On February 24, 2026, Patterson Belknap earned a significant victory on behalf of our client, Siemens Healthineers, in connection with a federal investigation and related False Claims Act (“FCA”) litigation concerning allegations about the shipment of its temperature‑sensitive in vitro diagnostic devices (“IVDs”). The U.S. Court of Appeals for the Second Circuit affirmed a January 2025 ruling from the U.S. District Court for the Eastern District of New York that dismissed the case, finding that the relator had failed to adequately allege an FCA claim because she had not identified even a single instance in which an IVD failed to perform as intended or otherwise became unreliable due to the manner in which they had been shipped. Patterson Belknap has represented Siemens Healthineers in this matter since it was initiated in 2016.

The litigation was first filed in the U.S. District Court for the Southern District of New York.  Following an extensive investigation, the government declined to intervene, and in September 2020—faced with the firm’s anticipated motion to dismiss—the relator voluntarily dismissed the action. In April 2021, the relator refiled a substantially identical complaint in the Eastern District of New York. After the government again declined to intervene, the firm moved to dismiss the complaint, arguing that the complaint failed to plead any false claims with particularity and failed to allege falsity or materiality under the FCA. The court granted Siemens Healthineers’ motion to dismiss in September 2023 and again in January 2025 after relator filed another amended complaint. After the relator’s motion for reconsideration was denied, she appealed to the U.S. Court of Appeals for the Second Circuit. In affirming the dismissal of the complaint, the Second Circuit held that the relator had failed to plead a viable claim under the FCA, because the complaint did “not allege a single example of an IVD that was actually rendered unreliable because Siemens [Healthineers] shipped it to a customer at improper temperatures.”

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