Intuitive Surgical Sued by Shareholders Over Withheld Complications

by Searcy Denney Scarola Barnhart & Shipley

Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci.

The 67-page shareholder derivative complaint was filed by the city of Birmingham and Alabama’s Relief and Retirement System naming Intuitive Surgical of Sunnyvale, California, the maker of the device, reports Courthouse News.

The da Vinci robot is expensive, anywhere from $1 million to $2.3 million, and is the only product made by Intuitive, which also derives its profits from sales of the accessories to the device.

Intuitive’s chief financial officer and nine-member board of directors are all named in the lawsuit.

The da Vinci was originally approved by the U.S. Food and Drug Administration (FDA) under its 510(k) approval process. Initially the medical device was used for laparoscopic surgeries but the FDA expanded use of the da Vinci for some cardiac surgeries and certain urologic surgeries such as hysterectomy and prostatectomy.

Under FDA regulations, the manufacturer is supposed to alert the agency if there are any injuries or fatalities associated with a device as well as any company-initiated voluntary recalls. Upon a patient death, for example, the maker has 30-days to alert the FDA. It must investigate the death and report the circumstances back to the FDA.

In other words, it is entirely in the hands of the medical device company to report on itself.

What kind of complications went underreported? The da Vinci operates using tip covers fitted to the end of the surgical scissors. They are geared to prevent any electricity, used to cut tissue, from hitting tissue next to the surgical site.

According to the shareholders claim, Intuitive hid reports of the tip cover malfunctions “resulting in burning of the patient’s internal tissue.” CNBC reports that one patient said she suffered excrutiating pain following her uterine fibroid surgery when electrical burns perforated her small intestine. Another woman had her uterus burned by the da Vinci robotic tip.

There have also been several deaths. One woman, undergoing a da Vinci procedure for cervical cancer, died eleven days after suffering small bowel damage during the procedure.

Intuitive underreported these deaths or seriously misclassified them as “other” to the FDA’s MAUDE database of adverse events, says the complaint, and the company had knowledge of the defective tips years earlier but failed to report that information to the FDA.

A published article in the Journal for Healthcare Quality reported last September that this severe underreporting took place from January 2000 to August 2012. When the numbers were recalculated, there were actually 9,839 incidents and approximately 62 deaths or injury reports occurred from September 2012 to December 2013 alone.

Top executives also reportedly sold off stock when it traded at “an artificially inflated value” says the complaint, just as the FDA began its inquiry. After the FDA launched a safety probe into Intuitive, its stock price fell from $573 to $392 a share.

There are presently about 80 product liability lawsuits pending against Intuitive for its da Vinci robot medical device and the company has been sued by two insurers.

The Intuitive Surgical da Vinci robot was approved under the FDA’s 510(k) clearance process in April 2011. As we’ve reported here many time, the 510(k) has allowed thousands of medical devices onto the market with no clinical trials to assure human safety. Also approved via 510(k) was the recalled DePuy ASR, a metal-on-metal hip implant.

Instead of putting patient safety first, manufacturers currently operate under FDA guidelines that were established in 1997 that impose the “least burdensome” standard on industry, allowing it to bring new products to the market with the least amount of interference.

A 2011 Institute of Medicine report concluded that the 510(k) process needed to be abolished. Clearly that would be a step in the right direction for all consumers and patients.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Searcy Denney Scarola Barnhart & Shipley | Attorney Advertising

Written by:

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Scarola Barnhart & Shipley on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.