In re Intuitive Surgical Shareholder Derivative Litigation

146 F. Supp. 3d 1106, 2015 U.S. Dist. LEXIS 155524, 2015 WL 7180666
CourtDistrict Court, N.D. California
DecidedNovember 16, 2015
DocketCase No. 5:14-cv-00515-EJD
StatusPublished
Cited by5 cases

This text of 146 F. Supp. 3d 1106 (In re Intuitive Surgical Shareholder Derivative Litigation) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Intuitive Surgical Shareholder Derivative Litigation, 146 F. Supp. 3d 1106, 2015 U.S. Dist. LEXIS 155524, 2015 WL 7180666 (N.D. Cal. 2015).

Opinion

[1109]*1109ORDER DENYING MOTION TO DISMISS

EDWARD J. DAVILA, United States District Judge

' Lead Plaintiff Robert Berg. (“Plaintiff’) filed- the instant shareholder derivative ac[1110]*1110tion for the benefit of Nominal Defendant Intuitive Surgical, Inc. (“Intuitive”) against certain members of the board of directors and senior management team (collectively, “Defendants”). Plaintiff alleges that since 2011, Defendants breached their fiduciary duties and committed serious misconduct when they knowingly failed to comply with the Food and Drug Administration’s (“FDA”) regulations, knowingly failed to establish sufficient internal controls to comply with FDA regulations, and participated in insider trading. Presently before the court is Defendants’ Motion to Dismiss pursuant to Federal Rules of Civil Procedure 23.1 and 12(b)(6). See Dkt. No. 64.

Federal jurisdiction arises pursuant to 28 U.S.C, § 1332(a). The court found this matter suitable for decision without oral argument pursuant to Civil Local Rule 7-1(b) and vacated the associated hearing. Having carefully considered the parties’ pleadings, the court finds Plaintiffs arguments meritorious. Therefore, the Motion to Dismiss will be denied for the reasons explained below.

I. BACKGROUND

A. The da Vinci System Defect

Intuitive is a company incorporated in the State of Delaware that designs, manufactures, and markets the da Vinci surgical system (“da Vinci system”), and related instruments and accessories. Compl., Dkt. Nos. 50-4 (filed under seal), 61 at ¶ 3. The da Vinci system translates a surgeon’s natural hand movements, which are performed on instrument controls at a console, into corresponding micro-movements of instruments positioned inside the patient through small incision or ports. Id. at ¶ 4. Using the da Vinci system, surgeons can perform operations remotely using tiny instruments attached to robot arms that are threaded into a patient’s body through small incisions. Id. at ¶ 5. The da Vinci system is Intuitive’s flagship product. Id. at ¶¶ 3.

Certain instruments used by the da Vin-ci system carry an electrical charge. Id. at ¶¶7, 87. The charged portions of the instruments are insulated with a device called the “tip cover,” which is a silicon and plastic sheath intended to prevent electricity from escaping the intended area. Id. However, due to a design flaw in the da Vinci system, the tip covers can fail to sustain wear and tear, causing surgeons to inadvertently crack the tip covers during procedures when they clean instruments by scraping one against another. Id. at ¶¶ 7, 88. If a tip cover is compromised, the electricity “arcs” from the instrument into the patient’s body. Id. This “arcing” can cause dangerous burns and puncture internal organs, and is particularly dangerous when surgeons are unaware of the problem given the limitations on their field of view through the console. Id. at ¶¶ 7, 88-89.

Plaintiff alleges that by mid-2011, the surgical community began to learn about the da Vinci system defects. Id. at ¶ 91. In January 2011, doctors associated with The Ohio State University Medical Center Department of Urology published an article in the Journal of Urology discussing failures in the accessory tip covers, and finding that such failures were discovered at a rate of 2.6%. Id. at ¶¶ 91, 212(b). Similarly, in August 2011, doctors associated with the Hospital Quiron Madrid, Santa Creu I Sant Pau, Barcelona, and Mayo Clinic in Arizona published an article in the American Journal of Obstetrics & Gynecology discussing insulation failure, and finding that such failure occurred in “robotic” la-paroscopic surgery at a rate of approximately 4-1 when compared to traditional laparoscopic procedures. Id. at ¶¶ 92, 212(b).

[1111]*1111B. Intuitive’s Recalls of the da Vinci System

Plaintiff alleges that since 2011, Intuitive’s board of directors and senior management team knew of this defect in the da Vinci system, which caused hundreds of serious injuries and dozens of fatalities. Id. at ¶6, 8. Consequently, Defendants authorized or turned a blind eye to three covert corrective actions, or “recalls,” that occurred in October 2011. Id. at ¶ 101.

The first recall was in response to the injuries caused by the da Vinci system’s tip cover accessory. Id. at ¶ 102. Plaintiff alleges that under Defendants’ direction, Intuitive sent a letter to hospitals and surgeons to whom it had sold the da Vinci system providing them with suggestions and recommendations for the proper use of instruments with tip covers. Id. Later, during an FDA investigation, the FDA found this letter constituted a “Class II” recall that should have been reported to the FDA, but Intuitive failed to do so. Id.

The second recall was in response to off-label marketing. Plaintiff alleges .that under Defendants’ direction, Intuitive sent a letter to da Vinci system owners stating that the da Vinci system was not approved for thyroidectomies even though Intuitive had previously made misleading claims suggesting that it was approved for such procedure. Id. at ¶ 103. Later, the FDA found this letter constituted a “Class II” recall that should have been reported to the FDA, but Intuitive failed to do so. Id. at ¶ 104.

The third recall was in response to cannula inspection related to the tip cover defect. Plaintiff alleges that Intuitive sent a letter to da Vinci system owners providing information about the inspection of cannulas, the flushing of instruments, and the transportation of da Vinci systems between buildings. Id. at ¶ 105. Later, the FDA also found this letter to constitute a “Class II” recall that should have been reported to the FDA, but Intuitive failed to do so. Id.

[redacted text]

C. Violation of FDA Regulations

The da Vinci system is a “Class II” medical device, which makes it subject to an intermediate level of scrutiny and regulation by the FDA. Id. at ¶ 68. When the da Vinci system first came to market, it was subjected to a rigorous approval process and remained so each time the circumstances of the device changed or expanded, referred to as an “indication.” Id. at ¶69. As such, Intuitive is subject to mandatory reporting pursuant to FDA Regulation 21 C.F.R. § 803. Id. at ¶ 94. If Intuitive failed to comply with these regulations, the FDA could institute a variety of enforcement actions including a regulatory letter, a public warning letter, and severe civil and criminal sanctions. Id. at ¶ 72.

Plaintiff alleges Intuitive violated FDA regulations in three ways. First, pursuant to FDA regulations, if a medical device causes or contributes to a death or serious injury, the user of the medical device (i.e., the hospital) must make a Medical Device Report (“MDR”) to the manufacturer. Id. at ¶ 95. In turn, the manufacturer is required to make an MDR reporting to the FDA. Id. at ¶¶ 8, 70, 96. The manufacturer is also required to investigate the adverse event to understand the underlying causes, and supplement any initial MDR sent to the FDA. Id.

Plaintiff alleges that Intuitive either failed to report adverse events, or under reported them. Id. at ¶ 9.

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Bluebook (online)
146 F. Supp. 3d 1106, 2015 U.S. Dist. LEXIS 155524, 2015 WL 7180666, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-intuitive-surgical-shareholder-derivative-litigation-cand-2015.