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Off-Label Promotion MDL Dismissed under FDCA

By James M. Beck and Mark Herrmann

As far back as the Bone Screw litigation, we've argued that many attempts to gin up litigation about alleged off-label promotion are really prohibited back-door attempts at private enforcement of FDCA violations. See Beck & Valentine, "Challenging The Viability Of FDCA-Based Causes Of Action In The Tort Context: The Orthopedic Bone Screw Experience," 55 Food & Drug L.J. 389, 413 & nn. 169-71 (2000). Among other places, we've blogged about the subject here ("first argument").

Well, that argument was just adopted, big time, in the Amgen MDL. Here's a copy of the opinion, which dismisses the entire MDL as little more than a disguised attempt to enforce the FDA's off-label promotion prohibitions. The bottom line:

In the present case, the Court finds that Plaintiffs? suit is largely an attempt to bring a private cause of action for violations of the FDCA. Under FDA regulations, drug manufacturers are prohibited from promoting off-label uses of prescription drugs. Dissemination of an advertisement not in compliance with FDA regulations causes a drug to be ?misbranded? in violation of the FDCA.... Although Plaintiffs have avoided explicit references to ?misbranding? in their Complaint, their RICO and state law claims are primarily based on allegations that Defendants promoted [the drug] for off-label uses.... These allegations of off-label promotion are, in essence, misbranding claims that should be reviewed by the FDA.

Slip op. at 6-8 (extensive quotes from plaintiffs' complaint omitted).

The court didn't just dismiss this or that count of the plaintiffs' complaint. Rather, the forbidden attempt at private FDCA enforcement against purportedly illegal promotion was so thoroughly woven through the entire complaint, that for now anyway, the entire MDL is dismissed (albeit with leave to replead). Slip op. at 11-12.

Happy Holidays, indeed.

Full post as published by Drug and Device Law on December 23, 2008 (boomark / email).