On May 26, 2015, the Solicitor General’s office responded to the United States Supreme Court’s Oct. 14, 2014 invitation for the government’s views on the certiorari petition filed in Athena Cosmetics, Inc. v. Allergan, Inc., No. 13-1379.  The brief is on Westlaw at 2015 WL 2457643, and is also referenced (although not yet with a link) at the SCOTUSblog page for the case, here.  We discussed the opinion being appealed from, Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir. 2013), here, and noted the cert. petition here (item #5).  As we pointed out, the question presented is of potentially great interest, even though Athena is not a product liability case:

The question presented is whether, under Buckman [Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)], the FDCA impliedly preempts a private state-law claim for unfair competition premised on a party’s purported failure to obtain FDA approval, where FDA itself has not imposed any such requirement.

Under the current administration, we’ve grown accustomed to the Solicitor General taking anti-preemption positions in prescription medical product cases that we consider extreme – even to the point of claiming that every appellate court in the country had misapplied Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Needless to say, we were not expecting a pro-preemption result in Athena, and we were right.  However, this time the SG’s arguments were surprisingly temperate, although (we would argue) still incorrect.

Briefly, Athena is a dispute between two competing manufacturers of a vanity product, eyelash thickeners.  Thus, the Court is being asked to take another look at Buckman preemption in the context of a product that is about as far away from the life-saving/improving prescription products that our clients make as it is possible to be, yet staying (arguably) within the bounds of FDA jurisdiction.  Robin Williams once said that “cocaine is God’s way of telling you you have too much money.”  The same could just as easily be said about eyelash thickeners.  But we digress….

Anyway, the plaintiff (Allergan) went through the time and effort to get its eyelash thickener approved as a drug.  The defendant (Athena) did not, taking the position that its eyelash thickener was a cosmetic.  As the SG pointed out, “[i]n contrast to drugs, cosmetics may be marketed without FDA approval.”  2015 WL 2457643, at *2.  The FDA had never taken any enforcement action against the defendant, although it had against other eyelash thickeners containing similar (or identical) active ingredients.  Id. at *5.  The difference between a “drug” requiring FDA approval and a “cosmetic,” which does not, is that a drug is “intended to affect the structure or any function of the body.”  Id. at *1 (quoting 21 U.S.C. 321(g)(1)(B)).

In our experience, most companies, when faced with a competitor that they believe is violating the FDCA (such as by off-label promotion) will tip off the FDA and watch as the Agency comes down upon the miscreant like a ton of bricks.  Whether the plaintiff tried that here, we don’t know.  What we do know is that it tried, successfully, to take matters into its own hands.  Rather than wait for the FDA to act, plaintiff sued under the California UCL, which due to the quirks of California law, discussed here, allowed a private right of action under California’s “little FDA Act” (called the “Sherman Act”), which mirrors the FDCA.  See SG br., 2015 WL 2457643, at *9 (“California directly incorporates the federal new-drug application regulations”).

Thus, as we explained in much greater detail in our earlier Athena post, the result was an injunction against selling an unapproved “drug,” even though the FDA had never determined that this product was a “drug” that required pre-marketing approval in the first place.  As we argued in that post, and as the defendant-petitioner argued to the Supreme Court, that runs afoul of Buckman’s holding that private enforcement of the FDCA is impermissible under 21 U.S.C. §337(a).

So how did the Solicitor General get around Buckman? Primarily, the government argued that the FDA didn’t act at all – the Agency never approved, or disapproved, the defendant’s product, since that product wasn’t ever submitted in the first place:

As respondent notes and petitioner essentially concedes, FDA has never approved [the product] to be marketed as a drug, nor has the agency taken any other affirmative step to authorize (or forbid) the sale of the product as a matter of federal law.

2015 WL 2457643, at *10.  Thus, according to the SG, a finding under the California UCL (allowing suit under the Sherman Act’s FDCA-identical standards) that the defendant was selling an unapproved “drug” rather than a “cosmetic,” didn’t conflict with anything the FDA did, because the FDA hadn’t done anything.

This discussion of FDA inaction is not what we usually see, because our clients’ drugs and medical devices are always subject to some form of FDA approval/clearance/whatever.  We know of Supreme Court implied preemption precedent, Spreitsma v. Mercury Marine, 537 U.S. 51 (2002), that an agency’s “decision to take no regulatory action left the law applicable to [the product] exactly the same as before the [agency] began.”  Id. at 65.  So Spreitsma found no preemption, even where an agency considered doing something and decided against it.  Id.  Cf. Geier v. American Honda Motor Co., 529 U.S. 861, 881-82 (2000) (deliberate, policy-driven decision to not require certain action can constitute preemptive agency action).  In a situation where a product was never even brought before an agency, Spreitsma’s no-preemption rationale would seem to apply even more strongly.

But, oddly, the SG’s brief never even cites Spreitsma.  Rather, it argues against preemption because there is no “direct and positive conflict” with any FDA action, citing an uncodified 1962 savings clause that essentially restates the definition of implied conflict preemption.  2015 WL 2457643, at *13-14.  That, we think is wrong, because it mixes express (the 1962 language) and implied preemption, when the Supreme Court has repeatedly – and in Buckman itself – held that the two types of preemption operate independently of each other.

Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA.  To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion last Term in Geier v. American Honda Motor Co., 529 U. S. 861 (2000), that neither an express pre-emption provision nor a saving clause “bar[s] the ordinary working of conflict pre-emption principles.”  Id., at 869.

Buckman, 531 U.S. at 352.  As Buckman observed, Geier also confirms that even express savings clauses cannot prevent implied preemption where “an actual conflict with a federal objective is at stake.”  529 U.S. at 871.

So the SG takes the position that, as long as the FDA hasn’t actually done anything, the state of California can enforce standards identical to what the FDA would have considered, should the Agency ever have decided to act.  “[Plaintiff’s] claim thus does not supplant any regulatory determination by FDA regarding the product’s status as a cosmetic or a new drug.  No conflict is presented between the federal and state standards in this regard.”  2015 WL 2457643, at *11.  See also Id. at *14 (“capacity to police the vast marketplace of consumer products that have never been submitted to FDA for pre-market review is even more constrained”); *16 (defendant “never submitted a marketing application to FDA, and FDA never approved [defendant’s] product for marketing. Thus, unlike in Buckman, [plaintiff’s] suit does not require a court to evaluate the propriety of submissions to FDA”).  Be that as it may with a product that is arguably a cosmetic requiring no FDA action at all, for our drug and device clients the SG’s arguments suggest a different result where “the propriety of submissions to the FDA” is placed at issue in a state-law action:

Whether false statements have been made to a federal agency, and what sanction to impose if they were, are matters to be decided by the federal government, the sovereign that established that administrative forum.

Id. (citation omitted).

Buckman, the SG argued, found a common-law claim preempted for three reasons:

• “First, the putative state-law claims sought to police fraud on a federal agency by entities the agency itself regulated, a matter of an exclusively federal character over which the federal agency at issue − the FDA − possessed ample direct authority.”
• Second, “the claims in Buckman, which were directed at a defendant that was not the manufacturer of the devices and therefore did not have a manufacturer’s duty to warn purchasers of safety risks, did not “rely[] on traditional state tort law.” 531 U.S. at 353. Rather, the plaintiffs relied on a theory that “exist[ed] solely by virtue of the FDCA,” ibid.”
• Third, “allowing plaintiffs to pursue a “fraud-on-the-FDA” claim under state law could compromise FDA’s “flexibility” to pursue “difficult (and often competing) objectives” under the FDCA’s medical device provisions. 531 U.S. at 349.”

2015 WL 2457643, at *12-13.  We’re not so sure about #2, since Buckman turned on the type of conduct (false statements to the FDA) rather than the source (a non-manufacturer).  Assuming arguendo that such a distinction exists, has nonetheless has some positive preemption attributes.
Item one should preempt any claims concerning informationtually given to (or withheld from) the FDA by those that “the agency itself regulate[s].”  We’ve always thought (as recently as a couple of days ago) that alleged failures to report/inaccurate reporting of adverse events to the FDA were preempted, and the SG’s brief doesn’t disagree.

Item two supports additional implied preemption – beyond fraud on the FDA − of claims brought against “a defendant that was not the manufacturer.”  So does Mensing/Bartlett, since as we discussed here, non-manufacturers can’t change labels (or anything else) unilaterally.  Inability to act independently = impossibility = implied preemption.

Item three not only reconfirms the FDA’s primacy over off-label use and promotion, which is what the quoted portion of Buckman was discussing, but gives the Court’s analysis potentially broader effect.  The FDA pursues a lot of “difficult” and “competing” objectives and strikes a lot of balances.

There are several other places where we find helpful nuggets – intended or not − in the SG’s brief.  These occur in the SG’s discussion of other courts of appeal’s decisions involving implied preemption under Buckman.  The same office that had been so quick to denounce cases as wrongly decided in prior briefs did not do so in Athena.  Most importantly, the SG’s brief endorsed preemption of “claims that defendant failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations” as being “in accord with this Court’s decision in Buckman.”  2015 WL 2457643, at *22 (describing In re: Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010)).

The SG also had no problem with preemption of statutory state-law liability-creating-exceptions based on fraud on the FDA:

In cases involving claims of fraud against a federal agency, courts of appeals have concluded that federal law does bar plaintiffs’ suits.  See Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 381 (5th Cir. 2012) (state-law claim of fraud on FDA preempted by the FDCA).  These outcomes are faithful to this Court’s decision in Buckman.

2015 WL 2457643, at *21-22 (non-FDCA citation omitted).

We’ve discussed Lofton here and here.  Thus, it appears that even the current anti-preemption SG’s office is on our side (and not on the side of Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d mem. by equally divided court, 552 U.S. 440 (2008)), concerning the preemption of  express state statutory “fraud on the FDA” exceptions.  Remember that if the SG ever tries to change his/her tune.

The SG’s brief also agreed that off-label use claims were properly preempted where “FDA was aware of the defendant’s off-label use, had actively taken steps to halt abuses, and ultimately approved the device for the relevant procedures.”  2015 WL 2457643, at *19-20 (discussing Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013)) (citations and quotation marks omitted).  To the SG it was an unobjectionable application of preemption to dismiss a claim that, contrary to an actual FDA determination, the defendant had violated the FDCA.  Id. at *19 (discussing PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010)). The SG likewise did not dispute the preemption of claims that a product (or a defendant’s conduct) involved something that was “illegal” under the FDCA.  Id. at *18 (discussing Loreto v. Procter & Gamble Co., 515 Fed. Appx. 576 (6th Cir. 2013)).

As we discussed in our earlier posts, we think that preemption was appropriate in Athena because the distinction between “state” and “federal” is evanescent where, as in California, purported state law simply adopts the FDA’s regulatory standards wholesale.  We don’t think that the congressional intent embodied by §337(a) can be so easily nullified.  Obviously, the SG disagrees, and is unwilling to look behind the California fig leaf. We also disapprove of the unnatural conjoining of express and implied preemption, since they operate independently. Beyond that, however, we find the Athena SG’s brief surprisingly helpful, since the fields in which we labor are planted by positive FDA decision-making, and the SG seems to find Buckman preemption a proper means of weed control for protecting our clients’ drug and device bounty.