Deconstructing Milward (part I)

I could write a long and tedious post about Milward v. Acuity Specialty Products Group, Inc. and that's why I'm having such a hard time writing a short and hopefully interesting blog post about it. The problem is that the opinion contains no formal arguments, eschews empiricism and denies the existence of objective facts. In other words, precisely because of the epistemological relativism it implicitly adopts, the attempt to blog about it has become a bit like trying to play croquet with a flamingo. But here goes - piecemeal fashion.

The trial court bifurcated the case into two phases. In the first phase the query was whether or not so-called "general causation" testimony by plaintiff's experts was admissible under Daubert. If such testimony proved to be admissible a trial on the rest of the case, including so-called "specific causation", would follow. Let's think about "general causation" and "specific causation".

The First Circuit's opinion refers us to comment c(3),section 28, of the Restatement (Third) of Torts: Liability for Physical and Emotional Harm for the meaning of the supposed two types of causation in a toxic tort case; the former being "when a substance is capable of causing a disease" and the latter being when "when exposure to an agent caused a particular plaintiff's disease". Everyone seems to think this is obvious but is it and, if it is, what should follow from it?

I readily admit that by 1995 I had added the general/specific causation idea to a CLE presentation I'd started to give on causal inference, A.B. Hill's "criteria" and the inherent difficulty in proving that a particular plaintiff's illness, sans aplastic anemia, asbestosis, etc, was caused by some agent established by frequentist methods to be a carcinogen. Now I'm not so sure. Here's why.

We all agree that fired bullets generally cause holes in those they strike and in the toxin context that carbon monoxide (or cyanide, etc) generally causes chemical asphyxiation. But why do we so readily agree? Because everyone struck by a bullet or exposed to carbon monoxide will experience some degree of indentation or asphyxiation. Yet the vast majority of workers exposed to benzene or asbestos never develop any symptoms nor even any signs of prior exposure. Take the unibestos workers at Pittsburgh-Corning's Tyler, TX facility. It's true that 9% have developed mesothelioma but why haven't the other 91%, after almost 50 years, developed mesothelioma? You can ask the same question about benzene or radium dial workers and you'll get the same answer. You'll also find that the dose response curves flatten out. What does it mean?

It means that amosite asbestos causes mesothelioma in people susceptible to getting mesothelioma from amosite asbestos and that benzene causes AML in people susceptible to getting AML from benzene. In essence it means that there is no "general causation" and that all causation is specific to the individual. That's actually a good thing for plaintiffs because causation can then be established by means other than by epidemiology - by detecting biomarkers, asbestos bodies and the like.

But it also means that Milward has to prove that somebody, somewhere got the form of leukemia from which he suffered, APL, following benzene exposure. Milward's expert could find no such case. The best he could do was to say that in some studies of benzene-exposed workers some cases of APL (a rare yet widely found and naturally occurring blood cancer) had been found. He basically admitted that such evidence would fail the inferential tests of strength and consistency and said instead that the fact that cases of APL were found bolstered his opinion by demonstrating that it was not manifestly false.

Thus my first beef (I'll go page by page in the days to follow): asserting that a claim (here, that benzene causes APL) is probably true, or is more likely true, because it has not been proven false is in fact the logical fallacy known as argument from ignorance. Not pretty. Not pretty at all.

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About Serratia marcescens

Contaminated IV bags used to deliver nutrients to critically ill patients are suspected as the source of at least 19 nosocimial infections detected in a number of Alabama hospitals resulting in nine deaths. Serratia marcescens is an opportunistic pathogen responsible for an increasing number of severe hospital-acquired infections. Here are some of the newest papers on the subject:

Three newborns died and six others sickened in the NICU - healthcare workers need to wash their hands before and after handling patients (it really is appalling that after Dr. Semmelweis' work 150 years ago so many health care workers continue to ignore this most basic sanitary measure). See "Investigation of an Outbreak of Serratia marcescens in a Neonatal Intensive Care Unit"

But maybe health care workers aren't always to blame. Looks like bulk-refillable dispensers of anti-bacterial soap may actually become contaminated with bacteria. See "Bacterial Hand Contamination and Transfer After Washing With Soap From Contaminated Bulk-Refillable Dispensers".

"Outbreak of Neonatal Infection by an Endemic Clone of Serratia marcescens"

"Serratia marcescens Outbreak in a Neonatal Intensive Care Unit Related to the Exit Port of an Oscillator"

Georgia-Pacific's Response in Bostic

 

It really will be The End of Toxic Tort Litigation in Texas (at least for any case involving multiple sources of exposure) if the Texas Supreme Court adopts the position on substantial factor causation urged by Georgia-Pacific in its recently filed Response in Georgia-Pacific Corporation v. Bostic. Let's hope the court begins and ends its analysis with exposure/risk as Bostic never proved more than a de minimis exposure to Georgia-Pacific's product.

Georgia-Pacific first says about substantial factor causation that the court's Flores opinion requires plaintiff to establish that "but for" his exposure to Georgia-Pacific's product he would not have developed mesothelioma if he's to carry his burden of proving substantial factor causation. To support this argument Georgia-Pacific says that the court adopted section 431 cmt. a (1965) of the Restatement (Second) of Torts when it decided the substantial factor causation issue in Flores. Georgia-Pacific quotes the comment emphasizing "it is not enough that the harm would not have occurred had the actor not been negligent ... [T]his is necessary, but it is not of itself sufficient. The negligence must also be a substantial factor in bringing about the plaintiff's harm." Georgia-Pacific argues then that "under Flores, to prove substantial factor causation, a plaintiff must prove that the harm would not have occurred "but for" the defendant's conduct."

I think Georgia-Pacific has it wrong. "Substantial factor" causes are a subset of "but for" causes and not the other way around - a vital distinction when we get to what constitutes a "but for" cause in a toxic tort case.

Under the Restatement's formulation (and that of every other court that has put some thought into it) causes that are substantial factors are clearly a subset of all "but for" causes. In essence, some "but for" causes are not "substantial factors" as they are, for whatever reason, beyond the limits of liability. Think for example of Ms Palsgraf's case. If we make a set of all non-trivial "but for" causes of her injury we find within it (a) a running, stumbling passenger; (b) defective fireworks; (c) overly vigorous guards who jostle the passenger; and, (d) an unsecured scale. Remove any one of (a) - (d) and the accident would not have occurred. Each is thus a "but for" cause. However, we know that (c) at least is not a "substantial factor" or "legal cause" or "proximate cause" (depending on your jurisdiction) and thus not all "but for" causes are substantial causes.

Asbestos presents a very different problem. What, according to the parties in Bostic, are the non-trivial members of the set of "but for" causes of Mr. Bostic's mesothelioma? There's only one - (a) asbestos exposure. Asbestos exposure is the "but for" cause.

Now, since the identity of the fiber or group of fibers actually responsible for a plaintiff's disease is unknowable, the questions to be answered are: (a) do you impose liability for every fiber; and, (b) if not, how do distinguish between those for which a jury can reasonably impose liability and those for which they cannot? Flores answered those questions (a) "no"; and, (b) not by requiring that a plaintiff do the impossible - i.e. prove which subset of his asbestos exposure was responsible and that without it he would not have become ill - but rather by requiring that a plaintiff merely prove that the exposure complained of was more than de minimis and to do so not by his expert's ipse dixit but rather by some estimation of the range within which the particular dose fell along with evidence that exposure to such a dose posed more than a de minimis risk. A substantial factor in the toxic tort context in Texas is thus an exposure that was more than de minimis and so one that posed more than a de minimis risk.

Georgia-Pacific then goes even further. It argues that "a plaintiff must show that his exposure to a defendant's asbestos-containing product was sufficient to cause his injury ..." A sufficient cause is a complete cause. In other words, Georgia-Pacific is taking the position that plaintiff must show not only that the dose was more than de minimis but also that the dose for which it was allegedly responsible was sufficient, without any other exposures, to have caused the illness complained of. Think of it this way, if it took 100 fibers to cause mesothelioma and three defendants each exposed a plaintiff to 99 fibers for a total of 297 fibers no defendant could be held accountable because none supplied at least 100 fibers. Combine that with Georgia-Pacific's argument that all sufficient causes must also be "but for" causes and a plaintiff who could prove a defendant's product was more likely than not the cause of his illness would never win so long as there was another sufficient cause of exposure within his set of all asbestos exposures. To so hold the Texas Supreme Court would have to overturn decades of precedent as it has for half a century held that such a rule would make it "impossible for a plaintiff, though gravely injured, to secure relief in the nature of damages through a joint and several judgment by joining in one suit as defendants all wrongdoers whose independent tortious acts have joined in producing an injury to the plaintiff, which, although theoretically divisible, as a practical matter and realistically considered is in fact but a single indivisible injury." Demanding an obviously wronged plaintiff do something that logically cannot be done in order to recover from those undoubtedly at fault doesn't seem very fair and so I'm pretty sure the current Texas Supreme Court won't be overturning Landers.

In the end Georgia-Pacific should prevail because Bostic never proved more than a de minimis risk from Georgia-Pacific's products. That's enough. I just hope the court doesn't buy into those other arguments discussed above because if adopted they'd place insurmountable hurdles between many wrongly and preventably injured plaintiffs and the courtroom.

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Why Most Experts Are Little Better Than Dart-Throwing Chimpanzees

The measure of any theory is its ability to accurately predict some event that must follow if it is true. Experts, especially those with one big idea or theme, tend to do quite poorly when their predictions are put to the test. See "Why Most Predictions Are So Bad" ht: MarginalRevolution.

To avoid the problem, clever experts try to construct opinions that aren't testable (at least not in their working lifetimes) so as to avoid the embarrassment (and financial loss) that would follow falsification of their ideas. Other experts, particularly those of the irrationalist school, deny that bad predictions undermine theories and may even argue that untestable theories can still be good science so long as an expert's subjective judgment convinces him of its truth. The Milward court couldn't find a problem with either approach.

So if henceforth our job will be to discover how firmly an expert is convinced of his opinion rather than the soundness of the foundations on which it rests how should we go about it? Immanuel Kant suggests the answer in "Critique of Pure Reason":

"The usual touchstone as to whether something asserted by someone is mere persuasion, or at least subjective conviction - i.e., firm belief - is betting. Often someone pronounces his propositions with such confident and intractable defiance that he seems to have entirely shed all worry about error. A bet startles him. Sometimes the persuasion which he owns turns out to be sufficient to be assessed at one ducat, but not at ten. For although he may indeed risk the first ducat, at ten ducats he first becomes aware of what he previously failed to notice, viz., that he might possibly have erred after all. If we conceive in our thoughts the possibility of betting our whole life's happiness on something, then our triumphant judgment dwindles very much indeed; we then become extremely timid and thus discover for the first time that our belief does not reach this far, thus pragmatic belief has merely a degree, which according to the difference of the interest involved may be large but may also be small."

The answer then is clear, I think. Let's put the fees of experts in escrow when they opine upon things not yet generally accepted. If they are proved correct, say within a decade (or at least not refuted - ties going to runners after all), then the expert claims his fees and all interest accrued. If on the other hand he is proved wrong he forfeits the fees and pays a 10% penalty with the total going to charity. Assuming the law retains some interest in the truth such a rule would undoubtedly work far better than any losing-party-pays rule.

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A Tonic for Radiation Anxiety

Worried about radiation from medical diagnostics like computed tomography colonography (CTC)? Turns out the benefits of getting scanned every 5 years far outweigh any risks. See: "Radiation-Related Cancer Risks From CT Colonography Screening: A Risk-Benefit Analysis".

Fretting about nuclear technology? The 45,970 workers employed at Atomics International from 1948-1999 have a 12% lower risk of all forms of cancer combined than do other Americans of similar age and race. See: "Updated Mortality Analysis of Radiation Workers at Rocketdyne (Atomics International), 1948-2008".

Panicking about meltdowns? Try the newest copy of Clinical Oncology and articles 16 - 18 and 21 - 25. Pay special attention to "A 25 Year Retrospective Review of the Psychological Consequences of the Chernobyl Accident". Worry-induced mental health problems and ostracization of "victims" turns out to have been the biggest harm

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More Evidence That Electric Currents and Electromagnetic Fields Are Not Associated With Childhood Leukemia

See "Exposure to Electrical Contact Currents and the Risk of Childhood Leukemia" in this month's Radiation Research journal. "In this California population (245 cases and 269 controls from the Northern California Childhood Leukemia Study), there was no evidence of an association between childhood leukemia and exposure to contact currents or magnetic fields.."

Milward v. Acuity Specialty Products: Popper Out; Feyerabend In

My write up of Milward v. Acuity Specialty Products Group, Inc. is seven pages long yet far from finished.  Since it's very late I'll post just this for now. Whether the court intended it or not Milward, a benzene/APL case, is a radical opinion and a dramatic departure from Daubert v. Merrell Dow.

Milward adopts the "free for all" view of the scientific method favored by technophobes, chemophobes and especially plaintiff lawyers. Meanwhile, it drops the requirements of testability and falsifiability, turns Sir A.B. Hill from a fan of Hume and Popper into a verificationist with a list of things that don't actually matter, and concludes by holding that if an expert's opinion rests on four propositions, all of which are faulty, his opinion is nevertheless admissible so long as he says that "the totality of the evidence" informed his subjective judgment.

To help it understand the scientific method and how tort law should incorporate the concept the Milward court turned to the author of "Legally Poisoned: How the Law Puts Us at Risk from Toxicants" as well as a number of articles going at least back to 1982 that advocate against cost/benefit analysis and in favor of what is now known as the Precautionary Principle and the use of the tort system, once Daubert is out of the way, to effect its purpose. Throw in the court's understanding of comment c from section 28 of the Restatement (Third) of Torts: Liability for Physical and Emotional Harm, then read "The Tyranny of Science" when it's released later this month and you'll understand what Milward is all about and why it's such a big deal.

In coming days I'll go through Milward item by item starting with the elevation of (paraphrasing) 'process of elimination through subjective judgment founded on concepts of society, collective duty and environmental justice' to a scientific method.

Fixing a bankrupt system, one law at a time

The Texas Legislature is set to consider a bill to close a gaping loophole in asbestos litigation: forcing Plaintiffs to apply to asbestos bankruptcy settlement trusts BEFORE initiating litigation. There are dozens of bankruptcy trusts set up to pay people who have an asbestos-related disease. Many of these involve the largest asbestos companies in the country, such as Johns Manville, Celotex, H.K. Porter, etc. They are funded with billions of dollars.

Texas also has a statute to allow defendants to prove liability by third parties, including bankrupt companies. The plaintiffs have to submit applications to the bankruptcy trusts which allege exposure to the products of the bankrupt companies. The trust applications and dollar amounts paid are then admissible in the lawsuit. This works to make sure there isn’t a double recovery for one injury.

All that goes wrong, however, when the plaintiff waits until after their lawsuit is concluded before applying to the bankruptcy trusts. This becomes a big issue in Texas where we have a fast-track docket that allows dying individuals to have an expedited trial setting. There is a very real potential for a plaintiff to swear they have no idea who manufactured the insulation or gaskets or joint compound they were exposed to, or to not remember the brands of bankrupt entities. Then, after the lawsuit is over to suddenly remember and file the trust applications.

This loophole is finally being addressed.

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Extrapleural Pneumonectomy: Debilitating Complications, Minimal Symptomatic Improvement and Little in the Way of Improved Survival

It runs up plaintiff's damages (in one case costing nearly $1 million) but does extrapleural pneumonectomy (EPP) actually help the plaintiff as a patient suffering from malignant pleural mesothelioma (MPM)? The newest review of the evidence, "Extrapleural pneumonectomy or Supportive Care Treatment of Malignant Pleural Mesothelioma?" establishes persuasively that it doesn't.

Sadly, this review of all the sound clinical literature on EPP is unlikely to change the minds of desperate people facing MPM.

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Courts Are Starting To Get Hindsight Bias

One day, out of the blue, a common and widely used chemical which had been tested many times on many different species of lab animals without effect caused a particular strain of mice to develop cancer. Government and industry got together, funded epidemiological and toxicological studies and then agreed on a new and dramatically lower occupational exposure limit. The system worked, right?

Soon those who produced the chemical, even those who produced its utterly innocuous precursors, those who made things with it and those who transported, bought, sold, released or disposed of it were all defending claims by plaintiffs who had been exposed to it decades before. But how could these claimants prove their cases when government and industry had tested the product repeatedly and had found no rat, mouse, dog or monkey that suffered any ill effect short of exposure levels in the range that would produce asphyxiation?

Easy! Find an article detailing the product's important metabolites, find an article suggesting that one of the metabolites is mutagenic, find an article showing that the metabolite was known to result from metabolism of the product, find an article showing that the particular strain of mouse in question was thought by someone, somewhere at some time to be a good model for human carcinogenesis and find an article suggesting an exposure protocol which wouldn't be used until years into the future but which would result in the metabolite otherwise not produced by traditional exposure methods. Having found such easily identified articles plaintiffs' counsel was able to claim that any good company truly interested in worker health would have discovered the product's carcinogenicity no later than 1964.

We went and deposed the authors of those old papers strung together to show that what was unknown was in fact knowable and they unanimously said "Ummm, no". No one cared about the product's metabolites because it wasn't considered to be a carcinogen and the metabolite in question was tested way back when because it was a metabolite of something else and that something else turned out not to be a carcinogen and oh by the way skin-painting and ingestion studies not what came two decades later were state of the art in the early 1960s. Whew.

Then we tried plaintiff's "duty to test / duty to discover" theory to three mock juries. Every one found for the plaintiffs and every one found that what would not be suspected, much less discovered, for another two decades was in fact knowable by the early 1960s. Indeed, the future was so obvious that one mock jury found "wanton indifference" and another decided exposing workers after 1960 amounted to an intentional tort.

Those thirty-six pretend jurors with an average education at about the tenth grade level were hardly oracles. Their extraordinary powers of foresight were, oddly, limited to the product in question. In breakout focus groups after the mock jury research they said that the internet, cell phones and air bags in cars were all unforeseeable in the 1960s (despite the fact that they either already existed or were being discussed in things like Popular Mechanics back then) but the carcinogenicity of the product, well, how could you miss it (despite the fact that it wasn't even hinted at back then precisely because of numerous tests that had come up negative)? So what granted them the power of perfect foresight though only for an obscure issue utterly tangential to their lives? Hindsight bias.

Courts in 2011 are starting to recognize the danger of unintentionally imposing a duty of omniscience if the faulty heuristic is not recognized and dealt with. See Rodriguez v. Stryker but also see Cristiani v. Money. Courts may be aware of the blindspot in our reasoning but how, within existing procedures, do you avoid it and how do you prove your jury was afflicted by it after the fact?

So Much For The Radioactive Drinking Water Scare

As we noted in "Reruns of the NORM Show", recent stories about drinking water drawn from rivers downstream of water treatment plants that handle waste water from gas production operations in Pennsylvania have been long on worries about naturally occurring radioactive materials temporarily concentrated in flowback water but short on any increase in radionuclides downstream. To see if there is in fact anything to worry about Pennsylvania's Department of Environmental Protection (DEP) began monitoring the water downstream of such plants last fall. Yesterday the results came in.

"All samples showed levels at or below the normal naturally occurring background levels of radioactivity." Said DEP's acting Secretary "Here are the facts, all samples were at or below background levels of radioactivity; and all samples showed levels below the federal drinking water standard for Radium 226 and 228".

Pittsburgh quickly discovered that good news isn't the news EPA wants to hear. See "EPA Wants Tougher Test of Pa. Water" in today's Pittsburgh Post-Gazette. Apparently EPA fired off a letter immediately upon learning of the good news. In it the agency demanded permitting and further testing. Its author writes "I stand ready to provide EPA's support and to utilize our federal authorities to require drinking water and wastewater monitoring if that becomes necessary. In addition, EPA is prepared to exercise its enforcement authorities as appropriate where our investigations reveal violations of federal law".

Apparently EPA refuses to take "it's safe" for an answer.

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Prevnar and ActHIB: Here We Go, Again

Post hoc, ergo propter hoc. There'd be far fewer toxic tort claims if it weren't for that little logical fallacy which informs so many opinions.

Today there's word from Japan that the use of Prevnar and ActHIB has been suspended following the deaths of four children who died after immunization against bacterial meningitis and pneumonia. Though the vaccines came from separate lots indicating that contamination was not an issue and despite the fact that pneumonia and bacterial meningitis are dreadful diseases the news prompted the usual outpouring of vaccine denunciations.

Here in Houston the news produced claims that (a) the autism-derived and fact-free belief that children get too many shots or that they're given "too close together" means lazy doctors are to blame; (b) vaccines lower I.Q. and cause a 700% increase in cancer; (c) the U.S. Supreme Court has put us at the mercy of drug companies so that "you give those vaccines to your children at their peril"; and, (d) there's a dark conspiracy, in which the media is complicit, to bury stories about the harmful effects of vaccinations. See them all at "The MomHouston Blog".

You may not know people like these but they show up on your juries. Ignore them at your peril.

Population Mixing and Childhood Leukemia: Is a Mosquito to Blame?

When Pat Buffler co-authors something I take notice. Of the many epidemiologists I've run across her reputation for sound science is perhaps the most unassailable. In "Unusual Space-Time Patterning of the Fallon, Nevada Leukemia Cluster: Evidence of an Infectious Etiology", Francis, Selvin, Yang, Buffler and Wiemels examine the Fallon childhood leukemia cluster and find that most of the cases arose during the early to mid summer. Furthermore, a parallel increase in childhood leukemia was found to exist among the children of the military personnel newly introduced to the area. Together these findings, along with information about the habits of the local mosquitos, suggest an infectious cause for the childhood cancer cases that followed.

Could a single event cause cancer weeks later? Doesn't it take years for cancer to unfold? Make chromothripsis your word of the day.

Finally, you plaintiff's lawyers working on childhood leukemia cases, instead of using experts who can only get their opinions published in low impact journals of which they're among the editors (see e.g. Green v. George's Farms, et al), consider instead the impact of, bah, you figure it out. It's obvious at this point.

 

What is Cancer?

In toxic tort cases plaintiffs' attorneys and their experts tend to rely on one of two theories about the cause of cancer. The first is the "one-hit" model in which a single mutagenic molecule, particle or fiber causes DNA damage leading to a malignant cell that self-replicates uncontrollably. The second theory imagines that the damage leading to the malignancy is the result, somehow (the hypothesis is never set out in any great detail) of the cumulative effect of exposure to many molecules, particles or fibers. They say "it's like a glass of water that finally overflows when one last drop is added, each drop in the glass was a necessary cause of the overflow."

The one-hit theory is rolled out in low dose cases involving from one to a handful of exposure sources. Here the idea is that carcinogenesis is like playing the skull and crossbones lottery. The more tickets you buy (i.e. exposures you encounter) the more likely you are to wind up with the losing ticket. "All it takes is one bullet and they shot trillions of bullets at my client".

The cumulative dose theory is deployed when there are many sources of exposure and where those responsible for the biggest portion of the exposures are bankrupt or have already settled.  Here the idea is that once the individual's defenses are overtopped a malignant clone is born (initiation) or conditions for propelling the spread of an existing malignant clone are created (promotion). The most odious example of this argument was directed, despite my objection, against a client in an asbestos trial in state court in Galveston  - "It takes several men to have a lynching. One to hold the man, one to get the horse; one to get the rope, etc. They (meaning my client) want you to believe that each and every man in the lynch mob must go free just because the act of each man alone would not have resulted in my client's death. I know that's wrong and you know that's wrong!"

Either way, whether it's a matter of each cell playing the cancer lottery one molecule at a time or of  each cell slowly filling over the years it's carcinogenic reservoir you'd think that the more cells you have in your body the more likely you'd be to hit the losing ticket or see a chemoprotective dam collapse. Even for cancers thought to be caused by mishaps during normal cell division you'd think that if you had a lot more cells you'd have a lot more opportunity for mishaps.

But you'd think wrong. People don't get cancer more often than mice and neither do whales - even though they (obviously) have a lot more cells and also live long enough to have them and their progeny divide many many more times. See  "The Mere Existence of Whales" and "Why Don't All Whales Have Cancer? A Novel Hypothesis Resolving Peto's Paradox". Hat tip Marginal Revolution.

So what's going on? Do bigger organisms have better cancer defenses? Does size confer some advantage as suggested by the hypertumor hypothesis? 

Maybe it's the underlying deterministic model that needs tweaking. Maybe cancer rates scale up with physical size because cancer is a system, or a subystem, rather than a simple switch, Indeed there's a growing body of literature showing a tight association between reproductive optimization, energy availability, aging and cancer. Maybe the 30% cancer rate seen across mammalian species represents an evolutionarily determined risk-of-cancer/benefit-of-plasticity ratio that holds true from mice to whales.

If so, that would mean that we're programmed to run a high risk of cancer.  Not exactly the "cancer is a man-made problem" meme in which labor, environmentalists and their lawyers found a common purpose and a common tool.