FCA Alert

FCA Alert

Tag Archives: medical device

D. Mass Grants Rule 9(b) Motion to Dismiss in Medical Device Case

Posted in Rule 9(b) Decisions
Last week we reported on the denial of Orthofix’s motion to dismiss the complaint of the relator, Jeffrey Bierman, on Rule 9(b) grounds in United States ex rel. Bierman v. Orthofix International, N.V. et al., Civil Action Nos. 05-10557-EFH, 08-11336-JLT, 2010 WL 4973635 (D. Mass.).  Bierman’s action is consolidated with another action against Orthofix brought … Continue Reading

D. Mass. Denies Rule 9(b) Motion To Dismiss In Medical Device Case

Posted in Rule 9(b) Decisions
Yesterday, we discussed the district court’s basis for denying the Rule 12(b)(6) motions to dismiss made by several medical device manufacturers in the Orthofix case pending in the District of Massachusetts.  Today, we examine the second part of the court’s opinion which addressed defendants’ motion to dismiss for failure to plead fraud with particularity under … Continue Reading

Can a Manufacturer Be Held Liable Under the False Claims Act if It Delivers Defective Medical Devices to the Government?

Posted in Decisions Interpreting FCA Elements
Since the mid-late 1990s, plaintiffs have been testing the limits of the False Claims Act in health care litigation and have been asserting increasingly creative and far-fetched theories of liability against drug and device companies for various types of alleged conduct, including deceptive marketing practices, off-label marketing, failure to pay the appropriate Medicaid rebate, and … Continue Reading
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