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

Friday, January 10, 2014

Shocking: Transvaginal surgical mesh scandal!


By Marion Scott  22 Dec 2013 07:31

POLITICIANS joined victims and experts yesterday to demand the immediate suspension of mesh implants as figures reveal hundreds of women suffered horrific side effects – not just six as ministers claimed.
The call comes as lawyers prepare to lodge the biggest medical claim in Scottish legal history, with 400 victims set to sue the implant manufacturers and the NHS.
Pressure was mounting on Health Secretary Alex Neil over the scandal – first exposed by the Sunday Mail in March – after his officials 
were accused of understating the number of women who endured terrible pain caused by the transvaginal mesh.
Yesterday, Labour’s health spokesman Neil Findlay said: “The Scottish Government do not appear to have a clue what is going on.
Heath officials told us just six women had been reported as suffering adverse effects, therefore mesh was safe to use to treat stress incontinence and pelvic prolapse.
“But figures from individual health boards across Scotland confirm almost 300 victims are showing such severe complications that 
surgeons are trying to remove the mesh.
“Two health boards are still to release figures so the final toll is likely to be many more.
“We must suspend mesh procedures until we know the true picture.
“The burden the NHS now face legally, as well as trying to treat those with life changing complications, is catastrophic.”
Government figures state just 2915 women have been given implants since 2007 but figures from health boards suggest at least 8077 women have had the surgery.
While the procedure was successful in many cases, some women were left with a legacy of crippling pain and have been forced to endure years of worry and further surgery.
Medical experts warn it can take years for the complications to emerge.
Lawyer Cameron Fyfe intends to use laws designed to allow asbestos victims to claim compensation without showing immediate physical damage.
He said: “We are so confident, we are proceeding on a no-win, no-fee basis so victims need not worry about the difficulties of trying to claim legal aid.
“The claim against manufacturers will state mesh was deficient and not fit for purpose.
“Claims against the NHS will be that they did not properly inform patients of all the risks or offer alternative treatment in many cases.
“Many were unaware mesh implants are supposed to be permanent. Others fear they have a timebomb inside them.”
Victims have had to undergo up to a dozen operations as doctors battle to remove mesh designed to merge with a patient’s tissue.
Complications range from pain during intercourse to bowel and bladder perforations, crippling nerve damage, lifelong pain and mobility problems.
Manufacturers claimed mesh was soft but evidence shows that it can harden inside the body and damage tissue and organs.
In one test sample of a mesh product, almost one in four showed bladder perforations.
In another test of almost 700 women, a third developed complications.
One of the world’s top specialists in the field wrote to Neil, imploring him to stop the use of the controversial products.
US professor Tom Margolis said: “The use of transvaginal polypropylene mesh for the treatment of prolapse and incontinence must stop immediately.
“There are a host of traditional surgical procedures available which have a zero mesh complication rate.”
The Health Secretary claims banning mesh ops may leave the Scottish Government open to legal action from manufacturers.
But Lothians MSP Findlay said: “Despite being alerted to the crisis nine months ago, Alex Neil has done nothing more than pay victims lip service while the numbers and seriousness of the situation have been obscured.
“As it is quite clear the government have no idea how many women are affected, they must issue a suspension notice on use of transvaginal mesh products until a public inquiry can establish the facts.
“Victims asked Neil to create a Scottish register and legally compel doctors to report adverse reactions to these products so we can get a true picture of the depth of this scandal.
“But although UK medical watchdog the MHRA have said Scotland has the power to do both things, he has refused to do so.
“When victims asked him to suspend the use of mesh products until an inquiry takes place, Alex Neil told them he feared legal action by manufacturers.
“Is he really prepared to put the quality of women’s lives at risk for the sake of offending manufacturers? Surely not.”
Last month, we revealed NHS officials knew four years ago that patients were not being fully informed of all the risks involved with mesh implant surgery. When Neil met victims in May, he promised that GPs would be contacted to inform them of all the possible side effects and every patient would be told which implant they have received.
But yesterday campaigner Elaine Holmes, 49, said: “We’re still waiting.
“GPs are still unaware of all the side effects to look out for and women are still not being told the truth about a device that can change their lives forever.
“If people were told the truth, nobody would consent to having these implants.”
The Scottish Government have denied that they have deliberately played down the number of women affected by the mesh scandal.
A spokesman said: “It is not possible to compare numbers without examining what questions health boards were asked or which procedures they were reporting on.”
Leslie McGlinchey was just 29 when she had the operation which doctors promised would change her life.
Yesterday, the mum-of-two said: “It did change my life. Because of what they did to me, I’m in a wheelchair until I die.”
She said: “When I think about it now, I could weep. I’d had a couple of ‘accidents’ when I was running about daft with the kids. When I told my doctor, she said, ‘Why not get treatment?’
The specialist said it was a routine operation, and I’d be back on my feet in a couple of days. It 
all sounded so simple.
“I didn’t realise they were going to implant a permanent mesh tape device which would cause so much pain and nerve damage, I’d end up crippled and in a wheelchair.
“If I’d known any one of the things I now know about mesh, I would never have agreed to surgery.
“When I woke up after the op, I was in agony but the nurses told me not to worry as some pain was normal.
“I was discharged from hospital the next day still in agony and I’ve now lost count of how many times I’ve had to go back.
“Eventually, the specialists finally agreed that the pain and numbness I was feeling in my back and lower body was down to the implant.
“In October, they tried to remove as much as they could but I’m convinced there’s still mesh inside me because of the pain.
“Now I can’t stand for more than a couple of minutes without falling on my face.
“My body feels as if it isn’t my own any longer. I can’t control it. I don’t feel like a woman any more – I’m broken and in constant pain.
“The doctors have told me all they can do now is try to manage my pain, which means I’ve got to spend the rest of my life taking the most powerful drugs my body can handle.
“I was about to start a new life and become a hairdresser. Now I’ll be on disability benefits for the rest of my life.”
The hardest thing for Leslie, of Drumchapel, Glasgow, is how to tell her daughters Morgan, 10, and Elle, eight, that she won’t ever be able to run with them in the park or take them out shopping.
She said: “They’re really frightened because they’ve seen me screaming in pain and trying to stand and falling over. I can’t find the words to tell them I’ll never be the mummy I used to be.
“Last time I tried to stand and fell over, the girls lay down beside me and stroked my hair and told me they had fallen down too.
“It’s gut-churning to see them trying to cope with what has happened.
“I can’t even dress myself. I rely on them, my parents or my friends to help me get washed and dressed in the mornings.
“I can’t do all the things I used to do for my girls, take them to the park or just a trip to the shops. I feel like someone has stolen my life and I’ve been left in this broken shell – and all because I believed what the doctors told me.
“I feel very angry. There are so many things I wasn’t told about this operation. I feel I have been betrayed and lied to.
“I yearned to be a mum and have my own family. Now my family are having to help me look after my girls. If it wasn’t for them all and my best friend, I don’t know how I would get through each day.”
Leslie never dreamed there were other women suffering the same life-changing complications until she read the Sunday Mail reports revealing the full extent of the mesh scandal.
She said: “When I read the paper, there were tears running down my face. These stories could have been written about me.
“The helplessness, the despair, the feeling of hopelessness and the lies we’ve all been told.
“Reading the Sunday Mail saved my life. I was in such despair, I’d been planning to end it all.
“But reading about the others has given me a new strength and resolve to get justice for what’s been done to us all.
“My friends and family have been able to sympathise but nobody really knows how this feels until it happens to them.
“If my story helps change anything and stops this happening to any other women, I will feel vindicated.
“Experts have known for years the damage these implants have been causing but they couldn’t even be bothered filling out a few forms to warn others about what’s been happening.
“Those who keep silent and do nothing now shouldn’t be allowed to be doctors because they know full well the harm this stuff is doing.
“It’s down to politicians to stop other women’s lives being destroyed. I dare them to look into my eyes and tell me this is all in my head.
“I want them to imagine having their whole life ahead of them and it all being taken away in an instant. Only then will they know how I really feel.
“Those who sit on their hands and do nothing to protect us are not fit to be in public office.
“They have to get this stuff banned before even more women are butchered.”
Mum-of-three Karen Neil was about to kill herself in despair after doctors told her she was imagining the horrific 
complications of her mesh op.
Only the fear that it would be her young daughter who found her body stopped her.
She kept a diary of her day-to-day battle with pain and the Sunday Mail initially told her story anonymously. Now she has the courage to go public after realising she is not alone.
She said: “From the moment that mesh implant was placed in my body two years ago, there was an immediate reaction and I awoke screaming in pain.
“But specialists told me the pain was just in my head – there was no way it was related to the mesh implant.
“They had me believing I was going crazy when all along they knew mesh was to blame. When I read the Sunday Mail, I couldn’t believe my eyes.
“I wasn’t alone after all but ours is the saddest sisterhood in the world.
“Our lives and health have been broken but together our determination to stop this happening to other women is keeping us strong.”
Teaching assistant Linda McLaughlin, 57, from Greenock, said: “I’ve had 10 operations to try to repair mesh damage and I’m waiting to go into hospital again.
“I get angry when I think about the legions of doctors who have seen for years the damage these mesh implants cause but they’ve all kept their heads down and their mouths shut instead of speaking out for their patients.

“Until recently, only two doctors in Scotland had reported an adverse complication and that is a shameful dereliction of duty.”

Thursday, January 9, 2014

Medical device industry is "unlike" just about any other consumer industry!



            BY JENNY GOLD   Washington Post  Wonkblog
            January 7 at 10:20 am

What will a gallon of milk set you back? How about a new car? You probably have a rough idea.
But what about a medical device, the kind that gets implanted during a knee or hip replacement? Chances are you have no clue. And you are not alone: The surgeons who implant those devices probably don’t know their cost, either, a new survey shows.
Medicare spends about $20 billion each year on implantable medical devices, nearly half of it for orthopedic procedures. And as the population ages and more Americans get joint replacements, that number is only going up, which will have a bigger and bigger impact on the nation’s health care spending.
But orthopedic surgeons don’t know much about how much their work contributes to that spending. They were able to correctly estimate the cost of a device only 21 percent of the time, according to a survey of 503 physicians at seven major academic medical centers published this week in the journal Health Affairs. Their guesses ranged from 1.8 percent of the actual price to 24.6 times the actual price. (Researchers could not release the actual costs because they signed nondisclosure agreements with the hospitals.)
Medical residents were worse at guessing — they were correct only 17 percent of the time. Estimates within 20 percent of the actual cost were considered correct. The study did not look at what patients know about cost.
“In orthopedic surgery, we’re never told how much things cost. We never see the cost displayed anywhere, and even if you were interested, there’s no great way to find it,” says Kanu Okike, lead author of the  study and an orthopedic surgeon at Kaiser Permanente Moanalua Medical Center in Honolulu (Kaiser Health News is not affiliated with Kaiser Permanente).
Unlike pretty much every other consumer industry, health care costs are not transparent, even for the surgeons. Each hospital system and purchasing group negotiates deals with device manufacturers and signs a nondisclosure form, promising not to share the details of those prices with anyone else.  That’s because “medical device manufacturers strive to keep their prices confidential so that they can sell the same implant at a different price to different health care institutions,” the study authors write.
But costs matter: For a total knee replacement, the actual piece of machinery that gets implanted can cost from $1,797 to $12,093, depending on the negotiated price. And there’s little evidence that one particular device is any better than another for the patient, says Okike.
The hospital actually has a financial incentive to use cheaper devices — it’s paid a lump sum for the procedure by Medicare (the government’s health insurance program for seniors and disabled people). That means that if a hospital uses a cheaper device, it ends up with a bigger profit.
But hospitals don’t tend to pressure surgeons to use the cheaper device, says Kevin J. Bozic, an orthopedic surgeon at the University of California San Francisco who studies the cost of medical devices. That’s because orthopedic surgeons are big moneymakers. “They don’t want to offend the doctors. They cater to them however they can, which includes not telling them which devices to use,” he explains.
And many orthopedic surgeons are aligned with a particular manufacturer, says Bozic, and receive a consulting fee or royalty for using that particular device. That makes them even less likely to take cost into consideration.
Some hospitals are seeking to make the devices' pricetags more transparent, in the hopes that just knowing what things cost will encourage surgeons to make different choices and lower spending. There are some glimmers of hope, including a national pilot project that makes a surgeon’s payment for each surgery dependent on the cost of the devices they use.
“But at the root of it, the biggest problem is the lack of price transparency across the industry,” says Okike. And device manufacturers aren’t in a hurry to change that without some sort of pressure.
Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.



Failed implant Device Alliance (JjrkCh) comment: 
Consumers must ask the orthopedic surgeon "What is the brand/model you are implanting?" and get a UDI- unique device identifier code.  "What is the warranty for this implanted product?"  "What are the validated clinical (live human) studies of patient outcomes from this specific implanted device?"  So far, the medical device industry has avoided accountability while gaining federal legal entitlements because of the ease of clearance by the FDA.  (The public believes there is a "regulator" for safety and effectiveness.)  If "informed consent" included this information, clarifying the loss of basic civil rights of the harmed patient, there would be no reason to discuss cost.  Who would purchase a car or a toaster this way?  My blog is Failed Implanted Device Alliance.  It compiles information about the safety and effectiveness issue. 



Tuesday, January 7, 2014

NPR: Johnson and Johnson $2 Billion Settlement for failed hip (metal toxicity)


Patients, Consumer Advocates Question Hip Implant Settlement



by ROB STEIN


January 07, 2014 4:29 AM

Lawyers for thousands of patients who had to have their defective hip replacements removed have reached a settlement with the company that made the faulty device. Many patients, however, aren't satisfied, and consumer advocates say the case illustrates what's wrong with how the government regulates implantable medical devices.

Listen to the Story  5 min 54 sec

Morning Edition

RENEE MONTAGNE, HOST:


The company that made a defective artificial hip has agreed to pay more than $2 billion to thousands of patients who had to have those implants replaced. But some patients are questioning whether the settlement is enough. Consumer advocates say the deal with Johnson & Johnson does nothing to prevent faulty medical implants from getting on the market in the future.


NPR's Rob Stein reports.


ROB STEIN, BYLINE: Mary Schrag is 69 and lives outside Seattle. Life has been a struggle since she got the defective metal joint implanted in her hip.


MARY SCHRAG: I'm still in a lot of pain in my back and my hips because I'm not really able to walk steadily. And I do feel very depressed because I - it's just trying to get through another day.


STEIN: And that's even after Schrag went through a complicated operation to have the implant replaced. She used to work, travel and hike. Now she has a hard time just standing up and can barely walk with a cane. She needs a wheelchair to go shopping.


SCHRAG: All I know is I'm just - I feel like I've been living in a hell for many, many years. My life just will never be the same.


STEIN: Schrag is one if about 8,000 patients who are candidates for compensation through the settlement with Johnson & Johnson, which owns the company that made the defective hip. Steven Skikos is a San Francisco attorney who helped negotiate the deal for the patients.


STEVEN SKIKOS: Those patients who had the implant taken out are eligible to participate in a settlement that amounts to two and a half billion dollars. And those patients are available to receive compensation, which is essentially around $250,000.


STEIN: The deal also pays patients' bills for getting their implants replaced and sets up a $475 million pool for those who suffered the worst complications. But the exact amount each patient gets could end up being higher or lower, depending on things like how long they had the bad hips, their age, their weight. Many patients would probably get about $160,000.


SKIKOS: There's no amount of money that, for a lot of these patients, will compensate for what they've been through. But the truth is, is that in terms of the negotiation of this particular agreement, there was no penny left on the table.


STEIN: Some patients are happy with the deal. Jeanette Trout is 66 and lives in Manchester, Pennsylvania. She's expecting about $165,000.


JEANETTE TROUT: I'm tickled to death with the money I'm getting. It's going to help me tremendously. I mean this - this is God-sent. This is God-sent.


STEIN: But some patients feel betrayed. Some are angry that lawyers are getting about $800 million. Others say the amount of money it looks like they'd get won't come close to making up for their suffering and any future medical bills they may have. Mary Schrag.


SCHRAG: I really do not think it's fair. I truly, truly don't. This has jeopardized my life and my health indefinitely.


STEIN: And patients aren't the only ones who aren't satisfied. Lisa McGiffert is with the Consumer's Union Safe Patient Project. She says the settlement does nothing for thousands of other people who also got the defective joints.


LISA MCGIFFERT: There are about 27,000 other people who got this particular brand of hip who are not included in this settlement.


STEIN: Not included because they haven't had their hips replaced yet or filed lawsuits, and there are thousands more who got similar devices. And, McGiffert says, the settlement does nothing to prevent another defective medical implant from destroying more lives in the future.


MCGIFFERT: I think the settlement is inadequate to address the fundamental flaws in this market.


STEIN: McGiffert says implants like artificial hips and knees can get approval without thorough safety studies if they are similar to other products already on the market.


MCGIFFERT: We think that all medical devices that are implanted in the body - that is, it takes surgery to put them in, it takes surgery to take them out - that those devices should have to go through rigorous testing that requires some clinical evidence that they are safe.


STEIN: And that every device should come with a warranty and be tracked closely to catch any problems more quickly. But the medical implant industry disputes all of this. David Nexon of the Advanced Medical Technology Association says the current system insures safety without stifling innovation.


DAVID NEXON: No process is perfect and sometimes things turn up that weren't detected when FDA reviewed it or when the manufacturer developed it. But by and large, patients can be very confident that the medical devices that are used in their procedures are very safe products.


STEIN: Johnson & Johnson would not make anyone available for an interview. In a statement, the company said the settlement was fair. Steven Skikos, the attorney who negotiated the deal, said the lawyers got patients the most they could.


SKIKOS: Every element of this was very hard fought, so I can say with confidence that the lawyers who put this together put together the best deal possible under these circumstances.


STEIN: Skikos says the lawyers will help any patients who need to have their hips replaced in the future get compensated. In the meantime, those who are eligible for this settlement have until April to decide whether to accept it or keep fighting for more. Rob Stein, NPR News.


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Monday, January 6, 2014

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


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.

        
         


see more

        
                 
         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
     
        
         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...