Westmoreland County Employee Retirement System v. Parkinson

727 F.3d 719, 2013 WL 4266586, 2013 U.S. App. LEXIS 17124
CourtCourt of Appeals for the Seventh Circuit
DecidedAugust 16, 2013
Docket12-3342
StatusPublished
Cited by41 cases

This text of 727 F.3d 719 (Westmoreland County Employee Retirement System v. Parkinson) is published on Counsel Stack Legal Research, covering Court of Appeals for the Seventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Westmoreland County Employee Retirement System v. Parkinson, 727 F.3d 719, 2013 WL 4266586, 2013 U.S. App. LEXIS 17124 (7th Cir. 2013).

Opinion

WOOD, Circuit Judge.

This is a shareholder derivative suit arising out of the protracted, and ultimately unsuccessful, efforts of Baxter International, Inc., to fix various problems with a medical device called the Colleague Infusion Pump. Westmoreland County Employee Retirement System (Westmoreland) alleges that Baxter’s directors and officers breached their fiduciary duties by “consciously disregarding] their responsibility to bring Baxter into compliance with [a 2006] Consent Decree and related health and safety laws.” This breach, it contends, caused Baxter to lose more than $550 million after an FDA-mandated recall of the Colleague Infusion Pumps in 2010. Westmoreland’s problem is that it did not first ask Baxter’s board of directors to pursue the claims it advances here; it alleges that it should be excused from the demand requirement because of futility. The district court concluded that Westmoreland failed adequately to plead demand futility, as required by Federal Rule of Civil Procedure 23.1(b)(3) and Delaware substantive law, and solely on that basis dismissed the complaint. We reverse.

I

We draw the following facts from Westmoreland’s amended complaint. In doing so, we bear in mind the fact that the *722 adequacy of its pleadings is measured by federal law — in particular, Rule 23.1. See Kamen v. Kemper Financial Servs., Inc., 500 U.S. 90, 96, 111 S.Ct. 1711, 114 L.Ed.2d 152 (1991); 7C Charles Alan Wright, Arthur R. Miller & Mary Kay Kane, Federal Practice and Procedure §§ 1831, 1836 (3d ed.2007). The function of the demand futility doctrine, however, is a matter of substance, not procedure. Kamen, 500 U.S. at 96, 111 S.Ct. 1711. Thus, for instance, although federal law governs the degree of detail that the plaintiff must furnish when it gives its “reasons for not obtaining the action or not making the effort,” see Rule 23.1(b)(3)(B), state law will determine whether those reasons are sufficient.

In the mid-1990s, Baxter began manufacturing and selling a product called the Colleague Infusion Pump (the Pump), an electronic medical device used to deliver intravenous fluids to patients. The Food and Drug Administration (FDA) closely regulates the medical device industry and requires that companies comply with “current good manufacturing practices” and “quality system regulations,” see 21 C.F.R. Part 820, when manufacturing such medical devices. Between 1999 and 2005, the Pumps were already suffering from a range of defects, some relating to the manufacturing process and others to flaws in the machinery. The FDA discovered some- of these problems during its inspections of Baxter’s facilities. The agency sent Baxter a series of warning letters in which it detailed Baxter’s failure to bring its manufacturing process into compliance with quality-control standards, but Baxter’s response was not satisfactory. In October 2005, the FDA took the drastic step of filing a complaint in federal court seeking forfeiture of all Baxter-owned Colleague Infusion Pumps.

On June 29, 2006, the FDA and Baxter entered into a Consent Decree of Condemnation and Permanent Injunction (Consent Decree), which the court approved. Baxter agreed to stop manufacturing and distributing all models of the Pump within the United States, and it committed to bringing the approximately 200,000 Pumps already in the hands of health care professionals “into compliance with the [Federal Food, Drug, and Cosmetic] Act, its implementing regulations, and this decree.” The Consent Decree did not set a deadline for Baxter to complete these remedial efforts, but it required Baxter to develop and implement a Comprehensive Action Plan within a matter of weeks. If at any time the FDA determined that Baxter “failed to comply with any provision of [the] decree, or ... violated the Act or its regulations, or that additional corrective actions [were] necessary to achieve compliance[,]” the Consent Decree authorized the Agency to take “any ... corrective actions [it] deem[ed] necessary,” including ordering a recall of the Pumps at Baxter’s sole expense.

Over the next several years, Baxter devoted significant attention and resources to the task of fixing the Pumps. Company records show that the full board of directors discussed the Pumps at least 28 times between 2006 and 2010, while Baxter’s Audit and Public Policy Committees reviewed Pump-related matters at least 19 and 13 times, respectively. During these meetings, Baxter’s directors were regularly apprised of “ongoing dialogue with the [FDA]” and “recent meeting[s] [with Agency officials] ... concerning proposed remediation plans.” The company also expended considerable resources on its remedial efforts, at least at first. From 2005 to 2007, it recorded charges and other costs totaling $185 million related to fixing the Pumps and another medical device that was subject to the Consent Decree. *723 During the first three quarters of 2008, Baxter recorded another $125 million in charges related to the Pumps. But this spending tapered off: in the fourth quarter of 2008, Baxter did not record any charges related to the Pumps, and in 2009, the company spent a relatively modest $27 million. Westmoreland’s complaint does not indicate how much, if any, Baxter spent in the first part of 2010.

Despite these efforts, problems with the Pumps persisted, and FDA officials grew increasingly frustrated with Baxter’s unsuccessful remedial efforts. According to FDA enforcement officials, whose declarations Westmoreland has submitted along with its Complaint:

the FDA consistently and repeatedly informed Baxter, during face-to-face meetings, on conference calls, and in writing, that its Colleague remediation efforts were insufficient and that Baxter’s time-line for remediating the Colleague was unacceptable because the Colleague, at all times, remained a violative device that posed significant and potentially deadly health risks to patients receiving treatment using the Colleague pump in the United States.

Because each new “fix” that Baxter devised “creat[ed] additional, significant problems with the Colleague pumps” (e.g battery and display failures, and diagnostic, software, and registry errors) the FDA informed Baxter at a November 25, 2008 meeting that Baxter would be required to submit clinical data to the FDA as part of its next “510(k) submission.” This filing was a critical part of the remedial process, but from late 2008 through early 2010, Baxter failed to generate clinical data (or even take preliminary steps necessary to set up such clinical trials) as instructed. The company also “continued to experience numerous internal quality deficiencies,” in violation of 21 C.F.R. Part 820.

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727 F.3d 719, 2013 WL 4266586, 2013 U.S. App. LEXIS 17124, Counsel Stack Legal Research, https://law.counselstack.com/opinion/westmoreland-county-employee-retirement-system-v-parkinson-ca7-2013.