We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption. 

Yes, we need a life, but let’s put that aside for the moment.

In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval deserve no deference—and indeed should be invalidated—because the Agency made the wrong call and Loper Bright says they should be ignored.  Further, according to plaintiffs, an invalid PMA means manufacturers cannot assert a preemption defense, and they are off to the races with their tort claims faulting the FDA-required warning label, the mandated device design, and the scrutinized and approved manufacturing process. 

Loper Bright does not allow plaintiffs’ lawyers to overturn an exercise of FDA discretion in carrying out its assigned function in deciding whether to grant a PMA or PMA Supplement. Loper Bright recognizes that “[w]hen the best reading of a statute is that it delegates discretionary authority to an agency, the role of the reviewing court” is pretty much limited to “ensuring the agency has engaged in reasoned decisionmaking.”  Loper Bright also says nothing about agency policymaking or factfinding, which get very deferential review.  (See our post here.)

But more than that, these plaintiffs’ lawyers have the whole thing entirely backwards.  Loper Bright doesn’t undermine express medical device preemption, it gives manufacturers and defense lawyers a chance to re-set and expand how medical device preemption works.

Loper Bright involved the National Marine Fisheries Service and a federal law from 1976 (the Magnuson-Stevens Fishery Conservation and Management Act) that had something to do with the Atlantic herring fishery.  Something about the herring needing paid chaperones?  Or maybe the fishing boats?  (We are trying to care about the details, and failing.) 

Anyway, the National Marine Fisheries Service had issued regulations based on its interpretation of the statute, and the question was whether the Supreme Court had to defer to the agency’s interpretation of that statute or not.  Given that it is called the Supreme Court, you will not be shocked to learn that the Justices on said court decided that, while it is fine for a federal agency to exercise its discretion when Congress has authorized it to do so, interpreting federal laws is the job of the federal courts and they do not need the agency’s help with that, thank you very much.

Stated another way, Loper Bright got rid of a rule (Chevron deference) which had required courts to defer to “permissible” agency interpretations of the statutes those agencies administer, even when the reviewing court read the statute differently.  It freed federal courts from having to pay heed to an agency’s interpretation of a federal statute, and allows them to figure out the statute’s meaning on their own.

Ok, now let’s look at another federal law from 1976:  the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, and in particular the express preemption provision for medical devices, 21 U.S.C. § 360k(a). 

The first Supreme Court decision to interpret Section 360k(a) is one of our all-time bottom ten cases, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  It is just a mess.  A plurality decision with no cogent rationale and conclusions that suggest the court perhaps forgot to read the statute it was interpreting.

How did Lohr get so off track?  Maybe it is because Lohr’s interpretation of 21 U.S.C. § 360k(a) was constrained by the FDA’s attempt to interpret that statute, 21 C.F.R. § 808.1(d). 

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), tells us that: 

In Lohr, a majority of this Court interpreted the MDA’s pre-emption provision in a manner “substantially informed” by the FDA regulation set forth at 21 CFR § 808.1(d)….That regulation says that state requirements are pre-empted “only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device.”

* * *

Informed by the regulation, we concluded that federal manufacturing and labeling requirements applicable across the board to almost all medical devices did not pre-empt the common-law claims of negligence and strict liability at issue in Lohr. 

* * *

Even though substantial-equivalence review under § 510(k) is device specific, Lohr also rejected the manufacturer’s contention that § 510(k) approval imposed device-specific “requirements.”

Riegel, 552 U.S. at 322 (emphasis added).

What Riegel is telling us is that because the Supreme Court in Lohr relied on an agency interpretation of a federal statute, it issued a cockamamie opinion.  One that said that general federal requirements aren’t “federal requirements”, and that device-specific 510(k) review doesn’t impose device-specific federal requirements.  Lohr made little sense, because the Agency’s interpretation of the “federal requirement” part of the statute made no sense.

Compare that with how the Supreme Court in Riegel handled the “state requirement” prong of 21 U.S.C. § 360k(a) after it concluded it was not constrained by the Agency’s statutory interpretation of 21 C.F.R. § 808.1(d).  (Yes, the Court has been throwing shade at deference to agency statutory interpretation for some time.)

The particular question for the Court in Riegel was whether “state requirements” include only positive enactments (statutes or regulations) or “state requirements” also encompass duties imposed tangentially, by imposing liability through common-law tort claims.

The FDA’s regulation said that “state requirements” in the federal statute only meant laws or regulations, not tort claims.  But the Court in Riegel didn’t agree, so it ignored the regulation and interpreted the statute as it wished:

All in all, we think that [21 C.F.R.] § 808.1(d)(1) can add nothing to our analysis but confusion.  Neither accepting nor rejecting the proposition that this regulation can properly be consulted to determine the statute’s meaning; and neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally; the regulation fails to alter our interpretation of the text insofar as the outcome of this case is concerned.

Riegel, 552 U.S. at 329-30.

We would all have been better off if Riegel ignored all portions of the Agency’s statutory interpretation regulation, both this state requirement bit and the federal requirement bit that Lohr had mangled.

But now that Loper Bright is here, maybe federal courts can start the statutory interpretation process over again based in the text of 21 U.S.C. § 360k(a), and free from the shackles of Lohr as tainted by the misguided regulation.  Bexis certainly thinks so.

If express preemption analyses started with the language of the statute, and Riegel instead of Lohr,we could revisit the question of whether the 510(k) process imposes device-specific federal requirements (it does), particularly in its modern, more enhanced form.  And we could revisit the question of whether federal requirements are “federal requirements” even though they apply to all devices and not just a particular device (they do).