Mass Torts: State of the Art : Mass Torts Lawyer & Attorney : Vorys, Sater, Seymour & Pease Law Firm : Toxic Torts & Wrongful Death

In their paper "Benzene-induced mutational pattern in the tumour suppressor gene TP53 analysed by use of a functional assay, the functional analysis of separated alleles in yeast, in human lung cells" Billet et al hypothesize that benzene-induced leukemia is the result of one or more mutations in the tumor suppressor gene known as TP53. They then report on their efforts to identify mutations in TP53 caused by benzene or its metabolites. It turns out that of the mutations linked to benzene exposure it is those in which guanine is substituted for adenine (A>G) that produce a pattern similar to that seen in benzene-induced acute myelogenous leukemia.

The authors conclude by suggesting that such an A>G transition could be "a fingerprint of benzene" that might help identify cases of AML produced by very low levels of past benzene exposure.

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Law.com is reporting that Philadelphia juries have awarded a total of $103 million in punitive damages alone to two women in separate breast cancer product liability trials. The women claimed that hormone replacement therapy (HRT) was responsible for their subsequent development of breast cancer.

In light of the recent controversy over the use of Bayesian decision-making approaches to mammography and Pap testing in which probabilities of outcomes are estimated and benefits are then weighed against costs (including other bad outcomes) I thought it might be of interest to see if such an approach had been applied to HRT. Sure enough, "Bayesian Meta-analysis of Hormone Therapy and Mortality in Younger Postmenopausal Women" was just published in The American Journal of Medicine.

So what does it show? It shows that across a number of randomized controlled trials of HRT in postmenopausal women under 60 those women had a reduced overall mortality compared to those postmenopausal women under 60 who weren't on HRT.

As is often the case in these modern times science does not yield a cure but does allow one to pick one's poison as it were; not to avoid death but to influence the odds of whether you die of stroke instead of breast cancer.

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Articles published in the last several months raise the question whether microbes found in the gut are responsible for Parkinson's disease.  In September researchers published an article titled "The Second Brain and Parkinson's disease" in which they reviewed and elaborated on emerging evidence that the enteric nervous system and the microbes that in part constitute it may, be responsible for precipitating Parkinson's disease.   Another group published "Autoimmune Disease and risk for Parkinson disease" in which they failed to find support for the hypothesis that Parkinson's is an autoimmune disorder.  Most recently in Medical Hypotheses Mark Lyte's "The Microbial Organ in the Gut as a Driver of Homeostatsis and Disease" speculates that the microbes living in our guts along with the enteric nervous system form a sort of organism within an organism that when disrupted can lead to diseases such as Parkinson's.  For more on this unfolding understanding of the role of these microorganisms in our lives see "They Are What You Eat".

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Why is the rate of lung cancer among nonsmokers increasing? In this paper published in Experimental Lung Research the authors not only found measles virus antigens in 83% of non-small cell lung cancer cases, they found that infection with the virus resulted in an excess of a protein typically seen in excess among lung cancer patients.

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Over at TED.com you'll find an entertaining and enlightening lecture by Dan Gilbert, a professor of psychology at Harvard University.

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Here's a case report of pericardial mesothelioma arising twenty-four years after the patient was treated with radiation therapy to the mediastinum for nodular sclerosing Hodgkin's disease.

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The Subcommittee on Commerce, Trade, and Consumer Protection held a hearing titled, "Prioritizing Chemicals for Safety Determination," on Tuesday, November 17, 2009, in 2322 Rayburn House Office Building. The hearing examined the options for prioritizing chemicals for safety determinations in the event that the Committee amends the Toxic Substances Control Act (TSCA).

See the Energy and Commerce's website for the testimony that was given on Tuesday, Nov. 17, including testimony by the EPA.
 

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In two weeks, representatives from 192 countries will assemble in Copenhagen for the purpose of setting global limits on carbon emissions. COP15, the official name of the climate change summit, referencing the 15th Conference of the Parties under the United Nations Framework Convention on Climate Change (UNFCCC), consists of environmental ministers who meet annually. The goal of the Copenhagen summit is “to secure binding emissions targets and overcome the division between the developed and developing world.”  Apparently, despite high hopes among proponents, it appears unlikely that a deal will be reached this year.

World leaders have confirmed that time has run out to secure a legally binding agreement at the COP15.  However, the United States and Britain hope to at least hammer out an outline of  the commitments to be put in place rather than postpone the formulation of a plan for an entire year.

So what's behind the delay?  Certainly the global economic turmoil makes it difficult for politicians to agree to changes that would at least in the short term cause even further job dislocations.  More significant perhaps is an apparent waning of public interest in the issue of global warming/climate change.

Recent polling has shown a marked decrease in both the belief that climate change is occurring and that such change is due to human agency.   What's behind this significant change in public opinion?  Over at Yale Environment 360 you'll find an excellent article addressing the concern that years of increasingly dire climate predictions have resulted not in more widespread and more confidently held belief in human-caused climate change but rather "apocalypse fatigue".

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The New York Times is reporting early this morning that a panel of the American College of Obstetricians and Gynecologists is recommending: a) that women not be tested until 21; b) that beginning at 30, and assuming three consecutive negative test results, screenings be reduced from every year to every third year; and, c) that testing can end altogether after age 65 with three straight tests without an abnormality in the last ten years.

First the PSA test, then mammograms and now Pap tests. An appreciation of the limitations of these tests, combined with the realization that many of the lesions detected by them never posed a risk, is responsible for this seismic-seeming shift. Changing a decades-long culture of screening early and often to catch cancer "when it's treatable" won't be easy and, as is apparent from the mammography fracas, won't happen without a fight.

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This evening a Broward Circuit Court jury rendered a mega verdict against Philip Morris USA consisting of $56.6 million in past and future medicals plus another $244 million in punitives for good measure. The plaintiff is a 61 year old wheelchair-bound emphysema sufferer.

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We ended yesterday's post by promising to show you how to more easily understand the debate over breast cancer screening.  Here's a handy way to calculate odds like the ones being discussed in the breast cancer debate. 

First, let's start with another test. Assume the following:

a) The accuracy rate of mammography is 95%

b) The false positive rate for mammography is only 3%

c) Only 1% of women over 50 have breast cancer

d) A woman over 50 has a positive mammogram
 
Question:  What are the odds that she actually has breast cancer?
 
Before we give you the answer let's talk a little bit about percentages.  First most people think they understand them, second they don't, and third even when they do most people tend to have a very difficult time reaching the right answer to a question like the one above.  On the other hand, people tend to do better when dealing with rates or frequencies.  So before we introduce you to Bayes' theorem (not today) let's try solving the question using rates.

If 1% of women over 50 have breast cancer that means that out of 10,000 women 100 of them will have breast cancer.  If all 10,000 women are screened by mammography and the accuracy rate is 95% then the test will detect 95 of the 100 cases.

However, if all 10,000 women are screened and the false positive rate is 3% then, of the 9,900 who don't have breast cancer, 297 (3% x 9,900) of them will have a mammogram indicating that they do have breast cancer.

The total number of positive mammograms thus equals the 95 who actually have breast cancer and whose cancers were detected plus the 297 who don't have breast cancer but who had a positive mammogram for a total of 392 possible cases of breast cancer.  So, if only 95 of the 392 women with positive mammograms actually have breast cancer what are the odds that your hypothetical patient is one of them?

Well, 95 is only 24% of 392 (95 / 392) - slightly less than a one in four chance that she actually has breast cancer.  So how did you do?

Risk is hard because it's counter-intuitive.  Comparing percentages is inevitably an apples to oranges trap.  Instead of thinking that a 95% accuracy rate is really high and 3% false positive rate is really low, maybe try asking yourself whether you'd rather have 95% of $100 or 3% of $10,000.

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The controversy over new breast cancer screening guidelines continues unabated today. There are already more than one thousand comments and letters to the editor addressing the issue at The New York Times alone.

Especially interesting are the statements from some of the physicians in both the articles and the comments. Many express a degree of confidence in the ability of mammograms to detect cancer well beyond what the literature would justify. How typical then is this discrepancy between medical opinion and what the numbers actually reveal? Quite.

Here's a test given to a group of obstetricians from a study published in 2006 :

There's a blood test available that can detect Down's syndrome in the fetuses of pregnant women. If the baby has Down's syndrome there's a 90% chance the test will catch it. The test has a false positive rate of only 1%. Just 1 in 100 fetuses are likely to have Down's syndrome. A pregnant woman walks into your office; she's had the blood test and it's positive for Down's syndrome. What advice do you give her about whether or not her baby actually has Down's syndrome?

Fifty seven percent of obstetricians got it wrong. Of those who got it wrong most got it spectacularly wrong, putting the odds of the baby having Down's syndrome at anywhere from 80% to 100%. And those who were most wrong were the most confident that their diagnosis was correct.

In fact the odds are (52.4%) that the woman's baby DOESN'T have Down's syndrome. Think about what advice that woman would probably get. That's a very real and chilling example of the inadvertent harm inflicted on women by doctors who put too much faith in even the most accurate diagnostic tests.

Want a handy way to figure out the odds in such cases? More on that tomorrow.

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Americans are exposed to seven times as much radiation from diagnostic scans as we were in 1980 according to the National Council on Radiation Protection and Measurement. Now Reuters is reporting that a typical heart attack patient receives a radiation dose equivalent to 725 chest X-rays over the course of his or her treatment. That cumulative dose is made of up X-rays, angiograms and CT scans received throughout the patient's care.

While the doses are nonetheless small and the risk therefore de minimis one has to wonder whether or not our fondness for exotic and expensive diagnositic procedures won't ultimately run afoul of the law of unintended consequences.

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Gina Kolata at The New York Times is reporting on new breast cancer screening recommendations by the United States Preventive Services Task Force. They are: a) routine mammograms for most women shouldn't begin until 50; b) even then they should occur only every two years; c) they shouldn't continue past 74; and, d) self examination is of no benefit and should be discontinued. The recommendations are based on analyses of a series of studies showing the cost (including the physical and emotional harm done to women overtreated due to false positives and unalterable cancers) of mass yearly screenings far outweighs the benefits.

That these recommendations will provoke a fight is obvious. But which side will prevail? In one corner: the probabilities and statistics. In the other: our beliefs, hopes, fears and intuitions. If this were Texas Hold 'Em we'd know which side would win. But this is breast cancer and so one side comes with all the psychological, sociological and political weight that tends to make many people poor judges of fights like this.

Expect a litany of logical fallacies, from supporters on both sides, in the comments section - chief among which, sadly, will be of the ad hominem variety. 

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Why is our blog subtitled "State of the Art"? For several reasons; chief among which is our fascination with the effect on mass tort litigation of our error-inducing mental shortcut responsible for what is called hindsight bias.

It turns out that mass tort defendants' claims of "I didn't know" or "I couldn't possibly have known" not only tend to fail but tend to backfire. Plaintiffs' counsel have learned how to exploit our tendency to Monday morning quarterback other peoples' decisions and now hindsight bias has become a problem in every mass tort case. Unwary defendants risk having "I couldn't possibly have known" turned into a belief that "they had to have known and thus their failure to act is evidence of gross neglect."

What is the hindsight bias? Here's an excellent introduction.

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We've written before about the dawning realization that the microbes that live in and on us can have a surprising degree of control over our lives. Today we learn that what we eat may control which microbes we host and whether we get fat or stay lean.

In a news release from Washington University titled "Junk food binge alters community of microbes in the gut in less than a day" researchers report that high fat / high sugar diets shift the distribution of bacteria in the intestines towards those bacteria which are exceedingly efficient at extracting calories from food. These super efficient microbes, once transplanted, could then cause weight gain and obesity even in mice fed a low-fat, plant-based diet. The shift towards the super efficient microbes occurred just 18 to 20 hours after the consumption of fatty/sugary foods. 

Finally, gut microbes were demonstrated to be capable of being passed from mother to offspring.

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A study published last week in Occupational and Environmental Medicine estimated exposures to asbestos fibers of specific sizes of workers exposed to chrysotile using data from transmission electron microscopy (TEM) and investigated the extent to which the risk of lung cancer varies with fiber length and diameter. The study used a cohort of 3803 workers that were employed from January of 1950 and December of 1973 in manufacturing asbestos textile products. Workers’ exposures to asbestos fibers were estimated from work histories and over 3500 industrial hygiene measurements.

Fiber length and diameter were significantly associated with an increasing risk of lung cancer. Exposures to longer and thinner fibers tended to be most strongly associated with lung cancer. The results supported the investigators hypothesis that the risk of lung cancer among workers exposed to chrysotile asbestos increases with exposure to longer fibers.

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When preparing for a jury trial, lawyers are more often focused on what to say rather than how they look when they say it. A recent study on human brain function and its interpretation of the words and gestures, reminds us that the gestures you make before a jury are as equally important as the words you say.

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A recently published study in Occupational and Environmental Medicine reanalyzed the results of a 1991 investigation conducted by NIOSH of 1749 workers potentially exposed to o-toluidine and aniline at a chemical manufacturing plant and the incidence of bladder cancer. In the reanalysis, the investigators used updated exposure categories based on additional information ascertained through plant visits, employee interviews, documents, and answers provided by company and union officials on specific questions. Increased risks of bladder cancer were observed the longer the exposed employee worked at the facility and the longer the latency period from the date the employee initially worked in a department in which exposure occurred.

The investigators concluded that the findings were comparable to the results reported in 1991 by NIOSH that workers at the plant have an increased risk of bladder cancer.
 

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In a study just published in the Oxford Journal of Toxicological Sciences the authors report that  bisphenol A (BPA) produced no sexual developmental disorders in the laboratory animals  tested.  Pregnant rats were exposed to very low to low doses of BPA and their offspring were studied for any signs of sex morphology disruptions.  The study was funded and conducted by Reproductive Toxicology Branch of the EPA.

Interestingly, ethinyl estradiol on the other hand even at very low doses produced numerous reproductive morphological disruptions.  Ethinyl estradiol is a form of estrogen used in almost all modern formulations of the Pill.

The National Institute of Environmental Health Sciences has announced a $30 million, two-year research effort to study the health effects of exposure to bisphenol A (BPA).  The funds for this effort were appropriated to the NIEHS as part of the American Recovery and Reinvestment Act.
BPA is an organic compound that is used in the production of polycarbonate plastics and epoxy resins. According to NIEHS’ press release in “2008, NTP [National Toxicology Program] and NIEHS concluded that there is evidence from animal studies that BPA may be causing adverse effects.” The press release continues that the “innovative two-year grants provided through the Recovery Act will support human and animal studies that address many of the research gaps identified by expert scientific panels, and provide a better understanding of how this chemical may impact human health.”
 

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Here’s some good advice about what to do when your opponent makes numerous arguments for ruling against your client. The short version is of course don’t take the bait because, as Perelman advises, the very act of acknowledging an argument is tantamount to telling your jurors that it’s worthy of their consideration.

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In Missouri Pacific Railroad v. Patricia Limmer, et al., the Texas Supreme Court held that state law tort liability for inadequate warnings was preempted when the railroad crossing improvements were federally funded because federal regulations specify what warning devices should be used.

After her husband was killed at a railroad crossing, Patricia Limmer and her two daughters brought a wrongful death action against the railroad company that maintained the crossing. The Limmers alleged that the crossbucks (black-and-white, X-shaped signs that read “RAILROAD CROSSING”) provided inadequate warning for the railroad crossing and that the railroad was negligent in failing to remove a gravel pile and vegetation that restricted drivers’ view of approaching trains. The railroad contended that Limmers’ claims were expressly preempted by the Federal Railroad Safety Act (FRSA) of 1970. The trial court concluded that federal regulations did not apply and a trial on the merits resulted in a $5.1 million verdict in favor of the Limmers, which the court of appeals affirmed.

On a petition for review, the Texas Supreme Court determined that when railroad crossing improvements were federally funded, federal regulations specify what warning devices should be used, and the United States Supreme Court had held that section 20106 of FRSA expressly preempted state tort law actions challenging the adequacy of these devices (Norfolk Southern Ry. v. Shanklin, 526 U.S. 344 (2000)). Similarly, the Limmers’ sight-restriction claim was preempted as it was simply a restatement of their claim that the warning at the crossing was inadequate. Accordingly, the court reversed the court of appeals and rendered a take nothing judgment.
 

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The New York Times is reporting on this study by Crider KS et al. in November’s Archives of Pediatrics and Adolescent Medicine which appears to demonstrate an association between certain antibiotics taken for urinary tract infections (used just prior to pregnancy or during the first trimester of gestation) and several common birth defects.

The antibiotics associated with the most pronounced increases in birth defects were  nitrofurantoin and the sulfonamides. Caution is in order when interpreting these results. First, it appears that the exposures were extrapolated from memory rather than measured quantitatively. Questionnaire epidemiology is notoriously prone to error. Second, there’s the question of where does the arrow of causal suspicion point. Maybe it’s the infection that’s responsible for the birth defects. Finally, this particular cohort would not appear to be a cross section of pregnant American women but instead is drawn from a narrower slice and is significantly homogeneous. Social structures and interactions are increasingly recognized as important independent causes of certain morbidities.
 

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