Bexis just got back from his Wyoming vacation, hiking in mountains where even his Blackberry couldn’t disturb him, and sure enough, the world didn’t grind to a halt in his absence. That’s fortunate, because if it had there wouldn’t be any material for this post. Bexis found a couple of interesting things in his in box on his return.

The first of these was Perez v. Nidek Co., now available at 2009 WL 2776379 (S.D. Cal. Aug. 31, 2009). It’s an important application of §337(a) of the Food, Drug and Cosmetic Act (“FDCA”) to bar private enforcement actions of alleged regulatory violations.

Perez is/was a California class action involving the off-label use of excimer lasers in LASIK eye surgery. It was yet another attempt to turn allegations concerning illegal off-label promotion into fodder for private litigation. Plaintiffs claimed that the lasers at issue, which had received FDA PMA approval for one type of eye surgery, were being operated with replacement computer chips that allowed their use in other, off-label types of surgery. The complaint sought to piggyback on FDA warning letters to this effect. 2009 WL 2776379, at *1-2.

Since the litigation was brought as a class action, the rest of the allegations were fairly predictable. There were no claims that the off-label use of these lasers actually hurt anybody, and “Plaintiffs do not allege that they or the other members of the class suffered personal injury as a result of the procedures.” 2009 WL 2776379, at *2. In short, Perez was precisely the sort of lawyer-driven, artificial litigation fostered by California’s notoriously broad consumer protection statutes.

There was, in addition, something of an oddball claim in Perez – violation of a California statute called the Human Subjects in Medical Experimentation Act (Cal. H. & S. Code §24176), which provides for statutory damages for informed consent violations in the context of “medical experiments.”

There was no federal question presented by the claimed FDCA violations, insofar as §337(a) precludes any private FDCA right of action. 2009 WL 2776379, at *3. No surprise there. That’s the unanimous conclusion of literally scores of federal and state courts. But thankfully there was CAFA. The court found that minimal diversity of the sort required by the Class Action Fairness Act was established, along with the requisite jurisdictional amount. Id. at *3-4.

Turning to the motions to dismiss, the court threw out the entire complaint, lock, stock and ad damnum clause. There was no statutory claim for informed consent violations, as off-label use was not medical “experimentation.”

Under [the Act], the investigational use of a drug or device. . .constitutes a “medical experiment.” [The Act] refers to investigations conducted in accordance with the requirements of [relevant provisions of the FDCA and FDA regulations]. Plaintiffs do not allege the investigational use of the Laser within the parameters of [the Act]. Indeed, the [complaint] specifies that the class does not include individuals who participated in an approved FDA clinical trial. Because there was no “investigational use” of the device. . .Defendants were not required to provide informed consent under [the Act].

2009 WL 2776379, at *5 (all sorts of statutory citations deleted – trust us, it reads far more comprehensibly this way).

That holding alone is enough to make Perez interesting (at least to us). We’ve been arguing this distinction, between off-label use and medical “experimentation,” for over a decade now. See Beck & Azari, “FDA, Off-Label Use & Informed Consent, 53 Food & Drug L.J. 71, 81-85 (1998). Perez is one more citation on the plus side of that ledger.

But there’s more. The plaintiffs’ consumer fraud claims also got bounced “because they impermissibly seek private enforcement of the FDCA” (they were barred by the statute of limitations, too, just for the record). 2009 WL 2776379, at *6. As the Perez court had already discussed in its jurisdictional ruling, §337(a) mandates “dismiss[al of] state law claims that seek to enforce the FDCA or its regulations.” Id. The court cited a bunch of cases, including a couple involving alleged off-label use of lasers, illustrating this point. Id. at *6-7.

But not every claim mentioning supposed FDCA violations is swept away under §337(a), however much we wish they were:

Of course, not all claims that touch upon subject matter regulated by the FDCA are preempted. For example, literally false or misleading statements made to promote drugs or devices are actionable if they do not depend on a determination by the court whether the FDCA has been violated.

2009 WL 2776379, at *7 (citations omitted). This is an interesting point because of the analogy it suggests. FDCA-related claims that don’t “depend” on a court’s interpretation of the FDCA, are the sort of claims that might be considered “parallel” claims under a PMA preemption analysis, since they would not give rise to conflicting constructions of FDA regulations.

So, would the plaintiffs’ claims in this case qualify? Of course not. This is a defense-related blog – we wouldn’t be telling you about the case if the court had held they did. Plaintiffs can do their own research.

Claims that a device was “adulterated” because of supposed off-label promotion involve the sort of complicated assessments of the FDCA that cross the line into the prohibited realm of private FDCA enforcement. This conflict remained notwithstanding the FDA’s warning letters:

Here, Plaintiffs’ [consumer fraud] claims rest upon allegations that (1) Defendants permitted the use, sale, lease, distribution and/or service of Lasers that were modified to perform [off-label procedures] in violation of the PMA, resulting in the device being “adulterated” within the meaning of the FDCA; (2) Defendants failed to re-certify and re-identify the modified Lasers as required by [FDA regulations]; and (3) Defendants failed to inform patients that the modified Lasers were not approved by the FDA and were not properly certified.

Plaintiffs’ claims require the Court to make determinations regarding the scope of the PMA, whether the modified Lasers were “adulterated”. . ., and whether re-certification was required. . . . These matters should be decided by the FDA in the first instance. Although the FDA issued Warning Letters regarding the modified Laser’s lack of pre-market approval and Defendants’ failure to re-certify and re-identify the Lasers. . ., such letters do not constitute a final decision by the FDA.

The Court will not permit Plaintiffs to privately enforce the FDCA and its regulations under the guise of state law claims. Accordingly, the Court dismisses Plaintiffs’ [consumer fraud] claims.

2009 WL 2776379, at *7 (various citations omitted). The bottom line: allegations of “adulteration” – at least by reason of off-label use – encroach too much on the FDA’s territory to be brought by anybody other than the Agency.

And a final point about Perez, lest it get buried. At the end of the second paragraph we’ve just quoted is a reference to warning letters not being “final” agency action. That’s another point of interest because, not being final action, a warning letter should be no more admissible in a civil action than things like criminal indictments that did not result in convictions, which are routinely excluded. Perez is hardly the only court to reach this holding. Other precedent for warning letter
s not being “final” are: Dietary Supplemental Coalition v. Sullivan, 978 F.2d 560, 562-63 (9th Cir. 1992); Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1377 (9th Cir. 1983); Bracco Diagnostics, Inc. v. Amersham Health, Inc., 627 F. Supp.2d 384, 470 n.250 (D.N.J. 2009); Genendo Pharmaceuticals N.V. v. Thompson, 308 F. Supp.2d 881, 884-85 (N.D. Ill. 2003); Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 306 (C.D. Cal. 1996); Professionals & Patients for Customized Care v. Shalala, 847 F. Supp. 1359, 1364 (S.D. Tex. 1994), aff’d, 56 F.3d 592 (5th Cir. 1995); Den-Mat Corp. v. FDA, 1992 WL 208962, at *5 (D. Md. Aug. 17, 1992); Estee Lauder, Inc. v. FDA, 727 F. Supp. 1, 5 (D.D.C. 1989). Since a lot of this prior precedent is regulatory (the FDA has its own reasons for not wanting warning letters to be reviewable in court), Perez is particularly useful because it asserts the same proposition in the context of the kind of private civil litigation that we do.

The second case that landed in Bexis in box is Cordis Corp. v. O’Shea, 2009 WL 2871566 (Fla. App. Sept. 9, 2009), a PMA preemption case. We summarized the trial court’s opinion in O’Shea in our device preemption scorecard as follows:

O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008).
Off-label use does not preclude preemption where the defect (in design claim) or
risk (in warning claim) is common to both on- and off-label use. True “parallel”
violation claims, including off-label promotion are not preempted. Express
warranty claims are not preempted. Fraud claims amounting to fraud on the FDA
are preempted under Buckman. Unfair trade practice claims are preempted.

The O’Shea trial court opinion was one of the first PMA preemption cases decided after Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), established a broad preemption defense for this type of device.

What you had in O’Shea, after the trial judge got done with the various motions to dismiss, was a partial dismissal of everything except express warranty and parallel violation claims. That’s not ordinarily an appealable order (except maybe in New York), so the defendant sought a writ of prohibition. That’s a dangerous sort of appellate strategy, since there’s a much tougher standard of review, and thus a much greater chance of losing – and thereby making bad precedent.

Well, the defendant lost in the O’Shea appeal, but fortunately didn’t make any really bad law in doing so. The court held only that the defendant wasn’t entitled to a writ of prohibition because PMA preemption was “defensive” and didn’t go to the jurisdiction of a state court to hear the case:

We agree with respondent that this is a case of defensive, and not complete, preemption. Further, the issues presented are more properly characterized as a “choice of law” issue rather than “choice of forum” preemption, which would provide exclusive jurisdiction in the federal courts.

O’Shea, 2009 WL 2871566, at *2. Thus the court dismissed the petition “without prejudice to petitioners’ right to raise their challenges on final appeal.” Id. In other words, the defendants didn’t meet the restrictive grounds upon which a petition for writ of prohibition could be entertained under Florida law, and they could try again later once they had a regular appealable order.

We hear what you’re thinking. Umm … guys, O’Shea seems like a non-event. The court never reached the merits of the appeal. Why are you wasting our time with that?

Frankly, you’re right. We wouldn’t have bothered with O’Shea except that Bexis’ in box also contained an “e-mail bulletin” from Mealey’s Emerging Drugs and Devices bearing the totally misleading headline, “Florida Appeals Panel: Parallel State Law Medical Device Claims Not Preempted.” That’s just not so. The Florida court decided nothing of the sort. It never reached whether the parallel claims were or were not preempted. It only held that there was no jurisdictional “complete preemption” that would allow interlocutory consideration of an extraordinary writ of prohibition. (For you non lawyers, that load of legal jargon simply means that the court said “you gotta wait your turn and take a normal appeal”).

We like the folks at Mealey’s just fine. That’s why Bexis subscribes to this service. But on O’Shea they simply blew it. Jurisdictional “complete preemption” isn’t anything like the preemption defense that Riegel recognized (a detailed explanation of why that is might even be a good idea for a post) – thus the erroneous headline.

As defense counsel, we wanted to set the record straight as soon as possible.