Mass Torts: State of the Art

"[A]dopting the Third Restatement Would Increase the Expense of Litigation"

David Oliver — Tue, 08 May 2012 15:36:49 -0600

An Arizona appellate court has looked at the evisceration of duty in the Restatement Third and recognized the effort for what it is: an approach that "significantly lessens the role of the court as a legal arbiter of whether society should recognize the existence of a duty in particular categories of cases; for this reason, adopting the Third Restatement would increase the expense of litigation." Accordingly the court held that while "restricting the dismissal of negligence actions for lack of duty may be thought desirable as more protective of a litigant's jury-trial right, such a fundamental change in the common law requires an evaluation of competing public policies that is more appropriately addressed to the Arizona Supreme Court" and so declined a request to adopt the Third Restatement. See Delci v. Gutierrez Trucking Company.

In Arizona duty remains an essential element of negligence. Which is to say that Arizona's courts, like most American courts, "do not understand the law to be that one owes a duty of reasonable care at all times to all people under all circumstances." Palsgraf lives.

Discretizations

David Oliver — Mon, 07 May 2012 00:34:50 -0600

Scientists are mobilizing in response to the emerging threat of hypervirulent strains of drug resistant hospital acquired infections.

Finding a way to keep microbes from setting up shop on fomites, which all too often harbor pathogens and facilitate their spread, is an obvious place to start.

One promising approach is to coat surfaces with silver or copper nanoparticles - and it seems to be working.

All good, right? Wrong. Some people are very much alarmed and want the reins pulled back on science. (Be sure to read the comments if you want to get the point).

But aren't microbes good? Some sure are and the only way to have a sound immune system for life is to be exposed to them ASAP - and the window may close within a week or two of birth.

That's not what we're talking about though. We're talking about the ones that want to kill you and feast on your decaying flesh.

Meanwhile, somewhere up in Colorado, a court thinks that "differential diagnosis" is a way to find a novel cause rather than to discriminate between established causes. Too bad it rests upon the twin fallacies of appeal to ignorance and post hoc ergo propter hoc when used in such a fashion.

5-Methylene-1,3-Cyclopentadiene

David Oliver — Fri, 04 May 2012 13:06:02 -0600

I thought of fulvene, also known as 5-methylene-1,3-cyclopentadiene, when I read the following in a new law review article (funded, strangely enough, by a National Science Foundation grant):

Tort actions may impel industry to take voluntary steps to redesign chemical molecules ... to be less toxic.

Fulvene you see is made up of six carbon and six hydrogen atoms. So is benzene and so are a few other molecules. The point of course is that while you might be able to rearrange a car's component parts to make it somehow safer while leaving it a car you can't rearrange benzene's atoms (or those of any other complex molecule for that matter) without turning benzene into something else. Something with a different boiling point, solubility, reactivity and the like. Something that cannot, as benzene can, be used to make the breast cancer drug tamoxifen.

The law review article is "Litigating Toxic Risks Ahead of Regulation: Biomonitoring Science in the Courtroom" and it dovetails with "How Chemicals Affect Us" which you've likely seen in the NYTimes. Each claims that very low levels of exposure to substances previously thought safe may be causing subtle changes and each ends with a call for regulation; the former by way of lowering evidentiary standards in tort proceedings so as to bring about more claims and bigger awards and the latter by way of the regulatory state. Irrespective of wielder the same tool is urged: one that resolves all uncertainties in favor of stasis, of inaction, i.e. the Precautionary Principle.

"Litigating Toxic Risks", funded under a $366,785 research grant for "Toxic Ignorance and the New Right-to-Know: The Implications of Biomonitoring for Regulatory Science", proceeds from the hypothesis that "toxic tort litigation has emerged as a means of controlling risks." It recounts 1) the number of chemicals that have never been tested for toxicity (tens of thousands); 2) the non-stop synthesis of new ones; 3) the purported shortcomings of TSCA; 4) the fact that asbestos and lead paint are made of chemicals and turned out to adversely affect some of those exposed; 5) the apparently obvious conclusion "it follows that many of today's routine chemical exposures are cause for great health concern"; and, finally, 6) the ability of biomonitoring to demonstrate those chemicals to which we've been exposed. The authors then deduce that the effort to regulate chemicals via toxic tort litigation "depends greatly on whether courts are able to apply tort theories to the scientific data used in appraising the health risks of chemicals".

They lament, however, that there's no cause of action for simply being exposed to the activities of other people; that plaintiffs must show harm - an adverse health effect - before they can prevail. Regarding those chemicals to which everyone is exposed in low doses they complain that it's not practical for plaintiffs to do epidemiological studies since there is (unsurprisingly) no unexposed reference population. Furthermore, the cost and time involved in doing epi and tox studies are significant. So, if standards of proof could just be lowered the class action mechanism would expose potential defendants to existential liability risks for harms they probably didn't cause (see pg. 6) so that vast sums could be extracted from them and the production of synthetic chemicals would be thereby curtailed or eliminated.

Additional helpful measures would include dropping the requirement that class members demonstrate that they have actually been exposed to the substance in question. As support for this assertion the authors write "[t]he courts' current stance contradicts standard scientific procedure, where it is well recognized that sampling can lead to reliable assumptions about population characteristics". (Really? A calculated sample mean is superior to knowledge of the actual population mean for making conclusions about the population? And superior to even knowing the actual exposure of each member of the population?)

To make sure that as many people as possible can assert medical monitoring claims the article's authors urge "implementation of the precautionary principle in the legal standards required to show significant exposure and increased risk of disease". The precautionary principle apparently will turn every "is it likely" hurdle to plaintiffs' recovery into an "is it possible" speed bump.

As for damages "courts can accept, as legally actionable injuries, subtle health and developmental impacts as well as emotional concern and stress related to chemical exposure."

So far some 50 million different chemical substances have been cataloged and 12,000 new ones are added every day. Most were synthesized by nature rather than by man. Over the eons our ancestors managed to survive in this sea of chemicals, surrounded and inhabited by countless biochemical factories constantly synthesizing new molecules in order to survive in and/or exploit their ever-changing environment - and our ancestors largely did it by synthesizing their own new molecules. We've only had trouble when we've been out-engineered by our biochemical competitors or when we've violated the rule: "all things in moderation". So what's with the chemohysteria over trace exposures and the discovery that our bodies notice and adapt to them on the fly?

I think a large part of it stems from the fact that we've come to realize our genetic code is more toolbox than blueprint; that we're far more impermanent than we ever imagined; and, that so much of what we believed about how it all works, especially decades old myths about the principal causes of human diseases, is being swept away by remorseless empiricism. The attempt to incorporate the Precautionary Principle into the law can thus be seen as part of a deeply conservative movement, standing athwart science, yelling Stop!

Why Don't Multiple Statistically Significant Studies Demonstrating A Strong Association, Plus Biologic Plausibility, Add Up To Causation?

David Oliver — Thu, 26 Apr 2012 09:24:11 -0600

Imagine that you've got a case involving a drug or chemical and there exist multiple well done studies including randomized controlled trials that show consistently strong and statistically significant associations between the drug or chemical and the plaintiff's disease. There's also a very plausible biologic mechanism whereby the substance causes the disease which has been proposed in the scientific literature. Furthermore, the medical records demonstrate via biomarkers that the plaintiff was indeed extensively exposed to the drug or chemical. Causation's a snap, right?

Probably, but it shouldn't be. Consider the case of periodontal disease (PD) and atherosclerotic vascular disease (ASVD). As we've noted previously there are some very intriguing studies published in the literature suggesting a link between the two; a link that has been theorized for many decades. Now, using an evidence-based approach to deriving recommendations from available research (Level of evidence A: recommendation based on evidence from multiple randomized trials or meta-analyses; Level of evidence B: recommendation based on evidence from a single randomized trial or nonrandomized studies; Level of evidence C: recommendation based on expert opinion, case studies, or standards of care) the American Heart Association has put the theory to the test and found it wanting.

You can download (free) a copy of the paper, "Periodontal Disease and Atherosclerotic Vascular Disease: Does the Evidence Support an Independant Association? A Scientific Statement From the American Heart Association" and see how sound causal inferences are made.

Even though "[a]n association between PD and ASVD is supported by evidence that meets standards for Level of Evidence A" and "[a] benefit of periodontal intervention in decreasing local periodontal inflammation is also supported by level A evidence. Causation of ASVD by PD is not supported by either level A or level B evidence." How could this be?

"[P]eriodontal and cardiovascular diseases share multiple risk factors that are prevalent and powerful promoters of disease, including tobacco use, diabetes mellitus, and age." Accordingly, "statements that imply a causative association between PD and specific ASVD events or claim that therapeutic interventions may be useful on the basis of that assumption are unwarranted."

So again, correlation, even strong and consistent, and even coupled to biologic plausibility, ain't causation.

The Debate About Science, Evidence and Scientific Evidence: A Plaintiff Attorney's Perspective

David Oliver — Mon, 23 Apr 2012 15:14:32 -0600

Competing ideas are sharpened as they're ground against one another. We've posted our thoughts about the role of science in the courtroom - now read: "The Difference Between Scientific Evidence And The Scientific Method" by Max Kennerly of the Beasley Law Firm.

Discretizations

David Oliver — Fri, 20 Apr 2012 12:04:19 -0600

Random variability often trumps genetics and environment

It's sensible to avoid vegetables irrigated with untreated sewage water.

There's another case of long term disease-free survival in a pleural mesothelioma sufferer.

HPV-associated cancers in women are now more common than ovarian cancer.

An outsider looking in would conclude that California asbestos litigation serves mainly to enrich lawyers.

How Science Works (When It Doesn't Work)

David Oliver — Fri, 20 Apr 2012 02:42:45 -0600

In light of the NYTimes' "A Sharp Rise in Retractions Prompts Calls for Reform" we thought it would be a good time to revisit some of our objections to "Reference Manual on Scientific Evidence (Third Edition)"; particularly the second chapter, "How Science Works". Here goes.

Avoiding any pretense of humility the Reference Manual dismisses as woefully naive and inadequate those claims about the essence of the scientific endeavor that were ingrained in us in school. Sir Francis Bacon's scientific method? "[E]ven ... in his own time there were those who knew better." The idea that scientists ought to be unbiased observers of nature? What is seen from the shoulders upon which observers stand in order to see a bit further depends as much on the giant as on the observer; meaning somehow "Bacon has been left behind". In the chapter's section on myths and facts about science the Reference Manual says "Myth: Scientists are people of uncompromising honesty and integrity. Fact: They would have to be if Bacon were right about how science works, but he was not." Talk about cynical.

Then there's the section on Sir Karl Popper, unaffectionately known among some academics as "the man who murdered Karl Marx and Sigmund Freud". Seeing no use for hypotheses that were infinitely explanatory yet unable to accurately predict anything, Popper accepted Hume's problem of induction but found in those theories that made claims about what would follow if they were true a way to distinguish science from pseudoscience. Can the hypothesis be put to a test that it would fail were it not true? This is the criterion of falsifiability which found its way into Daubert.

The Reference Manual (like so many attacks on Popper since Daubert came out) starts by body-slamming pro wrestling-style a straw man: the claim that Popper believed a good scientist should think mightily, perceive a pattern, find a sound explanation and then spend the rest of her days attempting to prove herself a fool; meanwhile taking no sensible action that would follow from her hypothesis. To the contrary, Popper clearly opined that we ought to act on the best available evidence while keeping an open mind.

The Reference Manual then points out that a falsified theory might actually be an indictment of the giant upon whose shoulders the scientist stands rather than her reasoning. Sure. It might be true that everything we thought we knew about something is wrong (and revolutions do happen - think e.g. the human microbiome) but such a claim would be extraordinary and demand extraordinary proof. Barring such proof we're pretty safe concluding that a claim requiring we throw out everything we know is likely false. Unsurprisingly the Reference Manual, operating on the view that objectivity is an illusion, that you can never prove anything is false and that you can never prove anything is true ("the apparent asymmetry between falsification and verification that lies at the heart of Popper's theory thus vanishes") and thus without any track to follow, quickly careens into post-modernism.

Suddenly "science" is about context. Suddenly "science" is no longer about a quest for truth. "It takes a great deal of hard work to come up with a new theory that is consistent with nearly everything that is known in any area of science. Popper’s notion that the scientist’s duty is then to attack that theory at its most vulnerable point is fundamentally inconsistent with human nature." Science is thus about self-interest and power:

Myth: Scientists must have open minds, being ready to discard old ideas in favor of new ones.

Fact: Because science is an adversary process in which each idea deserves the most vigorous possible defense, it is useful for the successful progress of science that scientists tenaciously hang on to their own ideas, even in the face of contrary evidence (and they do, they do).

Of Thomas Kuhn the Reference Manual shrugs and says that all that business about paradigms collapsing to be replaced by new ones is similarly unevolved thinking. Instead "science does not, as Kuhn seemed to think, periodically self-destruct and need to start over again, but it does undergo startling changes of perspective that lead to new and, invariably, better ways of understanding the world. Thus, science does not proceed smoothly and incrementally, but it is one of the few areas of human endeavor that is truly progressive." One imagines the author spray painting "Ptolemy Lives!" on a subway wall.

Finally, even poor Galileo gets thrown in the ash bin of scientific history. Remember "the authority of thousands is not worth the humble reasoning of one single person"? False (or so says the Reference Manual). "[A]uthority is of fundamental importance to science... The triumph of reason over authority is just one of the many myths about science ..." Ugh.

So all the great thinkers were wrong. Objectivity is out. Testability is out. Keeping an open mind is out. Skepticism is right out. The appeal to authority is not a logical fallacy but fundamental to science. And supposedly it all adds up to making 21st century science conducted under such an understanding the best ever since, according to the Reference Manual: "There is no doubt at all that twentieth century science is better than nineteenth century science, and we can be absolutely confident that what will come along in the twenty-first century will be better still." So how's that working out for us so far in the 21st century?

Not so well. From the NYTimes article linked above it appears that bad science, unreproducible science and downright fraudulent science are all way up. We find ourselves in a "dysfunctional scientific climate." The problem? "You can't afford to fail, to have your hypothesis disproven." "It's a much more insidious thing that you feel compelled to put the best face on everything." That's it then. The conduct the Reference Manual calls science, hatching and clinging tenaciously and unquestioningly to a pet theory, even in the face of falsifying evidence, in hopes of becoming an authority in order to get more money just to repeat the cycle all over again, has led to a crisis in science. And the solution? Happily Dr. Casadevall, on the committee that oversees the writing of the Reference Manual, preaches giving graduate students a better understanding of what science ought to be - "the science of how you know what you know". Dollars to donuts the sermon will be long on critical thinking and real short on appeals to authority.

Science gained its prestige and respect not only from its ability to predict (and thus to allow us to make better choices) but also from its promise to respect knowledge, however humble she who reasoned it out. And despite whatever rot and corruption has crept into it in the last 20 years, the science that Daubert embraced still commands enormous respect. It's a science undaunted by authority, unimpressed by mere credentials and unafraid to dip any belief we hold dear in its acid bath of skepticism. And, especially in the biosciences, it's on the verge of sparking changes on par with, or more likely surpassing, those that followed the industrial revolution.

Discretizations

David Oliver — Mon, 16 Apr 2012 11:38:27 -0600

Bernie Goldstein's belief that "it's 90% likely that benzene is a cause of multiple myeloma" carried the day in a case in which plaintiff wasn't exposed to benzene but rather to other aromatic hydrocarbons having (unsurprisingly) a benzene ring.

There's considerable uncertainty about the benefits and cardiovascular risks associated with diabetes drugs, including metformin.

Ten years later, the silly cooking-your-food-produces-acrylamide-which-will-give-you-cancer scare can finally be laid to rest.

Chicken meat is a likely reservoir for extraintestinal pathogenic E. coli - the cause of millions of cases of urinary tract infections in the U.S. annually.

Subsequent asbestos exposures do not appreciably increase the risk of mesothelioma in those exposed in the distant past.

Pretty Good, Except for Footnotes 82 and 105

David Oliver — Mon, 09 Apr 2012 21:18:39 -0600

See: "Admissibility Versus Sufficiency: Controlling the Quality of Expert Witness Testimony in the United States".

Though a co-author hails from a law school named after one of the lawyers who is said to have made hundreds of millions of dollars off of the breast implant hoax and the lead was one of the first experts called by plaintiffs to testify in Texas' asbestos MDL, they get it right, more or less, when writing that the decision to exclude an expert under Daubert is really a query into the sufficiency of plaintiff's evidence rather than the raw admissibility of the proffered testimony. Can the expert sustain plaintiff's burden of production? That's the question. If not, why bother wasting everyone's time and money to go through the motions of holding a horse race the outcome of which has already been decided?

Their second point, that Daubert's inquiries about falsifiability and the likelihood that the expert's method has produced a false positive, is less compelling. While it's true that you can find a heap of non-analytical philosophical papers positing that truth is personal, that the quest for objective knowledge is meaningless and that nothing can really be falsified, the people who design and especially the people who board airplanes prefer to have them tested first. So don't expect to see falsifiability or rate of error vanish anytime soon.

The third point, that the abuse of discretion standard on appeal needs a "hard look" seems a bit undeveloped and rates a "meh" in our opinion.

The fourth, and best point, is that courts ought not simply let the jury figure it out and then fix the verdict if they get it wrong. I first ran into the issue in a trace benzene case. Admitting that the plaintiff's exposure to benzene at my client's facility was considerably less than his EPA and OSHA estimated background dose the plaintiff's expert opined that "naturally occurring benzene has a different electron resonance orbit than synthetic benzene" and that only man-made benzene had the toxic electron resonance orbit. Having a chemistry degree undergrad came in handy (though a BS-O-Meter would work as well), but not handy enough. The judge refused to exclude the expert saying he'd "take care of it" if the jury didn't. Needless to say a cost-of-defense settlement was reached. So hooray for the conclusion that "in an adversarial system employing lay fact finders there are multiple reasons for imposing a reliability filter on expert evidence."

Our main gripes are with footnotes 82 and 105. In footnote 82 the authors write: "The idea that a regulatory agency would make a carcinogenicity determination if it were not the best explanations of the evidence, i.e., more likely than not, is silly." First, the idea that critical thinking and regulatory agencies subject to political whims make strange bedfellows ought not be surprising. Second, the idea that "specific causation is not scientific" fails both to acknowledge the usefulness of biomarkers and that the very same probabilistic approach to causal inference that works for general causation works for specific causation. Finally, sneaking in reasoning to the explanation as a proxy for "more likely than not" ignores the method's provenance. It is rather a "guess" awaiting a test.

Footnote 105 quibbles with the role of statistics in all this (quoting Haack approvingly) "as the phrase 'tested or verified' suggests, what this really says is that the plaintiff's experts have produced no statistically significant evidence supporting the claim that Parlodel increases the risk of postpartum stroke." No, what the cited case says is that what the plaintiff's experts produced was highly likely to have been wrong. The point of the statistical test is to ask how likely it is that your hypothesis rejecting the null hypothesis is wrong. If you remember that all we know, as we make our way through Galileo's dark labyrinth towards the truth, is what isn't so you'll appreciate the difference.

All in all it's a good read and its conclusion, that courts indeed ought to filter out those claims that can never be proven, makes it well worth the time invested.

1% of the Fault to Plaintiff, 2% to the Negligent Tortfeasor and 97% Percent to the Intentional Tortfeasor Means 99% of the Liability to the Negligent Tortfeasor

David Oliver — Tue, 03 Apr 2012 21:54:03 -0600

Huh? That's what we said.

Because the civil law (at least in the Court of Appeals of Indiana) is all about the Benjamins, a court has found that an ever so slightly negligent (2%) business owner needs to pay for 99% of the harm caused by a murderer. Citing the Restatement (Third) of Torts. Section 14, a public policy in favor of adequately compensating the wronged (though, without discussion, they may be inadequately compensated thanks to their own (1%) wrongs) and the difficulty murderers have in procuring insurance to cover their rampages, the appellate court in Santelli v. Rahmatulla found that the Restatement provides a handy way of escaping Indiana's reform of its joint and several liability rule. File this one under "Redistributive Justice".

Discretizations

David Oliver — Mon, 02 Apr 2012 22:28:49 -0600

DNA is Not Destiny: Gina Kolata explains why your genetic code plays second fiddle to luck when it comes to whether or not you develop a chronic disease.

The flirtation of some legal scholars with "reasoning to the best explanation", an educated guess at best and an unseemly dalliance with the post hoc ergo propter hoc logical fallacy at least, has gone under the microscope.

Caloric restriction, rapamycin and autophagy may extend life whereas obesity activates mTOR, impairs autophagy and thus may kill you via liver cancer.

"There are too many careless mistakes creeping into scientific papers". It's "shocking", for example, how many published findings in the realm of cancer investigation cannot be reproduced.

Be afraid. Be very afraid.

Bending the Dose Response Curve

David Oliver — Wed, 28 Mar 2012 14:57:17 -0600

The linear no-threshold model of dose-response meant that plaintiffs could continue to prevail on toxic tort claims even though their exposures had occurred in the modern era and thus were tiny fractions of those that led to epidemics in years past. Either courts permitted plaintiffs to rely on a one molecule / one particle theory of causation (consistent with the view that some risk is associated with a single molecule or particle) or they allowed plaintiffs to conflate causation with risk.

Eventually some courts began to grasp the absurdity that follows from basing proximate cause on a "one-hit" model in a world of trillions of hits while others began to take notice of the fact that despite probing larger and larger populations with low exposures epidemiology was unable to verify the linear no-threshold model for numerous diseases; thereby suggesting that there is indeed a threshold for diseases including leukemia (a new case making the latter point is Schultz v. Glidden Company.) Meanwhile we have argued that the old cases got it right - that causation in an individual toxic tort case is unfathomable and that the most sensible approach is to estimate the risk imparted (e.g. by a single molecule); to ask why it makes sense to impose liability for creating a 1:1,000,000,000,000,000,000 chance of harm; and, further asking why it wouldn't make sense to impose liability for a 1:100,000 or greater risk.

But all of that assumes risk goes to zero or at least continues to decrease as exposure is reduced below previously measured levels. If that assumption is false, if risk starts heading back up as exposure goes down, especially if unpredictably so, then all bets are off. We will have entered another period of great uncertainty, And it's in such times that toxic tort claims flourish. The horsemen of this new age of uncertainty have published a review paper on the topic and if you want to understand what's coming, why it's pitch perfect for the health and wellness movement and why what happened to BPA will be repeated again and again for other chemicals until some new way is established to either verify or refute their claim that dose doesn't make the poison you need to read it: "Hormones and Endocrine-Disrupting Chemicals: Low-Dose Effects and Nonmonotonic Dose Responses"

Discretizations

David Oliver — Wed, 28 Mar 2012 11:18:00 -0600

Rhetoric is an instrument of scientific discovery.

Groups are (for the most part) somewhat less susceptible to cognitive biases that skew decision-making than are individuals (including judges).

The debate over Palsgraf rages on.

It remains to be seen whether jurors are able to suspend the actions of neural circuits producing sympathy (or bias or prejudice) when instructed to do so by a judge.

Toxic tort Defendants should argue "the letter of the law" while plaintiffs should argue reasonable care and "the Defendant should have known better".

"Autism Diagnoses Were Increasing and Would Soon Become the Metanarrative of Vaccine Fear"

David Oliver — Fri, 23 Mar 2012 00:07:10 -0600

"The Legitimacy of Vaccine Critics: What Is Left After the Autism Hypothesis?" is well worth a look. It's something of a political account of the odd left-right populism that fueled the anti-vaccine movement (and that once made Southeast Texas the epicenter of mass tort litigation) and of what has become of the movement now that the lawyers have gone off on more promising quests.

As usual the crusade began with an invocation of Science but once the hypotheses were tested and found wanting, carrying the banner of "Science" was left to those scientists on the fringe, on the make and often both. Thanks to journals desperate for content, papers continued to be published but by an ever smaller cadre "scientists". Yet despite their hypotheses being unreproducible or otherwise found to be evidence-free, these warriors against the medico-industrial complex continue to this day to command large audiences and to rake in significant research dollars to churn out more of the same. Perhaps most tellingly, like those who claim evolution is "just a theory", one popular speaker is reported to have said of the germ theory of disease: "... the theory is that microorganisms are the cause of many diseases ... Might I say that this is just a theory. Germs may play a role in children getting sick, but they may not be the reason that children get sick." (pg. 84). On its best day such a statement is merely an exercise in sophistry.

The article has the same sad ending as so many past mass torts that relied on fear rather than falsificationism: "Vaccine critics have built an alternative world of internal legitimacy that mimics all the features of the mainstream research world - the journals, the conferences, the publications, the letters after the names - and some leaders have gained access to policy-making positions. " Enjoy; with antacids.

Discretizations

David Oliver — Tue, 20 Mar 2012 16:43:41 -0600

When it comes to lung cancer, keep your chickens close but keep your flock closer.

"They've internalized their own confusion": watch this video if you want to understand the difference between humble falsificationist evidence-based science and the authoritarian "because I say so" approach adopted by the 1st Circuit in Milward.

Antibiotic use in children less than six months old is strongly associated with the subsequent development of asthma, especially in those without a family history of asthma, and the greater the intake of antibiotics the greater the odds of developing asthma.

Attacks on randomized controlled trials (RCTs) miss the point.

A new paradigm for cancer prevention, indeed.

Gatecrashers, Blue Cabs and Bare Naked Statistics

David Oliver — Wed, 14 Mar 2012 19:04:16 -0600

For reasons identified in the very recent paper "Trial by Mathematics - Reconsidered" and the brand new "Epidemiology in the Courtroom: Mixed Messages From Recent British Experience", courts have long been reluctant to surrender their decision-making function to statistical and probabilistic inference. And it's a shame. A shame that such a powerful tool for uncovering what isn't so (as to us Popperians, all we really know is what isn't so) and the best bet for being so (h/t Thomas Bayes) is ignored at best and banned at worst.

The issue first came up for me as a young lawyer while carrying the briefcase for the partner defending a bad fire/burn case involving an allegedly defective electrical appliance. The client had indeed manufactured a number of the appliances with an appalling defect that undoubtedly led to fires. However, very few had the defect - less than 1%. As the appliance had been all but destroyed in the fire and it was therefore impossible to say whether it had the defect, our client claimed that plaintiff couldn't possibly prove her case since more likely than not she hadn't bought one of the defective variety.

On the other hand, plaintiff had the testimony of the fire marshal who said that he was "99% sure" that it was the appliance that had caused the fire (in large part because he'd had a similar experience investigating a fire involving the defective appliance). Since the appliances without the defect had never been reported to have caused a fire and as plaintiff's expert (along with, obviously, our expert) could think of no way the non-defective appliances could start one the fire marshal's testimony stood as a form of product ID. Plaintiff thus moved for partial summary judgment as it was, she averred, 99% certain that the product we'd sold her was one of the defective ones.

I got interested in the question and shortly came across base-rate neglect and Thomas Bayes. I excitedly reported to my boss that I had a way to fit all the facts together, including even the fire marshal's testimony, and demonstrate that the appliance was almost certainly not one of the defective ones. I laid it all out and he gave me the look you'd expect had I set out a proof of how 1 and 1 sums to 387. He went on to say that he privately believed the appliance was one of the defective ones. Our client even believed that the fire marshal's testimony meant that plaintiff had purchased one of the defective product. The case settled. For a heap of $$$s.

Since then I've had similar problems come up and I can report that mock jurors and judges are no more amenable to Bayes than my old boss. The former don't get it and the latter (for the most part) either haven't gotten it or refuse to turn such classically judicial questions over to "mere math". But if it's the truth we're after it's time we started to embrace the mathematical tools that have uncovered and corrected flawed reasoning in so many other areas of human inquiry. And that's the point of the two law reviews I commended to you above. Enjoy.

Clostridium Difficile Infections Are At Historic Highs

David Oliver — Wed, 07 Mar 2012 13:57:12 -0600

The CDC has a series of reports out about the growing problem of C. difficile infections contracted via health care-associated activities. The number of deaths attributable to C. difficile has increased more than seven-fold in a little over a decade and now stands at 14,000 annually.

The reports twist together a few threads we've been following for awhile now. First, chronic and often unnecessary antibiotic use in patients disrupts their normal gut microflora and provides an opportunity for C. difficile to gain a foothold and thereafter thrive. Second, these infections aren't just hospital-acquired, or nosocomial, anymore. Infected patients, especially those with diarrhea and on antibiotics transmit the pathogen to surfaces in clinics, nursing homes and doctors' offices and staff thereafter transmit it to other patients; thus they're healthcare-associated infections (HAIs). Finally, the infection is preventable.

The CDC makes the following recommendations to clinicians:

1. Prescribe and use antibiotics carefully. About 50% of all antibiotics given are not needed, unnecessarily raising the risk of C. difficile infections.

2. Test for C. difficile when patients have diarrhea while on antibiotics or within several months of taking them.

3. Isolate patients with C. difficile immediately.

4. Wear gloves and gowns when treating patients with C. difficile, even during short visits. Hand sanitizer does not kill C. difficile, and hand washing may not be sufficient.

5. Clean room surfaces with bleach or another EPA-approved, spore-killing disinfectant after a patient with C. difficile has been treated there.

6. When a patient transfers, notify the new facility if the patient has a C. difficile infection.

If you have a C. difficile case you might want to see how the healthcare provider filled out this form.

For more information try the following links:

CDC's March 2012 "Vitalsigns"

Centers for Medicare & Medicaid Services (CMS) Guidelines for Reducing the Spread of C. difficile.

Finally, there's a brand new research paper from the CDC which discusses the finding that C. difficile is an emergent disease affecting patients recently exposed to antimicrobial drugs.

Duty, Palsgraf, The Hand Rule and Public Interest: This Take Home Case Has It All

David Oliver — Tue, 06 Mar 2012 22:45:02 -0600

IN RE ASBESTOS LITIGATION, JANINE McCOY and MARVIN McCOY Limited to: PolyVision Corp., Superior Court of Delaware, New Castle County

Turning, ultimately, on the peril of limitless liability the Delaware court in McCoy reasoned that Pennsylvania, which has yet to weigh in on the issue, would not find a duty to the spouse of an employee allegedly grievously injured as a result of being exposed to asbestos dust carried home on her husband's work clothes.

First, on the issue of foreseeability, Palsgraf made an appearance (just long enough to introduce the relationship test of the limits of duty) but it merely cancelled out other opinions taking a limitless view of foreseeability. Next up was the Hand Rule comparing the expected value (loss) of an injury to the cost of prevention. Noting that extending duty to a spouse would necessarily imply extending a duty to everyone her husband might foreseeably have come in contact with the court found the burden of prevention sought to be imposed too high. Finally canvassing the states neighboring Pennsylvania, those likely to follow similar precedents and reasoning, the court found that 4 out of 5 refused to extend duty from employee to spouse.

And so the court came to the right answer though, as we keep saying, quantitative risk assessment as a proxy for substantial factor analysis reaches the same conclusion but in, we think, a cleaner and more predictable fashion.

April's "Gut" Has Some Very Interesting Articles.

David Oliver — Mon, 05 Mar 2012 16:33:19 -0600

Have a look at the cover and you'll see why double-dipping chip dippers are frowned upon. Elsewhere you'll find evidence that that if you want to stay lean or if you want to avoid type II diabetes you need to hold down the ratio of Firmicutes to Bacteroidetes that live in your gut. If you're looking for evidence that keeping H. pylori at bay keeps gastric MALT lymphoma away you'll find that too. There's also evidence that pancreatic cancer is associated with just a couple of bacteria found inthe saliva of those at risk of the deadly disease. Here's the link: Gut

Discretizations

David Oliver — Mon, 05 Mar 2012 12:14:38 -0600

Mild steel welding is associated with lung cancer.

There are lots of unattributed cases of severe non-O157 Shiga toxin E. coli infection - but that's changing.

A fascinating microflora is working to sweeten Canadian oil sands.

The time from outbreak to identification of the source of foodborne illness is getting shorter and shorter.

The importation of wild animal products into the U.S. poses a significant risk for the spread of zoonotic pathogens.