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MEDICAL MALPRACTICE – CERTIFICATE OF MERIT – FEDERAL COURT – JURISDICTION

Berk v. Choy, 2026 U.S. LEXIS 497 (January 20, 2026) U.S. Supreme Court Judges, Barrett & Jackson.

Reversed and remanded. Judges: BARRETT, J., delivered the opinion of the Court, in which ROBERTS, C. J., and THOMAS, ALITO, SOTOMAYOR, KAGAN, GORSUCH, and KAVANAUGH, JJ., joined. JACKSON, J., filed an opinion concurring in the judgment.

JUSTICE BARRETT delivered the opinion of the Court.

The cost of malpractice insurance for doctors and hospitals has significantly increased in some areas of the country. In response, several States have imposed a screening mechanism on malpractice suits, requiring plaintiffs to submit an affidavit from a medical professional attesting to the suit’s merit. We consider whether Delaware’s affidavit requirement applies in federal court and hold that it does not.

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 (whom we will call 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).

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 U.S. Dist. LEXIS 58927, 2023 WL 2770573, *1-*2 (D Del., Apr. 4, 2023).

The Third Circuit affirmed, holding that §6853 applies in federal court. See 2024 U.S. App. LEXIS 18336, 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. 2024 U.S. App. LEXIS 18336, [WL] 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, 58 S. Ct. 817, 82 L. Ed. 1188 (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, 85 S. Ct. 1136, 14 L. Ed. 2d 8 (1965). After applying this test, the Third Circuit concluded that §6853 is substantive and affirmed the dismissal of Berk’s suit. See 2024 U.S. App. LEXIS 18336, 2024 WL 3534482, *3-*4.

State-law claims are usually brought in state court. But if the parties are citizens of different States and the amount in controversy exceeds a certain threshold, a plaintiff may choose to sue in federal court. 28 U. S. C. §1332. In that event, the federal court faces a choice-of-law problem: whether to apply state or federal law. The Rules of Decision Act directs federal courts to apply state substantive law, leaving federal law to cover the rest. §1652. Following that direction is harder than it looks, because determining whether a state law is substantive requires a court to enter “Erie’s murky waters.” Shady Grove Orthopedic Associates, P. A. v. Allstate Ins. Co., 559 U. S. 393, 398, 130 S. Ct. 1431, 176 L. Ed. 2d 311 (2010).

Yet when a Federal Rule of Civil [*8] 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].” §1652. 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. §2072(a); see also Fed. Rule Civ. Proc. 1 (“These rules govern the procedure in all civil actions and proceedings in the United States district courts . . .”). Thus, a valid Rule of Civil Procedure displaces contrary state law even if the state law would qualify as substantive under Erie’s test. See Hanna, 380 U. S., at 469-474, 85 S. Ct. 1136, 14 L. Ed. 2d 8.

In this case, the disputed question is whether Berk’s lawsuit may be dismissed because his complaint was not accompanied by an expert affidavit. 1 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, 85 S. Ct. 1136, 14 L. Ed. 2d 8, that evidence of the claim is not required. Cf. Burlington Northern R. Co. v. Woods, 480 U. S. 1, 7-8, 107 S. Ct. 967, 94 L. Ed. 2d 1 (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, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (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, 127 S. Ct. 1955, 167 L. Ed. 2d 929.

By design, this system of pleading makes it relatively easy for plaintiffs to subject defendants to discovery—even for claims that are likely to fail. To protect defendants from this burden, lower federal courts have sometimes tried to require more information for certain kinds of claims: 42 U. S. C. §1983 actions against municipalities, Leatherman v. Tarrant County Narcotics Intelligence and Coordination Unit, 507 U. S. 163, 113 S. Ct. 1160, 122 L. Ed. 2d 517 (1993); employment discrimination suits, Swierkiewicz v. Sorema N. A., 534 U. S. 506, 122 S. Ct. 992, 152 L. Ed. 2d 1 (2002); and prisoner suits, Jones v. Bock, 549 U. S. 199, 127 S. Ct. 910, 166 L. Ed. 2d 798 (2007). We have consistently rejected such efforts. As we explained in Leatherman—which dealt with a demand that plaintiffs plead certain §1983 claims with added specificity—Rule 8(a)(2) requires “only” a “‘short and plain statement of the claim.’” 507 U. S., at 165, 168 (quoting Rule 8(a)(2)). Unless the Federal Rules single out a claim for special treatment, see e.g., Fed. Rule Civ. Proc. 9, Rule 8 sets a ceiling on the information that plaintiffs can be required to provide about the merits of their claims.

Perhaps recognizing this, defendants devote most of their energy to arguing that the Federal Rules contain a loophole. According to defendants, a proviso tucked into Rule 11 makes state affidavit laws applicable in federal court even if they conflict with other Federal Rules. Rule 11 provides that “[u]nless a rule or statute specifically states otherwise, a pleading need not be verified or accompanied by an affidavit.” Fed. Rule Civ. Proc. 11(a). Defendants argue that §6853 is a “statute [that] specifically states otherwise,” ibid., and it therefore applies in federal court regardless of whether it conflicts with other Federal Rules.

Even if Rule 11 incorporates some state affidavit laws, it does not incorporate this one. Rule 11 governs the conduct of those who practice before courts: the “attorney of record” or the “party personally if the party is unrepresented.” Ibid. It requires the attorney or pro se party to certify, after “reasonable” inquiry, that the legal and factual representations made to the court are warranted. Rule 11(b). The sentence on which defendants rely simply “acknowledges” that although Rule 11 generally puts the onus on the attorney or pro se party to vouch for representations, “in some situations represented parties are required by rule or statute to verify pleadings or sign affidavits.” Business Guides, Inc. v. Chromatic Communications Enterprises, Inc., 498 U. S. 533, 542, 111 S. Ct. 922, 112 L. Ed. 2d 1140 (1991) (emphasis added); see, e.g., Fed. Rule Civ. Proc. 23.1 (requiring complaints in shareholder derivative actions to be verified). The sentence has nothing to do with affidavits from third parties. Accordingly, Rule 11 does not shield Delaware’s law from displacement by Rule 8.

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) (“Such rules shall not abridge, enlarge or modify any substantive right”). The line between substance and procedure is hazy, and we draw it differently in different contexts. See Hanna, 380 U. S., at 471, 85 S. Ct. 1136, 14 L. Ed. 2d 8 (“The line between ‘substance’ and ‘procedure’ shifts as the legal context changes”). For purposes of the Rules Enabling Act, we use a modest test: whether the Federal Rule “really [*14] regulates procedure.” Sibbach v. Wilson & Co., 312 U. S. 1, 14, 61 S. Ct. 422, 85 L. Ed. 479 (1941). Or put differently, “[w]hat matters is what the Rule itself regulates: If it governs only ‘the manner and the means’ by which the litigants’ rights are ‘enforced,’ it is valid.” Shady Grove, 559 U. S., at 407, 130 S. Ct. 1431, 176 L. Ed. 2d 311 (plurality opinion) (quoting Mississippi Publishing Corp. v. Murphree, 326 U. S. 438, 446, 66 S. Ct. 242, 90 L. Ed. 185 (1946)).

Rule 8 “really regulates procedure.” Sibbach, 312 U. S., at 14, 61 S. Ct. 422, 85 L. Ed. 479. 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.” Shady Grove, 559 U. S., at 407-408, 130 S. Ct. 1431, 176 L. Ed. 2d 311 (plurality opinion).

The judgment of the Court of Appeals is reversed, and the case is remanded for further proceedings consistent with this opinion.

JUSTICE JACKSON, concurring in the judgment.

In short, our precedents establish that when a state law and a valid Federal Rule conflict— because they answer the same procedural question—the State’s requirement is inapplicable in federal court. Because §6853 answers the same question about what is required to commence a medical malpractice action as the unquestionably valid Rule 3, Delaware’s law must give way. See Hanna, 380 U. S., at 469-474.

• District Court and Third Circuit said that Delaware Certificate of Merit applies in a medical malpractice case which is in Federal Court because of a diversity of citizenship.
• The U.S. Supreme Court reversed.
• The plaintiff did try to comply with the Delaware Certificate of Merit rule but “the clock ran out” and hence Berk filed his medical records under seal.
• Berk argued that the Delaware Certificate of Merit rule was not enforceable in Federal Court.
• The case was reversed because Rule 8 prescribes information a plaintiff must present about the merits of this claim at the outset of the litigation. Rule 8 does not require anything more than a short and plain statement.
• Rule 12 reinforces the point. It provides only one ground for dismissal based on the merits and that is a failure to state a claim upon which relief can be granted
• It should be relatively easy for plaintiffs to subject defendants to discovery, even for claims that are likely to fail.
• The courts, however, sometimes try to require more information for certain kinds of claims, such as discrimination cases, prisoner suits and the United States Supreme Court has consistently rejected such efforts.
• Defendants attempt a workaround to rewrite Delaware law, and they argue that the Federal Rules contain a loophole.
• Defendants argue that Rule 11 makes affidavit laws applicable in Federal Court, even if they conflict with other Federal Rules.
• Even if Rule 11 incorporates state affidavit laws, it does not incorporate this one.
• Rule 8 and Rule of Decision 6853 provide the same answer. Rule 8 governs so long as it is valid under the Rules Enabling Act which requires a Federal Rules be procedural rather than substantive.
• Erie R. Co. v. Tompkins works in coordination with the Rules Enabling Act.
• The judgment of the Court of Appeals is reversed.
• Justice Jackson concurred in the judgment.