Archive for the ‘Art Exploration’ Category
Discretizations
Wednesday, February 22nd, 2012The end of the age of screening is at hand.
The XMRV fiasco could have been avoided by the application of an updated set of Koch’s postulates.
When Man’s Designs Don’t Include Nature’s
Tuesday, February 21st, 2012Does powdered infant formula (PIF) contaminated with Cronobacter sakazakii nee Enterobacter sakazakii constitute a design defect? The district court in The Security National Bank of Sioux City, Iowa v. Abbott Laboratories thinks so.
Creating (we think) a design defect dichotomy the court distinguished between "intended design", here PIF designed to specification but without bacteria and (apparently) "unintended design" – PIF designed to specification but with bacteria. Unintended design defects sound suspiciously like manufacturing defects since the bugs are picked up in the manufacturing process but the court held otherwise. Turning defendant’s argument that bacterial contamination is common in any food not specifically sold as sterile into an assertion that the PIF was thereby meant incorporate E. sakazakii the court wrote: "[a]ny assertion that Defendant’s intended design included the presence of E. sakazakii strains credulity."
Hammering away at defendant’s claim that the microbial world’s ancient and relentless assault on humanity and its works aren’t part of the design of PIF the court continued: "the implication is clear: their product is intended to contain E. sakazakii, as well as other potentially harmful bacteria. First, if 75% of a product does not contain a bacteria and 25% of a product does, elementary statistics dictates that the 75% without the bacteria constitutes the norm while the 25% with the bacteria constitutes a deviation therefrom. Second, a common defect, such as the persistent contamination of a food product with bacteria, if generally unknown and proven harmful, should increase a manufacturer’s total liability, rather than eliminate it." Finally, holding that plaintiff’s proposed alternate designs of adding a biocide to the unintentionally designed but on spec PIF, or of adding water so that PIF becomes IF, the court concluded that plaintiff’s design defect claims survived defendant’s motion to dismiss.
So, when a food company’s designs don’t include E. sakazakii’s does that constitute an "unintended design defect"? Even when its product is on spec? And is adding e.g. antibiotics or soaps or chlorine to PIF a valid alternate design of PIF? How about claiming that PIF can be changed to IF without somehow losing the P?
A half dozen other claims by plaintiff also survived the motion to dismiss including manufacturing defect and breach of implied warranty. Those we get but the design defect claim is a head-scratcher. Perhaps the court didn’t understand that we’re all in continuous contact with potentially harmful bacteria. In fact, we’re full of and crawling with countless numbers of them though we only notice if say one that lives peacefully on our skin winds up in our lungs. Or maybe the court understood and is imposing a duty to incorporate nature’s designs into our own. We’ll let you know if further light is shed on the matter.
For more about PIF, E. sakazakii and the devastating meningitis that caused severe and permanent brain damage in plaintiff see this very informative PowerPoint from the CDC: "Enterobacter sakazakii meningitis and death associated with powdered infant formula." and last December’s press release from the FDA, "Investigation of Cronobacter Bacteria Illness in Infants".
Texas Appellate Court Upholds Big Enterovirus Verdict – We Don’t Know Why
Friday, February 17th, 2012Before we get to why we think the dissent got it right in Scott’s Marina v. Brown assume the following:
1) plaintiff contracted an enterovirus infection resulting first in pharyngitis, then in meningitis and finally in Lemierre’s syndrome – an extrordinarily rare and potentially fatal complication following a throat infection (Lemierre’s is invariably blamed on Fusobacterium necrophorum or its cousins but go with it and assume the virus triggered the bacterial infection);
2) the plaintiff established that he was negligently exposed to raw sewage at work;
3) the majority of enterovirus infections are transmitted via the "fecal-oral" route
4) according to the CDC, which runs the National Enterovirus Surveillance System (NESS), only about 1300 to 1500 enterovirus are detected annually by NESS;
5) the onset of plaintiff’s symptoms were within the accepted incubation period; and
6) a "leading expert in the field of anaerobic infectious disease" is of the opinion that the sewage exposure was the likely cause of plaintiff’s illnesses.
Sounds like a pretty good case, doesn’t it?
Now consider a couple of additional facts:
1) according to the same CDC report there are 10 – 15 million cases of symptomatic enterovirus infections in the U.S. annually; and
2) as anyone who’s experienced gastroenteritis (thanks, norovirus) can attest, even when the predominate route of exposure is fecal-oral that hardly means you have to be exposed to sewage to get it – having children in school is more than sufficient.
So, back to the case. Was the strain of enterovirus that caused plaintiff’s infection ever detected in the sewage to which he was exposed? No testing was done. So what are the odds that a given sample of sewage would contain an amount of enterovirus sufficient to cause an infection? The expert couldn’t say. But if the overwhelming majority of enterovirus infections result from someone with insufficiently washed hands contaminating kitchen surfaces, plates and eating utensils or by shaking hands or sneezing, and when the virus can survive in all manner of environments including the lake in which plaintiff had been wakeboarding (and the polio virus is one of the enteroviruses – polio, lake water, ring any bells?), how did the expert rule rule out all the other routes of exposure? He wouldn’t say.
The dissent gets at the heart of the matter writing: "Nothing in this record explains why [the expert's] opinion Brown contracted an enterovirus from his "exposure to sewage water" is superior based on science. Rather, his opinions rested on his ipse dixit." Think about it. Somewhere between 1:20 and 1:30 Americans get an enterovirus infection each year. How many came through his store? How many are likely among his friends and family? How many swam in Grapevine Lake?
Parallel, Not Perfect
Friday, February 17th, 2012Walker v. Medtronic is another new case interpreting Riegel. This time the device failed utterly (given the undisputed evidence that the plaintiff’s decedent died when an implantable pain pump delivered a massive overdose). The case hinged on whether the (in)accuracy of the (over)dose administered, in this case the consequence of a complete failure, constituted a variance from a performance standard set out in the pre-market approval (PMA) so that a state tort claim could proceed.
Holding (essentially) that the FDA mandates design/manufacturing process fealty rather than perpetual operational accuracy, the majority recognized that a product made to the FDA’s exacting standards may fail nonetheless and that in such circumstances a parallel state claim cannot lie.
The dissent sought to make the performance standards basically a guarantee confusing, we think, accuracy with perfection.
Props to the majority for the Mr. Spock reference: "the benefit to the many … outweighed the cost to the few…"
Discretizations
Wednesday, February 15th, 2012Utah has a very loose definition of epidemiology – at least when it comes to cows / stray voltage.
There’s an enormous amount of evidence that childhood leukemia is the result of infections.
Concerns about PAHs in seafood from the Deepwater Horizon spill are overstated.
The Atlantic has a wonderful article about Toxoplasma gondii.
You can’t stand on their shoulders if the giants are locked behind paywalls.
Discretizations
Sunday, February 5th, 2012The conjunction paradox isn’t one and doesn’t require new standards of proof; rather, it’s evidence that the asymmetry in the law markedly favors false positives, whatever some may say.
Cancer-causing H. pylori might find its way into you by hitching a ride in food borne yeasts.
Blame for obesity: BPA vs BUG.
The evidence that hormone replacement therapy "causes" breast cancer isn’t as strong as you think.
Occupational exposure to animals: evidence for a causal link with cancer mounts.
Probability For Thee, Mere Possibility for Me
Friday, February 3rd, 2012And that’s exactly as things ought to be. When I got to Beaumont, TX, one of the first and most notorious of all judicial hell holes, I was appalled by what this lawyer/biochemist saw. Plaintiffs’ experts were willing to testify to anything (for a fat fee) and were being allowed to do so as long as they promised to say that e.g. it was more probable than not that the plaintiff’s pancreatic cancer was caused by formaldehyde from plywood in his trailer. Meanwhile, a defense expert, willing only to say that plaintiff had multiple risk factors for pancreatic cancer (like smoking) far more potent than formaldehyde and that plywood was at best a negligible factor, was not allowed to testify about any possible alternative causes at all since she refused to swear that any single possibly causative factor more likely than not actually caused plaintiff’s cancer. The result was that plaintiff’s experts, almost all of the Collegium Ramazzini-variety who passed the red-face test only because they believed that essentially every cancer was the result of exposure to man-made toxicants, could testify to anything, while more measured and critical-thinking experts could not testify at all.
"Causation must be pr oven on a more likely than not basis" said one judge over and over, and no argument to the effect that plaintiff bore the burden, and not the defendant, would change his mind. The result, I’m sorry to admit, was that we were forced to find experts as willing to sing whatever song paid for their supper as those employed by plaintiffs. Whatever the result it bore little relationship, if any, to our quest for truth.
The good news is that courts are starting to get it – that there are credentialed nitwits and judicial polymaths – and that the latter can see through the logical fallacies of the former though they haven’t an alphabet soup of letters beyond J.D. Take Benkendorf v. Advanced Cardiac Specialists Charted, for example.
"Requiring defense experts to testify based only on reasonable medical probabilities would effectively prevent defendants in many cases from presenting testimony regarding causation unless their experts could declare that a particular alternate cause more probably than not was the cause of plaintiff’s injury." The "inequities would abound" were a court to rule otherwise. "[W]e agree with the majority of jurisdictions that have addressed the issue and hold that an expert witness called by the defense to testify about causation … may testify about ‘possible’ causes of the plaintiff’s injury. A defendant … need not prove another cause for plaintiff’s injury, but may … testify as to alternative causes tending to undercut the plaintiff’s contention that the defendant’s alleged negligence more probably than not caused the injury."
Benkendorf is a med/mal case but nails the burden of proof of causation. Tomorrow (assuming we get our response out to SCOTUS on something else) a Bayesian smackdown on why false positives grotesquely outnumber the false negatives in toxic tort / mass tort litigation.
Discretizations
Tuesday, January 24th, 2012Our cooties would make beautiful music together.
This is the difference between case series and cohort studies.
Why does socioeconomic status influence cancer survival?
Caffeine and endometrial cancer: Drink up.
It’s Not That The Analytical Gap Was Too Wide
Monday, January 23rd, 2012It’s that analytical gaps are bridged by evidence and there was no evidence that therapeutic doses of Tylenol cause cirrhosis of the liver. Rather than simply saying so the court in Ratner v. McNeil-PPC, Inc. veered into the always unenlightening analytical gap width assessment:
"The plaintiff did not put forward any clinical or epidemiological data or peer reviewed studies showing that there is a causal link between the therapeutic use of acetaminophen and liver cirrhosis. Consequently, it was incumbent upon the plaintiff to set forth other scientific evidence based on accepted principles showing such a causal link. We find that the methodology employed by the plaintiff’s experts, correlating long term, therapeutic acetaminophen use to the occurrence of liver cirrhosis, primarily based upon case studies, was fundamentally speculative (see Lewin v County of Suffolk, 18 AD3d 621), and that there was too great an analytical gap between the data and the opinion proffered. We emphasize that when an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community."
Why not just say "plaintiff’s experts have no evidence that their theory is true"? In the court’s defense it was struggling to reconcile its ruling with Zito v Zabarsky in which it had previously held that in the case of a "new drug" plaintiffs need not wait for evidence (e.g. epidemiology) as otherwise:
" [a] strict application of the Frye test may result in disenfranchising persons entitled to sue for the negligence of tortfeasors. With the plethora of new drugs entering the market, the first users of a new drug who sustain injury because of the dangerous properties of the drug or inappropriate treatment protocols will be barred from obtaining redress if the test were restrictively applied.
(I am here reminded of a benzene / CML case I once tried in which plaintiff’s counsel in closing bellowed "Mr. Oliver says that not enough workers have gotten CML to prove benzene is the cause of their cancers. I hope when it’s his turn to speak that he answers this question: How high must the bodies be stacked before his client will admit that benzene was the cause?")
Anyway, as you can see the court was confronted with its prior opinion in which it had held that a well conceived hypothesis, though lacking utterly any evidence to support it, was enough to get a "new drug" case to the jury. Thus its effort to distinguish the two cases via "Tylenol is not a new drug" (more to the point would have been "there’s been ample opportunity to test your theory via retrospective epidemiological studies and yet still you have no evidence") and thereafter a retreat into the bushes of "analytical gaps".
Karl Popper said that science proceeds by conjecture and refutation. You think up a theory about how some aspect of nature works, determine what predictions follow from it, and then check to see if the predictions hold up. That last part is what’s called evidence. Without it you’re left with nothing but a more or less educated guess; and that isn’t enough to warrant depriving a citizen of life, liberty or property. That’s what Daubert was all about.
Finally, does it look to you like "deduction" has a different meaning in New York? Here it seems to refer simultaneously to the method by which a general rule is induced from observations and the method by which a causal association is inferred from the rule you’ve just induced, thus:
"Generally, deductive reasoning or extrapolation, even in the absence of medical texts or literature that support a plaintiff’s theory of causation under identical circumstances, can be admissible if it is based upon more than mere theoretical speculation or scientific hunch (see Zito v Zabarsky, 28 AD3d at 46; see also Black’s Law Dictionary [9th ed 2009] [defining "extrapolation" as "(t)he process of estimating an unknown value or quantity on the basis of the known range of variables" and "(t)he process of speculating about possible results, based on known facts"]). Deduction, extrapolation, drawing inferences from existing data, and analysis are not novel methodologies and are accepted stages of the scientific process.
For example, in Zito v Zabarsky (28 AD3d 42), this Court expressly recognized that extrapolation or deduction is warranted in instances where the theory pertains to a new drug."
Let me know. Thanks.
You Missed The Zombie Apocalypse
Sunday, January 22nd, 2012I meant to put this up on Halloween but a trial got in the way; it’s only relevant to mass tort litigation if you’ve been paying attention:
It’s no longer contested that certain microbes can hijack the brains of invertebrates and of vertebrates, including mammals.
But is there evidence that microbes can affect human behavior? Lots:
Do gut microbes influence the central nervous system? Yes.
Do microbes talk to your brain? Yes.
Can microbes make you anxious? Yes.
Are microbes likely the cause of schizophrenia and other behavior disorders? Yes.
Do they also cause personality disorders like neuroticism? Yep. (link to follow 
)