Consumer Fraud

Whistleblowers seek sanctions against medical device maker Masimo for concealing evidence

osha whistle Whistleblowers seek sanctions against medical device maker Masimo for concealing evidenceThree former sales representatives for California-based Masimo Corporation, who sued the company under the False Claims Act for allegedly promoting its defective patient-monitoring devices for off-label purposes and then billing government insurance programs for them, have asked a California judge to sanction the company, saying it is concealing evidence in the case and interfering with subpoenas.

The whistleblowers originally sued Massimo in October 2010 and amended their complaint in February 2011, alleging the company sold its Radical-7, Pronto, and Pront0-7 hemoglobin devices “despite the knowledge that the devices cannot measure hemoglobin … to the accuracy claimed by Masimo.” The company then “published misleading, inaccurate data that was selected without any validated basis concerning the accuracy of these devices,” the lawsuit claims.

The whistleblowers also claim that Masimo instructed its sales representatives to explain the devices’ inaccurate measurements by attributing them to standard deviation of 5 percent or less when the company knew that the rate of inaccuracy was much higher in reality.

In a motion submitted Sept. 17, the former sales representatives asked Judge Cormac Carney of the U.S. District Court for Central California to sanction Masimo for illegally hiding discovery requests and interfering with subpoenas to federal insurance programs seeking those documents.

According to Law 360, the whistleblowers “point to four specific pieces of information that they say Masimo wrongfully withheld: the company’s sales invoices, its contracts, the identities of agencies that purchased Masimo’s devices and advertising information used to elicit purchases.”

According to the plaintiffs, when sales information was subpoenaed from a WIC agency in one state, an in-house lawyer for Masimo contacted the agency “to offer assistance in responding to plaintiffs’ subpoena.” The attorney general in that state said she “felt compelled to advise relators’ counsel of this call because it was unusual for an attorney … to offer assistance in complying with a subpoena that attorney did not issue,” court documents state.

The sales representatives sued Masimo under the qui tam provisions of the False Claims Act, which allows private citizens with knowledge of fraud to bring civil actions on behalf of the government and to share in any recovery.


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