The Ninth Circuit just issued a major decision reaffirming the principle that FDA exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation.  See Photomedex, Inc. v. Irwin, No. 07-56672, slip op. (9th Cir. April 15, 2010).

First, an aside. Are we reading that number right?  This is a 2007 appeal?  We’ve heard criticism that the Ninth Circuit has become too big and ponderous, but we never thought about it all that much – being on the opposite coast.  Well, if the Ninth Circuit’s got a three-year appeal backlog, that’s just too much, and something really ought to be done to divide that court in half, or some other approach.  Justice delayed is justice denied, and so on and so forth….  Is the Ninth Circuit simply to big to succeed?

But back to the main point.

We’ve gone on until we’re blue in the face about how 21 U.S.C. §337(a) represents express congressional policy that nobody but the government (that is, the Department of Justice or the FDA) can seek to enforce the Food, Drug and Cosmetic Act (“FDCA”) in a court of law.  We’d list some posts, but there are, frankly, too many of them, so here’s the search results for “337(a).”

The no-private-right-of-action argument is especially important in dealing with negligence per se claims and the so-called “parallel violation” claims that are essentially the only avenue arguably left open to plaintiffs in Class III PMA medical device cases after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).

But the issue also comes up in Lanham Act cases involving litigation between commercial competitors. Indeed, when Bexis first got the idea to put the §337(a) argument to work in the personal injury field over a decade ago in the Bone Screw litigation, Lanham Act cases were the primary source of available precedent.

They continue to be valuable precedent today.  Photomedex involved a dispute between competing manufacturers of different lasers used for treating skin diseases (psoriasis, etc.).  The founder of the defendant company used to work for the plaintiff company, which no doubt added a bit of personal animosity to the mix.  The plaintiff made the usual potpourri of claims, but the important one for our purposes was the Lanham Act claim that the defendants sought commercial advantage by misrepresenting that the FDA had cleared (lasers are not PMA devices) their competing laser.  Photomedex, slip op. at 5544-45 (9th Circuit pagination is obviously unusual, as the first page here is 5539)

Because the Lanham Act is a federal statute, Photomedex, unlike Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), which involved state-law claims, there’s no preemption argument.  But the flip side of preemption where exclusive FDA enforcement is concerned, is standing.  The Court accepted that, in any kind of suit, §337(a) restricts the ability of a plaintiff to pursue a theory that turns on claimed FDCA violations:

Section 337(a) of the FDCA bars private enforcement of the statute, stating that “all such proceedings for the enforcement, or to restrain violations, of this [Act] shall be by and in the name of the United States.”  The Supreme Court has observed that Section 337(a) “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.”  Buckman, 531 U.S. at 349 n. 4.

The Supreme Court made clear in Buckman that this section also limits the ability of a private plaintiff to pursue claims under state law theories where such claims collide with the exclusive enforcement power of the federal government.  Id. at 343, 349-50, 353 (holding that a state tort claim based on alleged fraudulent representations made by a medical device manufacturer in the course of seeking market approval from the FDA “would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme”).

Slip op. at 5547-47 (citations omitted).  Where the FDA has not found a violation, no private party can assert that there is one.  “Because the FDCA forbids private rights of action under that statute, a private action brought under the Lanham Act may not be pursued when, as here, the claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.”  Id. at 5548.

The Photomedex court carved out a familiar exception – that a flat out yes/no misrepresentation of FDA approval would escape §337(a).  Id. (“an affirmative statement of approval by the FDA” where “no such FDA approval had been granted” may be pursued).  But that sort of yes/no situation, where examination of the underlying regulatory scheme was unnecessary, wasn’t what happened in this case.

Rather, the plaintiff’s FDA approval (technically “clearance,” see slip op. at 5550 n.3, distinguishing between “approval” and “clearance”) claim would have required a court to delve into the intricacies of the FDA’s “minor modification” rule.  That is, it involved whether modifications to an already cleared device were sufficiently “major” to require the submission of a whole new §510k submission under 21 C.F.R. §807.81(a)(3).  Slip op. at 5550-51.  Whether the device that the defendant sold was a “major” modification of the device that the FDA had previously cleared could not be determined without examining the application of the FDA’s regulatory scheme to the facts:

It is significant that under the regulatory structure established by the FDA for the medical devices at issue in this case, clearance to market a given device did not necessarily require an affirmative statement of approval by the FDA.  The FDA’s previous clearance of the [device that the defendant licensed] covered Defendants’ . . . device as well, as long as [it] was not significantly modified from the [prior] device.

Slip op. at 5551.  Determining whether modifications were “minor” was “the responsibility in the first instance” of the device manufacturer.  Id.  Although the court doesn’t dig that far into the facts, presumably the defendant had the necessary minor modification memo in its files.

So the underlying legal dispute boiled down to the plaintiff claiming that the defendant’s device didn’t really have FDA clearance/approval because it wasn’t really a minor modification of the cleared product that the defendant had licensed.  Slip op. at 5551-52.  That sunk pretty far into FDCA minutiae, and (it seems to us obviously) would have required examination of whether the FDA would find a violation.

Indeed, the plaintiff more or less cut its own throat in this regard, as it actually filed some sort of “complaint” with the FDA that led to an FDA investigation of the issue.  The defendant gave the FDA agent a copy of what we presume was its minor modification memo (although the court does not use this term), and the FDA closed its investigation without finding its violation.  Slip op. at 5552-53.  The significance of the plaintiff’s actions did not escape the court’s attention.  “That [plaintiff] engaged in an extensive campaign to try to convince the FDA to act on [defendant’s] supposed misstatements and violations demonstrates that [plaintiff] understood that this subject fell within the FDA’s domain.”  Id. at 5559.

Please note, we’ve only given a stripped down version of the facts, and the actual FDA proceedings, which included a supplemental submission seeking clearance of additional uses, were much more involved.  See slip op. at 5552-54.  All those details may be fodder for the FDA Law Blog, but from our perspective, they only make the rubble bounce.  We’re only concerned with the proposition that private plaintiffs can’t enforce purported FDCA violations, a point that’s readily transferable to the tort sandbox where we play.

What we like is this:  “The statute assigns to the FDA the responsibility for taking enforcement action against Defendants.”  Slip op. at 5554.  And this:  “[Plaintiff] is not permitted to circumvent the FDA’s exclusive enforcement authority by seeking to prove that Defendants violated the FDCA, when the FDA did not reach that conclusion.”  Id.  And this:  “[I]t is impossible for [plaintiff] to prove that [defendant’s] device had not been cleared by the FDA when the FDA itself did not take that position.”  Id.

As we said above, other Lanham Act cases have taken pretty much the same position – since before the Bone Screw litigation that began in the mid 1990s.  The court in Photomedex cites a bunch of these cases: IQ Products Co. v. Pennzoil Products Co., 305 F.3d 368, 372-74 (5th Cir. 2002) (not an FDCA case); Dial A Car, Inc. v. Transportation, Inc., 82 F.3d 484, 488-90 (D.C. Cir. 1996) (not an FDCA case); Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 230-32 (3d Cir. 1990); Summit Technology, Inc. v. High-Line Medical Instruments Co., 933 F. Supp. 918, 934 (C.D. Cal. 1996); Summit Technology, Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299, 305-07 (C.D. Cal. 1996).  See Slip op. at 5555-56.

Significantly, the Photomedex court discussed and distinguished Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934 (8th Cir. 2005), which dealt with FDA-approved uses for animal feed additives.  The court found that Alpharma was much more of a straight yes/no case on FDA approval, since in Alpharma “the FDA made it clear that there was no record of the defendant obtaining the FDA’s approval for the additional uses.”  Photomedex, slip op. at 5557.

If you want a bunch more cases – all of which involve the FDCA – see our prior post on “What To Do With Un-Preempted Fraud On The FDA Claims.”  If you’re still not satisfied, you’ll just have to buy Bexis’ book, which discusses the Lanham Act precedent in §4.02[2] and footnotes literally dozens of cases (Bexis has always been funny that way).  Anyway, we’re sure Bexis will be adding this one to his book, since the court concludes:

The FDCA explicitly says that enforcement power is reserved to the federal government.  To permit [plaintiff] to proceed with a claim that Defendants violated this law when the FDA did not so determine would, in effect, permit [plaintiff] to assume enforcement power which the statute does not allow and require the finder of fact to make a decision that the FDA itself did not make.  We therefore affirm the order of summary judgment for the claims based on Defendants’ statements that the [device] had FDA clearance.

Photomedex, slip op. at 5559.

Photomedex is the first time the Ninth Circuit has spoken on the issue of FDA enforcement exclusivity and its preclusive effect on private litigation of supposed violations.  While the opinion did not discuss state law because the plaintiff conceded it couldn’t pursue its consumer fraud claims, slip op. at 5559 n.7, other plaintiffs have not been so reasonable.  Thus, the recognition in Photomedex of the §337(a) exclusivity will be extremely useful precedent against plaintiffs bringing negligence per se/”parallel violation” claims, as we’ve already discussed here, as well as against plaintiffs seeking to bring economic loss claims under federal statutes such as RICO, as we already discussed here.

So if you’re facing a claim of any sort – be it statutory or common law – where the guts of the plaintiff’s arguments are that your client somehow violated the FDCA, you’ll want to read, and probably want to cite, Photomedex.