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”...
