Government Employees Health Association v. Actelion Pharmaceuticals Ltd.

CourtDistrict Court, D. Maryland
DecidedJanuary 19, 2023
Docket1:18-cv-03560
StatusUnknown

This text of Government Employees Health Association v. Actelion Pharmaceuticals Ltd. (Government Employees Health Association v. Actelion Pharmaceuticals Ltd.) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Government Employees Health Association v. Actelion Pharmaceuticals Ltd., (D. Md. 2023).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

GOVERNMENT EMPLOYEES * HEALTH ASSOCIATION, on behalf * of itself and all others similarly situated, * * Plaintiff, * v. * Civil Case No: 1:18-cv-03560-GLR ACTELION PHARMACEUTICALS LTD., et al, * Defendants. * * * * * * * * * * * * MEMORANDUM OPINION AND RECOMMENDATION1 Before the Court is Plaintiff Government Employees Health Association’s Motion for Spoliation-Related Sanctions. (ECF No. 194). The basis for Plaintiff’s Motion concerns the deletion of Electronically Stored Information (“ESI”) from five custodians who were former employees of Defendants Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc., and/or Janssen Research and Development, LLC (collectively, “Actelion”): Michael Flinn, Terry Cato, Lisa Wong, Juniette Kang’a, and Shalom Jacobovitz (the “at-issue custodians”). (ECF No. 194-1 at pp. 9–12).2 Plaintiff seeks to introduce evidence concerning the deletion at trial, requests an adverse inference instruction, argues to exclude three of Actelion’s defenses,

1 Because Plaintiff’s Motion seeks non-dispositive relief pursuant to Federal Rule of Civil Procedure 37, which addresses discovery violations, and this matter was referred by Judge Russell, the U.S. District Judge presiding over this case, to the undersigned for all discovery and related scheduling, the undersigned’s authority derives from 28 U.S.C. § 636(b) and Local Rule 301.5.a. as to such relief, subject to a “clearly erroneous” standard of review by Judge Russell. However, because Plaintiff also seeks to strike three of Actelion’s defenses (ECF No. 194-1 at pp. 32–34), this aspect of relief could be construed as “dispositive,” so as to limit the undersigned’s authority over this aspect of relief to a “recommendation” pursuant to Local Rule 301.5.b and change the standard of review by Judge Russell to a de novo determination as to the undersigned’s ruling on striking these affirmative defenses.

2 When the Court cites to a specific page range, it is referring to the page numbers provided within the electronic filing stamps located at the top of every electronically filed document. and seeks attorney’s fees and costs based on spoliation. Id. at p. 7. The Court has also reviewed Actelion’s Opposition (ECF No. 200) and Plaintiff’s Reply (ECF No. 203). The Court denied Actelion’s Motion to File Sur-Reply (ECF No. 206), but without prejudice to Actelion’s ability to raise the arguments contained therein at the hearing on the Motion, which was held on January

17, 2023. As set forth more fully below, the Court will GRANT in part and DENY in part Plaintiff’s Motion. I. BACKGROUND Actelion is a drug manufacturer and Tracleer is one of its products. More than ten years ago, generic manufacturers anticipated the expiration of Actelion’s patents on Tracleer and prepared to enter the market with a generic version. Those manufacturers requested samples of Tracleer from Actelion to assist them in developing such a generic version. Based on alleged intentional and unjustified delays by Actelion in that process, the generic manufacturers had litigation with Actelion that was resolved by settlement in April of 2014.3 The instant antitrust litigation, though similar in many of its allegations, does not include

generic manufacturers. Instead, the case subj judice is brought by a purported class of those forced to pay higher prices for Tracleer due to the unavailability of a cheaper generic version caused by Actelion’s actions in effectively blocking competition by withholding samples from

3 Additionally, the U.S. Department of Justice pursued Anti Kick-back litigation against Actelion, claiming that in 2014–2015 Actelion violated the False Claims Act by illegally reimbursing Medicare patients for their co-pay portion of Tracleer and other drugs to incentivize them to purchase those drugs. See Press Release, Department of Justice, Drug Maker Actelion Agrees to Pay $360 Million to Resolve False Claims Act Liability for Paying Kickbacks (Dec. 6, 2018), https://www.justice.gov/opa/pr/drug-maker-actelion-agrees-pay-360-million-resolve- false-claims-act-liability-paying. It does not appear that this prior litigation involved specific allegations against Actelion for blocking the development of generic drugs. A subpoena to Actelion in that action did include, inter alia, documents concerning “any pricing strategy or other business plan concerning [Tracleer and other drugs],” (ECF No. 194-24, Ex. 21 at p. 10), and included two of the at-issue custodians—Jacobovitz and Cato—in a long list of data custodians. (ECF No. 194-25, Ex. 22 at pp. 2, 4). However, in the context of that investigation, the Court is not convinced that such a request would necessarily include any strategy on the development of generic versions of Tracleer. Although the precise date of Actelion’s settlement of that litigation is not before the Court, the press release announcing the settlement is dated December 6, 2018, two days after the present lawsuit was served. generic manufacturers. Actelion defends, in part, by arguing that the samples were withheld due to certain regulations of the Food and Drug Administration (“FDA”), in particular the FDA’s Risk Evaluation Mitigation Strategies (“REMS”) regulation, as well as other legitimate business strategies.

This case was filed on November 19, 2018, and it was served on December 4, 2018. (ECF Nos. 1 & 28). On December 20, 2018, Johnson and Johnson (“J&J”), which had purchased Actelion in June of 2017 and was managing the data of the combined companies, instituted a “legal hold” to preserve relevant information for this case. (ECF No. 194-21, Ex. 18 at ¶ 18). At the January 17, 2023 hearing, Actelion explained that the Actelion data custodians included in the legal hold were determined by its in-house counsel at the time, Rahsaan Thompson, who had also been involved in the earlier litigation with the generic manufacturers. None of the five at-issue custodians were included on Thompson’s legal hold list. Because some Actelion employees did not join J&J after its acquisition of Actelion in 2017, J&J was making decisions as to whether the ESI of these former employees would be

retained as it was migrating the Actelion data to the J&J platform. In making these decisions, J&J relied on Thompson to advise which departed Actelion employees’ data was subject to an existing legal hold, whether in the instant case or any other matter. Id. at ¶¶ 16–22; (ECF No. 194-22, Ex. 19 at 169:6–10). In the fall of 2019, well after this lawsuit had been filed and served, J&J sent Thompson a list purporting to contain the names of all former Actelion employees not otherwise subject to a legal hold, asked for verification of the list, and informed him that custodial data for these former Actelion employees on the list was scheduled for deletion. (ECF No. 194-6, Ex. 3 at ¶ 3). According to J&J, in consultation with J&J’s outside counsel, Thompson confirmed the deletion list, which included all five of the at-issue custodians. Id. at ¶ 3–4.4 At the January 17, 2023 hearing, Actelion clarified that Thompson verified the proposed deletion list by comparing the names on that list to the earlier legal hold list that Thompson had previously drafted for the instant case when the hold was first instituted. Because the five at-issue custodians were not on Thompson’s original legal hold list for this case, the custodial data,5 including email data and, in some cases, the data from their Home Directory

files,6 for the at-issue custodians was deleted between September 6 and September 11, 2019. Id. at ¶ 4.

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Bluebook (online)
Government Employees Health Association v. Actelion Pharmaceuticals Ltd., Counsel Stack Legal Research, https://law.counselstack.com/opinion/government-employees-health-association-v-actelion-pharmaceuticals-ltd-mdd-2023.