Last week, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be pre-empted by the drug maker's compliance with Federal laws and regulations, particularly those related to FDA approval.

The case was brought by 500 users of Fosamax®, a drug administered to post-menopausal women to ameliorate the symptoms of osteoporosis.  At the time the FDA approved Fosamax®, Merck scientists had concerns (disclosed to FDA) -- but no clear evidence -- that long term use of the drug could cause femoral fractures later termed "atypical femoral fractures" (AFFs), characterized in the Court's opinion as "a rare type of complete, low-energy fracture that affects the thigh bone."  Because of the speculative nature of the association between AFFs and Fosamax® use at that time, the FDA did not require a warning regarding the risk of AFFs on the Fosamax® label.  As time went on, and adverse effects involving AFFs were reported by Fosamax® users, the risk association became more established, so much so that Merck submitted a proposed warning to the FDA in 2008; the FDA did not approve the warning.  Both the majority opinion and Justice Alito's concurring opinion suggest that the FDA's rejection was based at least in part on Merck's description of the side effect as a "stress fracture," which FDA did not believe properly notified the public of both the severity and atypicality of this type of fracture.  Nevertheless, in 2011, the FDA ordered Merck to include a warning that specifically called out AFFs as a risk of long term Fosamax® use.

Plaintiffs' complaint below was based on state law tort liability for failure to warn patients about the risk of AFF prior to 2011.  In its defense, Merck argued that the state law claims were pre-empted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., which governs, inter alia, drug labeling standards and requirements.  Additionally, Merck asserted that when it had attempted to have the FDA add a "risk of AFF" warning in 2008, the agency refused.

In a consolidated action before the District Court for the District of New Jersey, the Court agreed with Merck's argument and dismissed the complaint.  The Third Circuit vacated that decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (CA3 2017), based on its evaluation of the Supreme Court's decision in Wyeth v. Levine, 555 U.S. 555 (2009).  In the Third Circuit's opinion, Wyeth required that there be "clear evidence that the FDA would not have approved the change . . . to the label."  In explaining its reasoning, the Third Circuit opined that the Supreme Court had intended to set forth a standard of proof in its Wyeth decision, and that that standard was not intended to specify "the type of facts that a manufacturer must show, or to the circumstances in which preemption will be appropriate" but instead "how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change" (emphases in opinion).  To satisfy that burden, "the factfinder must conclude that it is highly probable that the FDA would not have approved a change to the drug's label" and (importantly for the Supreme Court's ultimate decision) "whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury."  In addition, however, the Third Circuit suggested that the "clear evidence" standard was itself unclear and had been unevenly applied by lower courts, and suggested that "it would be helpful for [the Supreme] Court to 'clarif[y] or buil[d] out the doctrine.'"

Merck's certiorari petition focused the question of whether the factfinder should be the judge or jury, and the Supreme Court granted certiorari based on the "differences and uncertainties among the courts of appeals and state supreme courts in respect to the application of Wyeth."

The Court's opinion was written by Justice Breyer, joined by Justices Thomas, Ginsburg, Sotomayor, Kagan and Gorsuch.  Justice Thomas wrote a concurring opinion; Justice Alito, joined by the Chief Justice and Justice Kavanaugh, wrote an opinion concurring in the judgment.

Justice Breyer gets right to the point at the beginning of his opinion, expressly citing Wyeth and announcing the holding of the Court that the pre-emption question was for the judge to decide, not the jury.  (The explication of the Court's reasoning might prompt a wry smile from patent practitioners in view of the Court's antipathy to patent law in many of its recent decisions, because it cites extensively from patent law precedent for this conclusion.)  Justice Breyer also announces the Court's meaning of "clear evidence" to be "evidence that shows the court 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."

Justice Breyer suggests that pre-emption would be limited to those circumstances where "it is 'impossible for a private party to comply with both state and federal requirements,'" citing Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 480 (2013).  After a brief recap of the Federal statutory scheme, the facts of the case below, and the Court's Wyeth precedent, Justice Breyer sets forth the Court's basis in precedent and Federal law for its understanding of the balance between Federal regulatory and state tort law.  Congress has never provided a federal cause of action or remedy for consumers harmed by "unsafe or ineffective" drugs, despite 70 years of experience since enactment of the FDCA and several amendments to the law; instead, in the Court's view, Congress enacted the FDCA "to bolster consumer protection against harmful products."  In doing so, he apparently sought to distinguish between substances harmful per se, as being adulterated or otherwise unsafe or ineffective in human use, and harm attendant (as here) in the use of otherwise safe and effective drugs.  From this, the Court understands that Congress, being aware of state law actions in tort for harm caused by drugs, did not intend to proscribe state sovereignty over such claims.  The "central premise," according to the Court's opinion, is that manufacturers bear the legal liability for such harms and for the content of their labels warning the public of those possible harms.  This responsibility translates to a duty to adequately warn "when the risks of a particular drug become apparent."  As the Court stated in Wyeth, "absent clear evidence that the FDA would not have approved a change to [the drug] label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements" (emphasis in opinion).

Justice Breyer's synthesis of precedent and law is that "[t]he underlying question for this type of impossibility pre-emption defense is whether federal law (including appropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law," and, in order to prevail, the drug maker must satisfy a court that the answer to this underlying question is yes.  But in order for this to be the case, a drug manufacturer must show "that it 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 changing the drug's label to include that warning."  In perhaps the pithiest citation in the opinion, Justice Breyer reminds us that "the possibility of impossibility is not enough," citing PLIVA, Inc. v. Mensing, 564 U. S. 604, 625, n.8 (2011).  In this regard, the opinion also notes that there are two ways to warn under Federal Food and Drug law.  First, FDA regulations contain a "changes being effected" (CBE) provision, where a drug label can be changed unilaterally by the manufacturer in view of new information without prior FDA approval (but such changes can be rescinded by the FDA if the agency disagrees) under 21 CFR § 314.70(c)(6)(iii)(A).  Second, the drug maker can file a Prior Approval Supplement (PAS) application under § 314.70(b) to obtain FDA approval of changes to the label before the drug manufacturer changes its label.

Turning to one of the Third Circuit's concerns (and apparently misapprehensions), the opinion states that:

We do not further define Wyeth's use of the words "clear evidence" in terms of evidentiary standards, such as "preponderance of the evidence" or "clear and convincing evidence" and so forth, because, as we shall discuss, infra, at 15-17, courts should treat the critical question not as a matter of fact for a jury but as a matter of law for the judge to decide.  And where that is so, the judge must simply ask himself or herself whether the relevant federal and state laws "irreconcilably conflic[t]."  Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982).

Finally, in Justice Breyer's explication of the legal standards, the opinion reminds us that "the only agency actions that can determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA's congressionally delegated authority" under the Supremacy Clause, U.S. Const., Art. VI, cl. 2, and within the confines of the authority conferred upon the agency by Congress, citing New York v. FERC, 535 U.S. 1, 18 (2002).

The opinion bases its determination that the pre-emption question is one of law for a court to decide by citing patent law precedent related to claim construction, for the principle that "judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency's determination.  Judges are experienced in '[t]he construction of written instruments,' such as those normally produced by a federal agency to memorialize its considered judgments," citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388 (1996), and particularly with regard to "understand and to interpret agency decisions in light of the governing statutory and regulatory context," under 5 U.S.C. § 706.  As it had in Markman, the Court voiced its confidence that this would "produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action."  And even then, considering that "brute facts" can sometimes themselves be determinative, Justice Breyer found guiding principles in this regard in patent law:  "we have also held that 'courts may have to resolve subsidiary factual disputes' that are part and parcel of the broader legal question," citing Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. ___ (2015) (slip op., at 6-7).  As the Court decided in Markman, the "better positioned" decisionmaker here is the judge.

Justice Thomas writes in his concurring opinion that he believes "physical impossibility" for compliance with state and Federal law should not be the standard for determining that these laws "directly conflict," thus implicating pre-emption.  Rather, he thinks the founders were more concerned with "logical contradiction[s]" in the law, because in some instances it may be physically possible to comply with a Federal law that permits an action that state law prohibits, merely by refraining from the action (reasoning from Wyeth).  Justice Thomas further asserts that mere compliance with FDA regulations and the FDCA does not give Merck (or any drug maker) "an unconditional right to market [a] federally approved drug at all times with the precise label initially approved by the FDA," again citing Wyeth.  Justice Thomas believes that Merck's assertion of "hypothetical future rejections" of their amended label did not constitute a pre-emptive "law" under the Supremacy Clause, and he concludes that "[b]ecause Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law."

Justice Alito's opinion concurring in the judgment emphasizes the "back and forth" between Merck and the agency regarding evidence that Fosamax® treatment was associated with risk of AFFs, and asserts that the majority's pre-emption analysis was "a skewed summary" of the law.  In particular, he believes that enactment of 21 U.S.C. § 355(o)(4)(A), which imposes a duty on the FDA to initiate a label change if presented with new information that supports the change, is something ignored by the Court that should be considered by the Third Circuit on remand.  And on the facts, Justice Alito's opinion states that:

[F]or years the FDA was: aware of this issue, communicating with drug manufacturers, studying all relevant information, and instructing healthcare professionals and patients alike to continue to use Fosamax as directed.  For this reason, the FDA itself, speaking through the Solicitor General, takes the position that the FDA's decision not to require a label change prior to October 2010 reflected the FDA's "determin[ation]" that a new warning "should [not] be included in the labeling of the drug," §355(o)(4)(A).

And this is consistent with Merck's position both below and before the Court.

Merck Sharp & Dohme Corp. v. Albrecht (2019)
Opinion by Justice Breyer, joined by Justices Thomas, Ginsburg, Sotomayor, Kagan, and Gorsuch; concurring opinion by Justice Thomas; opinion concurring in the judgment by Justice Alito, joined by Chief Justice Roberts and Justice Kavanaugh