We found a hidden (at least from us) Georgia federal court decision that we want to discuss because it hits on many of the effective defenses sometimes available to defendants on motions to dismiss. It’s two years old and, for whatever reason, we’re just now finding it. But better late than never.  In Connolly v. Sandoz Pharma. Corp., 2014 U.S. Dist. LEXIS 190163 (N.D. Ga. 2014), the court dismissed with prejudice a generic-drug complaint by invoking MensingBuckman and the learned intermediary doctrine. That’s a pretty good line-up.

It all turned on the plaintiffs’ decision to assert failure-to-warn claims. With generic drugs, that triggers Mensing preemption. Federal regulations do not allow generic drug manufactures to unilaterally change the content of the warnings in their labels, so a state-law claim seeking to impose liability for insufficient content in a label is preempted.

Plaintiffs tried to juke their way around this problem, however, by arguing that their claims were not about label content but instead defendants’ failure to follow federal regulations that would ensure that medication guides reached patients. Id. at *11-12.

But, setting aside that that’s not exactly what federal regulations require, that claim raises new problems. First, Buckman preemption. This revised claim alleges a failure to follow federal regulations. Yet there is no private right of action under the FDCA, meaning that only the FDA, not private litigants, can enforce the FDA’s regulations.  Any attempt by private litigants to do so, like this one, is preempted:

To the extent plaintiffs’ allegations are premised on Defendants’ alleged breach of federal regulations, they are preempted in accordance with Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001), in which the Supreme Court, citing 21 U.S.C. § 337(a), held that “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the [law].” . . . Plaintiffs’ claim for noncompliance with the federal regulation is preempted pursuant to Buckman.

Id. at *14-15.

Next, Georgia law follows the learned intermediary doctrine, which says that a manufacturer’s duty to warn is to the prescribing doctor, not the patient. So plaintiffs’ claims that the defendants didn’t ensure that patients received medication guides is irrelevant.

Within the context of prescription drugs … Georgia employs the learned intermediary doctrine. Under the learned intermediary doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product but, instead, has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer.” . . . . As such, Defendants did not have a duty to provide the Medication Guide or warn plaintiffs. . . . Accordingly, plaintiffs’ claims against Defendants based upon the allegation that plaintiffs did not receive the Medication Guide fail as a matter of law.

Id. at *15-16.

Finally, plaintiffs claimed that defendants engaged in inaccurate off-label promotion and that such an off-label-promotion claim is not preempted. Not so. It’s just a failure to warn claim in different clothing. The court understood this and dismissed the claim as preempted:

In essence, these allegations claim that Defendants’ alleged promotion resulted in failure to properly warn and hence are preempted by federal law.  Accordingly, plaintiffs’ allegations fail to set forth any viable claims against Defendants and must be dismissed.

Id. at *18.

Oh, and the court also saw the futility of these claims and denied plaintiffs’ request to amend its complaint. That was another nice touch. So, while we certainly wish we had found this decision earlier, we’re glad we finally did.