[Drug and Device Law] Medical Monitoring For Soft Drink Purchasers: Not The Choice For This Generation
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.
The reason that the court had to do a thorough analysis of the first two issues—which made the third issue moot—was that California is one of the jurisdictions that rode the wave after Friends and adopted a claim for medical monitoring in Potter v. Firestone Tire & Rubber Co., 863 P.2d 795 (Cal. 1993). The requirements set out in Potter are similar to those from some of the other cases endorsing medical monitoring: (1) the significance and extent of the plaintiff's exposure to chemicals;
(2) the toxicity of the chemicals;
(3) the relative increase in the chance of onset of disease in the exposed plaintiff as a result of the exposure, when compared to
(a) the plaintiff’s chances of developing the disease had he or she not been exposed, and
(b) the chances of the members of the public at large of developing the disease;
(4) the seriousness of the disease for which the plaintiff is at risk; and
(5) the clinical value of early detection and diagnosis.
2015 U.S. Dist. LEXIS 26494 at **18-19. The major problem with these requirements is part of why most courts have now rejected medical monitoring—a plaintiff could meet them and still not have an “injury” in the sense recognized in tort law developed over many decades. In Riva, the court recognized that it is difficult to meet the constitutional standing requirement of pleading an “injury in fact” that is “not conjectural or hypothetical” when the only “injury” is the alleged need for monitoring for a future disease. While the decision here looked to the specifics of the plaintiffs’ pleading—and, through the wise use of judicial notice, some of the documents referenced therein—it seems to us to be one step away from the conclusion that a medical monitoring claim by presently uninjured persons, in the traditional tort sense, cannot satisfy the federal constitutional requirements of standing, which also define an “injury in fact” as “actual and imminent” and “concrete and particularized.”
The core allegation of the amended complaint was that studies showed an increased risk of bronchioloalveolar cancer in mice exposed to daily doses of 4-Mel of more than 4,000 micrograms per kilogram of body weight, whereas each can of Diet Pepsi or Pepsi One might expose a human to about 1/1000 of that dose. Id. at **24-25. While this might have been enough for a warning under Prop 65, it was not enough for standing or the first three of the Potter criteria. The standing analysis was more direct: “Plaintiffs have alleged that mice experience increased risk of harm of a specific form of lung cancer at very high exposures to 4-Mel; but they have not alleged facts to show that humans experience the same increased risk, particularly at the exposures alleged.” Id. at *13 (emphasis in original).
To satisfy the first Potter criterion, plaintiffs “must demonstrate sufficient severity of exposure (its significance and extent) and that ‘the need for future monitoring is a reasonable certain consequence of [the] toxic exposure.’” Id. at *25 (internal citation omitted). Given how the doses given to mice in the studies compared to the amounts in a can of soda, one study relied on in the amended complaint concluded that “the amounts ingested from these beverages may not be significant.” Id. at **24-25. On top of this, the amended complaint alleged that the proposed class reps drank as much as four cans of the particular soda brands per day, but never alleged how many cans would cross the line to an increased risk of cancer. Thus, plaintiffs “failed to demonstrate a credible risk of bronchioloalveolar cancer resulting from the human consumption of cola products at the levels alleged by the named plaintiffs” and had not properly alleged significant exposure. Id. at *26. Similarly, for the second Potter criterion, the plaintiffs failed to allege that 4-Mel was toxic—at the level of consumption alleged. Recognizing that the degree of toxicity cannot be separated from the level of exposure—like the old saw “the dose makes the poison”—was the key to this analysis and (jumping ahead) helps cut down on lengthy and costly proceedings to get to this inevitable stumbling block. In addition, the court rejected the idea that being identified as a carcinogen by Prop 65 did not end the toxicity inquiry for purposes of medical monitoring:
Because the burden on a defendant to fund medical screening for thousands, potentially millions, of people is so substantial, the Potter factors serve a critical gatekeeping function, regulating a potential flood of costly litigation; Potter requires a higher level of proof of health risk than that required for inclusion of a substance on a Proposition 65 list.
Id. at **36-37. Well said. Inclusion on a Prop 65 list should not be enough to get past any substantive legal requirement, let alone the other big gatekeeper looming in a case like this—Daubert. The analysis of the third Potter criterion probably could have stopped with the lack of evidence about any increased risk with the level of 4-Mel in each can of soda, but it went deeper into the articles cited in the amended complaint—again, using judicial notice to look at the rest of what plaintiffs’ relied on without converting the Rule 12 motion into a Rule 56 motion—to see that low levels of 4-Mel are in lots of things a Californian might consume. Among them were baked goods, candies, “extruded” cereal, beer, soy sauce, and coffee. “The many sources of 4-Mel prevent the Riva Plaintiffs from satisfying the third Potter factor” because there could be no way to say that any increased risk of bronchioloalveolar cancer was from the little bit of 4-Mel in these brands of soda as opposed to the little bit of 4-Mel in lots of other stuff the putative class members might eat or drink. Id. at **38-41.
The last chance for plaintiffs was to ask for another shot at pleading standing and the Potter requirements. While we all know that amendments are to be granted “freely . . . when justice so requires,” they should not be granted where amendment will be futile. Here, the proof of futility came from plaintiffs’ concession at a hearing—honesty not found in pleadings or briefs sometimes leaks out when the judge asks questions directly—that they had no studies showing a risk to humans at the relevant exposure levels. So, that is it for the medical monitoring class. Time to have a Coke and a smile. Or obey your thirst. Or be a Pepper too. Or maybe just have a nice glass of cold water, which may not have any Prop 65 carcinogens in it, unless you poured it from a bottle or added an ice cube formed in a plastic tray.--
Posted By Eric Alexander to Drug and Device Law at 3/13/2015 07:00:00 AM --
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