Australian Inquiry: Pelvic Mesh Causes Catastrophic Harm

A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries

Joanne McCarthy

4 Aug 2017, 5:30 a.m.

Determined: Women pelvic mesh victims leave the Federal Court in Sydney as a six-month class action against pelvic mesh manufacturer Johnson & Johnson takes place. A Senate inquiry is considering how mesh was cleared for use in Australia.

AUSTRALIA’S peak health care commission has told a Senate inquiry that up to 3000 Australian women have been left with injuries ranging from very serious to catastrophic after pelvic mesh surgery that is no longer recommended as a front line treatment.

The Australian Commission on Safety and Quality in Health Care was highly critical of specialist training, information to women about pelvic mesh risks, the treatment of women after serious mesh complications and the failure of doctors to respond when they sought help.

“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue,” commission chief executive, Adjunct Professor Debora Picone told the inquiry during a public hearing in Melbourne.

Commission clinical director Dr Robert Herkes said 40 women interviewed during consultations in four Australian cities had complications that were “undoubtedly overwhelming those women’s lives”.

“The bulk of the women were separated or divorced. Only one woman held down a job. For those women the complications were catastrophic,” Dr Herkes said.

Many of the women did not know they had been implanted with mesh devices until they searched for explanations for complications including chronic infections, disabling pain, erosion of the mesh into other organs and an inability to have sex.

“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue.

- Associate Professor Debora Picone

”

“We’ve been extremely concerned by the issues raised by the women we’ve talked with about the informed consent process, and particularly the informed consent process in relation to mesh surgery to treat prolapse,” Professor Picone said.

“In fact some of the conversations we’ve had with women, informed consent has really been absent. There’s no question about that in our minds.”

She described “so-called patient information leaflets” about pelvic mesh surgery as “hopelessly inadequate”, and said the commission felt very strongly that “major steps” needed to be taken on credentialing of doctors who implant mesh devices.

The Senate inquiry into pelvic mesh was called after Australian Pelvic Mesh Support Group founder Caz Chisholm and other members spoke with Victorian Senator Derryn Hinch. He campaigned for an inquiry into “one of the greatest scandals against women in Australian history”.

It is hearing evidence from women who received mesh implants through the vagina for prolapse treatment – now not recommended as a front line treatment after complication rates of at least 10 per cent – and mesh for incontinence, with lower complication rates and recognised evidence of safety and efficacy.

At the first hearing day two doctors who gave evidence conceded they should have declared they were to appear as expert witnesses for Johnson & Johnson in the company’s defence of a class action brought by more than 700 women after mesh surgery for incontinence and prolapse treatment.

Dr Anna Rosamilia told the inquiry she “should have disclosed” that she would be giving evidence for the company after appearing as a representative of Monash Health at the inquiry.

“I wasn’t aware that I needed to,” she said.

Dr Peter Dwyer, who will also give evidence for Johnson & Johnson, told the inquiry most of these companies have got strict ethical protocols that they stick to, before conceding he was an expert witness for the company.

Dr Dwyer told the inquiry that specialist training on mesh surgery was “falling between the gaps a bit”.

“If they’re placed in the wrong place… I mean, patients have died from these devices. They’ve got to be placed correctly,” he said.

Mesh manufacturers, which have been training doctors, should not be left to train them, he said.

Medical colleges had been “very happy to pass this on to special interest groups to manage these problems”, he said.

In response to a question from Mr Hinch about mesh company representatives being present in operating theatres while women are being implanted with mesh devices via the vagina, Dr Dwyer said “on occasion the rep does come into the operating theatre”.

“It’s not unusual for them to come into theatre at times. As long as they’re not directing the operation or interfering in other ways,” Dr Dwyer said.

The inquiry will hold another public hearing in Perth on August 25.
http://www.theherald.com.au/story/4832324/peak-health-body-scathing-on-mesh-history/

Pelvic Surgical Mesh: "Living in Hell"

Western Australian pelvic mesh victims criticise government response to scandal

Joanne McCarthy

21 Jul 2017, 1 p.m. FiDA highlight

• Women call on WA Health Minister to order investigation into mesh surgery research

Women allege they were used as guinea pigs in pelvic mesh trials in WA public and private hospitals

SUE Turner and Jeanette McKinnon are the Western Australian women implanted with pelvic mesh devices in public hospitals who refuse to be regarded as unfortunate statistics.

They have made submissions to a Federal Parliament Senate inquiry into pelvic mesh – with a public hearing in Perth on August 25 – listing serious, permanent and life-altering consequences of their surgeries more than a decade ago.

They want answers from WA Health Minister Roger Cook about mesh research allegedly conducted in public hospitals, and whether they are included in mesh trials for which they say they did not consent.

They are scathing of Mr Cook’s commitment to “make some enquiries” about the alleged mesh research trials, in response to questions from Fairfax Media, and have called for a full investigation into whether women were used as “mesh guinea pigs” in public health facilities.  

“Something awful happened to me in 2004 and 2005 after I had mesh put into me. My world’s just so small now,” said Mrs McKinnon, who was 46 in 2004 when she was implanted with an Australian-developed pelvic mesh device at Bentley Hospital.

“It’s like living in hell. I’m dying a very slow and agonising death.”

Victorian Senator Derryn Hinch in February successfully argued for a Senate inquiry into how some pelvic mesh devices for women’s incontinence and prolapse problems after childbirth were cleared for use in Australia over the past two decades. He compared pelvic mesh products to Thalidomide, the drug that led to birth defects in babies in the 1960s.

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(Video on link.) Senator Derryn Hinch calls for a Senate inquiry into pelvic mesh.

The aggressive marketing of many mesh devices in Australia from 2003, without sufficient evidence of their safety and efficacy, led to “one of the greatest medical scandals and abuses of mothers in Australia's history,” Senator Hinch said in a speech to Parliament.

Nearly 200 Western Australian women have responded to a survey conducted by Victorian consumer health advocacy group, Health Issues Centre, for a submission to the inquiry representing the experiences of more than 2200 Australian women implanted with pelvic mesh devices.

More than 700 women are part of a current class action against major pelvic mesh manufacturer, Johnson & Johnson, in the Federal Court in Sydney.

Sue Turner, of Perth, has sought legal advice about a class action against an Australian manufacturing company, after she was implanted with an Australian-developed pelvic mesh device at Armadale Hospital in 2007.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial.

- Sue Turner, who had pelvic mesh surgery in 2007.

”

“I had a prolapse. I just trusted the doctor and our health system when he told me it would be a pretty easy fix,” Mrs Turner said.

“I was never told the device was high risk. I was never told about trials. I would never have consented to being part of a trial. If I was told there was a risk that if things went wrong I would never have a sex life again, or live a life of sometimes unendurable pain, or be left with mesh and anchors in my body that have moved and embedded into tissue very close to major blood vessels and nerves, I would never have consented. But I wasn’t told.”

In a statement to Fairfax Media Mr Cook said he would ask the Department of Health to “make some enquiries into the research undertaken, and the cases where the implants have been used”, after two senior Western Australian doctors released a series of papers from 2005 about trials in Western Australian public and private hospitals, including Armadale Hospital, using the Australian-developed pelvic mesh device.

In a statement by a WA Health Department unit, Fairfax Media was advised there are no records of research approvals for trials involving surgery on women at public hospitals using the Australian-developed pelvic mesh device.

Mrs Turner and Perth-based Australian Pelvic Mesh Support Group founder Caz Chisholm were angered by Mr Cook’s statements that the “WA Government understands the concern this has caused for some patients”, but “there have been very few complaints received by WA Health and the Health and Disability Complaints Office”.

“What are we? Guinea pigs?” Mrs Turner said.

“I want this stuff out of my body but my doctor’s told me the surgery could be life-threatening. This isn’t about numbers. It’s about how our health system allowed these devices onto the market, and how these doctors were allowed to do this surgery in public hospitals without telling us of the risks.”

Ms Chisholm said the lack of complaints was a consequence of women being told for years that their chronic problems, including often debilitating pain, repeated serious infections, and erosion of mesh into organs including the bladder and bowel, were not linked to mesh surgery, or not being told they were implanted with mesh.

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause.

- Australian Pelvic Mesh Support Group founder Caz Chisholm

”

“Many women who have presented to their doctors with pain and complications have been told it is not the mesh that is the cause. It is only because of recent media attention about stories of women's pain and complications that women are realising their own complications are identical to the media stories,” Ms Chisholm said.

“The minister says there have been very few complaints by women, but what about the doctors treating the women? Obviously doctors aren’t reporting complications either, and are they supposed to?”

Mrs McKinnon has spent more than a decade on antibiotics.

“I came out of hospital not very well in 2004 and had my first urinary tract infection shortly after that. Then it was one urinary tract infection after another. If I come off the antibiotics I get a urinary tract infection,” she said.

She had another four major surgeries over the following year to relieve the pain and address mesh erosion into organs. 

In 2009 Mrs McKinnon was diagnosed with the auto immune condition lupus, requiring steroid treatment.

“I was normal, healthy and fit before I had that surgery. I’m only 59 and I feel like a 100-year-old. I thought all these years it was just me. It’s just the nightmare that you live.”

In a statement in June the Royal Australian College of Obstetricians and Gynaecologists said the majority of women treated with mesh for incontinence or prolapse had “a good long-term result” but “in a small number of cases the complications have been very serious”.

In a submission to the Senate inquiry Victoria’s Health Issues Centre chief executive Danny Vadasz has criticised mesh debate “framed in terms of the good outcomes of the many outweighing the unfortunate experiences of a few”.

“Our health system is built on values such as equity and a universal duty of care, not on a cost/benefit analysis that accepts the unavoidability of collateral damage,” he said, in a Health Issues Centre submission arguing Australian regulators have been “asleep at the wheel” on pelvic mesh.

Do you know more? Email jmccarthy@fairfaxmedia.com.au

http://www.theherald.com.au/story/4804268/its-like-living-in-hell/

Johnson & Johnson shareholders: are you listening? Divest or be complicit!

Jury delivers $20 million verdict against Johnson & Johnson in local vaginal mesh case

POSTED:APR 28 2017 03:07PM EDT

UPDATED:APR 28 2017 03:09PM EDT  FiDA Highlight

PHILADELPHIA, PA (WTXF) - On Friday, April 28, a jury handed down a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after being implanted with a vaginal mesh device.

The verdict was the third consecutive eight-figure award against the corporate giant in a mesh case in a Philadelphia courtroom.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—for Peggy Engleman, now 56, of Cinnaminson, followed a three-week trial in Common Pleas Court in which her attorneys claimed the TVT-Secur medical device was not only defective but that J&J and its Ethicon subsidiary had failed to warn of its risks, risks they had been well aware of while continuing to market the product.

Engleman was implanted with the device in 2007 to relieve stress urinary incontinence, a leakage caused by things such as exercise or coughing. But within a month the TVT-Secur failed and Engleman's stress urinary incontinence returned.

She began experiencing pain and discomfort when the polypropylene mesh started to erode inside her body. Despite three subsequent surgeries, doctors were unable to remove all the remaining mesh.

As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

“I'm happy I could be a voice for other women,” Engleman said after the verdict. “It's been a nightmare, and I feel justice was truly served today."

The vaginal mesh product in Engleman’s case, the TVT-Secur, was launched in September 2006 but, as her attorneys noted, J&J had already had numerous reports of high failure rates from countries all over the world.

"This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated," said lead plaintiff’s counsel Benjamin Anderson.

• 
  

“The jury made the right decision,” added Thornburgh. “They looked at the evidence and heard the testimony and decided that the company had rushed the product to the market, did woefully inadequate studies and didn’t warn about the risks. So we feel they made the right decision and our client will finally get justice.”

Said Gomez: “The jury spoke and they sent a message that J&J and Ethicon need to take responsibility.”

The verdict was the third straight against a J&J vaginal mesh product in which the plastic-like device eroded inside a patient, leaving shards of mesh that doctors were unable to entirely remove.

The first two cases, in 2015 and 2016 respectively, produced verdicts of $12.5 million for an Indiana woman and $13.5 million for a Toms River, N.J., woman.

Please Sign this Change.org Petition to Restrict Uterine Power Morcellation

PLEASE SIGN THIS PETITION TO BAN UTERINE POWER MORCELLATION

FDA hearing July 10 & 11 (deadline)

A Surgical Procedure’s Risks,Unmentioned

By JANE E. BRODY MARCH 17, 2014 12:01 AM

PERSONAL HEALTH

Jane Brody on health and aging.

Many patients assume that, like prescription drugs, surgical procedures and instruments undergo extensive testing and must be government-approved. It’s not necessarily so.

Developers, of course, do test new instruments, and practitioners often train with an expert before using them unsupervised to treat patients. And the Food and Drug Administration must confirm an instrument’s safety and effectiveness before it can be marketed — but only if the device is deemed significantly different from others already approved.

Surgical techniques, however, are not subject to the stringent approval process that drugs go through. And as with drugs, problems with new procedures may not become apparent until after they have been used many hundreds or thousands of times.

Such is the case with a popular treatment for a very common medical problem: uterine fibroids. The technique, called electric or power morcellation, has widespread appeal for both surgeons and patients. It is used during laparoscopic or robotic-assisted operations that are fast and effective, require only a tiny incision or none at all, and involve less pain, a shorter hospital stay and a quicker recovery. In most cases, these operations are safer than traditional surgery.

As recent reports have shown, however, power morcellation can also cause serious and sometimes life-threatening complications. Experts say that prospective patients are often not told about these risks before consenting to the operation.

The technique involves insertion of a tiny instrument with a rapidly rotating blade, the morcellator, that breaks up the fibroid so that it can be sucked out through the small opening of a laparoscope. But problems can arise months or years later if pieces of tissue escape into the pelvic cavity and seed themselves on other organs.

This problem is all the more serious if the fibroid that was morcellated happens to have contained a hidden cancer. Although the overwhelming majority of fibroids are benign, there is no certain way to tell before their removal if they harbor a cancer, which happens in 1 in 400 to 1 in 1,000 cases.

One such case involves a 41-year-old Bostonian, Dr. Amy J. Reed, an anesthesiologist and a mother of six, who now has a Stage 4 leiomyosarcoma after undergoing uterine morcellation. It is a rare but particularly aggressive uterine cancer. Dr. Reed and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are waging a campaign through Change.org to halt use of the technique.

Despite several preoperative tests, neither Dr. Reed nor her surgeon suspected that cancer lurked within the fibroids that were removed. If she had had a traditional operation in which the fibroids were cut out or the entire uterus removed intact, it is highly unlikely that the cancer would have spread.

From 1983 through 2010, 13 unexpected uterine sarcomas were reported after uterine surgery on 5,666 patients. Among 1,192 women who underwent morcellation, two developed sarcoma that spread within the abdomen.

After reviewing the medical records of more than 1,000 women who received morcellation for fibroids, specialists at Brigham & Women’s Hospital in Boston found a ninefold higher rate of unexpected sarcoma than is now quoted to patients considering the procedure.

“These data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated risk of mortality much higher than appreciated currently,” the researchers wrote in the journal PLOS One in 2012.

Even benign uterine tissue, when it is spread to other parts of the abdomen during morcellation, can grow in places it doesn’t belong and cause pain, infection or bowel obstruction.

There is a technique that could make morcellation safer: encasing the tissue to be removed in a bag before it is broken up. But thus far, the procedure is infrequently used, and few surgeons are skilled in the technique.

Other established ways to treat bothersome fibroids are free of this potential risk, though complications like wound infection are possible.

Fibroids are extremely common, affecting half or more women during their reproductive years, when hormones foster their growth. They develop from the smooth muscle tissue of the uterus, ranging in size from tiny to huge, and often shrink after pregnancy and menopause.

Most women with fibroids are unaware they have them, but others can experience symptoms like prolonged heavy periods, bleeding between periods, pelvic pressure, constipation, frequent urination, backaches and anemia. They can sometimes cause infertility or miscarriage.

Fibroids are typically detected through a pelvic exam, sonogram or M.R.I., sometimes with saline solution or a dye used to better define their size and location.

Nothing needs to be done about a fibroid that causes no distress. Large, bothersome fibroids can often be shrunk by several months of treatment with medications that block estrogen and progesterone, causing temporary menopause and its attendant symptoms.

The drug mifepristone (RU-486) also can shrink fibroids, and Evista may do likewise, but only in postmenopausal women. Sometimes a low-dose oral contraceptive is used to reduce bleeding caused by fibroids without shrinking their size.

Noninvasive ultrasound surgery under M.R.I. guidance can be used to heat and destroy a fibroid without damaging the uterus. A fibroid also can be destroyed by injecting small particles into uterine arteries to cut off its blood supply.

Fibroids can be removed laparoscopically or robotically without damaging the uterus. If the fibroid is contained within the uterus, it can often be removed with surgical instruments inserted through the vagina and cervix. Some fibroids may be destroyed by applying heat or electric current to the uterine lining.

Very large, multiple or deep fibroids may require more traditional surgery, called an abdominal myomectomy, that spares the uterus, or with a hysterectomy, a more serious operation involving removal of the entire uterus, ending a woman’s menstrual periods and ability to bear children.

If you are contemplating treatment for symptomatic fibroids, your doctor should answer several important questions before you choose a method:

What is the nature of the problem, and how necessary is it to treat it?

What procedures are known to be effective, and what are the risks and benefits of each?

What is the approach you recommend, and how much experience do you have with it?

What are its possible complications, and how often do they occur?

Without a clear understanding of treatment options, their potential hazards as well as their effectiveness, it is not possible to for you to give informed consent.

http://en.wikipedia.org/wiki/Morcellator

Morcellator

From Wikipedia, the free encyclopedia

Jump to: navigation, search

A morcellator is a surgical instrument used for division ("morcellation") and removal of large masses of tissues during laparoscopic surgery.[1] It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges[1] or cutting jaws,[2] through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.[1][2]

Morcellation devices in surgery[edit]

Laparoscopic morcellation is commonly used at surgery to remove bulky specimens from the abdomen using minimally invasive techniques. Historically, morcellation was performed using a device that required the surgeon or assistant to manually 'squeeze' the handle. Other reports describe using a scalpel directly through the abdomen to create small specimens that can be drawn out of the abdominal cavity. In 1993, the first electric morcellator was introduced in the US market. It was initially used for uterine extraction, but later applied to other organs. The use of morcellators at surgery has now become commonplace, with at least 5 devices currently on the US market. Despite decades of experience, there remains limited understanding of the short-term and long-term sequelae of morcellation. Concerns have been raised about injury to surrounding organs including bowel, bladder, ureters, pancreas, spleen and major vascular structures. Long-term issues may include parasitic growth of retained tissue with the potential to cause adhesions, cause bowel dysfunction and potentially disseminate unrecognized cancer.

Safety concerns of morcellation devices in gynecologic surgery[edit]

Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for benign pathologies there is approximately a 0.09% risk of an unexpected leiomyosarcoma. After morcellation 64% of such cases may develop disseminated disease which is of particular concern because of the considerable mortality of leiomyosarcoma. Morcellation of the more frequent benign leiomyoma variants may also cause disseminated disease, which while not associated with increased mortality is frequently inoperable and therefore more difficult to manage than the original disease.[3][4]

On April 17, 2014 the Food and Drug Administration issued a warning that morcellators may spread occult cancer in the course of fibroid removal.[5] Johnson & Johnson subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community."[5]

See also[edit]

•                Instruments used in general surgery

References[edit]

1.             ^ Jump up to: 
a b c Disposable laparoscopic morcellator, GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000

2.             ^ Jump up to: 
a b Morcellator, Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.

3.             Jump up 
^ Seidman, M. A.; Oduyebo, T.; Muto, M. G.; Crum, C. P.; Nucci, M. R.; Quade, B. J. (2012). "Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms". In Sullivan, David J. PLoS ONE 7 (11): e50058. doi:10.1371/journal.pone.0050058. PMC 3506532. PMID 23189178. edit

4.             Jump up 
^ Cucinella, G.; Granese, R.; Calagna, G.; Somigliana, E.; Perino, A. (2011). "Parasitic myomas after laparoscopic surgery: An emerging complication in the use of morcellator? Description of four cases". Fertility and Sterility 96 (2): e90–e96. doi:10.1016/j.fertnstert.2011.05.095. PMID 21719004. edit

^ Jump up to: 
a b Robert Lowes (April 30, 2014). "J&J Suspends Power Morcellator Sales Over Cancer Risk". Medscape. Retrieved April 30, 2014.

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...