We have another guest post by friend-of-the-blog, Dick Dean of Tucker Ellis, along with his associate, Emmanuel Sanders.  This post speculates on whether recent personnel changes on the United States Supreme Court might mean the end of the case we call the “number of the beast,” Wyeth v. Levine, 555 U.S. 555 (2009).  To paraphrase John Lennon, “you may think he’s a dreamer, but he’s not the only one,” so we think it is a worthwhile exercise.  As always, our guest posters deserve 100% of the benefit (and any blame) for what they have written.  So take it away….


In the last few weeks, there has been much speculation about whether Justice Amy Coney Barrett’s elevation to the Supreme Court would result in the elimination of the Affordable Care Act or lead to a reversal of Roe v. Wade, 410 U.S. 113, 93 S. Ct. 705 (1973).  But in our sandbox, a big question is whether her addition to the court will lead to a reversal of Wyeth v. Levine, 555 U.S. 555 (2009) (finding that a jury can second guess whether an FDA-approved label is adequate) (“Levine”).  It should first be noted that there is little left of this decision given the fact that courts now determine the “newly acquired information” and “clear evidence” issues as a matter of law. But under Levine a jury still decides adequacy if there are any open issues after the aforementioned legal issues are adjudicated.

In Levine, three Justices (Alito, Roberts and Scalia) dissented, specifically finding that permitting juries to second guess the FDA warning decision  would frustrate the “purposes and objectives” of the FDA.  This is otherwise known as obstacle preemption.  The essence of the dissent is captured in these sentences:

Where the FDA determines, in accordance with its statutory mandate, that a drug is on balance “safe,” our conflict pre-emption cases prohibit any State from countermanding that determination. See, e.g., Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (after the FDA has struck “a somewhat delicate balance of statutory objectives” and determined that petitioner submitted a valid application to manufacture a medical device, a State may not use common law to negate it).

Id. at 609.

So, count the first two votes (Alito and Roberts) for a finding of obstacle preemption.

But getting to five presumably does not include Justice Thomas. His concurring opinion in Wyeth (joining the majority which upheld a jury making these decisions) was a broadside against obstacle preemption itself.  He objected to a “freewheeling judicial inquiry” into Congressional purpose leading to an invalidation of state law.  And he has often played this refrain in other cases.

Where would Justices Gorsuch and Kavanaugh stand on this question?  They have been on the Court for a few years and have left some footprints.  Bexis has partially addressed this question in “Viewing Buckman as a Logical Contradiction Decision” post.  There he cited to the concurrence of Justices Thomas and Gorsuch in an opinion denying certiorari.  Lipschultz v. Charter Advanced Servs. (MN), LLC, 140 S. Ct. 6, 7, 205 L. Ed. 2d 262 (2019).  In this concurrence, Justice Thomas cited himself in Wyeth that preemptive effect could be “given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text….”  Id. at 7 (citing Levine 555 U.S. at 586).  Bexis viewed this as an “engraved invitation” to advance a “logical contradiction” argument in the future. That post next cites Virginia Uranium, Inc. v. Warren, 139 S.Ct. 1894 (2019), where Justice Kavanaugh joined Justices Thomas and Gorsuch in suggesting that obstacle preemption could be successful only where a litigant could “point specifically to ‘a constitutional text or a federal statute’ that does the displacing or conflicts with state law.” Id. at 1901.

So – setting aside Justice Thomas for the moment – the initial question is whether there is enough in the FDCA to satisfy Justice Gorsuch and Kavanaugh on this point.  Under 21 U.S.C. § 355(a), a drug may not be marketed without FDA approval. The proposed labeling must be submitted to the FDA.  Id. § 355(b). The drug will be approved only if the FDA finds the drug “safe for use … suggested in the proposed labeling” and that the proposed labeling is not “false or misleading in any particular.”  Id. § 355(d).  After approval, the FDA follows the drug and its labeling.  Indeed, the FDA has the power to force a sponsor to change the label.  Id. § 355(o)(4).  No other governmental entity, federal or state, is given this power.  The FDA may also withdraw its approval of the drug.  Id. § 355(e).  A state court judge or jury cannot do that.  And only the FDA may deem a drug to be “misbranded.”  Id. § 352(j).  Those statutory provision on their face collectively conflict with a jury determining adequacy of a warning.  Would Justices Gorsuch and Kavanaugh be persuaded that this language meets the Lipschultz and Virginia Uranium test?  While by no means certain, that seems possible.

So maybe there are two more votes (Gorsuch and Kavanaugh).

And at this point, it should be noted the majority in Levine did not consider any of these statutes in ruling on obstacle preemption.  (It did note 21 U.S.C. 355(o)(4) in the introductory part of the opinion.)  The majority spent most of its time reflecting on the fact that Congress had not stated any express preemption policy.  And several paragraphs discussed whether an FDA preamble suggesting preemption should be given any weight.  This section of the majority opinion did not look at the statutory language critical to the Lipschultz formulation.

Justice Thomas’s concurrence in Levine did at least cite some statutory provisions.  555 U.S. at 592-93.  But his immediate conclusion after the recitation was that the FDA’s initial approval of a drug is not a guarantee that the label would never have to be changed. Id. at 593.  That of course is not the question.  Rather the question is who decides the issue of adequacy – a jury or the FDA?  In the very next sentence, Justice Thomas wrote – “And nothing in the text of the statutory or regulatory scheme necessarily insulates Wyeth from liability under state law simply because the FDA has approved a particular label.”  555 U.S. at 593.  That is a backhanded way of saying there is no express preemption.  There was no examination of whether the statutory language regulating the FDA was contradictory to letting juries second guess FDA labeling decisions.  So how would he apply his more specific test in Lipschultz against the statutory regimen?  Would he stand his ground or is he waiting to see if someone shows up with an “engraved invitation” in hand?

But what about Justice Barrett?  There is little or nothing in her judicial opinions or academic writings to shed light on what path she would take on obstacle preemption.  She was a clerk to Justice Scalia.  And she is clearly an admirer.  Justice Scalia was an obstacle preemption adherent.  Besides taking that position in Levine, he wrote one of the most sweeping obstacle preemption opinions of recent years:  AT&T Mobility LLC v. Concepcion, 563 U.S. 333 (2011) (invoking obstacle preemption arising from the Federal Arbitration Act to strike down a California law that prohibited contracts from disallowing class wide arbitration).  Justice Scalia never joined the concerns that Justice Thomas articulated about obstacle preemption in Wyeth.  Justice Barrett seems a more likely fifth vote – assuming Justices Gorsuch and Kavanaugh accept the logical contradiction argument.