We thought we were on a winning streak on medical monitoring. In August, we blogged about plaintiff lawyers stumbling in their efforts to walk the not-quite-yet-injury line. https://www.druganddevicelawblog.com/2017/08/monitoring-the-death-of-medical-monitoring.html In September, we blogged about a denial of a medical monitoring class action because the issues were more specific than common. https://www.druganddevicelawblog.com/2017/09/medical-monitoring-class-certification-fails.html. But with the falling
Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On that same day, co-blogger Steve Boranian alerted Bexis to a new defense argument in asbestos/mesothelioma cases that also utilizes genomics – certain mutations in a gene called “BAP1” – to identify persons at greater risk of idiopathic (that is, not related to asbestos) mesothelioma. Here’s a link to that article. A verifiable alternative cause could be a game-changer for asbestos litigation. The statement we quoted back in 2009, uttered by the first person ever to have his genome individually sequenced, that “individual genes are just not very informative,” appears in the process of being disproven by ongoing scientific events.
Both items, as informative as they were on scientific facts, were rather short on the law. That’s where we come in. We thought we’d take a look at what law exists concerning the intersection of pharmacogenomics, personalized medicine, and prescription medical product liability litigation. We’ve touched on these issues back in 2011, when we blogged about Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), one of the first cases in which the plaintiff made allegations about pharmacogenomically-based risks. Back then we said:
The plaintiff is claiming that a drug is defective, not because of anything inherent in the drug itself, but solely because it is less effective (and therefore has a different risk-benefit profile) due to the plaintiff’s peculiar genetic makeup. Essentially, the allegations seek to impose a non-FDA-approved contraindication, using state law, based upon human genetic variability. With advances in computer technology making genetic testing exponentially cheaper and more detailed as times passes (see Moore’s law), more and more genetic variability in the efficacy of prescription drugs is bound to be discovered. Eventually – certainly within some of our lifetimes – we’ll be able to carry our entire individual genetic code around with us on a chip, should we so choose….
The complaint in Mills is a bare genetic susceptibility claim, frankly based on an allegation of “variant” genetic characteristics shared by only a minority of the population. In our view, unless and until – and only to the extent that – the FDA decides to assess drug approvals and contraindications on the basis of genetic subgrouping, this type of tort claim should not be recognized, because it is flatly contrary to the criteria by which the intended uses of drugs are currently determined. Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.
It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a singularity-driven issue that needs to be addressed by the policy branches of our government, and not haphazardly in product liability litigation.
Those of us who have been paying at least marginal attention to developments in popular culture and product liability law—not necessarily the fanatical level of attention to these subjects paid by certain of our co-contributors—will recall that the “Cola Wars” and medical monitoring (for otherwise uninjured plaintiffs) were a big deal back in the 1980s and 1990s. For the former, people used to pay attention to new slogans, new formulations, celebrity endorsements, and ad campaigns. Whether one self-identified as a “Coke” or “Pepsi” person somehow mattered. (Maybe people still do care about these things, but they do not seem to have the place in our national consciousness that they once did.) Similarly—OK, not similarly at all, but we get latitude in an introduction like with leading questions to an expert about her qualifications at the start of direct examination—medical monitoring used to be a big deal and it was unclear where the weight of authority would eventually come down on whether manufacturers or other tort defendants might be regularly saddled with the cost of paying to monitor for diseases that had not been (and might never be) diagnosed. In 1984—a few months after Michael Jackson’s hair caught on fire filming a Pepsi ad—Judge Starr, with Judge Bork concurring, wrote the landmark decision in Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Circ. 1984), which is often credited with creating medical monitoring as a cause of action or type of relief, although the term “monitor[ing]” is not to be found in it. For years after Friends, there seemed to be trend toward acceptance of medical monitoring around the country for classes of plaintiffs who would not have been able to recover damages under traditional tort principles because they did not have compensable, present injuries. Somewhere in the early 2000s, the tide clearly shifted—for selfish reasons, we point to Wood v. Wyeth-Ayerst Labs., 82 S.W.3d 849 (Ky. 2002), as the arguable tipping point—and the recognition of medical monitoring for uninjured people became a clear minority position.
Yet, even well into the second decade of this millennium, we still have fights over colas and medical monitoring. Today’s case is about both. Riva v. Pepsico, Inc., No. C-14-2020 EMC, 2015 U.S. Dist. LEXIS 26494 (N.D. Cal. Mar. 4, 2015), also weaves in some of our favorites subjects, like the toxicological concept of dose, an aggressive look at pleadings, and rejecting serial amendments. The case stems from California’s notorious Proposition 65, which has spawned litigation over the years, but requires disclosure of purported carcinogens in consumer products rather than anything approaching medical monitoring for those who consume those products. Apparently, levels of a chemical called 4-methylimidazole (“4-Mel” in the opinion) in Diet Pepsi and Pepsi One sold in California passed the Prop 65 thresholds for disclosure in 2013. Id. at *5. In 2014, nine separate putative class actions were brought and, after some procedural wranglings, the court allowed an amended complaint to be filed by some plaintiffs to try to state a claim for medical monitoring on behalf of all California purchasers (not consumers) of these products over the course of about four years. Id. at **1-2 & 6. The defendant challenged the amended complaint on the grounds that it did not properly plead standing, the elements of medical monitoring in California, or the requirements for class certification.
We used to spend a lot of time defending against medical monitoring claims – cases where the plaintiff has not suffered any actual injury, but claims he or she is at risk of a future injury and demands that the defendant pay for future medical surveillance. We do not, however, see these kinds of cases so much anymore. The plaintiffs’ bar seems to have figured out that there is little money in medical monitoring in the drug and medical device context because the claimed future monitoring – say an annual blood test – often costs only a few hundred dollars. Medical monitoring cases therefore pencil out for the plaintiffs’ attorneys only when brought as class actions.
But medical monitoring class actions don’t work either. Every plaintiff treated with a drug or medical device has a medical condition, usually requiring follow-up medical care. The trick then is determining which follow-up (if any) is attributable to a drug or device risk and which is attributable to the plaintiff’s existing medical condition. You also have to look at the adequacy of the warnings, and at their impact, and at what monitoring the patient might actually need, and at whether the claimed monitoring actually promises medical benefit, etcetera, etcetera. Because these will be different inquiries for every patient, individual issues are the undoing of medical monitoring class actions, which is why they don’t get filed anymore.
We provide this preface because of the latest rejection of medical monitoring, this time in the First Circuit. The plaintiffs in Genereux v. Raytheon Co., No. 13-1921, 2014 WL 2579908 (1st Cir. June 10, 2014), claimed workplace exposure to beryllium. (Yes, we know it’s not a drug or medical device, but it’s a really interesting opinion with crossover appeal, so bear with us.) Beryllium is a useful substance
with known hazards: Exposure can cause Chronic Beryllium Disease, which damages the lungs and can impair organ function. Id. at *2. The precursor to Chronic Beryllium Disease is something called “beryllium sensitization,” which is regarded as a testable, abnormal medical finding. People with multiple positive tests for beryllium sensitization are at a higher risk of Chronic Beryllium Disease. Id.
The critical part of Genereux is that the plaintiffs claimed neither beryllium sensitization nor Chronic Beryllium Disease. No injury at all. Nothing. Nada. Zilch. How do we know that? Because the plaintiffs’ expert said so – he could not confirm that any plaintiff or any class member had developed even the precursor condition. Id. at *3.
We’re pleased to report that in Caronia v. Philip Morris, No. 227, slip op. (N.Y. Dec. 17, 2013), the New York Court of Appeals refused to create a new tort cause of action for medical monitoring. The money quote:
We conclude that the policy reasons set forth above militate against a judicially-created independent cause
A couple of quick hits today, on once “novel” causes of action whose time – at least in the novel legal spaces to which plaintiffs attempted to export them – appears to have passed.
The first of these is the shopworn effort, popular back in the late 1990s but more or less petered out by now, to use the ill-defined concept of public nuisance as a club to attack the products of an entire industry, and not incidentally, to try an end run around product specific causation. We’ve blogged on it before, criticizing public nuisance claims against products on various grounds.
Us? The Drug And Device Law Blog? Who listens to us?
Not too many people, unfortunately.
But a lot of people – most importantly, judges – listen to the American Law Institute. Bexis has joined the Members’ Consultative Group for the ALI’s Third Restatement of Torts: Liability for Economic Harm, and that group met recently. Preliminary Draft #2, circulated last month, has this to say about attempts to use “public nuisance” to encroach upon the law of product liability:
Tort suits seeking to recover for public nuisance have occasionally been brought against the makers of products that have caused harm, such as tobacco, firearms, and lead paint. These cases vary in the theory of damages on which they seek recovery, but often involve claims for economic losses the plaintiffs have suffered on account of the defendant’s activities: the costs of removing lead paint, for example, or of providing health care to those injured by smoking cigarettes. Liability on such theories has been rejected by most courts, and is excluded by this Section, because the common law of public nuisance is an inapt vehicle for addressing the conduct at issue. . . . If those [existing] bodies of law provide do not supply adequate remedies or deterrence, the best response is to address the problems at issue through legislation that can account for all the affected interests.
As noted in Comment g [sic, we think this should be “b”], problems caused by dangerous products might have seemed to be matters for the law of public nuisance only because the term “public nuisance” has sometimes been defined in broad language that appears to encompass anything injurious to public health. The traditional office of the tort, however, has been narrower than those formulations suggest, and contemporary case law has made clear that its reach remains more modest. The rules of this Section reflect that modesty.
In a pair of cases, the Maryland Court of Appeals (the state’s highest court) rumbled through more than $1 billion in verdicts in a gasoline spill case, reducing them to nothing (although one plaintiff managed a new trial on one issue unrelated to this post). See Exxon Mobil Corp. v. Albright, ___ A.3d ___, 2013 WL 673738 (Md. Feb. 26, 2013); Exxon Mobil Corp. v. Ford, ___ A.3d ___, 2013 WL 673710 (Md. Feb. 26, 2013). While a lot of the analysis in these opinions is devoted to property damage issues (purportedly from groundwater contamination) that we don’t see much in our drug/device sandbox, they also dealt with a couple of issues that are near and dear to our hearts – medical monitoring and fraud on the FDA.
A Tough Medical Monitoring Standard
First, we’re sorry to report, Albright (the lead opinion) did recognize a cause of action for medical monitoring by presently uninjured plaintiffs. 2013 WL
673738, at *26, 31. That being said, we’re pleased to report that the court attached rigorous requirements to the monitoring cause of action – a “proven necessary medical costs” requirement as tough as any state we’ve seen.
What do we mean? Well, first, medical monitoring is a “remedy”; thus plaintiffs must first prove some underlying cause of action. Albright, 2013 WL 673738, at *26-27. Second, medical monitoring costs must be both “necessary and reasonable.” Id. at *27 (emphasis original). “Necessity for medical monitoring . . . must be reasonably certain, rather than merely possible.” Id. Third, a plaintiff must “experience direct and hence discrete exposure.” Id. at *28 (emphasis original). Fourth, the condition for which monitoring is allegedly needed must be “related specifically and tangibly to that exposure.” Id. Fifth and finally, the risk must be “a direct and proximate result of th[at] exposure.” Id. (emphasis original).
The court in Albright was determined that medical monitoring not become an excuse for crappy, unsupported claims:
[W]e are wary of damages for speculative claims resting on tenuous proof of risk of disease attributable to the type of exposure. . . . [W]e believe that . . . recovery for a latent disease due to toxic exposure involves necessarily somewhat nebulous forecasts of a potential risk to develop a disease in the future. . . . Requiring quantifiable and reliable proof, however, will assist courts in determining whether causation and significant risk are present in a plaintiff’s prima facie case.
Id. at *28 (emphasis original). The medical monitoring standards that the court adopted are expressly intended to “inhibit damages awards for speculative, and thus unreliable, opinions as to a plaintiff’s potential risk of developing a future disease.” Id. at *29.
Medical monitoring is an odd-duck (we would say illegitimate) tort because it’s almost 100% dependent upon a particular procedure – the class action – for its existence. Procedure, of course, is not supposed to alter the substantive law, but in medical monitoring it has. Thus, kill the medical monitoring class action and one largely kills the tort.
We blogged not too long ago about the Third Circuit’s decision in Gates v. Rohm & Haas Co., 655 F.3d 255 (3d Cir. 2011), because of that court’s evaluation of the presence of individual medical/exposure in medical monitoring claims. The finding in Gates on the predominance question, we thought, pretty much closed the coffin on class certification of medical monitoring claims, at least under Pennsylvania law.
Kill the class action and we kill the tort.
Here’s another recent opinion putting some nails in the coffin: Fiorentino v. Cabot Oil & Gas Co., 2011 WL 5239068 (Disc. Sp. Master M.D. Pa. Nov. 1, 2011). The special master’s ruling arises in a somewhat odd context, a discovery dispute. It’s not entirely clear, but we think it’s a fracking case – part of the latest environmental guerilla war in these parts (although with natural gas less carbon-intensive than coal, we’re not sure what the fight is really supposed to be about).
The Third Circuit has decided Gates v. Rohm & Haas Co., No. 10-2108, slip op. (3d Cir. Aug. 25, 2011). Although not a pharmaceutical case, it’s something our readers would want to know about. Gates was decided under Pennsylvania law – somewhat bizarre because the contamination occurred in Illinois. It pretty much kills medical…
We say it often: tragic facts lead to bad law. And the case we ranked #4 on our list of worst drug/device decisions of 2009 was definitely a case of tragic facts (and, as you can guess, we didn’t like the law too much). In that case, an infant who was born with Down Syndrome…