Higgins v. Boston Scientific Corporation

District Court, D. Minnesota·Decided February 28, 2020·No. 0:11-cv-02453·Unknown

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

United States of America and the State of Case No. 11-cv-2453 (JNE/TNL) California, ex rel. Steven Higgins,

Plaintiffs,

v. ORDER

Boston Scientific Corporation,

Defendant.

Daniel R. Miller and Jonathan Z. DeSantis, Walden Macht & Haran LLP, 2001 Market Street, Suite 2500, Philadelphia PA 19103; Joy P. Clairmont and William H. Ellerbe, Berger Montague PC, 1818 Market Street, Suite 3600, Philadelphia PA 19103; and E. Michelle Drake, Berger Montague PC, 43 Southeast Main Street, Suite 505, Minneapolis MN 55414 (for Relator Steven Higgins); and

Fredrick Robinson and Lesley Reynolds, Reed Smith LLP, 1301 K Street Northwest, Suite 1100 – East Tower, Washington DC 20005; Caitlin Chambers, Reed Smith LLP, 811 Main Street, Suite 1700, Houston TX 77002; and Allison M. Lange Garrison, Norton Rose Fulbright US LLP, 60 South Sixth Street, Suite 3100, Minneapolis MN 55402 (for Defendant Boston Scientific Corporation).

I. INTRODUCTION This matter is before the Court on Relator’s Motion for Sanctions. (ECF No. 281). The motion was originally ruled upon on by the Honorable Judge Steven E. Rau, United States Magistrate Judge for the District of Minnesota, on October 16, 2019. United States ex rel. Higgins v. Boston Sci. Corp., 2019 WL 5206221 (D. Minn. Oct. 16, 2019) (hereinafter “Oct. 16 Order”).1 The Oct. 16 Order was vacated to permit for oral argument

1 Also available at ECF No. 313. and reconsideration. United States ex rel. Higgins v. Boston Sci. Corp., 2019 WL 6328135 (D. Minn. Nov. 25, 2019) (noting due process concerns) (hereinafter “Nov. 25 Order”).2 This case was reassigned to the undersigned3 to hear the parties’ arguments as to the factual

and legal bases for their positions and to review Relator’s motion anew. Id. at *1. The Nov. 25 Order made no decision as to the merits of the Oct. 16 Order. Id. (“This decision is made solely to provide the magistrate judge with an opportunity to reconsider Defendant’s arguments and is not a reflection on the merits of the order.”). The undersigned thereafter heard argument from the parties. (ECF No. 338). For the following reasons, the

motion is granted in part and denied in part and the sanctions specified herein are imposed on Boston Scientific. II. PROCEDURAL AND FACTUAL BACKGROUND A. Pre-Discovery: The Complaint, the Amended Complaints, Related Motion Practice, and the Parties’ Rule 26(f) Report Relator Steven Higgins, MD, initiated this qui tam action on August 26, 2011 on behalf of the United States and the State of California under the False Claims Act and the California False Claims Act. (Compl. ¶ 1, ECF No. 1). Relator alleged that Boston

Scientific engaged in two distinct schemes: (1) selling defective cardiac defibrillator devices under the names Cognis and Teligen; and (2) providing kickbacks. (Compl. ¶ 2). Almost five years later, the United States and the State of California declined to intervene

2 Also available at ECF No. 334. 3 Due to Magistrate Judge Rau’s unfortunate passing, this case was reassigned to the undersigned while the Oct. 16 Order was on appeal to the Honorable Joan N. Ericksen, United States District Judge for the District of Minnesota. (ECF No. 331). and, on May 6, 2016, Relator was permitted to pursue this action on their behalf. (ECF Nos. 44, 47).

Relator thereafter filed his Amended Complaint on October 7, 2016. (Am. Compl., ECF No. 61). The Amended Complaint alleged one fraudulent scheme: that Boston Scientific sought Food and Drug Administration (FDA) approval and subsequently sold defective cardiac defibrillator devices under the names Cognis and Teligen. (Am. Compl. ¶ 2). Boston Scientific moved for dismissal of Relator’s suit. (ECF No. 63). In deciding that motion, the Court first addressed whether the Court had subject matter jurisdiction

with respect to the False Claims Act’s public disclosure bar, concluding it does. United States ex rel. Higgins v. Boston Sci. Corp., 2017 WL 3732099, at *3–*4 (D. Minn. Aug. 29, 2017).4 The Court next found that while Relator appeared to state a viable claim under Rule 12(b), he failed to satisfactorily plead his fraud claim with particularity as required by Rule 9(b). Id. at *4–*10. Relator’s Amended Complaint was dismissed but he was

permitted to amend his complaint to cure the Rule 9(b) pleading deficiencies. Id. at *10. Relator filed his Second Amended Complaint on September 19, 2017, alleging that Boston Scientific engaged in a fraudulent scheme whereby it sought FDA approval and subsequently sold defective cardiac defibrillator devices under the names Cognis and Teligen. (Sec. Am. Compl., ECF No. 98). Again, Boston Scientific sought dismissal of the

complaint, arguing that Relator failed to plead his fraud claims with particularity. (ECF Nos. 103, 106). The Court rejected that argument, finding “Higgins has particularly pled

4 Also available at ECF No. 97 at 5–8. fraud in how Boston Scientific allegedly misled the FDA.” United States ex rel. Higgins v. Boston Sci. Corp., 2017 WL 6389671, at *1 (D. Minn. Dec. 13, 2017).5

Next, the Court set a pretrial scheduling conference and the parties were directed to jointly prepare a Rule 26(f) report. (ECF No. 121). As the Court previously summarized: The parties disagreed on nearly every part of the discovery plan and schedule. (ECF No. 130 passim). Following the pretrial conference, this Court directed the parties to meet and confer further in an attempt to reach an agreement on a pretrial schedule that met all parties’ needs in lieu of a wholly court- imposed schedule. (ECF Nos. 134, 135). The parties complied and developed a pretrial schedule. (ECF No. 135). The parties also agreed that regular telephone status conferences would “keep discovery in this case moving forward efficiently.” (ECF No. 135, at 1). This Court incorporated the parties’ agreed-upon deadlines in a pretrial scheduling order and set monthly telephonic status conferences. (ECF Nos. 137, 138). United States ex rel. Higgins v. Boston Sci. Corp., 2018 WL 5617565, at *1 (D. Minn. Oct. 30, 2018).6 While there was some struggle getting it accomplished, the parties outlined their respective positions in the Rule 26(f) report. Relator summarized his lawsuit as follows: This lawsuit seeks to recover for tens of thousands of false claims submitted to government health care programs for reimbursement of [Boston Scientific’s] defective cardiac defibrillator devices known as Cognis and Teligen. These defective devices were sold in the United States from August 2008 through their eventual FDA recall due to defects—the same defects that are the subject of this action—on July 20, 2009, almost a year after they first were sold in the United States.

(ECF No. 130, at 1). Relator described the build-up to the launch of the Cognis and Teligen devices, including Boston Scientific’s acquisition of Guidant in 2006, which “had been plagued with FDA recalls for faulty medical devices for years leading up to the

5 Also available at ECF No. 117. 6 Also available at ECF No. 177. acquisition”; that Boston Scientific knew of the defects in the Cognis and Teligen devices due to launching the devices in Europe in February 2008; and a failure to inform the FDA

of the European-revealed defects prior to approving them in May 2008. (ECF No. 130, at 2). Relator noted Boston Scientific knew of the defects and developed corrected “Version 2” of the Cognis and Teligen devices while still selling the older, defective Cognis and Teligen devices throughout 2009. (ECF No. 130, at 2–3). For its part, Boston Scientific denied the claims and “intends to show that it provided robust and complete disclosures of information to the FDA about its experiences with the

Cognis and Teligen devices, including disclosures dating from both before and after U.S.

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