U.S. Supreme Court Holds LIA Preempts Asbestos Friction Product Claims

All members of the court in Kurns v. Railroad Friction Products Corp., et al. felt bound by stare decisis (in this case Napier) to hold that the petitioners' design defect claims against the manufacturers of asbestos-containing friction products used in locomotives were preempted by the Locomotive Inspection Act (LIA).  Nevertheless, the case produced both a concurrence and a dissent.   The debate revolved around the question of whether or not a "failure-to-warn" claim is 1) a  subset of design defect; 2) subsumed within the power of the LIA to require or prohibit the use of a particular product as it would thus have the power to make use of the product conditioned upon warnings; or, 3)  an independent cause of action separate from design defect and thus outside the field preempted by LIA.

The majority, relying on the following from the Restatement (Third) of Torts:  Products Liability:

A failure-to-warn claim alleges that a product is defective 'when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, . . . and the omission of the instructions or warnings renders the product not reasonably safe'

held, "[t]hus, the 'gravamen' of petitioners' failure-to-warn claims 'is still that [plaintiff] suffered harmful consequences as a result of his exposure to asbestos contained in locomotive parts and appurtenances.'"  In other words, a complaint about a lack of a warning is a complaint about the product that lacks it so that the LIA's control over any product that went into a locomotive necessitates a finding of preemption.

Justice Kagan concurred writing "... if an agency has the power to prohibit the use of locomotive equipment, it also has the power to condition the use of that equipment on proper warnings."  She concluded "[a] nd because the agency could have required warnings about the equipment's use, the petitioners' failure-to-warn claims, no less than their defective-design claims, are preempted under Napier."  Her decision turned on the implicit power of the agency to direct how products were to be used given that it had the power to which products were to be used.

In a dissent joined by Justices Ginsberg and Breyer, Justice Sotomayor reasoned " a product may be flawlessly designed and still subject its manufacturer or seller to liability for lack of adequate instructions or warnings."  Accordingly she concluded "[r]ather, the 'gravamen' of these claims is that petitioners' decedent . . . could have avoided the harmful consequences of exposure to asbestos while repairing precisely the same locomotive parts had respondents cautioned him, for example, to wear a mask."  Their notion then is that preemption ends at the product itself and does not extend to the information necessary for its safe use.

The majority responded in a footnote as follows:

A failure-to-warn claim imposes liability on a particular design of locomotive equipment unless warnings deemed sufficient under state law are given.  This duty to warn and the accompanying threat of liability will inevitably influence a manufacturer's choice whether to use that particular design.

Warnings then are seen by the majority as inseparable from a product's design.

So is this a big deal or not?  On the one hand, the idea that warnings and instructions, the information component if you will of a product, are just part of a product's design (which in turn incorporates the common law's regulatory scheme, such as it is) and not a foundation for an independent cause of action sounds fairly revolutionary.  But upon reflection it not only makes a lot of sense, it's unlikely to have much impact since claiming that a product's design is defective because its warnings are inadequate ought not require any proof beyond the usual in failure-to-warn cases.  On the other hand, in those cases where courts have found preemption but held that warnings were somehow separate from the product specified by the government so that plaintiffs' claims survived, this could be a very big deal indeed.



There's Something About Nevada

After getting hammered in quick succession for $500 million, $162 million and $90 million worth of punitive damages in three cases involving a total of just five plaintiffs, Teva settled its Nevada hepatitis C (HCV) / Propofol claims.  The price tag was just past a quarter billion dollars. 

So what happened?  Teva's generic Propofol wasn't defective.  It didn't leave the factory contaminated with HCV.  Instead the claims arose out of the following findings of the CDC:

Inappropriate reuse of syringes on individual persons and use of medication vials intended for single-person use on multiple persons was identified through direct observation of infection-control practices at clinic A (Desert Shadow Endoscopy Center). Specifically, a clean needle and syringe were used to draw medication from a single-use vial of propofol, a short-acting intravenous anesthetic agent. The medication was injected directly through an intravenous catheter into the patient's arm. If a patient required more sedation, the needle was removed from the syringe and replaced with a new needle; the new needle with the old syringe was used to draw more medication. Backflow from the patient's intravenous catheter or from needle removal might have contaminated the syringe with HCV and subsequently contaminated the vial. Medication remaining in the vial was used to sedate the next patient.

and the final report of the Southern Nevada Health District which includes the following graphic demonstrating how the clinic contaminated the Propofol:

The vials were clearly labeled for single use and the warning was further emphasized when reports surfaced that some were being used for multiple doses.  Discovery apparently revealed that the larger vial size helped reduce manufacturing costs. 

Okay, so Teva was found liable for not guarding against the (allegedly) foreseeable blatant disregard of its warning labels and of standard vaccination administration safety procedures by the endoscopy clinic.  Nevada seemingly has an expansive view of duty and its jurors a limitless view of foreseeability.  But what explains the repeated mega punitive verdicts?  Every mass tort has its outliers but we've not seen anything like this.  If we hear any scuttlebutt we'll let you know.

Along the way it certainly looked like the cases were going well for Teva.  For example, it made some good law at the Nevada Supreme Court which we've mentioned previously.  Specifically the court recognized that a rule preventing a defendant from discussing other possible causes (unless its experts are willing to testify that such alternate cause(s) were, in reasonable medical probability, the cause in fact of plaintiff's illness) would work a great injustice.  As we've said before the effect of such a rule would be to admit the most speculative claims of causation while excluding the most reasoned and sober assessments of causal attribution.

Why did Teva settle?  Again, we're not privy to any inside information but hazard the following guess.  The recent tendency of the Nevada Supreme Court to affirm eye-popping jackpot verdicts weighed heavily in Teva's analysis.  Usually when you get a huge judgment before a supreme court, as Teva had here, you're pretty confident that at the very least the outlier award will be substantially reduced.  Yet in Nevada these days such payouts are quite likely to be affirmed. In any event we're betting that the Nevada civil courts will be busy and that tort claims arising out of the spread of pathogenic bacteria, viruses and prions will increasingly be the focus of the plaintiffs' bar.

When Man's Designs Don't Include Nature's

Does 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".


Parallel, Not Perfect

Walker 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..."


Texas Appellate Court Upholds Big Enterovirus Verdict - We Don't Know Why

Before 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?



Plaintiff Avoids Preemption and Twombly in Parallel

The Fifth Circuit has held in Bass v. Stryker  that plaintiff's claim against the manufacturer of an allegedly defective hip replacement device is not preempted by the Medical Device Amendments of 1976 to the FDCA, and that his complaint satisfies Twombly.  Because plaintiff's allegation "paralleled" an FDA manufacturing practice and asserted that the "good" practice was not followed, resulting in a device that did not work as contemplated causing his injuries, the lower court's dismissal of plaintiff's manufacturing defect, negligence and implied warranty claims was reversed.  

The manufacturing practice at issue involved ensuring that the "final wash" was not contaminated so that the device would not become "adulterated". Were the wash to be so contaminated the microbes could set up shop on the device, in this case the ceramic shell, and prevent the bony ingrowth that would otherwise help secure the implant. Some months before this particular device was implanted the FDA had warned the manufacturer that it had not implemented necessary changes to the final wash portion of its manufacturing process and further had failed to verify that the wash met the standards for bioburden. Though Bass had not specifically plead that his device (which had been recalled) was contaminated, nor that doctors removing it had found evidence of an infectious process, the pleading was nevertheless sufficient to put Stryker on notice as to just what it was that plaintiff was claiming.

The bottom line is that if a plaintiff can find a way to turn a design defect into a manufacturing defect (e.g. claiming the device as manufactured was contaminated rather than claiming that the design failed to include an anti-bacterial agent) by finding a potential for variance in the manufacturing process, and then plead a plausible nexus between the resultant device and her injury, she ought at least be able to make it to the discovery stage.


Dismissed With Prejudice

Today we filed this responsive brief in the United States Supreme Court. Question: Is a summary judgment dismissal necessarily with prejudice? Who would have thought this would (maybe) make it to SCOTUS? We’ll keep you posted should an order nunc pro tunc catch their eye.


Check Our Math

What are the odds that a jury, having found for the plaintiff in a typical occupational cancer case, got it right (which is to say, got to the truth)?

Assume the following:

a) The odds that a jury will correctly attribute the cancer to the defendant when, in fact, it was an occupationally-induced cancer is 75% (i.e. the chance of a false negative, that plaintiff loses when she shouldn't, is only 25%)

b) The odds that a jury will find for the defendant when the defendant had nothing to do with plaintiff's cancer is 75% (i.e. the chance of a false positive, that a defendant will be held liable when it had nothing to do with plaintiff's cancer, is only 25%).

c) The odds that a given cancer case is occupationally related is 10% (that's 2.5x the typical estimate of 4% by Sir Richard Doll (of cigarettes-cause-lung-cancer fame) but let's go with it).

In such cases, when the jury has found for the plaintiff, they only get it right 1 in 4 times. Why? Because the vast majority of cancer cases aren't occupationally related. The false positives pile up. It's like the lesson we've learned with PSA tests and mammograms. Imagine 1000 cancer cases. 100 are occupational (using our plaintiff-friendly assumption above). 75 of those 100 will be detected by the jury but of the remaining 900 non-occupational cancer 225 (25%) will be wrongly assumed to have been occupational. That means that the odds that a given verdict in an occupational cancer case is the just one, the one that got it right, is  75/(225 + 75) = .25 = 25%.

Play with the numbers and assume that juries identify the deserving plaintiff 51% of the time and absolve the innocent defendant 51% of the time and use Doll's 4% figure for the number of occupationally related cancers. You'll find that for any given verdict under such a scenario there's less than a 1 in 20 chance that the defendant really caused plaintiff's cancer.

To move the number up to a point where we can be confident of the verdict, while sticking to a "featherweight", 51% more-likely-than-not standard for finding a defendant at fault, we have to assume that most cancers are caused by working. That assumption was popular several decades ago but it's no longer one that has anything to do with reality. Nowadays the math really only works for one type of cancer - mesothelioma.


Plaintiffs' Experts Call for Research on the Health Effects of Fracing; looking for a link to disease

There is a hearing today in front of the House Energy and Environment Subcommittee, of the Committee on Science, Space and Technology. The subcommittee is studying the draft report by the EPA on the effects of unconventional natural gas drilling in and around Pavilion, Wyoming which found some groundwater contamination, particularly from gas drilling wells which were not cased to a depth below the bottom of nearby water wells.

Bernie Goldstein, MD, a frequent paid expert on behalf of plaintiffs in benzene litigation has released the outline of his testimony. He calls repeatedly for money from congress to prospectively study the health impacts of unconventional shale gas drilling, commonly known as hydraulic fracturing or fracing.

While no health effects have currently been found to result from fracing, Dr. Goldstein implores Congress to study not just whether fracing fluids are somehow getting in the water or air (which is currently being studied) and is a necessary precursor to eventual disease caused by fracing. Instead, Dr. Goldstein seems to want to study all of the chemicals used in fracing fluids (as well as noise, truck exhaust, and anything else that goes on at a well site) and see if any can cause disease, if they are released in the water, air, or some other way. He cites community groups who are worried about the potential harm as evidence that there is a potential harm. His stated major concern is that “It is possible that unconventional gas drilling will cause index cases of unusual diseases over time given how little we know about the health implications of the fracking mixtures.” It is possible, but not shown because as of now, there is neither a signature disease of fracing fluids or an established mode of exposure.

Dr. Goldstein’s real conclusion is that it is a virtual certainty that adverse health effects will be statistically associated with unconventional gas development activities. This may be because statistics can be found to support almost any association if the data are parsed to fit the conclusion sought.

The plaintiffs’ attorneys are clearly gunning to make fracing the next toxic tort.


Probability For Thee, Mere Possibility for Me

And 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.