On February 24, 2026, the Second Circuit affirmed the Eastern District of New York’s dismissal of a qui tam action brought against Siemens Medical Solutions USA, Inc. (“Siemens”). The relator alleged that Siemens delivered defective medical devices to patients, but the claims were dismissed for failure to plead even a single example of a defective shipment.
The relator brought suit against Siemens under the False Claims Act (“FCA”) and the United States declined to intervene. According to the relator’s allegations, Siemens submitted and caused others to submit false claims to the government related to in vitro diagnostic devices (“IVDs”). Because IVDs are temperature-sensitive and may malfunction if exposed to excessive heat or cold, relator alleged that Siemens systematically delivered unreliable IVDs by shipping them at improper temperatures.
On April 9, 2025, the district court dismissed the relator’s Second Amended Complaint for failure to allege with sufficient specificity that Siemens’ shipping practices actually compromised any IVDs. On appeal, the Second Circuit agreed. Applying Rule 9(b)’s requirement that FCA plaintiffs plead the “who, what, when, where, and how” of the alleged fraud, the Court found the relator’s complaint fatally deficient. While the relator alleged that Siemens systematically exposed all of its IVDs to improper temperatures, she failed to allege any “single example of an IVD that was actually rendered unreliable because Siemens shipped it to a customer at improper temperatures.” Reiterating circuit precedent that requires whistleblowers to identify specific instances of falsity, the Court stated, “Siemens sold millions of IVDs in the relevant time period, all of which [r]elator theorizes were shipped defectively. But [r]elator fails to specify a single example of a defective shipment, so she has not made plausible allegations creating a strong inference that specific false claims were submitted to the government.”
The Second Circuit also rejected the relator’s alternative theories that Siemens falsely certified compliance or caused civilian customers to submit fraudulent claims to the government. The Court found that the relator merely “speculate[d] that some IVDs shipped to the government may have become unreliable” without “sufficiently alleg[ing] that Siemens deprived the government of the intended benefits of its contracts.” As to the civilian-customers theory, the court ruled that the relator failed to identify any Siemens customer who actually submitted an IVD claim to the government, instead relying on the assumption that because Siemens sells so many devices, a reimbursement claim must have reached the government at some point.
A copy of the Second Circuit’s summary order is available here.
