Life-Threatening Baby Slings Sold In Massachusetts Recalled

The Consumer Product Safety Commission, in cooperation with Infantino, LLC, issued a recall on March 24, 2010 of two models of baby slings that have caused at least three infants to fatally suffocate.
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The models – “SlingRider” and “Wendy Bellissimo” – were sold from January 2003 through March 2010 at Walmart, Burlington Coat Factory, Target, Babies “R” US, BJ’s Wholesale and other retailers.
The slings pose two distinct risks of suffocation to infants who are carried in them. Some infants may suffocate when the sling curls the baby’s body, bending the baby’s chin to her chest, thus constricting the baby’s airway. Additionally, a baby whose mouth or nose is pressed up against the sling’s fabric may be unable to breathe.
Parents should immediately discontinue using the baby sling and make sure that it is not re-sold or given to others. Thank you to personal injury lawyer Bob Kraft for alerting me to this serious recall.

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Massachusetts Man Wins $1.5 Million In Table Saw Case

table_saw_product_liability.jpgIn a recent Boston Globe article, reporter Jenn Abelson covered a $1.5 million jury verdict in favor of a Malden man, Carlos Osorio, in a products liability action against a table saw manufacturer that claimed the saw was defective because it was not equipped with “flesh detection technology” that would have caused the blade to stop when it got too close to human flesh. Yes, such “flesh detection technology” does exist and is quite effective.
Flesh detection technology is just another example of a safety device that would probably not exist if there were no products liability lawyers to force manufacturers to internalize the costs that society incurs through the use of dangerous and defective products. Table saws without such safety technology are cheaper. Most table saws are probably purchased and used by construction companies, who generally can’t be sued by their employees because of Worker’s Compensation technology. Do you think construction companies would be willing to shell out extra for a premium model? It seems unlikely. But manufacturers sell saws equipped with flesh detection technology because it’s cheaper to offer safety technology than to pay up in lawsuits.
A couple generations ago, products liability lawyers were the ones who got manufacturers to adopt safety guards and other “bells and whistles.”
If you see a lawyer today, give her a hug. She may have saved your fingers from being sawed off.

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Link Roundup (Week Of 3/22/10)

Dallas personal injury lawyer Bob Kraft (I assure you, he’s a totally different guy than the Bob Kraft we New Englanders tend to think of, not to mention a much better lawyer than the other Kraft) and New York medical malpractice lawyer Eric Turkewitz had good posts this week on how the new health care laws will affect typical patients and personal injury victims.
You should also check out David Bernstein’s post over at The Volokh Conspiracy about a recent Ninth Circuit Court of Appeals opinion about expert evidence in a medical malpractice case.
Lastly, the Wall Street Journal’s law blog has a poignant post about the death of Tony Torosian, a Boston man who was no stranger to the courthouse galleries around the city. Rest in peace, Tony.

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Journal Article Reveals Undisclosed Conflicts Of Interest In Avandia Studies

Professor Alberto Bernabe’s Torts blog has a good round-up of the recent coverage of a British Medical Journal article revealing undisclosed financial ties between researchers who discounted a link between the diabetes drug and heart attacks and the drug’s maker, GlaxoSmithKline.
In 2007, the FDA issued a warning that Avandia may elevate a patient’s risks for a heart attack. Since that time, more than 200 scholarly articles have been published. In about 90 of those articles, the authors had a financial interest in Avandia. However, one-quarter of the time when authors had a financial conflict of interest, they did not disclose the conflict.
And in fourteen percent of the articles, the authors stated that they had no conflict of interest, when in fact, the authors of this new article say they did.
The authors of this new British Medical Journal say that the number of Avandia researchers who disclosed their conflicts of interest was “unexpectedly low.” They also found that 94 percent of researchers who had positive opinions of Avandia received industry funding.

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Plaintiff Loses In First Seroquel Trial To Go To Jury Verdict

It’s been reported that the first Seroquel trial to go to jury verdict anywhere in the country has resulted in a loss for the plaintiff, with jurors voting 7-1 on Wednesday that AstraZeneca, Seroquel’s manufacturer, adequately warned the plaintiff’s doctors about Seroquel’s putting the plaintiff at an elevated risk for diabetes.
Seroquel is a pharmaceutical most often used to treat patients for bipolar disorder, schizophrenia or other mental illnesses, but is frequently also prescribed as a sedative and as a treatment for restless leg syndrome. Seroquel is AstraZeneca’s second-biggest selling drug.
A number of people prescribed Seroquel have filed lawsuits against AstraZeneca, claiming that the drug maker failed to warn adequately that the drug can lead to diabetes and pancreatitis.
The Seroquel lawsuits filed in federal court have all been consolidated into a single class action, however, individual lawsuits have proceeded in various state courts. This Seroquel defense action was one such case; it was filed on behalf of a single plaintiff in New Jersey.
It should be noted that verdict does not mean that the jury found that Seroquel does not cause diabetes. What the jury was simply supposed to consider was the question of whether AstraZeneca, Seroquel’s makers, adequately warned the patient’s doctors of the risks in the materials they provided the doctors.
In October of 2009, AstraZeneca settled two whistleblower lawsuits about Seroquel for $520 million and agreed to enter into a “Corporate Integrity” agreement with the United States Department of Justice. The allegations raised by the company’s internal whistleblower concern clinical trials of Seroquel but are otherwise confidential. Should the details of these cases also become public, we will report on that. In the meantime, we will keep you posted as these Seroquel cases reach jury verdict in other states.

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The Checklist Manifesto: How To Get Things Right (A Book Review)

bn_checklist_manifesto_medical_malpractice.JPGMedicine has made amazing advances over the past century. At the beginning of the century, doctors killed more patients than they saved. We’ve only known the that hypertension, smoking, diabetes and cholesterol contribute to heart disease for a few decades, yet we’ve made incredible strides in treating heart disease.
How have our doctors changed in response to the changes in medicine? By becoming more and more of a professional class. At the beginning of the twentieth century, you only had to have a high-school diploma and a one-year medical degree if you wanted to be a doctor. Now you need a college degree, a four-year medical degree, an additional three to seven years of residency training (where you work eighty plus hours a week in a clinical setting), and, in recent years, many young doctors have started capping off their formal training with a one- to three-year fellowship.
Today’s doctors are orders of magnitude better-trained and better-educated than their counterparts from a century ago. But despite this enhanced training, knowledge and expertise, doctors and other medical professionals continue to commit an astonishing number of routine medical errors. For every patient in an Intensive Care Unit, doctors and nurses perform an average of 178 actions a day – and commit an average of one to two mistakes per day in their treatment. So-called “line infections” – easily preventable bacterial contamination of IV lines – affect eighty thousand patients a year in the United States and are fatal between five and twenty-eight percent of the time. Virtually all central line infections could be avoided if doctors and nurses followed the simple five-step procedure for putting in a central line, but studies show that at least one-third of the time, one of the steps gets skipped.
Is there anything we can do to reduce the rate of medical error – a rate that doesn’t seem to be much improved from decades past? Dr. Atul Gawande, a favorite of this blog, proposes one such solution in his new book: The Checklist Manifesto: How To Get Things Right. And the answer, as his title suggests, is simple: have doctors and medical professionals adopt checklists.
As seen in the TV interview below, Dr. Gawande suggests that we’re at our “B-17 moment” when it comes to medicine. He is referring to a 1935 test flight of Boeing Model 299 (later known as the B-17 Flying Fortress). The plane had four-engines, a 103-foot wingspan and was light years more sophisticated than what the Wright Brothers flew at Kittyhawk three decades earlier. On its first test flight, the B-17 crashed and burned. Newspapers proclaimed that it was “too much airplane” for man to fly.
What Dr. Gawande finds most interesting about the Boeing engineers’ reaction is is what they did not do. They did not suggest that the chief pilot undergo longer and more intensive training before getting in the cockpit. (They did not add another year to medical school). Instead, Boeing a set of checklists for the pilots. Flaps down, check. Rudder straight, check. And the rest is history: planes are bigger and more complex than ever, but very safe to fly.
In 2006, the World Health Organization (WHO) reached out to Dr. Gawande for his assistance in developing a global program to reduce avoidable deaths and harm from surgery. Dr. Gawande understood that the program could not be an ivory tower one. Surgeons in Tanzania or in India did not have the same resources that he had in Boston.
The solution that Dr. Gawande and his colleagues eventually hit upon was a low-cost one that drew upon the insights of those early Boeing engineers and some pioneering work by Johns Hopkins researcher Dr. Peter Pronovost: it was (as you’ve guessed) checklists.
The end result of the WHO project was a nineteen-step checklist that, in a worldwide pilot study, reduced deaths by 47 percent and major complications by 36 percent. There are some signs that the checklist is catching on. Lord Darzi and Sir Liam Donaldson of Britain’s National Health Service are attempting to implement it throughout Britain. But only twenty percent of American hospitals have adopted it.
When I was reading Gawande’s book, I couldn’t help but think that an analogy to another era of aviation might better capture where medicine is today (an allusion that Gawande eventually makes in his final chapter “The Hero In The Age of Checklists”). Rather than American medicine being at its “B-17″ moment, I think perhaps it is in its “Right Stuff” -era, the era of the early space program, as chronicled by Tom Wolfe in his eponymous book.
As Wolfe tells it, the early astronaut corps drew from the ranks of the country’s finest test pilots. They were a high-testosterone group with an undeniable swagger, culled from the military’s ranks on the basis of their superior reflexes, their astonishing visual acuity and their overall physical fitness. In short, they were an elite who believed they possessed The Right Stuff, the qualities necessary for successful flight.
Yet, when their version of The Right Stuff wasn’t needed for the space program – when the space program didn’t need their reflexes or their vision – (the astronauts were just basically men strapped to a rocket they couldn’t steer or control; chimpanzees had served the same purpose in earlier flights) – the astronauts rebelled and insisted that the spacecraft be fitted with functionless windows and manual overrides that actually made space travel less safe.
Doctors too are undoubtedly believers in the cult of The Right Stuff. Not everyone has what it takes to be a doctor. I certainly don’t. In reading one passage in “The Checklist Manifesto,” about a patient’s intestines bulging in and out of his open abdomen with each CPR chest compression, I nearly gagged as I visualized the scene.
But now, doctors’ belief in The Right Stuff – the idea that they are an elite whose work requires an autonomy commensurate to their expertise – may be endangering patients. It seems that doctors should be doing more checklist-following and less aerobatics.
Following checklists can be valuable for several reasons. First of all, checklists are obviously a valuable aid to fallible human memories. But, as Gawande suggests, checklists’ effectiveness might also lie in the fact that they take doctors down off their pedestal and make the hospital more democratic. (Checklists open up a space for nurses and other non-MDs to speak their minds and provide the surgeon with important information and warnings).
This thesis – that the importance of checklists lies not in their aids to memory – but in their undermining hierarchy, receives some endorsement from Gawande but surprisingly little critical analysis from him. The idea that checklists succeed by undermining hierarchical command structures seems especially important to me in light of another anecdote from aviation history – one that I came across in Malcolm Gladwell’s book Outliers. In the early 1980s, Korea Airlines (KAL) was, by far, the world’s least safe airway. Its crash rate was startling.
Yet, from all outward appearances, KAL was a first-rate airline. It had top-notch equipment and pilots with years of experience who trained at the same facilities as other pilots worldwide.
An American executive eventually took over KAL and discovered the problem that lay at the heart of KAL’s troubles: the authoritarian relationship between the pilot and his crew. Co-pilots bowed to their pilots, made them tea and carried their luggage.
This culture led to co-pilots and others fearing to speak up and provide the chief pilots with important information, ultimately causing disastrous consequences. Gladwell reviews the black box tape of one crash where a deferential co-pilot fails to set a pilot straight on an error, resulting a crash into a mountainside. When KAL instituted new policies, including abolishing the bowing to the pilot, KAL’s safety record became exceptional.
Gawande relates one anecdote about being in an Operating Room and watching a surgeon order a surgical resident who dared to question him to go stand in the corner until he “felt sorry.” It may be that the single best thing we can do to reduce the incidence of medical malpractice is to rid the medical community of doctors like that surgeon, who embody the mentality of The Right Stuff, and replace them with ego-less checklist technicians.
I may blog one later post about a sort of philosophical premise of “The Checklist Manifesto”: the idea that the world, or at least the human body, is irreducibly complex and therefore we cannot always checklist or flowchart our way to proper diagnosis or treatment. I may challenge that idea in a later blog. Until then, you can hear a good summary of the book from Atul Gawande himself in this excerpt from The Daily Show:

The Daily Show With Jon Stewart Mon – Thurs 11p / 10c
Atul Gawande
www.thedailyshow.com
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On Uncontrolled Acceleration And Black Boxes

Last week, big business shill Theodore H. Frank wrote an op-ed drawing on data from a Los Angeles Times article reviewing the fifty-six fatalities attributed to sudden uncontrolled acceleration problems with Toyotas. Frank noted that, in about half of the car crashes, the driver’s age could be ascertained from the LAT‘s compilation and the ages of the drivers skewed to the elderly.
The next day, blogger Megan McArdle tracked down the ages of “all but a couple” of the drivers involved in the Toyota crashes and revealed that the “overwhelming majority” were over fifty-five years old.
A lot of people have hypothesized that the sudden uncontrolled acceleration accidents involving Toyota might be caused by a computer or electronic bug in the cars’ throttle. Since there’s no reason to believe that Toyotas with a computer bugs would discriminate against older drivers, Frank and a host of other bloggers* trumpeted the results as proof that there is no electronic problem with Toyota’s computerized engines and that, in fact, the blame lay with older drivers’ driving skills (or lack thereof). (Question(s): McArdle used a cutoff age of 55 and up. Are 55 year olds, in today’s world, frail or senescent? Most research does not show a significant decline in driving ability until a couple of decades after 55 and I know many people in their sixties who are in far better physical shape than I am. What would her findings have been if she included only drivers 70 and up?).
Ted Frank and a bunch of his colleagues from the (shallow end of the) think tank business used the findings to question the honesty of drivers who reported uncontrolled acceleration problems, likening them to frauds like “balloon boy.”
So what should we conclude? Should we conclude that the whole “Toyota panic” is merely a media-driven phenomenon about routine errors committed by all elderly drivers?
I don’t think so. As I blogged over a month ago, in 2009 forty-one percent of complaints of sudden uncontrolled acceleration involved Toyotas, while Toyota only held sixteen percent market share – a fact that was lost on a lot of people. Since the time I posted that blog, NPR’s Robert Benincasa did something that the government does not do - track reports of sudden uncontrolled acceleration by make and model – and found that, since 2002, Toyota has seen a troubling rise in complaints of sudden uncontrolled acceleration. The problem doesn’t seem to be old people and driving; the problem seems, if anything, to be old people and Toyotas specifically.
In addition, the “older driving theory” doesn’t account for the most spectacular Toyota crash of all – the (physically fit) California state trooper whose recorded conversation with a 911 operator details his efforts to get his Lexus to brake.
Ultimately, I think we – whether as consumers or jurors or simply concerned citizens – need to come to grips with the fact that there may be a problem with Toyotas that we may never directly explain. A lot of people have theorized that Toyota’s problems may lie with a computer bug inside its engines. (Competing explanations – floor mats, driver error, etc. – don’t seem to account for the disproportionate number of Toyotas involved in these crashes). If it’s the case that there’s a computer bug that plagues Toyotas, we may never find out precisely what it is and why, in some cases, it caused crashes. Toyota’s engines may forever remain to us a bit of a “black box” - a computerized system that we can’t see inside or fully understand.
People tend to assume that, if there’s a computer programming error, we can simply pore over the code and figure out if there’s an error. After all, computer programming is just logic and logic is supposed to be completely transparent. But, as science fiction writers like Isaac Asimov have shown us, you can start with a few logical principles that dictate the behavior of computers or robots and wind up with some completely unintended consequences.
We are all familiar with real life examples of this. One dramatic, and fairly recent example, was the Great Northeast Blackout of 2003 (which was caused in part by computers behaving in unexpected ways). Giant companies like Microsoft come out with products like Windows Vista that are so ridden with programming problems that they become unsalable.
Sometimes the bugs are never figured out. When a program that you’re running crashes, often the product’s designer has no reason why it crashed – that’s why, after the program returns to life, it asks you for permission to send a report to the manufacturer for analysis. My friends in computer programming tell me that, very often, software engineers are unable to untangle the reasons for these errors.
We may never get to the bottom of Toyota’s uncontrolled acceleration car crashes. But that does not mean the problem is not real. Or that Toyota should not be held accountable for its failure to investigate and address these issues.

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Proving Workplace Discrimination Through Circumstantial Evidence: A Review Of Thermo King

Claims for unlawful workplace discrimination are typically proven through two types of evidence: direct and circumstantial. Direct evidence is often referred to as “smoking gun” evidence where, for example, a company informs an employee that he or she is being terminated because of his or her age. Circumstantial evidence is much more subtle. As a great trial lawyer once said, “We better know there is a fire whence we see much smoke rising than we could know it by one or two witnesses swearing to it. The witnesses may commit perjury, but the smoke cannot.” Abraham Lincoln, Unsent Letter to J.R. Underwood and Henry Grider, October 26, 1864. Thus, in an age discrimination case, circumstantial evidence may take the form of an older employee (who is at least 40 years old) who is terminated without explanation.

This brings us to the case of Vélez v. Thermo King de Puerto Rico. There, the employer terminated a 56 year old employee without explanation. The company finally provided a reason for the termination after the employee filed a claim for age discrimination with the Equal Employment Opportunity Commission. The employer changed its reason thereafter. The First Circuit found the employer’s initial silence to constitute circumstantial evidence of discrimination:

Thermo King did not initially provide Vélez with any reason for firing him. One month later, Soto told the ADU and the EEOC that Vélez had been fired for violating the company’s policy on receiving gifts from suppliers. It was not until over a year later that Thermo King, responding to this lawsuit, first said that Vélez had been fired for stealing and selling company property. The fact that the employer gave different reasons at different times for its action surely supports a finding that the reason it ultimately settled on was fabricated.

In my interview with Massachusetts Lawyers Weekly, I discussed the significance of the Thermo King decision:

It appears to be the first time the 1st Circuit has held that an employer’s failure to articulate the reasons for a termination before litigation equals pretext for discrimination.

Our prediction is that the Thermo King decision will encourage more transparency. Employers are now incentivized to articulate a clear reason as to why an employee is being terminated from the outset or risk an inference of discriminatory motive.

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What Medical Malpractice Lawyers And Hedge Fund Managers Have In Common

bigshort_medical malpractice.jpgI’m currently reading Michael Lewis’ new book The Big Short: Inside The Doomsday Machine, about the subprime mortgage collapse. (Side note: while I was happy to see Sandra Bullock win an Oscar the other night for her role in the movie production of Lewis’ book The Blind Side, where was the Oscar nom for Tim McGraw, who was just great in his role as Sean Tuohy?).
One of the heroes of The Big Short is Dr. Michael Burry, a Stanford-trained neurologist who left the practice of medicine to manage a hedge fund called Scion Capital. Mike Burry was one of a handful of Wall Street-types who foresaw the collapse of the subprime market. What was it about Burry that enabled him to see what financial giants like AIG, Lehman Brothers, Bear Stearns and Merrill Lynch missed?
Lewis offers two of Burry’s personal traits as explanations. First, Burry lost one of his eyes as a child and the glass eye he wore as a replacement made it difficult for him to engage in normal eye contact in social situations and difficult for him to participate in team sports, imparting to him something of an outsider’s perspective.
Second, Burry, like Warren Buffet’s partner Charlie Munger (another guy with only one eye), had a preternatural ability to ferret out the hidden incentives that motivate people’s behavior. Even before he was in finance, back when he was a neurology resident, Dr. Burry spotted his colleagues’ tendency to act in their own financial best interests, rather than doing what was best for the patient.
Burry noticed:

“Even in life or death situations, doctors, nurses, and patients all responded to bad incentives. In hospitals in which the reimbursement rates for appendectomies ran higher, for instance, the surgeons removed more appendixes. The evolution of eye surgery was another great example. In the 1990s, the opthamologists were building careers on performing cataract procedures. They’d take half an hour or less, and yet Medicare would reimburse them $1,700 a pop. In the late 1990s, Medicare slashed reimbursement levels to around $450 a procedure, and the incomes of the surgically minded ophthalmologists fell. Across America, ophthalmologists rediscovered an obscure and risky procedure called radial keratomy, and there was a boom in surgery to correct small impairments of vision. The inadequately studied procedure was marketed as a cured for the suffering of contact lens wearers. ‘In reality,’ says Burry, ‘the incentive was to maintain their high, often one- to two-million dollar incomes, and the justification followed. The industry rushed to come up with something less dangerous than radial keratomy, and Lasik was eventually born.’”

What does any of this have to do with medical malpractice law? Well, as our country struggles to find a way to overhaul our dysfunctional health care system, people are casting about for ways to reduce health care costs. The Republicans and the tort reformers have proposed a one-size-fits-all answer: medical malpractice reform – making it harder for people to sue their doctors and capping their damages for pain-and-suffering.
The Republicans and the tort reformers say that fear of medical malpractice lawsuits has driven doctors to practice “defensive medicine” – ordering numerous unnecessary tests and procedures to protect them in case they get sued for medical malpractice.
What hedge fund managers and medical malpractice lawyers understand is that, very often, doctors aren’t running unnecessary tests and procedures because they fear medical malpractice lawsuits; they are, very often, whether consciously or not, ordering the tests and procedures because they are lucrative.
But don’t take my word for it. Take the word of a certified financial genius like Dr. Burry, who saw what virtually everyone else on Wall Street missed.
Now to plow through some of the other books on my nightstand, including Dr. Atul Gawande’s Checklist Manifesto.

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FDA To Investigate Link Between Osteoporosis Drugs And Femur Fractures

In response to research and media reports suggesting a link between a certain class of osteoporosis drugs – known as oral bisphosphonates – and femur fractures, the FDA announced yesterday that it is working with outside experts to insure that the osteoporosis drugs are safe.
Fosamax, Actonel, Boniva and Reclast are all oral bisphosphonates, the class of drugs under investigation. Some have claimed that long-term use of these drugs raises the risk of an unusual type of femur fracture just below the hip that is known as a subtrochantreric fracture.
The Wall Street Journal reports that two studies that were presented this week at the American Academy of Orthopaedic Surgeons’ annual meeting suggests that long-term use of Fosamax and Boniva (where “long-term” means four or more years of use) may lead to reduced “bone structural integrity.”
In 2008, the FDA warned that Fosamax had been lined to serious joint pain.
The FDA cautioned yesterday, however, that people taking oral bisphosphonates should not stop taking the drugs without first consulting with their physicians. At this point, the FDA believes that the benefits of Fosamax and the other oral bisphosphonates outweigh the potential risks that it is investigating.

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