United States: Ninth Circuit Rejects FCA Suit Alleging Medical Device Inaccuracies

In United States ex rel. Ruhe v. Masimo Corp., 640 Fed. App’x 666 (9th Cir. 2016), the Court of Appeals for the Ninth Circuit affirmed a grant of summary judgment for defendant Masimo Corporation, a medical device manufacturer. The relators in this False Claims Act (“FCA”) case had alleged that Masimo made fraudulent statements about the accuracy of the company’s pulse oximeter devices, rendering false any subsequent claims for payment to federal health care programs relating to the devices. The Ninth Circuit rejected those claims outright, holding that the relators had presented no evidence of false statements to customers or to the Food & Drug Administration (“FDA”), and no evidence of the required scienter.


Masimo manufactures and develops pulse oximeters, medical devices that measure blood characteristics. The products at issue in this litigation, known commercially as the Pronto devices, are oximeters capable of measuring both oxygen and total hemoglobin levels without drawing a blood sample. The Pronto devices are “point-of-care” tools that enable physicians to obtain real-time test results on-site without the need for laboratory tests. Such point-of-care devices are typically less accurate than laboratory tests, but carry the advantage of greater convenience and speed.

Between 2008 and 2011, the FDA cleared for marketing several iterations of the Pronto devices through the 510(k) premarket notification process. See 21 C.F.R. § 807 et seq.

The relators were Masimo sales representatives from 2009 until 2010, when they resigned allegedly over concerns about the Pronto devices’ performance. The relators reported their concerns in resignation letters to the company. Masimo responded by requesting additional information from the relators, conducting an internal investigation, and voluntarily notifying the FDA of the allegations. The relators then filed suit under the FCA.

On February 2, 2011, FDA investigators arrived unannounced at Masimo to perform an audit inspection. The FDA concluded its inspection without taking any enforcement action.

The relators alleged that Masimo knowingly made false or fraudulent statements relating to the Pronto devices by misrepresenting validation study data that Masimo submitted to the FDA during the 510(k) process and by failing to inform the FDA that the Pronto devices were less accurate in clinical use than in laboratory conditions. Indeed, the relators alleged that the Pronto devices were so clinically inaccurate as to be effectively worthless. Finally, the relators alleged that Masimo had knowingly provided false information to the American Medical Association (“AMA”) when requesting the creation of new billing codes for use by healthcare providers who bill for the Pronto devices.

Ninth Circuit Decision

The Ninth Circuit affirmed in whole the District Court’s grant of summary judgment in Masimo’s favor. The Court of Appeals held that Masimo had not misled the FDA about the Pronto devices’ accuracy, because the information Masimo submitted to the FDA “correctly stated the accuracy ranges at which the devices had been validated in laboratory testing conducted pursuant to” the FDA’s recommended standards, and the relators “pointed to no evidence undermining either the studies or tests results underpinning these accuracy specifications.” 640 Fed. App’x at 668.

While the relators had pointed to evidence of some customer feedback on the Pronto devices’ accuracy and internal Masimo discussions about improving accuracy, the District Court’s earlier decision held that Masimo had “in no way concealed or misrepresented the [FDA-cleared] accuracy specification for its devices” as determined through lab tests. 977 F. Supp. 2d 981, 994 (C.D. Cal. 2013). The Court of Appeals agreed, holding that “[i]solated complaints and anecdotal feedback about the accuracy of the Pronto Devices do not support an inference that Masimo committed knowing fraud by continuing to sell the devices with a stated FDA-clearance accuracy specification.” The Court of Appeals also rejected the “worthless services” allegation, holding that the company had provided “unrebutted testimony that the Pronto devices have clinical utility even with accuracy deviations beyond those cleared by the FDA.” 640 Fed. App’x at 669.

The Ninth Circuit summarily rejected the relator’s allegations that Masimo had knowingly provided false information to the AMA, noting that Masimo had provided the AMA with copies of its 510(k) clearance materials and FDA-cleared product manuals.

Finally, the Ninth Circuit held that even if Masimo had made some kind of false statement to customers concerning the Pronto devices’ accuracy, the relators had nonetheless failed to submit evidence establishing scienter as required by the FCA. That ruling endorsed the District Court’s earlier determination that the relators “presented no evidence that Masimo did not have a good faith belief that its devices were accurate.” 977 F. Supp. 2d at 995. In so holding, the Ninth Circuit adopted the reasoning of Masimo’s counsel during oral argument that an FCA suit is “not a referendum about how good are [the] devices” but rather the pertinent question is “[d]id we lie? Did we have scienter to mislead, to cause false claims against the government?”


The Ninth Circuit’s opinion makes clear that the FCA is not a mechanism for whistleblowers to second-guess the FDA’s regulatory decision-making process. When medical device manufacturers are transparent with the agency through the pre-market approval or clearance procedures, relators face a steep challenge to undermine the agency’s safety and efficacy determinations in subsequent civil litigation.

The decision is also a further reminder that the FCA’s scienter requirements have real bite. To survive summary judgment, relators must identify more than data trends or scientific inaccuracies; they must identify evidence that the defendant failed to act in good faith and, in short, that the defendant lied.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.