...and the claims are preempted to boot!

This just in: The Ninth Circuit has ruled that off-label use is not medical experimentation under a California statute, the Protection of Human Subjects in Medical Experimentation Act (“MEA”) (Cal. Health & Safety C. §24171). See Perez v. Nidek Corp., ___ F.3d ___, No. 10-555877, slip op. (9th Cir. March 25, 2013). The court also held that similar common law claims, for “fraud by omission” were expressly and impliedly preempted when brought against the manufacturer of a pre-market approved medical device. This is a big deal. These sorts of claims have been kicking around for quite some time.

Perez was a putative class action brought – typically– by plaintiffs who were not injured in the slightest and thus had no business suing in the first place. Perez,slip op. at 5. But sue they did. They claimed that the MEA required that patients be notified every time that their physicians engaged in an off-label use of a prescription medical product. They brought the case against the manufacturer of, and against surgeons using, a PMA laser in eye surgery. Id.at 6. Since the failure to notify them of off-label use violated the NEA, they claimed they had a pass-through claim under the Unfair Competition Law’s “any illegal act” provision.

They lost.

It was not a bright idea to pick a PMA device against which to bring claim that were“vacuous” in the first place. Perez,slip op. at 8.

In the first place, plaintiff brought suit against doctors that had never treated him –only, supposedly, absent members of the class. That dismissal was easy. Even under the capacious California consumer protection statute, there’s no standing to bring a suit like that. Slip op. at 9-10.

More interesting from our viewpoint are the holdings regarding off-label use and preemption. First, ordinary off-label use occurring in the context of medical treatment intended to benefit particular patients is not “medical experimentation.”

[Plaintiff] admits that the surgeries had a therapeutic purpose. He does not claim that this therapeutic purpose was merely incidental to a broader research goal – in fact, he does not claim that there was any research goal whatsoever. Without doubt, the [treatments] at issue here were “reasonably related” to “improving [plaintiff’s] health” and “directly benefiting” him.

Perez, slip op. at 12. The “broad definition” plaintiff sought would “swallow up all off-label use.” Id. Off-label use was not only “accepted and necessary,” id. (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001)), but also was “purposefully excluded” by the California state legislature when it initially enacted the MEA. Perez, slip op. at 12-13. The plaintiff’s further calumny – that their surgeons were behaving venally and that the procedures were elective – sought to add elements to the MEA that simply weren’t there. Id. at 13-14. Those allegations did not create a “medical experiment” where there was merely off-label use.

Nor could plaintiffs bring suit under that portion of the MEA that concerned FDA-regulated clinical trials (“investigations”),particularly when their primary grievance was that they were not enrolled in such investigations. Perez, slip op. at 15. Non-“investigational” uses of drugs and devices were not what this part of the statute was directed against:

Although [plaintiff] may find it “perverse and inequitable,” as he puts it, to provide patients admitted to clinical trials with “more protection than those who are subjected to the same experimental procedures outside the gaze of the FDA,” [the MEA], by its terms, applies only to investigations conducted under the requirements of the FDCA or state law. [Plaintiff] was not subject to the“investigational use” of a device.

Id.

Then we get to preemption (which involves plaintiff’s “fraud by omission” claim). By bringing this suit, initially, against a PMA medical device, plaintiff put himself in the cross-hairs of an express preemption argument under Riegel. The plaintiff in Perezwas demanding special notification about off-label use, which the FDA has never required. That type of additional warning requirement was squarely preempted by the MDA’s “different from or in addition to” express preemption language:

[P]laintiffs’ claims were preempted because [they] sought to enforce state-law requirements that would have required [defendant] to give additional warnings, precisely the type of state requirement that is“different from or in addition to” the federal requirement. . . .

[L]ike the claim in Riegel, the claim here depends on a requirement that is “in addition to” those federal requirements. [Plaintiff] effectively seeks to write in a new provision to the FDCA: that physicians and medical device companies must affirmatively tell patients when medical devices have not been approved for a certain use.

Perez, slip op. at 19 (citations and quotation marks omitted). Plaintiffs have long sought to impose such requirements (usually against doctors) under the doctrine of informed consent, withoutmuchsuccess. Happily, we can now add that such claims are equally invalid against medical device companies under Riegelpreemption.

What’s more, such claims are also impliedly preempted under Buckman. Perez, slip op. at 21-22. Since implied preemption is not limited by the express preemption language of the MDA, this means that plaintiffs cannot bring similar claims against the manufacturers of prescription drugs or non-PMA-medical devices. Claims demanding notification about off-label use cannot exist without the FDA-approved label, which delimits an approved/cleared product’s “intended uses” for which it can be labeled for marketing. Such claims are thus inherently bound up in the scope of the FDA approval, and amount to private attempts to enforce the FDCA – a no-no, since the FDA expressly limits enforcement actions to the government:

[Plaintiff’s] fraud by omission claim exists solely by virtue of the FDCA requirements with respect to approved use of the [device]. . . . [T]he existence of these federal enactments is a critical element in their case. Although [plaintiff] is not barred from bringing any fraud claim related to the surgeries, he cannot bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of PMA approval. While courts have acknowledged that some fraud and false advertising claims related to FDA status may go forward, [plaintiff] cites to no case where a court has allowed a plaintiff to bring suit solely for failure to disclose lack of FDA approval.

Perez, slip op. at 21-22 (citations, quotation marks, and footnote discussing cases involving affirmative misrepresentation of FDA regulatory status omitted). Thus, plaintiff’s off-label disclosure claims in Perez failed to squeak through the “narrow gap through which a state-law claim must fit to escape preemption by the FDCA.” Id. at 23.

We’ve been fighting against off-label disclosure claims for several decades, going back to our Bone Screw days. Perez is the strongest precedent yet that such claims are both substantively meritless and, for good measure, preempted.