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

CourtDistrict Court, D. Minnesota
DecidedMarch 2, 2018
Docket0:13-cv-01686
StatusUnknown

This text of West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc. (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., (mnd 2018).

Opinion

UNITED STATES DISTRICT COURT

DISTRICT OF MINNESOTA

WEST VIRGINIA PIPE TRADES HEALTH & WELFARE FUND, Civil No. 13-1686 (JRT/FLN) EMPLOYEES’ RETIREMENT SYSTEM

OF THE STATE OF HAWAII, and

UNION ASSET MANAGEMENT MEMORANDUM HOLDING AG, OPINION AND ORDER

Plaintiffs,

v.

MEDTRONIC, INC., WILLIAM A. HAWKINS, GARY L. ELLIS, RICHARD E. KUNTZ, JULIE BEARCROFT, RICHARD TREHARNE, and MARTIN YAHIRO,

Defendants.

Shawn A. Williams and Christopher M. Wood, ROBBINS GELLER RUDMAN & DOWD LLP, One Montgomery Street, Suite 1800, San Francisco, CA 94104; William H. Narwold, MOTLEY RICE LLC, 20 Church Street, Seventeenth Floor, Hartford, CT 06103; and Carolyn G. Anderson, ZIMMERMAN REED, PLLP, 80 South Eighth Street, 1100 IDS Center, Minneapolis, MN 55402, for plaintiffs.

Joseph G. Petrosinelli and Sarah Lochner O’Connor, WILLIAMS & CONNOLLY LLP, 725 Twelfth Street Northwest, Washington, DC 20005; and Theresa Bevilacqua, DORSEY & WHITNEY LLP, 50 South Sixth Street, Suite 1500, Minneapolis, MN 55402, for defendants.

Plaintiffs retirement and investment funds (“Plaintiffs”) bring this consolidated class action alleging that Medtronic, Inc., (“Medtronic”) and a number of its officers and employees (“Individual Defendants”) engaged in a scheme to defraud investors. In particular, Plaintiffs allege that Medtronic artificially inflated its stock price by manipulating early clinical studies of two bone-morphogenetic-protein (“BMP”) products

– INFUSE and AMPLIFY. Individual Defendants William A. Hawkins, Gary L. Ellis, Richard E. Kuntz, Dr. Julie Bearcroft, Dr. Richard Treharne, and Dr. Martin Yahiro move for summary judgment for the scheme-liability claims and control-person claims brought against them. The Court will grant in part and deny in part the Individual Defendants’ Motion for Summary Judgment.

BACKGROUND

I. FACTUAL BACKGROUND INFUSE is the “trade name of rhBMP–2,” which is a BMP that induces the body to develop new bone tissue.1 (Am. Comp. (“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 Plaintiffs allege

are somewhat limited treatment purposes: degenerative disc disease, dental surgery, and certain shin fractures. (Id. ¶ 8.) INFUSE is a key part of Medtronic’s “spinal segment” of business, which generated more than $3.5 billion in revenue in 2008, 2009, and 2010. (Id. ¶ 20.) Medtronic also sought FDA approval for AMPLIFY, a second-generation BMP. (Id. ¶¶ 22, 24.)

1 The Court has previously described the facts of this case at length in a previous order. See W. Va. Pipe Trades Health & Welfare Fund v. Medtronic, Inc., 139 F. Supp. 3d 976 (D. Minn. 2015). 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 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 Chief Executive Officer (“CEO”), (id. ¶ 47); Gary Ellis, Chief Financial Officer (“CFO”), (id. ¶ 48); Richard Kuntz, Chief Scientific, Clinical, and Regulatory

Officer, (id. ¶ 49); Dr. Julie Bearcroft, Director of Technology Management in Medtronic’s Biologics Marketing Department, (id. ¶ 50); Dr. Richard Treharne, Senior Vice President of Clinical and Regulatory Affairs, (id. ¶ 51); and Dr. Martin Yahiro, Medtronic Senior Director of Regulatory Affairs, (id. ¶ 52). The Complaint also alleges violations by three consultants (“Consultant Defendants”): Dr. Thomas Zdeblick, (Id.

¶ 53); Dr. Kenneth Burkus, (id. ¶ 54); and Dr. Scott Boden, (Id. ¶ 55). Plaintiffs contend that Medtronic engaged in a scheme to manipulate the early clinical studies by omitting many of INFUSE’s adverse events. (Id. ¶¶ 162-65.) 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, 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 in 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. ¶ 16.) Plaintiffs also allege that Medtronic “failed to disclose that Medtronic had paid millions of dollars to the same physician authors” and “heavily edited the articles and specifically excised true facts learned during clinical trials about the efficacy and side effects of INFUSE, which would have alerted the public and physicians using INFUSE about its harmful side effects and lack of clinical benefit.” (Id. ¶ 17.)

On June 28, 2011, The Spine Journal released an issue devoted to concerns regarding INFUSE. (Id. ¶ 103; see also Decl. of Christopher M. Wood (“Wood Decl.”) ¶ 54, Ex. 26, Apr. 7, 2015, Docket No. 103.) Plaintiffs contend that, “[t]aken as a whole, the June 28, 2011 issue of The Spine Journal began to inform the market, for the first time, that the research supporting the safety and efficacy of INFUSE was not reliable.”

(Compl. ¶ 103.) That same day, Medtronic filed its FY11 Form 10–K, which included a statement about The Spine Journal articles and “conceded that the articles would have an impact on future sales.” (Id. ¶¶ 112.) Plaintiffs contend that these disclosures led to a drop in the value of Medtronic stock. (Id. ¶¶ 113-16.)

II. PROCEDURAL BACKGROUND Plaintiffs allege that Medtronic and the Individual Defendants violated Section 10(b) of the Exchange Act by making false and misleading statements to investors (Count

I) and by engaging in a scheme to pay physician authors to conceal adverse events associated with INFUSE and AMPLIFY (Count II). (Id. ¶¶ 157–65.) Additionally, Plaintiffs allege that the Individual Defendants are liable under Section 20(a) of the

Exchange Act as control persons of Medtronic (Count III). (Id. ¶¶ 166-70.) This is not the Individual Defendants’ first effort to dismiss this case. On September 14, 2014, the Court granted in part and denied in part Defendants’ motions to dismiss. W. Va. Pipe Trades Health & Welfare Fund v. Medtronic, Inc., 57 F. Supp. 3d 950 (D. Minn. 2014). The Court granted the Consultant Defendants’ motion after concluding that the applicable date for the statute of repose is June 27, 2008. Id. at 977-

80. However, Medtronic and the Individual Defendants did not move to dismiss based on the statute of repose, and their motion was granted in part and denied in part. Id. at 980- 84. On September 30, 2015, the Court granted summary judgment against Plaintiffs on all remaining claims based on the statute of limitations. W. Va. Pipe Trades Health &

Welfare Fund v. Medtronic, Inc., 139 F. Supp. 3d 976 (D. Minn. 2015).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Merck & Co. v. Reynolds
559 U.S. 633 (Supreme Court, 2010)
Anderson v. Liberty Lobby, Inc.
477 U.S. 242 (Supreme Court, 1986)
Janus Capital Group, Inc. v. First Derivative Traders
131 S. Ct. 2296 (Supreme Court, 2011)
WPP Luxembourg Gamma Three Sarl v. Spot Runner, Inc.
655 F.3d 1039 (Ninth Circuit, 2011)
Public Pension Fund Group v. KV PHARMACEUTICAL CO.
679 F.3d 972 (Eighth Circuit, 2012)
Metge v. Baehler
577 F. Supp. 810 (S.D. Iowa, 1984)
In Re Parmalat Securities Litigation
414 F. Supp. 2d 428 (S.D. New York, 2006)
Integrity Floorcovering, Inc. v. Broan-Nu Tone LLC
503 F. Supp. 2d 1136 (D. Minnesota, 2007)
Cummings v. Paramount Partners, LP
715 F. Supp. 2d 880 (D. Minnesota, 2010)
CTS Corp. v. Waldburger
134 S. Ct. 2175 (Supreme Court, 2014)
Hotel 71 Mezz Lender LLC v. National Retirement Fund
778 F.3d 593 (Seventh Circuit, 2015)
Howe v. Shchekin
238 F. Supp. 3d 1046 (N.D. Illinois, 2017)
Carlucci v. Han
886 F. Supp. 2d 497 (E.D. Virginia, 2012)
Metge v. Baehler
762 F.2d 621 (Eighth Circuit, 1985)

Cite This Page — Counsel Stack

Bluebook (online)
West Virginia Pipe Trades Health & Welfare Fund v. Medtronic, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/west-virginia-pipe-trades-health-welfare-fund-v-medtronic-inc-mnd-2018.