[Update, March 2013: I originally wrote this post in December 2012. Three months later, the FDA announced it “is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.” Several news agencies ran with the news, including AP and Bloomberg, as did some pharma industry bloggers. The JAMA Internal Medicine medical journal ran a column urging more research into the link between the drugs and pancreatic cancer, an article with a concerning, but perhaps harmless, revision after it was published. We think the latest attention and research makes the case against these drugs even stronger, and we’re moving forward in our own litigation.]

Diabetes is a global epidemic, affecting over 25 million Americans and ten times that worldwide. That also makes it an economic opportunity: the diabetes control medication market is worth more than $40 billion in the United States alone. There are thirteen types of approved Type 2 Diabetes medications on the market today (comprising over two dozens drugs), with another seven therapies in various stages of research and development. There’s big money to be made, if you’re a pharmaceutical company — hence the recent advertising push for Januvia, Byetta, and Victoza (the one Paula Deen endorses), relatively new entries to the overcrowded diabetes control market.

I’ve discussed before on this blog how one of the biggest public health problems in America is the pharmaceutical industry’s reliance on the “blockbuster” drugs that exceed $1 billion in annual sales. The whole industry, from research, to clinical trials, to physician education, is oriented around creating and promoting drugs that will become household names — to the exclusion of other useful medicines and to the detriment of patient safety. A year ago, I wrote about why Merck still didn’t admit Propecia caused persistent erectile dysfunction more than eight years after competent research showed the problem. The reason is quite simple: Propecia / Proscar was routinely bringing in more than half a billion dollars a year for Merck, and they wanted to keep it going for as long as possible.

Which brings us to Januvia, a drug that stock market analysts call a “real success story” for Merck. The Type 2 Diabetes market is huge, and Januvia (marketed as “Janumet” when mixed with metformin) has captured 75% of the dipeptidyl peptidase 4 (DPP-4) inhibitor market — for $4.6 billion in revenue in 2011 and likely topping $5 billion this year. It’s not hard to see why Januvia and other DPP-4 drugs have been successful and their sales are growing. They’re a one-a-day pill, not a shot, they haven’t been shown to cause weight gain, and they have a lower incidence of the nausea, abdominal pain, and digestive problems that characterize most diabetes treatments.

But there’s a big problem brewing.
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Misdiagnosis is the most common type of medical malpractice case – roughly one-quarter of all claims – and the failure to diagnose cancer is the most common form of misdiagnosis that results in a malpractice claim. (For those interested in the statistics, the most commonly missed cancers are breast cancer, colorectal cancer, and prostate cancer.) I thus spend a lot of time thinking and talking about cancer as part of my legal practice, but over the past two weeks it has seemed like cancer has been a part of almost everything I’ve read and discussed.

Last week, I had to tell a woman that, though I thought her doctor was negligent in failing to diagnose her ovarian cancer, I couldn’t bring a lawsuit on her behalf. As will be explained below, there’s a big difference between malpractice in patient care and proving a malpractice claim in court.

First, a couple words about Steve Jobs. Now that the initial grieving has ended, the big question has been asked several times: would Jobs have lived longer if he hadn’t delayed surgery?

Most medical experts who have discussed his case in public believe the answer is “yes.” MedPageToday rounded up a number of surgical oncologists opining that Jobs should have undergone surgery immediately — a conclusion implicitly backed by a paper Jobs’ own surgeon published in 2006, and by a related follow-up paper earlier this year — for reasons explained in detail by a post on Quora by medical researcher Ramzi Amri:

The big confusion in the media is that Jobs had pancreatic cancer. Though his tumor might have originated in his pancreas, we’re not speaking of the dreaded pancreatic adenocarcinoma that has such a horrible prognosis and makes up for 95% of pancreatic tumors.

Jobs is cited to have said himself that he had an islet-cell tumor, which is a colloquially used, less accurate name for the other 5% of pancreatic tumors, so-called neuroendocrine tumors.

Neuroendocrine tumors are relatively mild forms of cancer. …

Neuroendocrine tumors caught in time can be treated just by surgically removing the tumor.

This is a relatively low-risk treatment that — especially compared to chemo and radiation — has negligible disadvantages. In many cases, a simple enucleation (just cutting out the tumor with a safe margin around it) is enough and leaves no residual side-effects.

In short, Jobs’ “pancreatic cancer” was initially a gastroenteropancreatic neuroendocrine tumor that, although it interfered with his hormone levels, could have been treated by simply removing it and performing a resection of any parts of the pancreas he lost. It wasn’t just a matter of buying him a couple months or years, the treatment would have changed his prognosis considerably, adding years to his life, potentially leading him to live an ordinary life span.

Cancer Remission MisconceptionsBut that’s the strange part about cancer. Until we or someone close to us has gone through cancer treatment, we tend to see it as the process memorably described by the beginning of xkcd’s comic, “Lanes,” part of which is posted on the right.

Consider this article from last week in the Dayton Daily News:

Glenda Christian’s license plates on her Chrysler Town & Country minivan say it all: She proudly wears pink as 19-year breast cancer survivor. …

Although the cancer is in remission, the 54-year-old Washington Twp. resident is adamant in sharing her story to help raise breast cancer awareness in people of all ages and stress the importance of early detection.

After spending 3½ years with her cancer misdiagnosed, Christian is admirably upbeat in recounting the details of her illness and, in particular, how faith guided her through the arduous process of treatment. …

She was diagnosed with stage 3B estrogen-receptor-negative breast cancer.

She had a left mastectomy in 1992 and then chemotherapy. Since she tested positive for BRAC1 – a gene mutation that increases a woman’s risk for breast and/or ovarian cancer – she also had an elective right mastectomy and a hysterectomy in 2008. …

From the beginning, the outlook was grim. Christian was given a two-year survival rate of 50 percent.

In addition to being a survivor of cancer, Glenda Christian is also a survivor of blatant medical malpractice. She first noticed symptoms more than two years before she was properly diagnosed. A mammogram was done and she was cleared. A year later, another mammogram and an ultrasound, and another all-clear. Two separate exams, two failures to diagnose. It wasn’t until she had “cottage cheese-like lumps encompassing more than half of her left breast” that a different doctor diagnosed her with breast cancer.

By the odds, she should have died a long time ago. Yet she’s still here, despite having spent two years with her cancer undiagnosed, while Steve Jobs went a mere nine months refusing treatment of his then-largely-benign tumor and it spread throughout his pancreas and duodenum, requiring he get the dreaded Whipple procedure before dying seven years later.

Their differing outcomes aren’t just due to the differences between breast cancer and pancreatic cancer (or neuroendocrine tumors), but rather to the arbitrary tragedy of cancer.
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The New England Journal of Medicine released a new study in today’s issue, Malpractice Risk According to Physician Specialty, which concluded:

There are few recent estimates on the likelihood of malpractice claims and the size of payments according to physician specialty. Using physician-level malpractice claims from a nationwide liability insurer, we found substantial variability

Last month the American Journal of Medicine published a new study (“Longer Lengths of Stay and Higher Risk of Mortality among Inpatients of Physicians with More Years in Practice”) with the unexpected conclusion that hospitalized patients were more likely to die or stay long in the care of an experienced physician than in the care of a recent graduate from residency:

According to findings in the American Journal of Medicine, patients whose doctors had practiced for at least 20 years stayed longer in the hospital and were more likely to die compared to those whose doctors got their medical license in the past five years. …

Over the course of the study, there were 59 different attending physicians. The researchers divided them up based on how long they were practicing: five years or less, six to 10 years, 11 to 20 years, or more than 20 years. …

At first glance, compared to patients with the newest doctors, those with the most experienced physicians had more than a 70 percent increase in their odds of dying in the hospital and a 50 percent increase in their odds of dying within 30 days.

However, when the researchers took into account how sick the patients were, they found that only the sicker patients — those with complicated medical problems — were at higher risk in the hands of the more experienced doctors.

Southern’s group also found that while the doctor’s experience played a role in how long patients stayed in the hospital, it also mattered how many hospitalized patients he or she was taking care of.

When doctors weren’t very busy, they kept patients in the hospital for roughly the same average time no matter how many years of experience they had. But when they did have a lot of patients to see in the hospital, those with more than 20 years of experience kept patients there about half a day longer than their peers who’d been practicing for less than five years.

Description from Reuters. The authors suggested that the younger doctor’s “familiarity with more current guidelines and practices” explained the difference, and suggested requiring periodic re-certifications. Scepticemia notes some possible confounding variables and sample size issues, but on the whole the study’s conclusions look robust.

We have a fair amount of experience investigating medical mistakes around here, including malpractice by hospital residents, so let me offer another possibility.

There is a misunderstanding about medical malpractice law which goes like this: if a doctor is faced with multiple potential diagnoses and treatments and the doctor chooses the wrong one, the doctor will be liable for medical malpractice.

Such myth is not and has never been the law.
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Today’s Legal Intelligencer tells us what we already know: in Pennsylvania and New Jersey, patients’ right to compensation for injuries caused by medical malpractice is dying. Not a quick death, mind you, like the death of patients’ rights in Texas (a punishment insurance companies and medical associations are trying to inflict upon New York),

It may sound strange coming from me, but I don’t like suing people, particularly not in personal injury or professional liability actions where the real target of the suit is not even the company that employed the negligent person, but really the employer’s insurance company.

But I often end up suing everyone I can, including

Insurance-Funded Congressional Representatives Again Try To Deny Justice For Patients Injured By Medical Malpractice

Some bad ideas just will not go away. A few days ago The Pop Tort noted that the new, anti-patient Congress was holding hearings on medical malpractice liability. If they had listened to the excellent testimony of Joanne Doroshow, Executive Director of the Center for Justice & Democracy, they would have realized that injured patients need more, not less, legal protection.

But the “hearings” were a sham anyway, and a few days later the insurance-backed members of Congress introduced a new plan to strip away the rights of medical malpractice victims.

Phil Gingrey (R-GA11) ran unopposed last election, but that did not stop health services companies, HMOs, hospitals, pharmaceutical companies, medical device companies, and insurance companies from contributing nearly $500,000 to his “campaign.”

It seems like he is ready to pay them back. As his press release trumpets:

Senior Health Subcommittee Member Phil Gingrey, M.D. (R-Ga.), House Judiciary Committee Chairman Lamar Smith (R-Texas), and Congressman David Scott (D-Ga.) today introduced The HEALTH Act (H.R. 5), a bill that includes meaningful medical liability reforms to lower the cost of health care while strengthening the doctor-patient relationship.

The press release has little by way of facts, except for this whopper: “According to the Harvard School of Public Health, 40% of malpractice suits filed in the U.S. are ‘without merit.’”

That’s funny, since I actually read the Harvard study on medical malpractice, and it said:

The researchers analyzed past malpractice claims to judge the volume of meritless lawsuits and determine their outcomes. Their findings suggest that portraits of a malpractice system riddled with frivolous lawsuits are overblown. Although nearly one third of claims lacked clear-cut evidence of medical error, most of these suits did not receive compensation. In fact, the number of meritorious claims that did not get paid was actually larger than the group of meritless claims that were paid. …

“Some critics have suggested that the malpractice system is inundated with groundless lawsuits, and that whether a plaintiff recovers money is like a random ‘lottery,’ virtually unrelated to whether the claim has merit,” said lead author David Studdert, associate professor of law and public health at HSPH. “These findings cast doubt on that view by showing that most malpractice claims involve medical error and serious injury, and that claims with merit are far more likely to be paid than claims without merit.”

Most claims (72%) that did not involve error did not receive compensation. When they did, the payments were lower, on average, than payments for claims that did involve error ($313,205 vs. $521,560). Among claims that involved error, 73% received compensation.Overall, the malpractice system appears to be getting it right about three quarters of the time,” said Studdert. “That’s far from a perfect record, but it’s not bad, especially considering that questions of error and negligence can be complex.” The 27% of cases with outcomes that didn’t match their merit included claims that went unpaid even though the injury was caused by an error (16%); claims that were paid but did not involve error (10%); and claims that were paid but did not appear to involve a treatment-related injury (0.4%).

The title of the study’s own press release was “Study Casts Doubt on Claims That the Medical Malpractice System Is Plagued By Frivolous Lawsuits.” Who are you going to believe, a paid-for Congressman or your lying eyes?

The study did not find that 40% of medical malpractice lawsuits were without merit. The study found that one-quarter of medical malpractice victims did not recover compensation, while, at most, only one-tenth of successful claims involved injures not caused by medical malpractice — and the plaintiffs in those cases received far less than the plaintiffs who had injures which even a panel of doctors thought were caused by medical malpractice.

The system works imperfectly, but so does every system — including our medical system, which costs the economy a minimum of $20 billion just in treating medical (iatrogenic) injuries. When you recognize that our entire medical malpractice liability system costs under $5 billion a year, you realize that, all in all, our medical malpractice liability system is downright cheap, and is compensating victims of medical negligence for only a fraction of their damages.

Even if we put aside the fact that, for every dollar spent on compensating the victims of medical negligence, more than $5 dollars in damage was caused by medical negligence, it bears repeating that the overall costs of compensating injured patients is so small that it the medical malpractice liability system does not restrict access to health care. Similarly, malpractice lawsuits have not been shown to change of physician behavior — so-called “defense medicine” — even in high-risk, high-liability cases like obstetricians’ decisions to perform c-sections when the baby shows signs of fetal distress.

I could go on — like how Gingrey’s proposal of “non-economic caps” would slam the courthouse doors shut on all but a few injured patients, and even then only those patients who were earning high incomes when they were injured or died — but I think the burden of proof here should lie with the people, like Gingrey, saying there’s a “medical malpractice crisis.” So far, he can’t muster anything more than a lie about the Harvard study.


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Of the over one million people injured or killed annually by preventable medical malpractice, only a fraction have their claims reviewed by the legal system. We can’t be sure how small that fraction is — since the health care industry spends millions of dollars every year convincing Congress to frustrate error-reporting — but we know

Some of the largest cases involve medical malpractice cerebral palsy. A recent medical malpractice case from the bought-yourself-an-appeal department:

Citing multiple trial errors, a New Jersey appeals court has reversed an $18.9 million verdict against an obstetrician whose delay in ordering a Caesarean delivery a jury found to have caused cerebral palsy in

I’ve posted many times before about the economic realities of medical malpractice liability. Via The Pop Tort, a new study commissioned by the the Society of Actuaries has revealed the economic cost of medical malpractice in America:

SCHAUMBURG, Ill., (Aug. 9, 2010)–Findings from a new study released today estimate that measurable medical errors cost the U.S. economy $19.5 billion in 2008. Commissioned by the Society of Actuaries (SOA) and completed by consultants with Milliman, Inc., the report used claims data to provide an actuarially sound measurement of costs for avoidable medical injuries. Of the approximately $80 billion in costs associated with medical injuries, around 25 percent were the result of avoidable medical errors.

"This report highlights a singular opportunity for both improving the overall quality of care and reducing healthcare costs in this country," says Jim Toole, FSA, CERA, MAAA and managing director of MBA Actuaries, Inc. "Of the $19.5 billion in total costs, approximately $17 billion was the result of providing inpatient, outpatient and prescription drug services to individuals who were affected by medical errors. While this cost is staggering, it also highlights the need to reduce errors and improve quality and efficiency in American healthcare."

Medical errors are a significant source of lost healthcare funds every year. For example, the study found that $1.1 billion was from lost productivity due to related short-term disability claims, and $1.4 billion was lost from increased death rates among individuals who experienced medical errors. According to a recent SOA survey, which identified ways to bend the national healthcare cost curve, 87 percent of actuaries believe that reducing medical errors is an effective way to control healthcare cost trends for the commercial population, and 88 percent believe this to be true for the Medicare population.

"We used a conservative methodology and still found 1.5 million measureable medical errors occurred in 2008," says Jonathan Shreve, FSA, MAAA, consulting actuary for Milliman and co-author of the report. "This number includes only the errors that we could identify through claims data, so the total economic impact of medical errors is in fact greater than what we have reported."

(Emphases added.)

Compare that nearly $20 billion cost — a conservative estimate limited to the ascertainable economic harm, excluding any pain, suffering, embarrassment, humiliation, or mental anguish, caused by avoidable medical errors — to the mere $4.694 billion paid out to medical malpractice plaintiffs in 2008 (see Exhibit D).

That is to say, payouts to malpractice victims amount to less than one-quarter of the economic damage caused by the malpractice itself.

If someone told you that oil companies only paid twenty-three cents for every dollar of damage they negligently caused through avoidable oil spills, what would you say?

If someone told you that car, airplane or boat companies only paid twenty-three cents for every dollar of damage they negligently caused through defective designs and manufacturing, what would you say?

If someone told you that fast food companies only paid twenty-three cents for every dollar of damage they negligently caused through avoidable food poisoning, what would you say?

If someone told you that consumer appliance companies only paid twenty-three cents for every dollar of damage they negligently caused through electric shorts that caused fires, what would you say?

Would you say there was a liability "crisis" caused by an "explosion" of "frivolous" litigation?

Or would you say those companies weren’t living up to their responsibilities?


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