Duty Exists For Take-Home Exposure - Texas Asbestos MDL

Judge Mark Davidson, who presides over the Texas asbestos MDL denied summary judgment on the issue of whether a duty exists for take-home exposure to the spouse of a defendant’s employee. In Carrie Ramsey v. Borg Warner Morse Tec. Inc., et al, he issued a letter ruling in which he determined that DuPont owed a duty to the spouse of one of its workers who developed mesothelioma.

The plaintiff’s ex-husband had worked at a DuPont facility from 1964 to 1974. He worked as an operator and later as a supervisor who patrolled the plant, and worked in various areas during startups and shutdowns as needed. He did not work hands-on with any asbestos products but worked around those who did. Plaintiff laundered, on a daily basis, the clothes her ex-husband wore home his from DuPont. Before she placed his clothes in the washing machine she would shake the dust off his clothes, which she breathed. She was diagnosed with pleural mesothelioma in 2008.

According to Judge Davidson’s ruling, documents produced by DuPont indicated that DuPont knew of the dangers of asbestos by the early 1960s. DuPont knew of a link between small exposures to asbestos and cancer by June 2, 1966. A 1964 DuPont document authored by the director of DuPont's Haskell Laboratory for Toxicology and Industrial Medicine stated that cases of mesothelioma could be caused by "exposure to dust brought home by relatives working with asbestos.” This report also identified three types of exposures to asbestos that are recognized as leading to an increase of mesothelioma: 1) factory workers manufacturing asbestos textiles; 2) insulating materials; and 3) “exposure to dust brought home by relatives working with asbestos.”

A DuPont document dated May 21, 1968 detailed DuPont’s knowledge of asbestos dangers and that “Wives and children of asbestos workers are also being involved because of the dust laden clothes a man wears home at night.”

In his ruling, Judge Davidson stated that the evidence in this case went far beyond that in Behringer v. Alcoa in which the Dallas Court of Appeals held Alcoa owed no duty to an employee’s spouse who developed mesothelioma. Davidson stated the following:

“If this isn’t enough evidence to comply with Behringer, I really can’t imagine what is. Mr. Ramsey’s exposure continued for six years following the time interval DuPont documents show they were aware of the dangers to its employees’ families. The Behringer case held that the [sic] Alcoa had no knowledge of the dangers of household exposure in the 1950s, and that no duty existed in the absence of that knowledge. In this case, there is some evidence that the Defendant knew as early as 1964 and certainly by 1968. Exposure continued until 1974."

Clostridium Difficile in the News

Can C. difficile be spread through the air? What does C. difficile have to do with COPD? How should physicians treat the new and especially virulent strain of C. difficile? At what temperature should you cook ground meat to kill C. difficile and its spores? Do alcohol-based gels kill it? Why do antacids administered in hospital increase the risk of infection? Are there new antibiotics that work against C. difficile?

Click on the links for a sense of current thinking on these issues.

How, and Why, Do Some Bacteria Facilitate Cancer Metastasis?

When you ask a physician or researcher how bacteria cause and/or promote cancer usually the only answer you get is "inflammation" and some hand waiving. It sort of makes sense. Lots of new and different stuff is going on, lots of new and different cells are running all around and lots of old cells are busily dividing and multiplying - surely a recipe for an accident.

But what if the bacteria are actively promoting the metastasis? That's the finding in "Bacteria Peptidoglycan Promoted Breast Cancer Cell Invasiveness and Adhesiveness by Targeting Toll-Like Receptor 2 in the Cancer Cells". Why, in the "what's in it for them" sense, would bacteria promote something that kills their host? Something to ponder over the weekend.

OSHA Director Claims Regulations For Workplace Exposure to Infectious Agents Are Inadequate

The title is taken from a quote in a New York Times piece headlined: Safety Rules Can't Keep Up With Biotech Industry. The article details several accidents resulting in serious injury or death plus an alleged whistleblower's $1.4 million recovery. David Michaels, author of "Doubt is Their Product: How Industry's Assault on Science Threatens Your Health", and now Director of OSHA, is also quoted as saying "[w]orker safety cannot be sacrificed on the altar of innovation."

A new Rachel Carson and a new Erin Brockovich have already been proclaimed; now it seems there's also a new Karen Silkwood and a new Eula Bingham. The casting is complete. If this production has a run like the last one mass tort lawyers will be busy for years to come.

Tags:

An Unusual Benzene/MDS Opinion

In Quillen v. Safety-Kleen Systems, Inc., 2010 WL 2044508 (E.D.Ky.) the court determined that plaintiff's expert, Dr. George Rogers, could properly attribute a case of myelodysplastic syndrome (MDS) to benzene by doing a differential diagnosis. That some courts have taken to using differential diagnosis to identify the root cause of say splenomegaly rather than to distinguish histoplasmosis induced splenomegaly from Hodgkin's disease induced splenomegaly would likely set many physicians' eyes rolling.  Yet, that's apparently what the 6th Circuit said in Hardyman v. Norfolk & Western Railway Co., 243 F.3d255 (6th Cir. 2001) and thus the thinking by the Quillen court.

The point of doing a differential diagnosis, of course, is to rule out possible causes until just one is left - it's a process of elimination. But just because every other cause of splenomegaly has been ruled out in the case of a male patient that doesn't mean that it makes sense to conclude that the cause must be the remaining possibility - a metastatic ovarian cancer. To be considered for elimination in the first place the putative cause has to be one that makes sense. In Quillen though there was no effort to demonstrate that plaintiff's experience with benzene was the sort that would make benzene a reasonably plausible cause of his MDS.

Finally, please ponder the following. In response to the defendant's objection that plaintiff's expert had not ruled out ionizing radiation  the court wrote: "Defendant points to nothing in the record demonstrating that Quillen was ever exposed to a statistically significant amount of such radiation." Somewhere an epidemiologist just fell out of her chair.

Something to Consider When Considering a State of the Art Defense

When putative cause and effect are perceived to be closer, in time, the degree of belief in the alleged causal nexus increases. That's one way to look at the results of a new study on how people perceive causal relationships in time being reported at MindHacks. But how does that explain the ease with which many juries find a link between a decades old exposure and a modern case of mesothelioma? Perhaps because too often defendants fail to adequately explain the long and difficult path from surmise and suspicion to confirmation of the link; and, because they often fail to demonstrate (sometimes due to judges who prevent it) in a detailed time line all of the intervening and nowadays usually superseding causes.

Tags:

E. Coli O157:H7: Not the Only Bad Apple in the Family?

E. coli O157:H7 produces Shiga toxin, a cause of dysentery, and in some cases hemolytic uremic syndrome followed by kidney failure, particularly in the young. The government and industry have become increasingly vigilant in screening food for the bacterium. But what about all the kissing cousins of this promiscuous bug?

According to a new article in the NYTimes the recent outbreak of illness caused by lettuce wasn't due to E. coli O157 but rather by E. coli O145. In the article the owner of an organic food farm is quoted as saying that E. coli O145 and a handful of other non-E. coli O157 relations are being found more and more often in even organic food. Read all about it: "In E. Coli Fight, Some Strains Are Largely Ignored".

Life evolves to exploit underexploited energy dense environments. To microbes, we're still walking, talking energy dense environments. The long war continues.

Autism/Vaccine Proponent Andrew Wakefield, Banned from Medicine in Britain

As a follow-up to our post on the death of the vaccine/autism litigation last week, we report the following news: Dr. Andrew Wakefield, the chief proponent of the now discredited junk science behind the MMR vaccine/autism link, has been banned from practicing medicine in his native UK.

Wakefield has moved to Texas and set up an autism clinic.

A brief synopsis of the whole sorry history of the MMR vaccine/autism scare is encapsulated in this prior post and comic strip which is eloquent in its brevity and accuracy.

Tags:

How Do Statins Work?

Could the answer, at least in part, be inferred from the following?

Statins appear to reduce the risk of sepsis and nosocomial pneumonia ; Antimicrobial and Immunomodulatory Attributes of Statins ; Unexpected Antimicrobial Effect of Statins ; Fungal rDNA Signatures in Coronary Atherosclerotic Plaques

It's quite an eye-opener, to glance through all the articles being published demonstrating links between good health or disease and the vast previously unappreciated hordes of microbes that live in and on us. And it makes you wonder what the President's Panel on Cancer was thinking when it prepared its report since, to anyone caring to look, the evidence that our ancient nemeses are responsible not just for acute infections but for a large part of cardiac disease and cancer is overwhelming.

 

Statins: A Little Sour With the Sweet

As evidence confirming the hypothesis that statins reduce the risk of cardiovascular disease piles up along with it comes data suggesting that some other risks may be elevated by taking statins. So far, however,  the benefits of statin treatment appear to easily outweigh the risks. Here's some of that data published in the last couple of weeks:

Lipid-lowering Agents and New Onset Diabetes Mellitus

Unintended Effects of Statins in Men and Women in England and Wales; Population Based Cohort Study Using the QResearch Database

Acute Renal Failure With the Combined Use of Rosuvastatin and Fenofibrate

Balancing the Intended and Unintended Effects of Statins

How is Multi-Drug Resistant Acinetobacter Baumannii Spread Through Hospitals?

It's not just unwashed hands nor even mostly unwashed hands. Gloves and gowns of healthcare workers are contaminated with A. baumanni more often than hands. Following contact with infected patients 38.7% of gloves/gowns were contaminated whereas hands only picked up the bacteria 4.5% of the time. A. baumannii looks to be more readily transmissible than even MRSA. See "Frequent Multidrug-Resitatant Acinetobacter Baumannii Contamination of Gloves, Gowns, and Hands of Healthcare Workers".

Final Nail In the Vaccine/Autism Coffin?

The Court of Appeals for the Federal Circuit recently drove what we hope is the last nail in the coffin of the vaccine/autism litigation. Rarely has a toxic tort had the potential to cause so much harm based on such shoddy science. The history of this tort and its shortcomings have been reported in great detail.

In short, the scientific evidence that vaccines cause autism came from a discredited article by Andrew J. Wakefield and two follow-up articles. Dr. Wakefield’s article created a public health crisis with parents, including celebrity parents Jenny McCarthy and Jim Carey, urging parents not to get their children vaccinated. As a result, formerly endemic childhood diseases which had become effectively eradicated in the developed world began to make a reemergence. Wakefield’s article was finally withdrawn from the Lancet earlier this year after 10 of the 12 co-authors disavowed it. Wakefield, himself, refuses to withdraw the article even though it was found that he committed scientific misconduct and lied in the article. The UK’s General Medical counsel’s Fitness to Practice Panel issued a judgment against him for his vaccine/autism paper. Wakefield continues to testify. Others testify based on his work.

Thankfully, the vaccine litigation was consolidated in the federal Vaccine Court pursuant to The Vaccine Act (passed in response to the health scare where the DTP vaccine was accused of causing neurological damage and in response to lawsuits, stopped being manufactured). Plaintiffs in three bellwether cases all failed on causation. The Special Masters wrote massive opinions eviscerating Wakefield and the causation theories of Plaintiffs.

Hopefully parents can now rest assured that vaccines are not a risk for autism. And, they can recognize the far greater risks to their children and society from not vaccinating.

Nanoparticles to the Rescue

While some fret that man-made nanoparticles may bear unanticipated hazards that won't manifest for decades cancer researchers press forward with the development of revolutionary nano-scale drugs. What are they? How will they work? Will they be regulated as drugs, devices or biologics? An excellent (and free) discussion can be found at Nature Reviews: Clinical Oncology in "Conscripts of the Infinite Armada: Systemic Cancer Therapy Using Nanomaterials".

Can't Prove a Negative: Mobile Phones and Brain Cancer

A World Heath Organization (WHO) study on cell phones and brain cancer has been published. It tracked 13,000 cell phone users over a number of years. The study showed no association between brain cancer and cell phone use. Statistically, people who used cell phones had a decreased rate of brain cancer.

Despite this, and despite every prior study showing no statistical evidence of an increased rate of brain cancer in cell phone users, the authors state that “[t]he results really don’t allow us to conclude that there is any risk associated with mobile phone use but it is also premature to say that there is no risk associated with it.”

This is true. It is just about impossible to prove a negative. This has not stopped the authors of the recently released President’s Cancer Panel from arguing for a “precautionary principle” to regulation. Their precautionary principle would have cell phones outlawed until they could be proven safe. Specifically, the panel argues that cell phones should be banned until there is no risk of cancer associated with them. The obvious question, however, is how to prove that there is no risk. Study after study finds no association but cannot prove the negative, an absolutely risk free product. All the freedoms and advances in wireless technology would be banned until a 30-year long term study showed there would be no risk. By 2040, what other life-changing technologies would we have missed?
 

Tags:

An Epidemic of Head and Neck Cancer

Cancer of the oropharynx in men is on the rise. Such cancers have traditionally been blamed on smoking and/or drinking so what accounts for its increase in a time of reduced rates of smoking and alcohol abuse? A virus; human papillomavirus (HPV). See "HPV-Associated Head and Neck Cancer: A Virus-Related Cancer Epidemic".

Remember, (1) the focus of this year's World Cancer Day was a call for greater awareness of the contribution of infectious disease to cancer; and, (2) the "age of receding panemics" never really passed - we just stopped looking for them.

 

EPA Greenhouse Gas Permitting: Final Rule

The EPA has just announced its final rule for greenhouse gas emissions from large fixed sources such as power plants and refineries. Starting in January of next year large facilities already required to obtain Clean Air Act permits for other emissions will have to seek a greenhouse gas permit if such admissions increase by 75,000 tons/yr or more. Six months later the requirements will expand to cover all new facilities with emissions of at least 100,000 tons/yr and older installations with modifications that result in increases of 75,000 tons/yr or more. The rule covers not only CO2 but also methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons and sulfur hexafluoride. It's anticipated that the rules will be expanded to additional sources effective July 2013.

The EPA believes that these new standards will avoid overwhelming permitting burdens that otherwise would have fallen on the government and most sources of greenhouse gas. The EPA notes that without this rule the permitting and "best available control technology" burdens would fall on operations with emissions as low as 100 tons/yr producing "an absurd result" - not to mention an immense political backlash propelled by an impossible to administer regulatory scheme. Instead, conceding in essence the slippery slope objection, expansion of the regulations to smaller emitters will proceed "one-step-at-a-time". Had the rules become effective for all emitters at once an estimated 6 million U.S. farms and businesses would have suddenly become subject to the permitting process with the time from application to permit approval lengthening to a decade or more.

The CliffsNotes version is here: Fact Sheet and here's the Final Rule

Tags:

Evidence For a Benzene-Leukemia Supralinear Dose Response?

What is the risk of leukemia in workers exposed to relatively low cumulative levels (<100 ppm yrs) of benzene? To get at the answer researchers examined nine published studies from which exposure-response data could be extracted. The exposure response curve that best fit the data shows a supralinear response, by which it is meant that the rate of response falls less rapidly for an interval before returning to its former rate of descent. The primary explanation offered for the deviation from the linear is that at some level the mechanism by which benzene is ordinarily metabolized is overwhelmed, or saturated, and metabolism by some other mechanism, one responsible for metabolites that cause leukemia, takes over until it too is saturated beyond which point risk rises at a lower rate.

The obvious problem with the best fitting curve graphed in the study is that it manages to predict a positive risk for benzene-induced leukemia even when the exposure to benzene is zero - an apparently absurd result. This best fitting model shows greater risk of benzene induced leukemias down to 10 ppm years than would be predicted by a typical linear no threshold model and a doubling of the risk level at just above 40ppm yrs. However, the second best fitting curve shows a sharp decline, especially below 40 ppm yrs and one which might be consistent with a threshold for risk at some non-zero level.

The paper is free and you can find it here: "Flexible Meta-Regression to Assess the Shape of the Benzene-Leukemia Exposure-Response Curve"

Libby Vermiculite and Death From Cardiovascular Disease

While examining the effect of cumulative fiber exposure on lung cancer and mesothelioma among Libby, MT vermiculite workers researchers from the ATSDR noticed dose related increase in deaths from cardiovascular disease. Using a "within-cohort comparison" they were able to demonstrate a significant dose response relationship at or above 44.0 f/cc years. See "Vermiculite Worker Mortality: Estimated Effects of Occupational Exposure to Libby Amphibole".

Breast Cancer and Diet: Good News and Bad News

in "Meat Mutagens and Breast Cancer in Postmenopausal Women - A Cohort Analysis" the researchers report the results of their study of breast cancer risk among women who consume meat cooked at temperatures high enough to produce heterocyclic amines (endocrine disruptors) and so-called "meat-derived mutagens". The good news is that the women were at no increased risk of estrogen-receptor positive breast cancer and at a slight decreased risk of estrogen-receptor negative breast cancer.

The bad news, if you've been forcing down lots of leafy greens in hopes of fending off breast cancer, is that cruciferous vegetable consumption seemed to have no effect, one way or the other, on breast cancer risk.

The Strange Case of the Report of the President's Cancer Panel

By now you've surely heard or read about "Reducing Environmental Cancer Risk: What We Can Do Now", which is the title of the recently released annual report of the President's Cancer Panel. You've also likely read that the American Cancer Society, no laggard when it comes to stirring up anxiety about cancer, has criticized the report's unfounded claims of wanton devastation from heretofore largely unknown, and still yet to be identified, man-made and occasionally natural carcinogens. But have you read the report itself? You should; it's quite an eye opener.

First, there's the advocacy. There are calls for massive new regulatory schemes based on what the authors think the "precautionary principle" means - i.e. that everything with a CAS number is suspect and can't be trusted until it has been studied not just alone but in every conceivable combination and concentration with the other 80,000 chemicals in use today. There are calls for "environmental justice". There are calls for expensive home water filtering, the end of plastic food and beverage containers, the consumption of "organic" food, lots more "black box" epidemiology and, most importantly for the plaintiffs' bar, "an environmental health paradigm for long-latency diseases .. to enable regulatory action based on compelling animal and in vitro evidence before cause and effect in humans is established". That last bit is all about the emerging "low dose" theory, the newest attack on "the dose makes the poison", explained in the introduction of the report as "harmful effects that may occur only at very low doses".

Then there's the science, or rather, the argumentum ad ignorantiam. The document is largely free of objective data. The authors admit at the outset that cancer incidence and mortality is falling, that not much is known about the causes of cancer and that the evidence concerning the consequences of "cumulative lifetime exposure" to most environmental contaminants is unknown and unstudied. Yet because so much is unknown, because environmental cancers are "grossly under-recognized" and because they are "shattering" and "devastating" the lives of so many Americans, congress must act. And what sorts of things are imperiling our well being? Electricity, clean water, cell phones and juice bottles to name a few. When data does make an appearance it is often put to embarrassingly bad purposes. For example, one section implies the following: ionizing radiation causes cancer; electromagnetic fields are a form of radiation; therefore, electric wires, cell phones and Wi-Fi routers need to be avoided and regulated as carcinogens. 

Early on the authors set out their premise: "Most environmental hazards with the potential to raise cancer risk are the product of human activity ..." The claim is never supported (which is not surprising as it conflicts with what is known about the causes of cancer today) but it's the one consistent theme that runs throughout the paper and it thoroughly accounts for its conclusions. At the end there's a laundry list of chemicals and things to worry about; it's long enough to keep toxic tort lawyers and their experts (some of whom were interviewed by the panel) busy for decades. So it goes.

Tags:

Anti-H.pylori Therapy Cures MALT Lymphoma in H.pylori-Negative Patients. Hmmmm

We've defended a few gastric lymphoma cases in which the alleged cause was benzene exposure. The discovery that Helicobacter pylori was was the cause of most instances of the disease made the litigation go away. Nevertheless there have continued to be cases of MALT lymphoma in patients without evidence of H. pylori infection. Could their cancers have been caused by something besides a bacteria?

In "Treatment Outcome of Localized Helicobacter pylori - Negative Low-Grade Gastric MALT Lymphoma" the authors report on what happened when they treated some MALT lymphoma patients who had no evidence of H. pylori infection with anti-H.pylori antibiotics. Complete remission was achieved in each case.

The authors offer the following hypotheses about why giving people a drug to kill a particular strain of bacteria that they don't have that bacteria might nevertheless cure them of lymphoma: (1) a first cousin, H. heilmannii, might actually be the causative organism; (2) unknown bacterial agents susceptible to the antibiotics caused the lymphoma; (3) H. pylori at populations too small to be detected are still enough to cause lymphoma; and, (4) antibiotics eradicate MALT lymphoma not by simply killing H. pylori but rather by altering the resident immune system - resetting the system as it were.

Unless the answer is (3) MALT lymphoma will serve as yet another example of the fact that, save for very rare instances like pleural mesothelioma and erionite, "but for" causal attribution in cancer cases is exceedingly difficult.

Tags:

Was Estrogen-Progestin Hormone Replacement Therapy Responsible for High Rates of Breast Cancer in Marin County?

It certainly looks that way. Read: "Recent Trends in Hormone Therapy Utilization and Breast Cancer Incidence Rates in the High Incidence Population of Marin County, California".

There are three very interesting observations reported in the study. There's of course the strong correlation between the sharp drop in the incidence rate of invasive breast and the discontinuation of estrogen plus progestin hormone replacement therapy (EPHT). But there's also the fact that this group of well to do and well educated women apparently picked up on the HERS and WHI study results and almost overnight collectively and dramatically altered their preferences for a medical treatment. And then there's the discovery that hysterectomy rates varied wildly throughout the various counties in California.

As for the first finding, these and similar results continue to add to the overwhelming evidence that the breast cancer clusters in Marin County, CA and Long Island, NY are not due to environmental pollutants but instead are due to a mix of lifestyle, surgical procedures and medications along with a genetic component.

As for the second and third findings they reinforce the emerging view that comparing cancer rates from one county to those of other counties, to the state as a whole, or to national rates is perilous at best. Here Marin County women adopted EPHT early, did so at a high rate relative to women elsewhere in the state and underwent hysterectomies at a low rate relative to other women yet those causal factors were completely unaccounted for in early studies. As a result, activists and some researchers concluded that the cancer cluster had to do with the environment of Marin County rather than the lifestyle choices of its residents.

One of the underlying assumptions of epidemiological studies is that the population investigated and the group to which it's compared are the same. These results demonstrate that merely accounting for gender, race and age isn't enough and that lifestyle choices afforded by education and wealth can make a critical difference, both positive and negative.

But Sometimes Causation is Really, Really, Really Easy

As we wrote yesterday, causal attribution in most toxic tort cases is hard and the discovery that life and many of its diseases are emergent rather than predetermined phenomena has made the exercise even more complex. That said, sometimes causal attribution is easy - as in the cases of falling, being shot or developing mesothelioma after exposure to erionite.

50.5% of all deaths were due to mesothelioma in one village in Turkey and of women who moved from areas without erionite to this same village 69% of all deaths were due to mesothelioma. Read about it in: "Endemic Malignant Mesothelioma: Exposure to Erionite is More Important Than Genetic Factors".

Is there any carcinogen as potent as erionite? What do these numbers suggest about the mode of action of erionite? It sure looks as though the biological insult from erionite is more akin to that of some physical trauma than from some molecular biological disruption as in the case of a genetic mutation.

Causation is Really, Really, Really Hard

Life would be so much simpler if causation were binary - e.g. stay out of the sun and never get melanoma or worship the sun and die young of skin cancer. That way we'd have real choice, the virtuous would be spared and the heedless would be plagued. It doesn't work that way, of course.

Shockingly (or not) most people who sunbathe, drink or smoke don't die of skin cancer, throat cancer or lung cancer. What gives? Maybe the numbers are wrong or maybe the statistics are just some trick of government / industry / academia / nefarious "other". Those are a few of the explanations offered up by the readers of the San Francisco Chronicle in response to its new article: "Vitamin D Levels Dip" in which the claim that sunbathing might be good for you is explored.

That biological cause and effect, even at the level of a single protein, can't be put into simple one-to-one correspondence doesn't just vex bloggers; it is profoundly troubling to researchers and it's prompting many to reexamine views about causality in biological systems that were being investigated decades ago but which fell out of favor in the modern reductionist era.

In "Order Without Design" Alexei Kurakin nicely sums up the evidence for life, and thus diseases of life, being emergent processes unexplainable by reducing the system to its parts and its inputs. Life (and its afflictions) instead seems to be a dynamic process driven essentially by economic competition for energy and materiel at the molecular level. What is the evidence for this claim? One very big piece of it is found in the amazing plasticity of proteins.

We've all been taught that proteins, especially cytokines, work like locks and keys. It's an easy to grasp metaphor and promised easy-ish cures for what ails us. Disease was the product of missing keys or broken locks. Supply the missing key, or one that worked the broken lock, and the door to good health was open again, right? Too often though it turned out that replacement keys didn't work as expected and that broken locks weren't actually broken - they were just performing other functions.

Closer examination revealed that proteins were often found far from where they were thought to do their work and were twisted and folded into completely unexpected shapes. Further investigations revealed that many if not most proteins exist not in some concrete form with concrete functionality but rather in a "disordered" state waiting to be shaped and directed not by some genetic program or external event but rather by the tides of energy and matter within the cell itself. And it is out of the ebb and flow of those tides that the organized activity of the cell emerges.

There's much more in the paper and those which it cites, of course, but for our purposes suffice it to say that the question of causation in biological systems cannot sensibly be asked, as we do in our courts, "Was chemical "X" a producing cause of Plaintiff's cancer?" Perhaps the question should be something more akin to "Given Plaintiff's condition before exposure to chemical "X"  by how much was her risk of cancer increased by that exposure?" But then that doesn't really get it either. Take mesothelioma and amphibole exposure as an example. 

It's commonly said that amphibole exposure is a risk factor for mesothelioma in humans. But if that's the case why didn't the other 95% of the workforce at say the unibestos plant in Tyler, Texas get mesothelioma? Is it that amphibole-induced mesothelioma is a purely stochastic process such that those who developed the disease were just unlucky? Or rather is it the case that causation, in the case of chronic diseases anyway, isn't generalizable? That's the takeaway - there may not be such a thing as what lawyers call "general causation".

Vapor Intrusion Rises in Importance in 2010

Eight years after issuing “draft” guidance on vapor intrusion, the EPA will issue an “interim” guidance this year that is supposed to move the organization closer to issuing a final guidance in 2012. This sudden rise in importance was prompted by an evaluation that the lack of final guidance on vapor intrusion by the organization impedes efforts to assess indoor air risks. Since 2002, more than half the states and other governmental bodies have issued their own vapor intrusion standards, leading to ad hoc and inconsistent standards across the board. So why not finalize the draft? Well, the times have changed and so has the EPA’s approach. This new risk based approach no longer supports some of the assumptions inherent in the draft guidance. For instance, the EPA will use updated toxicity values, beginning with trichloroethylene (TCE) and tetrachloroethylene (PCE) toxicity values, to determine at what level an indoor risk exists, and consider more significantly atmospheric and building specific effects. But, alas, there are many more than assessment questions to be answered in the final guidance. Again, not waiting for the answers, ASTM International announced last week that it will soon release its ASTM E 2600 Guide: Vapor Encroachment Screening standard for conducting due diligence for sale of properties where potential vapor intrusion is a concern, a revision of its 2008 standard that was criticized for being overbroad. The ASTM standard will focus on identifying potential sources in the surrounding areas of the real estate property rather than broad assessment of an existing vapor intrusion problem. Years after the 2002 guidance, many thought the final guidance would be immediately forthcoming, but it was not. While more certainty is definitely desired by all parties involved on this issue, what we hope is that the “interim” guidance does not dance to the same tune as the “draft” guidance…one step forward and two steps back!

Tags: