Yesterday Merck won an important appeal in a California Vioxx class action in which plaintiffs had argued that the California Supreme Court's recent decision in In re Tobacco II Cases, 46 Cal. 4th 298 (2009) required the reversal of a trial court's refusal to certify a class action under California's Unfair Competition Law. See In re Vioxx Class Cases, No. B216521 (Cal. App. -- 2d Dist. Dec. 15, 2009). The Vioxx Class Cases decision is important because it recognizes that although Tobacco II imposed a new understanding of the UCL's standing requirement, it did not fundamentally alter the other elements of the statute, and a proposed class can still fail the class action prerequisites where the relief requested requires individualized determinations and where the named plaintiffs' claims are not typical of those of other class members.
Vioxx was a Non-Steroidal Anti-Inflammatory Drug ("NSAID") that was used to treat pain until it was removed from the market in 2004. Unlike aspirin or naproxen, which are NSAIDs that can cause gastrointestinal complications, Vioxx was a "COX-2" inhibitor that was expressly designed to avoid the gastrointestinal effects inherent in NSAIDs like naproxen. Vioxx was removed from the market after studies determined that it presented a risk of adverse cardiovascular effects.
Plaintiffs brought a statewide class action under the UCL, the False Advertising Act, the Consumer Legal Remedies Act, and common law unjust enrichment. They sought classwide restitution of the difference in price between what they paid for Vioxx and what they would have paid for a safer, equally effective, pain reliever. Their economist calculated that price differential to be $8.3 billion nationally, but did not break it down to what allegedly was owed to California purchasers.
Plaintiffs' theory of liability was simple: Merck knew its drug presented cardiovascular risks, but concealed that fact and marketed Vioxx as safe to the public and to doctors. Slip op. at 7. As a result, they said, they were entitled to classwide restitution of the difference between the price of Vioxx and the price of generic naproxen.
Interestingly, in discovery, plaintiffs would not say that they would have taken naproxen instead of Vioxx. Rather, they would only say that they would not have taken Vioxx if they had known the risks, and that the drug they would have used instead was irrelevant. Slip op. at 6.
In the trial court, Merck had established that roughly 16,500 people in the US died from gastrointestinal bleeds -- the most common NSAID complication -- each year, and over 100,000 were hospitalized. It presented medical testimony that for patients with a history of serious gastrointestinal problems who could not tolerate traditional NSAIDs, COX-2 inhibitors like Vioxx were the only appropriate option. Further, it presented evidence from third party payors -- who were included in the class of purchasers, even though the named plaintiffs were all individuals -- establishing that some third party payors' Pharmaceutical and Therapeutics committees had studied the risks of Vioxx thoroughly and only approved the drug for use with patients who had a history of gastrointestinal disease and had first tried one or two traditional NSAIDs without success. The third party payors' records also established that when Vioxx was removed from the market, most patients did not switch to generic NSAIDs like naproxen, but rather switched to another branded COX-2 inhibitor with a price comparable to Vioxx.
Merck also established in the trial court that doctors apply their clinical judgment to each patient's unique situation in choosing which pain medicine to prescribe, looking at eight different factors. Merck also established that doctors rely on different sources of information, with some even rejecting out of hand research the company provides.
On appeal, plaintiffs challenged three conclusions of the trial court. First, they challenged the trial court's conclusion that the individual plaintiffs' claims were not typical of the claims of third party payors. Second, they said the trial court erred in concluding that individual issues of reliance barred a class action. And third, they urged that their method of calculating damages was subject to common, class-wide proof, making classwide restitution appropriate.
Typicality and Third Party Payors
Plaintiffs argued that the individual plaintiffs could represent the interests of the third party payors -- like union health benefit plans -- because if an individual relied on Merck's alleged misrepresentations to buy Vioxx, then the third party payor who paid for most of that prescription should be entitled to recover, too. The Court of Appeal held that the flaw in this analysis is that it treats the third party payor as a passive entity that pays without having any say in what is prescribed. But the evidence showed that, at least for some large third party payors, their Pharmaceutical and Therapeutics committees conducted literature reviews and studies, and made their own decisions about what they were going to pay for. As a result, evidence about what alleged misrepresentations the individuals received or relied upon could not apply to third party payors, and the court could not presume reliance across all third party payors based on any individual's reliance. Slip op. at 21. Indeed, for third party payors who only paid for Vioxx where there was a history of gastrointestinal problems and the patient could not tolerate other NSAIDs, every penny it paid for Vioxx was for a patient who benefited from the prescription. Id. at 22. Accordingly, the individuals' claims were not typical of the third party payors.
Individual Issues of Reliance Predominate the CLRA Claim
California's Consumer Legal Remedies Act requires some form of causation between the unlawful act and the consumer's damages: it gives a cause of action to "[a]ny consumer who suffers any damage as a result of the use or employment" of an unlawful act. Cal. Civ. Code sec. 1780(a) (emphasis added). Some California cases have held that an "inference of reliance" may arise for the class where a material misrepresentation has been made to the whole class. But "if the issue of materiality or reliance is a matter that would vary from consumer to consumer, the issue is not subject to common proof, and the action is not properly certified as a class action." Slip op. at 16.
Plaintiffs suggested that hiding an increased risk of death from cardiovascular complications is about as material as a misrepresentation can get, and that reliance should be inferred to the whole class for purposes of the CLRA. But the Court of Appeal rejected this notion for four reasons.
First, Vioxx did not present an increased risk of death for all patients, because there were patients with gastrointestinal problems who would have been more likely to die from complications with traditional NSAIDs like naproxen. Second, the record evidence reflected that there were patients who would still take Vioxx if it were on the market today, and physicians who would still prescribe it. Thus, for some subset of the class, the cardiovascular risks were not material to their decision whether to take the medicine. Third, the differences in how doctors study and evaluate the risks of medicines prevented a classwide inference of materiality. And fourth, the patient-specific factors that doctors evaluate in prescribing a pain medicine also made a presumption of materiality not viable. For example, a doctor might downplay the clotting risk of Vioxx for a patient already receiving a blood thinner like Coumadin. Slip op. at 24.
Individual Issues Regarding Injury and Restitution Predominate the UCL and FAA Claims
The Court of Appeal noted that although the UCL liberalizes the standards for finding liability, it narrowly prescribes the remedies available under the statute: injunctive relief and restitution. There was no need for injunctive relief, since the product had been pulled from the market. So the question was one of restitution. Plaintiffs' economist proposed comparing the price of Vioxx with the price of generic naproxen, using the difference as the amount of restitution.
But the Court of Appeal concluded that this approach could not be applied to the class as a whole, because there was substantial record evidence that after Vioxx was withdrawn from the market, most Vioxx patients switched to other similarly-priced brand-name COX-2 inhibitors, not generic naproxen. Plaintiffs argued that adjudicating the validity of naproxen as a comparison improperly went to the merits of the action, but the Court of Appeal said no. Rather, it went to whether a "measurable amount" of restitution could be proven on a classwide basis. The court held that it could not, and that class members thus would have to individually establish the appropriate comparator medicine, and then whether he suffered an injury. This was a patient-specific issue, the court held, "incorporating the patient's medical history, treatment needs, and drug interactions."
Dicta on the Class Definition
The Court of Appeal was highly critical of the plaintiffs' class definition, which included "all individuals or entities in California who . . . paid some or all of the purchase price for the prescription drug Vioxx." Slip op. at 6-7. Besides improperly lumping individuals and third party payors together, the Court of Appeal also was clearly troubled that there was no carve-out for people who suffered physical injuries (slip op. at 5-6, n.4), thereby presenting problems of claim-splitting. The court said the class definition was overbroad, and that those with physical injuries "should not be bound in an action pursuing only economic damages for the price of Vioxx." Slip op. at 20, n.16. Moreover, the class definition also was overbroad because it included those with flat co-payment obligations who would have paid the same amount of co-payment regardless of what drug was applied; they would have suffered no injury, and thus should not be in the class. Id.
Moreover, given the fact that -- as the Court of Appeal noted -- many of the class members actually derived benefit from Vioxx's lack of gastrointestinal effects, I would argue that the class definition also should have been required to exclude those people from the class.
The decision in Vioxx Class Cases is an important reminder that the elements of the causes of action for UCL, CLRA, FAA and unjust enrichment claims in California provide important defenses to class certification. Just because a UCL claim may survive a demurrer does not mean that it can be tried on a classwide basis. Defendants would be wise to follow Merck's lead and develop strong factual bases for why classwide presumptions are not viable and individual proof of injury should be required.
.jpg)
