While most of the buzz late last week concerned the Darvocet affirmance, we also recommend that defense counsel check out this case: Amos v. Biogen Idec, Inc., 2014 WL 2882104 (W.D.N.Y. June 25, 2014). Amos involved the prescription drug Tysabri. The allegation in Amos, as in most Tysabri, cases, is that the drug caused an opportunistic type of CNS infection.
That’s not what interests us about Amos, but rather the product being an innovator drug, not a generic. That’s why we’re pleased with Amos’s first holding – that design defect claims are preempted. Ever since our first reading of Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), we have believed thatBartlett’s rationale mandates impossibility preemption of design defect claims with any drug. That’s because no drug manufacturer, generic or innovator, can change the design of its drug in any way that alters its safety or effectiveness without getting prior FDA approval of the change. That’s precisely what the court held in Amos, preemption of design defect claims as to any drug in “interstate commerce,” albeit without much resistance from the plaintiffs:
[D]efendants move to dismiss plaintiff's design defect claims on grounds that such claims are preempted by federal law. In support of their argument, defendants cite the recent United States Supreme Court case of Mutual Pharmaceutical Co., Inc. v. Bartlett, which held that state-law causes of action for the alleged defective design of a drug regulated and approved by the FDA were preempted by federal law. Specifically, the Court held that because a drug manufacturer could not simultaneously comply with FDA requirements mandating the specific design of an approved drug and state law requirements mandating that the design be altered, the state-law requirements were preempted by federal law. [long quote from Bartlett omitted].
The plaintiffs concede that design defect claims are preempted under federal law, and have agreed to withdraw those claims without prejudice. Because, however, such claims are preempted as a matter of law, I grant defendants' motion to dismiss plaintiffs’ claims of design defect . . . with prejudice.
Amos, 2014 WL 2882104, at *3 (emphasis added).
Another useful holding in Amos is the last one, concerning the New York consumer protection statute. There, the court’s logic seems equally applicable to similar statutes elsewhere. Amos dismissed the consumer protection claim as a matter of law, because under New York’s learned intermediary rule, claimed deficiencies in information directed solely to physicians isn’t “consumer oriented” so as to fall within a consumer protection statute:
[P]laintiff alleges that the defendants deceived consumers by concealing information about the dangers of taking [a prescription drug]. . . . [B]ecause a drug manufacturer’s duty to warn of a drug’s side effects runs to the doctor prescribing the drug, and not to the user of the drug, the issuance of drug warnings, for purposes of [the consumer fraud statute], is not an act directed at consumers, and therefore any alleged deceptive act related to the issuance of those warnings is not a “consumer oriented” act actionable under [the statute].
Amos, 2014 WL 2882104, at *8 (emphasis added). Like many (but not all) consumer fraud statutes, New York’s requires “conduct of the defendant that is consumer-oriented.” Id. Under the learned intermediary rule, however, “a manufacturer's duty to warn extends to a patient's doctor” and “not to the patient himself.” Id.
Accordingly, because the defendants’ alleged deceptive practice of failing to provide adequate warnings by concealing information is not, as a matter of law, a practice directed at consumers, plaintiff has failed to allege a consumer-oriented practice cognizable under [the consumer fraud statute].
Neither design defect claims nor consumer fraud claims are at the heart of prescription medical product liability litigation – that heart remains failure to warn claims (which were not dismissed in Amos) – but this opinion provides useful authority for getting rid of these increasingly prevalent claims, which can greatly increase the scope of discovery and evidence at trial.