Through the Food, Drug & Cosmetic Act (FDCA) and its amendments, Congress put the Food and Drug Administration (FDA) in charge of establishing uniform, national regulation of consumer products. In the past decade, private litigants and state officials have increasingly undercut regulatory uniformity through state tort and consumer-protection lawsuits. Rather than defend its congressional mandate through amicus briefs or other courtroom advocacy, FDA remained mostly silent during that period.
This year, under the leadership of Commissioner Scott Gottlieb and Chief Counsel Rebecca Wood, FDA has stepped off the sidelines and is once again promoting uniformity by defending its regulatory role in several third-party legal action. That is a positive development for the producers and purchasers of FDA-regulated goods, which comprise nearly 25% of U.S. consumer spending.
In this post, we will discuss the three instances in which FDA has advanced arguments supportive of uniformity this year. In a forthcoming second post, we will suggest another area the agency should consider for further, similar advocacy.
New York City Menu Labeling Mandate
On August 14, the Acting U.S. Attorney for the Southern District of New York filed a “Statement of Interest” brief on behalf of FDA in Nat’l Ass’n of Convenience Stores v. New York City Dept. of Health & Mental Hygiene, a suit that challenged the city’s intent to enforce a newly expanded menu-labeling mandate. Concerned with the proliferation of state and local menu-labeling laws, Congress included in the Patient Protection and Affordable Care Act of 2010, a.k.a. ObamaCare, a provision directing FDA to implement a uniform labeling rule. FDA has finalized the regulation and recently set May 18, 2018 as the national compliance deadline.
The government’s brief supported the plaintiff’s argument that ObamaCare preempts New York City’s rule. The law contains a clause that expressly preempts any “requirement” that is not “identical” to the rules FDA would adopt at Congress’s direction. The brief argued that the city’s rule is not identical to the pending FDA regulation, and that the court should thus hold it invalid.
Two weeks after the Statement of Interest was filed, New York City announced that it would not enforce its new rules pending implementation of the federal labeling mandate.
Shuker v. Smith & Nephew PLC
FDA’s next courtroom engagement arose from an invitation from the U.S. Court of Appeals for the Third Circuit to weigh in on a negligence and products-liability suit against a medical-device maker. On September 14, the Department of Justice’s Civil Division filed an amicus letter addressing the express- and implied-preemption issues in the case.
Shuker sued Smith & Nephew alleging harm from several of its FDA-approved devices implanted during hip-replacement surgery. His surgeon deployed one device in an off-label manner, a use that Shuker claimed the company had promoted illegally. The federal district court held that a section of the Medical Device Act (which amended the FDCA) expressly preempted the plaintiff’s state-law claims.
The government’s amicus filing supported the trial judge’s preemption conclusion with regard to the device that had undergone FDA’s rigorous premarket-approval process (PMA). State-law claims lodged against PMA devices generally are expressly preempted because they could impose “different or additional requirements on approved devices.” Significantly, the letter stated that express preemption applies even if a PMA device is used in an off-label manner.
The government disagreed, however, with the lower court’s decision regarding the device approved under the Device Act’s “substantial equivalence” (i.e. § 510(k)) process. Though the amicus letter agreed that claims involving a § 510(k) device could be expressly preempted if the device was “otherwise subject to device-specific federal requirements,” the § 510(k) device in Shuker did not fall into that category. Defendants in Smith & Nephew’s situation, the letter explained, could independently assert an implied preemption defense. Implied preemption can occur, for instance, if “divergent state requirements … stand as an obstacle to the operation or objectives of the federal scheme.”
The Shuker appeal remains pending before the Third Circuit.
FDA Opposes an International Trade Commission Investigation
The final example of FDA engagement in 2017 arises not from a third-party legal dispute, but from Amarin Pharma, Inc.’s request for a U.S. International Trade Commission (ITC) investigation. The company alleged that certain synthetically produced omega-3 products were being labeled and marketed as dietary supplements in violation of the FDCA, among other statutes. The request argued that ITC should investigate such activity and if legal violations were found, bar importation of the omega-3 products at issue.
Amarin argued that the omega-3 products were not dietary supplements, but in fact were drugs lacking FDA approval. On October 6, FDA formally requested that ITC decline the investigation request as its actions “may conflict with later determinations by FDA.” The status of the omega-3 products, it stated, was “an open question of law and policy.”
The letter explained that the agency was currently assessing that very “complex” question, and that even if the Complainant had pled a viable claim, ITC should demonstrate “comity to FDA—the federal agency that has the congressionally-delegated authority to determine the status of the products at issue.” An investigation in this instance, FDA argued, would “create an incentive for other parties to file similar complaints about other FDA-regulated products,” which, it reminded ITC, include biologics, blood products, tobacco, medical devices, and cosmetics.
In addition, the claim brought before ITC was not viable, FDA argued, because private parties are prohibited from enforcing the FDCA. Private lawsuits would be entirely contrary to Congress’s decision to “provide uniformity of administration of the FDCA” by “centraliz[ing] authority .. in the FDA.”
On October 27, citing FDA’s objection, ITC declined Amarin’s request.
Consumer products such as prescription drugs, medical devices, packaged food, and cosmetics are sold in a national marketplace. Uniform regulation of product approval and labeling lowers manufacturing costs by creating predictable, reliable standards and preventing the need for state-by-state production. Consumers are also assured that they are receiving the same product, with the same warnings and other information, regardless of the state of purchase.
The three actions discussed above demonstrate the new FDA leadership’s appreciation for how private plaintiffs, judges, and even other federal agencies can erode that vital uniformity. Washington Legal Foundation encourages FDA to continue on this path and my next post will suggest an additional candidate.
Also published by Forbes.com on WLF’s contributor page.