Trial Magazine

In Merck Sharp & Dohme Corp. v. Albrecht, the U.S. Supreme Court clarified how to—and who should—decide whether state and federal law conflict when drug manufacturers introduce the “impossibility ­preemption” defense in failure-to-warn cases.¹ Plaintiffs should take note of the Court’s decision, which raises the bar for proving impossibility preemption and specifies that a judge, not a jury, should decide whether a drug label change is preempted.

When raising impossibility preemption, manufacturers of FDA-approved drugs often argue that they could not provide a warning allegedly required under state law because federal regulations prohibited it. A decade ago, in Wyeth v. Levine, the Supreme Court held that drug manufacturers claiming impossibility preemption must produce “clear evidence” that the FDA would have prohibited the additional warning.²

Confusion Post-Wyeth

Since that decision, drug manufacturers have pushed lower courts to adopt an expansive view of impossibility preemption—one that turned not on actual impossibility (whether a manufacturer really could have added particular warnings to a label without violating federal law) but on hypothetical impossibility (whether the FDA hypothetically might have rejected a warning had the manufacturer attempted to comply with an alleged state law duty). This forced courts into the difficult position of speculating what the FDA would have done had it known all the relevant facts and been presented with the actual proposed warning language.

In those post-Wyeth cases, manufacturers pointed to an assortment of tea leaves to claim impossibility preemption. In one instance, it was the fact that the FDA did not proactively require a particular warning despite periodically reviewing evidence concerning the ­relevant risks.³ In another case, the manufacturer noted that a similar warning was required for a similar drug around the time at issue but no new warning was proactively required for the drug at issue.⁴

Clarity on Clear Evidence

Had the Court in Merck sanctioned a form of impossibility preemption that turned on these types of facts, it would have opened the door to freewheeling speculation about hypothetical FDA responses and transformed Wyeth’s statement about clear evidence into a license to construct elaborate theoretical scenarios in which all of the FDA’s actions would be mined for hints of regulatory intent.

The Court took a different tack  with six justices holding that a drug manufacturer seeking to bar state law claims under impossibility preemption must provide clear evidence that complying with both federal and state law would actually be impossible.⁵ As the Court explained, the “possibility of impossibility [is] not enough.”⁶ Instead, under Wyeth’s clear evidence standard, a defendant must show “that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.”⁷

The Court’s discussion of clear evidence confirms that when it comes to impossibility preemption, there is no such thing as hypothetical preemption. Instead, a drug manufacturer pressing an impossibility preemption defense must show that the FDA actually rejected the warning at issue—not just that the FDA could or likely would have rejected it. This bright-line rule can be applied across the range of failure-to-warn cases and is faithful to the idea that state law gives way only when it actually conflicts with federal law.

The Court also made clear that, when it comes to impossibility preemption, “the question is a legal one for the judge, not a jury” because it “often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute.”⁸ Judges, the Court explained, “are better equipped to evaluate the nature and scope of an agency’s determination . . . in light of the governing statutory and regulatory context.”⁹ This was true, according to the Court, even when contested facts may prove relevant to the preemption determination—in those cases, the facts are “subsumed within an already tightly circumscribed legal analysis” and so may be resolved by a judge.¹⁰ Ultimately, given that courts regularly undertake this inquiry, the Court’s decision on this question is unlikely to affect the preemption analysis meaningfully.

Questions Remain

To win on impossibility preemption claims going forward, a drug manufacturer will now need to present evidence that it “fully informed” the FDA of the justifications for adding a new warning and that the FDA, in response, actually “informed” the manufacturer that it “would not approve a change to the drug’s label to include that warning.”¹¹

Even so, Merck leaves open several questions about how impossibility preemption will work in practice. One unresolved issue is what type of FDA action will sufficiently “inform” a manufacturer that a label change is disallowed by federal law. The Court’s opinion makes clear that only agency actions taken pursuant to congressionally delegated authority may “determine the answer to the preemption question.”¹² It lists three examples of how the FDA may, under federal law, “communicate its disapproval of a warning,” including “by means of notice-and-comment ­rulemaking setting forth labeling standards; by formally rejecting a warning label that would have been adequate under state law; or with other agency action carrying the force of law.”¹³ Although this language suggests that drug manufacturers must demonstrate that any alleged disapproval qualifies as a formal, legally binding action from the FDA, it will be up to the lower courts to work out the contours of this question in future cases.

Another question left open is whether an FDA decision disallowing a label change, even if congressionally authorized, is sufficiently clear evidence of impossibility. In Merck, the Court explained that if the FDA rejected a proposed label change because insufficient information supported the change, then determining impossibility preemption could turn on the context of that decision.¹⁴ But how that context might affect preemption remains uncertain. For instance, it might depend on what information the FDA had when it made the decision, and litigants could disagree about whether the manufacturer submitted all material information to the FDA at the relevant time.

Some of these questions are already being taken up in the lower courts. For example, in a suit against ­GlaxoSmithKline (GSK) over allegations that the company concealed cardiovascular risk data about its blockbuster drug Avandia, the Third Circuit has ordered supplemental briefing on how (if at all) Merck should guide resolution of the case.¹⁵ The plaintiffs argued that because preemption cannot be hypothetical, the manufacturer’s preemption defense must fail because it neither told the FDA everything it knew about the drug’s risks nor received a formal FDA rejection of any proposed warning.¹⁶

GSK, in contrast, argued that it fully informed the FDA of the relevant data and that the agency did not allow it to change the drug’s label; instead, the FDA convened an advisory committee to review the data and obtain additional information from an ongoing study, which it ultimately found did not show increased cardiovascular risks.¹⁷

We can expect to see more briefing on Merck’s impact in the coming months as these and related questions percolate across failure-to-warn cases in the lower courts.

Ultimately, although the Court’s decision in Merck will provide welcome clarity to plaintiffs confronting a manufacturer’s argument that state law failure-to-warn claims are preempted, not all impossibility preemption questions may be resolved through the Court’s newly refined clear evidence standard. Pay careful attention to Merck’s language and framework when faced with claims of impossibility preemption from drug manufacturers trying to escape liability.

Matthew Wessler is a principal at Gupta Wessler in Washington, D.C., and can be reached at matt@guptawessler.com.

Notes

1. 139 S. Ct. 1668 (2019). For more on Merck oral arguments and the case history, see Matthew Wessler, Merck and Impossibility Preemption, Trial 42 (April 2019).  
2. 555 U.S. 555, 571 (2009).
3. Forst v. Smithkline Beecham Corp., 639 F. Supp. 2d 948, 954 (E.D. Wis. 2009).
4. Hunt v. McNeil Consumer Healthcare, 6 F. Supp. 3d 694, 701–02 (E.D. La. 2014).
5. The Court’s judgment was unanimous. Justice Stephen Breyer’s opinion was joined by Justices Clarence Thomas, Ruth Bader Ginsburg, Sonia Sotomayor, Elena Kagan, and Neil Gorsuch. Justice Thomas filed a concurring opinion (while also joining in the majority’s), and Justice Samuel Alito filed a concurring opinion, which Chief Justice John Roberts and Justice Brett Kavanaugh joined. 
6. Merck, 139 S. Ct. at 1678 (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 625 n.8 (2011)).
7. Id. at 1672.
8. Id. at 1679–80.
9. Id. at 1680.
10. Id. 
11. Id. at 1672.
12. Id. at 1679.
13. Id. (internal citations omitted). 
14. Id. at 1680.
15. Order, In re Avandia Mktg., Sales Practices & Prods. Liab. Litig. (3d Cir. May 20, 2019) (No. 18-1010).
16. See Supplemental Brief for Appellants, In re Avandia Mktg., Sales Practices & Prods. Liab. Litig. (3d Cir. June 3, 2019) (No. 18-1010).
17. See Supplemental Brief for Defendant-Appellee, In re Avandia Mktg., Sales Practices & Prods. Liab. Litig. (3d Cir. June 3, 2019) (No. 18-1010).