Rule 9(b) in FCA Product-Defect/Shipping Theories Requires a Concrete, Identifiable Compromised Item or Claim

Introduction

In Wood v. Siemens (2d Cir. Feb. 24, 2026) (summary order), relator Mary Bixler Wood brought a qui tam action under the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq., and state analogs against Siemens entities that manufacture and distribute in vitro diagnostic devices (“IVDs”).

The relator’s central theory was not that Siemens billed the government for a particular known defective IVD, but that Siemens’s allegedly “cheap shipping solutions” caused systematic temperature excursions that rendered IVDs “dangerously unreliable,” and that Siemens thereby submitted (or caused others to submit) false claims to government payors by representing IVD reliability while delivering compromised products.

The district court dismissed the Second Amended Complaint under Rules 12(b)(6) and 9(b), concluding that the relator failed to plead with particularity that Siemens’s shipping practices compromised any IVDs for which claims were actually submitted. On appeal, the Second Circuit affirmed, holding that the complaint’s theory remained too abstract and speculative to satisfy Rule 9(b)’s heightened particularity requirement for FCA fraud claims.

Summary of the Opinion

  • The Second Circuit affirmed dismissal because Wood did not plead a single concrete example of an IVD that was actually rendered unreliable due to temperature exposure in shipping, and therefore did not allege the “who, what, when, where, and how” of the alleged fraud.
  • Reliance on internal and consultant studies indicating that temperature excursions can affect IVD performance did not bridge the gap to pleading that Siemens shipped specific IVDs that were compromised and tied to specific claims for government payment.
  • “Information and belief” pleading failed because it did not create a strong inference that specific false claims were submitted.
  • Alternative theories—false certification of compliance and causing customers to submit Medicare reimbursement claims—also failed for lack of particularized allegations (including materiality and identification of specific claims/customers).
  • Having dismissed the federal FCA claims, the district court properly declined supplemental jurisdiction over state-law claims.
  • The court did not reach Siemens’s argument that qui tam suits are unconstitutional.

Analysis

Precedents Cited

United States v. Strock, 982 F.3d 51 (2d Cir. 2020)

The panel invoked United States v. Strock for the standard of review: a Rule 12(b)(6) dismissal is reviewed de novo, accepting factual allegations as true and drawing reasonable inferences in the plaintiff’s favor. While not unique to the FCA, this framing matters in FCA cases because courts must separate well-pleaded facts (assumed true) from conclusory assertions of falsity and causation (not entitled to the same deference).

Miller v. United States ex rel. Miller, 110 F.4th 533 (2d Cir. 2024)

Miller v. United States ex rel. Miller supplied the governing Rule 9(b) articulation: FCA claims are subject to heightened particularity, requiring the relator to plead the “who, what, when, where, and how” of the fraud—“the first paragraph of any newspaper story.” The court used Miller as a direct comparator: just as a complaint alleging altered compliance reports failed where it did not identify specific altered statements or reports, Wood’s complaint failed where it did not identify specific compromised IVD shipments, specific false representations connected to those shipments, or specific payment claims.

The decision thus reinforces that, in the Second Circuit, Rule 9(b) is not satisfied by pleading a plausible mechanism of misconduct at scale (e.g., “systematic temperature excursions”) without tying that mechanism to an identifiable fraudulent claim transaction (or a sufficiently detailed substitute for a claim transaction).

United States ex rel. Chorches for Bankr. Est. of Fabula v. Am. Med. Response, Inc., 865 F.3d 71 (2d Cir. 2017)

United States ex rel. Chorches for Bankr. Est. of Fabula v. Am. Med. Response, Inc. played two roles.

  1. Information-and-belief pleading constraint: The panel quoted Chorches for the rule that a relator may plead on information and belief only if they allege facts supporting a strong inference of fraud and those facts are peculiarly within the defendant’s knowledge. Here, the court found Wood’s allegations did not create a “strong inference” that specific false claims were submitted.
  2. What particularity can look like: The panel contrasted Wood’s complaint with Chorches, where dismissal was reversed because the complaint described ten specific instances in which an employee was directed to falsify patient care reports. That contrast underscored the panel’s view that Wood’s case lacked comparable “anchoring events” (specific shipments, specific failed temperature maintenance, specific resulting unreliability, and specific claims or reimbursements).

Doe 1 v. EviCore Healthcare MSI, LLC, No. 22-530-cv, 2023 WL 2249577 (2d Cir. Feb. 28, 2023) (summary order)

The panel cited Doe 1 v. EviCore Healthcare MSI, LLC for a parallel pleading failure: allegations of a fraudulent scheme were insufficient where the complaint did not identify even one specific instance—there, a fraudulent or unnecessary medical procedure for a particular patient on a particular date. That analogy reinforced a consistent Second Circuit theme: Rule 9(b) often requires at least one concrete exemplar transaction illustrating the alleged fraud, particularly where the relator does not possess billing records but claims pervasive misconduct.

United States ex rel. Foreman v. AECOM, 19 F.4th 85 (2d Cir. 2021)

United States ex rel. Foreman v. AECOM was used to reject Wood’s alternative “false certification” theory on materiality. The panel reasoned that Wood’s allegations—at bottom, speculation that some IVDs shipped to the government “may have become unreliable”—did not plausibly show that Siemens deprived the government of the intended benefit of its bargain, and therefore did not plausibly establish that any noncompliance was material to the government’s payment decision. By invoking Foreman, the court emphasized that FCA liability is not triggered by regulatory or contractual deviations in the abstract; the relator must plausibly connect noncompliance to payment significance (and, under Rule 9(b), do so with particularity when the claim sounds in fraud).

Motorola Credit Corp. v. Uzan, 388 F.3d 39 (2d Cir. 2004)

After affirming dismissal of the federal claims, the panel cited Motorola Credit Corp. v. Uzan to uphold the district court’s discretionary decision to decline supplemental jurisdiction over state-law claims—restating the general proposition that when all federal claims are dismissed before trial, state claims should usually be dismissed as well.

Legal Reasoning

The court’s reasoning proceeds in a structured Rule 9(b) sequence:

  1. FCA liability requires a “false or fraudulent claim” (or a false statement material to such a claim): The panel began with the statute—31 U.S.C. § 3729(a)(1)(A)-(B)—framing the core requirement that the defendant presented (or caused to be presented) a false claim for payment, or used a false record/statement material to such a claim.
  2. Rule 9(b) applies and demands particularity: Citing Miller, the court reiterated the “who, what, when, where, and how” requirement. In practice, that means a relator must plead identifiable conduct tied to identifiable claims, not merely a plausible story that claims must have been false given a hypothesized systemic problem.
  3. Mechanism evidence (studies) is not transaction evidence (compromised product tied to a claim): Wood’s internal/consultant studies plausibly suggested risk—that temperature excursions can occur and can affect IVD functionality. The court treated that as insufficient because the complaint did not allege any actual IVD made unreliable by shipping conditions—leaving the “fraud” unmoored from a concrete misrepresentation in connection with payment.
  4. Information-and-belief allegations must still point to specific false claims: Even assuming details of shipping logistics were within Siemens’s knowledge, the complaint still needed “specific facts” that create a strong inference that specific false claims were submitted. Without at least one example shipment, customer, affected IVD lot, time window, destination, or associated government reimbursement, the pleading did not cross the line from possibility to strong inference.
  5. Alternative theories failed for the same reason—lack of particularity and materiality: (a) Under a false certification theory, Wood did not plausibly allege that any alleged noncompliance was material to payment (invoking Foreman). (b) Under a “caused customers to submit Medicare claims” theory, Wood did not identify any customer who submitted a claim; she alleged only that, given Siemens’s volume, a claim must have “reach[ed] the governmental insurers” at some point—an inferential leap the panel held inadequate under Rule 9(b), citing Chorches.
  6. State claims properly dismissed once federal anchor claims were gone: Applying Motorola Credit Corp. v. Uzan, the panel found no abuse of discretion in declining supplemental jurisdiction.

Notably, the panel affirmed solely on pleading grounds and therefore did not engage (and expressly declined to address) Siemens’s constitutional argument about qui tam suits.

Impact

Although designated a nonprecedential “summary order,” Wood v. Siemens is a clear signal of how the Second Circuit expects Rule 9(b) to operate in FCA cases involving alleged product unreliability arising from systemic processes (such as shipping, storage, manufacturing controls, or quality systems). Likely practical effects include:

  • Higher pleading burden for “systemic defect” theories: Relators should expect dismissal if they cannot plead at least one concrete, traceable instance linking the alleged systemic practice to an actually compromised product and an actual (or adequately detailed) false claim for payment.
  • Studies and risk assessments are insufficient without linkage facts: Internal testing and consultant reports may support scienter or risk, but they will not substitute for allegations connecting the risk to real-world compromised performance tied to billed items.
  • Pressure to plead exemplar transactions: Complaints are more likely to survive where they include representative examples (specific shipment dates/lanes, container type, temperature data logs, lot numbers, customer sites, malfunctions traced to shipping, and reimbursement paths).
  • Materiality remains a gatekeeper for certification theories: Even if noncompliance is plausibly alleged, relators must still plead why it mattered to the government’s payment decision, not merely that it violated a term or expectation.
  • Downstream-claim (“caused others to submit”) theories require identifying downstream claim activity: Volume-based speculation that claims “must” have been submitted is unlikely to satisfy Rule 9(b) without identifying at least one customer/claim or facts that strongly imply specific claim submissions.

Complex Concepts Simplified

False Claims Act (FCA)
A federal statute imposing liability for knowingly submitting (or causing submission of) false claims for government payment, or using false statements material to such claims.
Qui tam / Relator
A private person (the relator) may sue on behalf of the government for FCA violations and potentially share in any recovery. Here, the government and states declined to intervene.
Rule 12(b)(6)
A motion to dismiss for failure to state a claim—testing whether the complaint plausibly alleges a legal claim, assuming well-pleaded facts are true.
Rule 9(b) “particularity”
A heightened pleading rule for fraud allegations requiring specific detail: who did what, when, where, and how. In FCA cases, this often means pleading details about specific false claims or concrete representative examples.
Information and belief pleading
Alleging facts based on inference rather than direct knowledge. It is permitted in limited circumstances, but the plaintiff must still provide specific supporting facts that strongly suggest fraud and explain why key details are uniquely in the defendant’s possession.
Materiality
The idea that a misrepresentation must matter to the government’s decision to pay. A technical violation that would not affect payment is typically not enough for FCA liability.
Supplemental jurisdiction
A federal court’s discretion to hear state-law claims connected to federal claims. When the federal claims are dismissed early, courts commonly dismiss state claims too.

Conclusion

Wood v. Siemens reinforces a demanding application of Rule 9(b) in FCA cases: alleging a plausible systemic practice that could create defective products is not enough without pleading at least one concrete instance tying that practice to an actually compromised product and an identifiable false claim (or a comparably particularized substitute). The decision also underscores that alternative FCA theories—false certification and “caused submission” of downstream claims—require particularized allegations of materiality and actual claim submission, not volume-based speculation. Finally, it reiterates the standard approach to dismissing state-law claims once the federal anchor claims fall out at the pleading stage.