Here’s another guest post by friend-of-the-blog, Dick Dean of Tucker Ellis. Dick is a big fan of primary jurisdiction (if only more courts shared his enthusiasm), and this post deals with some recent Supreme Court precedent that is helpful to such arguments, and that might otherwise have been missed. As always our guest bloggers deserve 100% of the credit (and any blame) for their ideas.
Timing is everything in life. On April 29, after I finished reading Steve McConnell’s post playing off of the NFL draft, I started reading Supreme Court cases decided within the last few days. By chance the first one I looked at was Atlantic Richfield v. Christian, —S.Ct.—, 2020 WL 1906542 (April 20, 2020). It does not have to do with our sandbox; it is a CERCLA Superfund case. But when I read it, I immediately thought of primary jurisdiction (the 16th pick in in Steve’s post) though that term is never used in the case. It is not a classic primary jurisdiction case which involves prudential deference by a court to an agency with specific expertise on an issue before the court. However, the underlying rationale of the doctrine was implicated in Atlantic Richfield by statutory scheme, since Congress gave the EPA specific powers relevant to the issue before the court (remediation of Superfund sites). The case was resolved on that statutory basis.
Atlantic Richfield bought the Anaconda Copper Smelter in Montana at a deep discount hoping to turn it into something profitable. That attempt failed miserably. It turns out that what it had bought was soon to be a Superfund site. Atlantic agreed to a remediation plan with the EPA which is to continue to 2025. Then a group of 98 Montana landowners sued Atlantic in Montana state court for restoration damages under Montana law. Plaintiff’s remediation demands went substantially beyond what the EPA had ordered, for example, plaintiffs proposed that the land have a maximum contamination level of 15 parts per million of arsenic. The EPA had prescribed 250. There were many other remedies sought beyond what was in the plan Atlantic challenged the lawsuit.
The first issue was whether CERCLA barred this action. The trial court and the Montana Supreme Court said no. The U.S. Supreme Court agreed. The Court held that CERCLA deprived state courts of jurisdiction of claims brought under the Act but that it did not “displace state court jurisdiction over claims brought under other sources of law.” Since the claims for restoration was under state law, it was not displaced. The second question was whether the landowners needed EPA approval to seek remedial action. The Superfund law provides that when a remediation plan was underway “no potentially responsible party” could undertake separate remediation unless it was authorized by the EPA. So this part of the case turned on a determination of whether the land owners were “potentially responsible parties” under the Act. The Supreme Court found that they were. In sum, the landowners could sue in state court and were not barred from doing so by the CERCLA remediation but they could not sidestep the EPA. It was not exclusive jurisdiction because the suit could proceed if the EPA allowed it but it was the equivalent of primary jurisdiction by statute.
In Steve’s post he referenced the use of primary jurisdiction in our sandbox. He embedded posts discussing a number of food labeling and advertising cases. While those are clearly the most numerous primary jurisdiction cases implicating the FDA within the last ten years, there are over 500 other primary jurisdiction cases involving the FDA. (You can’t say much when discussing a 16th round pick). There have been a number of cases finding primary jurisdiction where the claim was related to or premised on the assumption that a drug was safe and effective. Not only does the FDA have significant medical and scientific expertise to bring to bear on whether a drug is safe and effective, Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 654 (1973), it is the only entity that is authorized to make such decisions. Weinberger v. Hynson, Westcott & Dunning, Inc. 412 U.S. 609, 627 (1973). So it is not surprising that claims implicating that decision have been dismissed or side-tracked by primary jurisdiction. National Ethical Pharmaceutical Assn. v. Weinberger, 503 F.2d 1051 (4th Cir. 1974) (attempt to challenge FDA determination of what was or was not a new drug could proceed only after a formal ruling from the FDA); Israel v. Baxter Laboratories, Inc., 466 F.2d 272 (D.C. Cir. 1972) (action by drug manufacturer that competitor and others conspired to keep drug off market by preventing fair consideration required remand and consideration by FDA to determine safety and efficacy).
From approximately 2000 to 2010, plaintiffs’ lawyers often tried to influence or modify the course of FDA generated recalls. More specifically, they would request that courts change language in a recall already issued to be more expansive. Courts generally declined those requests since the issue in a recall is “what is the appropriate dissemination of medical information to the consuming public.” Clark v. Actavis Group hf, 567 F. Supp.2d 711 (D.N.J. 2008). And since that is a medical issue it is within the province of the FDA, and courts should defer to that expertise. Those cases are discussed in “Out of Your Jurisdiction: Why FDA Recalls and Courts Do Not Mix” in IADC Drug, Device and Biotechnology Newsletter (August 2011).
Most recently the doctrine has been advanced in state court opioid litigations against the pharmaceutical companies alleging improper marketing or advertising. The companies argued that courts should stay proceedings until completion of studies ordered by the FDA regarding specific opioids. Those cases are discussed in Stapleton “In Defense of the Hare: Primary Jurisdiction Doctrine and Scientific Uncertainty in State-Court Opioid Litigation,” 86 U. Chi. L. Rev. 1697 (Oct. 2019).
16th draft picks may not be as exciting as a top 5 pick, but they can make big plays helping to win games.