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BERK v. CHOY et al.

certiorari to the united states court of appeals for the third circuit No. 24–440. Argued October 6, 2025—Decided January 20, 2026 Delaware law provides that a plaintiff may not sue for medical malpractice unless a medical professional attests to the suit's merit in an “affdavit of merit” that “accompanie[s]” the plaintiff 's complaint. Del. Code, Tit. 18, § 6853(a)(1). Petitioner Harold Berk sued Dr. Wilson Choy and Beebe Medical Center in federal court for medical malpractice under Delaware law, but failed to provide the affdavit required by § 6853. Berk argued that § 6853 is not enforceable in federal court because it is displaced by the Federal Rules of Civil Procedure. The District Court dismissed Berk's lawsuit for failure to comply with Delaware's affdavit law. The Third Circuit affrmed.

Held: Delaware's affdavit law does not apply in federal court. Pp. 191–200. (a) When a plaintiff brings a state-law claim in federal court, the 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 unless the Constitution, a treaty, or a statute otherwise requires or provides. 28 U. S. C. § 1652. 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). So, when a valid Federal Rule of Civil Procedure is on point, it displaces contrary state law even if the state law would qualify as substantive under Erie R. Co. v. Tompkins, 304 U. S. 64. The analysis is straightforward: The Court frst asks whether a Federal Rule answers the disputed question. If a Federal Rule does, it governs, unless it “exceeds statutory authorization or Congress's rulemaking power.” Shady Grove Orthopedic Associates, P. A. v. Allstate Ins. Co., 559 U. S. 393, 398. Pp. 191–192.

(b) Here, Rule 8 answers the disputed question whether Berk's lawsuit may be dismissed because his complaint was not accompanied by an affdavit. Rule 8 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 v. Plumer, 380 U. S. 460, 470, that evidence of the claim is not required. Rule 12 reinforces the point by providing only one ground Page Proof Pending Publication for dismissal based on the merits—“failure to state a claim upon which relief can be granted,” Rule 12(b)(6)—and prohibiting courts from considering “matters outside the pleadings” when evaluating whether a plaintiff has stated a claim, 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. Lower federal courts have sometimes tried to demand more information than Rule 8 requires for certain kinds of claims. This Court has consistently rejected such efforts. Dela- ware's law and Rule 8 thus give different answers to the question whether Berk's complaint can be dismissed as insuffcient because it was unaccompanied by an affdavit.

Defendants offer a workaround: They rewrite Delaware's law. After defendants' edits, the Delaware law is no longer a pleading requirement but a free-foating evidentiary requirement that can serve as the basis for an early dismissal. But that requirement could not be enforced under the Federal Rules. Defendants concede that the absence of an affdavit is not grounds for dismissal under Rule 12(b)(6). And Rule 56 already prescribes the mechanism for putting a plaintiff to his proof: a motion for summary judgment.

Finally, defendants' argument that Rule 11's proviso concerning affidavits incorporates state affdavit laws like § 6853 fails because the proviso cannot be read to address affdavits from third parties. Pp. 192–198. (c) 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). Rule 8 is valid under the Rules Enabling Act because it “really regulates procedure.” Sibbach v. Wilson & Co., 312 U. S. 1, 14. Defendants argue that determining whether a Rule is valid under the Rules Enabling Act requires also asking whether the displaced state law is substantive, but “the substantive nature of [a state] law, or its substantive purpose, makes no difference” to the analysis of a Federal Rule's validity. Shady Grove, 559 U. S., at 409. Pp. 198–200. Reversed and remanded.

C. J., and Thomas, Alito, Sotomayor, Kagan, Gorsuch, and Kavanaugh, JJ., joined. Jackson, J., fled an opinion concurring in the judgment, post, p. 200.

Andrew T. Tutt argued the cause for petitioner. With him on the briefs were R. Stanton Jones, Anthony J. Franze, Kolya D. Glick, Samuel I. Ferenc, and Dana Kagan McGinley. Page Proof Pending Publication Frederick R. Yarger argued the cause for respondent Wilson C. Choy, M.D. With him on the brief were Michael L. O'Donnell, Kevin D. Homiak, William P. Sowers, Rebecca Graves Payne, John A. Elzufon, and Nathan V. Gin. Sarah E. Harrington fled a brief for respondent Beebe Medical Center, Inc. With her on the brief were David M. Zionts, Kendall T. Burchard, and John J. Hare.*

Opinion of the Court

Amy Coney Barrett — joined by Roberts, Thomas, Alito, Sotomayor, Kagan, Gorsuch

The cost of malpractice insurance for doctors and hospitals has signifcantly increased in some areas of the country. In response, several States have imposed a screening mechanism on malpractice suits, requiring plaintiffs to submit an affdavit from a medical professional attesting to the suit's *Briefs of amici curiae urging reversal were fled for the American Association for Justice by Robert S. Peck and Jeffrey R. White; for Civil Procedure Professors by Alan B. Morrison; for Public Justice by John J. Korzen and Leah M. Nicholls; and for the Hon. Mark W. Bennett et al. by D. Chanslor Gallenstein.

Briefs of amici curiae urging affrmance were fled for the State of Tennessee et al. by Jonathan Skrmetti, Attorney General of Tennessee, J. Matthew Rice, Solicitor General, and Harrison Gray Kilgore, Senior Assistant Attorney General, and by the Attorneys General for their respective States as follows: Steve Marshall of Alabama, Tim Griffn of Arkansas, Philip J. Weiser of Colorado, James Uthmeier of Florida, Chris Carr of Georgia, Raúl Labrador of Idaho, Theodore E. Rokita of Indiana, Brenna Bird of Iowa, Kris W. Kobach of Kansas, Russell Coleman of Kentucky, Liz Murrill of Louisiana, Keith Ellison of Minnesota, Lynn Fitch of Mississippi, Andrew Bailey of Missouri, Michael T. Hilgers of Nebraska, Matthew J. Platkin of New Jersey, Drew H. Wrigley of North Dakota, Dave Yost of Ohio, David W. Sunday, Jr., of Pennsylvania, Alan Wilson of South Carolina, Marty Jackley of South Dakota, Ken Paxton of Texas, Derek Brown of Utah, Charity R. Clark of Vermont, Jason Miy ares of Virginia, and John B. McCuskey of West Virginia; for the American Hospital Association et al. by Colleen E. Roh Sinzdak; for the American Medical Association et al. by Jack R. Bierig; for the DRI Center for Law and Public Policy by Hillary A. Taylor; for Insurance Companies et al. by Kendra N. Beckwith and Michael D. Miller; and for Michael T. Morley by Richard A. Simpson and F. Andrew Hessick.

merit. We consider whether Delaware's affdavit requirement applies in federal court and hold that it does not.

I

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 ftted with a protective boot.

The ftting 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 affdavit of merit “accompanie[s]” the complaint. Del. Code, Tit. 18, § 6853(a)(1) (2025). The affdavit 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 fle the affdavit, ibid., but he must fle the extension motion before or when he fles the complaint, § 6853(a)(2). If an affdavit does not accompany the complaint and the plaintiff has not fled a timely extension motion, then the clerk of court shall “refuse to fle 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 Page Proof Pending Publication affdavit of merit is fled. § 6853(a)(4). Upon the defendants' motion, the court must determine in camera if the affdavit satisfes the statutory requirements. § 6853(d).

Attempting to comply with § 6853, Berk immediately moved for an extension of time to fle an affdavit. The District Court granted Berk's motion, and Berk tried to track down a doctor willing to provide an affdavit (an ordeal spawning separate litigation). But the clock ran out, and coming up empty-handed, Berk instead fled 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 affdavit law. See 2023 WL 2770573, *1–*2 (D Del., Apr. 4, 2023).

The Third Circuit affrmed, 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 affdavit 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 affrmed the dismissal of Berk's suit. See 2024 WL 3534482, *3–*4.

We granted certiorari. 604 U. S. 1193 (2025).

II

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 Page Proof Pending Publication Page Proof Pending Publication 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 Associ ates, P. A. v. Allstate Ins. Co., 559 U. S. 393, 398 (2010). Yet 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].” § 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.

Analyzing whether a Federal Rule displaces state law is straightforward. We frst ask whether the Federal Rule “answers the question in dispute.” Shady Grove, 559 U. S., at 398. In doing so, we interpret the Federal Rules the same way we interpret federal laws more generally: by giving them their “plain meaning.” Walker v. Armco Steel Corp., 446 U. S. 740, 750, n. 9 (1980). If a Federal Rule answers the disputed question, it governs, unless it “exceeds statutory authorization or Congress's rulemaking power.” Shady Grove, 559 U. S., at 398.

A

In this case, the disputed question is whether Berk's lawsuit may be dismissed because his complaint was not accompanied by an expert affdavit.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, that evidence of the claim is not required. Cf. Burlington North ern 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 feld 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 satisfes this standard is “wellpleaded” and “may proceed even if it strikes a savvy judge that actual proof of the facts alleged is improbable.” Id., at 556.

1The concurrence objects to our framing the disputed question around dismissal because doing so “assumes that Berk's lawsuit has already been . . . fled and docketed.” Post, at 202 (Jackson, J., concurring in judgment). But Berk's lawsuit has already been fled and docketed, see No. 1:22–cv–01506 (D Del., Nov. 18, 2022), ECF Doc. 1, which is how it found its way here. The only question in dispute is whether Berk's lawsuit may be dismissed—indeed, that is the question on which we granted certiorari. See Pet. for Cert. i. The concurrence reframes the question in dispute as “what is required to start a medical malpractice case.” Post, at 203. But because no one argues that the court violated § 6853 by docketing Berk's complaint, the concurrence is ultimately forced to grapple with the question whether Berk's lawsuit may be “dismiss[ed].” Post, at 209. By focusing on dismissal from the start, we do not “jum[p] the gun,” post, at 202, but rather cut to the chase.

Page Proof Pending Publication 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 (1993); employment discrimination suits, Swierkiewicz v. Sorema N. A., 534 U. S. 506 (2002); and prisoner suits, Jones v. Bock, 549 U. S. 199 (2007). We have consistently rejected such efforts. As we explained in Leather man—which dealt with a demand that plaintiffs plead certain § 1983 claims with added specifcity—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.

Delaware's affdavit 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 affdavit of merit.” § 6853(a)(1). Under Rule 8, factual allegations are suffcient, but under the Delaware law, the plaintiff needs evidence too. See Dishmon v. Fucci, 32 A. 3d 338, 344 (Del. 2011) (describing § 6853 as imposing a “prima facie evidentiary requiremen[t]”); see also Brief for Respondent Beebe 23 (same). The two rules thus give different answers to the question whether Berk's complaint can be dismissed as insuffcient because it was unaccompanied by an affdavit. It is true, as defendants and the concurrence are quick to point out, that an affdavit of merit is a document separate from the “pleading,” and that, by its literal terms, Rule 8 defnes only what the “pleading . . . must contain.” But we think it is fair to infer that by specifying what information about the merits is required in the “pleading,” Rule 8 exPage Proof Pending Publication Page Proof Pending Publication cludes the possibility of requiring even more information on the same topic—whether in the “pleading” itself or on a separate sheet of paper attached to it. Cf. Jones, 549 U. S., at 205, 212–217 (rejecting requirement that prisoners “attach proof of exhaustion . . . to their complaints” as inconsistent with Rule 8). Rule 8 addresses what information a plaintiff must provide about the merits of his claim at the outset of litigation. Section 6853 addresses the same issue—and in doing so, imposes a different standard.2 Resisting this conclusion, defendants cite Cohen v. Benef cial Industrial Loan Corp., 337 U. S. 541 (1949), for the broad proposition that all state “preconditions to proceeding” are consistent with the Federal Rules. Brief for Respondent Beebe 26–27; see Brief for Respondent Choy 20– 21. They substantially overread Cohen. There, a state law rendered an unsuccessful plaintiff in a shareholder derivative suit liable for all the defendant's expenses, including attorney's fees, and as security for that potential liability, required the plaintiff to post a bond before proceeding with the action. 337 U. S., at 543. The plaintiffs argued that the bond requirement was displaced by then-Rule 23, which governed shareholder derivative suits in federal court. Id., at 556. 2The concurrence accuses us—and the “many Courts of Appeals” that agree with us—of “contorting” Rule 8 by reading it to implicitly preclude courts from requiring plaintiffs to provide additional information. Post, at 208, and n. 6. Yet drawing a negative inference from text is sometimes the best way to understand it. See A. Scalia & B. Garner, Reading Law: The Interpretation of Legal Texts 107–111 (2012) (negative-implication canon). And while the concurrence criticizes the negative inference we draw as “inattentively capacious,” post, at 206, its Rule 3 analysis depends on an analogous inference. Rule 3 establishes what happens once a complaint is fled: “A civil action is commenced by fling a complaint with the court.” Fed. Rule Civ. Proc. 3. Section 6853, meanwhile, establishes what is required “to fle the complaint . . . with the court”: an affdavit of merit or an extension motion. § 6853(a)(1). The concurrence fnds a collision only by reading Rule 3 to implicitly foreclose any precondition to fling the complaint. So if a negative inference is a “contortion,” the concurrence's argument fails by its own measure.

Page Proof Pending Publication Cohen held that there was no confict because the state law and Rule 23 addressed different issues: The state law created a liability, while Rule 23 dealt with “disclosure to the court and notice to the parties in interest.” Id., at 555–556. Cohen thus did not identify and exempt a broad category of so-called preconditions to proceeding from confict with the Federal Rules. It held that a particular state law addressed a matter that was unaddressed by the relevant Federal Rule. Here, by contrast, the 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 affdavit requirement as a “preconditio[n] to proceeding” does not magically dispel the confict.

Defendants offer a workaround: They rewrite Delaware's law. While § 6853 provides that an affdavit must “accompan[y]” the complaint, defendants suggest that the district court can simply require it “early in [a] case.” Brief for Respondent Beebe 13; see also Brief for Respondent Choy 36 (suggesting affdavit can be fled “weeks” or “months” after the complaint). This proposal is inspired by § 6853's allowance for an extension of time in which to fle the affdavit. But defendants treat this exception—which is available only “for good cause shown”—as the rule and rework the exception to boot. In federal court, apparently, an extension motion need not precede or accompany the complaint; nor is the district court limited to granting one 60-day extension. See, e. g., Brief for Respondent Beebe 23–25. And defendants' proposed changes do not stop there: They would also have us delete the provision that absolves a defendant from “tak[ing] any action with respect to the complaint” until the affdavit is fled. § 6853(a)(4). Under Federal Rule 12(a)(1), service of the summons and complaint triggers a defendant's obligation to respond, and defendants admit that the Federal Rule controls on this point.

Page Proof Pending Publication After defendants' edits, the Delaware law is no longer a pleading requirement that serves a gatekeeping function; it is a free-foating evidentiary requirement that can serve as the basis for an early dismissal. Yet even were it acceptable to take creative license with the Delaware law, there would be no way to enforce such a requirement. Defendants concede that the absence of an affdavit is not grounds for dismissal under Rule 12(b)(6). They foat the possibility of dismissal for failure to prosecute, but that does not work because Berk actively participated in the litigation. Defendants' frst choice is the course the District Court took here: dismissal based on the court's inherent authority. The problem, however, is that the Federal Rules already prescribe a mechanism for putting a plaintiff to his proof: a motion for summary judgment. See Fed. Rule Civ. Proc. 56. And that does not offer defendants the protection they want, because before ruling on the motion, the court must allow the nonmovant “adequate time for discovery.” Celotex Corp. v. Catrett, 477 U. S. 317, 322 (1986); see also Rule 12(d) (requiring a “reasonable opportunity to present all the [pertinent] material” if motion to dismiss is converted to motion for summary judgment). That defendants cannot ft the affdavit requirement into the Federal Rules illustrates that it has no place there.

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 affdavit laws applicable in federal court even if they confict with other Federal Rules. Rule 11 provides that “[u]nless a rule or statute specifcally states otherwise, a pleading need not be verifed or accompanied by an affdavit.” Fed. Rule Civ. Proc. 11(a). Defendants argue that § 6853 is a “statute [that] specifcally states otherwise,” ibid., and it therefore applies in federal court regardless of whether it conficts with other Federal Rules.

Even if Rule 11 incorporates some state affdavit 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 affdavits.” Business Guides, Inc. v. Chromatic Communications Enterprises, Inc., 498 U. S. 533, 542 (1991) (emphasis added); see, e. g., Fed. Rule Civ. Proc. 23.1 (requiring complaints in shareholder derivative actions to be verifed). The sentence has nothing to do with affdavits from third parties. Accordingly, Rule 11 does not shield Delaware's law from displacement by Rule 8.

B

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 (“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 regulates procedure.” Sibbach v. Wilson & Co., 312 U. S. 1, 14 (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 (plurality opinion) Page Proof Pending Publication Page Proof Pending Publication (quoting Mississippi Publishing Corp. v. Murphree, 326 U. S. 438, 446 (1946)).

In applying this analysis, we have “rejected every statutory challenge to a Federal Rule that has come before us.” Shady Grove, 559 U. S., at 407 (plurality opinion). We have upheld Rules governing the certifcation of class actions, id., at 408 (Rule 23); see id., at 416, 436 (Stevens, J., concurring in part and concurring in judgment) (Rule 23); service of process, Mississippi Publishing Corp., 326 U. S., at 445–446 (Rule 4(f)); compelled mental and physical examinations, Sib bach, 312 U. S., at 14–16 (Rule 35); sanctions for frivolous appeals, Burlington, 480 U. S., at 8 (Rule 38); and sanctions for signing court papers without reasonably investigating the facts asserted, Business Guides, 498 U. S., at 551–554 (Rule 11).

Like those Rules, 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.” Shady Grove, 559 U. S., at 407–408 (plurality opinion).

Defendants do not contend otherwise. Instead, they argue that determining whether a Rule is valid under the Rules Enabling Act requires asking a second question: whether the displaced state law is substantive. We rejected that approach eight decades ago and decline to reconsider it now. See Sibbach, 312 U. S., at 14. On the contrary, 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 affdavit 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.

It is so ordered.

Concurrence

Ketanji Brown Jackson

I agree with the Court that Delaware's affdavit requirement cannot apply in federal court. I write separately because, in my view, the relevant conficts are with Federal Rules of Civil Procedure 3 and 12, not Rule 8.

I

As the majority explains, Delaware's law is, at bottom, an “affdavit requirement.” Ante, at 190. If a medical malpractice plaintiff wants her complaint deemed “fled” and her case docketed, the statute mandates that an affdavit of merit signed by a medical professional (or a motion for an extension of time to fle the affdavit) must accompany the complaint. See Del. Code, Tit. 18, § 6853(a)(1) (2025). By contrast, the Federal Rules require no such additional fling. Rather, “[a] civil action is commenced by fling a complaint with the court.” Fed. Rule Civ. Proc. 3.

Thus, § 6853 and Rule 3 confict regarding the requirements to “commence” a medical malpractice action. If a federal court were to follow Delaware's law, a plaintiff would have to do more than merely tender the complaint in order for his medical malpractice lawsuit to be fled and docketed. But, under the language of Rule 3, civil suits commence as soon as the complaint—and only the complaint—has been fled by the plaintiff. In my view, this clash warrants reversal here.

As the majority explains, our cases make clear beyond cavil that “a valid [Federal] Rule of Civil Procedure displaces contrary state law.” Ante, at 192. Thus, the nub of the confict inquiry is to determine whether the State's requirement Page Proof Pending Publication is, in fact, contrary to a Federal Rule. Over time, we have expressed this central inquiry in various ways. See, e. g., Hanna v. Plumer, 380 U. S. 460, 472 (1965) (asking whether “the applicable Federal Rule is in direct collision with the [state] law”); Burlington Northern R. Co. v. Woods, 480 U. S. 1, 4–5 (1987) (asking whether the scope of the Federal Rule is “ `suffciently broad' ” to “ `control the issue' ” before the Court, “thereby leaving no room for the operation” of the state law (quoting Walker v. Armco Steel Corp., 446 U. S. 740, 749–750, and n. 9 (1980))). But as the majority acknowledges, our most up-to-date approach to identifying the necessary confict is to ask whether the Federal Rule and the state statute “attemp[t] to answer the same question.” Shady Grove Orthopedic Associates, P. A. v. Allstate Ins. Co., 559 U. S. 393, 399 (2010); see also ante, at 192.1 Per Shady Grove, once a confict between the State's requirement and a Federal Rule has been identifed, the Federal Rule displaces the State's requirement so long as the 1To the extent that the Court suggests that the Federal Rule's plain text is all that matters when answering this question, that is not what our precedents hold. In Gasperini v. Center for Humanities, Inc., 518 U. S. 415 (1996), we explained that Federal Rules must be interpreted not solely based on their text—as the much earlier case of Walker v. Armco Steel Corp. had suggested in a footnote—but also “with sensitivity to important state interests and regulatory policies,” 518 U. S., at 427, n. 7. The majority opinion in Shady Grove subsequently criticized Gasperini's “search for state interests and policies that are `important' ” as “standardless.” 559 U. S., at 405, n. 7. But fve Justices in that case (i. e., a majority) agreed nevertheless with Gasperini's approach to interpreting the Federal Rules in this context. See 559 U. S., at 437 (Ginsburg, J., dissenting) (writing for three other Justices that the Court should “continue to interpret Federal Rules with awareness of, and sensitivity to, important state regulatory policies”); id., at 418 (Stevens, J., concurring in part and concurring in judgment) (explaining that the Federal Rules “must be interpreted with some degree of `sensitivity to important state interests and regulatory policies' ” (quoting Gasperini, 518 U. S., at 427, n. 7)). So, under our precedents, courts must be mindful of state interests and policies when determining whether a Federal Rule conficts with state law.

Page Proof Pending Publication Page Proof Pending Publication Rule is “valid,” meaning that it “governs only `the manner and the means' by which the litigants' rights are `enforced.' ” 559 U. S., at 407 (plurality opinion) (quoting Mississippi Pub lishing Corp. v. Murphree, 326 U. S. 438, 446 (1946)); see also 28 U. S. C. § 2072(b) (Rules Enabling Act). And for similar reasons to those given in Part II–B of the majority opinion, Rule 3 easily satisfes this standard. See ante, at 198–199; see also Shady Grove, 559 U. S., at 407 (plurality opinion) (noting that we have “rejected every statutory challenge to a Federal Rule that has come before us”).

Accordingly, Delaware's affidavit requirement cannot apply in federal court.

II

The majority and I start in the same place and ultimately reach the same conclusion, but we have taken different paths, marked by different assumptions and nuances. I agree with the majority that the frst step of today's analysis is to identify the relevant confict by ascertaining the question that the Delaware law and the Federal Rule “attemp[t] to answer.” Shady Grove, 559 U. S., at 399; see ante, at 192. But I disagree that, in this case, “the disputed question is whether Berk's lawsuit may be dismissed because his complaint was not accompanied by an expert affdavit.” Ante, at 192–193. Here is why.

A

First and foremost, that formulation of the question assumes that Berk's lawsuit has already been properly accepted by the court clerk (i. e., fled and docketed) and thus that § 6853 is answering whether the “lawsuit may be dismissed” for want of the required affdavit. Ante, at 192.

But that assumption jumps the gun. Delaware's law states that “[n]o health-care negligence lawsuit shall be fled in this State unless the complaint is accompanied by: (1) [a]n affdavit of merit” or (2) “a motion to extend the time to fle said affdavit.” § 6853(a)(1) (emphasis added). The statute further specifes that “[i]f the required affdavit does not accompany the complaint or if a motion to extend the time to fle said affdavit . . . has not been fled with the court, then the . . . clerk of the court shall refuse to fle the complaint and it shall not be docketed with the court.” Ibid. (emphasis added).

Accordingly, the text of § 6853 makes clear that the statute's frst order of business is not to address the requirements for dismissal of an affdavit-free lawsuit such as Berk's. Instead, § 6853 most directly answers the threshold question of what is required to start a civil action for medical malpractice under Delaware law. Delaware's response is that the plaintiff must submit an affdavit of merit, or a motion for an extension of time to fle such affdavit, because (to repeat) the clerk cannot “fle the complaint” or “docke[t]” the case without that additional filing.

§ 6853(a)(1).

Rule 3 provides a completely different answer to the question of what is required to start a medical malpractice case. As explained above, under that Rule, “[a] civil action is commenced by fling a complaint with the court”—period. That answer leaves “no room” for Delaware's insistence that an affdavit of merit (or a motion for an extension) must be submitted in order to commence this kind of legal action. Bur lington, 480 U. S., at 5. Indeed, Rule 3 uses the uncompromising, declarative phrase “is commenced,” plainly indicating that Congress meant for the “fling [of] a complaint” to be both necessary and suffcient to begin any civil case (including a malpractice action) in federal court. Cf. Walker, 446 U. S., at 750, n. 10 (“ `Rule 3 simply provides that an action is commenced by fling the complaint and has as its primary purpose the measuring of time periods that begin running from the date of commencement' ” (quoting 4 C. Wright & A. Miller, Federal Practice and Procedure § 1057, p. 191 (1969))); Hallstrom v. Tillamook County, 493 U. S. 20, 26 (1989) (readPage Proof Pending Publication ing Rule 3 to mean that “fling a complaint with the court” is synonymous with “fl[ing] suit”).2 Resisting this conclusion, defendants rely on three cases to argue that “this Court has long found applicable in federal court” “state-law condition[s] on allowing suits to proceed.” Brief for Respondent Beebe 26–27, and n. 11; see also Brief for Respondent Choy 36–37. But that argument mischaracterizes our past rulings. See Cohen v. Benefcial Industrial Loan Corp., 337 U. S. 541 (1949); Woods v. Interstate Realty Co., 337 U. S. 535 (1949); Walker v. Armco Steel Corp., 446 U. S. 740.

The majority has already ably explained that defendants “substantially overread” Cohen for the proposition that “all state `preconditions to proceeding' are consistent with the Federal Rules.” Ante, at 195. I think Walker and Woods are also easily distinguishable.

2The majority contends that its dismissal-focused formulation of the question is the right one because, in this case, “Berk's lawsuit has already been fled and docketed,” and “we granted certiorari” on the question “whether Berk's lawsuit may be dismissed.” Ante, at 193, n. 1. That argument confates the question presented with the “question” that, under Shady Grove, is supposed to serve as the linchpin of our confict analysis. 559 U. S., at 401. The latter comes not from the facts of the case, but rather from our interpretations of the potentially conficting state law and Federal Rule. So, while it may be that the question presented is “whether Berk's lawsuit may be dismissed,” the relevant question for our Shady Grove analysis is “what is required to start a medical malpractice case,” because that is the question that § 6853 and, as it happens, Rule 3, “attemp[t] to answer,” Id., at 399.

Nor is the majority correct that, regardless, I am “ultimately forced to grapple with the question whether Berk's lawsuit may be `dismiss[ed].' ” Ante, at 193, n. 1 (alteration in original). As I stated above, § 6853's confict with Rule 3 is enough to hold that the law cannot apply in federal court. And, as I have shown, the Rule 3 analysis is about the commencement of the action, not its dismissal. Once we determine that § 6853 and Rule 3 answer the same commencement-related question, § 6853 cannot apply in federal court, meaning that Berk's lawsuit cannot be thwarted for failure to satisfy the requirements of that state law.

Page Proof Pending Publication As with Cohen, respondents overstate the effect of Walker. There, we held that a federal court sitting in diversity must apply an Oklahoma law that deemed an action “commenced” upon service of the summons for purposes of the State's statute of limitations. 446 U. S., at 742. Rule 3, we explained, “governs the date from which various timing requirements of the Federal Rules begin to run, but does not affect state statutes of limitations.” Id., at 751. Here, by contrast, § 6853 and Rule 3 serve precisely the same function, in the same context: Both establish when a malpractice lawsuit is deemed initiated (i. e., fled and docketed) for purposes of determining “the date from which various timing requirements of the Federal Rules begin to run.” Ibid. That is precisely the kind of confict that bars the application of state law in federal court under our precedents.3 Defendants' reliance on Woods is similarly unavailing.

There, we held that a federal court sitting in diversity must apply a Mississippi law prohibiting out-of-state corporations from bringing suit in the State unless they designated an agent for service of process. 337 U. S., at 536, n. 1. Mississippi's law was enacted to ensure that only those out-of-state corporations that consented to being sued in Mississippi had the privilege of accessing Mississippi's courts. See ibid. In other words, Mississippi's law had a broad substantive purpose and effect that went well beyond what the Federal Rules addressed. That was why we had to wade through “Erie's murky waters” to decide the conficts question that case presented. See Shady Grove, 559 U. S., at 398; see 3Proving this point, another provision of the Delaware law, § 6853(a)(4), provides that a defendant is “not required to take any action with respect to the complaint . . . until 20 days after plaintiff has fled the affdavit.” Under the Federal Rules, however, the deadline for a responsive act by the defendant is anchored to the fling of the complaint. See Fed. Rules Civ. Proc. 4(m) (a plaintiff must serve the complaint and summons “within 90 days after the complaint is fled”) and 12(a)(1)(A)(i) (a defendant “must serve an answer . . . within 21 days after being served with the summons and complaint”).

Page Proof Pending Publication also Erie R. Co. v. Tompkins, 304 U. S. 64 (1938). Delaware's affdavit requirement, by contrast, is plainly procedural in scope and well within the territory of the Federal Rules. In short, our precedents establish that when a state law and a valid Federal Rule confict—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, Dela- ware's law must give way. See Hanna, 380 U. S., at 469–474.

B

If we accept, for the sake of argument, that the question Delaware's law attempts to answer is “whether [a medical malpractice complaint] may be dismissed because [it] was not accompanied by an expert affdavit,” ante, at 192–193, a problem arises: The Federal Rule the majority points to does not answer that same question.

The majority discerns a confict with Rule 8 by reasoning as follows. With respect to the dismissal-related question quoted above, Delaware's law says that such a complaint must be dismissed because the affdavit of merit is missing, whereas Rule 8 prescribes all “the information a plaintiff must present about the merits of his claim at the outset of litigation”—namely, “ `a short and plain statement of the claim showing that [he] is entitled to relief.' ” Ante, at 193 (quoting Fed. Rule Civ. Proc. 8(a)(2)). “By requiring no more than a statement of the claim,” the majority continues, “Rule 8 establishes `implicitly, but with unmistakable clarity,' . . . that evidence of the claim is not required.” Ante, at 193. The problem with this reasoning is not that it is based on “a negative inference” about Rule 8, ante, at 195, n. 2, but rather the inattentively capacious scope of that negative inference. I agree that Rule 8(a)'s fnite list “preclude[s] courts” from imposing additional requirements. Ibid.; see Leatherman v. Tarrant County Narcotics Intelligence and Coordination Page Proof Pending Publication Unit, 507 U. S. 163, 168 (1993). But context is critical: Rule 8 does not purport to establish all that a medical malpractice plaintiff can be required to say about the merits of his claims at the beginning of the case, much less that nothing more than the fling of a complaint can be mandated. Rather, it (more narrowly) addresses what any “pleading” stating a claim for relief must contain. See Rule 8(a) (“A pleading that states a claim for relief must contain . . .” (emphasis added)). The majority neither holds nor suggests that §6853's affdavit of merit is, itself, a “pleading”; to the contrary, the majority admits that the affdavit is not. Ante, at 194. So, as I see it, Delaware's law—which prescribes what a plaintiff must submit in addition to his pleadings in order for his complaint to be fled and his case docketed—does not actually confict with Rule 8.

The majority acknowledges this “pleading” problem and offers, apparently as a solution, yet another formulation of the question that Rule 8 is answering: Rule 8, it says, tells us “what information a plaintiff must provide about the merits of his claim.” Ante, at 195. But, again, this description fails to acknowledge that Rule 8 operates entirely within a specifc universe: the pleadings. The majority's unbounded characterization subtly frees Rule 8 from the constraint of its subject matter, allowing it to expand until it collides with Delaware's law.4 4The majority's description of Rule 8's work is inaccurate even if confned to the universe of pleadings. Rule 8 does not “addres[s] what information a plaintiff must provide about the merits of his claim” in the pleadings. Ante, at 195 (emphasis added). Instead, with respect to a pleading that states a claim for relief (as opposed to one that does not, see Rule 7), Rule 8 governs how much a plaintiff must say concerning his claim. Rule 8's primary purpose is to install a “simplifed pleading system” that requires a complaint to include nothing more than “ `short and plain statement[s]' ” of the claim, the grounds for jurisdiction, and the relief sought. Swierkiewicz v. Sorema N. A., 534 U. S. 506, 512, 514 (2002). In other words, Rule 8's innovation is the “short and plain” bit, not the substance of what is required to be stated in that manner.

Page Proof Pending Publication When properly construed, Rule 8 addresses a particular (and particularly important) procedural question: “What must a pleading that states a claim for relief contain?” 5 In my view, this narrower formulation of the question—the one tethered to the required contents of a “pleading”—keeps Rule 8 within the bounds of its plain meaning, consistent with Gasperini's command not to overread the Federal Rules at the expense of “important state interests and regulatory policies” in cases such as this one. Gasperini v. Cen ter for Humanities, Inc., 518 U. S. 415, 427, n. 7 (1996); see also n. 1, supra.

Accordingly, because § 6853 does not address or govern the required contents of a pleading, Delaware's law does not answer the same question as Rule 8. Instead, the State's affdavit requirement (which, incidentally, neither describes the affdavit of merit in relation to a plaintiff 's obligation to state a claim for relief nor treats it as evidence) is an additional fling requirement for commencing any medical malpractice civil action under state law. See § 6853(a)(1) (“No healthcare negligence lawsuit shall be fled in [Delaware] unless the complaint is accompanied by . . . [a]n affdavit of merit”). Finding a Rule 8 confict, as the majority does, thus requires contorting both Rule 8 and § 6853. There is no need to do so here, especially given the ready confict with Rule 3 (discussed above) and Rule 12 (described below).6 5The answer, under the Rule, is (1) “a short and plain statement of the grounds for . . . jurisdiction,” (2) “a short and plain statement of the claim showing that the pleader is entitled to relief,” and (3) “a demand for the relief sought.” Rule 8(a).

6To be sure, many Courts of Appeals have also relied on a confict with Rule 8 to hold that state affdavit-of-merit laws like Delaware's do not apply in federal court. See Albright v. Christensen, 24 F. 4th 1039, 1048– 1049 (CA6 2022); Gallivan v. United States, 943 F. 3d 291, 293 (CA6 2019); Pledger v. Lynch, 5 F. 4th 511, 519 (CA4 2021); Young v. United States, 942 F. 3d 349, 351 (CA7 2019). But a closer look at the relevant cases reveals that these courts, like the majority, got there by manipulating the Page Proof Pending Publication

III

The majority and I appear to agree that Delaware's affdavit requirement—as interpreted by the Delaware Supreme Court—conficts with Rule 12(d). See ante, at 193.

That confict suffces to displace § 6853's requirement. But to the extent that the majority ties its Rule 12 analysis to the purported Rule 8 confict, see ibid., I think the majority has gone further than it needs to, introducing incoherence in the process.

While the statute itself does not so specify, the Delaware Supreme Court has interpreted § 6853 to mean that (assuming the clerk of court accepts an affdavit-free medical malpractice action and dockets the case notwithstanding the statute's prohibition) “[t]he fling of a healthcare negligence action without the requisite affdavit of merit constitutes grounds of dismissal of medical negligence claims as a matter of law.” Hall v. Sorouri, 996 A. 2d 793 (Del. 2010) (Table). That reading of Delaware law answers the question, “What can a court consider when dismissing a medical malpractice case?” Because “[t]he highest state court is the fnal authority on state law,” Fidelity Union Trust Co. v. Field, 311 U. S. 169, 177 (1940), we must read this statute as that court does, i. e., as establishing dismissal requirements for medical malpractice cases. Thus, if a valid Federal Rule answers that same dismissal question, § 6853 cannot govern in federal court. See Shady Grove, 559 U. S., at 398.

relevant question. In Gallivan, for example, the Sixth Circuit posed as the pertinent question: “[D]oes someone need an affdavit of merit to state a claim for medical negligence?” 943 F. 3d, at 293. This leading question not only ignores (as the majority does) that Rule 8 is solely about “pleadings,” but, worse, also preordains a confict by naming the very thing that the state law requires but the Federal Rule does not (i. e., an affdavit). The Fourth and Seventh Circuits make the same error. See Pledger, 5 F. 4th, at 519 (asking “whether a medical malpractice plaintiff must provide pre-suit expert support for his claim”); Young, 942 F. 3d, at 351 (asking whether Rule 8 “require[s] attachments”).

Page Proof Pending Publication Enter Rule 12. As the majority correctly explains, Rule 12(b)(6) provides the “only . . . ground for dismissal based on the merits,” and Rule 12(d) prohibits courts from considering “ `matters outside the pleadings' ” in deciding motions to dismiss brought under Rule 12(b)(6). Ante, at 193; see also Stanley v. City of Sanford, 606 U. S. 46, 49 (2025) (explaining that, under Rule 12(d), a judge considering a motion to dismiss must “take as true the well-pleaded facts in the plaintiff 's complaint, . . . and [must] not consider evidence beyond that pleading”). Furthermore, by all accounts, the affdavit required by Delaware's law is a “matte[r] outside the pleadings.” Rule 12(d); see ante, at 194 (“It is true . . . that an affidavit of merit is a document separate from the `pleading' ”).

We know the affdavit of merit qualifes as a “matter outside the pleadings” for several reasons. For one thing, Delaware law provides that the affdavit is to “accompany” the complaint. § 6853(a)(1). A thing cannot “accompany” that of which it is already a part.7 Indeed, Delaware's Legislature apparently felt so strongly about the affdavit not being part of the complaint that it mandated physical separation: By statute, the affdavit must be fled in its own sealed envelope, alongside (but apart from) the complaint. See ibid. Nor do the Federal Rules suggest that affdavits of the nature specifed by the Delaware law can qualify as “pleadings.” Rule 7, which sets forth a list of “[p]leadings [a]llowed” in federal court, does not include an “affdavit” (or anything like it) on its list.

Pulling these threads together, Delaware's law, as interpreted by the Delaware Supreme Court, requires judges to 7To be sure, plaintiffs can, in limited contexts, “incorporat[e]” certain documents “into the complaint by reference.” Tellabs, Inc. v. Makor Is sues & Rights, Ltd., 551 U. S. 308, 322 (2007). But the affdavit of merit is not such a document because its content is neither discoverable nor admissible. See § 6853(d).

Page Proof Pending Publication Page Proof Pending Publication account for a matter outside the pleadingsi. e., the existence or suffciency of an affdavit of merit (or lack thereof)— when deciding whether to dismiss a medical malpractice case. Rule 12(d), however, forbids such extraneous considerations. And Rule 12 is valid under the Rules Enabling Act (for similar reasons as the Court lays out in its opinion, see ante, at 198–199). So Delaware's law cannot be enforced in federal court.

As far as I can tell, then, there is no daylight between my view of the Rule 12 confict and the majority's assessment. But far from “reinforc[ing]” a confict with Rule 8, ante, at 193, our shared evaluation of Rule 12 is, to me, yet another reason why Delaware's law is not in confict with Rule 8.

See Part II–B, supra. The conficts analysis concerning these two Rules is based on diametrically opposed characterizations of Delaware's affdavit of merit: The affdavit must be either a “matter outside the pleadings” (and thus § 6853 conficts with Rule 12, per the Delaware Supreme Court's decision in Hall) or it is part of what the pleadings must contain (giving rise to the purported confict with Rule 8). A coherent conficts analysis cannot have it both ways.

* * * Read for what they are—by their “plain meaning,” sensitive to context yet without distortions created by the task of checking for a confict, see Walker, 446 U. S., at 750, n. 9; Gasperini, 518 U. S., at 427, n. 7—Rules 3 and 12 answer the same questions as Delaware's affdavit requirement. That means that the majority and I share the same conclusion: There is a confict between state law and valid Federal Rules, precluding application of Delaware's affdavit requirement in federal court. For the reasons discussed above, I think the majority is wrong to further maintain that § 6853 answers the same question as Rule 8. And I cannot see how the affdavit that the Delaware law requires can be a “matter outside the pleadings” (for Rule 12-confict purposes) and also part of the “pleadings” (for Rule 8-confict purposes). Therefore, I concur only in the judgment.

Page Proof Pending Publication Page Proof Pending Publication Reporter’s Note The attached opinion has been revised to refect the usual publication and citation style of the United States Reports. The revised pagination makes available the offcial United States Reports citation in advance of publication. The syllabus has been prepared by the Reporter of Decisions for the convenience of the reader and constitutes no part of the opinion of the Court. A list of counsel who argued or fled briefs in this case, and who were members of the bar of this Court at the time this case was argued, has been inserted following the syllabus. Other revisions may include adjustments to formatting, captions, citation form, and any errant punctuation. The following additional edits were made: p. 188, line 7: The sentence “This Court has consistently rejected efforts by lower federal courts to require more information than Rule 8 requires.” is replaced with “Lower federal courts have sometimes tried to demand more information than Rule 8 requires for certain kinds of claims. This Court has consistently rejected such efforts.” p. 200, Part I, line 3: “his” is changed to “hers” p. 204, line 4: “from 1949, arguing” is changed to “to argue” p. 206, line 1: “also” is inserted before “Erie R. Co.