Class Action Reform Bill Introduced

House Judiciary Committee Chairman Bob Goodlatte (R-Va.) and Constitution and Civil Justice Subcommittee Chairman Trent Franks (R-Ariz.) recently introduced the Fairness in Class Action Litigation Act of 2015 (H.R. 1927) to modify federal class action rules.

The bill calls for reform to the current federal class action lawsuit framework by requiring classes to consist of members with the same type and extent of injury.  That is, under the bill, no federal court shall certify any proposed class unless the party seeking to maintain a class action affirmatively demonstrates through admissible evidentiary proof that each proposed class member suffered an injury of the same type and extent as the injury of the named class representative or representatives.

The Subcommittee on the Constitution and Civil Justice is scheduled to hold a legislative hearing on the bill on Wednesday, April 29, 2015, at which my partner Mark Behrens is set to testify.

The sponsors noted that the Fairness in Class Action Litigation Act is a simple, one-page bill, that furthers a common sense principle that should apply to class action lawsuits in the future. Only those people who share injuries of the same type and extent should be part of a class action lawsuit.  They view the bill as an answer to the glut of "no injury" class actions. In one sense, the bill might be seen as an enhancement of the typicality requirement.

Introduction of the bill followed a February hearing before the Constitution and Civil Justice Subcommittee on the state of class action law a decade after the enactment of the Class Action Fairness Act .

 

Shook Ranked as One of Top Firms for Woman Attorneys

Shook, Hardy & Bacon ranked 21st in Law360’s inaugural list of The 100 Best Law Firms for Female Attorneys.

For the first time ever, Law360 ranked the 100 best U.S. law firms for women, based on the firm's female representation at the partner and non-partner levels and its total number of female attorneys.

This follows on the note that Working Mother magazine and Flex-Time Lawyers named Shook among their 2014 “50 Best Law Firms for Women.” Fifty law firms were selected based on a lengthy survey of their family-friendly benefits and policies, flexibility, leadership, and compensation of women, among other factors.

 

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Chocolate Class Action Dismissed

A California federal court recently rejected a putative consumer class action alleging the defendant somehow misled customers about antioxidants in its chocolate and cocoa products.  See  Leon Khasin v. The Hershey Co., No. 5:12-cv-01862 (N.D. Calif. 3/31/15).

Plaintiff was a California consumer who, since 2008, allegedly purchased more than $25.00 of Defendant’s products, including Special Dark Chocolate, Milk Chocolate, Special Dark Kisses, Special Dark Cocoa, Natural Unsweetened Cocoa, and Sugar Free Coolmint IceBreaker Mints. Plaintiff originally made a host of claims about the marketing of these various products, but in motion practice the Court trimmed most of the claims in the suit, preserving only lead plaintiff's claim under California’s Unfair Competition Law that the statement “natural source of flavanol antioxidants” on some of the Hershey products was allegedly  "false and misleading."  

Hershey moved for summary judgment. First, Hershey argued that, to prevail on his UCL claim, plaintiff had to prove he was deceived by Hershey’s “natural source of flavanol antioxidants” statements. Second, Hershey contended that there was no evidence of class-wide deception because reasonable consumers would likely not have been misled by Hershey’s statements. Third, Hershey claimed that there was no evidence that plaintiff suffered injury as a result of being deceived by Hershey’s statements. The Court agreed there was insufficient evidence that the “natural source of flavanol antioxidants” statement on the challenged Hershey products was likely to mislead reasonable consumers and that the label statements were therefore unlawful on that basis. 

The Court noted as background that the FDA has yet to promulgate a regulation defining the word “natural” as it pertains to packaged food. See Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food (“FDA Policy Statement”), 58 Fed. Reg. 2303, 2407 (Jan. 6, 1993) (explaining that “FDA is not undertaking rulemaking to establish a definition for ‘natural’ at this time.”). Instead, the FDA opted to “maintain its current policy . . . not to restrict the use of the term ‘natural’ except for added color, synthetic substances, and flavors as provided in [21 C.F.R.] § 101.22.” Id. “Additionally,” the FDA stated that “the agency will maintain its policy regarding the use of ‘natural,’ as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.” Id. 

Against that regulatory backdrop, plaintiff argued that the labels on the challenged Hershey products were (1) unlawful and (2) misleading. The Court noted that the UCL claim was governed by the “reasonable consumer standard,” which requires evidence that “members of the public are likely to be deceived” by the business practice or advertising at issue. Williams v. Gerber Prods. Co., 552 F.3d 934, 938 (9th Cir. 2008). Thus, to survive summary judgment, a plaintiff “must produce evidence showing ‘a likelihood of confounding an appreciable number of reasonably prudent purchasers exercising ordinary care.’ ” Clemens v. DaimlerChrysler Corp., 534 F.3d 1017, 1026 (9th Cir. 2008) (quoting Brockey v. Moore, 107 Cal. App. 4th 86, 99 (2003)). Put differently, plaintiff had to show “it is probable that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.” Lavie v. Procter & Gamble Co., 105 Cal. App. 4th 496, 507 (2003).  Although surveys and expert testimony regarding consumer expectations are not required, “a few isolated examples of actual deception are insufficient” in the Ninth Circuit. Clemens, 534 F.3d at 1026. Moreover, under California law, a plaintiff cannot “obtain relief by arguing how consumers could react; [he] must show how consumers actually do react.” Zeltiq Aesthetics, Inc. v. BTL Indus., Inc., 13-cv-05473-JCS, 2014 U.S. Dist. LEXIS 40402, at *33 (N.D. Cal. Mar. 25, 2014).

Here, plaintiff testified that he was misled by Hershey’s “natural source of flavanol antioxidants” label. According to Khasin, he believed at the time of purchase that flavanol antioxidants made them a “better choice” than other products. He produced evidence he said showed that flavanol antioxidants are not known to provide health benefits. Hershey maintained that its product labeling was not false and did not mislead consumers because its products in fact retain flavanol antioxidants that are naturally found in the cocoa bean. There was evidence that plaintiff also understood that Hershey’s products are candy, not health foods. 

Here, Khasin’s evidence was insufficient to create a genuine dispute of material fact.  While plaintiff argued that he was “mislead” by the label “natural source of flavanol antioxidants” and the “implicit representation[s]” that the FDA has established a Recommended Daily Intake (“RDI”) or Recommended Daily Value (“RDV”) for flavanol antioxidants, his solitary testimony, without more, was not enough to survive summary judgment. “[A] few isolated examples of actual deception are insufficient” to survive summary judgment.” Clemens, 534 F.3d at 1026; see also Ries v. Arizona Beverages USA, No. 10-CV-00139, 2013 WL 1287416, at *7 (N.D. Cal. Mar. 28, 2013) (granting summary judgment where defendants’ owner testified that some consumers of AriZona Iced Tea “were confused by the term a hundred percent natural” because such testimony, without more, “does not demonstrate that it is probable that a significant portion of the consuming public could be confused by the ‘all natural’ labeling of defendants’ products.”). Thus, absent additional evidence in addition to his own testimony, plaintiff did not meet his burden on the question of deception.

Moreover, even if the Court were to accept this testimony as evidence of deception, the facts in the record spoke to the contrary. Plaintiff in fact had testified in his deposition that Hershey’s products are candy, not health foods. And he didn't know what an RDI was.  In any event, plaintiff had to provide other extrinsic evidence in addition to his allegations to prove whether a reasonable consumer was likely to be misled. See Rice v. Fox Broad. Co., 330 F.3d 1170, 1181-2, n. 8 (9th Cir. 2003); but he produced no extrinsic evidence to suggest that a reasonable consumer would have expected or assumed that any particular level of flavanol antioxidants would be found in the alleged Hershey products. There was insufficient evidence presented such that the Court could find that a reasonable consumer would be misled by Hershey’s statements.

Further, “not every regulatory violation amounts to an act of consumer fraud.” See Mason v. Coca-Cola Co., 774 F. Supp. 2d 699, 705 n.4 (D.N.J. 2011).  Plaintiff''s showing of FDA letters regarding the characterizing level or amounts of nutrients was not relevant to showing that consumers are likely to be misled by Hershey’s statements.

Third, Khasin did not meet the burden of showing he suffered injury as a result of purchasing and relying on Hershey’s statements. Plaintiff was required to prove that he “lost money or property,” as a result of Hershey’s deceptive labeling to “demonstrate some form of economic injury.” Kwikset, 51 Cal. 4th at 322-23. Khasin proffered no evidence to show economic injury, but rather claimed that his purchases were “legally worthless” because they are inaccurate representations of what he thought he was purchasing. Alternately, he claimed that he paid a “price premium” because Hershey products with the statement, “natural source of flavanol antioxidants,” were objectively worth less than what he paid.  But the plaintiff's evidence did not include a model to determine how to calculate this presumed “price premium.”  Hershey produced historical sales data and a consumer survey indicating that there was no price change attributable to the labeling phrase, “natural source of flavanol antioxidants.” Therefore, plaintiff had not met his burden of showing that he suffered economic injury through loss of money or property, as a result of Hershey’s alleged deceptive labeling.


Therefore, the Court granted the defense motion.
 

 

Federal Court Rejects Off-Label Marketing Class Action

A Pennsylvania federal court recently refused to certify a proposed class action accusing a drugmaker of off-label marketing. See  In re: Actiq Sales and Marketing Practices Litigation, No. 2:07-cv-04492 E.D. Pa. March 23, 2015).

Plaintiffs were various entities who pay for employee's prescription drugs.  They alleged that defendant promoted its drug Actiq for uses not approved by the FDA.  As readers know, it is legal for doctors in their judgment to prescribe medications for uses other than those approved by the FDA, i.e., off-label uses. Plaintiffs argued that Cephalon’s conduct somehow caused Plaintiffs to make excessive off-label prescription payments for Actiq to treat conditions not approved by the FDA and for whom less expensive pain management drugs were appropriate. They asserted that under the circumscriptions of Actiq’s approved label, off-label marketing is not permissible since most forms of off-label use were for contraindicated conditions.

Plaintiffs moved for certification of one Nationwide Class defined as follows:
All Third Party Payors (“TPP”) in the United States who paid and/or reimbursed, in whole or in part, for the cost of Actiq prescribed for indications other than cancer and for consumption by their members, employees, plan participants, beneficiaries or insureds during the period from January 1, 2002 through December 31, 2006. Plaintiffs also suggested multi-state classes. 

The class action is an exception to the usual rule that litigation is conducted by and on behalf of the individual named parties only. Comcast Corp. v. Behrend, 133 S. Ct. 1426, 1432 (2013) (quoting Califano v. Yamasaki, 422 U.S. 682, 700-01 (1979)).  Class certification is proper only if the trial court is satisfied, after a rigorous analysis, that the prerequisites’ of Rule 23 are met. In re Hydrogen Peroxide Antitrust Litig., 552 F.3d 305, 309 (3d Cir. 2008) (quoting Gen. Tel. Co. of Sw. v. Falcon, 457 U.S. 147, 161 (1982)).

A decision to certify a class requires findings by the court, not merely a threshold showing by a party, that each requirement of Rule 23 is met.  In re Hydrogen Peroxide, 552 F.3d at 306; see Wal-Mart Stores, Inc., 131 S. Ct. at 2551. In conducting its analysis, a court is to resolve factual disputes by a preponderance of the evidence and to consider all relevant evidence and arguments by the parties. In re Hydrogen Peroxide, 552 F.3d at 306, 320. “Frequently [the court’s] ‘rigorous analysis’ will entail some overlap with the merits of the plaintiff’s underlying claim.” Wal-Mart Stores, Inc., 131 S. Ct. at 2551. Merits questions may be considered to the extent that they are relevant to determining whether the Rule 23 prerequisites for class certification are satisfied.  Amgen Inc. v. Conn. Ret. Plans and Trust Funds, 133 S. Ct. 1184, 1195 (2013). Plaintiffs’ burden is to show that the elements of their claims are capable of proof through evidence that is common to the class. See In re Hydrogen Peroxide, 552 F.3d at 311-12.

In opposing class certification here, Cephalon argued that individualized factual issues would predominate over their common claims, and the class action would be impossible to manage if certified. The Court agreed.

Nationwide and multi-state classes raise the issue of applicable substantive law.  Because choice of law is thus relevant to a determination under Rule 23, the Court first had to determine what law applied to Plaintiffs’ claim of unjust enrichment. 22 Powers v. Lycoming Engines, 328 F. App’x 121, 124 (3d Cir. 2009). Irreconcilable conflicts among state laws may defeat class certification. Federal courts sitting in diversity are to use conflict of laws rules of the forum state to determine which substantive law applies. Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496-97 (1941); Kaneff v. Del. Title Loans, Inc., 587 F.3d 616, 621 (3d Cir. 2009). This Court therefore used Pennsylvania rules on conflict of laws.

“[U]njust enrichment is a tricky type of claim that can have varying interpretations even by courts within the same state, let alone amongst the fifty states.” In re Sears, Roebuck & Co. Tools Mktg. and Sales Practices Litig., Nos. 05 C 4742, 05 C 2623, 2006 WL 3754823, at *1 n.3 (N.D. Ill. Dec. 18, 2006).  Here, Cephalon presented several bases upon which states’ laws conflict. For example, states apply various statutes of limitations to unjust enrichment claims. These differences meant that Plaintiffs’ claim for unjust enrichment  could withstand a statute of limitations defense in some jurisdictions but not in others, depending on the applicable law. A statute of limitations evidences a state’s policy interest in preventing litigation of delayed claims and preventing injustice by affording a defendant a fair opportunity to defend.

Additional variances in states’ unjust enrichment jurisprudence existed, including the availability of unjust enrichment as an independent cause of action, the need to show an absence of an adequate remedy at law, the requirement that a benefit be obtained at the direct expense of the plaintiff, the level of misconduct a plaintiff must prove, and the availability of defenses such as unclean hands and laches.  

Applying Pennsylvania's choice of law rules,most of the relevant factors weighed in favor of applying the laws of TPPs’ various home states, including the most important factors. See Restatement (Second) of Conflict of Laws § 221 cmt. d. Policy considerations also led to the same conclusion. Plaintiffs’ home states had a regulatory interest in providing redress to its citizens for acts of wrongdoing.

For the same reasons why an actual conflict existed among the unjust enrichment laws of the fifty states, individual issues of law predominated with regard to a nationwide class. In addition to proving different elements for all class members to establish unjust enrichment at trial, other individual issues that may predictably arise included the level of misconduct required to be proven and whether defendant might avail itself of particular defenses. 

Plaintiffs argued their smaller multi-state classes addressed this issue. Plaintiffs’ notable grouping efforts, however, still did not account for individual fact issues such that common issues predominated. “The polestar of the unjust enrichment inquiry is whether the defendant has been unjustly enriched[.]” Limbach Co., LLC v. City of Phila., 905 A.2d 567, 577 (Pa. Cmmw. Ct. 2006). Resolution to this question is, by nature, fact-sensitive. Id. Even if some common proof regarding equitable circumstances was present here, Plaintiff’s proposal to make a class-wide showing of whether Cephalon’s enrichment was unjust failed. Under an unjust enrichment theory, all facts and circumstances are considered to determine whether, without a remedy, inequity would result or persist. It is a physician’s prerogative whether to prescribe Actiq for any medical purpose, on-label or off. Physicians may have accounted for a number of factors in making their Actiq prescriptions, including their experiences with patients and their experiences with prescribing Actiq. See Ironworkers Local Union 68 v. AstraZeneca Pharm., LP, 634 F.3d 1352, 1362 (11th Cir. 2011) (“Several considerations shape the physician’s medical judgment, including both individual patient concerns and drug-specific information regarding the propriety of a drug’s use for treatment of a patient’s given condition . . . The physician learns about a drug through multiple sources, only one of which might be the drug manufacturer’s promotions and literature.”  It was also uncontested that Actiq provided the benefit of effective pain relief to many who used it. If doctors would have written Actiq prescriptions regardless of the defendant's alleged acts, then payment for prescriptions beyond would not be unjust.  In sum, whether  payments for Actiq prescriptions resulted in "unjust" enrichment is a question resolved by examination into the actions not only of Cephalon, but also of individual payers  and prescribing doctors. See Marcus v. BMW of N. Am., LLC, 687 F.3d 583, 611 (3d Cir. 2012).

The class also failed the superiority prong. Together with predominance, the superiority criterion is designed to “achieve economies of time, effort, and expense, and promote . . . uniformity of decision as to persons similarly situated, without sacrificing procedural fairness or bringing about other undesirable results.” Amchem Prods., Inc., 521 U.S. at 615 (quoting Fed. R. Civ. P. 23 advisory committee’s note). The Court here considered the factors enumerated in Rule 23(b)(3) for determining superiority:
(A) the class members’ interests in individually controlling the prosecution or defense of separate actions;
(B) the extent and nature of any litigation concerning the controversy already begun by or against class members;
(C) the desirability or undesirability of concentrating the litigation of the claims in the particular forum; and
(D) the likely difficulties in managing a class action.

Here, the largest impediment to a finding of superiority was the difficulty of managing a class action in which the laws of plaintiffs' various home states applied and individual questions of fact predominated. Also, plaintiffs here were sophisticated institutional entities with an interest in controlling litigation when relatively large amounts of money are at stake.  Indeed, some putative absent class members had already filed suit based on Cephalon’s distribution of Actiq.

Motion for class certification denied.

Medical Monitoring Class Action Rejected at Pleading Stage

A federal court recently rejected a proposed medical monitoring class action brought by alleged Pepsi drinkers.  The case reminds readers of the importance of the causation element of medical monitoring claims, even though plaintiffs don't need to allege traditional personal injury.  See Riva v. Pepsico, Inc., No. C-14-2929 EMC, 2015 WL 993350 (N.D. Cal.,  3/4/15).

Plaintiffs alleged that two of defendant's beverages contained levels of a chemical, 4–MeI, that caused them to experience an “increased risk of cancer,” specifically bronchioloalveolar cancer.  Plaintiffs sought  medical monitoring as a remedy; specifically, seeking an order requiring Pepsi to establish a “fund from which those individual class members can seek monetary recovery for the costs of actual or anticipated medical monitoring expenses incurred by them.”  Plaintiffs alleged that outcomes in bronchioloalveolar cancer show a clinically significant benefit from early evaluation, detection, and diagnosis. 

California is one of the few states that recognizes a claim for medical monitoring. “In the context of a toxic exposure action, a claim for medical monitoring seeks to recover the cost of future periodic medical examinations intended to facilitate early detection and treatment of disease caused by a plaintiff’s exposure to toxic substances.” Potter v. Firestone Tire & Rubber Co., 6 Cal.4th 965, 1004–05, 25 Cal.Rptr.2d 550, 863 P.2d 795 (1993). In Potter, the California Supreme Court identified five factors in determining the reasonableness and necessity of 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.

Based on such factors, the trier of fact decides, “on the basis of competent medical testimony, whether and to what extent the particular plaintiff’s exposure to toxic chemicals in a given situation justifies future periodic medical monitoring.” Id.

Defendant attacked the medical monitoring claim under Rule 12(b)(6), particularly as to the Potter factors related to whether medical monitoring is reasonable and necessary.  Accordingly, the Court examined the allegations related to these critical Potter factors: plaintiff’s exposure to chemicals; the toxicity of the chemicals; and 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.

To demonstrate the proximate causation element of the claim, a plaintiff seeking medical monitoring must. among other things, show the significance of her exposure to the toxic chemical. Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795; see also Abuan v. Gen. Elec. Co., 3 F.3d 329, 335 (9th Cir.1993) (applying comparable Guam law on medical monitoring). The California Supreme Court has explained, “[e]vidence of exposure alone cannot support a finding that medical monitoring is ... necessary.” Lockheed Martin Corp., 29 Cal.4th at 1108–09, 131 Cal.Rptr.2d 1, 63 P.3d 913. A plaintiff must demonstrate sufficient severity of exposure (its significance and extent) and that “the need for future monitoring is a reasonably certain consequence of [the] toxic exposure” Id. at 1109, 131 Cal.Rptr.2d 1, 63 P.3d 913 (citation omitted).

In this case, Plaintiffs alleged that the chemical had been found to cause lung tumors in laboratory animals -- at a daily dose thousands of times higher than the amount in soda.  Plaintiffs sought to represent a class of all persons who purchased Diet Pepsi or Pepsi One within a four-year period, regardless of consumption amount. What was missing was any allegation of what the significance of this unspecified exposure to the chemical may be; they did not allege what threshold level of exposure allegedly created the increased risk.

Thus, there was insufficient information about the significance and extent of exposure of the class to make the necessary ultimate showing that “the need for future monitoring is a reasonably certain consequence of [the] toxic exposure” Lockheed Martin Corp., 29 Cal.4th at 1109, 131 Cal.Rptr.2d 1, 63 P.3d 913. They simply 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. In fact, if anything, the specific scientific finding incorporated into the Complalnt from the mice study was that the amounts of 4–MeI ingested in cola products “may not be significant.”

The Court also found that Plaintiffs had not sufficiently pled their injury or shown the toxicity of 4–MeI. It was not enough thatt 4–MeI is on the Proposition 65 list of known carcinogens, that a toxicologist has stated that there is “no safe level of 4–MeI,” and that advocacy groups have called for the FDA to ban 4–MeI.  The full picture was that “caramel coloring” (the manufacturing of which allegedly produces 4–MEI as a byproduct) is “generally recognized as safe” when used in accordance with good manufacturing practice and as a food color additive. Under the FDCA, the inclusion of “caramel color” as a “color additive” means that the FDA has determined that caramel coloring has not been found “to induce cancer when ingested by man or animal.” 21 U.S.C. § 379e(b)(5)(B).

So while Plaintiffs adequately pled that 4–MeI is toxic and is, generally speaking, a carcinogen—i.e., that 4–MeI is capable of causing cancer, they had not adequately pled their specific theory of injury—an increased risk for bronchioloalveolar cancer sufficient to warrant medical monitoring—“above the speculative level.” Twombly, 550 U.S. at 555. Plaintiffs are not mice, and there was nothing in the Complaint, or the studies incorporated by reference, to suggest that 4–MeI causes this specific form of lung cancer in humans. The same mouse study found no increased cancer in rats and discussed a “species difference” identified in previous studies in terms of how various species absorb, distribute, metabolize, and excrete this very chemical. So this study did not lead to a plausible inference that these Plaintiffs are at increased risk of the specific lung cancer for which they request screening. 


In short, the  Plaintiffs failed to plead factual content to show they had been injured due to a “significant” increase in their risk of lung cancer sufficient to justify medical testing in the absence of any symptoms or present injury. See Potter, 6 Cal.4th at 1008–09, 25 Cal.Rptr.2d 550, 863 P.2d 795. The only factual content supporting the allegation of increased risk of lung cancer came from scientific studies, which had no demonstrable bearing on cancer toxicity for humans at the consumption levels alleged in the case at bar.

A plaintiff seeking medical monitoring must show a need for “specific monitoring beyond that which an individual should pursue as a matter of general good sense and foresight.” Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795. In this case, Plaintiffs sought CT scans of their lungs and molecular screening for lung cancer. Lung scans are not needed to remedy injury absent a credible showing that 4–MeI causes this lung cancer in humans.

The Court took the Prop 65 argument head on.  Proposition 65 is broad; its listing embraces “ substances listed as human or animal carcinogens. In other words, “the Proposition 65 list includes chemicals that are known to cause cancer in animals, even though it has not been definitively established that the chemicals will cause cancer in humans.” Baxter Healthcare, 120 Cal.App.4th at 352, 15 Cal.Rptr.3d 430. Furthermore, listing under Proposition 65 only requires one excess case of cancer in an exposed population of 100,000, assuming lifetime exposure at the level in question. 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 the Proposition 65 list.

Finally, the Court addressed the increased risk above background, and other possible sources of exposure.  There can be many possible “causes,” indeed, an infinite number of circumstances which can produce an injury or disease. A possible cause only becomes “probable” when, in the absence of other reasonable causal explanations, it becomes more likely than not that the injury was a result of its action. This is the outer limit of inference upon which an issue may be submitted to the jury. As a result, under California personal injury law the mere possibility of causing cancer alone is insufficient to establish a prima facie case.

The Court said that this concept of causation inheres in the Potter test for the reasonableness of medical monitoring; the trier of fact considers, among other factors, “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.” Potter, 6 Cal.4th at 1009, 25 Cal.Rptr.2d 550, 863 P.2d 795. Consistent with this approach, the Ninth Circuit has affirmed a grant of summary judgment where plaintiffs seeking medical monitoring failed to introduce facts regarding the “quantitative (or even qualitative) increased risk to individuals.” Abuan, 3 F.3d at 335.

The Complaint admitted that there are many sources of consumption of 4–MeI, including “baked goods, confectionary, extruded breakfast cereals, instantaneous soups, and dark beers” as well as “soy sauce and coffee.” The many alternative sources of 4–MeI was problematic to the establishment of any causation between the Pepsi products at issue and the Plaintiffs’ alleged consumption of 4–MeI “at or above certain threshold levels” (whatever those threshold levels, if any, may be). The many sources of 4–MeI prevented these Plaintiffs from satisfying the third Potter factor.

Where the pleadings reveal so many commonly consumed foods with similar levels of a chemicaI, it is implausible to conclude that any alleged increased risk of cancer is “more likely than not” caused by drinking/using one product, said the Court.  As a result, the Plaintiffs’ claims were dismissed. See Twombly, 550 U.S. at 557 (“something beyond the mere possibility of loss causation must be alleged”).