengthening medical device oversight, the House weakened the requirements for testing even further.
What are patients to do?
First, remember that for many implants the benefits are overestimated and the risks underestimated. Before any implant procedure patients should at least ask:
■ What is the implant's failure rate?
■ How does the tissue react around the implant?
■ If the implant fails can it be taken out?
I was faced with a decision once to have metal cervical joints placed at multiple levels in my neck. I asked the above three questions. The first two were not known and the answer to the third was no. I chose to have the "old-fashioned" cervical fusion.
Some would think that a device that has long been in use would be safe. But, as exemplified by the morcellator, which was first marketed in 1994, if no one monitors for problems they may be perpetuated indefinitely. Out of sight, out of mind.
Next, patients should check the MRSA and C. Difficile rates at their hospital, available on Hospital Compare (https://www.medicare.gov/hospitalcompare/).
If you are having a hip or knee implant or a lumbar or cervical spine fusion, check for your surgeon's complication rates on ProPublica's Surgeon Scorecare website(https://projects.propublica.org/surgeons/).
Finally, remember nothing lasts forever and all man-made devices can fail, so keep your follow-up appointments.
For those with chrome-cobalt metal hip implants, consider having blood cobalt levels tested to screen for dangerous, and sometimes life-threatening, heavy metal poisoning. Your doctor may tell you there is not good literature to support the testing. But remember few are looking for or monitoring problems.
Dr. Stephen Tower just reported in the Journal of Patient Safety 25 cases of cobalt poisoning from hip implants. Until the true incidence is known, play it safe and get tested.
According to a report from Johns Hopkins published in the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. It is more likely than not that you are or will be an implant recipient.
Almost everyone has a stake in health-care policy regarding implants.
We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.
Dr. Kevin Kavanagh of Somerset is board chairman of Health Watch USA.
http://www.kentucky.com/2015/08/13/3987638_without-more-monitoring-medical.html?rh=1






My comment:  I trained 9/2010 at FDA/CDRH as a Patient Representative.  In 2008 my brother was implanted with a Tornier elbow that was designed by the Mayo Clinic surgeon that performed the implant.  The elbow failed(pain and loss of function) and was 'revised' by removing two of the components . . . yet it was not reported to the FDA as an adverse event.  Multidistrict lawsuits (MDL's) for metal-on-metal hips(100,000) and pelvic surgical mesh(75,000) have begun to prompt anemic settlements for the PREVENTABLY, severely and permanently harmed patients.  Implanted elbows are rare (@4,000 annually) and can be considered an 'orphan' device and lawyers have little incentive to bring a lawsuit.  The surgeon is not legally required to report an AE (adverse event) unless there is a fatality and the FDA does not investigate anyway.  If patients knew the catastrophic downside and actual patient outcome statistics on implants they would demand the medical device implant industry provide a product warranty on permanent implants.  Marketing statements should align with patient outcomes.  The 21st Century Cures Act is an affront to public health and all the SACRIFICIAL LAMBS that Dr. Kavanagh refers to.  

ProPublica consumer-accessible Surgeon Scorecard for hip & knee surgeons!

We Go Behind the Scenes on Surgeon Scorecard

by Minhee Cho

ProPublica, July 20, 2015

Last week, ProPublica launched Surgeon Scorecard, our new database showcasing the complication rates of nearly 17,000 surgeons nationwide. For the first time, patients can now weigh surgeons’ past performance before going under the knife and doctors themselves can see where they stand relative to their peers.

Our Surgeon Scorecard team – Marshall Allen, Olga Pierce and Sisi Wei – joined ProPublica’s Eric Umansky on the podcast to discuss how they tackled this ambitious, all-hands-on-deck project.

Highlights from their conversation:

• The lack of incentive for hospitals to track their own surgeons’ complication rates. It’s difficult to do and also very uncomfortable politically, Allen says. Surgeons are powerful, they bring in a lot of revenue to the institution, and there’s the risk that they’ll take their cases to another hospital. (7:38)
• What makes a compelling data story: “If there are relentless numbers in a story, it's often a sign that your data is not as strong as you think it is,” Pierce says. “The best data stories are ones where you've reached some sort of interesting finding and that is a launching plane for the rest of the story.” (21:15)
• How all ProPublica apps, including Surgeon Scorecard, have “a near view and a far view,” offering not only a look at broader trends but specific data on specific localities that journalists can use to power their reporting. “There are going to be so many local stories that we can't focus on,” Wei says. “But other journalists can use our app to do that.” (25:06)http://www.propublica.org/podcast/item/we-go-behind-the-scenes-on-surgeon-scorecard/?utm_source=et&utm_medium=email&utm_campaign=dailynewsletter&utm_content=&utm_name=
• 
  

You can listen to this podcast on iTunes, SoundCloud or Stitcher, and use our Surgeon Scorecard app to look up your doctor.

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=

Jail: White Collar Crime is Exempt?

Discussion: Why Are Big Companies Rarely EverPunished?

by Blair Hickman
ProPublica, Apr. 30, 2014, 5:00 am  FiDA highlight

Today, we co-published a story with the New York Times Magazine on the rise of corporate impunity. In sum: a series of missteps by the Department of Justice has left the agency ill-equipped to go after individuals at the top echelons of Corporate America. Now, in addition to banks that are Too Big To Fail, we have companies and CEOs that are Too Big To Prosecute.

The number of white-collar cases chased by the Department of Justice has fallen from an average of 17.6 percent of all federal cases in the mid-90s, to just 9.4 percent in the past five years. The agency received major backlash after shutting down consulting firm Arthur Andersen in 2002 and leaving tens of thousands out of a job.

After a federal judge ruled that the Justice Department violated constitutional rights by asking KPMG. executives to waive attorney-client privilege, the agency has become so cautious that it rarely acts against corporate indiscretion. Though Lehman Brothers misled the public about how much cash it had on hand before it filed for bankruptcy, the Department of Justice doesn’t appear to have pursued the investigation aggressively.

Why is the Justice Department failing to tackle the most basic questions in cases of wrongdoing? What would it take to beef up their capacity for prosecution? And if we do so, are these companies and people really above the law?

Join us on Reddit on May 1 at 11 A.M. EST to ask Jesse your questions. We’ll update this post Thursday morning with the link. Afterward, we’ll round up the best questions and answers.

You can also leave questions in advance in the comments here, or tweet them with #AskProPub.

Joleen Chambers •

Our democracy has been purchased by corporations (look at SCOTUS decision Citizens United). It is time to change this back by withdrawing their legal ability to do business in this country, informing the public so that the demand for their 'products' drops and jailing the human leaders that perpetrate crimes on the U.S. population. The entitled and empowered medical device industry is prime for this focus!

http://www.propublica.org/article/the-rise-of-corporate-impunity

Link to story with New York Times Magazine

ProPublica discloses NQF Conflict-of-interest: Dr. Christine Cassel and Dr. Charles Denham

Payments to CEO Raise New Conflicts at Top HealthQuality Group

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.

Pay-For-Peformance Shift

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.

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 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.

95% of Harmed Patients Can't Access Justice: Follow the Money!

Patient Harm: When An Attorney Won’t Take Your Case

by Marshall Allen and Olga Pierce
ProPublica, Jan. 6, 2014, 9:06 a.m.

Ernie Ciccotelli was trying to do a good deed when he donated a kidney to his brother. But within days of the surgery, his incision was oozing green fluid and his guts were rotting.

Ciccotelli said he was almost killed by an infection, and the follow-up surgeries and months of disability nearly ruined his fledgling legal practice. So he looked for a malpractice attorney who would help him file a case against the hospital.

 That’s when he ran into a problem faced by many who are harmed in a medical setting: Attorneys refuse their cases, not because the harm didn’t happen but because the potential economic damages are too low.

It’s estimated that hundreds of thousands of patients a year suffer some type of preventable injury or die while undergoing medical care. For many of these patients or surviving family, a lawsuit is the only hope to recover losses, learn the truth about what happened and ensure the problem is corrected.

But lawyers may have to invest $50,000 or more to pursue a case, and they usually only get paid if they win or settle. The payout is determined largely by economic damages – lost earnings, medical bills and future costs caused by the injury.  Those who don’t earn big paychecks – including children, the elderly and stay-at-home-moms – are the least likely to find an attorney, studies show.

A 2013 Emory University School of Law study found that 95 percent of patients who seek an attorney for harm suffered during medical treatment will be shut out of the legal system, primarily for economic reasons. Most attorneys would not accept a case – even one they might win – if the damages likely were less than $250,000.

“You’re basically saying for someone who doesn’t earn a lot of money, ‘It’s OK for a hospital to harm them,’” Ciccotelli said.

Ciccotelli’s experience is not uncommon. ProPublica has heard from hundreds of patients through its Patient Harm Facebook group and Patient Harm Questionnaire. The inability to find a lawyer is a common refrain.

For many cases, “the juice isn’t worth the squeeze,” said Stephen Daniels, a research professor at the American Bar Foundation, a legal research institute.

The elderly are probably affected the most, Daniels said, even when they’ve suffered an obvious medical error that led to permanent disability or death. Elderly patients are often retired, so their income is low. Plus, they usually have no dependents and Medicare picks up their medical bills.

By comparison, a 40-year-old who suffered the same type of harm but was a breadwinner for a family with three children, would be a much more attractive case, Daniels said.

Lawyers are the gatekeepers to the law,” Daniels said. “You can have all the rights in the world, but if no one will take your case, then those rights mean absolutely nothing.”

Ciccotelli, 58, donated his kidney in 2006 at Beth Israel Deaconess Medical Center in Boston. The transplant went off without a hitch, but his medical records show that within days he suffered nausea and intense pain in his gut, then chills and a steady greenish drainage that soaked his bandages and shirts.

He had an infection plus an additional complication: His intestines had knuckled under beneath his skin. Ten days after the transplant, doctors operated again, removing 15 inches of dying intestine from Ciccotelli’s gut and scraping out the infection. The hospital, which declined to comment for this story, didn’t charge him for the clean-up procedures.

The injury Ciccotelli sustained while being a Good Samaritan had a cascading effect on his life and finances. He had just started a new career as a lawyer, running a jack-of-all-trades shop near his home in Norwich, Vt. But because he couldn’t consistently travel to his office and hearings, he estimates he lost $45,000 in earnings.

Ciccotelli said he paid a few thousand dollars out-of-pocket traveling back and forth to the hospital for treatments. For about a year he was unable to carry any weight, and he said he still can’t exercise the way he did before the surgery, which has caused his weight to balloon.

Ciccotelli figured another lawyer would jump to take his case. He’d been fine before the surgery and clearly had suffered harm. But one by one, lawyers turned him away.

After about a half-dozen rejections, he asked one why no one would take his case. You can win, the attorney told him, but it won’t be enough money to be worth it.

As a new lawyer, Ciccotelli didn’t make much. He estimated his income would be about $41,000 that year. Because the hospital performed the repair surgeries for free, there were no big medical bills, the attorney told him. Plus, he’d be able to earn income again.

Given the potentially high costs of suing a hospital, the attorneys took a pass.

In some states, the problem is exacerbated by strict caps on damages for medical malpractice. A 2011 study in the journal Qualitative Sociology however, found that the emphasis on damages affects patients nationwide, no matter the state limits.

The study included interviews with attorneys and found that monetary damages were the most important factor in taking cases. “I turn down clearly meritorious cases all the time because I think they’re just not worth enough money,” said an attorney from Pennsylvania, which the study said did not have caps on damages.

More than 450 attorneys were surveyed for the Emory study, “Uncovering the Silent Victims of the American Medical Liability System,” which found that three out of four medical malpractice attorneys reject more than 90 percent of the cases they screen. The study found:

•               About 95 percent of patients who are harmed will find it extremely difficult to get representation.

•               Almost no attorney will take a case, even when the chance of winning is 95 percent, if the damages are less than $50,000.

•               More than half refuse any case, no matter the likelihood of winning, if the damages are less than $250,000.

The study recommended reforming the system by increasing funding for legal services, so attorneys could be compensated for their time; making defendants who lose a case pay the plaintiff’s attorney fees; or sending malpractice complaints to an administrative system with neutral adjudicators and medical experts so patients wouldn’t need an attorney. 

Malpractice attorneys agree that many legitimate cases aren’t pursued, though not because they’re greedy or don’t want to help.

Patrick Malone, a Washington, D.C., attorney who has represented patients in medical malpractice lawsuits since 1985, said he triages cases to focus on those that resulted in permanent harm. That’s necessary, he said, because of the time and emotional investment the patient will need to make to bring the case to trial, and because of his investment in the case.

Most cases settle, Malone said, but not usually until the last minute, years into the process. So he has to prepare the patient and himself for a long haul.

Some patients are initially outraged when he declines to take their case, but Malone said it can cost up to $20,000 just to assess a case and up to $300,000 in expenses to bring a complex case to trial. If there’s a verdict or settlement in the patient’s favor, the attorney fees eat up a third and expenses take up more.

If you spend $50,000 and only get $50,000, the lawyer gets nothing and the patient gets nothing,” he said. “Nobody wants to do that.”

Some call patients who can’t access legal system “hidden victims,” said the American Bar Foundation’s Daniels. No one knows how many there are because their cases never get a hearing. 

Not all patients who suffer harm have the same experience. A small but growing movement in the medical community encourages openness with patients when they’ve suffered harm.

Doctors and hospital officials who subscribe to this philosophy, such as those at the University of Michigan Health System, the University of Illinois at Chicago Medical Center and Stanford University Medical Center say they tell patients when something went wrong and offer an apology and sometimes even compensation. They say the method is more humane and often eliminates lawsuits.

ProPublica is conducting an ongoing investigation of health care safety. Have you been harmed while undergoing medical care? Please complete our Patient Harm Questionnaire

       23 comments

         


         

Mike McDermott •

     


Who's to say that lawyers aren't taking whatever info that a prospective litigant offers them and selling it to the very people involved in the potential lawsuit? Most people don't realize that the conversation that they had with the lawyer which was probably at no charge is not protected by lawyer/client privledge. Since hospitals are usually non profit, they don't have to disclose as to whether they paid a lawyer off. So, that conversation might be worth $50,000 without ever leaving the office, from the very people intending to be sued.


        

         




        

         


         

Lenore Alexander •


Fact: my 11 year old daughter died as the result of 100% preventable medical error(s)
Fact: I live in California, so her life had no monetary value ( MICRA )
Fact: I got a high powered A list attorney to take the case, because it was connected to a $30 million dollar computer system that had a lot of known problems
Fact: when it became clear, we would not have enough information to tie her death to this system, my case was given to the newest hire in the firm
Fact: everything about my life was subpoenaed . financial , education, medical, all records. The hospitals investigation into my childs death was protected from being subpoenaed by law.
Fact: weeks after her death, 400 doctors met, off site, and voted unanimously not to return to work until this computer system was pulled.( Jan. 22 2003 L.A times by Charles Ornstein)
Fact: it was pulled
Fact: the executives responsible for making the profit driven decision to " work out the problems" on the general floors, are still there, and have never been questioned about this abuse of power and lack of concern for patient safety.
I was advised by my attorney to settle, because although my case was strong, and i was a very credible witness, a jury would not know any award they decided on would be reduced to $250,000 because of the MICRA law.
I personally felt, my only "win" was that I never signed a confidentiality agreement.
The LA county coroner kept her body for 4 months. The pressure from the hospital to find a heart problem was very strong. Finally, I was told by the coroners office , off the record, the best they could do for me was put, cause of death " unknown"
Any admission of error, any apology, would have changed the last 11 years of my life dramatically. I am the only one who was there that accepts any portion of responsibility. I do believe sorry saves money. I also think, had they been honest, and admitted a part of the problem was that she was overmedicated, and not monitored, something could have been changed in terms of protocol. Knowing my daughters life had saved the next kids life would have been worth more than $250,000, which is about what I owed the law firm at that point after 2 years.


        

         


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Danny Long Lenore Alexander •


Lenore, I agree, most of us would feel a LOT better knowing a lesson was learned, and prevented others from our collective horror... The "intentional heartbreak" even after a true error, "Knowing NOTHING was learned, nor do they care" That is the heartbreak that is the driving force keeping many in the fight. Knowing they simply do not care because the medical complex is protected by it's own NO MATTER how horrid, intentional, negligent the acts.. they are ALL protected by each other up and down, side to side on the medical food chain. 
Power, Greed, Money are the hallmarks of corruption.


        

         




                  


         

Bruiser02 •

When I had a case for medical malpractice not only was the cost prohibitive but the lawyer told me I would be hard pressed to find a doctor who would go against another doctor.


        

         

Nightmare-daily • 4 hours ago

        


I was an RN and suffered serious and permanent harm from my cancer surgery. There were many errors, including my waking up during surgery, life-threatening infection, internal sutures that did not dissolve, renal failure, a collapsed lung after hospital discharge, abscesses, wound dehiscence.......Years later, I am essentially homebound and unable to work. I would be making $80-100,000/year now or more, but am stuck barely above poverty on Social Security Disability. Since I and the various insurances have spent over 2 million for my care, and I do not have enough money to obtain all the care & medications I need, I am very unhappy. I have a potential new abscess now. It is a living horror, and the cancer may return. I am always in pain. No attorney would take my case. Even the failure to diagnose the cancer for years, with facts right there for every doctor I went to with my symptoms, isn't actionable. I am however, alive.


        

                  


         

Jacob Kuriyan •                  

         
The point that is not made clear in the article is that most attroneys do not take such cases on a "contingency" basis. You can always get an attroney to represent you - if you are willing to pay for their services up front. In my experience, most mal-practice insurers will pay a reasonable (and small) amount to avoid their cost of litigation. But when the claim is very high - for whatever reason - it is only fair that everyone have a fair share of the risk. Mal-practice insurance should be treated as a vehicle for compensating victims and punishing physicians for their mistakes - not as a system to enrich lawyers. In my opinion - The administrative judge approach, using a separate judiciary to resolve such disputes, with their costs paid from judgments, is a workable solution.


        

         

dkulwicki Jacob Kuriyan

Eric (below) is correct. If there was easy money in med mal litigation, lawyers would flock to it. In fact, the opposite is true. Lawyers are turning away from this area of practice due to the economics. Lee (below), too, is correct. Administrative judges are not a good answer because they are subject to political pressures and bias based on who appoints them. You at least have a fighting chance with a jury and an elected judge.


                 

         


         

Lee T Jacob Kuriyan


As a plaintiff's lawyer, I don't think the administrative judge approach is at all workable. The defendants will always be able to make up bogus proximate cause defenses. They will have the resources to invent them. You will not have the resources to overcome them. Simple as that. Most malpractice cases are defended on proximate cause issues, not negligence issues. The reason is that proximate cause defenses can be much more complicated than negligence issues.


        

                 

         


         

marshall_allen ProPublica Jacob Kuriyan •                  
Hi Jacob, thanks for reading our story and taking the time to comment. I wanted to point out that research shows that these cases are typically taken on a contingency basis: https://www.documentcloud.org/.... Also, I've spoken to many medical malpractice attorneys who have told me the same.


        

                 

         


         

Eric Andrist Jacob Kuriyan •                   
Most states have tort reform laws; only 22 do not. Most of those have caps on attorney fees, so I'm not so sure that lawyers are getting rich off of malpractice cases. Here in California, there is a sliding attorney fee scale built into the tort reform law. The higher the verdict, the less the attorney gets.


        

                  


         

Carol Dye                   
When my father passed from MRSA aquired after open heart surgery either in the hospital or rehab center I called 40 attorneys and was told the exact same thing as the writer states. He was too old, had lost his viability (translate earning potential), no wife (had passed). Most would not tell me why they would not take the case,but one did. It's not only hard to hear that your elderly parent has no value legally but this is exactly why doctors and hospitals and other medical facilities continue their poor attempts at keeping hospitals as clean as possible. They answer to no one.


        

                  


         

Danny Long •

                  
Compounding the whole out of control medical cartel here in North Carolina... As the number one employer in NC, Duke University corruption owns NC government. At the same time the number one cause of personal bankruptcy, and number three cause of death... North Carolina is a true "STATE OF ADDICTION"


        

         

Danny Long •                  

         
Scared silent: the clash between malpractice lawsuits & expert testimonyhttp://www.nationalme...


        

         




         

Marcie Jacobs •


It’s not just that the manufacturers of faulty products and doctors and other providers that repeatedly do grave harm it is also that society and insurance companies’ use the information against you to deny other life-saving benefits such as LTD and access to affordable living. And the health insurance companies, our tax dollars and family members are burdened with their mistakes. There is no fairness in this. Corporations and providers should not be allowed to maim and kill with impunity. Many families will be bankrupted by not being able to get justice and it is not just the victim of the injury that is harmed. It’s also your tax dollars that have to pay for these injuries so in my estimation that means everyone should be concerned about where the financial responsibly should fall. 
If we created this legal nightmare we can undo it. Make your voice be heard and make sure a legislator that votes in favor of a Supreme Court Justice for life knows that you will not tolerate another corporatist Supreme Court Justice whose decisions favor corporations over citizens.


        

                  


         

Eric Andrist •                   
After caring for my disabled sister full time for 9 years, she died in March 2012 of medical negligence. I had never heard of California's MICRA law, which limits noneconomic damages to $250,000. But I sure started to hear about it once I started looking for a lawyer to take my case. I was turned down by a dozen or more lawyers in an 8 month period. You only have 1 year to file a case, and that only left me 4 months or I'd have been out of luck. I was lucky enough to find a lawyer who took my case, but only because I had made some connections in a campaign to fight the MICRA law. He took my case solely on its merits and told me flat out that he has accepted that he will likely lose money on my case. 
There are still a few really good people in this world. 
I was even given a recommendation to a big-time Los Angeles lawyer by my neighbor who happens to be a judge. I spoke to a lawyer in the firm who was really nice and very understanding. I told him that I was aware of the MICRA law and had already been turned down by a number of lawyers because of it. I told him I didn't want to waste anyone's time if MICRA was going to be a problem for them. He told me flat out that if my case had merit, it would NOT be a problem for them. He asked for a month to go over the case and talk to his firm about it. That's a scary request when you only have 12 months in total to file your case and 1/2 of those are already gone. 
One month later I received a letter from that lawyer turning down my case. And what was the reason? MICRA. He wrote it right in the letter! I sent him a letter back reminding him that I had told him not to bother if MICRA was going to be a problem...but I never heard back from him. 
Fast forward to a year later. I'm now working with Consumer Watchdog and the Consumer Attorneys of California to get the MICRA law changed. With Bob Pack, we are pushing to get the Troy and Alana Pack Patient Safety Act on the November, which in part will raise the $250,000 to cap to match inflation (currently over a million dollars). I've been sent on meetings with 8 legislators trying to talk them into taking the matter on, and they usually send a lawyer from the Consumer Attorneys with me. On my last meeting, they happened to send a really great lawyer from the very same firm (above) that turned me down. She had not heard my story until that meeting and I think realized what a great case we actually have upon hearing it. After the meeting I told her of my experience with her firm. I think she was genuinely embarrassed and sad that it happened.
I was awarded the Public Advocate of the Year Award this past November and the lead partner of that firm paid (sponsored) to have Kenny Rogers perform at the ceremony at the Palace Hotel in San Francisco. I couldn't help be irked by all the money that must have cost him when his firm feigned not being able to take my case due to MICRA. Again, this is a HUGE firm in Los Angeles. Losing my case would have been a drop in the bucket for them. 
Since being on this journey, I've met a number of people who didn't get lawyers and some who did, but never made it to court because the costs surpassed the amount of money they could win. One person's lawyer fought for 3 years only to give up. So not only did they lose their daughter, they also lost the ability to hold the people that killed her accountable. 
I'm very grateful to have found a lawyer (who is one of the top malpractice attorneys in California), but also suffer great guilt every time I hear a story of someone who can't get a lawyer. 
We need to do something about this. Far too many people and institutions are getting away with murder.


        

         


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MightyCasey •                   
Seems to me that the legal profession could set up what amounts to a pro-bono pool for cases like this. Attorneys/firms donate time and talent, with the treasure (damages awarded) divided between the plaintiff and the "pool" in the state where the case was tried. 
I get that we're all trying to make a living, but giving the Heisman to patients with winnable cases simply because the dollar amount would be too low smells like another example of the American tendency to put too much focus on ROI without enough room for ethics ...


        

         




        

         

kratliff73 MightyCasey •                   
I had the same issue after my daughter passed from medical harm. I did at one point, have a signed contract with an attorney. He had a friend in the medical field that he felt could review her 2500 pages of medical records. However, when his friend explained that because she was an infant who went in for heart surgery, you'd require a specialists, it didn't take long for the attorney to send me a letter stating he couldn't help me. I added that letter to the other dozen all stating we had a good case, but the financial limits made it impossible for them to take it. It was business. In my case, it was explained that we would need two specialists to review my daughters chart and testify. I was told it would cost roughly $50k to $75k per specialists. This doesn't include normal costs for the attorney. Although it was heartbreaking, I do understand the attorney's cannot lose that kind of money on a case. I even asked if it were possible for me to sign an agreement stating the attorney gets everything above expenses. I didn't want the money. I just wanted the hospital to have to own the mistakes. Although DHS did an inspection and found many errors on the hospitals side, there is no ownership of these errors. Nobody ever hears about the avoidable mistakes because the hospital won't allow it. And DHS just files a report which the hospital responds to with a plan to fix the problem. No penalty, No follow-up. I just wanted someone to take responsibility. As you read this, don't assume she passed because of her heart.... The surgery was successful, as expected. It was the aftercare that killed her. Avoidable infections, overdose of heparin, lines becoming dislodged, a Doctor collapsing her lung while removing a drain tube... It seemed endless, but was only 95 days. One heart surgery with a 99.9% success rate and 7 days recovery in the hospital turned into 3 heart surgeries, an exploratory abdominal surgery and 7 Hospital associated infections and 95 days later, her death. I wish there were a Medical Court (of sorts) that patients could go to without an attorney. They file a complaint and sit in a room with the doctor, nurses, specialists and a panel of "judges" and plea their case. Ask their questions. No attorneys. No "specialists". Just a place to get answers, and if needed, monetary compensation. Personally, I just wanted answers.


        

         


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Eric Andrist MightyCasey •

But you can't blame them. How many other professions have to do work on a pro-bono basis? Not many. And, I think good lawyers DO do a fair amount of pro-bono work. How many doctors and other "experts" are donating their $800 an hour time to testify in court for us? 
Part of making this more effective would be reducing the costs of actually getting to court. In California, the lawyer fees are already drastically reduced as part of the MICRA (tort reform) law. We should be putting realistic caps on the costs to bring cases to court.


        

         




         

kratliff73 Eric Andrist •

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Eric, I couldn't agree more with this point. I had attorney's that expressed their desire to take my case but with MICRA, they weren't sure there was even enough to cover the specialists that would be needed to review the files and testify. But in addition to the cost (and this is another topic I have read many articles about), they expressed the improbability on even finding the experts willing to testify against this particular hospital. At least 1/2 the attorney's I spoke to mentioned we would have to go out of state because many of the Pediatric Cardiologists in California are in some way connected to this hospital. In reading arguments for/against MICRA, you read over and over people blaming attorney's and their "greed". But many don't realize that the attorney's are limited to what they can take. And most times, they take all the risk. As I received letter after letter and call after call from Law Firms expressing their interest, but inability to help, I never blamed them. I understood the battle the minute I heard about MICRA. There has to be a way for people to get justice.


                           


         

MightyCasey Eric Andrist •

                        
I agree, Eric. However, it will take the legal lobby's participation in reducing the costs of getting to court, which they seem loath to do, at least to date. Talking about fee caps makes 'em go flying monkeys ...


                           


         

Jessamare •

                  
My younger brother died almost 2 years ago. He coded a couple days after a colostomy procedure. The doctors rushed him into surgery as he was clearly bleeding internally, they didn't find the source of the bleed, but after looking for a while, gave up and closed the surgery anyway. He continued to bleed, which led to 2 more surgeries, more complications and his eventual death. 
We have had multiple lawyers look at the case, All have told us that while they believe mistakes were made, it would cost too much to prosecute the case to be worth it. Since he was 25, single, and childless, there are no financial losses, no one who was depending on his paycheck. All we really want is answers and assurances that something has been done within the hospital to prevent similar mistakes from occurring again.


                           


         

Veronica James •

                  
Great article, Marshall Allen & Olga Pierce.
Thanks for bringing this more to light. Yes it is VERY frustrating! I
spoke with about four other attorneys who refused to take Mom's case, 
and finally found one who would. There are few good ones out there, but
you have to look hard and be persistent! I might also add that Patrick Malone is to be commended for his policy AGAINST settlement gag clauses!


                           


         

Patrick Malone

                  
This story does a good job highlighting the economic realities of the American legal system, which is expensive and time-consuming for everyone. The dilemma is that most proposals to make the process quicker and cheaper come at the expense of injured patients, so lawyers like me who represent patients are reluctant to endorse legal "reforms" that the medical industry backs. We do have extensive resources on our website for patients and families who want to make complaints about quality of care, many of which are very valid even if they don't make for a viable lawsuit. http://www.patrickmalonelaw.co...