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

In "Perinatal Exposure to Bisphenol-A and the Development of Metabolic Syndrome in CD-1 Mice", just published in the journal Endocrinology, researchers tested the claim that exposure to a typical dose of BPA (1ppb via diet) increases the risk of high-fat diet-induced obesity and glucose intolerance. The experimental data did not support the claim. Interestingly, the BPA-fed mice grew a bit quicker early in life but by adulthood were the same size and body composition as the mice not fed BPA.

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The New York Times reported today that EPA is adding Bisphenol-A (“BPA”) to its list of chemicals of concern. BPA is widely used in certain plastics, notably food packaging and baby bottles. New studies of concentrations of BPA in surface water, ground water and drinking water will be required. In addition, manufacturers using BPA in their products will be required to provide test data to help evaluate effects on growth, reproduction and development in aquatic organisms and wildlife.

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Sometimes mass tort litigation feels a lot like being in the movie "Groundhog Day". The names and the products may change from day to day but the plaintiffs', the true believers' and the media's overarching narrative is always some aspect of the one refined in the tobacco litigation. One such narrative goes towards abrogating personal responsibility and does so by purporting to show that a product is both irresistibly addictive and insidiously malignant.

Today's vignette is thanks to a (free) paper just published in Nature Neuroscience titled "Dopamine D2 Receptors in Addiction-Like Reward Dysfunction and Compulsive Eating in Obese Rats". In the study being reported eleven rats got their fill of "bacon, sausage, cheesecake, pound cake, frosting and chocolate", eleven others got to pig out on "bacon, sausage ..." but for only one hour per day while nine other rats got nothing but "rat chow". Shockingly, the rats stuck in a cage all day with nothing to do but eat pound cake with frosting put on weight.

Various permutations of the experiment were run including some involving IHC staining with fluorescent proteins so that the now obligatory brilliantly colored photomicrographs could be produced. Some other rats considering pigging out were "punished" with electric foot shocks while yet others had "stimulating" electrodes implanted in their brains and held in place by four stainless steel skull screws.

The pound cake with frosting didn't affect life expectancy since all the rats were sacrificed two weeks after their 40 day food odyssey. However, the researchers found evidence of classic addiction response whereby reward mechanisms (pound cake with frosting makes you happy) were gradually suppressed by the body as it tried to adjust to the good times and maintain homeostasis so that more and more pound cake with frosting was needed to reproduce the initial reward level. The rat chow rats and the one hour per day bingers on the other hand lived out their 54 days in much slimmer bodies and with the normal compliment of dopamine receptors implying that living in a cage and eating rat chow is not excessively rewarding.

The quote above from Gene-Jack Wang, M.D. was found at The Situationist in its write-up of the Nature Neuroscience article. He's also quoted as saying that purified modern food makes people eat "unconsciously" and animals "eat like a drug abuser [uses drugs]". Wang is said to be the chair of the medical department at the U.S. Department of Energy's Brookhaven National Laboratory.

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Apparently forty really is the new thirty. In several (free) reviews of the state of current knowledge on aging you'll read that life expectancy hasn't, contrary to popular opinion, reached any preset limit and that those who reach "old age" in good health (Americans, Swiss and Japanese, anyway) not only have a lot of life left ahead of them but the accretion of extra life is accelerating. In the paper "Biodemography of Human Ageing" there's an especially eye-popping graph showing the age at which remaining life expectancy is either five or ten years for women. American women lead Swiss women and look to be pulling away, almost going straight up, at a rate similar to Japanese women.

That all this extra life will bring profound political and economic changes almost goes without saying. In personal injury litigation some of the changes wrought by significantly increased life expectancies are already here.

When I got out of law school a good liability wrongful death cancer claim by the children of an eighty-something decedent might have settled for $50,000.00.Typically there would have been little in the way of medical bills, nothing in the way of lost wages and the adult children would have been thought lucky to have had their parents around for so long. At one point I collected all the awards to grown-up and on-their-own children (40+) in toxic tort wrongful death cases for several years here in Texas and the average was $30,000/child with a median of about $25,000.

Recently I was involved in a case in which the decedent had been making $150,000/yr at age 80, incurred over $300,000 in medical bills and the family had already collected more than $1,000,000.00 settlements. And a focus group, in another matter, when asked "to what age should people reasonably expect to live" collectively picked 85 as the magic number though almost half said the number should be 100. One hundred. And do you know what? A child born today has better than even odds of living to 100 according to the actuaries.

Not only are damages going up, people are dodging things like heart attacks and strokes that used to kill them at much younger ages and so are living long enough to develop diseases with extraordinarily long latent periods. Expect to see more, and more different kinds of latent disease litigation.

Finally there's the future. First though imagine you're in a Navy shipyard in 1941 and someone tells you that the material you're using might kill you when you're in your eighties. Since your life expectancy is sixty or so you might not be too alarmed. In fact, you might be relieved since the eighty somethings you know are woefully decrepit. Now come back to 2010 and imagine someone just told you that using a common and ubiquitous material may cause you to die, prematurely, of cancer ... at 125. What would you do? What should we do?

All of the articles about aging (or ageing - blame the Brits) are free (and excellent) in this month's Nature Insight. If you're daunted by the science try the podcast instead.

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See: "Hormone Therapy and Fatal Breast Cancer" finding no suggestive link between estrogen therapy and the risk of dying from breast cancer. Note that an increase in mortality from breast cancer among those taking both estrogen plus progestin could not be ruled out.

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In "Odds Are, It's Wrong", Tom Siegfried lays out the argument for the proposition that much of what you read in the scientific literature is wrong because many of the claims being made rely on statistical significance. You see, an impressive sounding statement like "the association between exposure and disease was highly significant (P<0.05)" does NOT mean (a) that there's a 95% chance that the association is causal; (b) that the absence of an association can almost certainly be ruled out; nor does it necessarily mean that (c) the finding is momentous, compelling or even important. It doesn't even say that if the test were to be repeated that its results would likely hold. A P-value, the arbitrary judge of "statistical significance", won't, and can't, have anything to say about the likelihood that a given hypothesis is or is not true.

The fact of the matter is that if you have a bunch of data and can't find at least one statistically significant association it in only proves one thing - that you're not trying hard enough. The magical P-value level of 0.05 is nothing but a trade-off; a balancing act between finding associations that don't exist (false positives) and missing true associations that do (false negatives). As a result, false associations are not only possible, they're guaranteed when you have enough data and slice it enough ways.

Now, lawyers are getting into the act. And while it's bad enough that "[a] lot of scientists don't understand statistics" (Steven Goodman quote from the "Odds Are, It's Wrong" article) it gets awful when lawyers try to deploy statistics to support or rebut claims. Law review articles are littered with claims resting on nothing more than small P-values. Some purport to show that certain appellate courts are biased against accident victims; others that tort reform is good for your health. And hardly a week goes by that I don't see a brief or a pleading asserting that Texas "jurisprudence" requires an epidemiological study with a risk ratio greater than 2 and a P<0.05 before a plaintiff can recover on a toxic tort claim. 

Apparently many lawyers, especially on the defense side, either forgot or never learned that it's easy to gin up false associations that meet the greater than 2 and less than 0.05 test. In fact, that's how most categories of toxic tort claims got started. Enshrining such a test in the law would turn out to be The Full Employment Act for toxic tort lawyers.

Causal inference from epidemiological statistical analysis is a crude method that nevertheless worked well for finding big effects like that of smoking on lung cancer risk and amphibole exposure on mesothelioma risk. On more subtle effects though, at the population level or molecular level, reliance on 20th century methods has produced so much bad science of late (bad only because statistics are routinely misused and abused and not because statistics aren't powerfully effective tools when properly used) that new methods of causal analysis are beginning to replace them. And these tools can answer the question of "how likely is it that drug A caused injury B?"

To see what the future of causal proof in toxic torts will look like read: "An Introduction to Causal Inference" by Judea Pearl.

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Does diet soda cause Type II diabetes? There are a couple of studies that suggest as much and now a hypothesis, yet to be tested, about how un-sugar could trigger a response to chronically too much sugar has emerged.

In "Stomach's Sweet Tooth" published online at ScienceNews the author considers the evidence for the proposition that artificial sweeteners essentially cause confusion in the body's metabolic processes by sending one signal via the tongue and another via previously unknown taste receptors in the stomach and intestines. How the release of various hormones and enzymes in response to the stomach and intestines "tasting" sugar when none is present might lead to diabetes or metabolic syndrome is unknown but apparently a large amount of research into the question is underway.

The long under-appreciated gut is now thought to be the largest hormone-releasing organ and the body's "second brain" with more neurons than than the spinal cord. And there's a new word for the study of this system: Neurogastroenterology. Neurogastroenterology?! We certainly live in interesting times.

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In a pair of decisions released on March 23, the Supreme Court of Ohio upheld RC 2745.01, which requires a showing of deliberate intent to make out a case of employment intentional tort for claims arising on and after April 7, 2005. This will make proof of employment intentional tort considerably more difficult in Ohio than under the prior standard, which required only a showing of knowledge of “substantial certainty” of injury. This ruling from the Supreme Court of Ohio is also notable in light of the Court’s prior decisions, striking down two prior tort reform efforts in this area. The two opinions, Stetter v. R.J. Corman Derailment Servs, LLC and Kaminsky v. Metal and Wire Prods Co., are available here.

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In the newest edition of the journal Cancer Causes and Control you'll find a paper titled "Endotoxin Exposure and Lung Cancer Risk: A Systematic Review and Meta-Analysis of the Published Literature on Agriculture and Cotton Textile Workers". The authors examined 28 studies of workers occupationally exposed to high levels of endotoxins and their risk of developing lung cancer. Previous studies had suggested acute and chronic lung conditions could be caused by endotoxins.

Interestingly, endotoxin exposure was consistently associated with a large and statistically significant decrease in lung cancer. Furthermore, the protective effect was strengthened as dose was increased.

Also this month, in Cancer Epidemiology, Biomarkers & Prevention, you'll find "Lower Risk of Lung Cancer After Multiple Pneumonia Diagnoses". It turns out that getting pneumonia three or more times is even better than high exposure to endotoxins if you want to avoid lung cancer.

What is it about these biological challenges to the lung that leads to significant anti-lung cancer protective effect? It's anyone's guess but perhaps keeping your immune system tuned up is part of the answer.

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“There are certain things only a government can do. And one of those things is ensuring that the foods we eat are safe and do not cause us harm.”  

That's a quote from President Obama that appears on the FDA's food safety website and is undoubtedly an indication of increasing federal regulation of food in the years to come.  It's expected that by May of this year a bill to modernize the FDA will become law.  Both the House and Senate versions of the bill require the establishment of a tracing system for contaminated food back to its source within two days.  While tagging foods so that they can be traced back to their source may be onerous for industrial-scale producers, for farmers' markets, truck farmers, and the whole locally grown / sustainability movement this requirement may prove to be crippling. 

The final bill will likely incorporate some sort of requirement for studies or pilot projects to determine the most effective and least expensive method of traceback and recordkeeping.  Any obligations eventually imposed won't become effective for eighteen months to three years.  Expect to see considerable debate about these provisions in the next couple months.

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That's the conclusion of just one of eight studies demonstrating the power of simplicity as summarized by Psyblog. ht Mindhacks

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A new review of available toxicological, mineralogical and epidemiological data pertaining to talc mined in northern New York by R T Vanderbilt shows no support for the claim that exposure to it causes mesothelioma. See: "Industrial-Grade Talc Exposure and the Risk of Mesothelioma" just published in Critical Reviews in Toxicology.

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The Texas Supreme Court has just decided another arbitration issue in the case of East Texas Salt Water Disposal Company, Inc. v. Werline, 53 Tex. Sup. Ct. J. 410 (Tex. 2010). This time it has further defined the limits of trial court’s ability to review arbitration decisions.

Werline was an employee of East Texas Salt Water Disposal. He had an employment contract that directed arbitration over any employment disputes. He also had a severance provision if he was terminated without cause. Werline’s employment ceased and he sought to enforce the severance provision. The parties proceeded to a three-day arbitration hearing in front of an AAA arbitrator. The arbitrator awarded in favor of Werline. East Texas Salt Water Disposal petitioned the district court to vacate, modify or correct the award on the basis that it was so against the great weight of the evidence that the arbitrator manifested bias.

The trial court vacated the award, determined all the material facts and issues in East Texas Salt Water Disposal’s favor and directed another arbitration to confirm the facts the court had found. Werline appealed and the court of appeals reversed and rendered in favor of Werline. East Texas Salt Water Disposal appealed, arguing that the court of appeals had no jurisdiction to hear the appeal.

The Supreme Court held that the court of appeals did have jurisdiction to hear the appeal from the trial court’s obviously erroneous decision.

The Texas Supreme Court then took the opportunity to remind the parties, once again, that there is limited trial court review of arbitration awards. The review is limited to the grounds expressly enumerated by Texas Arbitration Act section 171.098(a). In this way, the Texas Supreme Court’s decision is consistent with the United States Supreme Court’s decision in Hall Street v. Mattel, 128 S.Ct. 1396 (2008) decided recently on similar issues under the Federal Arbitration Act, which the TAA is modeled after.

Justice Jefferson, leading the dissent, argued that the limited issue presented on appeal, the appealability of the trial court’s order, should have been decided differently. He held that there was not sufficient finality in the trial court’s order to make it appealable. However, this is inconsistent with the purpose of the TAA to make arbitration faster and cheaper than litigation. As the Fifth Circuit stated recently in Citigroup Global Markets, Inc. v. Bacon, arbitration should be the end, not the beginning of the litigation. If the trial court’s order were not appealable, multiple arbitrations would have occurred based on reasons not listed in the statute.

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Yesterday, the federal judge that presided over the Garner v. BP trial issued a memorandum opinion and final judgment in which he ruled that gross negligence was not proven by clear and convincing evidence by plaintiffs as a matter of law. Judge Kenneth Hoyt’s opinion set aside all exemplary damages awarded by the jury in the first trial of ten plaintiffs that claimed injuries as a result of chemical release in 2007. Judge Hoyt’s opinion stated that plaintiffs failed to satisfy the objective test for gross negligence which requires a showing of an extreme risk of harm – “one that involves both high probability and high potential severity” of an occurrence. In addition, plaintiffs failed to demonstrate the requisite specific intent that showed BP ignored an obvious or known risk and took no precautions that would minimize or arrest the harm anticipated. According to Judge Hoyt, BP had implemented safety precautions which included monitors on workers and at various locations on the plant to detect the presence of toxic chemicals.

The judgment found that BP was responsible for the chemical release and permitted plaintiffs to recover actual damages which totaled $340,659.77.

Plaintiffs’ counsel Tony Buzbee told the Houston Chronicle that the first trial was “just a skirmish in the war.” Over 130 plaintiffs have pending claims in this litigation which remain to be tried.
 

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Read: "A Susceptibility Locus on Chromosome 6q Greatly Increases Lung Cancer Risk Among Light and Never Smokers". If you've got the gene your risk of lung cancer goes up nearly 500% even if you never smoke (in fact smoking only weakly increases your risk if you've got the gene). Interestingly, if you don't have the gene and you smoke your risk goes through the roof.

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"Tobacco smoking is responsible for one-third of the total cancer deaths among men." See "Estimation of Cancer Incidence and Mortality Attributable to Smoking in China". Secondary smoke exposure is said to be responsible for more than 11% of all cancer deaths in women.

Do you ever get the feeling that China is just going through what the U.S. went through in the 1960s, 1970s and 1980s when epidemiology and mass health panics were all the rage? If so, and if a "redistributional justice" model of tort law can be introduced in China, it may be deja vu all over again for classic mass tort litigation.

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See "Non-Occupational Exposure to Paint Fumes During Pregnancy and Fetal Growth in a General Population"

Though about half of the mothers surveyed said they'd been exposed to paint fumes in the home while they were pregnant the data suggested that the more fumes to which they'd remembered being exposed the lower the risk that their baby would be underweight. What? This study probably has more to say about the use of interview data as a proxy for exposure than it does about the relationship being examined.

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A greater than 40% decrease in Parkinson's if you smoke more than 30 years? So it seems from this huge NIEHS study of 305,468 Americans. "Smoking Duration, Intensity, and Risk of Parkinson Disease".

Obviously the risk of getting lung cancer, emphysema, etc from smoking is much higher. Still, if you knew you had the genes that protects you from lung disease (whatever they are) but not the ones that protect you from Parkinson's (whatever they are) would you smoke?

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According to "Occupational Factors and Risk of Parkinson's Disease: A Population-Based Case-Control Study" the risk of Parkinson's was not significantly affected by workplace exposures to  metals, solvents or pesticides.

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Even though cells drawn from a pleural effusion stain positive for calretinin and negative for CEA that doesn't mean the person has mesothelioma. Those mesothelial cells may be non-malignant yet still react to immunohistochemical stains used to identify malignant mesothelioma.

Is there a way to distinguish between malignant and merely reactive cells? According to a new paper in Cancer Cytopathology, "The Use of Immunohistochemistry to Distinguish Reactive Mesothelial Cells From Malignant Mesothelioma in Cytologic Effusions", a positive epithelial membrane antigen (EMA) stain coupled with a negative desmin stain strongly points to mesothelioma while the opposite pattern strongly suggests reactive mesothelial cells and not mesothelioma.

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If people with Type 2 diabetes are at a greatly increased risk of heart disease wouldn't it make sense to get their blood pressure and triglycerides down and their "good" cholesterol up? Quitting smoking and lowering "bad" cholesterol reduces the risk from very, very high to just very high so attacking these other presumed risk factors should help, right? Besides, pushing systolic blood pressure down closer to normal would obviously yield some benefits. And there's no way it could hurt. Right?

It turns out that these interventions, implemented on the basis of reasoning and not rigorous studies, either do no good, do no good and cause side effects, or do no good and increase the risk of heart attack by 50%. Be sure to read about the just published data and the reaction to it in an excellent write up by Gina Kolata in The New York Times.

How could this be? Well, what if the things everyone thinks are causes of heart disease in diabetics are really just other effects of the real cause? Or, and this is where it really gets scary, what if what everyone thinks is a cause in need of eradication is in fact part of the body's defense mechanism against the real cause? For a discussion about how obesity may be just such a protective mechanism see "One of the Scourges of Modern Life May Have Been Profoundly Misunderstood" in The Economist's Science and Technology section.

The takeaway from all this can be found in the first article. While these treatments seemed logical (and as noted in the article, at every meeting "some academic" would always be going on about how elevated blood sugar after a meal was dangerous and had to be lowered until eventually doctors had put thousands of people on these treatments) it turned out they were instead dangerous and ineffective. That'll always be the danger when we attempt to deduce solutions based on just the known variables of a complex and only partially understood system.

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In this recent article in JAMA(2010;303(10):943-950), the authors evaluate the impact of vaccinating children and adolescents on the incidence of influenza among non-vaccinated populations. They conclude that, if you vaccinate your children and teenagers, there is less disease among the rest of the population. Tell us something else that every parent already knew. Now, go wash your hands and come in to dinner.

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A Madison County jury rendered a defense verdict in an asbestos trial that ended Friday. Plaintiffs Larry and Meta Williams claimed he developed mesothelioma from his work with friction products that contained asbestos. The lone defendant at trial was Ford.

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Three more strikes against the claim that thimerosol causes autism spectrum disorders (ASD).

Mead v. Secretary of HHS

King v. Secretary of HHS

Dwyer v. Secretary of HHS (- the quote in the title can be found in this opinion)

Be sure to read the discussions of Petitioners' expert Sander Greenland and his opinions about the limits of epidemiology - at least on the "what it can't rule out" end of the spectrum. One wonders what his answer would have been if instead he'd been asked to formulate an "intervention policy" based on the same epidemiological studies - all of which show no association between thimerosol and ASD, and none of which show a "clearly regressive" subset of ASD. See "Epidemiologic Measures and Policy Formulations: Lessons From Potential Outcomes", by Sander Greenland, free online.

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Claims that bisphenol A causes hormone disruption have been refuted again and again by large, independent studies the results of which have been published in peer reviewed papers. Yet, based on nothing more than an uninspired theory (that estrogen-like molecules ought to do what estrogen does) and a few, small, poorly controlled studies the results of which can't be reliably reproduced elsewhere, the effort to ban a product that prevents bacteria from infecting much of the food you consume continues to accelerate. How could this be?

You can find Richard M. Sharpe's answer in "Is It Time to End Concerns over the Estrogenic Effects of Bisphenol A?" published in the journal Toxicological Sciences (free access!).

Like the autism/vaccine, limb reduction/Bendectin controversies the bisphenol A panic has spread like a virus. And if those past controversies are any guide it'll be several more years before civilization's immune response, empiricism, is able to bring us collectively back to our senses. In the meantime expect opportunistic infections to take advantage of the situation.

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There are more than 18 million articles in PubMed and more are added in a day than you could hope to analyze in a month. Surely if someone had the time to digest it all new associations and patterns would emerge suggesting new hypotheses and generating new knowledge. But how?

Here's an article available free at PLoS One setting out one possible solution : "A PubMed-Wide Associational Study of Infectious Diseases" In the paper, a sort of proof-of-concept effort, the authors demonstrate that by running focused text mining software (not just key word searches or tabulating rankings of key words) over more than half a million infectious disease articles they could not only uncover cumulative knowledge already confirmed but also generate new hypotheses from this "hidden public knowledge".

Be sure to have a look at the associational network maps in the article. Then imagine what hidden relationships you might find if you could run similar software over the two million documents just produced in your case and the great demonstratives you could generate to prove them.

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The FDA has reported on its ongoing safety review of oral bisphophonates and atypical subtrochanteric femur fractures. "Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these [Fosamax, Actonel, Boniva, Reclast] medications" "All available case reports and clinical trial data were requested. FDA's review of these data did not show an increase in this risk in women using these medications."

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In "On to a Fifth Age? How About We Finish the Second?" we discussed a JAMA editorial wherein Dr. Michael Gaziano asserted we may be entering a fifth age of the so-called epidemiologic transition. These transitions are claimed to be changes in the primary causes of morbidity and mortality and Dr. Gaziano opined that we are moving into an era in which obesity and inactivity will drive preventable illness. We discussed the origin of the idea of epidemiologic transitions and questioned  whether we'd ever finished the second age which would have required the conquest of infectious diseases.

The so-called third age was supposed to be the "age of degenerative and man-made diseases" but it keeps turning out that many illnesses thought to be due to wear and tear, lifestyle or pollutants actually have an infectious disease process at their core. Now there's growing evidence that coronary heart diseases (CHD) may in many cases have more to do with a number of infections, including influenza, than with lifestyle or the environment.

Here's a link to a letter published in the Reflections section of The Lancet: Infectious Diseases that nicely summarizes the pre-1970 thinking that pointed to infections as the cause of CHD, the subsequent predominating narrative of chronic diseases not being caused by infections, and the new evidence that chronic diseases are in fact often caused by previously undetected infectious processes: "Inflammation as the Cause of Coronary Heart Disease". And here's a link to a written debate about "this nascent field associating chronic diseases with infections" from 2002 with the author of the recent Lancet paper cited above: "Debate on the Paper by Maria Ines Reinert Azambuja & Bruce B. Duncan".

Given the enormous renewed interest in infections as a possible cause of chronic illness and the ease with which scientists can now find traces of bacterial, fungal and viral DNA (or RNA) at the scene of the suspected microbial crime it's fair to assume that we'll be seeing many more such stories in the future.

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Yesterday the U.S. Supreme Court granted a petition for writ of certiorari in Bruesewitz v. Wyeth, Inc. and will review the Third Circuit’s holding that a plaintiffs’ design defect claims against the manufacturer of a vaccination were expressly preempted by the 1986 National Childhood Vaccination Injury Act (“NCVIA”) and that plaintiffs failed to establish a manufacturing defect or a warning defect claim under the Act.

In a footnote in the Bruesewitz opinion the Third Circuit had distinguished the Supreme Court’s opinion in Wyeth v. Levine in which the Court held that federal law did not preempt state tort claims that alleged that a drug manufacturer failed to adequately warn of the dangers associated with a drug on the basis that unlike the NCVIA, there was no express preemption provision in the Food, Drug, and Cosmetic Act (“FDCA”). Another distinguishing factor was Congress’ silence on the issue of preemption in the FDCA “coupled with its certain awareness of the prevalence of state tort litigation” which was “powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness” as the Court stated in Levine. In addition, the Third Circuit noted that Levine recognized that under federal law, a drug manufacturer could strengthen a drug’s label without preapproval from the FDA, which “stands in contrast to the FDA’s far-more extensive control and oversight of the drug’s design and alternation.”

Also the Third Circuit had disagreed with the interpretation of the Georgia Supreme Court on this issue. In American Home Products Corp. v. Ferrari (in which a petition for writ of certiorari is pending), the Georgia high court had ruled that the Vaccine Act “clearly did not preempt all design defect claims against vaccine manufacturers, but rather provides that such a manufacturer cannot be held liable for defective design, if it is determined, on a case-by-case basis, that a particular vaccine was unavoidably unsafe.” The Third Circuit noted in Bruesewitz that if the NCVIA was interpreted to permit a case-by-case analysis of whether “particular vaccine side effects are avoidable, every design defect claim is subject to evaluation by a court.”

It will be interesting to see how the Supreme Court resolves the split between the Third Circuit and the Georgia Supreme Court on this issue.

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Mitochondrial DNA, or mtDNA, is increasingly assayed for early evidence of a disease which will eventually become manifest. Take a sample, amplify the DNA, examine it and look for change - makes sense, right? Your genes are the ones you're born with, right? And if they've changed that can't be good, right?

Well, it turns out that you, or your mitochondria at least, evolve or mutate within the course of your lifetime - and it's perfectly normal. We may have started out with Mom's mitochondria but it looks like by the time we're adults mitochondria in different parts of the body don't just express different genes, they have different genes. That's the conclusion of "Heteroplasmic Mitochondrial DNA Mutations in Normal and Tumour Cells" just published in Nature.

There's a great write-up of the findings at TheScientist.com and it makes two very important points for those of us dealing with litigation involving mtDNA biomarkers.

1) "we have to keep in mind [that] some of the changes we see may not really be [disease-related] mutations." - quote from author Nickolas Papadopoulos

2) "there's a big question mark about how early this increase in mtDNA variation appears in the blood. If it's only apparent once the cancer is well established then it isn't much use as a biomarker." - email from molecular biologist Ian Holt to The Scientist

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The genes belong to bacteria living in your gut. They, along with their fellow microbes in and on "your" body outnumber human cells 10 to 1. But their genes collectively outnumber yours 150 to 1. These findings are just part of what you'll find in "A Human Gut Microbial Gene Catalogue Established by Metagenomic Sequencing"  published in Nature and free online.

The authors conclude that  this catalogue of bacterial genes found in the human gut "will lead to a much more complete understanding of human biology than the one we presently have." I think it's fair to say that the realization that the microbes we host have so much control over our lives will lead to a revolution in how we think of ourselves and how we prevent, diagnose and treat conditions like obesity, diabetes and cancer.

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Apparently it depends on where they fall along the powerful/powerless spectrum.

"In determining whether an act is right or wrong, the powerful focus on whether rules and principles are violated, whereas the powerless focus on the consequences." - from "How Power Influences Moral Thinking" published in the Journal of Personality and Social Psychology. Hat Tip: Barking Up the Wrong Tree.

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Score one for transparency and fairness in the Mountain State.

The West Virginia Record reported in this article on March 3 that Circuit Judge Ronald Wilson has now ordered that all asbestos plaintiffs in West Virginia must henceforth disclose which bankruptcy trusts they have communicated with and against which trusts they might have a claim. The purpose of the order is to ensure that defendants in asbestos cases receive proper credit when plaintiffs are paid by trusts of bankrupt defendants.
 

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The Chemical Safety Board (CSB) has developed recommendations following its investigation of a triple fatality accident that occurred when welding on a tank containing hydrogen, due to bacteria digesting organic matter within, sparked an explosion. The seven key lessons learned from CSB's recent hot work accidents are:

1. Use alternatives when possible

2. Analyze the hazards

3. Monitor the atmosphere even in areas where a flammable atmosphere is not anticipated

4. Test the area whenever work is done near other tanks containing flammable liquids or gases.

5. Use written permits (Editorial comment: there are places where Hot Work permits aren't used? In 2010?

6. Train thoroughly

7. Supervise contractors - Provide safety supervision for outside contractors conducting hot work. Inform contractors about site-specific hazards including the presence of flammable materials.

CSB notes that while OSHA does not explicitly require the use of a combustible gas detector it is good practice to do so. The American Petroleum Institute and FM Global both have long stressed the need for combustible gas detectors to prevent fires and explosions.

As an aside, your writer learned, shortly after being admitted to the practice of law in 1986, that the oil and chemical companies here in Southeast Texas were using such gas detectors by the 1960s. In fact, in the case of one of my clients, a major refiner, its very first recorded fatality occurred in the 1930s when a man was killed by a manhole cover thrown through the air as the result of an explosion caused by hot work near a sewer. After its investigation the company paid to have someone develop a gas detector and it instituted a hot work permitting system more than 60 years ago.

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This just in from the British journal, Occupational Medicine (2010 60(1):53): “The Strange Case of Irving Selikoff.” The author traces Selikoff’s 1941-45 educational odyssey from the U.S., to Scotland, to Australia, back to Scotland, and back to the U.S. He concludes, “it is apparent Selikoff had an early struggle to qualify, but qualify he did.” That, and many of the other conclusions and suggestions of this paper may find their way into the asbestos courtroom, if they have not already.

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You can read about a new vaccine based therapy for mesothelioma that is both safe and, in some at least, effective in "Consolidative Dendritic Cell-Based Immunotherapy Elicits Cytotoxicity Against Malignant Mesothelioma"

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According to the Houston Chronicle the American Cancer Society has finally come to grips with mounting evidence that indiscriminate screening for prostate cancer causes more harm than good thanks to (a) the inevitable morbidity resulting from needless biopsies and surgeries due to false positive tests; (b) the realization that an awful lot of people who consider themselves "cancer survivors" would never have known they had cancer but for the screening test as their cancers would have gone away on their own or would have grown so slowly that they'd have died of something else before the prostate cancer became threatening; and, (c) the unfortunate fact that early detection, despite what everybody has been led to believe, does not mean that aggressive cancers can be cured - it just means that we get to be treated for them, and worry about them, longer.

Here's a link to the new screening recommendations: "Revised Prostate Cancer Screening Guidelines: What Has -- and Hasn't -- Changed"

Also of interest may be the readers' comments over at the Chronicle and elsewhere. Predictably there are two dominant camps. One sees this change as a nefarious plot by Big Pharma and Big Medicine to prevent early detection so they can make more money by making people wait until they need more expensive medicines and surgeries. The other one sees the new guidelines as a nefarious plot by Big Government to save money by preventing early detection so it can save money on treatment and hasten the deaths of Americans thereby saving money on Social Security payments as the cherry on top. I've run across veniremen able to hold both views simultaneously. But that's a discussion for another day.

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In May of 2006 PLOS One published an excellent paper summarizing the evidence that the reductionist approach embraced by medicine over the last century or so had done about as much as it could and was actually hindering further advances. You can find a free copy of that paper, "The Limits of Reductionism in Medicine: Could Systems Biology Offer An Alternative?" at PLOS One.

Modern medicine, the authors wrote, tends to assume (a) that each disease has a single cause; (b) that any deviation from homeostasis requires beating down levels of whatever is up and pumping up levels of whatever is down; (c) that a risk factor for disease in one person is a risk factor for disease in another person; and, (d) that in the case of multiple disease states they can each be treated separately rather than cumulatively. While this approach has been quite successful, particularly for certain diseases, the view of the body and its functions as a bunch of disconnected parts to be dealt with by hyperspecialized parts doctors is beginning to give way to a view that a deeper understanding of disease will occur only when when the complex systems governing the whole organism are understood.

Now there's another paper advancing this idea that afflictions of the body are more than just the sum of their signs and symptoms. In "Systems Biology as a Paradigm Shift in Clinical Research" available free at Oxford Journal of Nephrology Dialysis Transplantation. In particular the authors note the failed promise of biomarker identification to uncover either the causes of illness or effective treatments.

"Simply stated, molecules in a living cell are involved in networks of interactions that regulate the cell's basic functions ... [d]isruption of a partner in these interactions does not result in linear and definable effects but rather in global and often unpredicted perturbations of the whole network." The authors conclude with an overview of the systems biology approach and its promise particularly with regard to understanding and treating chronic diseases.

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Beta amyloid, aka abeta, builds up dramatically in the brains of patients with Alzheimer's. So, beta amyloid causes Alzheimer's, right? Or has something to do with causing it, right? At least it needs to be eliminated because people who don't have it don't have Alzheimer's so it must be bad somehow, right?

Maybe not. In a new report that demonstrates perfectly two (re-)emerging views about chronic diseases researchers at Massachusetts General Hospital have shown that beta amyloid is a potent antibiotic effective against fungi like Candida albicans and bacteria like Staphylococcus. They go on to hypothesize that far from being bad, beta amyloid may in fact be very good. It may well save you from brain infections that would otherwise kill you at a much younger age. An excellent write up can be found at Bloomberg and the article itself, "The Alzheimer's Disease-Associated Amyloid beta-Protein is an Antimicrobial Peptide", is at Plos One.

Oh, and those two (re-)emerging views about chronic diseases? The first is that too often scientists and physicians fall into the trap of assuming that the arrow of causation runs from biomarker to disease when in fact the body, with millions of years of fine tuning under the hood, has almost certainly some mechanism to deal with the build up of the by-products of its defenses such that fooling with that immune system, given our level of ignorance about how it works, is perilous at best. The second is that microbes, thought to have been essentially conquered 40 years ago, are in fact at the root of many if not most maladies commonly thought to be caused by man. Microbes it turns out have not been asleep over the eons nor even over the last 40 years. Almost weekly as new ways to culture and identify them are developed, new and heretofore unsuspected infections are identified. We're only beginning to understand the nature of the microbes that help us and prey upon us and so for now perhaps it's enough to consider the fact that in our own bodies they outnumber our human cells nine to one.

One last thing, isn't it interesting that many of the drugs currently being tested to determine their anti-aging potential are also potent anti-fungals? Correlation isn't, of course, causation, but it might be worth pondering.

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Since 2007, the results of certain animal studies have fueled speculation that certain nanomaterials may behave in ways suspiciously similar to asbestos. In this article published in the journal Nanotoxicology this month, the authors report on their review of 746 articles published or pre-published in 2008 on the possible health effects of carbon- and metal-based nanomaterials. These particular types of nanomaterials are produced and used worldwide. The authors conclude: “Unfortunately, due to the large variability in materials used and methods used conflicting data are generated hampering the risk assessment.”

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The case of Cull v. Perry Homes is long and winding and fits the old adage of being careful what you wish for; especially in litigation. Robert and Jane Cull of Mansfield, Texas bought a home from Perry Homes for $233,730. They alleged it had serious structural problems. They sued Perry Homes and two warranty companies in Texas District Court. One of the warranty companies moved to compel arbitration with the American Arbitration Association pursuant a contract clause. The Culls responded with a 79-page objection which called the AAA, among other things, “incompetent, biased, and fails to provide fair and appropriate arbitration panels.” The case proceeded in court. There was extensive discovery conducted, including 14 depositions and five motions to compel by the Culls. Four days before trial, the Culls moved to compel arbitration. The trial court agreed. The Supreme Court denied a petition for writ of mandamus blocking the move to arbitration.

The arbitrator gave the Culls an $800,000 award, including punitive damages and damages for mental anguish (things arbitration panels are supposed to protect litigants from versus jury trials).

Perry Homes appealed. The Texas Supreme Court reversed; not the arbitration award itself – for which the law is extremely deferential – but the trial court’s decision to go to arbitration.

The Supreme Court stated that the key issue was whether the party moving to compel arbitration had substantially invoked the litigation process. In this case, it clearly had. There is not much more that the Culls could have done to invoke litigation short of going through the trial itself. The plaintiff’s 79-page objection to the AAA seemed to have a large part in the Court’s decision.

On retrial, the jury awarded the Culls $51 million.

Perry Homes has incrementally gotten what it wished for (an arbitration set out in its contract, a new trial after the arbitration gave a bad result), with increasingly bad results. The Supreme Court’s 2008 opinion received lots of press for its seeming favoring of a well-connected defendant over even its historical favor of arbitration.

The case continually made for favoring arbitration is that it reduces cost and time. This frequently does not occur. Perhaps we should go back to favor arbitration only in cases where experts are needed to determine the outcome, not for run-of-the mill private litigation that has until recently been the purview of our public courts.

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We have been watching with interest recent developments in a solvents case currently pending in Summit County, OH: Widican v. Bridgestone/Firestone North American Tire, LLC, et al. A summary judgment order entered in that case may portend a serious body blow to employee "intentional tort" claims against Ohio employers for occupational illnesses with long latencies.

Beginning in 1939, worker's compensation was the exclusive remedy that Ohio workers could seek against their employers for injuries suffered in the course of their employment. That is to say, workers' compensation preempted employer tort liability. This involved the trade-off typical of most workers compensation systems: the employee received reliable compensation for workplace injuries without having to prove fault, and the employer in return received a predictable and reasonable cap on its liability for such injuries.

All that changed in 1982. That year, the Ohio Supreme Court held in Blankenship v. Cincinnati Milicon Chemicals, Inc. that there was an exception to worker's compensation preemption. If the employee could prove that the employer intended to harm him/her, he/she could recover both workers compensation and the full range of tort damages against his/her employer. Two years later, the Ohio Supreme Court in Jones v. VIP Development Company further expanded the exception, holding that "intentional tort" could be established by showing that the employer knew that injury to the employee was "substantially certain." The requisite "intent," the Court later explained in Fyffe v. Jeno's, Inc., was something more than "reckless" or "willful and wanton" conduct, but something less than specific intent to harm.

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In a perplexing opinion the Second Court of Appeals affirmed a summary judgment granted in favor of a manufacturer of asbestos-containing joint compound in a mesothelioma case. As we mentioned in our prior posting on this case, the appeal involved the review of the Texas asbestos MDL pre-trial court’s ruling that qualitative testimony of Dorman Smith’s use of a Kelly-Moore product “on a regular basis” was insufficient.

In Rosemary Smith, et al v. Kelly-Moore Paint Company, the appellate court first addressed and rejected plaintiffs’ contention that Borg-Warner only applied to asbestosis cases and did not apply to mesothelioma cases.

Second, in contrast to the pre-trial court’s ruling that plaintiffs’ qualitative evidence was insufficient, the appellate court reviewed the exposure testimony of fact witnesses, the opinions of plaintiff’s expert, and the opinion of a defense expert that opined that Dorman’s cumulative total exposure to asbestos amounted to 9 to 15 fibers/cc years over the course of his career and stated that “the Smiths at least raised a genuine issue of material fact as to the aggregate dose of Kelly-Moore asbestos-containing joint compound (and total asbestos fibers) to which Dorman was exposed.” The appellate court held that “the Smiths raised a genuine issue of material fact as to the Lohrmann factors.”

This holding is puzzling as the Texas Supreme Court made it clear in Borg-Warner that “proof of mere frequency, regularity, and proximity is necessary but not sufficient, as it provides none of the quantitative information necessary to support causation under Texas law.

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