Masimo: Whistleblowers’ accusations not only false, but improper

Masimo: Whistleblowers' accusations not only false, but improper

Masimo (NSDQ:MASI) argued yesterday that whistleblowers’ allegations in a False Claims Act lawsuit, that the patient monitoring company withheld evidence and interfered with subpoenas, are not only untrue but deserving of sanction.

The whistleblowers, former sales reps for Irvine, Calif.-based Masimo, sued in October 2010, accusing Masimo of promoting off-label uses of its Pronto and Pronto-7 devices and improperly billing government insurance programs for the off-label uses, according to court documents.

The reps – Michael Ruhe, Kristine Serwitz and Vicente Catala – accused Masimo of withholding sales records and interfering with subpoenas issued to federal insurance programs seeking those documents, according to the filings.

They asked Judge Cormac Carney of the U.S. District Court for Central California to sanction Masimo for the alleged violations, seeking to quash or delay Masimo’s bid for summary judgment "because defendant’s misconduct prevented plaintiffs from being able to fully present facts essential to justify their opposition to the motion," according to the documents. They’re also seeking legal costs associated with "Masimo’s misconduct in withholding evidence," fines, corrections to the lawsuit’s record and want the trial jury informed of the alleged misconduct, according to court filings.

Ruhe, Serwitz and Catala accused Masimo of failing to produce evidence of "specific sales data" to government programs, alleging that "there are records showing a direct link between specific representations, including face-to-face meetings, and specific payments," according to the filings.

"The documents relators have obtained, and continue to obtain on an almost daily basis, through 3rd-party subpoenas and [Freedom of Information Act] requests of state [Special Supplemental Nutrition Program for Women, Infants & Children] agencies, show defendant has improperly refused to produce evidence of its marketing and sales of the SpHb devices to federally funded agencies," according to the filings. "Defendant had communications, via email, and in person, including with presentations, to various state agencies using federal money to cover claims for defendant’s products. Nevertheless, defendant knowingly withheld this information," according to the filings. "E-mails and contracts produced by WIC agencies identify evidence relators requested in discovery and that defendant is withholding concerning its representations about its devices and that defendant is withholding concerning its representations about its devices to government agencies that induced their purchases."

But Masimo argued yesterday that it has already provided voluminous evidence of its sales of the devices, including to the WIC agencies (which would only become relevant during the damages phase of the trial), and accused the whistleblowers of demanding documents Masimo had already produced.

"Relators continue to multiply these proceedings with meritless motions that waste resources and time," according to the documents, which allege that the whistleblowers "sought categories of documents that Masimo had already produced."

"In numerous instances, these documents had been produced to Relators several months before," Masimo said in the filings. "Relators’ accusations are designed to mask Relators’ own failure to diligently pursue discovery in the matter.

"Relators had every opportunity to pursue discovery since filing this case almost 3 years ago," Masimo added, according to the filings. "Relators’ allegations are unsupported by the record and, in any event, are insufficient to justify any sanctions – much less the outlandish laundry list of sanctions requested by relators. On the contrary, as Masimo has previously detailed, and as evidenced by the current Motion, it is relators who have vexatiously multiplied these proceedings and caused undue expense warranting sanctions."

And the accusation that Masimo also sought to interfere with the plaintiffs’ attempts to secure the documents through subpoenas and FOIA requests is baseless because it’s based on triple-hearsay, the company argued.

"Relators’ failure to identify either unidentified person parties in this triple-hearsay chain makes it impossible for Masimo to meaningfully respond," according to the documents. "The consequences of relators’ baseless filings and reckless allegations are not negligible. Relators’ actions continue to harm Masimo’s business and reputation, as this court has previously acknowledged. Masimo has done nothing improper, and has instead been forced time and again to defend itself in this litigation against relators’ wasteful motions caused by their own dilatory conduct."

RSS From Medical Design & Outsourcing

  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]
  • Continuous 225W with natural convection for medical type BF power supply
    Powerbox, a European power supply company, introduces new Medline 225 series ac and dc single output open frame converters for medical type BF applications. The new OFM225 with its 3 x 5 in. footprint and 1.5 in. height is designed for a continuous output power of 225W with natural convection and 40°C ambient temperature, increasing to […]
  • Using data science to achieve ultra-low dose CT image reconstruction
    Prof. Jeff Fessler and Prof. Yong Long, Ph.D. of the University of Michigan-Shanghai Jiao Tong University (UM-SJTU) Joint Institute are collaborating on a project to develop a dramatically improved approach to low-dose X-ray CT image formation by extracting and using information from a big-data corpus of regular dose X-Ray Computed Tomography (CT) images. The research is […]
  • New vented dust caps from Qosina prevent damage and contamination on a new level
    Qosina is pleased to announce the addition of eleven new soft TPE vented dust caps (#11300, #11301, #11320, #11330, #11331, #11340, #11341, #11350, #11360, #11361 and #11380) in stock and ready for immediate delivery. These components are available in a variety of colors including blue, green, red, white and yellow; sizes range from 0.187 in. […]
  • Nader Najafi: A dream that saves lives
    Miniature wireless sensing and computing devices have the potential to improve people’s health, even save lives. Twenty years ago, working on microelectromechanical systems (MEMS) as a student at Michigan, Dr. Nader Najafi had a dream to be part of this future reality. He turned that dream to action when he left a promising career at […]
  • PBC Linear’s guide for approved bearing inspection method
    Understanding the method to properly inspect the Frelon liner in PBC Linear’s Simplicity plain bearings is essential to taking full advantage of the product. The Frelon liner supplies numerous attributes that make it preferable in many unique applications; however, being a teflon-based material requires a different method of inspection: Approved Inspection Method: Pin Gauges (AKA: Go or […]
  • 3W to 10W DIP-24 DC-DC converters have medical certification
    TDK announces the introduction of the TDK-Lambda PXC-M series of DC-DC converters. Operating over a 4:1 input range, the 3W, 6W and 10W products are enclosed in the industry standard 1.25 x 0.8 x 0.4 in. DIP-24 package. Applications include a wide variety of medical applications and battery powered equipment. With a 5,000 Vac input […]
  • How do you mend a broken heart? By converting fat cells into stem cells that can help that vital organ repair itself
    Editor’s Note: This article is written by Jeannie Kever and discusses the recent research from the University of Houston. There has been little time to savor the successes of the moment as Dr. Robert Schwartz and members of his lab push relentlessly toward their goal. Their goal is to begin clinical trials that will showcase how common fat cells, treated […]

Leave a Reply