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In re Vioxx Class Cases

December 15, 2009


Appeal from a judgment of the Superior Court of Los Angeles County, Victoria G. Chaney, Judge. Affirmed. (Los Angeles County Super. Ct. No. JCCP 4247).

The opinion of the court was delivered by: Croskey, J.


Defendant Merck & Co., Inc. (Merck) manufactured and marketed Vioxx, a pain-relieving drug. Vioxx was pulled from the market on September 30, 2004, after a study indicated that the drug created a risk of adverse cardiovascular effects. The plaintiffs in this action brought suit against Merck. The plaintiffs do not assert that they suffered any adverse effects from taking Vioxx. Instead, they assert that, due to its cardiovascular risks, Vioxx was less safe than other, less expensive, pain relievers. The plaintiffs seek recovery, on behalf of all persons and entities in California who paid for Vioxx, of the difference in price between what they paid for Vioxx and what they would have paid for a safer, equally effective, pain reliever. Alleging that Merck knew about the dangers of Vioxx but engaged in a campaign to hide or explain away those risks, the plaintiffs pursued causes of action for unfair competition (Bus. & Prof. Code, § 17200; UCL), false advertising (Bus. & Prof. Code, § 17500; FAL), the Consumers Legal Remedies Act (Civ. Code, § 1750 et seq.; CLRA), and unjust enrichment.*fn1

Plaintiffs moved for certification of a class action. After considering thousands of pages of documents, the trial court denied the motion, concluding that common issues of fact did not prevail over individual issues. The court also concluded that the named plaintiffs, who were all individuals, did not possess claims typical of prescription drug benefit providers who had paid all or part of the purchase price of Vioxx for their subscribers. (These providers are referred to by the parties as "Third-Party Payors" or "TPPs.")

Plaintiffs appeal, arguing, in part, that the Supreme Court's intervening decision in In re Tobacco II Cases (2009) 46 Cal.4th 298 (Tobacco II) undermines the trial court's rationale. We conclude that the trial court's ultimate decision is consistent with Tobacco II, and is supported by substantial evidence. We therefore affirm.*fn2


1. Vioxx - Its Risks and Advertising

Vioxx is an NSAID - a non-steroidal anti-inflammatory drug. Aspirin is an NSAID, as is naproxen, which is sold over-the-counter under the trade name Aleve. NSAIDs work by inhibiting the pain- transmitting enzyme cyclooxygenase. There are two such enzymes, known as COX-1 and COX-2. Earlier Cox-inhibitor NSAIDs, such as aspirin and naproxen, inhibit both COX enzymes. Inhibiting COX-1, however, leads to a risk of adverse gastrointestinal effects. Therefore, drug manufacturers sought a selective COX inhibitor, which would inhibit only COX-2, and, in theory, result in pain relief without the usual risk of adverse gastrointestinal effects. The first such COX-2 inhibitor was celecoxib, marketed by Pfizer under the trade name Celebrex. The second COX-2 inhibitor was rofecoxib, which was marketed by Merck under the name Vioxx.

It was subsequently determined that, although Vioxx inhibited pain without the risk of adverse gastrointestinal effects of other NSAIDs, Vioxx caused a greater risk of adverse cardiovascular effects. It is beyond the scope of this opinion to consider or discuss the scientific basis for this, although it is speculated that the COX-2 enzyme has an anti-clotting effect, and selective inhibition of this enzyme may therefore cause the formation of dangerous blood clots.

Around the time of Vioxx's initial release, Merck sponsored a study on Vioxx, called the VIGOR study. The goal of the study was to establish Merck's hypotheses that Vioxx was: (1) equally effective at pain relief as naproxen; and (2) substantially safer from a gastrointestinal point of view. The VIGOR study did establish both of these points. However, the group of VIGOR participants who were taking Vioxx experienced a (statistically significant) greater amount of adverse cardiovascular events than the group of VIGOR participants who were taking naproxen. Barring coincidence, only two possible explanations existed for this result: either Vioxx caused adverse cardiovascular events or naproxen protected against them.*fn3 There was no existing scientific evidence that naproxen had any cardio- protective effect. Nonetheless, when the results from the VIGOR study were published in the New England Journal of Medicine in November 2000, the article suggested that the results were due to naproxen being cardio-protective, a theory referred to by the parties as "the naproxen hypothesis." Ultimately, the naproxen hypothesis would be proven false.

The VIGOR study - its design, its results, and the way those results were presented - represents a key point in plaintiffs' understanding of the history of the case. According to plaintiffs, Merck advertised Vioxx to the public (through press releases, commercials and magazine advertisements) as safe, without mentioning its cardiovascular risks. Similarly, plaintiffs allege that Merck represented to prescribing physicians (through marketing representatives, product labels, direct-mailed letters, and published studies) that Vioxx did not cause a risk of adverse cardiovascular effects. Plaintiffs allege that after the VIGOR study, Merck knew or should have known that Vioxx was unsafe from a cardiovascular point of view, but rather than acknowledge this, Merck downplayed any cardiovascular risk and instead clung to the baseless naproxen hypothesis. Merck withdrew Vioxx from the market on September 30, 2004, after another study indicated that Vioxx was indeed responsible for an increased risk of adverse cardiovascular events. Plaintiffs allege that Merck knew about this risk for years, but intentionally deceived the public, and physicians, about it in order to increase sales.

2. Gravamen of Plaintiffs' Complaint

While plaintiffs pursue four causes of action (UCL, FAL, CLRA, and unjust enrichment), each cause of action is based on the same general theory of relief.*fn4 The plaintiffs assert that, as Vioxx was no more effective than generic naproxen at relieving pain, and less safe than generic naproxen, Vioxx was actually worth no more than generic naproxen. Vioxx, however, was a non-generic drug and generally cost more than generic naproxen. As Merck misled consumers into paying more for Vioxx by misrepresenting it as safer than generic naproxen, plaintiffs sought the difference between the price paid for Vioxx and the price which would have been paid for generic naproxen. In their declarations, the named plaintiffs did not assert that they would have purchased generic naproxen instead of Vioxx; they simply stated that had they been informed that equally effective and safer alternatives were available, they would not have purchased Vioxx. Merck attempted, through discovery, to determine which alternative drug the named plaintiffs would have used had they known about the risks of Vioxx. The plaintiffs responded that the drug they would have used was irrelevant. What matters, according to plaintiffs, is that they paid for Vioxx believing that it was better than a generic NSAID, when, in fact, Vioxx was no better than (and was perhaps worse than) a generic NSAID. Thus, a generic NSAID is a proper conservative estimate of the true value of the Vioxx received.

3. Plaintiffs' Motion for Class Certification

On July 27, 2007, plaintiffs filed a motion for class certification, seeking to certify the class of "[a]ll individuals or entities in California who, from June 1, 1999 to October 1, 2004, inclusive, paid some or all of the purchase price for the prescription drug Vioxx manufactured by Merck & Co., Inc."*fn5 Plaintiffs supported their motion with substantial documentation intended to show that Merck's representations to the public and prescribing physicians were all part of a common, unified campaign to downplay or outright ignore the cardiovascular risks of Vioxx which were known to Merck. While the precise details of the representations and omissions need not be discussed here, we note that, in general, Merck's direct-to-consumer advertisements did not address the cardiovascular risks at all. In contrast, adverse cardiovascular data from the VIGOR study was disclosed to physicians via the publication of the study*fn6 and Vioxx's labeling, but Merck attempted to downplay the significance of that data by: (1) advancing the naproxen hypothesis; (2) pointing to favorable data culled from other studies; and (3) making reassurances that Vioxx was safe. Indeed, plaintiffs allege in their complaint that an April 2002 label revision on Vioxx would have revealed the cardiovascular risk to "someone with enough medical knowledge to make sense of Merck's warning," but that this was undermined by a near-simultaneous press release stating that the significance of the cardiovascular findings from the VIGOR study was " `unknown' " and that Merck was " `confident in the efficacy and safety profile of Vioxx.' "

Plaintiffs also relied on the declaration of a medical expert, John David Abramson, M.D., to the effect that: (1) Merck's representations were biased and misleading; and (2) "a responsible physician who received the full and accurate disclosure of information about the risks and benefits of Vioxx would not have prescribed it as there were on the market other alternatives that were as effective and/or safer." Plaintiffs also relied on the declaration of an expert in pharmaceutical economics to the effect that, if generic naproxen is used as the comparator, the proper mathematics exist to enable the price differential to be calculated on a class-wide basis.*fn7

4. Merck's Opposition

Merck opposed the certification motion with an equally impressive quantity of documentation designed to establish that individual, rather than common, issues prevailed. Merck relied on the many different warning labels used on Vioxx and several published Vioxx studies in order to demonstrate that Merck's ...

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