Saturday, May 09, 2009

Vioxx Class Action Goes Down to Defeat In California

A lot of state courts are getting the message that the federal courts received over a decade ago. Class action litigation involving prescription drugs is a no go. Richard Goetz over at O'Melveny passes along the latest - a California Superior Court denial of class certification in a consumer fraud action over Vioxx.

What led to this result? The usual. The plaintiffs didn't allege either that Vioxx actually hurt anyone or that it was ineffective for its FDA-approved use as a painkiller in certain situations. Slip op. at 2. Also, the plaintiffs mixed in third party payors with individual class representatives. The latter cannot possibly be typical of the former. Slip op. at 5.

But, as usual, predominance is the killer:
Under all of plaintiffs' causes of action, a central issue will be whether defendant's alleged misrepresentations and nondisclosures were material to those who purchased [the drug]. A misrepresentation of fact is material if it induced the plaintiff to alter his position to his detriment. Stated in terms of reliance, materiality means that without the misrepresentation, the plaintiff would not have acted as he did. To recover, therefore, each class member must demonstrate, or it must be inferrable classwide, that the misrepresentation or nondisclosure influenced each class members prescription decisionmaking.

Slip op. at 9 (citation and quotation marks omitted). Even under California's broad consumer fraud act, to obtain anything other than an injunction, reliance is an essential aspect of causation. Slip op. at 10. With physicians as learned intermediaries, this is an inherently individualized inquiry:
The process by which a physician decides whether and what to prescribe for a pain patient requires an individualized approach that applies a physician's clinical judgment to each patient's unique situation. This decision requires a physican to assess a number of factors which vary from patient to patient, including, among others: a) The condition being treated, including the nature, location, and extent of the pain; b) The risks and benefits associated with the drug; c) The anticipated dose and duration of the prescription; d) The patient's medical history....; e) The potential for adverse interactions with a patient's other medications; f) The anticipated degree of patient compliance; g) The drug's cost and the patient's insurance coverage; and h) The patient's concerns regarding treatment and his or her perception of the severity of the pain.

Slip op. at 10 (quotation marks omitted). We've posted before about how these failures of pleading are fatal to class certification where prescription decisions are controlled by physicians.

TPPs fared no better:
[T]he court is well satisfied that TPP decisionmaking is almost as variegated as is individual physician/patient decisionmaking. Some TPPs used open formulary, basically deferring risk assessment to physicians. Others used closed formularies. Even those that used closed formularies sometimes include cardio-risk drugs.

Slip op. at 11. Nor, given these facts, is any uniform inference of reliance possible. "Because materiality of the representation is not uniform, reliance on it cannot be inferred classwide." Id. at 12.

These findings are well within the majority ruld rejecting consumer fraud damages class actions in cases involving prescription drugs. We'll see how it fares on appeal, but we have to be optimistic.

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