United States of America ex rel. v. Janssen Biotech, Inc.

CourtDistrict Court, D. Massachusetts
DecidedFebruary 17, 2022
Docket1:16-cv-12182
StatusUnknown

This text of United States of America ex rel. v. Janssen Biotech, Inc. (United States of America ex rel. v. Janssen Biotech, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States of America ex rel. v. Janssen Biotech, Inc., (D. Mass. 2022).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

THE UNTED STATES OF AMERICA et al. ex rel. JULIE LONG, Plaintiffs,

v. Civil Action No. 16-12182-FDS

JANSSEN BIOTECH, INC., Defendant.

MEMORANDUM AND ORDER ON DEFENDANT’S MOTION TO RECONSIDER COURT’S ORDER OF DECEMBER 20, 2021 (#251)

KELLEY, U.S.M.J. I. Introduction. This is a qui tam action alleging that a pharmaceutical company unlawfully provided free business advisory services to physicians who prescribed its medications, in violation of the Anti- Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7b(b), and caused physicians to submit false claims for reimbursement to Medicare in violation of the False Claims Act (“FCA”), 31 U.S.C. § 3729(a). Relator Julie Long alleges that Janssen Biotech, a company that manufactures and sells two infusible drugs, Remicade and Simponi ARIA, improperly employed teams of practice advisors, including relator, and hired outside consultants to provide services such as presentations, advice, and customized analyses to doctors to assist them in running profitable infusion businesses (“in- office infusion suites,” or “IOIs”). The facts of the case and a detailed analysis of the claims in the Second Amended Complaint (“SAC,” #55) are set out in Chief Judge Saylor’s Order and Memorandum on Defendant’s Motion to Dismiss (#75) and will only be repeated here as necessary to put the discovery motions at issue in context.

II. Background Concerning the Scope of Discovery. At the Rule 16 scheduling conference, Chief Judge Saylor explained that before “plunging into” nationwide discovery, the parties would engage in discovery relating to the specific allegations of relator, who worked as an “Area Business Specialist” (“ABS”) for Janssen in Pennsylvania from 2003 to February 2016, and whose job involved “advising and assisting physician practices with, among other things, establishing and operating in-office infusion suites where Remicade and Simponi ARIA infusions were administered.”1 (#75 at 2; #90 at 4.) The parties were to take discovery on “her claims, what she did, what her managers . . . told her to do, information she got from people at a national level, if she got any, what happened with these . . .

1 Chief Judge Saylor had mentioned this path of limited discovery in his Order and Memorandum on Defendant’s Motion to Dismiss. The SAC contains details concerning only nine “top accounts” located in the territory in which relator worked for Janssen in Pennsylvania, and defendant argued that the court should limit the scope of discovery to those nine practices. (#69 at 11-12; #75 at 32.) The court noted:

In cases where relators have alleged the submission of particular false claims only in some parts of the country, courts in this district have indeed limited discovery to those regions in order “to probe the validity of the kickback allegations before considering whether to authorize nationwide discovery.” See, e.g., United States ex rel. Carpenter v. Abbott Lab’ys, Inc., 723 F. Supp. 2d 395, 409-10 (D. Mass. 2010); U.S. ex rel. Rost v. Pfizer, Inc., 253 F.R.D. 11, 17 (D. Mass. 2008). The First Circuit has upheld such limits after reviewing them for an abuse of discretion. United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 719 F.3d 31, 39-40 (1st Cir. 2013). The Court will address that issue, as appropriate, in the Rule 16 scheduling conference.

(#75 at 33 n.12.) nine accounts and see where we are at that point.” (#90 at 10.) The court opined that this early discovery would concern “how the company organizes its business, how it trained people, how it supervised people, what writings there were and so on and so forth, and my hope is that once that information is out there, we’ll have a better sense of . . . what the next phase of discovery ought to

look like, assuming there is a phase.” Id. at 10. Soon after the scheduling conference, the parties began having discovery disputes, which were referred to this court. See, e.g., #100, Relator’s Motion to Compel. Over the next several months, this court had frequent hearings concerning discovery, see, e.g., #116 (April 6, 2021 hearing); #126 (April 23, 2021 hearing); #131 (May 6, 2021 hearing); #157 (July 26, 2021 hearing). At the outset, this court made clear that discovery would not be limited to what relator knew, but would extend “up the chain of command” from relator to national policy-makers, and would include discovery concerning national strategies and policies concerning the programs in relator’s territory. (#116 at 8.) This included information from those who “devised these policies and vetted them and assessed their legality.” Id. Janssen agreed that this information was relevant.

Id. at 10. The court also found that relator was entitled to discover “internal documents discussing [the] legality [of any program] that aren’t privileged.” Id. at 16. The court will not go point by point through its rulings across the multiple hearings; suffice it to say that the court’s aim was to cabin the discovery, so that the parties could meet the fairly short deadlines set by Chief Judge Saylor and, in this initial stage of discovery, to give relator just enough information to test her claims. This court repeatedly assured relator that however limited discovery was during what the parties came to refer to as “phase one,” relator would, in the future, get more discovery. See, e.g., #131 at 10; #157 at 8-11. Janssen, which persistently argued that discovery should be as narrow as possible, conceded that phase one discovery was “not the end of discovery. We’re trying to look at the claims through a lens, and then you see where you are after [p]hase [one].” (#116 at 15.) In some instances, the court persuaded relator to back down from requests by assuring her counsel that she would be able to take certain discovery later in the case, even when the requested discovery concerned key elements which relator was obligated to prove,

such as Janssen’s scienter. See, e.g., #157 at 9-10. In short, this court agrees with relator that this court, in an effort to provide her with “samples of the evidence,” limited the number of custodians, limited discovery temporally, and postponed discovery on important issues such as scienter. (#266 at 7.) While it was understood that the goal of phase one discovery was “to probe the validity of the kickback allegations before considering whether to authorize nationwide discovery,” (#75 at 33 n.12 (quoting United States ex rel. Carpenter v. Abbott Lab’ys, Inc., 723 F. Supp. 2d 395, 409- 10 (D. Mass. 2010))), it was not clear what would happen at the end of it. In May 2021, for instance, Janssen intimated that it would file a motion for summary judgment after phase one. (#131 at 16 (“We’re trying to take the relator’s allegations and what happened in the relator’s district and see

if it violates that statute. If it doesn’t, the case is over.”)) Relator’s counsel disagreed and responded that their understanding was that phase one discovery was to “get more information about the services” and other “key issues in the case,” after which the parties would engage in broader discovery. Id. at 16-17; #157 at 6-7.

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United States of America ex rel. v. Janssen Biotech, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-of-america-ex-rel-v-janssen-biotech-inc-mad-2022.