Ten Patient Stories: When Attorneys Refused My Medical Malpractice Case

After surgery on her ankle, Jeanine Thomas suffered a potentially deadly bacterial infection that required seven more operations to save her leg and nearly five years of recovery.

Thomas found a medical malpractice attorney to file a lawsuit on her behalf. But then he withdrew, she said, because he wouldn’t make much money if they won. Thomas had just started a consulting business and didn’t make much. Because economic damages in lawsuits are largely based on lost income, she was told the potential rewards weren’t high enough, she said.

Thomas moved on. Now, she fights for better infection prevention standards in health care through her advocacy organization, the MRSA Survivors Network. She was one of dozens of readers who shared similar experiences in the comments section for ProPublica’s recent story, “Patient Harm: When An Attorney Won’t Take Your Case.”

Their stories cut across many dimensions of the problem, so we decided to highlight a few. The excerpts below were edited for clarity, and some writers did not provide their names.

As we reported, the medical malpractice system often discriminates against certain patients, particularly those with low incomes. Those who can’t get representation ­— often women, children or the elderly — are sometimes called the “hidden victims” of medical malpractice. Studies show that the problem isn’t limited to states that have strict limits on malpractice awards.

In addition to commenting on the story, many readers responded by filling out the ProPublica Patient Harm Questionnaire or by posting to ProPublica’s Patient Harm Facebook group. Both are part of our ongoing reporting about patient safety, and we invite you to check them out.

1. "He was too old"

When my father passed from MRSA acquired after open heart surgery (acquired either in the hospital or rehab center) I called 40 attorneys and was told the exact same thing as the article states: He was too old, had lost his viability (translate earning potential) and had no wife (she had died). Most of them 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.

— Carol Dye

2. “What was done to me was clearly negligence”

This is really so painful to re-live. All of the attorneys I discussed my case with said that what was done to me was clearly negligence and that the case had merit indeed. However, the potential award would have fallen below the $250,000 mark, and to fight it would have been a gamble because jurors – for whatever reason – see physicians in a “can do no wrong” light and may decide in favor of the negligent doctor. I wanted to fight it out of principle more than anything else.

— Gloria Shen

3. Rejection Letter

Our son's case was a good example. There were many instances of error, but because he was single we couldn't bring case because there was no “pain or suffering” allowed for parents of adult children over the age of 25. I did call many attorneys and mostly was asked how old he was and if he was married. Then I got a rejection letter. The solution is very simple. Be honest when errors take place, and compensate victims fairly, then peace will come a lot sooner for everyone, including doctors.

— John

4. "It was business"

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 2,500 pages of medical records. However, when his friend explained that because she was an infant who went in for heart surgery, you'd require two specialists to review my daughter’s chart and testify. I was told it would cost roughly $50,000 to $75,000 per specialist. This doesn't include normal costs for the attorney. 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.

Although it was heartbreaking, I do understand the attorneys 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.

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 percent success rate and a week of recovery in the hospital turned into three heart surgeries, an exploratory abdominal surgery and seven 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 could file a complaint and sit in a room with the doctor, nurses, specialists and a panel of “judges” and plead 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.

— kratliff73

5. “Dad’s life was worth nothing”

My Dad was an elderly, and he was killed by the misuse of an off-label medication that was contraindicative for his medical conditions. The harm was totally preventable. After Dad’s death, we talked to 20+ attorneys. 99 percent of them said there was malpractice and the doctor was negligent. But because of my Dad’s age and the lack of future earning, no attorney was willing to take my Dad’s case on contingency.

One attorney wrote to us that my Dad’s age was above the average life expectancy, and therefore it “seriously reduces the damages likely to be awarded for loss of future life earnings. Certainly this does not excuse the poor care he received but this makes the case economically untenable as the expenses will likely eat up the majority of likely recoverable damages. We do not have punitive damages in Washington (state) that an outraged jury could award to punish the Dr. and Hospital for their callousness. For these reasons our firm does not wish to undertake this case.”

So we learned quickly that, in our current legal system, Dad's life was worth nothing because he was old.

— Yanling

6. "I’ve never sued anybody"

I attempted to get recompense for my elderly mother after medical neglect that resulted in her losing her ability to walk, additional surgeries, and months of pain. I had no idea WHY the lawyers I contacted didn't even want to listen to the details. Now I know, and am disheartened to learn the reason for their disinterest. I've never sued anybody, am not one of those people who would sue when I dump coffee in my lap. But when one has a legitimate reason and legitimate damages, it's horrendous that our legal system provides no avenue of recompense for actual damage that is life altering.

— Kathleen

7. "I am, however, alive"

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 and wound dehiscence. Years later, I am 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 and 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.

— Nightmare-daily

8. "Perverse incentive"

We got dropped the moment our attorney heard mom had died. It creates a very perverse incentive when a hospital realizes that they have committed a serious harm. The best thing it can do is kill you, which is precisely what we think the hospital did.
— Debra Van Putten

9. "It was not cost effective anymore" When I went back to work my lawyers dropped my case. It was NOT cost effective anymore.

— Ron Giovagnoli

10. "It would cost too much"

My younger brother died almost 2 years ago. He coded (his heart stopped beating) 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 two more surgeries, more complications and his eventual death.

We have had multiple lawyers look at the case. All of them 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.

— Jessamare


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Source: ProPublica (Allen-Pierce, 1/09)

Acetaminophen doses over 325 mg might lead to liver damage

You're in pain after surgery, and your doctor prescribes you Vicodin, or maybe Percocet. But when you get home, the pain hasn't subsided and you decide to pop some Extra Strength Tylenol.

Unknowingly, you may have just taken more of the drug acetaminophen than is safe.

Don't combine aspirin and ...

Acetaminophen is often used in pain medications with opioids such as oxycodone (Percocet), hydrocodone (Vicodin) and codeine (Tylenol with Codeine).

These are called combination drugs, and the Food and Drug Administration is asking doctors to stop prescribing those that have more than 325 mg of acetaminophen per dose.

FDA warns of acetaminophen liver damage FDA: Pain meds may cause liver damage

The FDA says no data show that taking more than that amount provides enough benefit to outweigh the risk of liver damage.

"Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much," the FDA said in a statement Tuesday.

The warning does not apply to over-the-counter drugs such as Tylenol, which contains acetaminophen. The FDA said it will address over-the-counter products in another regulatory action.

In 2011, the FDA asked manufacturers to limit the amount of acetaminophen in prescription combination drugs to 325 mg per capsule or tablet by January 2014. While more than half of the manufacturers agreed, some combination drugs with higher amounts of acetaminophen remain on the market. The federal agency says it plans to start the process of withdrawing approval of prescription combination drugs from manufacturers that have not complied.

Health risks

"Acetaminophen overdose is one of the most common poisonings worldwide," according to the National Institutes of Health.

Taking too much of this pain reliever can lead to liver failure or death.

The FDA has set the recommended maximum for adults at 4,000 milligrams per day. It's easier to reach this limit than you might think; one gel tablet of Extra Strength Tylenol, for example, contains 500 mg.

New Tylenol cap will have warning label

Consumers should not take more than the prescribed dose of any medication that contains acetaminophen, according to the FDA, and should avoid taking more than one acetaminophen product at a time. Drinking alcohol while taking acetaminophen also puts you at risk.

To find out if your medications contain acetaminophen, read the drug label or the list of ingredients in the patient information leaflet that came with your prescription. Look for the word "acetaminophen" or the letters "APAP," an abbreviation sometimes used for the drug. If you are still unsure, contact your doctor or pharmacist.

Acetaminophen may also cause serious skin reactions in some people. According to the FDA, the skin reactions are rare but can be deadly. These conditions can cause blisters, serious rashes, reddening of the skin and the detachment of the upper surface of the skin, the epidermis.

Anyone who develops these types of conditions after using acetaminophen should stop taking the product immediately and visit a doctor or emergency room. FDA issues warning about acetaminophen and skin reactions

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Source: CNN (Yan, 1/16)

Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan.

The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device.

A spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. An announcement about the plan is expected in the coming days, the lawyers said.

The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip, said the lawyers who spoke about the agreement only on the condition of anonymity.

Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition.

The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases.

The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future, the lawyers said. Under the plan, patients who have not had a replacement would not receive compensation, the lawyers said.

The A.S.R. hip was sold by DePuy until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.

DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate.

Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years.

Internal DePuy projections estimate that it will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices.

It had been long anticipated that DePuy would try to settle the case. Of the two lawsuits that have gone to trial, the company lost one lawsuit and won the other one.

However, it was facing the start of several new trials around the country with the prospect of large damage awards. The outlines of a settlement proposal were reported Tuesday by Bloomberg News.

The hip was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version for use here in standard hip replacements that used the same cup component as the resurfacing device. Only the standard version was sold in the United States; both were sold outside the country.

About 93,000 patients received an A.S.R., about one-third of them in the United States.

Problems with the design first came to light in Australia and England just a few years after its marketing began. But DePuy officials insisted for years to surgeons who complained about that device that patient problems reflected their surgical technique rather than the implant’s design.

Last year, The New York Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant.

The agency also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it.

DePuy never disclosed the F.D.A. ruling to regulators in other countries, where it was still marketing the resurfacing version of the implant.

The head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw, according to internal DePuy documents disclosed during a trial earlier this year.

When DePuy recalled the hip in 2010, it announced a program in which it offered to pay the medical costs of a replacement procedure.

All-metal replacement hips like the A.S.R. were once highly popular with orthopedic surgeons who believed the devices would last longer than traditional replacement devices made of plastic and metal. But the metal devices are rarely used anymore because of their high early failure rates.

While the settlement, if approved, would resolve much of the litigation against DePuy involving that device, it continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.

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Source: The New York Times (Meieir, 11/12)

Malpractice Payouts to U.S. Veterans Reach 12-Year High

Christopher Ellison went to a veterans medical center in Philadelphia to get eight teeth extracted in 2007. What should have been a routine dentist visit left him permanently incapacitated.

The $17.5 million Ellison and his family received in a malpractice judgment against the Department of Veterans Affairs was the largest against the agency in a dozen years -- and one of more than 400 payments the U.S. government made last year to resolve VA malpractice claims, according to agency records obtained through a Freedom of Information Act request. The total cost came to $91.7 million, also the highest sum in at least 12 years.

Iraq war veteran SGT Luis Rosa-Valentin, who lost both of his legs, left arm and hearing while serving in Iraq shows the tattoo he got in memory of a friend killed in Iraq, at Walter Reed Army Medical Center in Washington, in this July 30, 2008 file photo. Photographer: David S. Holloway/Getty Images The cases against the VA have included missed diagnoses, delayed treatment and procedures performed on wrong body parts. U.S. lawmakers and veterans’ advocates say they reflect deep flaws in the agency’s health-care system even as the department tends to more former troops, including those who fought in Iraq and Afghanistan.

“The rapid rise in malpractice judgments against VA mirrors the emerging pattern of preventable veteran deaths and other patient safety issues at VA hospitals,” Representative Jeff Miller, a Florida Republican and chairman of the House veterans committee, said in an e-mailed statement. “What’s missing from the equation is not money or manpower -- it’s accountability.”

‘Not Warned’

Miller’s committee held a hearing in Pittsburgh today to probe lapses that include a Legionnaires’ disease outbreak at a VA hospital that killed at least five veterans and also led to malpractice claims. The VA’s inspector general is conducting a criminal investigation into the outbreak, which involved bacteria in the hospital system’s water, Robert Petzel, the department’s undersecretary for health, said during the hearing.

Family members of veterans who died after being exposed to the bacteria said the VA didn’t immediately let relatives know there was a potential health problem.

“For sixteen days my father was allowed to shower and drink the water without any warning,” said Robert Nicklas, whose father, William, a Navy veteran, died last year after the Pittsburgh VA outbreak.

“Why were we not warned?”

More Patients

More veterans are taking advantage of VA medical care, including those requiring more complex treatment. As many as 1.2 million additional soldiers are due to become veterans in the next four years. Some of the soldiers from the wars in Iraq and Afghanistan are suffering post-traumatic stress disorder while others are living with injuries that would have been fatal in World War II or the Vietnam War.
The age of recent veterans may be a contributing factor in the rise of claims payments, said W. Robb Graham, an attorney in Cherry Hill, New Jersey, who has represented former troops filing claims against the agency. Younger claimants tend to get larger malpractice payouts, often tied to how long victims will suffer, he said.

The median age range of veterans who served after the Sept. 11, 2001, terror attacks in New York and Washington was 25 to 34 years old, according to a 2011 Labor Department study. That’s compared to veterans who served during the World War II, Korean War and Vietnam eras, whose median age range was 65 and older, the study said.

Higher Payments

“If the VA cuts off the wrong leg of a veteran who is 70 years old and his life expectancy is 75, he’s entitled to five years of damages,” Graham said in a phone interview. “If they cut off the wrong leg of a veteran who is 25, you’re now dealing with someone who is entitled to 50 years of damages.” The department has 152 hospitals and about 19,000 doctors. Last year, the VA tended to 5.6 million veterans, a 32 percent increase from fiscal 2002, according to agency data.

“It’s the largest health-care system in the U.S., and they do an incredible amount of good work,” said Jerry Manar, deputy director of national veterans service at the Kansas City, Missouri-based Veterans of Foreign Wars. “However, there are so many more things they could do in terms of oversight that they don’t appear to be doing now. As a consequence, sometimes you wind up with poor results that were avoidable.”

The department is “deeply committed to providing the quality care and benefits our nation’s veterans have earned and deserve,” Gina Jackson, a VA spokeswoman, said in an e-mail. “If employee misconduct or failure to meet performance standards is found to have been a factor, VA will take appropriate corrective action immediately.”

Taxpayers’ Bill The 2012 malpractice payments stemmed from both court judgments and administration settlements. The payouts, made by the U.S. Treasury’s Judgment Fund, rose 28 percent last year from about $72 million in 2011, the VA records showed. Taxpayers have spent at least $700 million to resolve claims filed against the veterans agency since 2001, according to the data.
Many valid VA malpractice claims never get paid, said attorney Graham, who served as a judge advocate general in the Navy in the 1980s. Some are rejected because paperwork isn’t filed properly, he said.

“My strong belief is a lot of lawyers don’t know how to sue the VA,” he said.

Some law firms aren’t interested in representing people suing the federal government because of laws that limit attorney fees to 25 percent of malpractice awards, Graham said.

‘An Alarming Pattern’

In a May letter, Representative Miller asked President Barack Obama to help address “an alarming pattern of serious and significant patient care issues” at VA medical facilities.

The House panel is reviewing the Legionnaires’ outbreak in Pennsylvania, and the department’s handling of two overdose deaths and two suicides at an Atlanta veterans hospital. Also under scrutiny are poor sterilization procedures and possible patient exposure to infectious diseases such as HIV at VA locations.

“We are not here as part of a witch-hunt, to make VA look bad or to score political points,” Miller said during the hearing. “We simply want to ensure that veterans across the country are receiving the care and benefits they have earned.”

The agency isn’t holding employees, especially executives, accountable for preventable deaths, Miller said. Department officials also gave bonuses to doctors even if they practiced without a license or left residents unsupervised during surgery, according to a Government Accountability Office report last month.

VA Bonuses

The recipients of $150 million in bonuses to VA health-care providers in fiscal 2011 included a radiologist unable to read a mammogram and an emergency-room doctor who refused to see patients, the report found.

Miller has said the VA employees should be punished -- not rewarded -- for their incompetence.
The number of malpractice claims filed with the VA has remained at 1,544 for the past two years, said Jackson, the agency spokeswoman. The leveling off came after a 33 percent spike in cases to 1,670 between 2010 and 2005, according to an October 2011 GAO report.

The VA’s malpractice payment rates may be similar to national levels, said Anupam B. Jena, an assistant professor at Harvard Medical School and physician at Massachusetts General Hospital.

Ellison’s Case

Less than 25 percent of the claims filed against the veterans agency result in payment, according to the VA. About 20 percent of malpractice claims filed with the largest insurer of physicians between 1991 and 2005 resulted in a payment, according to a 2011 study published in the New England Journal of Medicine, said Jena, who worked on the report.

Last year’s “noticeable increase” in medical malpractice payments was partly due to an “exceptionally large” $17.5 million court judgment, Jackson said in an e-mail. Such payments are “highly variable from year to year,” she said.

That record judgment went to Ellison, who was honorably discharged from the Marines in 2001. He was a 49-year-old electronics technician from Bridgeport, Pennsylvania, in 2007 when he visited the dentist to have eight teeth extracted because of tooth decay and gum disease.

During the procedure at a VA facility in Philadelphia, Ellison’s blood pressure dropped several times to “unusually low” levels, his attorney, Shanin Specter, a partner at Kline & Specter P.C., a law firm in the city, said during a 2011 trial.

‘Catastrophic’ Stroke

Ellison wasn’t sent to the emergency room, and the dentist continued with the extractions, said Specter, son of Arlen Specter, the former senator from Pennsylvania who served as a Republican for more than 28 years and became a Democrat during his last 20 months in office. Arlen Specter died last year. Ellison had a “catastrophic” stroke while driving his car shortly after leaving the dentist office, Specter said.

The government argued that the veteran’s existing health problems caused the stroke, not the care he received at the VA. Ellison had a history of smoking, diabetes, hypertension and many other stroke risk factors, Thomas Johnson, an assistant U.S. attorney, said during the 2011 trial in U.S. District Court in Philadelphia.

After the stroke, Ellison was left with limited vocabulary, “severe and pervasive deficits in all mental abilities,” and “negative personality changes,” according to court documents.

“He wound up being totally incapacitated, requiring 24-hour-a-day care,” Specter said. “This is about as devastating an injury as a person can have, and that’s what the award reflects.”


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Source: Bloomberg (Miller, 9/09)

Parkland Memorial Hospital’s make-or-break survey is underway

The critical government survey that will determine whether Dallas County’s public hospital retains its state and federal funding is currently underway. The surveyors arrived — unannounced — Monday and began combing through Parkland Memorial Hospital, looking for signs of patient-safety problems that were detected in 2011. The county hospital has been operating under federal oversight for more than a year as it retrained its staff of 9,000 and made other significant changes in patient operations.

Hospital spokesman Mike Malaise confirmed Tuesday that the inspectors had arrived. The visit will determine the fate of more than $400 million in annual government funding that Parkland currently receives.

The survey was expected to occur before Aug. 31, although the starting date was not known.

The inspection team, which is working on behalf of the federal Centers for Medicare and Medicaid Services, includes 14 surveyors. Three additional life-safety experts are checking to be certain all hospital exits, entrances and hallways are clear.

“They have told us they will be here 24/7 until the survey is complete,” Malaise said of the survey team.

After failing a series of inspections in 2011, Parkland was forced to make changes in nearly 500 areas of the countywide public health system. They included revamping the hospital’s nursing department, upgrading the staff in the busy emergency room and psychiatric services department, assuring physician oversight of doctors in training and improving better infection control, including a crackdown on basic hand-washing procedures by staffers.

As of April, the county facility had completed 97 percent of the mandated corrective-action plan, said officials overseeing the upgrades. The changes have cost the county hospital an estimated $75 million.

In recent months, Parkland officials have confirmed that the staff was ready for the critical review and the hospital’s top leaders have vowed that it would pass it.

Throughout the 14-month rehabilitation process, many of Parkland’s top leaders resigned and were replaced on an interim basis. The hospital has been operating without a permanent chief operating officer since December, 2011, when Dr. Ron Anderson stepped down after 29 years as CEO.

The survey’s results will be known sometime this summer.

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Source: The Scoop Blog (Jacobson, 6/18)

Can Doctors Use Copyright Law To Get Rid Of Negative Reviews?

Online review sites are becoming an increasingly important catalyst to digital commerce — when it comes to shopping at local businesses, review sites like Yelp are many consumers’ first stop. Plenty of businesses don’t like the negative reviews they get, but a few thousand doctors have gone the extra mile to try to erase that bad press. Working with a company called Medical Justice, they’ve designed a system that tries to use copyright law to control and remove unflattering reviews. Now, a group of law professors are challenging that system, saying it’s illegal and against the purposes of copyright.

Medical Justice was founded in 2002, and today has about 3,000 members, located in various states and representing different medical specialties, who pay an average of $1,200 a year. The company sells membership as a batch of services, mainly centered around helping doctors that are facing medical malpractice litigation. But the Medical Justice benefit that has drawn the most scrutiny is its program of fighting “physician internet libel and web defamation.” The system works by getting patients to sign contracts that assign away the copyright in any future review they might of a doctor-to the doctor.

Why use copyright at all? A Medical Justice spokesman says the first system the company used-a simple contract doctors could give to all patients that banned reviews outright-was seen as “draconian” and the company was hunting for a more nuanced solution. Additionally, some courts have punished companies that have tried to use contracts to directly stop consumer reviews.

By having patients assign copyright in any reviews to their doctor, Medical Justice hopes to sidestep those problems. It’s also an effort to help doctors get around Section 230 of the Communications Decency Act (an “arcane nuance of cyberlaw,” according to Medical Justice’s website), the law that protects web services from getting sued over content posted by their users. When doctors send review sites a note complaining that a review is false or defamatory, the website is protected by CDA Section 230 and is unlikely to remove the review. But when the same sites receive copyright takedown notices, the law compels them to act-and act quickly. Section 230 doesn’t cover intellectual property claims, and copyright infringement has harsh legal penalties.

Medical Justice argues they’re just leveling the playing field. CDA 230 results in a skewed situation for doctors, who can be reviewed by their patients but are prevented from responding because of privacy laws, it says. “Some sites say, we don’t know if you’re telling the truth, and we don’t know if they’re telling the truth-it’s the internet, so deal with it,” says Shane Stadler, a spokesman for Medical Justice.

But a group of legal academics led by law professor and blogger Eric Goldman have big problems with this interpretation of the law. Today Goldman, together with his partner, UC Berkeley Law Professor Jason Schultz, launched a website called doctoredreviews.com. On the site, the two law professors offer their views on how patients, doctors, and review sites should deal with Medical Justice’s strategy, which they argue is likely illegal and surely unethical.

“There’s a substantial risk a court would deem [the Medical Justice copyright transfer] unconscionable,” Goldman wrote in an e-mail yesterday. Copyright takedown notices sent based on Medical Justice copyright transfers could actually expose doctors to liability, Goldman says, because there are legal penalties associated with sending false takedown notices. In a statement posted on his personal blog, Goldman wrote: “Should the website fail to curb the bad practices, we may need to reconsider more aggressive options.”

Stadler says he’s confident that Medical Justice’s use of copyright transfers is, in fact, legal, and it lets doctors defend their reputations while still letting most patients review away. “Can it be abused? Sure,” says Stadler. “Anything can be abused.” While it’s not a perfect system, most doctors use the power responsibly, he says.

Asked what he thinks of Goldman’s website, Stadler is diplomatic: “The gentleman who launched it is a real ardent advocate of total free speech-that you can say pretty much anything on the internet.”

Goldman admits to being an “ardent advocate” of CDA Section 230. “On that basis, we need to fix any legal artifices-like Medical Justice’s legal ‘hack’-that subvert Section 230′s social benefits.”

How are the review sites themselves handling the requests from Medical Justice? According to Goldman’s website, Yelp has refused to honor one doctor’s takedown notice based on an anti-review contract. Another website, RateMDs, has created a “Wall of Shame” to identify doctors who use anti-review contracts.

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Source: Paid Content (Mullin, 4/14)

Losing My Leg to a Medical Error

LAST Fourth of July, during a day at the beach, I experienced a sudden pain in my left calf. Two months later, I required an above-the-knee amputation. Compounding my distress was the fact that my doctors had no explanation for why the blood flow to that leg had been cut off. I had none of the usual risk factors for atherosclerosis, the hardening of the arteries. I had low cholesterol and no evidence of diabetes, and I had never smoked. No blood vessels were blocked elsewhere in my body.

It took some further detective work to reveal what must have been the cause. Seventeen years earlier, in 1995, I had surgery on my left Achilles’ tendon. To prevent bleeding during the procedure, a pressurized cuff was placed above my left knee to block the blood flow. Apparently, the cuff was left on too long, injuring the arteries. In the years since, the vessels progressively scarred and calcified, which eventually blocked all blood flow to my lower leg.

I lost my leg because of a preventable error. The loss of a limb is traumatic, and I experience waves of sorrow and regret. I struggle with continual pain in my residual limb, and am trying to learn how to walk with my prosthesis. My work as a physician has been put on hold.

For the past two decades I have been studying how to prevent errors in health care, and the irony of my present predicament strengthens my motivation to continue the quest. No one should ever have to experience such preventable harm.

And yet many people do. Exactly how many, we can’t say, because there is no national registry for injuries or deaths caused by medical errors. Over a decade ago, in the best study of its kind, the Institute of Medicine estimated that there were 44,000 to 98,000 deaths per year because of preventable errors in the American health system. For every death there are likely to be at least 10 serious injuries, so we can assume that roughly a million patients are seriously injured each year.

Despite calls to action by patient advocates and the adoption of safety programs, there is no sign that the numbers of errors, injuries and deaths have improved. Why? Because those responsible for the delivery of health care have been unable to change how they do things.

They could help themselves by embracing the lessons of great manufacturing companies to improve quality and efficiency. Automatic alarm systems and shut-off switches can be designed to make it nearly impossible for caregivers to do the wrong thing. Checklists and specific protocols based on best practices for each procedure can also help.

In my case, if an alarm had alerted the doctor to how long the cuff had been in place, if the cuff had automatically deflated after a period of time, or if a checklist had reminded the doctor to remove it, my leg might never have been injured. Better yet, if the doctors had not used the cuff, which evidence has shown can be dangerous to patients, I would still be walking on that leg today.

Most of all, perhaps, we need better coordination and communication among caregivers. Consider what happened to Mary, my former wife and the mother of our two children. In 1988, she was lying in an intensive care unit with less than a 10 percent chance of survival. Her first symptom, a pain in the sole of her right foot, had seemed so innocent. A neurologist said she had most likely injured a nerve during aerobic dance and the doctor ignored our requests for further tests. But when Mary’s leg began to swell, we sought the help of an internist. She diagnosed thrombophlebitis, inflammation from blood clots. Mary was then admitted to the hospital for a blood thinner, but the medical team gave her too small a dosage. Her clots extended into her lungs. Next she suffered a heart attack, respiratory failure, renal failure and shock.

In desperation we transferred her care to another physician, who finally began treating her with corticosteroids for inflammation of the blood vessels. Over the next 24 hours, Mary’s symptoms reversed and she fully recovered. But we nearly lost her as a consequence of delayed decision-making, poorly coordinated care and a medication error.

Eliminating errors has the added dividend of reducing costs. The cost for treating Mary’s thrombophlebitis should have been $16,000; the complications pushed the cost nearly six times higher. The hospital bill for my leg amputation was approximately $150,000, my prosthesis cost more than $50,000, and I have lost months of work.

The Affordable Care Act has recognized this reality and is creating new reimbursement systems that reward the quality rather than the quantity of care. The act has also empowered an expert panel to create evidence-based treatment recommendations.

I wish I could go back in time and implement these changes before my surgery. But there is no way to turn back the clock. My life will never be the same, nor will the lives of roughly a million other patients who suffer similar preventable injuries each year. But we can make sure that future patients don’t suffer the same life-changing harm.

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Source: The New York Times (Southwick, 2/19)

When implanted medical devices go wrong, who pays?

Insurance companies, often stuck with the tab for health services when a medical device fails, are ready to share the pain.

As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.

If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.

"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.

In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.

Rawlings is one of the largest firms providing claims recovery services for the healthcare industry, along with Trover Solutions Group, both based in Louisville, Kentucky. Others include HealthCare Subrogation Group and Meridian Resource Company.

Rawlings is currently retained to pursue more than 30 mass tort cases related to healthcare, compared with an average of about three in a given year just a decade ago, Fischer said.

"There has been a drastic increase in the number of cases being pursued," he said. Insurers tend to hire Rawlings when there are enough cases being filed over a product to warrant multi-district litigation status.

Fischer helped recover funds for insurers from claims on Sulzer Medica's defective hip implants in 2000 and Medtronic Inc's faulty Fidelis defibrillator leads in 2007.

In the Fidelis case, Medtronic settled U.S. lawsuits covering more than 9,000 individual personal injury cases for $221 million, according to their regulatory filings.

Fischer then pursued Medtronic to recover money for clients like WellPoint Inc that had paid doctors and hospitals for treatment relating to the defective leads, or wires that connect an implantable defibrillator to the heart.

He expects a settlement - the first collected from a medical device maker - to be signed by year's end, but would not give a dollar amount.

WellPoint spokeswoman Lori McLaughlin said the insurer routinely tries to collect from manufacturers on recall-related health claims.

Aetna Inc, the nation's third largest insurer, said it has managed to wrest reimbursement from drug and device markers, and has negotiated payments to patients for costs from defective or recalled products, without providing details.

Trover Solutions Chief Executive Robert Bader reckons that about 80 percent of health insurers turn to firms like his to pursue manufacturers in recall cases.

"It's the fiduciary responsibility of the insurer to recover members' premiums from the manufacturer. It's a highly specialized process and so a lot of them outsource," Bader said.

The government's Medicare health plan for the elderly recovers part of the money it paid for recall-related medical services once a settlement is reached, said spokeswoman Kathryn Ceja. She would not give details on how it pursues those funds.

FALLOUT OVER THE RIATA RECALL

A 2010 recall of Riata defibrillator leads by St. Jude Medical could become the next tug-of-war between insurers and medical device makers over who picks up the tab.

Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart. Deciding on how to proceed is tricky since removing the leads may be riskier than leaving them in.

The Food and Drug Administration in August said all Riata patients should receive medical imaging tests to see whether the insulation covering the thin wires eroded, exposing the cables and making them more prone to short-circuit, as well as making the surrounding tissue vulnerable to heat damage.

The agency did not say how often imaging tests should be performed. But ordering just one test per patient will add millions of dollars to the cost of their care.

A single fluoroscopy - which shows a real-time, continuous X-ray image on a monitor - for each Riata patient could cost between $7.9 million and $45.3 million overall, based on a Reuters review of the procedure's cost at different hospitals.

Doctors say more than one X-ray would be needed to monitor the leads, which can remain in a patient's body for many years. Dr. Bruce Lindsay, section head of Cardiovascular Medicine at the Cleveland Clinic, said doing an annual imaging study would probably be sufficient.

Even before the FDA guidelines, Medicare covered the extra cost of imaging studies in almost every instance, doctors say. But some private insurers had balked.

"I've had to call (insurers) constantly and justify it," said Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago Medicine.

"We're definitely finding more problems (with Riata leads), but surveillance has gone up. We're finding more because we're looking more," he said.

St. Jude spokeswoman Amy Jo Meyer said the company has expanded its regular warranty to include a baseline fluoroscopic or X-ray screening if a patient's insurer does not cover it. Paying for additional imaging would be reviewed on a case-by-case basis.

"It would not be in device makers' best interest to balk at paying these costs. In the end, they do have to stand behind their products and these products do sometimes fail," said Debbie Wang, an analyst with Morningstar.

TALLYING THE COSTS

Burke and colleagues estimate that Medtronic's Fidelis recall cost Medicare some $287 million over five years for monitoring or replacing the leads, according to a study published in the Heart Rhythm Journal.

Medtronic spokesman Chris Garland said the company gave a credit to patients for its recalled Fidelis leads, plus $1,200 for "reasonable unreimbursed medical expenses." He would not say how many people received the replacement and additional funds.

The Fidelis case was just one out of 113 medical device recalls between 2005 and 2009 classified as serious enough to cause significant health problems or death, according to an analysis published in the Archives of Internal Medicine last year. Most involved devices that correct heart problems.

The study found that 24,000 patients underwent procedures in 2005 related to problems with devices from Medtronic or from Guidant, now part of Boston Scientific Corp.

"We expect manufacturers to take reasonable responsibility for costs associated with a recall of their products to prevent the healthcare system from absorbing the impact," said Aetna spokeswoman Tammy Arnold.

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Source: Reuters (Sherman, 10/8)

Groups cast doubt on validity of state hospital's electrotherapy consent forms

Texas' public psychiatric hospitals never should have used a controversial treatment on more than 120 aggressive patients because the consent forms they signed did not spell out potential side effects and other information required under state rules, mental health watchdogs said this week.

Patients who received cranial electrotherapy stimulation at North Texas State Hospital in Vernon were not told in writing that the treatment can cause headaches, nausea, dizziness and skin irritation, said Beth Mitchell, a lawyer with Disability Rights Texas, a federally funded mental health advocacy group. The consent form — a copy of which was obtained by the Austin American-Statesman — also fails to mention alternative treatments and the condition that is being targeted.

But state officials say the form was adequate and is just one piece of the informed consent process.

"The form alone may not be the full picture," said Carrie Williams, spokeswoman for the Department of State Health Services, which oversees the 10 public psychiatric hospitals. "Risks, benefits and alternatives could have been laid out verbally and documented in the progress notes."

Challenges to the validity of the consent forms come several weeks after health department officials said they learned that a North Texas State Hospital psychiatrist had conducted unauthorized research on the use of cranial electrotherapy stimulation on violent, mentally ill patients.

The consent forms go to the heart of the questions advocates have posed on the issue: Did the patients understand and willingly agree to the treatment? Or were they being used as research subjects without regard to their civil rights?

"Honestly, I just don't understand how this could happen," Mitchell said. "I think there was a breakdown across the board here."

State officials say they are still trying to determine whether patients truly gave consent to the treatment. They have not yet spoken to any patients, Williams said.

[If you think you've been a victim of medical malpractice, contact the Cole Legal Group]

The Citizens Commission on Human Rights, a mental health watchdog group whose questions about the use of cranial electrotherapy stimulation sparked the health department's inquiry, says the state needs to make sure patients' rights weren't violated.

"What we want to see is a very thorough investigation and a formal plan of correction on any findings," said Lee Spiller, the group's policy director. "This must include actual interviews of patients to determine what their actual experiences were. That needs to be made public and reported to the Legislature. The idea here is to strengthen and protect the rights of this highly vulnerable population."

About the treatment

Cranial electrotherapy stimulation is a treatment that administers a small electrical current into a patient's brain. The concept behind it is that the current increases the brain waves that cause relaxation, thus easing anxiety and other ailments.

Although the treatment is approved by the U.S. Food and Drug Administration for anxiety, depression and insomnia, it is not approved for aggression. Physicians, however, can prescribe drugs and devices for conditions other than those for which they are approved if they believe it will help patients. The FDA and the makers of cranial electrotherapy stimulation devices are currently battling over whether the treatment is safe and effective.

Since 2001, North Texas State Hospital and two other state hospitals administered the treatment with Alpha-Stim, a hand-held device powered by a 9-volt battery that delivers the current through two electrodes clipped to the patient's earlobes. It was used on aggressive patients with schizophrenia, autism, intellectual disabilities and other disorders.

But last month, state officials said they learned that North Texas State Hospital psychiatrist Allen Childs had published research studies in 2005 and 2007 on how patients reacted to the treatment. The doctor did not have permission to conduct such research, state officials say.

Childs, who is listed as a part-time employee but who state officials said has not worked at Vernon in almost a year, did not respond to requests for comment. On May 15, the Department of State Health Services prohibited the use of the treatment, saying they wanted time to sort through the issue. Alpha-Stim had not been used at any hospital campus since February, Williams said.

The nature of consent

An informed consent form is a document that details a course of treatment and its risks, benefits and possible alternatives. In essence, it says that patients have the information they need to make an educated decision about the treatment to which they have agreed.

In general, consent can be obtained orally and documented in the physician's notes, said Rocky Wilcox, general counsel for the Texas Medical Association. In most cases, there is no requirement that all the information be listed in a form.

But state rules make a distinction for people receiving mental health treatment, said Mitchell, of Disability Rights Texas. Informed consent for that population is defined as the "knowing written consent" of information, including a description of any "discomforts and reasonably expected risks" and a disclosure of any appropriate alternative procedures, according to the Texas Administrative Code.

Written consent is required for multiple reasons, Mitchell said. Patients in psychiatric hospitals are not free to leave at any time, so a detailed consent form is an extra precaution to ensure that they have been fully briefed on their care and did not feel coerced into agreeing to treatment they did not want, she said. It's also a way to make sure that all patients get a consistent message about what treatments entail, she said.

State officials say that the consent form provided to patients was adequate, though it could have been improved with more details and clearer language.

"Informed consent is not just about a piece of paper," Williams said. "It's about the deep dialogue that happens between doctor and patient about a treatment. That's when it's determined whether the patient truly understands the risks and benefits. The form comes into play as the final, written acknowledgement."

According to the company that makes Alpha-Stim, side effects can include skin irritation, headaches, nausea and dizziness. But the four-paragraph consent form provided to patients does not mention any potential side effects. The document states that "no significant negative side effects have been reported from CES treatment since it first began in the U.S. in the late 1960s."

"I think this borders on deception if they're not spelling out what the side effects are and then just say we just chatted about it verbally," said Jim Harrington with the Texas Civil Rights Project, a nonprofit foundation that promotes civil rights and economic and racial justice. "That's nonsense."

The consent form states that the treatment reduces stress and that there have been more than 45 scientific studies of anxiety, 30 of depression and 30 of insomnia published in U.S. scientific literature. Whether doctors were prescribing cranial electrotherapy stimulation for any of those problems is unclear, as the forms do not say what problem is being treated. Childs' studies focus only on aggression.

Paul Lombardo, a Georgia State University College of Law professor who specializes in mental health law, said the consent form does contain some important elements. It describes the treatment and how it works, though not in language that most patients could understand, he said.

But parts of the document appear to be promoting the treatment, he said, particularly the mention of scientific studies.

"They are, in a consent form, essentially repeating claims that were obviously written by an advocate of this process," Lombardo said. "That's what it looks like."

Typically, state hospital consent forms are written by the agency's clinical oversight committee, whose members approve new treatments and create standardized forms for all the hospitals.

The consent form for cranial electrotherapy stimulation was not created by the committee, and the agency is still trying to determine who wrote it, Williams said.

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source: Austin American Statesmen (Ball, 5/31)

An idea to tackle tort reform, defensive medicine in Georgia

It’s been 20 months since the Georgia Supreme Court threw out a key plank of the state’s 2005 tort reform: a $350,000 cap on noneconomic damages for medical malpractice. During that time there’s been some hopeful talk among supporters of the cap, but precious little action by legislators.

Here’s a thought: Why not scrap the medical tort system entirely, saving several billion dollars in the process?

Before every trial lawyer within 200 miles heads for my office, let me explain.

The idea is to replace the current legal system for medical malpractice with an administrative law system that draws heavily on the current arrangement for workers compensation claims.

No more lawsuits, no more juries, no more jackpot justice. Instead, patients injured while undergoing medical treatment would file a no-fault claim. Independent experts then would determine whether there was negligence and, if so, award the patient compensation based on national norms for the type of injury suffered.

The potential results: More patients receiving payments, in a fraction of the time lawsuits take today. Doctors no longer facing the specter of ruinous lawsuits. Even trial lawyers would stand to make more money on the whole.

“Our approach is basically fair compensation — quickly, and more of it,” says Richard L. Jackson, who is pushing this plan through his advocacy group called, well, Patients for Fair Compensation.

The group’s name is straightforward enough, except that Jackson isn’t only or mostly a patient. He’s a longtime health-care executive whose Alpharetta-based medical-staffing company, Jackson Healthcare, employs doctors in all 50 states.

Nor did he come at the issue of tort reform only or mostly from a legal perspective. Rather, his interest is reducing the practice of “defensive medicine” by doctors eager to avoid lawsuits.

During the 2008 presidential primaries, Jackson told me by phone this week, his firm surveyed its doctors about various candidates’ health reform plans. “What happened,” he said, “was we kept hearing the defensive medicine issue being a huge problem. We didn’t ask them about it. It just came out unsolicited.”

Jackson took another survey of 3,000 doctors nationally about “totally unnecessary medicine for the purpose of avoiding a lawsuit.” A whopping 92 percent said they had practiced it in the previous 12 months, and the respondents attributed 34 percent of all health-care costs to defensive medicine.

“I was really caught off-guard by that,” Jackson said.

Last year, he hired Gallup to poll 500 doctors. A similar proportion of them said they practiced defensive medicine, to which they attributed 26 percent of health costs.

Even using that lower estimate, Jackson said, defensive medicine may account for as much as $650 billion in health spending nationally and $13.25 billion in Georgia. That’s roughly $100 a month for every American, or almost 4.5 percent of the U.S. gross domestic product.

Reducing that cost is what sparked Jackson’s interest in medical malpractice reform. But he believes it would be good for patients, too.

“Patients really don’t have access to justice in our [current] system,” Jackson said. If a claim is for less than $150,000, “you can’t find an attorney to represent you. They have to basically go for the big deals. And that’s why they’re so vehemently opposed to caps and those kinds of tort reforms, because it eliminates the ability to go after the big claims so they can fund the other ones.”

Jackson’s group is awaiting a final actuarial study, but he said he is confident that four times as many patients as today will receive some sort of compensation, which, combined, will total two to three times the current sum.

The “extra” money, as well as the funds to operate the new system, would come from existing med-mal insurance premiums, with savings from lowering costs of administration and not having to defend against lawsuits.

The next step will come soon, as Georgia and Florida are the first states where Jackson will try to get legislation passed. I’ll withhold final judgment until there’s an actual bill with actual details. For now, it’s a promising solution to a vexing problem.

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source: Atlanta Journal-Constitution (Wingfield, 12/1)