Leeseberg & Valentine

The New York Times, May 16, 2013, by Joanna C. Schwartz

MUCH of the discussion over the Affordable Care Act has focused on whether it will bring down health care costs. Less attention has been paid to another goal of the act: improving patient safety. Each year tens of thousands of people die, and hundreds of thousands more are injured, as a result of medical error.

Experts agree that the best way to reduce medical error is to gather and analyze information about past errors with an eye toward improving future care. But many believe that a major barrier to doing so is the medical malpractice tort system: the threat of being sued is believed to prevent the kind of transparency necessary to identify and learn from errors when they occur.

New evidence, however, contradicts the conventional wisdom that malpractice litigation compromises the patient safety movement’s call for transparency. In fact, the opposite appears to be occurring: the openness and transparency promoted by patient safety advocates appear to be influencing hospitals’ responses to litigation risk.

I recently surveyed more than 400 people responsible for hospital risk management, claims management and quality improvement in health care centers around the country, in cooperation with the American Society of Health Care Risk Managers, and I interviewed dozens more.

» Read Entire Article

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

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. » Read Entire Article

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. » Read Entire Article

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. » Read Entire Article

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.