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Big changes in med-mal: SCOTUS bars Delaware’s affidavit-of-merit in Federal Court

1/30/26

By: Robert Scavone Jr.

In Berk v. Choy (Jan. 20, 2026), the U.S. Supreme Court considered whether Delaware’s medical-malpractice “affidavit of merit” statute applies in federal court when a plaintiff sues under diversity jurisdiction. Delaware law generally requires an affidavit from a medical professional stating there are “reasonable grounds” to believe negligence occurred, and it contemplates that the affidavit must “accompanie[s]” the complaint (subject to a limited extension).

The Court held (9-0) that Delaware’s affidavit requirement does not apply in federal court. The Court’s reasoning followed the familiar Hanna/Shady Grove framework: when a Federal Rule of Civil Procedure is “on point” and answers the question in dispute, the federal rule governs and the court “bypasses” the usual Erie inquiry.

The Court framed the operative question as whether Berk’s suit could be dismissed because his complaint was unaccompanied by an expert affidavit, and concluded Rule 8 supplies the controlling rule—setting a “ceiling” on what plaintiffs may be required to provide at the pleading stage unless the Rules themselves impose special pleading requirements. The Court also emphasized that Rule 12 limits what a court may consider at the motion-to-dismiss stage (“matters outside the pleadings”).

Defendants’ attempts to salvage Delaware’s statute failed. The Court rejected the notion that state-law affidavit screening can be imported through federal practice and pointed to the Federal Rules’ own mechanism for testing proof—summary judgment after “adequate time for discovery.” It also rejected reliance on Rule 11’s verification proviso, explaining that it “has nothing to do with affidavits from third parties.”

On the Rules Enabling Act question, the Court reiterated that Rule 8 is valid because it “really regulates procedure,” and that the state law’s substantive purpose “makes no difference” to the validity analysis once a Federal Rule is on point.

For med-mal lawyers, Berk makes forum selection and removal strategy even more consequential: state affidavit-of-merit requirements may remain potent in state court, but they cannot be used as a federal pleading-stage gate when the Federal Rules answer the same question.

Defense counsel should adjust playbooks accordingly—pressing Rule 12 defenses and building an early Rule 56 record, rather than over-investing in “missing affidavit” dismissal arguments. And beyond med-mal, the decision is a reminder that state “attached proof,” pre-suit certification, or pleading-stage evidentiary screens in other practice areas may likewise be displaced in federal court when the Federal Rules already “set a ceiling” on what must accompany a complaint.

For more information, please contact Robert Scavone Jr.at robert.scavone@fmglaw.com or your local FMG attorney.

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