Dismissal of Masimo Whistleblower Suit Upheld
The 9th Circuit Court of Appeals has affirmed a California federal court award of summary judgment to Masimo Corp. throwing out a whistleblower suit brought by three former company sales representatives. The whistleblowers had contended that the company violated the False Claims Act by failing to inform FDA that clinical use of its Pronto pulse oximeter devices demonstrated less accuracy than the specifications cleared by the agency.
“The information Masimo submitted to FDA correctly stated the accuracy ranges at which the devices had been validated in laboratory testing…,” the appeals court decision says. “Relators (the sales representatives) have pointed to no evidence undermining either the studies or test results underpinning these accuracy specifications.”
The three-judge panel ruling rejected each of the whistleblowers’ arguments and said there was no evidence submitted to show that the company knowingly made false statements about its devices.