Food and Drug Cases to Watch in 2023*

We asked our Top Cases chapter authors for their picks on which current litigations, regulatory actions, and other developments have the potential to change the food and drug landscape in the balance of 2023. Some of the cases described here are appeals or other forms of continuation of important cases discussed in preceding chapters in this volume; others represent new issues that may result in important new rulings and precedents.

Loper Bright Enterprises v. Raimondo^[1]

Whether federal courts should defer to an agency’s construction of an act of Congress will be revisited by the U.S. Supreme Court during its October Term 2023. In 1984, a unanimous 6–0 Court adopted the two-step “Chevron deference”—which prescribed that a federal agency’s construction of a statute it administers is not to be upset by a court unless either: 1) Congress already directly addressed the question at issue, or 2) the agency’s construction is not a permissible one.^[2] The first Chevron “step” checks for legislative silence or ambiguity; the second “step” tests for reasonableness. The Court had reasoned that in empowering an agency to administer its law, the legislature may have delegated both policy formulation and “the making of rules to fill any gap left, implicitly or explicitly, by Congress.”

The petitioner (a commercial fishing firm) challenged rulemaking by a federal agency charged with administering a law intended to protect against overfishing. That law requires fishing vessels to make room for federal observers, among other requirements. Notwithstanding that New England herring fishing was not one of the three settings where Congress had expressly authorized imposition of observer costs, the agency invoked its “necessary-and-appropriate” authority to impose those costs on New England herring fishing vessels. A divided 2–1 panel of the U.S. Court of Appeals for the D.C. Circuit ruled that Congress had provided “no wholly unambiguous answer” on the matter and that the agency’s fee impositions were not an impermissible construction of Congress’ statute. The Supreme Court granted certiorari on two issues: should Chevron deference be overruled or, alternatively, should Congress’ silence on the use of an authority granted by its statute inapplicably elsewhere foreclose judicial deference to an agency’s construction of that law?

Shears v. Ethicon, Inc.^[3]

In April 2023, the Fourth Circuit Court of Appeals certified to the Supreme Court of Appeals of West Virginia the following question:

Whether Section 411 of the West Virginia Pattern Jury Instructions for Civil Cases, entitled “Design Defect—Necessity of an Alternative, Feasible Design,” correctly specifies the plaintiff’s burden of proof for a strict liability design defect claim pursued under West Virginia law.

More specifically, whether a plaintiff alleging a West Virginia strict liability design defect claim is required to prove the existence of an alternative, feasible product design—existing at the time of the subject product’s manufacture—in order to establish that the product was not reasonably safe for its intended use. And if so, whether the alternative, feasible product design must eliminate the risk of the harm suffered by the plaintiff, or whether a reduction of that risk is sufficient.

The appeal to the Fourth Circuit followed the award of summary judgment to the defendant on the design defect theory in a pelvic mesh product liability case because the plaintiff couldn’t meet the current West Virginia standard for proof of alternative design, by contrast with which the actual product could be ruled deceptive. The question certified by the Fourth Circuit describes West Virginia’s “Elimination Mandate,” under which a plaintiff alleging a design defect “must prove that there was an alternative, feasible design that eliminated the risk that injured” the plaintiff. The district court held, in granting summary judgment, that plaintiff had not proven the existence of an alternative design meeting these two criteria of 1) feasibility and 2) elimination, as opposed to mere reduction, of the possibility of the type of injury complained of.

Melinta Therapeutics, LLC v. Food and Drug Administration^[4]

In this matter arising out of a Hatch-Waxman case, Melinta sued FDA to suspend approval of an Abbreviated New Drug Application (ANDA) filed by a generic entrant with respect to Melinta’s drug Minocin, which treats bacterial infections. The district court granted a temporary restraining order and preliminary injunction for Melinta because, it held, the generic manufacturer’s notice was insufficient, due to FedEx’s COVID-19 contactless delivery policy. Melinta claimed that it did not have actual notice until March 31, 2021, rather than December 8, 2020, when the notice was delivered.

Co-defendant Nexus Pharmaceuticals has appealed the case to the D.C. Circuit Court of Appeals. We will be watching this case for its implications for sufficient notice of the filing of an ANDA.

Nissan Chemical Corporation v. Food and Drug Administration^[5]

Nissan Chemical Corp. v. FDA is an Administrative Procedures Act challenge by Merck (and related entities) regarding FDA’s determination of the regulatory review period for patent term restoration for the animal drug BRAVECTO. The case was under voluntary remand to FDA for much of last year but was recently reinvigorated. The government answered the recently amended complaint and filed the administrative record at the end of last month, and summary judgment filings are underway.

AMA Systems, LLC v. Food and Drug Administration^[6]

Plaintiff filed this complaint against FDA for failure to respond to a Freedom of Information Act (FOIA) request within twenty-four months. FDA answered the Complaint in April 2023. FDA’s defense appears to be, in part, that the complained-of delay happened in the midst of COVID. This case is worth watching for a potential indication of how responsive the agency is required to be to FOIA requests.

Alliance of Nurses for Healthy Environments v. Food and Drug Administration^[7]

This is an APA case brought by Public Citizen and NRDC, among others, alleging that FDA’s determination to allow the continued use of medically important antibiotics for disease prevention in healthy livestock and poultry was arbitrary and capricious, citing concerns about the contribution to the creation of antibiotic-resistant bacteria that can be transferred to humans. NRDC asserts that “the ability of disease-causing bacteria to withstand the drugs designed to kill them is one of the greatest threats to public health today.”^[8]

Plaintiffs in this case claim that “many” of the antibiotics used in these animals are not used to treat sick animals, but rather prevent diseases caused by the unsanitary and stressful conditions in which they are often kept. As they put it, “The FDA has shirked its duty to ensure that the use of drugs in food-producing animals is safe for human health,”^[9] although their case alleges not that the antibiotics are directly harmful to humans through ingestion, but rather that they contribute more generally to a human health hazard by creating an environment where bacteria are more resistant and antibiotics less effective. The case is worth watching for the viability of this unconventional theory.

FDA must file its answer by May 24, 2023.

 

*   We extend extra thanks to these contributing authors to other chapters of this volume who also suggested and summarized cases to watch for this chapter.

[1]   No. 22-451 (Sup. Ct.), appeal from 45 F.4th 359 (D.C. Cir. 2022).

[2]   See Chevron U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843–44 (1984) (Marshall, Rehnquist & O’Connor, JJ., not participating).

[3]   No. 22-1399 (4th Cir. 2023), appeal from No. 1:20-cv-00264-IMK (N.D. W. Va.).

[4]   No. 22-5288 (D.C. Cir.), appeal from No. 1:22-cv-02190 (D.D.C.).

[5]   No. 1:22-cv-01598 (D.D.C.).

[6]   No. 8:23-cv-00489 (D. Md.).

[7]   No. 8:23-cv-00176 (D. Md.).

[8]   Alliance of Nurses for Healthy Environments et al. v. FDA et al. (Antibiotic Resistance), NRDC (Jan. 24, 2023), https://www.nrdc.org/court-battles/alliance-nurses-healthy-environments-et-v-fda-et-antibiotic-resistance.

[9]   Id.