Anti-Tort Reform Goodies Buried in Health Care Bill

The House version of the health care bill, titled “Affordable Health Care for America Act,” includes a section (pgs. 1431-33) for incentive payments to be made to each State that has a compliant alternative medical liability law. For those of you short on time, scroll down to the bolded portion of Section 2531.

SEC. 2531. MEDICAL LIABILITY ALTERNATIVES.

(a) INCENTIVE PAYMENTS FOR MEDICAL LIABILITY REFORM.—

(1) IN GENERAL.—To the extent and in the amounts made available in advance in appropriations Acts, the Secretary shall make an incentive payment, in an amount determined by the Secretary, to each State that has an alternative medical liability law in compliance with this section.

(2) DETERMINATION BY SECRETARY.—The Secretary shall determine that a State has an alternative medical liability law in compliance with this section if the Secretary is satisfied that—

(A) the State enacted the law after the date of the enactment of this Act and is implementing the law;

(B) the law is effective; and

(C) the contents of the law are in accordance with paragraph (4).

(3) CONSIDERATIONS FOR DETERMINING EFFECTIVENESS.—In determining whether an alternative medical liability law is effective under paragraph (2)(B), the Secretary shall consider whether the law—

(A) makes the medical liability system more reliable through prevention of, or prompt and fair resolution of, disputes;

(B) encourages the disclosure of health care errors; and

(C) maintains access to affordable liability insurance.

(4) CONTENTS OF ALTERNATIVE MEDICAL LIABILITY LAW.—The contents of an alternative liability law are in accordance with this paragraph if—

(A) the litigation alternatives contained in the law consist of certificate of merit, early offer, or both; and

(B) the law does not limit attorneys’ fees or impose caps on damages.

(b) USE OF INCENTIVE PAYMENTS.—Amounts received by a State as an incentive payment under this section shall be used to improve health care in that State.

(c) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to the States applying for or receiving an incentive payment under this section.

(d) REPORTS.—Beginning not later than one year after the date of the enactment of this Act, the Secretary shall submit to the Congress an annual report on the progress States have made in enacting and implementing alternative medical liability laws in compliance with this section. Such reports shall contain sufficient documentation regarding the effectiveness of such laws to enable an objective comparative analysis of such laws.

(e) DEFINITION.—In this section—

(1) the term ‘‘Secretary’’ means the Secretary of Health and Human Services; and

(2) the term ‘‘State’’ includes the several States, District of Columbia, the Commonwealth of Puerto Rico, and each other territory or possession of the United States.

(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such sums as may be necessary, to remain available until expended.

No wonder it’s 1900+ pages long.

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Dihydrogen Monoxide - Another Dose Response Toxin

The maxim “the dose makes the poison” is regularly offered by defendants in toxic tort cases as a premise for the assertion that a particular dose was too small to have been toxic. To demonstrate the concept examples of toxicity due even to essential substances like water are deployed. I’ve done it myself and the retort from plaintiff’s counsel has been invariably mocking. Here are sixteen million reasons why they should reconsider.

 

A Biomarker for Past Crocidolite Exposure

It was only a matter of time before molecular biological methods allowing screening for past potentially toxic exposures were developed.  In "DNA Double Strand Breaks by Asbestos, Silica and Titanium dioxide: Possible Biomarker of Carcinogenic Potential?' the authors from NIOSH, Health Effects Laboratory Branch, report that crocidolite was much more likely to produce  DNA double strand breaks leading to a molecule that can be detected by fluorescent antibody.  What this will mean for mass torts is anyone's guess but its implications for cases involving medical monitoring claims or mesothelioma claims where the plaintiff has failed to identify any amphobile exposures are obvious.

Interestingly, while similar effects were seen for crystalline silica and titanium dioxide, they were significantly less pronounced than that induced by crocidolite.

Do Carbon Nanotubes Cause Fibrosis and/or Mesothelioma?

In this paper the authors, including Arnold Brody, report that carbon nanotubes are responsible for inflammation on the pleural surface of mice following a brief exposure.  A subsequent immune response lead to areas of pleural fibrosis.  Non-fiber shaped carbon nanoparticles failed to produce a similar outcome suggesting that the fibrous tube structure may be an important aspect of this phenomenon.  The authors suggest minimizing inhalation of nanotubes until longer term assessments are completed.

The Fundamental Principle of the General-Specific Causation Dichotomy

The idea that there are two types of causation, one general and the other specific, is rarely enlightening but increasingly the source of confusion, mischief-making and legal bickering. Take for instance the recent per curiam and dissenting opinions in Huss v. Gayden.

In Huss the plaintiff claimed that the drug Terbutaline caused her to develop debilitating cardiomyopathy. At trial the court permitted some testimony by the defendant's expert to the effect that Terbutaline does not cause cardiomyopathy in humans but prevented him from testifying that Terbutaline did not cause Huss' cardiomyopathy. The holding on appeal was that the defendant's expert had not been allowed to fully express his views on general causation and so the case was reversed and remanded. The dissent vigorously objected, writing that the expert had indeed expressed to the jury all that needed to be said on the subject of general causation, that he was not, through education, training or experience, able to opine on the subject of specific causation and that the verdict should thereby stand.

The dissent, citing Tanner v. Westbrook, wrote that the court was required "to acknowledge the fundamental principle of the general-specific dichotomy: that a witness may be competent to testify about general causation but not specific causation." Now, before I discuss this "fundamental principle" (tomorrow) let's first think a bit about reasoning from the general to the specific.

Assume that Wilbur is a pig and the allegation is that Wilbur has been flying. My expert on pigs takes the stand and testifies "No pig can fly". This is of course a general statement about pigs; but Wilbur is a subset of pigs. My expert ought therefore be allowed to testify that Wilbur cannot fly, whether he's ever examined him or not, because what is true of pigs must necessarily be true of Wilbur. Imagine my dilemma if the dissent had its way and I was required to put on specific expert testimony to the effect that Wilbur hadn't been flying. Where exactly would I find someone with the education, training and expertise in recognizing (to paraphrase the test set out by the dissent) the prior flying habits of pigs "in a particular and unique case"?

Tanner on the other hand presents a distinctly different sort of issue. Let's go back to Wilbur. Now he's alleged to have incubated the H1N1 swine flu and given it to his owner, Zuckerman. The plaintiff's expert takes the stand and opines generally that pigs, being swine, are capable of incubating swine flu. He then concludes that Wilbur, being a pig, must have harbored the flu since he was capable of doing so and since Zuckerman now has the flu. Here the criterion of specificity is in order since not all pigs had the flu and since there were other possible non-swine vectors for Zuckerman's flu. Because plaintiff's expert never isolated antibodies to that flu strain from Wilbur's blood nor did he evince any expertise in the forensic diagnosis of H1N1 in pigs his specific causation testimony is unfounded and rightly excluded.

The real problem is that "the fundamental principle of the general-specific dichotomy" isn't fundamental because there's no real dichotomy. More on that tomorrow.

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John O'Quinn Dies in Car Wreck

John O'Quinn who did as much or more than anyone to change the nature of mass torts died today in an automobile accident in Houston.  I first saw Mr. O'Quinn try a lawsuit some twenty years ago when a client for whom we were preparing to defend three benzene leukemia cases sent me to watch the entire Skeen v. Monsanto trial.  O'Quinn already had a fearsome reputation and so, being a brand new lawyer and not knowing much about how lawsuits were really tried, I expected to see quite a spectacle.  Instead, I learned a lot about how to try a lawsuit.

I suppose I expected all-star wrestling but instead it was much more like a chess match.  By the time O'Quinn was done with voir dire the defendant was left with a panel ranging from bad to awful.  His command of the facts and ability to recall them in the minutest detail was amazing.  And every good cross-examination of one of his witnesses turned out, on re-direct, to have been a well-laid trap so that the witness was not only rehabilitated but the cross was made to appear disingenuous, at best.

Nevertheless, probably because I understood the defendant's case and the science behind it, I thought that the defendant would win.  So each week when I would call my Dad, who's been trying lawsuits for decades, and excitedly recount the week's events. I was always surprised when he would reply that it sounded to him as though the plaintiff was thoroughly thrashing the defendant.  He said that O'Quinn had spun a simple and emotive narrative into which all the pieces of the case easily fit whereas the defendant's story lacked a compelling theme and was overly complex. 

After closing arguments I made a wager with my Dad that the defendant would win.  My Dad predicted a verdict of $10 million dollars.  The jury awarded $100 million dollars in punitive damages alone.

A few years ago I was trying a mesothelioma case in Beaumont.  Down the hall O'Quinn was trying a Fen-phen case.  Suddenly there was a commotion in the hall and our judge sent the bailiff out to see what was happening.  She returned and handed the judge a note whereupon he asked the jurors to leave the courtroom.  After the jurors left Judge Sanderson said "they're not sure exactly how much it comes to but O'Quinn just got a verdict of more than $1 billion dollars for one wrongful death."

John O'Quinn's legendary trial skills need no further elaboration.  However, the impact on the law of his brand of mega-verdicts which posed existential threats to corporations has dramatically changed the practice and much remains to be said about it.  More thoughts on that in a future post.

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Chicken: The Next Mass Tort?

Two plaintiffs in Connecticut have sued Burger King, McDonalds and Friendly Ice Cream Corp. for failure to warn them that “well done grilled, or barbecued chicken contains chemicals known to cause cancer.” Plaintiffs, represented by the Cancer Project’s general counsel, allege that grilled chicken contains PhIP (2-Amino-1-methyl-6phenylimidazo [4,5-b]pyridine) a chemical that can increase a person’s risk of developing cancer even if consumed in very small amounts, according to a statement by the Cancer Project.

It is interesting to note that the plaintiffs seem not to have cancer. It is further interesting to note that the plaintiffs do not allege how much the risk of cancer is increased if consuming grilled chicken.

The crux of Plaintiffs’ alleged grief, as alleged in their complaint, is that if restaurants had truthfully informed consumers of the presence of a known carcinogen in their grilled chicken products, many consumers would have chosen to avoid the cancer risk by choosing healthier food options.

It seems that Plaintiffs should have to prove that they have actually been done some harm. If there is only an increased risk, that risk should be weighed against the risk of eating fried chicken, raw chicken, no chicken, a burger, or going hungry. Interestingly, the increased risk of cancer from grilled chicken may have to be juxtaposed against the risk of obesity from eating something fattier, though without PhIP.  Click here.

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$24 Million Meso Verdict Reversed; Bendix Letter Should Have Been Redacted

Plaintiffs alleged that Dr. Stephen Guilder was exposed to chrysotile asbestos in the 1970’s and 1980’s when he remodeled an attic, worked in road construction, and repaired automobiles. He subsequently developed peritoneal mesothelioma and sued Honeywell as successor to Bendix, Borg-Warner, Honda, and other defendants that settled before trial.

Honeywell filed a motion in limine to exclude or redact a portion of a Bendix employee’s letter to an asbestos supplier which was written in the late 1960’s on the grounds of relevance, which the trial court denied. After Honeywell rested, plaintiffs sought and obtained a directed verdict on Honeywell’s claim that the verdict form should include third parties such as Honda and Honda and Borg-Warner as outlined by the Florida Supreme Court in Fabre v. Marin. The jury awarded plaintiffs over $24 million in damages which included $10.4 million for Guilder’s children for loss of parental consortium.

First, the appellate court addressed the letter written by a Bendix employee. Although the appellate court stated that the letter was relevant to proving Honeywell’s knowledge of the dangers of asbestos in its products, the appellate court agreed with Honeywell that the portion which stated, “My answer to the problem is: if you have enjoyed a good life while working with asbestos products why not die from it. There’s got to be some cause[,]” was unfairly prejudicial and the trial court erred by refusing to redact that portion.

Second, the appellate court mentioned that the Florida Supreme Court in Fabre v. Marin, stated that “the legislature intended that damages be apportioned among all participants to the accident” and that “the only means of determining a party’s percentage of fault is to compare that all of the other entities who contributed to the accident, regardless of whether they could have been joined as defendants.” Because Honeywell pleaded the fault of non-parties and presented sufficient evidence regarding two non-parties, the appellate court found that Honeywell satisfied Fabre, and was entitled to have those non-parties listed on the verdict form for apportionment of liability.

Next, the appellate court addressed the award of parental consortium damages. By statute, Florida provides for loss of parental consortium for “acts of negligence occurring on or after” the statute’s effective date of October 1, 1988. The appellate court held that the negligent act was Guilder’s last known exposure to asbestos which occurred in 1982. Because those acts were before the effective date of the parental consortium statute, the appellate court found that the loss of consortium damage award was improper.

Finally, the appellate court addressed whether Honeywell was entitled to an set-off for $2,820,000 in settlements the plaintiffs received. The appellate court held that the trial court erred by failing to set-off the settlement proceeds from the verdict before entering final judgment.

The appellate court reversed the final judgment and remanded for a new trial.  Honeywell International, Inc. v. Guilder.

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Deposing a Hematologist and Need to Understand "CD4"? There's an App for That!

This is cool: BioGene.

Hat tip: OpenHelix.

Good News on Styrene

A review of the studies of workers exposed to styrene found no evidence of a causal link between styrene exposure and cancer. The literature contains numerous studies of workers with exposures to styrene during its manufacture or use in synthetic rubber or plastics production. Though a couple of studies have found an increase in either non-Hodgkins lymphoma or esophageal cancer many others did not and no dose response was seen in the outliers. The authors conclude that the available epidemiologic literature does not support a causal inference for styrene and any form of cancer.

The paper, published in the October issue of Journal of Occupational and Environmental Medicine is titled “Epidemiologic Studies of Styrene and Cancer: A Review of the Literature” and was authored by Boffetta P, Adami HO, Cole P, Trichopoulos D and Mandel JS.

Mortality Among 127,266 Petroleum Company Employees

The Journal of Occupational and Environmental Medicine is publishing in its October issue the results of an epidemiological study of 127,266 men employed in the U.S. by a major petroleum company with at least one day of employment from 1979 through 2000. Standardized mortality ratios were calculated for 94 causes of death. Overall these workers had risks below, and often well below, those of typical American males of the same age. However, the mesothelioma rate was triple that expected (CI=1.15 – 1.90) but only for men hired before 1960. Overall, the rate for acute non-lymphocytic leukemia (including AML) was essentially as expected though a subgroup in the chemicals portion of the business did show a statistically significant increase. Interestingly, there was a statistically significant increase in mortality from melanoma among truck drivers.

As is typical of refinery worker studies, these employees fared quite well as a group. Whether that’s because, as a plaintiff attorney friend of mine speculates, the oil companies are especially good at spotting people who’ll be less likely to die of say stomach cancer or whether it’s because these workers tend to be better paid, have better access to health care and so tend to live healthier lives remains to be seen.

The article is titled “Mortality Patterns and Trends Among 127,266 U.S.-Based Men in a Petroleum Company: Update 1979-2000” and was authored by Huebner WW, Wojcik NC, Jorgensen G, Marcella SP and Nicolich MJ.

Neither a Product Nor a Premise Claim Says Texas Silica MDL Court

Yesterday, the Texas Silica MDL Court granted a defendant’s no evidence summary judgment motion in a case in which the plaintiff alleged that pipes specified by the defendant to be sandblasted offsite and thereafter installed on its premises were either defective products or somehow an extension of the defendant’s premises over which it retained and exercised control. Plaintiff had sandblasted the pipes but had never actually worked at defendant’s facility. He was subsequently diagnosed with silicosis and “silica related lupus”.

Plaintiff claimed that the defendant’s specifications for a particular surface finish on the pipes, which plaintiff argued could only be achieved by using high silica containing flint or other abrasive, meant that the defendant exercised enough control over the manner of plaintiff’s work that it could be held liable for his injury. The defendant argued that there was no legal duty to the plaintiff and that there was no control that would give rise to Chapter 95 liability.

The Texas MDL court rejected plaintiff’s attempt to use premise liability theories to maintain product liability or negligence claims when there was no product created, manufactured or sold by the defendant and none of the acts allegedly responsible for his injuries occurred on the defendant’s premises. Plaintiff had admitted that there was no Texas case law to support his theory.
 

Bayesian Trials 77030

John Cook at The Endeavor posted this comment by Mithat Gönen of Memorial Sloan-Kettering Cancer Center about a recent paper concerning Bayesian clinical drug trials of chemotherapeutics.

"While there are certainly some at other centers, the bulk of applied Bayesian clinical trial design in this country is largely confined to a single zip code."

That zip code is 77030 and it’s the zip code for M.D. Anderson Cancer Center. Here’s a great article about M.D. Anderson just published in the New York Times by Gina Kolata.

Bayesian decision-making approaches are proving their worth every day in a wide variety of fields and more than a few courts are starting to grasp and apply probabilistic decision rules. Expect to see more and more Bayes decision theory as courts take an increasingly modern approach to the question of causal inference in mass tort cases.

Coal Ash is Dirty Stuff, But is it Hazardous?

This question has been posed by coal ash’s recent notoriety, and the answer is without consensus. European scientists recently published a paper aimed at determining the levels of mercury in coal ash (one of coal's more dangerous components) and its potential to leach into the surrounding environment. The researchers concluded that concentrations of mercury or leaching values were not so high as to justify considering coal ash a hazardous waste by European standards. (The EPA has made a similar determination but it is being reviewed.)

Such findings, while restricted to mercury, seem to take the fire out of recent lawsuits filed by individuals affected by coal ash spills and/or disposal claiming coal ash mercury and other components are leaching into water sources at dangerous levels. While mercury, arsenic, lead and other compounds are undeniably harmful at certain exposure levels their concentration and propensity to leach are not so clear. Thus, the question of coal ash harmfulness is subject to debate and will be studied in greater detail by courts and administrative agencies grappling with this issue.

An Anniversary to Remember

Forty years ago Clarence Borel, dying of mesothelioma, filed his landmark claim against the leading manufacturers of asbestos products.  Borel prevailed at trial and when the defendants appealed his $75,000 judgment saying he couldn't prove which defendant was responsible the 5th Circuit open the floodgates of mass toxic tort litigation by holding:  

“[I]t is impossible …to determine with absolute certainty which particular exposure to asbestos dust resulted in injury...” “[E]ach exposure may result in an additional and separate injury…. therefore … the jury could find that each defendant was the cause in fact of some injury…”

Snatching Defeat from the Jaws of Victory

When should you poll the jury? Generally speaking, when you lose. But how about when you win? Maybe it's not such a great idea. Juries makes the point today in a post about a Washington state criminal trial in which a defendant’s attorney decided to have the jury polled after it had returned its verdict – a “not guilty” verdict. The very first juror polled by the judge stated that she did not in fact agree with the verdict and so the jury was sent back for further deliberations. Upon further review the jury came back with a unanimous verdict of “guilty” on a charge of vehicular assault. Oops.
 

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Overdiagnosis is Pure, Unadulterated Harm

That's a quote from an article in today's New York Times by Gina Kolata, the finest journalist covering medical issues out there IMHO.

It appears that the American Cancer Society is about to take a stand, at long last, on excessive screening for breast and prostate cancers. It's a practice that results in few, if any, cures of otherwise lethal cancers but which is responsible for a vast amount of unnecessary morbidity. People in whom cancers which would never spread nor even produce symptoms are, thanks to modern techniques, diagnosed with the dread disease thereafter precipitating needless surgeries and treatments, not to mention worry and stress.

This is vindication for a woman I sat next to on a plane back from Washington D.C. several years ago. She was a researcher at one of the best cancer facilities in the country and she'd gone to present evidence to Congress that screening young women for breast cancer did little if anything to arrest the course of aggressive cancers but did lots of serious and needless harm to thousands of women annually. For her troubles she was accused by some breast cancer advocates of being a lackey of the insurance companies as they thought, I presume, that the only reason anyone would oppose mass screenings would be the costs involved. It's nice to see science prevail over emotion.

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5th Circuit Rules Landowners Have Standing for Claims Related to Oil Companies' Greenhouse Gases

Hurricane Katrina came and went but the landowners class action claims for damages caused by oil companies' greenhouse gases are still standing. On October 16, 2009, the Fifth Circuit Court of Appeals in Comer v. Murphy Oil held that plaintiff landowners had standing to assert causes of action for negligence, private and public nuisance, and trespass against oil companies for their release of greenhouse gases, which caused rising sea levels and increased the ferocity of Hurricane Katrina. In reversing the district court's dismissal of the property damage claims, the court ruled that plaintiffs’ Mississippi tort common law claims met the state’s liberal standing requirements, but also the federal standing requirements because their alleged injury could be traced to defendants’ greenhouse gas contributions. The U.S. Supreme Court’s decision in Massachusetts v. EPA played a critical role in the court’s analysis of the standing issue. The court also held that these claims did not present nonjusticiable political questions. While the standing issue is the beginning and not the end of how much liability, if any, the oil companies have for damages resulting from greenhouse gases in this case. This decision may signal the beginning of the expansion of liability for damages directly, or indirectly, related to a person, company or industry’s contributions of greenhouse gases.

How will the Second Court of Appeals Interpret Borg-Warner?

The oral argument in Rosemary Smith, et al v. Kelly-Moore Paint Company that took place October 15, 2009 before the Second Court of Appeals can be heard here.  The plaintiff appellant is asking the appellate court to hold that Borg-Warner v. Flores does not apply in a mesothelioma case because, they claim, there is "no safe level" for exposure to asbestos and because even minute exposures have been declared to be causative.  Accordingly they ask that in mesothelioma cases plaintiffs be excused from having to demonstrate quantatively the dose given by any particular defendants' product, premise, etc.

We’ll let you know when Second Court of Appeals reaches its decision.
 

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The Case of The Missing Title

A recent post on Winning Trial Advocacy Techniques entitled "Does your case have a title?" reminds us of the importance of simplifying our trial narrative and that developing a title can provide a shortcut to framing your entire case.

With a title in an instant you convey a hint of what your case is about while helping to raise an inquiring attitude among your jurors that will help them follow your examinations and arguments and understand how they fit within the framework you’ve developed.

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The Same Facts Seen From Different Perspectives

Deliberations reminds us that facts are rarely just “facts”. How facts are perceived depends very much on the perspective of the person assessing those facts so that the very same fact may drive two different people to draw two different conclusions from that fact.

Always be mindful that your perspective on how a particular fact impacts the narrative of your case may not be shared by your jurors. A billionaire isn’t just someone with a billion dollars; a billionaire is someone who has succeeded wildly or someone who has exploited the system. She’s someone to be admired, or envied or despised. Facts then, even seemingly simple numeric ones, are often laden with emotive potential and peril.

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Long-Term Disappearance of Mesothelioma

A Japanese man who was diagnosed with advanced malignant pleural mesothelioma is disease-free more than two years after being treated with a mushroom extract containing agaricus blazei Murill Kyowa and a modified form of acupuncture. The authors, who note that the patient had undergone debulking and chemotherapy but thereafter, as is typically the case, fared poorly, conjecture that his remarkable recovery may be due to “some immunological reactions of the host to the tumor” induced by either or both of the alternative treatments. The free paper was published in the Journal of Medical Case Reports.

What Role Does Immunosuppresion Play in the Pathogenesis of Mesothelioma?

Although the precise mechansim for mesothioma is currently unknown, one study has postulated that immunosupression plays a role in the pathogenesis of this cancer. Mesothelioma in an HIV/AIDS patient without history of asbestos exposure: possible role for immunosuppression in mesothelioma: a case report, involved the study was of 41-year-old man who had asthma, HIV with progression to AIDS in the past 3 years, and a 20-pack year smoking history, was diagnosed with malignant mesothelioma.  This individual had no occupational history of asbestos exposure but did have a brief history of assisting in the demolition of a house over an 8-hour period a year before his diagnosis but it was unknown if he was exposed to asbestos during that work.

The authors of the study noted that the polyoma virus SV-40 has been implicated as a participant in some cases of mesothelioma. Studies have postulated that since the virus inactivates anti-tumor genes such as retinoblastoma, it promotes immunosuppression that may lead to enhanced susceptibility to mesothelioma. Similar to SV-40 virus, HIV is also an oncovirus and therefore capable of inducing cancer. Because HIV suppresses the immune system the authors think that HIV increases the susceptible to mesothelioma.

The authors also noted that transplant patients are immunosuppressed due to administration of drugs to prevent transplant organ rejection and elderly patients undergo physiologic immunosenescence which is characterized by reduced immune responses. Mesothelioma has been reported in transplant patients, without notable asbestos exposure, and mesotheliomas are classically reported in elderly patients.

The study notes that mesothelioma may be more prevalent in SV-40 virus-infected patients, HIV/AIDS patients, organ transplant patients, and elderly patients, than in the general population. The study concludes the development of mesothelioma in patients with HIV/AIDS, SV-40 infection, organ transplant, or advanced age suggests that chronic immunosuppression enhances susceptibility to mesothelioma.

Does Smoking Cause Lung Cancer?

Of course it does. But what was the evidence in favor of the hypothesis, what was the evidence against it and how was a judgment about what lawyers call general causation finally reached? Fifty years ago a remarkable paper was published that demonstrates how a causal inference is rationally reached.

The paper itself is important to anyone trying to understand the rise of epidemiology, its methods and the profound respect it earned; and its reasoning is important to anyone who wants see how a causal hypothesis is properly dipped in the acid bath of skepticism; and what it looks like if it survives.

In the case of cigarette smoking the effect, lung cancer, was nine fold higher in smokers than in non-smokers. In retrospect it was an easy case. The question today of course is whether epidemiology can shed any light on subtler risks attributed to suspected carcinogens which are themselves just one part of a staggeringly complex causal web involving genes, epigenes, pathogens and other as-yet undiscovered causes. More about that in a future post.

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The Linear No Threshold Risk Model: Invalid at Low Doses

In a paper to be published in November’s issue of Health Physics entitled “Does Scientific Evidence Support a Change From the LNT Model for Low-Dose Radiation Risk Extrapolation”, by D Averbeck, the author challenges the conventional thinking about radiation and risk. Citing both molecular biological evidence of efficient repair mechanisms working well at low doses and an absence of animal or human epidemiological data to support the no threshold risk model Averbeck concludes that the linear no threshold assumption “appears to be scientifically invalid in the low-dose range.”

The same linear no threshold assumption is, of course, the basis for claims that each fiber of asbestos or molecule of benzene imposes a significant risk and would, assuming a population large enough to detect it, be causative for mesothelioma or leukemia, respectively. Conflating risk and causation plaintiff lawyers go beyond risk to argue that each fiber or molecule was actually causative in every case of each disease. There was, of course, never any evidence to support such claims; just a conservative regulatory position that is now on increasingly shaky ground.

The November issue of Health Physics contains several articles fleshing out this issue of what risk, if any, is associated with low-level exposure to radiation.

A Stick in Time Saves 69,679

When should Americans get the H1N1 vaccine? How many years of life would be saved if just 40% of the population is vaccinated this month? How many lives would be lost if they wait a month? And if vaccinations are to begin in earnest now rather than one month later would the cost outweigh the benefit? Complete answers to those questions can be found here. For those short on time the short answers are: October; 69,679; 583; and, yes.

COPD is an Independent Risk Factor for Cancer

After adjusting for smoking chronic obstructive pulmonary disease (COPD), chronic bronchitis and emphysema were associated with a doubling of the risk for lung cancer in this just published paper.  It's part of the ongoing Environment and Genetics in Lung Cancer Etiology (EAGLE) study.

Noting that a family history of chronic bronchitis and emphysema alone have been associated with lung cancer, that COPD has been associated with lung cancer in never-smokers and that COPD is thought to be responsible for 10% of all lung cancers, the authors concluded that these findings support the hypothesis that COPD alone causes lung cancer and they further conjectured that chronic inflammation is the essential mechanism in COPD/emphysema-induced lung cancer.

Are Current PELs/TVLs for Manganese Protective?

A risk assessment for impairment measured by five neuropsychological performance parameters showed a statistically significant association with manganese exposures (estimated by air and blood sampling) below permissible levels.  The article is titled "Exposure-Response Relationship and Risk Assessment for Cognitive Deficits in Early Welding-Induced Manganism".  It's published in the Journal of Occupational and Environmental Medicine authored by RM Park, RM Bowler and HA Roels.

Why are Mesothelioma Rates Still Rising in Alberta?

The incidence rate for mesothelioma continues to rise in Alberta, Canada. This paper just published in Chronic Diseases in Canada reports a continuing and significant increase in reported cases of mesotheliomas among male Albertans and projects that the incidence of the disease may not peak for another 10 years.

An interesting issue touched upon but not worked out is the impact on current projections of past misdiagnoses. Think about what it would mean for these projections if past less refined diagnostic procedures understated the number of cases of mesothelioma; then think about what it would mean if reported cases of mesothelioma in the 1960s and 1970s were overstated.

Improving the Consistency and Effectiveness of Hazard Communication

The United Nations Globally Harmonized System (GHS) of Classification and Labelling of Chemicals was developed by a number of countries, including the United States, to address inconsistencies in hazard classification and communications. 

OSHA is adopting the GHS approach and believes it will increase workplace safety, facilitate international trade in chemicals, and generate cost savings from production efficiencies for firms that manufacture and use hazardous chemicals.

Subsequent Application of Asbestos: Whose Duty to Warn?

In Merrill v. Leslie Control, Inc., a California appellate court reversed and set aside a verdict in favor of plaintiffs and held that a defendant “owed no duty to warn against dangers in products, used in association with or as replacement parts of its valves, which it did not manufacture or supply.”

Richard Merrill filed suit for his mesothelioma that was allegedly caused by exposed to asbestos during his service in the Navy. The jury found that Leslie Controls valves were defective because it failed to warn of potential risks, the valves were defectively designed, and Leslie Controls was negligent.

Merrill had worked on Leslie Control valves that were used on ships on which he served. The valves had asbestos-containing internal gaskets which Leslie Controls did not manufacture. Leslie Controls instructed purchasers of its valves to insulate around its valves but it did not provide insulation and its field engineers were aware that asbestos insulation was applied to and removed from its valves and were even present when it was done. Leslie Controls also provided manuals for their valves and was aware that packing would be removed or added during maintenance and the manuals contained no warning of the dangers of asbestos.

The appellate court found that there was no evidence that Leslie Controls manufactured or supplied any asbestos-containing internal packing and gaskets to which Merrill was exposed, it did not manufacture or supply gaskets attached to the exterior of its valves, and it did not supply or manufacture asbestos-containing insulation used around the valves. Thus the appellate court held that Leslie Controls was not liable in strict liability “for failing to warn of hazards associated with the handling of these products.”

The Court stated that a manufacturer’s duty to warn is limited to its own products. The court also rejected liability premised on the component parts doctrine because Merrill could not provide evidence he removed the old internal packing that had been supplied by Leslie Controls in the valves.

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And Now For Something Completely Different

Yesterday was the 40th anniversary of the first broadcast of Monty Python's Flying Circus. Today the NYTimes gave me a reason to boast about owning all the shows on DVD. In an article titled "How Nonsense Sharpens the Intellect" the author discusses recent research into how people make sense of the world; how they find meaning in the absurd; and, how incomplete and dissonant bits of stories caused their brains to work overtime to find patterns otherwise invisible or nonexistent. One result of the exercise was to tune up their pattern-recognizing abilities so that they thereafter performed better on tests of implicit learning: knowledge gained without awareness.

I'm not sure that this means you should work a dead parrot into your next voir dire but you should probably be aware of the tendency of jurors to fill in holes in your narrative in ways that you might find nonsensical.
 

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Trichloroethylene: A Risk Factor for Cancer?

US EPA has been working on a risk assessment of trichloroethylene (TCE) for some time now. Here’s a link to the EPA Issue Papers through 2005. Now a comprehensive review of the issues has been published in Critical Reviews in Toxicology. The article is entitled “Trichloroethylene risk assessment: A review and commentary” and it provides an excellent overview of the developing molecular biological and molecular epidemiological approach to causal attribution and risk; one we’re sure to see increasingly in asbestos, benzene and other mass tort litigation.

The Power of Metaphor

“Metaphor most brings about learning; for when he calls old age “stubble” he creates understanding and knowledge…” – Aristotle, Rhetoric.

Appreciation for the power of metaphor is ancient. Yet today tools newly available to cognitive scientists are revealing metaphors to be the underlying frame on which thought is formed. The Situationist reports on recent research in the field and concludes ”[m]etaphors aren’t just how we talk and write, they’re how we think”. And Situationist contributor John Bargh, professor at Yale, is quoted as saying “The abstract way we think is grounded in the concrete, bodily world much more than we thought.” Aristotle (and George Berkeley) must be smiling somewhere.

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Chemical Management Reform: New EPA Principles

You can read about the Obama Administration's plans for reforming TSCA here.  US EPA Administrator Lisa Jackson is quoted in the press release as saying:

“...as more and more chemicals are found in our bodies and the environment, the public is understandably anxious and confused. Many are turning to government for assurance that chemicals have been assessed using the best available science, and that unacceptable risks haven’t been ignored.

Our oversight of the 21st century chemical industry is based on the 1976 Toxic Substances Control Act....over the years, not only has TSCA fallen behind the industry it’s supposed to regulate - it’s been proven an inadequate tool for providing the protection against chemical risks that the public rightfully expects.

Today I’m announcing clear Administration principles to guide Congress in writing a new chemical risk management law that will fix the weaknesses in TSCA.”

Risk assessment is becoming a hot topic in mass tort litigation and as a result EPA's 2008 efforts regarding a new risk assessment for asbestos were especially contentious. You can read about the Administration's "Essential Principles" for planned reform here.

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EPA Announces New Nanoparticle Research Effort

The US EPA discusses its upcoming efforts to support research into the uses and potential risks posed by nanoparticles in this press release. You can read more about some of the issues at EPA's Nanotechnology Research: Basic Information webpage.

1st Court of Appeals Decides Union Carbide v. Smith

In a decision significant for its discussion of Texas’ Chapter 95 premises liability scheme the 1st Court of Appeals today reversed a $4+ million judgment against Union Carbide and Hexion arising out of a mesothelioma case tried to verdict in Galveston and rendered a take nothing judgment in favor of both defendants.

Essentially the court held that there was no evidence of control sufficient to support a verdict against Union Carbide. Providing asbestos-containing gaskets to the plaintiff contractor was not control – especially as any asbestos exposure arose out of the manner in which he used them rather than any intrinsic property. Specifying asbestos-containing insulation be applied by other contractors was not control, employing other contractors who stirred up dust was not control and requiring and holding mandatory safety meetings for plaintiff’s supervisors was not control.

Interestingly however, on page 9 at footnote 7, the court spends considerable time discussing a jury question the plaintiff didn’t request that would have led to a jury considering whether a premises owner exercised control over some other contractor, such as an insulator, which in turn led to the plaintiff’s exposure. There’s clearly a hint here that the court doesn’t think the control inquiry is limited to whether premises owner exercised control over the manner in which plaintiff did his work but extends to whether the premises owner controlled the manner of the work of some other contractor who in turn injured the plaintiff. But the plaintiff didn’t ask for the question so too bad.

Regarding the claims against Hexion, the plaintiff’s employer, they appear not to have been the usual Article 16 Section 26 workers’ comp avoiding effort we typically see in Texas. Instead the plaintiffs appear to have latched on to the idea that Hexion was not actually the plaintiff’s employer during that period of time during which plaintiff worked for Hexion’s predecessor so that the comp act’s bar to common law claims against employers for on the job injuries wouldn’t apply. The court basically held that public policy argued for an expansive view of worker’s comp coverage. The plaintiff made a last ditch plea to have the court adopt the “dual persona” doctrine, which would have separated Hexion into with and without coverage entities. Noting that no Texas court has ever done so as a means for imposing liability on a covered employer otherwise immune to suit the court declined the invitation.