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Strike Suit Strikes Out

By James M. Beck and Mark Herrmann

We're pleased by the dismissal of Myers-Armstrong v. Actavis Totowa LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009). In M-A, the defendant was basically shut down by the FDA over Good Manufacturing Practices issues at its plant. The defendant recalled over 100 drugs (it was a generic manufacturer) at the wholesale, but not retail level. The plaintiff took one of these drugs, was not hurt by it, but sued over all 100+ drugs.

What a worthless lawsuit. Of course, it was a putative class action.

The court threw it out on the eminently sensible ground that a plaintiff who took a drug that was effective, and wasn't hurt by it, hasn't been injured just by the drug being "adulterated" under the FDCA because there were GMP violations at the plant were it was made. The court literally concluded that "life's too short" to allow this kind of 100% opportunistic litigation:

As a concession to the shortness of life, California law does not allow a civil lawsuit to recover the purchase price for medicine consumed by the purchaser which performed as intended with no harm or fear of future harm merely because the consumer would not have purchased it had he or she known that the medicine came from a plant whose quality-control had been compromised. That the CDP was adulterated due to a lack of compliance with GMP requirements is not enough, without more, to state a claim. A plaintiff must allege an actual manifestation of a defect that results in some injury or rational fear of future injury in order to state cognizable claims. There must be at least some physical manifestation such as physical harm, or a failure of the drug to work as intended, or a rational fear of future harm, none of which are alleged.

If the pills had not been consumed, the consumer might possibly have a claim for a refund. But after consuming the pills and obtaining their beneficial effect with no downside, the consumer cannot get a refund on the theory that the pills came from a source of uncertain quality.... [T]he civil law should not be expanded to regulate every hypothetical ill in the absence of some real injury to the civil plaintiff.

2009 WL 1082026, at *4 (citations and footnote omitted).

The case as to the 100+ drugs that the plaintiff never took was given the back of the court's hand. "As to the other 106 drugs, state law does not supply her with a damages remedy for the additional reason that she did not even purchase or ingest any of the other 106 drugs. Plaintiff cites no California decision that shows her extreme theory should go forward." Id. at *5. We hope the defendant gives serious consideration to Rule 11 sanctions.

This case will also be fondly listed in our no-injury scorecard.

The only discordant note in M-A was the court's rejection of a preemption argument based upon a perceived conflict with the FDA's decision not to recall the drugs on the retail level. Id. We think a better preemption argument - and one that wouldn't have flown in the face of Levine - would have been that the claims were disguised attempts at private enforcement of the GMP violations that brought about the recall, and thus barred by §337(a) and Buckman. As we've pointed out before, the exceptions allowing private FDCA enforcement in the food area don't apply to drugs.

Full post as published by Drug and Device Law on May 08, 2009 (boomark / email).