Background Facts
While on a trip to Delaware, Harold Berk fell out of bed. According to his complaint, he was taken by ambulance to
a hospital owned by Beebe Medical Center, Inc., where an X ray revealed a fractured ankle. Dr. Wilson Choy recommended that Berk be fitted with a protective boot.
The fitting did not go well. Hospital employees forced Berk’s leg into the boot, twisting his fractured ankle. Still,
Dr. Choy did not immediately order another X ray; he told Berk to keep weight off his ankle, proposed a follow-up appointment in two weeks, and sent Berk on his way. At the follow-up, Berk got a second X ray, which showed that his ankle was not just fractured but also severely deformed, requiring surgery.
Berk sued Beebe Medical Center and Dr. Choy (defendants) for medical malpractice under Delaware law. Because Berk and defendants are citizens of different States, Berk could sue in federal court based on diversity jurisdiction.
Under Delaware law, a plaintiff may not sue for medical malpractice unless an affidavit of merit “accompanie[s]” the
complaint. Del. Code, Tit. 18, §6853(a)(1) (2025). The affidavit must be signed by a medical professional, §6853(c),
and it must state that there are “reasonable grounds to believe that there has been health-care medical negligence
committed by each defendant,” §6853(a)(1). A plaintiff with “good cause” may secure a single 60-day extension of time
in which to file the affidavit, ibid., but he must file the extension motion before or when he files the complaint, §6853(a)(2). If an affidavit does not accompany the complaint and the plaintiff has not filed a timely extension motion, then the clerk of court shall “refuse to file the complaint and it shall not be docketed.” §6853(a)(1). The defendants need not take any action with respect to the complaint until 20 days after the affidavit of merit is filed. §6853(a)(4). Upon the defendants’ motion, the court must determine in camera if the affidavit satisfies the statutory requirements. §6853(d).
Attempting to comply with §6853, Berk immediately moved for an extension of time to file an affidavit. The District Court granted Berk’s motion, and Berk tried to track down a doctor willing to provide an affidavit (an ordeal spawning separate litigation). But the clock ran out, and coming up empty-handed, Berk instead filed his medical records under seal. Defendants moved the District Court to review Berk’s submissions in camera to determine whether they complied with §6853. Berk countered that §6853 is not enforceable in federal court because it is displaced by the Federal Rules of Civil Procedure. The District Court disagreed with Berk and dismissed his lawsuit for failure to comply with Delaware’s affidavit law. See 2023 WL 2770573, 1–2 (D Del., Apr. 4, 2023).
Substantive v. Procedural
The United States Court of Appeals for the Third Circuit affirmed, holding that §6853 applies in federal court. See 2024 WL 3534482, *4 (July 25, 2024). The court concluded that the Federal Rules of Civil Procedure are silent as to whether an affidavit must accompany the complaint. Id., at *2–*3. Where the Federal Rules are silent, state law applies if it is substantive. See Erie R. Co. v. Tompkins, 304 U. S. 64, 78 (1938). A state law is substantive if (1) it is outcome determinative, and (2) failing to apply it in federal court would promote forum shopping and the inequitable administration of the law. See Hanna v. Plumer, 380 U. S. 460, 467–469 (1965). After applying this test, the Third Circuit concluded that §6853 is substantive and affirmed the dismissal of Berk’s suit. See 2024 WL 3534482, *3–*4.
United States Supreme Court Opinion
The United States Supreme Court stated in its January 20, 2026 Opinion: “In this case, the disputed question is whether Berk’s lawsuit may be dismissed because his complaint was not accompanied by an expert affidavit. Rule 8 gives the answer. It prescribes the information a plaintiff must present about the merits of his claim at the outset of litigation: “a short and plain statement of the claim showing that [he] is entitled to relief.” Fed. Rule Civ. Proc. 8(a)(2). By requiring no more than a statement of the claim, Rule 8 establishes “implicitly, but with unmistakable clarity,” Hanna, 380 U. S., at 470, that evidence of the claim is not required. Cf. Burlington Northern R. Co. v. Woods, 480 U. S. 1, 7–8 (1987) (declining to apply a state statute where a Federal Rule “occupies the statute’s field of operation”).”
“Rule 12 reinforces the point. It provides only one ground for dismissal based on the merits: “failure to state a claim
upon which relief can be granted.” Fed. Rule Civ. Proc. 12(b)(6). When evaluating whether a plaintiff has stated a claim, the court cannot consider “matters outside the pleadings.” Rule 12(d). The court instead asks only whether the complaint’s factual allegations, if taken as true, “state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U. S. 544, 570 (2007). A complaint that satisfies this standard is “well-pleaded” and “may proceed even if it strikes a savvy judge that actual proof of the facts alleged is improbable.” Id., at 556.”
“Delaware’s affidavit requirement is at odds with Rule 8 because it demands more: A medical malpractice suit cannot proceed “unless the complaint is accompanied by . . . [a]n affidavit of merit.” §6853(a)(1). Under Rule 8, factual allegations are sufficient, but under the Delaware law, the plaintiff needs evidence too … the two rules thus give different answers to the question whether Berk’s complaint can be dismissed as insufficient because it was unaccompanied by an affidavit.”
“[T]he state law and the Federal Rule address the same issue: the information that a plaintiff must provide about the merits of his claim at the outset of litigation. Describing the affidavit requirement as a “preconditio[n] to proceeding” does not magically dispel the conflict.”
“Because Rule 8 and §6853 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. 28 U. S. C. §2072(b) … For purposes of the
Rules Enabling Act, we use a modest test: whether the Federal Rule “really regulates procedure” … Rule 8 “really regulates procedure.” Sibbach, 312 U. S., at 14. 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” … we underscore that “the substantive nature of [a state] law, or its substantive purpose, makes no difference.” Shady Grove, 559 U. S., at 409 (plurality opinion). To determine whether a Rule is valid under the Rules Enabling Act, the only question is whether it “really regulates procedure.” Sibbach, 312 U. S., at 14. Rule 8 does, so it governs, and Delaware’s affidavit law does not apply in federal court.”
“The judgment of the Court of Appeals is reversed, and the case is remanded for further proceedings consistent with
this opinion.”
Source Berk v. Choy, 607 U. S. __ (2026).
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