West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc.

139 F. Supp. 3d 976, 2015 U.S. Dist. LEXIS 132547, 2015 WL 5736961
CourtDistrict Court, D. Minnesota
DecidedSeptember 30, 2015
DocketCivil No. 13-1686 (JRT/FLN)
StatusPublished
Cited by2 cases

This text of 139 F. Supp. 3d 976 (West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Minnesota primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc., 139 F. Supp. 3d 976, 2015 U.S. Dist. LEXIS 132547, 2015 WL 5736961 (mnd 2015).

Opinion

MEMORANDUM OPINION AND ORDER MOTION FOR SUMMARY JUDGMENT

JOHN R. TUNHEIM, Chief Judge, United States District Court

Plaintiff retirement and investment funds (“plaintiffs”) bring this consolidated class' action against Medtronic and several of its officers and employees (“Medtronic Defendants” or “defendants”), alleging that the defendants made fraudulent state[978]*978ments, and engaged in a fraudulent scheme, in violation of federal securities laws. The case centers on the bone product INFUSE and alleges that the defendants made false statements about the safety and efficacy of INFUSE, which led to artificially high prices for Medtronic stock.

In a prior Order, the Court dismissed some of the plaintiffs’ false statement claims against various Medtronic Defendants and dismissed the plaintiffs’ scheme liability claims against several consultant defendants (“Consultant Defendants”). The Order rejected the motion to dismiss against the Medtronic Defendants as to one false-statement claim, the scheme liability claims, and related control person claims.

Now, with the benefit of additional record material, the Medtronic Defendants move for summary judgment, arguing that the plaintiffs’ claims are barred by the two-year statute of limitations found in 28 U.S.C. § 1658(b)(1) and the five-year statute of repose found in Section 1658(b)(2). Because the remaining false statement claim clearly falls outside the statute of limitations, the Court will dismiss that claim. Additionally, because publicly available information would have allowed the plaintiffs to plead plausible scheme liability claims prior to June 27, 2011, the Court will dismiss the plaintiffs’ remaining scheme liability claims. Finally, the Court will dismiss the control liability claims and deny as moot the defendants’ objections to a Magistrate Judge order regarding discovery issues.

BACKGROUND1

1. INFUSE AND THIS ACTION

INFUSE is the “trade name of rhBMP-2,” which is a bone morphogenetic protein (“BMP”) that induces the body to develop new bone tissue. (Consolidated Class Action Compl. (“Compl.”) ¶7, Nov. 4, 2013, Docket No. 28.) INFUSE is an alternative to grafting replacement bone tissue and was the first BMP to reach the market. (Id.) The FDA approved INFUSE in 2002 for what the plaintiffs allege are somewhat limited treatment purposes: treatment of degenerative disc disease, dental surgery, and certain shin fractures. (Id. ¶ 8.) INFUSE was never approved, however, “for any spinal fusion indication other than [the lower back] surgeries.” (Id.) INFUSE is a key part of Medtronic’s “spinal segment,” which generated more than $3.5 billion in revenue in 2008, 2009, and 2010. (Id. ¶20.) Relevant to this case, Medtronic also sought FDA approval for AMPLIFY, a second-generation BMP. (Id. ¶¶ 22, 24.)

The lead plaintiffs in this case are several institutional investors: West Virginia Pipe Trades Health & Welfare Fund, Union Asset Management Holding AG, and Employees’ Retirement System of the State of Hawaii, all of which allege that they purchased Medtronic common stock during the Class Period2 and were damaged by the conduct alleged in the complaint. (Id. ¶¶ 43-45.) They bring this action against Medtronic and several of its officers and employees, including: William Hawkins, former Chair of the Board of Directors and CEO, (id. ¶ 47); Gary Ellis, [979]*979Chief Financial Officer, (id. ¶ 48); Richard Kuntz, Chief Scientific, Clinical and Regulatory Officer, (id. ¶ 49); Julie Bearcroft, Director of Technology Management in Medtronic’s Biologies Marketing Department, (id. ¶ 50); Richard Treharne, Senior Vice President of Clinical and Regulatory Affairs, (id. ¶ 51); and Martin Yahiro, Medtronic Senior Director of Regulatory Affairs, (id. ¶ 52). The complaint also alleges violations by three consultants: Dr. Thomas Zdeblick, (id. ¶ 53); Dr. Kenneth Burkus, (id. IT 54); and Dr. Scott Boden, (id. ¶ 55).

The plaintiffs make two substantive claims in this case.3 First, in Count I, they allege that the defendants made materially false statements during the Class Period in order to assure investors of the continued viability of INFUSE as a product and the prospect of AMPLIFY. (Id. ¶¶ 157-61.) The plaintiffs claim that these materially false statements artificially inflated Medtronic’s stock price, which led investors, to buy it, but that when the truth was revealed the value dropped. The complaint asserts these claims against Med-tronic, Hawkins, Ellis, Kuntz, and Zde-blick. As discussed in more detail below, however, the Court’s prior Order on the defendants’ motions to dismiss rejected all false statement claims except as to Hawkins.

The remaining false statement claim against Hawkins involves a February 22, 2011 conference call for analysts and investors that followed Medtronic’s release of its 3Q11 financial results. (Id.. ¶ 73.) On that call, Hawkins was asked about whether the. FDA might delay its approval of AMPLIFY and whether any delay might negatively impact INFUSE sales. (Id.) The plaintiffs contend that Hawkins’s responses “falsely suggested that approvability 'had not yet been determined, and ..'. that even if there were a delay, it would not impact [Medtronic’s] current business.” (Id.)' The plaintiffs contend that this statement was “knowingly materially false and misleading because ... [Med-tronic] had received a letter from the FDA before January 28, 2011, stating that AMPLIFY would not be approved.” (Id. ¶ 74.) Later in the complaint, the plaintiffs explain that in Medtronic’s 3Q11 10-Q, it “disclosed for the first time that ... it had received a non-approval letter from the FDA concerning AMPLIFY: In the third quarter of fiscal year 2011, the FDA sent Medtronic a letter advising that they were not - able to approve AMPLIFY at that time without additional information from Medtronic.” (Id. ¶ 79.)

In Count II, asserted against all defendants,4 the plaintiffs contend that before and during the Class Period, the defendants engaged in a scheme or course of conduct to manipulate the early clinical studies, which propelled INFUSE to success despite omitting many of INFUSE’S adverse effects. (Id. ¶¶ 162-65.) The plaintiffs allege that early INFUSE clinical studies revealed safety risks that threatened Medtronic’s goals for the product and, as a result, Medtronic “embarked on a scheme with physician investigators and authors to conceal the significant safety risks from the public and physician community.” (Id. ¶ 15; see also id. ¶ 163.) They allege that Medtronic did so by “forg[ing]. relationships, including financial relationships, with physician authors who published research articles in respected medical journals and knowingly concealed [980]*980in those original articles, or omitted altogether, known facts regarding INFUSE’s adverse side,.effects observed in clinical trials,” and that these research articles “overstated apparent disadvantages of alternate -bone graft,procedures ... as opposed to treatment with INFUSE.” (Id.

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139 F. Supp. 3d 976, 2015 U.S. Dist. LEXIS 132547, 2015 WL 5736961, Counsel Stack Legal Research, https://law.counselstack.com/opinion/west-virginia-pipe-trades-health-welfare-fund-v-medtronic-inc-mnd-2015.