Insurance Journal, May 8, 2013

Efforts to lower health care costs in the United States have focused at times on demands to reform the medical malpractice system, with some researchers asserting that large, headline-grabbing and “frivolous” payouts are among the heaviest drains on health care resources. But a new review of malpractice claims by Johns Hopkins researchers suggests such assertions are wrong.

In their review of malpractice payouts over $1 million, the researchers say those payments added up to roughly $1.4 billion a year, making up far less than 1 percent of national medical expenditures in the United States.

“The notion that frivolous claims are routinely resulting in $100 million payouts is not true,” says study leader Marty Makary, M.D., M.P.H., an associate professor of surgery and health policy at the Johns Hopkins University School of Medicine. “The real problem is that far too many tests and procedures are being performed in the name of defensive medicine, as physicians fear they could be sued if they don’t order them. That costs upwards of $60 billion a year. It is not the payouts that are bankrupting the system — it’s the fear of them.”

Called catastrophic claims, payouts over $1 million are more likely to occur when a patient who is killed or injured is under the age of 1; develops quadriplegia, brain damage or the need for lifelong care as a result of the malpractice; or when the claim results from a problem related to anesthesia, the researchers found in a study published online in the Journal for Healthcare Quality.

Makary and his colleagues reviewed nationwide medical malpractice claims using the National Practitioner Data Bank, an electronic repository of all malpractice settlements or judgments since 1986. They looked at data from 2004 to 2010, choosing a 2004 start date because that is when data regarding the age and gender of patients and severity of injury became available for the first time. The information includes only payments made on behalf of individual providers, not hospitals or other corporations, meaning the number of payouts may be underestimated by 20 percent, Makary says.

Over that period, 77,621 claims were paid, and catastrophic claims made up 7.9 percent (6,130 payouts). The seven-year nationwide total of catastrophic payouts was $9.8 billion, representing 36.2 percent of the $27 billion worth of total claims paid over that time period.

The most common allegations associated with a catastrophic payout were diagnosis-related (34.2 percent), obstetrics-related (21.8 percent) and surgery-related (17.8 percent) events. Errors in diagnosis showed twice the odds of a catastrophic payout compared with equipment- or product-related errors and were associated with a roughly $83,000 larger payment.

The age of the physician was unrelated to the likelihood of a claim, suggesting inexperience is not necessarily a factor. But 37 percent of catastrophic payouts involved a physician with a previous claim in the database. The largest payout in the study was $31 million.

Makary says the data suggest that the focus of legal reform efforts should be on doctor protections aimed at reducing defensive medicine rather than the creation of malpractice caps.

He says his findings argue for more research to determine what interventions might prevent the type of errors that result in catastrophic payouts, with the overall goal of improving patient safety and reducing costs at the same time.

But real cost reductions, he says, will come from reducing the overuse of diagnostic tests and procedures.

Other Johns Hopkins researchers who contributed to this study include Paul J. Bixenstine, B.A.; Andrew D. Shore, Ph.D.; and Julie A. Freischlag, M.D.

Source: Johns Hopkins Medicine

From Cleveland Academy of Trial Attorneys Magazine, Spring 2011

Editor’s Note: Recently, Ellen Hobbs Hirshman [EHH] hosted a “roundtable” conference
call with three plaintiffs’ lawyers, one defense lawyer, and a judge, to discuss obstructionist
tactics during depositions, and how to handle them. The plaintiffs’ attorneys were Gerry
Leeseberg [GL] of Leeseberg & Valentine in Columbus, Ohio; Steve Collier [SC] of Connelly,
Jackson & Collier, in Toledo, Ohio; and Toby Hirshman [TH] of Linton & Hirshman in
Cleveland, Ohio. The defense attorney was Bill Bonezzi [BB]of Bonezzi, Switzer, Murphy,
Polito & Hupp in Cleveland, Ohio. The judge was Richard McMonagle [JRM]of the
Cuyahoga County Court of Common Pleas. Here are some of their insights. Special
thanks go to Laura Ware, who acted as Court Reporter for this conference call.

For the article, click here

The Boston Globe, January 27, 2013, by Dr. Darshak Sanghavi

DANIELLE BELLEROSE WENT THROUGH HELL before she finally got pregnant with twins in late 2003. Shortly thereafter, the then 28-year-old nurse and Massachusetts native developed a complication that required months of bed rest at home. Suddenly, on a June night nearly three months before her due date, Danielle’s uterus began bleeding profusely. At 4:56 a.m. she had an emergency caesarean section at Beth Israel Deaconess Medical Center. Her daughters, Katherine and Alexis, entered the world weighing only about 3 pounds each.

Everything seemed to go well until the end of the first week. When Danielle and her husband, John, visited the unit, Alexis looked fine, but Katherine appeared mottled and pale. Panicked, Danielle found a nurse, and testing confirmed that Katherine was in profound shock due to necrotizing enterocolitis, a devastating intestinal complication that affects premature babies. The infant’s blood had turned acidic. An X-ray indicated a tear in her bowel. Just after midnight, Katherine was taken by ambulance to Children’s Hospital Boston.

Extremely premature infants such as Katherine and Alexis are entirely unprepared to live outside their mother’s womb. After only 30 weeks of gestation, the newborn heart isn’t fully developed, and the intestines can’t easily digest breast milk or formula. At that age, a baby’s brain often doesn’t remember to breathe. In 1963, when President John F. Kennedy’s son, Patrick, was born prematurely, the only thing to do was “monitor the infant’s blood chemistry,” as a newspaper of the day put it. Patrick Kennedy died after two days. By the time Katherine Bellerose was being cared for in the same hospital, however, new treatments had increased survival rates in very low birth weight infants to 96 percent.

Still, at Children’s Hospital, Katherine struggled to survive. Surgeons made a last-ditch effort to save her life by removing her colon, in the hope that this would halt further damage. She failed to improve. Multiple rounds of CPR were performed.

At 5:22 a.m. on June 21, 2004, 8-day-old Katherine Bellerose was declared dead.

In the days and weeks ahead, Danielle tried to get someone to explain why no one had diagnosed Katherine’s condition sooner. She made three requests to meet with the caregivers from Beth Israel. Promises were made, she says, yet no meeting materialized. Later, when Danielle contacted the hospital to get Katherine’s medical records, she recalls a clerk saying no such patient had ever been treated (a problem later ascribed to a paperwork error). Danielle began to think the hospital was hiding something.

In time, Danielle got in touch with Lubin & Meyer, a Boston law firm perhaps best known for winning $40 million in a 2005 birth-injury case, the largest malpractice award in Massachusetts history.

Danielle’s attorneys, William Thompson and Elizabeth Cranford, obtained Katherine’s medical records, then asked a doctor and professional expert witness to review them. As is customary, the expert never spoke with the infant’s physicians, nor did she see a need to interview the Bellerose family while preparing her report. The 10-page document, issued two years after Katherine’s death, is not nuanced, even though the early warning signs of enterocolitis — such as a slight increase in the size of the abdomen and higher breathing rate — are often nonspecific and present in babies who go on to do fine. It claimed Katherine suffered a “premature and preventable death” from necrotizing enterocolitis that occurred as a “direct result” of “deviations from the accepted standards of care.” Reading the report steeled Danielle Bellerose against the Beth Israel doctors and solidified her suspicion that their negligence had killed her daughter. In 2006, her attorneys filed a lawsuit against six of the doctors and nurses who had treated Katherine.

The paradox of modern medicine is that the increasing specialization that has revolutionized care has also depersonalized it. When a mistake is suspected, it may be unclear who from a team must step in to take responsibility. For patients seeking information, the only obvious recourse is to call a malpractice lawyer, whose livelihood depends on replacing a patient’s desire for comfort and understanding with a need for vengeance. “In the beginning, all I wanted were answers,” Danielle says. “If someone had just talked to me, none of this ever would have happened.”

The longer the silence from the doctors and nurses stretched on, the more upset Danielle felt. By the 2011 trial, her disgust was so complete that, when the they were testifying, she often had to leave court “to throw up.”

In the end, the jury decided one doctor and one nurse practitioner were negligent — the other four defendants were determined not to be at fault — and awarded the Bellerose family $7.05 million (nearly $11.5 million with interest). It was the largest malpractice award in the state that year.

But the march to the courtroom was not inevitable. There is reason for hope that things can be done differently, even among doctors like myself who are conditioned to be suspicious of malpractice claims. Massachusetts recently enacted a law that, among other things, usually allows doctors to speak more openly to patients and families who were harmed, even apologize to them, without worry that their words will later be used against them in court. The law addresses only a small part of the problem, but it — together with data-driven efforts to find patterns of error in similar cases — is a step toward getting doctors and insurers to admit that malpractice claims often are sparked by both real failures of communication and failures in clinical care.

***

SOMETHING DAWNED on attorney Richard Boothman when he defended his first client, a Detroit surgeon, against a malpractice claim in 1981: Sometimes patients just want to be heard. The plaintiff, a woman who’d suffered a major infection after abdominal surgery, hadn’t spoken with her doctor in the six years between the surgery and the trial. While listening to her doctors’ testimony in court, however, the woman realized he’d done his best. She won the case, but as the jury filed out, she turned to the surgeon and said, “If I’d known everything I know now, I would never have sued you.”

Later, at the University of Michigan Health System, where he is now executive director for clinical safety, Boothman put what he had learned in that courtroom to work. After a lawsuit was filed by a patient left partially blind, Boothman proposed having the patient’s family and surgeon meet to discuss what had happened. The first meeting didn’t go well; the patient’s spouse was so upset that she immediately turned around and walked out. Boothman rescheduled and she again exited. On the third try, both sides finally started talking, and the doctor expressed his sympathies. “A transformational moment occurred,” Boothman recalls. The patient later withdrew the lawsuit and then underwent a procedure that restored some of his lost sight.

The experience gave Boothman confidence in his efforts to remake the hospital network’s medical liability program. In the past, all malpractice claims had been immediately outsourced to defense attorneys, who tended to fight them indiscriminately. Boothman proposed that claims first should be reviewed by impartial medical providers. If the review found a real mistake causing harm, providers were encouraged to apologize face to face, and the hospital quickly offered reasonable cash settlements.

Boothman’s “disclosure with early offer” program worked well. Consider the case of Jennifer Wagner, a schoolteacher and mother of two young boys, who saw a University of Michigan doctor in 2003 for a suspicious lump in her breast. Without conducting any testing, the provider concluded it was benign. (Later the doctor said, “I guess I put the onus on the patient to monitor for changes.”) Reassured, Wagner didn’t mention the lump at her physical the next year. But another year later, the lump became painful, and a biopsy found advanced breast cancer. Wagner required a complete mastectomy, chemotherapy, and radiation.

Wagner’s attorney, Thomas Blaske, sent a notice of intent to sue, alleging the missed cancer caused lost wages, shorter life expectancy, and psychological stress. Boothman’s insurance analysis suggested an exposure to the hospital network of at least $3 million, and he suspected Wagner’s attorneys would claim her prognosis was dire. That might reinforce and further inflame the worst fears of a young mother already plagued by anxiety.

In the old malpractice system — one that doctors and lawyers call “deny and defend” — parties on both sides of the case would have then begun girding themselves for an ugly courtroom battle. In Boothman’s new system, however, five impartial doctors reviewed Wagner’s case files and concluded her physician had indeed made a mistake. Within three months, Wagner and doctors sat down for an earnest two-hour meeting, where they explained she almost certainly was now cured. Wagner’s lawyer, who said his role during the process changed from “warrior to counselor,” remembers that as they left the meeting, Wagner turned to him and said, “I feel so good after that meeting that I don’t care if I get a dime.” (She eventually received $400,000 to start college funds for her sons.) Wagner’s fatigue improved and she returned to teaching. “I felt like I had finally been heard,” she later said. “I can’t even describe how euphoric I felt when I left that meeting.”

The outcome for Wagner was more humane than a prolonged malpractice trial, and also much cheaper for the insurer and hospital network. In a 2006 commentary for the New England Journal of Medicine, a pair of US senators pointed out that the number of pending lawsuits against the University of Michigan fell by more than half with Boothman’s system, and the average time to claim resolution dropped from 21 months to 10. Despite their apparent success, however, disclosure-and-offer programs still exist only in a small number of areas. And when those two senators, Barack Obama and Hillary Rodham Clinton, proposed a new federal office to promote the programs, their bill failed.

***

TALK FOR A WHILE TO PHYSICIANS and they’ll bemoan how they’re often victims of frivolous lawsuits, which are costly to both their personal reputations and the US health care system. Many of my colleagues at UMass Medical School and elsewhere were outraged by the $11 million judgment in the Bellerose case. The death was undeniably tragic, but did the jurors really understand anything beyond their own sympathy for the parents’ suffering? The deck seemed stacked against the baby’s doctors and nurses, whose complicated statements on the stand were no match for a grieving mother’s sorrow.

Such attitudes lead many doctors to see themselves as the real victims in malpractice cases. By the time they reach 65, data show, the vast majority of general surgeons and internists will face a malpractice claim of some type. (In my 15-year medical career, I’ve so far been one of the lucky ones.) Though many of these lawsuits go nowhere, the process can be intensely traumatic. Physicians tend to view malpractice cases as attacks that demand retaliation, not appeasement.

Still, there is a yawning chasm between physicians’ perception of malpractice costs and the reality of them. Insurance premiums are expensive, but perhaps not as outrageous as some might guess. According to a 2012 survey by Medical Liability Monitor, an independent industry newsletter, base rates for OB-GYN doctors in this state are roughly $97,000 a year at one major insurer, but that is a particularly high-risk specialty. By comparison, general surgeons pay about $45,000 and internists about $15,000. UMass pays roughly $12,000 a year for my coverage.

In addition, those annual bills for doctors haven’t been rising the way, say, the average person’s health insurance premiums have. On the contrary, a recent analysis showed that inflation-adjusted malpractice premiums actually fell from 1975 to 2005 for 96 percent of all Massachusetts physicians. (That didn’t stop the American Medical Association from declaring this a “crisis state.”)

The specter of a lawsuit is also said to drive an increase in unnecessary medical testing and care. As the mantra goes, no doctor gets sued for doing too much. In a 2008 Massachusetts survey, doctors claimed “defensive reasons” motivated them to order roughly one-quarter of all MRI and CT scans, one-quarter of all referrals to specialists, and 13 percent of hospitalizations.

But studies show that doctors order a lot of questionable testing and treatment even when malpractice risks are very low. On top of that, Harvard researchers recently estimated that all medical liability costs add only 2.4 percent to national health care spending anyway (though, to be fair, that percentage still represented more than $55 billion in 2008).

Contrary to many doctors’ beliefs, there is no epidemic of frivolous lawsuits. In 2006, the New England Journal of Medicine published an analysis of 1,452 randomly selected malpractice cases from around the country. It came as a surprise to most readers that 97 percent involved a medical injury, while almost two-thirds involved a mistake on the part of health care professionals. Looking at case outcomes, the researchers concluded that although the malpractice system is not perfect, it “performs reasonably well.” In fact, when doctors make an actual mistake, the system is slightly biased in their favor.

The misleading image of the doctor besieged by bogus lawsuits dangerously obscures an important fact: The vast majority of major medical errors never see the light of day. A classic 1991 study found that only about 2 percent of patients harmed by medical negligence filed a claim. According to a spreadsheet I was given, Harvard-affiliated hospitals were the target of only 90 malpractice claims relating to children between 2006 and 2010, a period when doctors racked up millions of patient encounters. The vast majority of the medical care at these hospitals is superb, to be sure, but it strains credibility to think that any major academic center makes a harmful mistake so rarely (especially when a 2010 study showed that 15 percent of all hospitalizations result in preventable harms).

The remarkable thing, therefore, isn’t that Americans file too many malpractice lawsuits, it’s that they file so few. Some physicians courageously fess up and communicate with compassion after an error and defuse a patient’s anger. At the same time, some appear to sweep errors under the rug. For example, I became aware that a serious misread of an ultrasound led to a patient’s death at a large medical center. When I reported the matter to a senior administrator there, I was asked not to engage the matter further.

Like many physicians, I know about dozens of such cases. While I worked a stint at a health center for underserved patients, a provider evaluated a young woman with intermittent abdominal pain and discharged her back to school, missing the fact that she was giving birth. Later in the day, the patient — who didn’t know she was pregnant — delivered her baby alone in her bedroom, panicked, and shut the baby into a suitcase. The baby died, the mother was propelled into the criminal justice system, and the provider faced no major consequences.

Last August, Massachusetts enacted reforms that usually make doctors’ apologies inadmissible in court, require claimants to file “letters of intent” before suing, and impose a six-month waiting period to allow doctors and patients to work out the matter. The law might pave the way for earlier, more amicable settlements.

But the bitter fact is that there is no appetite in the medical community to come clean preemptively about every medical error. The list of them is just too long. No major reforms, including those just passed here, are truly proactive, since they all still require patients or families to call a lawyer before anything happens.

And so we have our peculiar, perverse system. Injured patients are often left in the dark unless they decide to act. Most never do. But a few call an attorney, the medical system springs to respond, and the battle eventually ends with much collateral damage and expense. Progressive proposals seek to take a case like that over the death of Katherine Bellerose, de-escalate it, and resolve it out of court. That’s a good thing for patients and doctors, and such programs deserve wide adoption. The problem is, they would still not be enough.

***

THOSE ON THE CUTTING EDGE of malpractice reform focus on studying the 2 percent of mistakes that enter the court system, in hopes of applying what they find to the 98 percent of errors that quietly send tens of thousands of Americans to the grave each year. These innovators parse thousands of claims and, mostly hidden from view, mine the data to find ways of stopping errors from occurring in the first place.

At a conference room in Cambridge overlooking the Charles River, Dr. Luke Sato and a colleague project a spreadsheet on the wall. Sato oversees a team that studies data in malpractice claims at CRICO, or the Controlled Risk Insurance Company, a not-for-profit consortium that insures all claims from Harvard-affiliated hospitals. Over the past 30 years, the team has created a taxonomy of medical errors, with hundreds of codes for everything from “failure to identify provider coordinating care” (CS1001) to “policy/protocol not followed” (AD1026).

This spreadsheet is an analysis of the records from a deceased young girl, whose parents sued doctors for allegedly failing to diagnose and treat her heart defect. For every claim such as this one, an impartial medical expert reviews the patient’s chart for mistakes. (Interestingly, the only way for a patient to obtain such a case review is by having a lawyer file a malpractice claim.) In the girl’s case, the review found six specific contributing factors. Each was coded, recorded, and added to the data on similar cases.

This concept was employed in the 1980s by the American Society of Anesthesiologists, whose specialty was being buffeted by massive jumps in malpractice premiums and waves of bad publicity. Anesthesiologists created a national database of closed malpractice claims and fed them into a computer at the University of Washington. Surprisingly, it turned out that many patients were dying of the same mistake: incorrectly inserted breathing tubes. A simple technological fix — monitoring the patient’s oxygen level with a sensor — was made a standard of care in 1986. Lawsuits against anesthesiologists dropped dramatically.

The key, says retired CRICO president John McCarthy, was that the doctors didn’t see lawsuits as nuisances to be stamped out, but as “the tip of the iceberg” of substandard medical care. McCarthy immediately saw promise for his hospitals in this data-driven approach. In the 1990s, when many doctors were sued for missing breast cancer, CRICO analyzed claims and discovered that doctors had no uniform approach to monitoring lumps. McCarthy’s team developed a standard breast care algorithm for Harvard hospitals and offered doctors who learned the procedure discounts on their malpractice insurance premiums. As a result of the changes, he says, there was “almost complete resolution” of related litigation in the Boston area.

CRICO has replicated its results in other medical situations. When its data showed doctors getting hammered for obstetrical complications, largely as a result of teamwork problems, CRICO created a team-training course and gave premium discounts to enrollees. Claims soon fell by 50 percent. Then data showed that 20 percent of Boston-area claims involved communication breakdowns, and CRICO found that surgical trainees didn’t want to appear weak by contacting senior physicians for help. In response, a “trigger card” automatically notified senior physicians of certain alarming developments, relieving trainees of the responsibility. The list of improvements goes on. Overall, CRICO’s paid claim rates now are less than half that of insurers in California and one-fourth of those in New York and Pennsylvania. Most notably, CRICO improved care for all patients, not just those who filed lawsuits.

Since 1990, CRICO has been analyzing claims from 520 health systems around the country that employ more than 75,000 physicians. The database it has created — the Comparative Benchmarking System — is the most detailed repository of malpractice data in the world. “This can transform the system of care,” says Mark Reynolds, CRICO’s current president. “If I had to be bold, I’d say our data mining largely explains why our claims rates are lower than other regions’.”

Thinking of Katherine Bellerose, I asked CRICO to examine necrotizing enterocolitis claims in the repository from the past decade, a data set it turns out no one had previously asked for. Two weeks later, a member of the team e-mailed me a detailed spreadsheet containing more than two dozen cases (none included information that would identify patients).

The CRICO team tagged 137 errors that could be grouped into 35 categories. There were several patterns among the cases. In more than half, there was a delay in ordering X-rays or other tests. In a third, the team overlooked the possibility of enterocolitis in spite of clinical signs. In a quarter, there were communication problems among doctors, often related to shift changes. There were instances of “failure to question” an incorrect medical order and others where staff “failed to respond” to repeated concerns from patients.

Twenty to 30 percent of very low birth weight infants who develop necrotizing enterocolitis die from it — that mortality rate hasn’t budged in more than a decade, despite advances in medical technology. The claims data won’t be a miracle fix, but they do make a constructive suggestion for improvement: Standardize care. Neonatal doctors need to agree on the early signs of the condition and on when to use antibiotics and order tests. Then they need to improve how they interact with each other and with families. The data might not tell us exactly how to fix problems, but they do show how the care of preemies with necrotizing enterocolitis repeatedly goes wrong.

***

IN LATE 2011, Danielle Bellerose sat with me on a bench in front of her modest Colonial home north of Boston.

In the time after her daughter’s death, she told me, all she wanted was to meet with her baby’s doctors and be reassured that they had done all they could. But they never spoke again.

For her, seeking legal redress was “not a therapeutic process,” and the stress led to years of depression and therapy. Awaiting trial, she lacked any sense of closure — she could never even bring herself to put a headstone at Katherine’s grave. In the meantime, her anger at the doctors and nurses festered.

In medical training, doctors are taught the importance of listening to patients and their families, but the lessons are often too easy to forget. If Danielle Bellerose felt her daughter’s doctors and nurses responded better to her questions, they might have avoided a major malpractice suit. I also told Danielle about the CRICO analysis — like most, she was unaware such processes existed — and she seemed pleased to know that some improvement in future care might come from her daughter’s death.

So it’s not too late: Katherine Bellerose and other patients are still telling their stories, just now in a different way. We have another chance to listen.

A London, Kentucky hospital and 11 cardiologists performed over 3,000 unnecessary cardiac catheterization surgeries and countless other heart procedures on healthy patients. These unfortunate victims of medical malpractice will now be required to take dangerous blood-thinning medications for the rest of their lives. The US attorney’s office and other governmental offices are currently investigating the hospital and doctors. USA Today brought the story to us:

Hundreds sue Ky. hospital over heart procedure

USA Today, February 17, 2013, by Andrew Wolfson, The (Louisville, Ky.) Courier-Journal

LONDON, Ky. — After enduring at least two-dozen heart procedures over two decades, disabled former meat cutter Edward Marshall decided in September 2010 that he’d been treated long enough by cardiologists at St. Joseph London hospital.

So he saw a specialist in Lexington, who told him some disturbing news: An artery treated just months earlier was barely blocked, and there had been no need for Dr. Sandesh “Sam” Patil to enlarge it with a balloon angioplasty, then prop it open with a stent.

“I would have not carried out this procedure,” the Lexington cardiologist, Dr. Michael R. Jones, told Marshall in a letter that is included in the court record.

Marshall, 67, who lives in London, became the first of nearly 400 people to sue the London hospital and 11 cardiologists, including Patil, claiming they conspired to perform unnecessary, risky and often painful heart procedures to unjustly enrich themselves.

The suits, which also name the hospital’s parent company, Catholic Health Initiatives, allege that two patients died and that the others will be required to take dangerous blood-thinning medications for life and are at risk of other potentially fatal complications.

The hospital and other physicians named as defendants deny the allegations.

“These were very sick people who needed the interventions, and got them,” said the hospital’s lead lawyer, Todd Thompson, who calls the conspiracy allegations “Alice in Wonderland stuff.”

But records show the plaintiffs aren’t the only ones who have Patil and the London hospital in their sights:

– The U.S. attorney’s office in Lexington is investigating the medical necessity of cardiac procedures performed there, and the financial relationship between the St. Joseph system and Patil’s cardiology group, according to a disclosure in CHI’s most recent annual report.

– Patil is the subject of a federal criminal health care fraud investigation, his lawyer disclosed last month when Patil refused to answer 109 questions at a deposition in Marshall’s suit, declining even to say whether he is a doctor.

– The Kentucky Medical Licensure Board last month found that Patil provided substandard care to four of five patients whose records it examined, placing stents without justification in three of them.

Mirroring claims in the lawsuits, the board’s consulting doctor found that Patil showed a “consistent inappropriate rush to invasive testing” in one patient and an “inexplicable plan” to place stents in an unobstructed artery in another. Still, the board allowed Patil to continue to practice, with monitoring and remedial education.

– The Centers for Medicare and Medicaid in 2011 cited the hospital for failing to review the medical necessity of 3,367 cardiac catheterizations performed there the year before. In those procedures, a wire is inserted through an artery in the groin into the heart.

The citation said a doctor on the hospital’s “quality assurance committee” had never reviewed any medical records regarding the procedures and that one patient had them annually — 20 in all — even though he had no symptoms of heart disease. The hospital agreed to take corrective measures.

– In research conducted for his Kentucky Health Policy Institute blog, University of Louisville professor emeritus Peter Hasselbacher found that in 2008 and 2009, St. Joseph London did more angioplasties with stents than either of the state’s two major teaching hospitals.

Hasselbacher, an internist, also found that after lawsuits were filed — when St. Joseph London came under the spotlight — the number of invasive procedures dropped by one-third, which he called “the most persuasive evidence that too many cardiac catheterizations with placement of stents might have been performed.”

Barbara Mackovic, a spokeswoman for KentuckyOne Health, which operates the St. Joseph system and Jewish Hospital HealthCare Service for CHI, declined to comment on Hasselbacher’s analysis, the citation from the Centers for Medicare and Medicaid, or the Kentucky Board of Medical Licensure findings.

She also declined to comment on the lawsuits, citing a corporate policy against discussing pending litigation.

In a statement, she said St. Joseph London hospital is cooperating with the U.S. attorney office’s investigation. She also said Patil has not had privileges at the London hospital since December 2010 and has not practiced there since.

Neither Patil, who now works for Appalachian Regional Healthcare in Whitesburg, Ky., nor his lawyers, responded to requests for comment.

U.S. Attorney Kerry Harvey, citing Justice Department policy, said he could neither confirm nor deny that the hospital and Patil are under investigation.

A focus on hearts

CHI operates 73 hospitals in 19 states and in November, KentuckyOne Health began taking over management of most of the operations of University Hospital in Louisville.

St. Joseph London has touted its cardiology services and the fact that in 2008 it was named one of the top 100 cardiac hospitals in the country by Thomson Reuters, an information company.

The hospital has said it decided to focus on cardiac care in part because of its location in “coronary valley,” an area in southeast Kentucky with a high rate of heart disease.

But Louisville lawyer Hans Poppe, the lead counsel for the plaintiffs, says in the suits that unnecessary stents — which allow health care providers to generate revenue from health insurance companies, the government and patients — have become a pervasive problem, with cases in Texas, Tennessee, Maryland and Pennsylvania.

CHI agreed to pay $22 million to the federal government in 2010 to settle allegations that its hospital in Towson, Md., made improper payments to a cardiology group that included a doctor who was later stripped of his license. The government had alleged that doctors were regularly performing unnecessary procedures.

Marshall filed his suit in London in September 2011. His lawyers then placed ads in the London Sentinel Echo seeking other potential plaintiffs.

Since then, about 40 additional suits have been filed, including one that names 280 plaintiffs. No trial dates have been set.

The hospital’s attorneys say it has turned over as many as a half-million medical records, but Poppe said the hospital has refused to disclose an internal investigation it submitted to the U.S. attorney’s office, or the portion of doctors’ contracts that Poppe says will show they were “incentivized” for performing additional procedures.

Depositions have been taken of just two of Poppe’s clients, Marshall and Rhonda McClure.

McClure, 54, a retired trucking company dispatcher and bookkeeper who lives in London, alleges that she went into the hospital for shingles in 2007 and ended up having unnecessary bypass surgery.

Dr. Paula W. Hollingsworth, a Lexington cardiologist who examined McClure’s records, said in a letter produced in the lawsuit that McClure did not need the bypass.

McClure acknowledged during her statement that she has multiple medical problems and needed at least some of the cardiac care she received.

A question of care

Marshall said in a deposition that he had the first of five heart attacks in 1992 and started seeing one of Patil’s partners in 1996.

His suit says that over the ensuing years Patil and other doctors unnecessarily implanted a pacemaker and stents and did unneeded angioplasties and catheterizations.

He said in an interview that he had the procedures so routinely that nurses in Patil’s practice would joke about seeing him for the next one. He said in his deposition that when he started to question Patil about the need for the procedures, he would change the subject.

Marshall said he became more suspicious on Aug. 2, 2010, when Patil was doing a angioplasty and announced that he’d found no blockage in the artery but was going to insert a stent anyway.

Marshall then went to Jones, the Lexington cardiologist, who reviewed his records and said in an Oct. 2, 2010, letter that the artery that Patil stented was only “25 percent blocked” and that “in cardiology, we almost never treat … a narrowing of less than 70 percent.”

Thompson, the hospital’s lawyer, notes that Jones practiced at a competing hospital, Central Baptist.

Marshall said the revelation destroyed his faith in doctors.

“It made me mad,” he said in his deposition. “I think I had a few curse words.”

Asked why St. Joseph London should be held responsible, he said: “I just think that the hospital should know what the doctors are doing in their building. And if they don’t know, they should.”

Marshall, who has three daughters and nine grandchildren, said the procedures scared his family unnecessarily.

“It is serious business when someone is fooling with your heart,” he said in an interview. “It is just not right what they put people through.”

The last time that the state raised the minimum amount of auto insurance a driver must carry, a Ford Gran Torino cost $3,200.

Now those levels are poised to increase for the first time since 1969.

Under a law that will take effect in December, minimum-insurance requirements will at least double — to $25,000 per person, $50,000 for a multiperson accident and $25,000 for property damage.The Ohio Insurance Institute estimates that about 400,000 Ohioans — roughly 5 percent of the state’s insured drivers — carry the minimum levels.

How much more they will pay in premiums under the new mandate is difficult to say.

Several insurance companies declined to speak about the law or said it’s too early to know.

Industry officials note that a variety of factors — age, driving record, vehicle type, driver’s place of residence, among others — are used to set rates, making it tough to figure out how much they might change for a particular driver. Officials also note that Ohio’s competitive market for insurance coverage gives drivers options.

“It’s going to affect everyone differently,” said Dan Kelso, institute president.

“The Department does not have any premium projections based on the recently passed minimum-requirements law,” Chris Brock, spokesman for the Ohio Department of Insurance, said in an email. “Ohio currently has the 10th-lowest auto rates in the country, and these changes only impact one of many rating factors used by companies to determine premiums.”

State Rep. Gerald L. Stebelton, who sponsored the legislation to raise the minimum levels, said drivers who carry the minimum should expect to pay a few dollars more a month for coverage.

“We weren’t too concerned about that,” said Stebelton, R-Lancaster. “There’s a cost associated with driving a car.”

Even with the increase, he said, the new minimums won’t provide a lot of coverage.

Through the years, Kelso said, the insurance institute has opposed or remained neutral about higher minimums. If drivers want to have more insurance, he said, nothing prevents them from buying it. “The question is whether the state should be telling them that.”

The industry stayed neutral on the legislation this time, Kelso said, but the legislation became more palatable with the addition of some other provisions.John Van Doorn, executive director of the Ohio Association of Justice, a group for trial lawyers, said the increase “is long overdue.”A lthough members of the group stand to benefit financially from the increase, Van Doorn said the increase was needed because of the damage that drivers with inadequate insurance can inflict on others when involved in an accident.A new car today costs an average of $27,000.

“It’s more out of frustration with some of my members representing someone when they’re hit by an underinsured or uninsured driver,” he said.

One concern is that the law will drive up policy prices enough that more drivers will skip insurance altogether.

The state’s program of randomly checking drivers for coverage has found that about 11 percent typically lack insurance.Kelso doesn’t foresee a big problem. “This is not going to turn the market upside down,” he said. “There will probably be a certain segment that because of the increased cost will drop coverage.”

Van Doorn said that research in other states hasn’t found a correlation between minimum insurance levels and number of uninsured drivers.

The key, he said, is strict enforcement of the law.

Source: The Columbus Dispatch, February 3, 2013, by Mark Williams

By BARRY MEIER, The New York Times – January 22, 2013

An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.

The company’s analysis also suggests that the implant is likely to fail prematurely over the next few years in thousands more patients in addition to those who have already had painful and costly procedures to replace it.

The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson’s DePuy Orthopaedics division knew about the device’s problem before its recall and the actions they took or did not take.

The trial, which is expected to begin Friday in California Superior Court in Los Angeles, may also provide a guide to the consequences of the A.S.R. episode to Johnson & Johnson, both for the company’s finances and its reputation. Last year, the company took a $3 billion special charge, much of it related to medical and legal costs associated with the device. DePuy has offered to pay patient costs for replacement procedures.

The A.S.R. belonged to a once-popular class of hip implants in which a device’s cup and ball component were both made of metal. While the A.S.R. was the most failure-prone of those implants, surgeons have largely abandoned using such devices in standard hip replacement because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.

On Friday, Judge J. Stephen Czuleger, who is presiding over the Los Angeles case, unsealed a number of motions that contained portions of pretrial depositions of DePuy officials as well as related company records. Those disclosures, like the company’s estimate of the A.S.R.’s failure rate, represent only a tiny fraction of the information that will become public if the trial proceeds. Over the last two years, plaintiffs’ lawyers working on A.S.R.-related lawsuits have reviewed tens of thousands of internal DePuy documents and taken depositions from dozens of company executives.

Executives of DePuy have long insisted that their handling of the A.S.R. was forthright and appropriate. In mid-2010, when DePuy recalled the implant, officials said they were doing so because data that year from the National Joint Registry of England and Wales showed for the first time that it was failing prematurely at a higher rate than competing implants. In 2011, the British implant registry updated its projected failure rates for A.S.R. patients who had had it the longest, saying it was failing in one-third of them. It was that estimate that was challenged by DePuy.

About 7,000 of the A.S.R. lawsuits have been consolidated in a federal court in Ohio. An additional 2,000 cases have been consolidated in a California state court. The California case chosen to go to trial this week was selected because the plaintiff, a man named Loren Kransky, has cancer and may not live much longer, lawyers involved in the case said. DePuy has already settled a few A.S.R. cases before trial and it may choose to do so in Mr. Kransky’s case as well.

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

There are two versions of the A.S.R., one used in standard hip implants and the other used in an alternative replacement procedure known as resurfacing. Only the standard implant was sold in the United States. Both versions of the A.S.R., however, used the same metal hip cup as part of their design.

Asked for comment about the company’s internal analysis, a spokeswoman for DePuy, Mindy Tinsley, said in a statement that it “was based on a small, limited set of data that could not be used to generalize” the overall failure rate for the A.S.R.

In 2011, when DePuy challenged the British joint registry’s findings, the company made similar comments. Other medical organizations, however, have also projected very high failure rates for the A.S.R.

Hip implants, which are generally made from metal and plastic, often last for 15 years before they wear out and need to be replaced. Such devices can fail prematurely for a variety of reasons, but the early replacement rate is typically 1 percent after a year, or 5 percent at five years.

In pretrial testimony, Paul Voorhorst, DePuy’s director of biostatistics and data management, said that the company performed several reviews of A.S.R. failures in patients in fall 2011, a year after it recalled the model.

Based on the number of patients who had already undergone device replacement at the time, DePuy estimated that about 37 percent of patients who got an A.S.R. might need to have it replaced within five years of receiving it.

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

The F.D.A. 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.

In other pretrial testimony released Friday, a DePuy engineer stated that company officials were aware in 2008 of reports by an English surgeon that the resurfacing version of the A.S.R. was releasing high levels of metallic ions, particularly in women. As a result of the reports, company officials felt they had to move quickly to redesign the implant.

Once again, the medical malpractice lawyers and personal injury lawyers at Leeseberg & Valentine have earned the distinction of being named “Super Lawyers.”  Congratulations to Gerald Leeseberg and Anne Valentine for being named Super Lawyers, and to Susan Hahn for being named a Super Lawyers Rising Star.

Super Lawyers is a rating service of outstanding lawyers from more than 70 practice areas who have attained a high-degree of peer recognition and professional achievement. The selection process is multi-phased and includes independent research, peer nominations and peer evaluations, making it a truly special honor.

The Columbus medical malpractice lawyers and personal injury lawyers at Leeseberg & Valentine are honored to be named “Super Lawyers” and look forward to continuing to fight for justice on behalf of those injured from the negligence of others.

Gerald S. Leeseberg

visit superlawyers.com

Anne M. Valentine

visit superlawyers.com

Susan L. Hahn

visit superlawyers.com

Once again, the medical malpractice lawyers and personal injury lawyers at Leeseberg & Valentine have earned the distinction of being named one of the “Best Law Firms” in the country by U.S. News & World Report’s 2013 Best Lawyers publication. Leeseberg & Valentine was named a Tier 1 law firm for personal injury litigation, which is the highest distinction given by the publication. This honor is especially rewarding in that the “Best Law Firms” are determined by a rigorous evaluation of a combination of client feedback and our firm’s reputation among other lawyers in the legal community.

The Columbus medical malpractice lawyers and personal injury lawyers at Leeseberg & Valentine are honored to be named a “Best Law Firm” and look forward to continuing to fight for justice on behalf of those injured from the negligence of others.

By Gerald S. Leeseberg, Columbus Medical Malpractice Lawyer
For Publication in Ohio Trial Magazine

The Supreme Court has recently published for comment proposed changes to Civil Rule 10, governing affidavits of merit in medical claims, as well as some changes to the evidentiary rules pertaining to the qualifications of expert witnesses in medical claims.  This discussion will attempt to briefly summarize those changes.  By way of explanation, the history of the Rule is important and will be discussed as well.  Moreover, it is necessary to understand that the proposed changes to Civil Rule 10 are actually part of a “package” of changes including anticipated statutory changes (outside the authority of the Supreme Court), intended to improve the way in which medical claims are litigated.

The origin of the requirement for an affidavit of merit in Civil Rule 10 arose out of attempts by the Ohio State Medical Association (OSMA) to enact mandatory physician screening panels modeled after the system in place in Indiana.  Members of Ohio Association for Justice testified against such legislation, disputing the notion that physician screening panels were a) fair, or b) an expeditious manner of weeding out “frivolous claims.”  Experience in Indiana showed that such panels found in favor of physicians in approximately 95% of all cases, added thousands of dollars of expense to each case, and took on average 46 months to complete before litigation of the actual case could commence. The Indiana model worked exactly as intended by the medical profession and insurance industry proponents, not to “expeditiously weed out frivolous claims” but instead to interpose an expensive, difficult, and lengthy roadblock to such claims.  Fortunately, when informed of such effects, the Ohio legislature saw fit to establish a working group to analyze the proposal and make recommendations.  Instead of mandatory physician screening panels, through a process of negotiation the affidavit of merit requirement was enacted in Civil Rule 10.  (The Rule has been amended once previously following its enactment, because of shortcomings in the original version.)

The affidavit of merit provision has since worked well, serving a “gatekeeper function” in Ohio, and is thought to be responsible for a significant decrease in the number of medical claims filed.  Nevertheless, some in the medical profession and defense bar felt that the Rule did not impose enough requirements as a precondition to filing a medical claim, and/or was not being applied strictly enough by trial courts.  Limited anecdotal evidence was collected demonstrating, at most, isolated instances where complaints had been filed without affidavits, affidavits were defective, and/or considerable leeway was granted by trial courts in complying with the Rule.  (Despite the OSMA’s wishes, the Supreme Court has made it very clear that failure to comply with the Rule resulting in a dismissal constituted a dismissal otherwise than upon the merits.  See Troyer v. Janis, 132 Ohio St.3d 229, 2012-Ohio-2406 (syllabus) (“[a] dismissal of a complaint for failure to attach the affidavit of merit required by Civ.R. 10(D)(2) is an adjudication otherwise than on the merits and is a dismissal without prejudice by operation of law”).  Armed with such limited “evidence”, the OSMA’s lobbyists drafted proposals for more changes to Civil Rule 10, that would have imposed significant burdens on plaintiffs, and created enforcement headaches for trial courts.  The OSMA proposal was submitted to the Supreme Court earlier this year for consideration.

In response, the Ohio State Bar Association, through William Weisenberg, reconvened a working group first established several years ago to discuss various issues specific to medical claim litigation and propose improvements, including the first affidavit of merit provision.  (That group has at various times been comprised of representatives of the trial bench, defense bar, plaintiff bar, the OSMA, and the Ohio Nursing Association.)  Through a prolonged process of discussion and negotiation, the affidavit of merit proposal submitted by the OSMA was changed to its present proposed form.  More importantly, the entire process of initiating and litigating medical claims was reviewed in order to try to address the biggest complaint of the OSMA and its membership: the “shotgunning” of defendants in medical claims.  When it was pointed out to the OSMA that this pernicious evil was the direct result of the shortest statute of limitations of any cause of action, compounded by a line of recent court decisions such as Theobald v. Univ. of Cincinnati, 111 Ohio St.3d 541, 2006-Ohio-6208, (and its progeny), Comer v. Risko, 106 Ohio St.3d 185, 2005-Ohio-4559, Natl. Union Fire Ins. Co. of Pittsburgh, PA v. Wuerth, 122 Ohio St.3d 594, 2009-Ohio-3601, and Erwin v. Bryan, 125 Ohio St.3d 519, 2010-Ohio-2202, it became clear that additional changes would have to be made to minimize this practice.  Fortunately, the OSMA was receptive to discussions about making constructive fixes.  Those changes, which will require legislative amendments, essentially will allow plaintiffs to file a medical claim with a qualifying affidavit of merit, and thereafter gain a finite period of time within which to conduct discovery for the purpose of identifying any additional individuals that need to be joined as defendants.  This is obviously better than the current system in which every possible tortfeasor needs to be named at the outset and later dismissed if appropriate, but only after significant time, expense and professional angst has been incurred by the physician being dismissed.  Those positive changes will be discussed in more detail after they are enacted.

As to the proposed changes to Civil Rule 10, they can be summarized as follows:

• identifies specific types of claims to which the affidavit requirement applies (“a medical claim, as defined in section 2305.113 of the Revised Code”]
• establishes expert qualifications for affidavits, consistent with Rule 702 of the Ohio Rules of Evidence
• mandates identification of the specific medical records or other information reviewed by the expert witness, including the source of such records and the dates of medical service encompassed within such records
• requires an affidavit for every named defendant, and that each defendant to whom the affidavit applies be identified (while allowing for “consolidated” affidavits from an expert that apply to multiple defendants, if appropriate)
• requires an averment by the expert:
  • establishing the expert’s qualifications sufficient to comply with Evid.R. 702
  • indicating the basis for the expert’s familiarity with the standard of care applicable to the named defendant(s) to whom the affidavit applies
  • asserting a breach in the standard of care by the named defendant(s)
  • as to the existence of injury or harm proximately caused by the breach in the standard of care

There are also concomitant changes proposed to the pertinent Rules of Evidence.  They include reverting back to the old requirement that an expert meet the “75% rule” (as opposed to 50% under the current Rule).  However, the criteria for qualification has been expanded to include not only professional time in the active clinical practice of medicine or to its teaching in an accredited medical school, but also includes research pertinent to the medical issues in the case as well.  This change was intended to avoid situations where national or world authorities in various medical conditions were precluded as experts simply because a substantial portion of their time is spent researching, rather than just treating, a specific medical condition.  Since research is often the foundation for establishing appropriate standards of medical care, it was not rational to exclude such authorities; provided, however, they are still required to spend at least 50% of their time in the active clinical practice so as to demonstrate familiarity with clinical standards of care.

Additionally, the time as of which an expert’s qualifications are to be determined has been changed from the time of trial to the time at which the cause of action arose.  This is a significant improvement over the existing version, because the standards of care at the time of trial are inadmissible as irrelevant; it is the standard of care applicable as of the time the cause of action arose which is the only relevant time period.  This change is intended to allow unquestioned authorities in a medical field to serve as an expert, and not be precluded simply because they may have retired or significantly cut back their clinical practice as of the time of trial.  It also precludes the absurd converse situation where an “expert” may not have even been licensed to practice medicine at the time of the events giving rise to the claim, but may well qualify as of the time of trial several years later – when applicable standards of care may have changed and are, therefore, inadmissible as irrelevant.

In sum, the proposed changes are essentially directed at requiring more specificity as to what information has been relied upon by an expert, a prima facie assertion of the expert’s qualifications, and some indication of the basis upon which the expert is familiar with the standards of care as to defendants against whom the affidavit is offered, when giving the plaintiff the “green light” to proceed in a medical claim.

For years, the public has been fed a giant misinformation campaign designed to convince people that their constitutional right to file a lawsuit, when they have been injured or harmed, should be restricted or eliminated.  Much of that campaign seeks to get people to believe that the court system needs “reform,” in the manner of closing the courthouse doors to ordinary Americans when they need it the most.

For those interested in the truth about what still is happening in the real world, the NOW I KNOW MORE website is dedicated to bringing to light the TRUE stories of destructive business decisions, preventable medical errors, and predatory financial practices, among others, to warn that we all need to be vigilant in protecting ourselves, our families, and our communities from those who cause harm.   By understanding that bad things still happen to good people, it is more important than ever to keep justice available to those who need it and protect the 7^th Amendment to the Constitution.

Visit the Now I Know More website to read more.