Sheinfeld v. B. Braun Medical Inc.

Background

David N. Sheinfeld proceeded without a lawyer and sued B. Braun Medical, Inc. and Aesculap Inc. He alleged that an ActivL artificial disc used during his November 2019 spinal surgery migrated because its spikes detached or failed to attach properly. He also alleged that corrective surgeries were required and asserted claims based on negligent design, negligent manufacturing, and failure to warn.

The defendants previously moved to dismiss under Federal Rules of Civil Procedure 12(b)(2) and 12(b)(6). Judge Ona T. Wang recommended dismissal of the claims, concluding that the design and manufacturing claims were preempted by federal law governing certain medical devices because Sheinfeld had not identified a specific federal requirement that the device violated. She also concluded that the warning claim was inadequately pleaded. Judge Analisa Torres adopted that recommendation on March 12, 2024, and gave Sheinfeld an opportunity to seek permission to amend his manufacturing-defect claim.

Motion to Amend

Sheinfeld moved for leave to file an amended complaint but did not attach a proposed amended complaint. His motion papers alleged that the device’s spikes were not sufficiently sharp or strong, did not properly penetrate the bone, and failed because of improper workmanship. The recommendation found that the missing proposed complaint was not by itself fatal because the motion and reply described the factual allegations and the defendants did not rely on that omission as a reason for denial.

Under Rule 15, courts generally should allow amendment when justice requires, but may deny permission when amendment would be futile. Amendment is futile when the proposed claim would be immediately subject to dismissal for failure to state a legally sufficient claim.

Reasons for the Recommendation

The recommendation concluded that Sheinfeld had not cured the deficiencies previously identified. His new allegations again relied on the device’s failure to attach to the vertebrae but did not identify a specific error in the manufacturing process, improper workmanship, defective material, or other manufacturing mishap. The recommendation also found that his allegations did not plausibly show that a specific defect caused his injury.

Sheinfeld cited a federal regulation, 21 C.F.R. Part 820.90, concerning procedures for handling nonconforming products. The recommendation found that his assertion that the defendants violated that regulation was unsupported and that the regulation was too general, standing alone, to provide the specific federal violation needed to avoid preemption. The attached records, including X-rays, physician notes, an FDA device-safety summary, and a manufacturer and user facility device experience report, likewise did not identify a specific manufacturing or design defect or a specific violation of a federal requirement. The report appeared to attribute the problem most probably to patient- or usage-related causes, which further undermined the alleged causal connection to a manufacturing defect.

Disposition

Magistrate Judge Valerie Figueredo recommended that Sheinfeld’s motion for leave to file an amended complaint be DENIED. This is a report and recommendation rather than the district judge’s stated final ruling in the opinion. The parties were given 14 days after service to file objections with the Clerk of Court, and the recommendation stated that untimely objections could limit a party’s ability to raise objections on appeal.