Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—S.D. Miss.: Manufacturers failed to dismiss claims that their surgical robot malfunctioned causing injury, (Jul 16, 2026)

By Susan L. Smith, JD, MA

With the exception of express warranty and failure to warn claims, two medical device manufacturers failed in their attempt to dismiss the strict liability and breach of warranty claims.

The U.S. District Court for the Southern District of Mississippi granted two medical device manufacturers’ motion to dismiss the breach of warranty and failure to warn claims brought by a man who was injured when, during a surgical procedure, the robotic arm of a surgical robot malfunctioned, but allowed the man to seek leave to file an amended complaint on those counts and dismissed the man’s implied-warranty claim with prejudice. The man sued the physician and the manufacturers asserting medical malpractice against the physician and strict liability and breach of warranty against the manufacturers. The manufacturers of the Globus Excelsius GPS (EGPS) surgical robot, Globus Medical Inc. (Globus Medical) and Globus Medical North America, Inc. (GMNA), filed a motion to dismiss the claims against them. After considering all of the arguments presented, the court dismissed the man’s implied-warranty claim with prejudice, dismissed his express-warranty and failure-to-warn claims without prejudice, while his design-defect and manufacturing-defect claims survive the manufacturers’ motion to dismiss (Nalder v. Walsh, M.D. , No. 3:25-CV-933-DPJ-Ash (S.D. Miss. July 9, 2026)).

Background. The man, who began experiencing back pain in 2024, was examined by a physician that recommended a minimally invasive transforaminal lumbar interbody fusion. The physician, who performed the surgery on January 16, 2025, used the EGPS manufactured by Globus Medical and GMNA to place multiple pedicle screws in the man’s back. After the surgery, the physician told the man that the robotic arm had malfunctioned and a pedicle screw was drilled in the wrong location. She explained that the device re-diagrammed itself onto the incorrect vertebrae, causing her to initially misplace the screw requiring her to reposition the screw during the surgery. Before discharging the man, the physicians conducted a neurological evaluation and found that the man’s right foot was weak without reflection.

Court’s analysis. Globus Medical and GMNA argued that the man failed to state a claim because he omitted any reference to the Mississippi Products Liability Act (MPLA) and whether the man stated a claim under the MPLA. The court concluded that even though the man did not cite the MPLA, the omission is not fatal because the complaint includes allegations under his strict liability header track the MPLA and, thus, rejected Globus Medical and GMNA’s regarding the man’s failure to cite the MPLA.

MPLA claims. The court explained that the man must show that the product was defective when it left control of the manufacturer, designer, or seller. Defects include (1) deviation from design specifications, (2) failure to adequately warn, (3) defective design, or (4) breach of an express warranty. A plaintiff must also prove that the defective condition rendered the product unreasonably dangerous to the user or consumer and the defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought. The court found that the man alleged that the EGPS surgical robot was defective in every way the MPLA recognizes.

Specifically, the man includes two well-pleaded facts, (1) the surgeon observed the EGPS malfunction, specifically, that the EGPS re-diagrammed itself causing her to misplace the pedicle screw twice during the surgery and (2) the Food and Drug Administration (FDA) sent Globus Medical a warning letter on July 15, 2024, regarding compliance issues related to its EGPS surgical robot six months before the EGPS allegedly malfunctioned by misplacing screws during the man’s surgery. While the man contends that the letter offers non-conclusory facts making a defect plausible, Globus Medical and GMNA argued that the letter merely addresses compliance issues and does not accuse the manufacturers of manufacturing a defective product.

The court found that the FDA letter does more than Globus Medical and GMNA acknowledged stating that the letter cites Globus Medical for failing to comply with various federal requirements, noting numerous alleged violations related to the failure to investigate complaints or properly report them; but the court pointed out that it is what Globus Medical failed to investigate or properly report that matters for this motion.

Design and manufacturing claims. The court stated that Globus Medical and GMNA correctly noted that Nalder did not plead key facts he may need to ultimately prove that the EGPS was defectively designed or manufactured. Specifically, to show a manufacturing defect, he would need to prove the EGPS deviated in a material way from the manufacturers or designers’ specifications or from otherwise identical units manufactured to the same manufacturing specifications. For his design defect claim to survive, he would need to prove that when the product was sold there existed a feasible design alternative that would have to a reasonable probability prevented the harm. To prove his defect design and manufacturing claims, the court stated that the man must merely nudge his claims across the line from conceivable to plausible allowing the court to make reasonable inferences, drawing on its judicial experience and common sense. However, the court found that the non-conclusory facts raise a reasonable expectation that discovery will reveal evidence of the necessary claims or elements. Thus, Globus Medical and GMNAs’ motion to dismiss the design and manufacturing claims denied.

Failure to warn. The man also claimed that Globus Medical and GMNA failed to include adequate warnings about the EGPS’s potential to re-diagram. He contended an ordinary user like the physician would not realize the EGPS’s dangerous condition. The court explained that Mississippi follows the learned-intermediary doctrine, which provides that a manufacturer’s failure to warn the patient of the product’s risks does not render the product defective or unreasonably dangerous so long as the manufacturer adequately warns the learned intermediary. The doctrine applies to medical devices as well as prescription drugs. The court found that the Complaint failed to identify the warnings that gave Globus Medical and GMNA gave. Without knowing that, the court could not say whether it is plausible that the physician would not have used the EGPS had she received a different warning. The omission is fatal because a failure-to-warn claim is not completely stated when it doesn’t allege a plaintiff’s physician would not have used the medical device had there been an adequate warning. The court stated that although the failure to warn claim falls short of the pleading standard, the man should be given the opportunity to plead his best case. Therefore, the court dismissed the failure to warn claim without prejudice.

Breach of warranties. The man claimed that Globus Medical and GMNA breached an express warranty or failed to conform to other express factual representations that the EGPS device was sufficiently capable of aiding surgeons in the placement of surgical screws but failed to identify the express warranties they allegedly breached. Thus, the man did not plead facts showing a plausible claim. The court granted Globus Medical and GMNA’s motion to dismiss the express warranty claim without prejudice.

The case is No. 3:25-CV-933-DPJ-Ash.

Judge: Jordan, D.

Attorneys: Walter C. Morrison, IV (Gainsburgh, Benjamin, David, Meunier & Warshauer, LLC) for Maxwell D. Nalder. Cecil Maison Heidelberg (Heidelberg Patterson Welch Wright, PLLC) for Kelsey A. Walsh, M.D. Michael Casey Williams (Bradley Arant Boult Cummings, LLP) for Globus Medical, Inc. and Globus Medical North America, Inc.

Companies: Globus Medical, Inc.; Globus Medical North America, Inc.

Cases: CaseDecisions MDeviceNews PLDeviceNews MississippiNews