Sheinfeld v. B. Braun Medical Inc.

Background

David N. Sheinfeld, proceeding without a lawyer, brought a products-liability action concerning the activL artificial disc replacement device. The complaint alleged failure to warn, design defects, and manufacturing defects. The defendants moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which addresses failure to state a legally sufficient claim, and Rule 12(b)(2), which addresses personal jurisdiction.

The court had referred the motion to Magistrate Judge Ona T. Wang. Judge Wang’s Report and Recommendation advised granting the defendants’ motion under Rule 12(b)(6) and allowing Sheinfeld an opportunity to seek permission to amend the manufacturing-defect claim. Sheinfeld filed objections.

Objections and Analysis

Sheinfeld objected to dismissal of his failure-to-warn claim. He argued that he could not allege enough facts about causation without additional discovery of Food and Drug Administration trial data. The court agreed with the recommendation that he had not stated a failure-to-warn claim and that amendment of that claim would be futile. It therefore rejected his request for additional discovery based on evidence he only speculated might be relevant.

Sheinfeld also submitted trial data from other artificial disc manufacturers concerning migration of the devices. The court held that this evidence did not address whether the information had to be included in the activL Device’s warning materials. It also did not support an inference that surgery was necessarily inappropriate when the device had migrated less than 3.5 millimeters or that the defendants were required to warn against surgery in that situation.

The court treated Sheinfeld’s remaining objections as general, conclusory, or repetitive of his earlier arguments. It reviewed the unchallenged portions of the recommendation for clear error and found none.

Disposition

Judge Torres overruled Sheinfeld’s objections and adopted Judge Wang’s Report and Recommendation in full. The order does not separately state a disposition of the defendants’ Rule 12(b)(2) personal-jurisdiction argument. It adopts the recommendation to grant dismissal under Rule 12(b)(6), while providing that Sheinfeld may request leave by April 16, 2024, to amend his complaint to allege facts showing that the specific activL Device implanted in his spine had a manufacturing defect and that the defect caused his injury. The Clerk was directed to terminate the defendants’ motion and mail Sheinfeld copies of the recommendation and order.