MARKEWICH EX REL. MEDTRONIC, INC. v. Collins

622 F. Supp. 2d 802, 2009 WL 1323827
CourtDistrict Court, D. Minnesota
DecidedMay 11, 2009
DocketCiv. No. 08-92 (RHK/AJB)
StatusPublished
Cited by7 cases

This text of 622 F. Supp. 2d 802 (MARKEWICH EX REL. MEDTRONIC, INC. v. Collins) 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
MARKEWICH EX REL. MEDTRONIC, INC. v. Collins, 622 F. Supp. 2d 802, 2009 WL 1323827 (mnd 2009).

Opinion

622 F.Supp.2d 802 (2009)

Iris MARKEWICH, Derivatively, on behalf of MEDTRONIC, INC., Plaintiff,
v.
Arthur D. COLLINS, Jr., William A. Hawkins, Richard H. Anderson, David L. Calhoun, Denise M. O'Leary, Kendall J. Powell, Robert C. Pozen, Jack W. Schuler, Michael Demane, Stephen Mahle, Pat Mackin, Susan Alpert, Stephen Oesterle, and Gary Ellis, Defendants, and
Medtronic, Inc., Nominal Defendant.

Civ. No. 08-92 (RHK/AJB).

United States District Court, D. Minnesota.

May 11, 2009.

*803 Gregory M. Nespole, Wolf Haldenstein Adler Freeman & Herz LLP, New York, NY, Garrett D. Blanchfield, Jr., Reinhardt Wendorf & Blanchfield, St. Paul, MN, for Plaintiff.

Jeffrey B. Rudman, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, Michael G. Bongiorno, Wilmer Cutler Pickering Hale and Dorr LLP, New York, NY, Patrick S. Williams, Briggs and Morgan, PA, Minneapolis, MN, for Defendants and Nominal Defendant.

MEMORANDUM OPINION AND ORDER

RICHARD H. KYLE, District Judge.

INTRODUCTION

This derivative action was commenced after Medtronic Incorporated ("Medtronic") *804 voluntarily removed its product, the Sprint Fidelis lead ("the Fidelis lead"), from the market in 2007. Plaintiff, Iris Markewich, on behalf of Medtronic, alleges that certain officers and directors of the company (hereinafter referred to collectively as the "Defendants"), are liable to Medtronic for breach of fiduciary duty, abuse of control, gross mismanagement, insider trading, and aiding and abetting breaches of fiduciary duty. Defendants now move to dismiss. For the reasons described herein, the Court will grant the Motion.

BACKGROUND

The following facts are set forth in the Second Amended Derivative Complaint (the "Complaint"), documents relied upon therein, and documents in the public record. Medtronic is a medical technology business incorporated in Minnesota. (Compl. ¶¶ 3, 37.) Plaintiff is and at all relevant times was an owner of Medtronic stock. (Id. ¶ 36.) Defendants are eight of the eleven members of Medtronic's Board of Directors on the date this action was filed (the "Director Defendants")[1], and six high-ranking executives who are not on the Board of Directors.[2] (Id. ¶ 38-54.)

A. The Fidelis lead

Medtronic manufactures medical devices, including implantable cardioverter defibrillators ("ICDs"). (Id. ¶¶ 4-5.) ICDs are small devices implanted in patients' chests to monitor heart rates and correct heart rhythm disorders. (Id. ¶ 5.) Complex wires called "leads" connect the ICD to the patient's heart muscle. (Id. ¶ 6.) If a lead detects that the patient's heart is out of rhythm, the ICD sends an electric shock through the lead to correct the problem. (Id.) "If a lead fractures, breaks or otherwise malfunctions, it can deliver unnecessary and frightening shocks, or not operate at all when needed." (Id.)

The Fidelis lead was developed by Medtronic as a "small diameter, high voltage" lead. (Id. ¶ 7.) Soon after its release, the Fidelis lead became the world's most popular. (Bongiorno Decl. Ex. B.) In fact, the Fidelis lead was being used in 90% of Medtronic's new defibrillators. (Compl. ¶ 15.)

Problems with the Fidelis lead began to surface following its introduction to the market. An investigation conducted by a physician at the Minneapolis Heart Institute, Dr. Robert G. Hauser, concluded that the Fidelis lead was failing at a significantly higher rate than expected. (Id. ¶ 9.) The results of this study (hereinafter referred to as the "Hauser Study") were communicated to Medtronic in February 2007 and published in July 2007 in Heart Rhythm Journal. (Id.)

The Hauser Study analyzed the failure rate of the Fidelis lead in comparison to the failure rate of another popular Medtronic lead, the Sprint Quattro. (Bongiorno Decl. Ex. D.) The difference in the rates was found to be significant, with the failure rate of the Fidelis lead being ten times greater than that of the Sprint Quattro. (Id.; Compl. ¶ 10.) However, the Hauser Study noted that as a "single-center study," it may not "reflect experiences at other centers." (Bongiorno Decl. Ex. D.)

In February 2007, Dr. Hauser met with Medtronic to discuss his findings. (Compl. ¶ 101.) Medtronic officials met again with *805 Dr. Hauser in July 2007. (Id. ¶ 112.) At that time Medtronic did not pull the Fidelis lead from the market, determining that it needed to conduct a further statistical analysis. (Id. ¶¶ 112-14; Bongiorno Decl. Ex. B.)

Plaintiff alleges that Defendants were aware that several hospitals and clinics were discontinuing the implantation of the Fidelis lead. (Compl. ¶ 103.) Plaintiff further alleges that Defendants were aware that nearly 600 Fidelis leads had experienced failure and that 679 adverse event reports regarding the Fidelis lead had been filed on the Manufacturers and User Facility Device Experience database ("MAUDE"). (¶¶ 91-92.) Nevertheless, Plaintiff contends that Defendants did nothing to prevent or remedy this situation and instead made fraudulent statements regarding the Fidelis lead. (Id. ¶ 21.)

On October 15, 2007, Medtronic voluntarily recalled the Fidelis lead. (Id. ¶ 23.) The FDA issued a Class I recall that same day. (Id. ¶ 118.) Medtronic stated that its decision to recall the Fidelis lead stemmed from its review of performance data from 25,000 Fidelis leads indicating that the lead was viable in 97.7% of cases, lower than the 99.1% viability rate for the Sprint Quattro. (Id. ¶ 115.) During the recall announcement, Medtronic noted that the recall would cause the company to suffer a revenue loss of $150 to $250 million dollars. (Id. ¶ 116.) After the recall, Medtronic stock fell $6.33 per share, an 11.2% decline. (Id. ¶ 119.)

Plaintiff claims that "Defendants' long inaction in the face of reports of defects in Fidelis Leads is made more egregious by its recent extensive history of regulatory problems and litigation with its cardiac rhythm products." (Mem. in Opp'n at 7.) Specifically, in 2004 and 2005, Medtronic and the FDA issued several recalls of cardio-implant products, some resulting in litigation. (Compl. ¶¶ 67-79.)

B. Infuse

Plaintiff amended her Complaint in October 2008 to add allegations regarding Infuse Bone Graft ("Infuse"), a Medtronic spinal product. (Id. ¶ 1.) As an FDA-approved medical device, Infuse is labeled with a description indicating its approved uses. (Id. ¶ 123.) While a manufacturer may not promote uses of its products other than those described on the label, physicians may use products in ways not listed on the label ("off-label uses"). (Id. ¶¶ 124-25.)

Eighty to ninety-five percent of Infuse use is "off-label." (Id. ¶ 31.) Plaintiff asserts that Defendants knew that Medtronic was illegally paying physicians to endorse and teach off-label uses of Infuse. (Id. ¶¶ 28-30.) In making this assertion, Plaintiff relies on several qui tam actions involving Medtronic. (Id. ¶¶ 29-34.) One of these actions alleged that Medtronic paid kickbacks to induce doctors to use its spinal products from 1998 to 2003. (Id. ¶ 130-35.) This lawsuit was settled for $40 million dollars with Medtronic disclaiming any wrongdoing. (Bongiorno Decl. Ex. J.) No individual Defendant is named in any of the qui tam actions referenced by Plaintiff.[3] (Id. Exs. G-J.)

C. The present action

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Cite This Page — Counsel Stack

Bluebook (online)
622 F. Supp. 2d 802, 2009 WL 1323827, Counsel Stack Legal Research, https://law.counselstack.com/opinion/markewich-ex-rel-medtronic-inc-v-collins-mnd-2009.