Wyeth v. Rowatt: Substantial Confusion About Causation

Reading and re-reading and even re-re-re-reading the Nevada Supreme Court's opinion in Wyeth v. Rowatt only leaves me more perplexed about Nevada's take on causation in pharma/toxic tort cases. Typically a plaintiff must prove that if she hadn't been exposed to defendant's product she'd have been better off. In other words, defendant's product was a "but for" cause of her injury. There are of course cases that relieve plaintiff of having to prove to which of several defendants' identical products she was exposed (e.g. Sindell v. Abbott Laboratories) but she always has to prove, irrespective of who made it, that the product complained of is actually what made her ill.

The court in Wyeth v. Rowatt held that the following jury instruction was either OK or at least not harmful: "A legal cause of injury, damage, loss, or harm is a cause which is a substantial factor in producing or promoting the injury, damage, loss, or harm." Nevada has an instruction on "but for" causation and plaintiffs and defendant all requested it. However, the trial court instead gave a modified pattern jury instruction for substantial factor causation that reflected its understanding of the promoter theory of carcinogenesis - the idea that some things initiate cancer and other things propel or promote it, with hormone replacement therapy allegedly falling into the latter category - and stuck it not into the pattern instruction for "but for" causation but rather into the instruction on substantial factor causation. The pattern substantial factor causation instruction is to be used when the jury is confronted with two competing causes, either of which "would have been sufficient to cause the injury".

How can a promoter be a sufficient cause? It can't of course, but that's just a quibble about loose language. The real problem is that any sufficient cause, absent a superseding cause, is necessarily the "but for" cause and "substantial factor causation" is just "but for" causation + reasonableness so why not require the "but for" instruction in either instance unless you're watering down the causation standard?

In Texas we had an instruction similar to that used by the trial court in Rowatt. It was the old instruction for a "Producing cause" and years of jury trials and focus group experience conclusively demonstrated that the instruction - "Producing cause' means an efficient, exciting, or contributing cause that, in a natural sequence, produces the incident in question. There may be more than one producing cause" - led jurors to believe that they were permitted to find causation whenever the putative cause might have or could have been one among a constellation of possible causes. The Texas Supreme Court finally made the instruction conform to the law in 2007 with it's opinion in Ford Motor Company v. Ledesma writing that the components of a producing cause are "that (1) the cause must be a substantial cause of the event in issue and (2) it must be a but-for cause, namely one without which the event would not have occurred."

Within the Rowatt opinion is a brief discussion of risk but rather than using it to inform the state's "substantial factor causation" jurisprudence the court instead held that a four-fold increase in risk claimed by plaintiff's expert somehow made the lack of the "but for" instruction harmless. So are they saying that anytime relative risk is above two, causation is established? They don't say anything like that and even if they did it still has to be (everywhere else) a "but for" cause. The big risk increase is just a way to satisfy the preponderance of the evidence burden on "but for" causation.

If you've got an insight into how Rowatt fits within a modern conception of causality in the law I'd appreciate it if you'd drop me an email re: same.

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Risk Factors For Pancreatic Cancer

Smoking and H. pylori are at the top of the list. Further down you'll find much weaker risks like alcohol, diabetes, metabolic syndrome and having a non-O blood type. Here's the newest review: "Epidemiology of Pancreatic Cancer: An Update".

Pesticides and Prostate Cancer: A Two-fer

Epi + Biomarkers = "An Update of Cancer Incidence in the Agricultural Health Study" + "Pesticide Use Modifies the Association Between Genetic Variants on Chromosome 8q24 and Prostate Cancer".

"A Global Toxic Emergency"?

The Story of Stuff people have now released "The Story of Electronics". In it they proclaim "a global toxic emergency" declaring that Silicon Valley is "one of the most poisoned communities in the U.S." and repeat an old canard about the alleged toxic perils of working in high tech manufacturing in general and clean rooms in particular. As is typical of such pieces even the most modern facilities are portrayed as little better than the Triangle Shirtwaist Factory.

Coinciding with the video's release comes the publication of its antidote. In "Cancer Mortality Among US Workers Employed in Semiconductor Wafer Fabrication" the health outcomes of 100,081 semiconductor workers employed between 1968 and 2001 were examined and analyzed. Compared to people in the general population of similar age, gender and race their overall risk of death from all causes combined was cut in half and their risk of dying of any sort of cancer was just three quarters that of other people. As for cancers of the blood referenced in "The Story of Electronics", there's nothing to worry about in that regard either.

The paper concludes "Work in the US semiconductor industry, including semiconductor wafer fabrication in cleanrooms, was not associated with increased cancer mortality overall or mortality from any specific form of cancer."

The exposure assessment for these same workers was also just published and can be found in "Exposure Assessment Among US Workers Employed in Semiconductor Wafer Fabrication".

Another Paper Reports a Strong Association Between Chrysotile and Lung Cancer

Interestingly, there's a dramatic difference in risk between those with heavy and those with moderate exposure to chrysotile asbestos and, in fact, the small increase in risk to those with moderate exposure did not reach statistical significance. See "Lung Cancer Mortality From Exposure to Chrysotile Asbestos and Smoking: A Case-Control Study Within a Cohort in China".

Baron & Budd Takes Georgia-Pacific v. Bostic to the Supreme Court of Texas

Georgia-Pacific v. Bostic, which prompted us to write The End of Toxic Tort Litigation in Texas? may be on its way to the Texas Supreme Court. Here's Baron & Budd's Petition For Review. Bostic is a mesothelioma case in which plaintiff prevailed at trial against a peripheral defendant but lost the claim on appeal when the Fifth Court of Appeals held that she had failed to prove that her decedent's exposure to that peripheral defendant's product was a "but for" cause of his fatal cancer.

Bostic's best argument is that the application of a "but for" standard of causation to a particular exposure by the appellate court makes it impossible for any toxic tort plaintiff whose illness was allegedly caused by one or more of several exposures to prevail. Here, plaintiffs get it exactly right. Whenever plaintiff's injury has been proved to have been caused "but for" a bullet (as in the "one hit" case of Summers v. Tice) or "but for" a sufficiently high concentration of salt (as in a cumulative injury as in Landers v. Texas Salt Water Disposal Co.), and where each actor's conduct was tortious, plaintiff is relieved of the logically impossible task of proving that each tortfeasor's conduct was a "but for" cause. The Texas Supreme Court has already made this point in in the asbestos context in  Borg-Warner v. Flores.

Baron & Budd gets it wrong however when they argue that (1) Borg-Warner only demands a Lohrmann-esque frequency, regularity and proximity exposure qualification in malignancy cases in general and in mesothelioma cases in particular; (2) that dose, and therefore risk, quantification is only required when the parties dispute what, in general, caused plaintiff's injury (e.g. it ought not be required when the parties agree that asbestos exposure was responsible for a plaintiff's mesothelioma); and, (3) that the standard for substantial factor causation somehow changes according to the facts of the case.

The whole point of Borg-Warner and the almost two decades of Texas Supreme Court cases that preceded it is to put the requirement for demonstrating wrongful, unreasonable conduct back into the state's law of torts. For Georgia-Pacific to have prevailed on appeal it should have been because its product posed at most a de minimis risk of mesothelioma,.not because plaintiff couldn't prove that its asbestos contributed to Bostic's cancer.  

If all your product poses is a vanishingly small risk of harm, in this a world of inevitable and uncountable risks, then you've acted neither unreasonably nor wrongfully and the substantial factor test, which is a combined query about causation and legal responsibility, will decide the matter and you'll not be deprived of your property. It's precisely because calculations of risk (the measure of the reasonable man and which are derived from estimates of dose) often show peripheral defendants to have acted neither wrongfully nor unreasonably that plaintiffs' counsel hate dose estimation.

Cell Phones and Brain Cancer: What Was The New York Times Thinking?

Recently the NYTimes published "Should You Be Snuggling With Your Cellphone?" in which it reported that the question of whether cell phones pose a risk of brain cancer is far from settled. Indeed, largely ignoring the overwhelming evidence that electromagnetic radiation does not increase the risk of brain cancer the article references an unidentified study showing an increased rate of brain cancer in the presumably cellphonophilic 20-29 year old age group, "400 scientific papers" that support the theory that radio waves cause "damaged brain DNA", and concludes with this quote by epidemiologist and author of the newly published "Disconnect" Devra Davis: "I do think I'm looking at an epidemic in slow motion". 

Google serves up a link to Environmental Health Trust which has front and center handy links to a "press kit", and variety of write-ups including (1) that the best evidence does support a causal link; (2) a warning to women to keep cell phones away from their chests as the radio waves "seep directly into soft fatty tissue" and may cause breast cancer; (3) heavy cell phone use decreases sperm count by 50%; (4) that we should be horrified by the sight of young children using iPhones as they are frying their young brains; (5) a conspiracy by industry and lobbyists to obfuscate the facts and prevent urgently needed anti-cell phone legislation; and, (6) the inevitable lawsuit by someone with an unidentified form of brain cancer who claims cell phones are as addictive as cigarettes and just as deadly - the evidence that cell phones caused his cancer seems to be limited to the fact that he was athletic, a non-drinker / non-smoker who led "an over-the-top healthy lifestyle".

Well, increasing risk of brain cancer in young adults, "damaged brain DNA", a corporate conspiracy and a plaintiff who talked on his phone four hours per day 365 days per year, how is this NOT the start of a massive mass tort? Here's how.

Let's take that troubling trend of increasing brain cancer in 20 - 29 year olds. Open up this month's journal of Neuro-Oncology and you'll find "Brain Cancer Incidence Trends in Relation to Cellular Telephone Use in the United States". Yes, there's small increase in incidence for males but the increase began "before cell phone use was highly prevalent". Yes there was an increase for women in that age group too but it was limited to frontal lobe cancers and since I've never seen a woman use her cell phone by holding it to her forehead I have to wonder if the absence of any increased risk in brain cancers near the ears isn't the most important finding of this huge study. And in fact its authors conclude "these incidence data do not provide support to the view that cellular phone use causes brain cancer". See also: "Mobil Phone Base Stations and Early Childhood Cancers: Case-Control Study" which found "no association between risk of early childhood cancers and estimates of the mother's exposure to mobile phone base stations during pregnancy" and, of course, "Brain Tumour Risk in Relation to Mobile Telephone Use: Results of the INTERPHONE International Case-Control Study" which showed that most cell phone users were if anything at a decreased risk of cancer.

Damaged brain DNA (whatever that is)? "Analysis of Proteome Response to the Mobile Phone Radiation in Two Types of Human Primary Endothelial Cells".

And the claim of industry bias or outright conspiracy to silence the truth or co-opt scientists? Try "Studies of Mobile Phone Use and Brain Tumor Risk Are Independent of Industry Influence".

Finally, brain cancer is always tragic, whether it strikes down a U.S. Senator or my next door neighbor at age 48; and their drinking, smoking and exercising status makes no difference as none are risk factors, positive or negative.

To this day the cause or causes of brain cancer remain unknown. All you can do is drink your coffee or tea and hope that one of life's deadly bolts out of the blue doesn't strike you.

New Voir Dire Question: Do You Own Shares in Any Lawsuit?

Mass tort litigation is big business. In the past, thanks to rules prohibiting fee sharing with non-lawyers, it was a big business in which only lawyers could participate. Not anymore; at least not if you're in private equity, a hedge fund or are a bank. All it takes is cash, high tolerance for risk and an appetite for big returns.

Today the NYTimes has an excellent (save for one common misperception) article on the subject: "Putting Money on Lawsuits, Investors Share in the Payouts".  My quibble is with the claim that the money pouring into investments in contingent fee recoveries "... is helping to ensure that cases are decided by merit rather than resources ". It's not true and hasn't been for decades; at least not for the big dogs and not for mass tort cases. They already (a) have bigger and faster jets than the companies they're suing; (b) own or control their own banks; (c) only have to focus their efforts in one jurisdiction; and, (d) can readily syndicate really big cases within a network of very business savvy lawyers. Those entrepreneurial lawyers who started all this vowed long ago never to be outspent and I've yet to see it happen.

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What's the Skinny, Captain Hindsight?

On several occasions we've written about how successful plaintiff lawyers exploit hindsight bias and turn the so-called forseeability defense back on unsuspecting defendants. Why are emergent phenomena impossible to predict yet obvious in retrospect? Take it away, Captain Hindsight

Childhood Leukemia and Population Mixing: The Evidence Mounts

Despite numerous attempts to blame anything and everything associated with a deep pocket for a cluster of childhood leukemia cases in Fallon, NM,  the strongest evidence by far supports the hypothesis that an infection, spread by the sudden mixing of two or more populations, was responsible. Now there's evidence that childhood leukemias previously blamed on nearby nuclear reactors are in fact strongly associated with population mixing. See "Childhood Leukaemia, Nuclear Sites, and Population Mixing".

That introducing lots of new workers to a formerly rural environment to build a military base or nuclear power plant often is accompanied by an increase in childhood leukemia cases is now confirmed by more than a dozen studies. That often unnoticed infections cause cancer is also well established. So, what duty, if any, is owed to the local children and to the children of its own employees when a business sets up say a slaughterhouse in rural North Carolina and staffs it with workers from a long way away? And if there is a duty, how is it to be fulfilled? To warn? Of what? To monitor? For what? To protect? With what?

More Evidence That Exposure to Diesel Exhaust is Causally Associated With Lung Cancer

The increased risk is smallish, with an odds ratio of 1.31, but the finding was consistent, showed a strong dose-response relationship and statistically significant (95% CI of 1.19 - 1.43). Read about it in "Exposure to Diesel Motor Exhaust and Lung Cancer Risk in a Pooled Analysis from Case-Control Studies in Europe and Canada".

What Do Hamburgers and King Tut Have In Common?

The key to preservation well past their expiration date is dessication.

One of the best things about the Internet is that urban myths don't circulate very long before someone who learned how to think critically puts the smack down on a specious claim. A perfect example is the claim that McDonald's hamburgers aren't "real food" because they don't rot. See e.g. "McDonald's Happy Meal Resists Decomposition for Six Months" and, for the use to which a 12 year old unrotted McDonald's hamburger is put, see: "1996 McDonald's Hamburger".

It didn't take long for someone with critical thinking skills to ask the right question: is a McDonalds'hamburger any more resistant to rot than a homemade burger.? In "The Burger Lab: Revisiting the Myth of the 12-Year Old McDonald's Burger That Just Won't Rot (Testing Results!)" a simple experiment answered the question. McDonalds hamburgers are no more resistant to decay than one made by hand from ground beef and fresh buns from the grocery store. Mummies and hamburgers that dry out and are kept away from moisture last a long time and for the same reason.

The efforts to demonize food prey on the gullible. Stay skeptical.

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Bisphenol A Roundup

Since it's detected at low levels in 95% of us and since Americans have been exposed to it for more than 50 years you'd think someone would have noticed if exposure to bisphenol A (BPA) were responsible for widespread illness, deformity and death. Apparently not, at least not if the findings from a recent wave of BPA studies are to be believed.

The new findings are, in no particular order, that BPA: (a) damages sperm (b) inhibits the normal development of ovaries (c) alters brain development (d) causes premature birth (e) may be a carcinogen like DES (f) damages blood cells (g) activates breast cancer cells (h) impairs the body's defenses against colon cancer especially in women; and, (i) makes offspring anti-social and neurotic. And those are just a few of the "findings" published in the last two months. Obviously the world that existed before 1950 or so, before  BPA was everywhere used to seal bacteria out of food and dental cavities, had to have been a much healthier and more peaceful one. Alas.

Maybe That's Why You Fell For Her. She Cooks Just The Way Your Mom's Gut Microbes Like It.

Biological causation gets more complex by the day and the simple, reductionist model of toxin in - disease out common to toxic tort cases gets more absurd by the day. Imagine what you'd have thought two years ago about this claim: the diet of a fruit fly changes the composition of the bacteria in its gut and those bacteria then change the pheromones she releases so that she will attract a male fruit fly with the same sort of bacteria in his gut resulting in a mating preference change that lasts up to 37 generations even if her offspring's diet changes along the way.

Thus, it's not just a matter of "They Are What You Eat"; it may well also be a matter of "You Are What Your Great Great Great Great Grandmother's Intestinal Bacteria Ate". See "Bacteria Can Drive the Evolution of New Species" in Nature News for the write-up and "Commensal Bacteria Play a Role in Mating Preference of Drosophila melanogaster" for the paper that heralds the discovery.

For more on the idea of a "hologenome" - i.e. the idea of thinking of "your" genetic code as consisting of the genes in your chromosomes plus those in the bacteria that live in and on you - see the following:

"Role of Microorganisms in the Evolution of Animals and Plants: the Hologenome Theory of Evolution"

"The Hologenome Theory of Evolution Contains Lamarckian Aspects Within a Darwinian Framework"

"Whole-Body Systems Approaches for Gut Microbiota-Targeted Preventive Healthcare"

Tracing For The Win

So much for SanGar Produce & Processing Company's objections to state testing procedures that detected Listeria monocytogenes in its San Antonio plant. The FDA has not only confirmed the presence of L. monocytogenes at the plant it has also confirmed that the strain found is identical to that which sicked many and killed four already immune compromised individuals.

This is what the investigation of foodborne outbreaks will produce increasingly from now on - swift and irrefutable tracing back to their origin.
 

Why Do Acquarians and Geminis Differ About the Efficacy of Bone Marrow Transplants?

Let's say that you had chronic myeloid leukemia (CML) and that your doctor recommended a bone marrow stem cell transplant. Let's also say that you decided to check out the literature so as to be better informed. When you did you found that in a well designed study of 626 CML patients a large and highly statistically significant difference in risk of death from the procedure was revealed. Indeed, those transplant patients with the astrological sign of Aquarius were likely not to die in the following 5 years whereas those born under the sign of Gemini had a much greater risk of death and in fact were more likely than not to die within 5 years of the procedure. Finally, let's say that you are, in fact, a Gemini. Do you go ahead with the transplant?

Ok, ok. Before you make up your mind you go looking for other papers published in respected peer reviewed journals that look at zodiac sign and medical treatments. Guess what? You find other papers also showing that your sign is associated with a statistically significant increase in risk of injury or death! Now what?

Well, the first thing you need to remember is if you're dredging data for statistically significant associations and you don't find any, well, all that proves is that you don't know what you're doing. Epidemiology works when you formulate a hypothesis and then test it. When you go dredging for data without having in hand a hypothesis to be tested, knowing that the laws of probability will invariably generate statistically significant yet spurious associations, you're just manufacturing "science"; discovering nothing and flaunting the scientific method in the process.

For a fun read about why Geminis ought not worry about their sign and how statistically significant associations, based on the most rigorous statistical analyses, can be be generated at will to support, if that's the word for it, the most absurd causal inferences read: "Sign of the Zodiac as a Predictor of Survival for Recipients of an Allogeneic Stem Cell Transplant for Chronic Myeloid Leukaemia (CML): An Artificial Association".

A Man Is Not A Mouse, At Least When It Comes To Butadiene

Why are mice so much more susceptible to butadiene? Apparently it's because they metabolize it into potent mutagens at 200 times the rate of humans. As a result, while mice exposed to butadiene at current occupational levels promptly yield evidence of genotoxicity there's no evidence of genotoxicity in humans at current workplace exposure levels. See: "1,3-Butadiene: Biomarkers and Application to Risk Assessment".