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FDCA Violations (Still) Not Privately Actionable

By James M. Beck and Mark Herrmann

Remember the old SNL Weekend Update report: ?This just in, Generalissimo Francisco Franco is still dead??  In that spirit, we bring you today?s post.

In the wake of the Chinese heparin scandal, the FDA has promised stepped-up enforcement of CGMP (see one report on the FDA Law Blog, here).  And where there is enforcement action, there is inevitable tag-along action by private plaintiffs. But not every violation of statute gives rise to a private remedy. And the FDCA has no private right of action. Still.

Thus, it was fitting for U.S. District Court for the Eastern District of Missouri Stephen N. Limbaugh Jr. to dismiss as preempted a putative class action against KV Pharmaceutical Co. over its generic version of a hypertension drug, which was recalled in 2009 after KV entered a consent decree in which it admitted to having violated federal regulations in its manufacture. Lefaivre v. KV Pharmaceutical Co., No. 4:09CV00588SNLJ, slip op. (E.D. Mo. Jan. 5, 2010).

Judge Limbaugh first cited Buckman Co. v. Plaintiff?s Legal Comm?n, 531 U.S. 341 (2001), for the proposition that there is no private right of action under the FDCA:

The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: ?[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.? 21 U.S.C. § 337(a).

Slip op. at 5 (citing Buckman, 531 U.S. at 349 n.4).

Then, he explained that to avoid being impliedly preempted, a claim must rely on ?traditional state tort law which had predated the federal enactments in question.? Slip op. at 6 (citing Buckman, 531 U.S. at 353). In other words:

If a plaintiff?s claim is premised on conduct that would give rise to liability under state law?and would give rise to such liability ?even if the FDCA had never been enacted??the plaintiff may pursue the claim. [But if] the defendant?s conduct is not of this type, then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiff?s claim is thus impliedly preempted under Buckman.

Slip op. at 5-6 (citing Riley v. Cordis Corporation, 625 F.Supp.2d 769 (D.Minn. 2009)).

Then he looked at Lefaivre?s claim. And despite plaintiff's having characterized his claim as one for lack of merchantability under the Missouri Merchandising Practices Act, the court found it to be ?wholly dependent upon the federal violations and would not exist absent the federal violations.? Slip op. at 6. It helped the court reach this conclusion that ?plaintiff[?s] complaint for the most part is a word for word recitation of the FDCA?s violations listed in the Consent Decree.? Id.

The judge also rejected the Lefaivre?s argument that the Supreme Court's decision in April 2009 in Wyeth v. Levine, __ U.S. __, 129 S.Ct. 1187 (2009) (see one of many posts here), saved his claims. ?As noted, the case in Wyeth was predicated on a state law theory of liability for failure to warn that was wholly independent of the FDCA. In contrast, Lefaivre?s claim here is based solely on the FDCA itself.? Slip op. at 7.

?Consistent with Buckman, Wyeth should be read only for the proposition that a plaintiff may assert a cause of action against a drug manufacturer if he or she has an independent state-law theory of liability (i.e., if the cause of action would exist independently of the FDCA).? Id.

We could not have said it better ourselves. But that doesn?t mean we haven?t said it. In fact, we have said pretty much the same thing in our prior analyses of what constitutes a ?parallel? violation claim. The same analysis applies. To be a ?parallel? claim, but not to be preempted under Buckman, a violation claim must (in addition to actually being the same as the FDA?s regulations) parallel a pre-existing state law. Otherwise it?s just like the claim thrown out in Lefaivre ? a disguised private enforcement action.

Full post as published by Drug and Device Law on January 11, 2010 (boomark / email).