February 6, 2026 | Volume 33, Issue 6
This Report summarizes opinions issued on January 20 and 26, 2026 (Part I); and cases granted review on January 16 and 26, 2026 (Part II).
Opinions
Berk v. Choy, 24-440.
Without dissent, the Court held that a Delaware law requiring plaintiffs suing for medical malpractice to include an “affidavit of merit” with their complaint does not apply in federal court. Relying on diversity jurisdiction, Harold Berk sued Dr. Wilson Choy and Beebe Medical Center for medical malpractice under Delaware law in federal district court. He alleged that he injured his ankle while on a trip to Delaware, and that this injury was exacerbated by Dr. Choy and hospital staff. Delaware law requires a plaintiff to obtain and attach to his complaint an “affidavit of merit” executed by a medical professional, attesting that the suit has merit. Berk’s complaint did not attach the required affidavit, so the district court dismissed his lawsuit. The Third Circuit affirmed. It reasoned that the Federal Rules of Civil Procedure are silent as to whether an affidavit must accompany a complaint, and that under Erie R. Co. v. Tompkins, 304 U.S. 64 (1938), where the Federal Rules are silent, state law applies if it is substantive. The court then concluded that Delaware’s affidavit law is substantive and thus applies in federal court. In an opinion by Justice Barrett, the Court reversed and remanded.
The Court first looked to the Rules of Decision Act, which requires federal courts to apply state substantive law, “leaving federal law to cover the rest.” That leads to complex inquiries into whether a state law is substantive in nature. But, noted the Court, “when a Federal Rule of Civil Procedure is on point, a federal court bypasses Erie’s inquiry altogether. That is because the Rules of Decision Act dictates that state substantive law must yield if the Constitution, a treaty, or a statute ‘otherwise require[s] or provide[s].’ And the Rules Enabling Act, which authorizes the Supreme Court to adopt uniform rules of procedure for district courts, provides for the application of federal law. Thus, a valid Rule of Civil Procedure displaces contrary state law even if the state law would qualify as substantive under Erie’s test.” In other words, if a Federal Rule “answers the same question” as a state law, it displaces state law unless it exceeds statutory authorization or Congress’ rulemaking power.
Applying this framework, the Court concluded that Federal Rule of Civil Procedure 8 conflicts with and controls over Delaware’s affidavit rule. Rule 8 and Delaware’s affidavit law “ask the same question” because they both control the information a plaintiff must present “about the merits of his claim at the outset of litigation.” Yet whereas Rule 8 requires only “a short and plain statement of the claim showing that [he] is entitled to relief,” Delaware’s affidavit law “demands more: A medical malpractice suit cannot proceed ‘unless the complaint is accompanied by . . . [a]n affidavit of merit.’ Under Rule 8, factual allegations are sufficient, but under the Delaware law, the plaintiff needs evidence too.” (Citation omitted.) The Court added that Delaware’s affidavit law also conflicts with Rule 12, which requires courts to consider only the allegations in a complaint when ruling on a motion to dismiss, rather than extraneous material like Delaware’s “affidavit of merit.”
Respondents (defendants) argued that Rule 11 makes Delaware’s affidavit law applicable in federal court because Rule 11 states that, “unless a rule or statute specifically states otherwise, a pleading need not be verified or accompanied by an affidavit.” And here, Delaware’s affidavit law “specifically states otherwise.” The Court rejected this argument, reasoning that this language has nothing to do with third-party representations or affidavits, nor is it intended to incorporate all state law. Rather, this text from Rule 11 pertains to attorneys or pro se parties when a rule or statute requires a complaint to be verified by a represented party.
Finally, the Court explained that “[b]ecause Rule 8 and [the Delaware affidavit law] answer the same question, Rule 8 governs so long as it is valid under the Rules Enabling Act, which requires that Federal Rules be procedural rather than substantive.” The Court stated that “[f]or purposes of the Rules Enabling Act, we use a modest test: whether the Federal Rule ‘really regulates procedure.’” The Court then ruled that “Rule 8 ‘really regulates procedure.’ It determines what plaintiffs must present to the court about their claims at the outset of litigation. Although the Rule may have some ‘practical effect on the parties’ rights,’ it regulates ‘only the process for enforcing those rights,’ not ‘the rights themselves, the available remedies, or the rules of decision.’” (Citations omitted.) The Court rejected respondents’ contention that the “Rules Enabling Act requires asking a second question: whether the displaced state law is substantive.” The Court said it “rejected that approach eight decades ago and decline[d] to reconsider it now. On the contrary, we underscore that ‘the substantive nature of [a state] law, or its substantive purpose, makes no difference.’” (Citations omitted.)
Justice Jackson filed an opinion concurring in the judgment. In her view, Delaware’s affidavit law conflicts with Rules 3 and 12 rather than Rule 8. Justice Jackson focused on language in Delaware’s affidavit law providing that a case may not even be docketed unless the complaint is accompanied by the affidavit. According to Justice Jackson, this causes Delaware’s affidavit law to conflict with Rule 3 rather than Rule 8 because Rule 3 provides what is required to commence and docket an action in federal court, whereas Rule 8 controls only what must be in a complaint. Justice Jackson also agreed that Delaware’s affidavit law is incompatible with Rule 12’s directive to consider only the allegations in a complaint when deciding a motion to dismiss. But, she said, this demonstrates another problem with the majority’s comparison to Rule 8: the majority assumes that Delaware’s affidavit law requires “matters outside the pleadings” (for Rule 12-conflict purposes) but also assumes the affidavit to be part of the pleadings (for Rule 8-conflict purposes)—and both cannot be true.
Klein v. Martin, 25-51.
In an 8-1 per curiam opinion, the Court summarily reversed a Fourth Circuit judgment that had granted habeas relief based on a Brady claim. Charles Martin was convicted of attempted murder in Maryland state court after witness testimony and DNA evidence tied him to a homemade gun silencer (made from a modified Gatorade bottle) found at the scene of a shooting. The state also presented evidence suggesting that Martin had a motive for aiding the attempted murder based on his relationship with the victim, that he had texted the victim that day to discern when she would be home, that he owned the type of gun seemingly used in the shooting, and that he left a friend’s house shortly before the shooting and, upon his return, asked the friend to dispose of a brown paper bag. The gun used in the shooting was never found. The jury found Martin guilty as an accessory before the fact. His conviction was affirmed on direct appeal. Martin sought post-conviction relief in state court, arguing that the state failed to disclose a forensic report that tended to discredit a witness’ (Carter’s) testimony that Martin had used his laptop to research gun silencers not long before the shooting. The postconviction court agreed and granted Martin a new trial under Brady v. Maryland, 373 U.S. 83 (1963). The Maryland Court of Special Appeals reversed, concluding that even if the forensic report completely discredited that witness, there was no “reasonable probability that the result of [the] trial would have been different.”
A federal district court granted Martin federal habeas relief, and a divided Fourth Circuit panel affirmed. The Fourth Circuit majority concluded that the Maryland Court of Special Appeals “had not actually done what it said it did—had not held that there was no ‘reasonable probability’ that the disclosure of the forensic report would have changed the verdict—but instead had applied the sufficiency-of-the-evidence rule [] condemned in Kyles [v. Whitley, 514 U.S. 419 (1995)].” The Fourth Circuit further concluded that the state court’s discussion of the evidence lacked nuance, and its decision omitted or misconstrued certain evidence such that no fairminded jurist could agree with it. Through a per curiam opinion, the Court reversed and remanded.
The Court noted that AEDPA “sharply limits federal review of habeas claims raised by state prisoners.” Section 2254(d) requires federal habeas courts to defer to state courts’ merits decisions, even if the state court did not make detailed findings on the evidence before it; and it requires a state prisoner to show that the court’s error was so great that “every fairminded jurist would disagree” with the decision. With these principles in mind, the Court held that the Fourth Circuit erred in two ways. “First, it grounded its holding that the state appellate court applied the wrong legal rule on its conclusion that the state court had not actually applied the materiality test that it clearly invoked. Second, it erred in holding that no fairminded jurist could find the forensic report on the computer to be immaterial.”
On the former point, the Court found that the Maryland Court of Special Appeals correctly applied the “reasonable probability” test, and did not apply a sufficiency-of-the-evidence test. “The state court accurately summarized our Brady precedents, correctly stated the governing rule on materiality, and stated unequivocally that its decision was based on that rule. . . . [B]ased on its review of the ‘entire record,’ the court found that the evidence ‘linking’ Martin to the crime was so ‘strong’ that there was no ‘reasonable probability that the result of his trial would have been different.’” The Court ruled that the Fourth Circuit, in ruling otherwise, defied AEDPA, “which bars federal courts from imposing opinion-writing standards on state courts and demands that the relevant state-court decision be given the ‘benefit of the doubt.’”
The Court next held that “[t]he panel majority also went astray in holding that every fairminded jurist would find that the undisclosed forensic report about Martin’s laptop was material. On the contrary, the record contains ‘strong support’ for the state court’s conclusion that Martin ‘would have been convicted’ even if the forensic report ‘severely impeached’ Carter.” The Court walked through all the evidence supporting Martin’s guilt. The Court faulted the Fourth Circuit for suggesting that the Brady evidence would have supported the defense’s theory that the Gatorade “bottle was a device used to smoke marijuana, not a silencer.” “[A] fairminded jurist could find that theory farfetched.” The Court then walked through the rest of the Fourth Circuit’s reasoning, rejecting it at every turn. “Based on all the evidence, a fairminded jurist could easily conclude that disclosure of the forensic report on the laptop would not have made a difference.”
Justice Jackson would have denied the petition for a writ of certiorari.
Ellingburg v. United States, 24-482.
The Court unanimously held that restitution under the Mandatory Victims Restitution Act (MVRA) is criminal punishment for purposes of the Ex Post Facto Clause. Under the MVRA, defendants convicted of certain crimes must pay monetary restitution to victims. The MVRA went into effect on April 24, 1996. Later in 1996, Ellingburg was sentenced and ordered to pay $7,567.25 in restitution for a federal crime he committed before the MVRA was enacted. Ellingburg mounted an Ex Post Facto Clause challenge to his continued restitution obligation. The Eighth Circuit declined to disturb the restitution order because it concluded that restitution is not criminal punishment under the Ex Post Facto Clause. The United States did not defend that ruling, prompting the Court to appoint an amicus curiae to defend that court’s judgment. In an opinion by Justice Kavanaugh, the Court reversed and remanded.
The Court began by noting that whether a law violates the Ex Post Facto Clause turns on whether, as a matter of statutory construction, the law imposes a criminal sanction, as opposed to a civil remedy. The Court then reviewed the text and structure of the MVRA, and concluded that “[r]estitution under the MVRA is plainly criminal punishment for purposes of the Ex Post Facto Clause.” First, noted the Court, the MVRA labels restitution a “penalty” for a criminal “offense.” 18 U.S.C. §3663A(a)(1). Next, a court may impose restitution under the MVRA only on a criminal defendant convicted of a qualifying federal crime. Restitution is ordered at sentencing along with other punishments like imprisonment or fines. For certain offenses, such as misdemeanors, restitution could be the only punishment imposed. The Court acknowledged that the MVRA provides for some participation by victims, but concluded that restitution does not resemble a civil remedy because victims cannot initiate or settle the restitution process. Rather, the Government is the adverse party at sentencing. The Court added that refusal to pay restitution may result in imprisonment. And the MVRA is codified in the criminal code. Thus, “[w]hen viewed as a whole,” “the MVRA makes abundantly clear that restitution is criminal punishment.” The Court cited precedents that understood restitution to be criminal punishment and distinguished Smith v. Doe, 538 U.S. 84 (2003), which held that sex offender registration was a civil remedy.
Justice Thomas filed a concurring opinion, which Justice Gorsuch joined. Justice Thomas suggested that the Court should reject the modern Ex Post Facto Clause framework that asks whether a law is criminal or civil. Instead, he said, the Court should recognize that under Calder v. Bull, 386, 389-91 (1798), when interpreted properly and in accordance with English Common Law, the Ex Post Facto Clause prohibits retroactive laws that impose a “coercive sanction—meaning a traditional deprivation of life, liberty, or property—redressing [a] public wrong.” That inquiry most often comes down to “who enforces the law.” For example, here, the MVRA was subject to the Ex Post Facto Clause “because it was enforced against Ellingburg by the United States, not by the First Union National Bank, whose private rights Ellingburg violated when he robbed it.” Interpreting the Ex Post Facto Clause in this way would harmonize it with its historical purpose, simplify its application, and secure its protections “in a wide range of contexts” including civil proceedings seeking fines for public offenses and enforcement actions brought by administrative agencies.
Coney Island Auto Parts Unlimited, Inc. v. Burton, 24-808.
The Court unanimously held that Federal Rule of Civil Procedure 61(c)(1)’s requirement to file a motion for relief from a judgment “within a reasonable time” applies to a motion for relief from an allegedly void judgment under Rule 60(b)(4). After Coney Island Auto Parts filed for bankruptcy, Vista-Pro Automotive initiated adversarial proceedings against Coney Island to collect unpaid invoices. Coney Island did not respond, and the bankruptcy court entered a default judgment. About a year later, Coney Island received a letter from Vista-Pro’s trustee again notifying it of the judgment. Six years later, a marshal seized funds from Coney Island’s bank account to satisfy the judgment. Coney Island filed a motion to vacate the judgment under Rule 60(b)(4), arguing that Vista-Pro did not make proper service, the judgment was therefore void, and a void judgment can never be valid regardless of the time passed because it was always legally null. The bankruptcy court denied the motion, holding that Coney Island failed to file its motion within a reasonable time. The district court and Sixth Circuit affirmed, reasoning that Rule 60 plainly requires that a motion for relief from a void judgment be made within a reasonable time of the judgment, and Coney Island’s six-year delay was unreasonable. In an opinion by Justice Alito, the Court affirmed.
The Court relied on the plain language of Rule 60(c)(1), which requires that certain motions for relief under Rule 60(b) be made “within a reasonable time.” Because a motion for relief from a void judgment is made under Rule 60(b)(4), the language of Rule 60(c)(1) applies. The Court also noted that Rule 60(c)(1) imposes an express 1-year time limit to file motions based on mistake, new evidence, or fraud. “[O]ne would expect Rule 60 to include an analogous provision if a special, unlimited-time principle applied to motions alleging voidness.” The Court was unconvinced by Coney Island’s contention that the passage of time cannot cure a void judgment. The Court reasoned that this principle holds true for most legal errors, yet statutes and rules governing those errors routinely limit the time by which a party can seek relief. The Court also rejected Coney Island’s argument that courts have not historically enforced time limits to challenge a void judgment. The Court cited cases showing that courts have often enforced time limits or other procedural barriers to reconsidering an allegedly void judgment. And even if that was not the case, a rule’s text and structure take priority over historical practice.
Finally, the Court explained that a party in Coney Island’s position needs to present a cogent constitutional challenge under the Due Process Clause if it wants the Court to depart from a rule or statute—which Coney Island did not do. The Court further suggested that such a due process challenge would be unlikely to succeed. The Court reasoned that allowing parties to perpetually challenge judgments would undermine jurisdictional rules such as those requiring time limits to file a notice of appeal or petition for a writ of certiorari.
Justice Sotomayor concurred in the judgment. She opined that it was unnecessary for the majority to consider the validity of a due process challenge to Rule 60’s time limits because Coney Island did not make a due process argument, lower courts did not rule on any due process argument, and this case does not present unusual circumstances that could justify ruling on an unpresented issue.
Cases Granted Review
Chatrie v. United States, 25-112.
At issue is whether the execution of a geofence warrant violated the Fourth Amendment. A geofence warrant allows law enforcement to obtain from cell service providers the identities of cell phone users within a particular location and window of time. Okello Chatrie was convicted of armed robbery based on evidence obtained from a geofence warrant. Law enforcement served a geofence warrant on Google and obtained the anonymized location data from devices within 150 meters of a bank within one hour of a robbery. Under the same warrant, law enforcement gathered information about the movement of certain devices within a two-hour period and ultimately the names of individuals associated with three devices. One of these devices belonged to Chatrie. Chatrie moved to suppress the evidence obtained by the geofence warrant. The district court found the warrant lacked probable cause, but denied the motion to suppress under the good-faith exception. A divided Fourth Circuit panel affirmed, with the majority concluding that the government had not conducted a search under the Fourth Amendment because Chatrie had no reasonable expectation of privacy over location data that he voluntarily shared with Google. 107 F. 4th 319. Upon rehearing en banc, the Fourth Circuit affirmed by a 7-7 vote in a one-sentence per curiam opinion; nine judges authored separate opinions. 136 F. 4th 100.
Chatrie argues that the execution of the geofence warrant was an unconstitutional search. In Carpenter v. United States, 585 U.S. 296 (2018), the Court held that individuals have a reasonable expectation of privacy in their cell-site location information (CSLI). Chatrie argues that “Location History offers even more precise tracking than CSLI and provides a detailed map of all of a person’s movements”; and, like CSLI, it is “easy and cheap to obtain.” Also, under a “property-based approach,” “Location History belongs to users, not Google.” Chatrie disputes that sharing his location data with Google was meaningfully voluntary. He therefore maintains that the geofence warrant constituted a search, yet geofence warrants do not comply with the Fourth Amendment’s particularity requirement. Chatrie relies on a Fifth Circuit decision holding that geofence warrants are per se not particularized because “law enforcement cannot obtain its requested location data unless Google searches through the entirety of its Sensorvault—all 592 million individual accounts—for all of their locations at a given point in time.” Chatrie further argues that, “[e]ven assuming, contrary to the Fifth Circuit’s view, that geofence warrants are sometimes constitutional, the execution of the warrant violated the Fourth Amendment here. The government should have obtained a warrant after Google returned its list. Obtaining a warrant at the first step was insufficient under the Fourth Amendment to justify the government’s winnowing process and ultimate unmasking of petitioner’s identity without further court review.”
The United States responds that Chatrie “relinquish[ed] any privacy right” when he “opt[ed] in to the Location History service.” The government distinguishes Carpenter because the CSLI showed “seven days or more of cellphone location information.” In contrast, the location history showed only that Chatrie “had been at the credit union at the time of the robbery,” much like “tire tracks” or “boot prints” and “time-boxed” information about Chatrie’s whereabouts before and after the robbery. The government disagrees that Chatrie had an ownership interest in his location history. Finally, it says, geofence warrants are not per se unconstitutional as failing the particularity requirement. Although Google “cull[s] information from a large database” to respond to a warrant, “the Fourth Amendment’s particularity requirement focuses on the information the government itself gets to view or employ in its investigation, not the information exposed to private actors that is never shown to the government.”
Monsanto Co. v. Durnell, 24-1068.
The Court will consider “[w]hether the Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA] preempts a label-based failure-to-warn claim where EPA has not required the warning.” Congress enacted FIFRA to regulate the use, sale, and labeling of pesticides. Under FIFRA, manufacturers must “register” their products with EPA, which requires them to show that the product does not create an unreasonable risk of adverse effects on human health and environment. FIFRA also prohibits manufacturers from “misbranding” products. A pesticide is “misbranded” if its label contains a statement that is “false or misleading in particular” or “does not contain a warning or caution statement which may be necessary and if complied with [] . . . is adequate to protect health and the environment.” Section 136v(b) of FIFRA preempts all state “requirements for labeling or packaging” that are “in addition to or different from those required” under FIFRA.
Plaintiff John Durnell sued Monsanto in Missouri state court alleging that exposure to Roundup caused him to develop non-Hodgkin’s lymphoma. The jury found Monsanto liable for failing to warn Durnell of cancer risk. Monsanto appealed to the Missouri Court of Appeals, arguing that any duty to warn under state law is preempted by §136v(b). Monsanto submitted that EPA has not historically required a cancer warning label for Roundup because EPA does not consider glyphosate—a chemical contained Roundup—to pose “an unreasonable risk of adverse effects on human health and environment.” Durnell’s claim would thus require Monsanto to carry a label “in addition to or different from” the one approved by EPA, contrary to §136v(b). The Missouri Court of Appeals rejected Monsanto’s argument, relying on opinions from other state appellate courts and the Ninth and Eleventh Circuits considering the same issue. Those courts reasoned that FIFRA’s prohibition of misbranding is consistent with state common law imposing a duty to warn of cancer risks, and thus any warning required by state law is not “in addition to or different from” labeling required by the EPA. In other words, EPA registration is conditioned on the product not being misbranded, and a product is inherently misbranded if it does indeed cause cancer yet carries no warning. These courts also reasoned that EPA’s registration of a product is not conclusive of FIFRA compliance. Put differently, just because EPA does not require a cancer risk label does not mean a product cannot still be “misbranded” under FIFRA.
In its petition, Monsanto insists that glyphosate does not cause cancer, as evidenced (it says) by studies it previously submitted to EPA and EPA’s decision not to require a cancer warning for Roundup. Monsanto also argues there is a clear circuit split on the preemption issue, citing a favorable ruling from the Third Circuit. Reiterating the Third Circuit’s reasoning, Monsanto maintains that state law cannot survive preemption simply because its standard of liability is equivalent to FIFRA’s statutory definition of “misbranding.” If this was the case, §136v(b) would be superfluous because states could enact their own warning label requirements regardless of FIFRA or EPA’s determinations, defeating the purpose of having a uniform federal standard for pesticide regulation. In Monsanto’s view, FIFRA preempts Missouri state law because EPA’s registration of Roundup without requiring a cancer warning confirms that EPA does not consider Roundup to be harmful to human health. Monsanto should have no affirmative duty under state law to warn of a risk that the federal government itself does not recognize. Monsanto also argues that the plain language of §136v(b) makes clear that state law cannot require more labeling than the EPA requires, yet Durnell’s suit does just that.
In his response, Durnell argues that EPA’s registration of a pesticide does not preclude a claim for misbranding under FIFRA. In support, Durnell relies on recent cases suggesting that even if a label is determined by EPA to be “adequate to protect health” based on materials submitted by the manufacturer, other information such as a pesticide’s marketing or a subsequent incident involving a pesticide’s toxic effects can demonstrate misbranding. Durnell also argues that FIFRA’s misbranding provisions are not meaningfully different from Missouri’s common law duty to warn. Durnell disputes Monsanto’s assertion that EPA does not consider glyphosate to be dangerous, pointing to scientific studies EPA did not consider when it last registered Roundup. With respect to express preemption, Durnell maintains that FIFRA allows states to regulate even EPA-registered pesticides; Congress thus could not have intended §136v(b) to give manufacturers broad immunity from many forms of state tort liability.
Salazar v. Paramount Global, 25-459.
The Video Privacy Protection Act (VPPA) provides a private right of action against a “video tape service provider” that, without consent, “knowingly discloses, to any person, personally identifiable information concerning any consumer of such provider.” 18 U.S.C. §2710(b)(1). The term “consumer” is defined as “any renter, purchaser, or subscriber of goods or services from a video tape service provider.” §2710(a)(1) (emphasis added). The Court will decide whether the phrase “goods or services from a video tape service provider” refers to all goods and services or only audiovisual goods or services.
Michael Salazar filed a complaint alleging that he subscribed to an online newsletter from 247Sports.com, owned by Paramount, and that he “used his 247Sports.com digital subscription to view Video Media” “while logged into his Facebook account.” In turn, Paramount shared his Facebook ID and video watch history with Facebook without his consent. The district court dismissed the complaint. The court concluded that Salazar was not a “consumer” under the VPPA because he did not access audiovisual content through the 247Sports.com newsletter. A divided panel of the Sixth Circuit affirmed, noting that the VPPA’s definition of “consumer” does not include consumers of all “goods or services,” but only those “from a video tape service provider.” 133 F.4th 642. Thus, the court concluded that a “consumer” is a person who subscribes to “goods or services’ in the nature of ‘video cassette tapes or similar audio visual materials.’”
In his petition, Salazar argues that the Sixth Circuit’s approach diverges from that of the Second and Seventh Circuits, and that it contravenes the VPPA’s text, context, and structure. As noted, the VPPA defines the term “consumer” as “any renter, purchaser, or subscriber of goods or services from a video tape service provider.” §2710(a)(1). And a “video tape service provider” is a person engaged in the “rental, sale, or delivery of prerecorded video cassette tapes or similar audiovisual materials.” §2710(a)(4). Salazar argues that §2710(a)(1) employs the “unmodified phrase” “goods or services.” Adding the word “audiovisual” changes its ordinary meaning. He also argues that the Sixth Circuit’s view cannot be harmonized with §2710(a)(3)’s narrower definition of “personally identifiable information” as including “information which identifies a person as having requested or obtained specific video materials or services.” He says that the Sixth Circuit, by “read[ing] ‘goods or services’ in Section 2710(a)(1) to mean the same thing as ‘video materials or services’ in Section 2710(a)(3)[,] renders the video-specific modifier in the latter provision superfluous.” Salazar suggests that Congress intentionally defined “consumer” more broadly to include persons who may or may not have handed over “personally identifiable information.”
Paramount acknowledges the circuit split but argues that it is illusory because Salazar’s claims would fail on other grounds in those circuits. On the merits, Paramount responds that “247Sports is a news website focused on college sports,” and that “[a]ll Salazar allegedly did was sign up for a free, written email newsletter.” A person who “watches free online video content” and subscribes to a written newsletter is not a “consumer” under the VPPA. Paramount insists that the VPPA’s title, its heading (“Wrongful disclosure of video tape rental or sale records”), and the definition of “personally identifiable information,” which covers “specific video materials,” suggest that the consumer must subscribe to audiovisual content. Paramount adds that as a general matter, courts should apply the VPPA narrowly given its substantial penalty provision and its authorization of punitive damages. Paramount argues that a broader application would not be administrable.
Anderson v. Intel Corp. Investment Policy Committee, 25-498.
At issue is “whether, for claims predicated on fund underperformance, pleading that an Employee Retirement Income Security Act [(ERISA)] fiduciary failed to use the requisite ‘care, skill, prudence, or diligence’ under the circumstances and thus breached ERISA’s duty of prudence when investing plan assets requires alleging a ‘meaningful benchmark.’” Winston Anderson brought a putative class action alleging that Intel’s fiduciaries breached ERISA’s duty of prudence by investing retirement plan assets in hedge funds and private equity funds that charge high fees and allegedly performed poorly, costing plan participants hundreds of millions of dollars. The district court dismissed the complaint for failure to state a claim. As relevant here, the court found that the allegations of poor performance and excessive fees were not plausible because they failed to allege “adequate benchmarks against which to compare the Intel Funds.” The Ninth Circuit affirmed. 137 F.4th 1015.
The Ninth Circuit agreed with the district court that Anderson’s claim for breach of the duty of prudence must fail because Anderson “did not plausibly allege that Intel’s funds underperformed other funds with comparable aims.” In other words, he failed to identify a “meaningful benchmark.” The court held that “[t]he need for a relevant comparator with similar objectives—not just a better-performing plan or investment—is implicit in ERISA’s text.” And it held this was so even if the plaintiff alleges that “there are no meaningful comparators for the fiduciaries’ decision” because the fiduciaries’ investment decision “was unusual, if not unparalleled.”
Anderson argues that under Supreme Court precedent, “categorical pleading rules” are inconsistent with the context-specific inquiry ERISA requires. And the Ninth Circuit imposed an impermissible categorical rule when it required Anderson to identify a “meaningful benchmark,” which is not “explicitly require[d]” by ERISA’s text. More broadly, Anderson asserts that “[t]he extratextual ‘meaningful benchmark’ requirement adopted by the Ninth Circuit undercuts ERISA’s role in protecting participants and beneficiaries, and it entirely forecloses relief in circumstances where fiduciaries’ conduct is so beyond the pale that no close comparator even exists.”
Intel responds that the “meaningful benchmark” requirement is not a categorical pleading rule, but “a shorthand for describing the analysis inherent in enforcing the pleading standards of Rule 8(a) and Rule 12(b)(6).” When a plaintiff asks a court to infer that a breach of the duty of prudence occurred because an investment underperformed relative to other funds, it is a “common-sense notion” that “the plaintiff must plead both the existence of a comparator fund and allegations establishing why it is an appropriate comparator.” Doing so is what allows a plaintiff to allege, under the text of ERISA, that a prudent fiduciary “acting in a like capacity . . . in the conduct of an enterprise of a like character and with like aims,” 29 U.S.C. §1104(a)(1)(B), would have acted differently than the defendants. Intel also argues that the Ninth Circuit correctly rejected Anderson’s “novel argument” that there were “no meaningful comparators for the fiduciaries’ decision because Intel’s approach was unusual, if not unparalleled.”
Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., 24-889.
The Court will address whether “accurately calling a generic drug the ‘generic version’ of a branded drug and citing public information about the brand (e.g., annual sales) now exposes a generic drugmaker to potential damages for inducing infringement of patents on ‘any of the [brand’s] approved uses’—even when, as here, the generic drug is labeled only for an unpatented use.” Under 35 U.S.C. §271(b), patentholders may bring a civil claim for induced infringement of a patented use. In the pharmaceutical industry, this statute authorizes a branded drugmaker to sue a generic drugmaker when the generic drugmaker induces a third party (usually a prescribing physician) to infringe on patented uses of a branded drug. To ensure that §271(b) lawsuits do not discourage development or availability of generic drugs, Congress passed the Hatch-Waxman Act. In pertinent part, §355(j)(2)(A)(viii) of the Act authorizes the FDA to approve “skinny labels,” through which generic drugmakers “carve out” patented uses of a branded drug, leaving only instructions to use generic drugs for their unpatented uses.
In this case, Amarin Pharma developed and received a patent to use an icosapent ethyl product, Vascepa, to treat severe hypertriglyceridemia. Hikma Pharmaceuticals began developing its own generic icosapent product during Vascepa’s FDA approval process, but did not receive FDA approval to go to market until Vascepa had already been on the market for some time. Per the Hatch-Waxman Act, Hikma’s generic drug had a skinny label carving out the uses provided in Amarin’s Vascepa patent. After bringing its generic drug to market, Hikma issued press releases referring to its product as a “generic version” of Vascepa. The press releases also referenced therapeutic categories and sales figures for all uses of Vascepa—including Amarin’s patented uses. Amarin sued Hikma in federal court under §271(b), alleging that Hikma induced infringement of Vascepa’s patented uses. Amarin alleged that Hikma’s marketing showed specific intent to encourage prescribing the generic version of Vascepa for indications which Amarin—but not Hikma—received FDA approval, such as severe hypertriglyceridemia indication. The district court granted Hikma’s motion to dismiss, but the Federal Circuit reversed. 104 F.4th 1370.
The Federal Circuit agreed that Hikma’s “label does not, as a matter of law, recommend, encourage, or promote an infringing use.” But it found that the collective circumstances—the combination of pre-market circumstances, the skinny label, and Hikma’s marketing—were adequate to show that induced infringement was at least plausible under the Iqbal/Twombly pleading standard. In reaching this conclusion, the Federal Circuit distinguished prior Hatch-Waxman cases on grounds that none involved facts where a generic drug had both a proper skinny label and marketing like Hikma’s.
In its petition, Hikma argues that the decision below undermines the purpose of the Hatch-Waxman Act—to make generic drugs available for public benefit—by imposing §271(b) liability anytime a drugmaker markets a skinny-labelled generic drug as a “generic version” of a branded drug. Hikma also points to the word “actively” in §271(b), arguing that it requires express encouragement to infringe on a patented use. In other words, if a generic drug has a skinny label and the generic drug has already been brought to market, a branded drugmaker should not be able to prevail in a §271(b) suit unless the generic drug maker is actively and directly encouraging physicians to prescribe generic drugs for patented uses. Hikma argues that its marketing merely listed all the potential uses for generic Vascepa to provide physicians with necessary information about the drug’s uses and effects, and Hikma made no statements encouraging prescription for specific patented uses. In sum, Hikma argues that the Federal Circuit decision creates too low a pleading barrier for §271(b) suits and therefore threatens generic drug competition upon which the U.S. healthcare system relies.
In response, Amarin argues that the Federal Circuit decision is fact-specific and does not disturb settled legal standards regarding §271(b) claims or Rule 12(b)(6) motions to dismiss. Amarin submits that its 52-page complaint alleges a plausible §271(b) claim through the combination of circumstances surrounding Hikma’s development and marketing. Finally, Amarin argues that granting certiorari and ruling for Hikma would allow generic drugmakers to evade §271(b) liability by using the FDA approval process and skinny labels as improper shields for post-market actions that otherwise actively encourage infringing activities. All told, Amarin asks the Court to see this case as a garden-variety §271(b) claim that depends on evidence of collective circumstances rather than any single act of the defendant, as civil claims often do.
NAAG Center for Supreme Court Advocacy Staff
- Dan Schweitzer, Director and Chief Counsel
- Lauren Watford, Supreme Court Fellow
- Alex Tucker, Supreme Court Fellow
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