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United States ex rel. Nargol v. DePuy Orthopaedics, Inc.

Citations: 159 F. Supp. 3d 226; 93 Fed. R. Serv. 3d 1819; 2016 U.S. Dist. LEXIS 12205; 2016 WL 407064Docket: Civil Action No. 12-10896-FDS

Court: District Court, D. Massachusetts; February 1, 2016; Federal District Court

Narrative Opinion Summary

In this case, orthopedic surgeons initiated a qui tam action under the False Claims Act (FCA) against DePuy Orthopaedics, Inc., and others, alleging fraudulent claims related to the Pinnacle metal-on-metal hip replacement device. The relators claimed DePuy misrepresented the device's failure rates, leading to false claims submitted to government programs. After the government declined to intervene, the relators filed a Second Amended Complaint (SAC) specifying four FCA-related counts. DePuy moved to dismiss the SAC, arguing it failed to meet the heightened pleading standards for fraud under Rule 9(b). The court granted DePuy's motion, emphasizing the SAC's lack of specific details necessary to substantiate FCA claims, such as dates and identification of the false claims made. The court also dismissed the conspiracy claim, as a corporation cannot legally conspire with its own employees, and the state FCA claims due to similar deficiencies in pleading. Additionally, the court deferred judgment on the implied certification theory, pending Supreme Court guidance. The relators' request to amend the SAC further was denied due to undue delay and insufficient justification. Consequently, the court dismissed the case with prejudice and ordered the unsealing of certain documents.

Legal Issues Addressed

Conspiracy Claims under the False Claims Act

Application: The conspiracy claim against DePuy was dismissed as a corporation cannot conspire with its own employees, adhering to established legal precedent.

Reasoning: DePuy argues that the conspiracy claim should be dismissed, citing legal precedent that a corporation cannot conspire with its own officers or employees.

False Claims Act - Materiality and Specificity Requirements

Application: The relators' SAC was dismissed due to the failure to meet Rule 9(b) specificity requirements, lacking details on the alleged false claims related to the Pinnacle MoM device.

Reasoning: Relators must provide specific allegations regarding false claims under the False Claims Act (FCA), detailing the 'who, what, when, where, and how' of the alleged fraudulent activity.

Implied Certification under the False Claims Act

Application: The court deferred judgment on the implied certification theory until the Supreme Court provides clarity, affecting DePuy's motion to dismiss under Rule 12(b)(6).

Reasoning: The Court indicates that it may need to defer judgment on DePuy’s motion to dismiss under Rule 12(b)(6) until the Supreme Court clarifies the validity of the implied-certification theory, particularly as established in Escobar by the First Circuit.

Motion to Dismiss under Fed. R. Civ. P. 9(b) and 12(b)(6)

Application: DePuy's motion to dismiss was granted as the SAC did not meet the heightened pleading standards for fraud, lacking specificity about the actual false claims submitted.

Reasoning: DePuy argues that the FCA claims should be dismissed for failing to satisfy the heightened pleading requirements of Federal Rule of Civil Procedure 9(b), which mandates specificity in fraud allegations.

State and Municipal False Claims Act Analogues

Application: The state and municipal FCA claims were dismissed due to non-compliance with Rule 9(b), except for California and New York, which also lacked specificity.

Reasoning: DePuy's motion to dismiss the state and municipal FCA claims (Counts Four through Thirty-Seven) is granted for non-compliance with Rule 9(b).