Sunday, April 18, 2010

Mismatched dose claim survives preemption

In re Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litig., --- F.Supp.2d ----, 2010 WL 1268196 (E.D.N.Y.)

This multidistrict litigation involves claims that Bayer misrepresented its Women’s Low Dose Aspirin + Calcium (Bayer Calcium) and Aspirin with Heart Advantage (which combines low-dose aspirin with phytosterols, marketing them as if they were FDA-approved, appropriate for long-term use, and provided health benefits (a source of calcium and cardiovascular benefits, respectively). Allegedly, none of this was true; a person couldn’t take either combination product and get both the recommended daily dose of aspirin and the recommended daily dose of calcium or phytosterols. Taking the recommended amount of aspirin would leave you with one-third the recommended amount of calcium and one-half the recommended amount of phytosterols, respectively. Plaintiffs alleged that the labeling was confusing, commingling statements about the virtues of low-dose aspirin with those about the health benefits of calcium and phytosterols: a whole less than the sum of its parts.

Any aspirin maker can sell aspirin under the FDA aspirin monograph as long as it makes only permitted claims and includes standard directions and warnings, including that a low-dose aspirin regimen should be pursued only under a doctor’s supervision. Bayer sells its low-dose aspirin under the FDA monograph.

The FDA has approved unqualified health claims for calcium, for reducing the risk of osteoporosis, and phytosterols, for lowering cholesterol and reducing the risk of heart disease, reflecting significant scientific agreement on the claim. Food and dietary supplements with the requisite levels of these ingredients can put health claims on their labels.

Bayer promotes Bayer Calcium and Heart Advantage with qualified health claims about low-dose aspirin and the health benefic claims authorized for high-calcium and high-phystosterol foods, respectively.

Bayer Calcium’s package states, “Provides 300 mg of Calcium Which Helps Strengthen Bones To Help Fight Osteoporosis” and “Aspirin Protects Your Heart by Keeping Your Blood Flowing Freely.” In 2008, the FDA warned Bayer that, because of Bayer Calcium’s combined active ingredients and combined labeled uses, it was a new drug that couldn’t be sold OTC, and its current marketing constituted misbranding because it didn’t have “directions under which the layman can use a drug safely for the purposes for which it is intended.”

Heart Advantage likewise has the standard daily dose of aspirin and half the recommended daily dose of phytosterols. The label says it’s Bayer aspirin “Plus Cholesterol Lowering Phytosterols,” “[t]he only product that contains ... aspirin, to protect your heart by keeping your blood flowing freely [and] Phytosterols, to help lower bad cholesterol.” The FDA sent the same warning letter about Heart Advantage.

The named plaintiffs alleged that they bought one of the products based on Bayer’s promises of decreased risk of osteoporosis or lowered cholesterol. Had they known that they wouldn’t get a full dose of calcium/phytosterols, they alleged, they would have purchased other low-dose aspirin, which cost a lot less (as low as 2 cents per pill, compared to 18 cents per pill for the Bayer version). Doubling the Bayer dose to get the recommended daily dose of phytosterols would have subjected them to risks from the extra aspirin. In sum, it would be impossible for them to get both the recommended daily amount of low-dose aspirin and phytosterols/calcium from the products.

The alleged harm is that the plaintiffs paid a premium for a product they thought was superior due to Bayer’s false representations, and that they wouldn’t have bought the products at all without those representations. Thus, they claim to be entitled to a full refund of the purchase price. They sued under the consumer protection laws of their states of residency (New York, New Jersey (for a nationwide class), California (a subclass), and Illinois) and, in the alternative, similar statutes of 43 other states. State consumer protection claims may require Rule 9(b)’s heightened pleading. “Notably, the named plaintiffs have each specified where they saw the misleadingly packaged Heart Advantage or Bayer Calcium; where their purchases occurred; how long they continued purchasing the product; and how they were deceived.”

Bayer argued that plaintiffs were impermissibly trying to enforce the FDCA, arguing that allegations of substantive defects in the products (the dose mismatch between the two components) were irrelevant because there was no claim of physical injury. A viable state-law claim must be premised on conduct that would give rise to recovery under state law even in the absence of the FDCA. But this statement won’t entirely work because the FDCA does exist, making possible things like misrepresentations about FDA approval. So the state law claim can incorporate FDCA violations, but must not depend entirely on them. State consumer protection law, and the Lanham Act, complement FDCA labeling requirements. To thread the needle, a plaintiff must show an FDCA violation, but also that defendant’s wrongdoing would entitle plaintiff to recover under traditional common-law principles. Thus, Wyeth v.Levine, --- U.S. -- (2009), allowed a failure to warn claim despite FDA approval of a drug’s labeling. State common law is an extra layer of protection, focused on the truth or falsity of advertising claims as the FDCA is not. False or misleading claims made in connection with drug marketing can be actionable, even if their truth is generally within the FDA’s purview.

Plaintiffs have failed when they argued that merely placing drugs on the market with standard inserts falsely implies FDA approval. Plaintiffs must point to some claim or representation that is reasonably clear from the advertising or inserts. False representations of FDA approval are evaluated the same as claims about misrepresentations about other aspects: “where plaintiffs sufficiently detail their allegations and point to specific instances where defendants have made false or misleading representations, they have actionable claims.” So one case found a well-pleaded claim of false implication of FDA approval when defendants placed drugs on comparative clinical databases. It wasn’t the simple fact of marketing a nonapproved drug that was the problem, but the particular form of the marketing, a form that allegedly carried certain false implications.

Applying these principles, the court refused to dismiss the claim. Plaintiffs argued that Bayer’s reputation itself gave the combination products the imprimatur of FDA approval, cemented by Bayer’s repetition of claims for low-dose aspirin and use of FDA-approved health benefit claims for phytosterols and calcium. By using FDA-approved statements about the component parts, Bayer allegedly falsely implied that the combination products were themselves FDA-approved. Bayer argued that this was precisely what FDA approval of the claims allowed it to do, even though the FDA never approved any combination product or any claims related to a combination product.

Plaintiffs also argued that, because of the dose mismatch, Bayer misrepresented the safety and efficacy of its products: one could not receive the benefit of one component without taking the wrong dose of the other.

The court held that plaintiffs had identified specific instances of the alleged implications of FDA approval. Moreover, the dose discrepancy claims were traditional claims of misrepresentation, not an attempt to enforce FDCA labeling requirements. Though the claims “ouch on areas regulated by the FDA, and may even require reference to FDA definitions as to what the requirements are for adequate sources of calcium and phytosterols and what the dangers of larger doses of aspirin are, they are not preempted.” Whether the claims are misleading can be verified without relying on any special FDA expertise.

Bayer argued that the FDA’s silence since its 2008 warning letters meant tacit approval of the advertising, preempting state law claims. This was the reasoning rejected in Wyeth. Even if the labeling meets the federal floor, it could still be actionable under state consumer protection law.

The court also refused to dismiss plaintiffs’ claims under the laws of states other than those in which the named plaintiffs reside (claims made in the alternative to using New Jersey law; plaintiffs also broke out a California subclass). There was no constitutional standing problem because plaintiffs weren’t bringing claims on their own behalf, but only seeking to represent other similarly situated consumers in those states. Class action certification, of course, is an issue for another day.

Bayer also argued that plaintiffs lacked standing because they hadn’t suffered physical injury. But economic injury, including loss of the benefit of one’s bargain, is sufficient for standing.

The court further refused the motion to dismiss under other states’ laws for failure to state a claim. Choice of law is determined at the class certification stage. Plaintiffs can’t use class actions to escape pleading requirements, though. The court found that the pleadings set forth sufficient information to outline the elements of the claim or permit the inference that those elements existed. Plaintiffs did more than list the state consumer fraud statutes; they connected the statutes to Bayer’s conduct. “Cursory, yes, but especially when considered in conjunction with the detailed choice of law analysis to be conducted at class certification, the allegations are sufficient to survive defendant's motion to dismiss.” Focusing on the New Jersey law, as the parties did, the court found the allegations specific enough, including a causal nexus between Bayer’s allegedly unlawful practice and plaintiffs’ ascertainable losses.

Bayer argued that plaintiffs got what they were promised: a combination of low-dose aspirin and phytosterols or calcium. The court found that this ignored the dose mismatch argument. Moreover, rather than arguing a price inflation theory (which has been rejected), plaintiffs argued that the misrepresentations were the reason for their purchases. They alleged a defect in the product and a failure to perform as advertised. But for the misrepresentations, they alleged, they would have purchased an available less expensive alternative. This is not necessarily the same as a fraud on the market theory and could be sufficient to allege injury; it was inappropriate to dismiss the case on the pleadings. Moreover, other courts have accepted “benefit of the bargain” damages, in the alternative.

Similar analysis preserved plaintiffs’ breach of warranty and unjust enrichment claims.

No comments: