HALMAN ALDUBI PROVIDENT AND PENSION FUNDS LTD. v. TEVA PHARMACEUTICAL INDUSTRIES LIMITED

CourtDistrict Court, E.D. Pennsylvania
DecidedMarch 25, 2022
Docket2:20-cv-04660
StatusUnknown

This text of HALMAN ALDUBI PROVIDENT AND PENSION FUNDS LTD. v. TEVA PHARMACEUTICAL INDUSTRIES LIMITED (HALMAN ALDUBI PROVIDENT AND PENSION FUNDS LTD. v. TEVA PHARMACEUTICAL INDUSTRIES LIMITED) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
HALMAN ALDUBI PROVIDENT AND PENSION FUNDS LTD. v. TEVA PHARMACEUTICAL INDUSTRIES LIMITED, (E.D. Pa. 2022).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

HALMAN ALDUBI PROVIDENT AND CIVIL ACTION PENSION FUNDS LTD., Individually and On Behalf of All Others Similarly Situated, NO. 20-4660-KSM Plaintiff,

v.

TEVA PHARMACEUTICALS INDUSTRIES LIMITED, et al.,

Defendants.

MEMORANDUM

MARSTON, J. March 25, 2022

Lead Plaintiff Gerald Forsythe, individually and on behalf of all others similarly situated, alleges that Teva Pharmaceuticals Industries Limited (“Teva”) and Teva executives Erez Vigodman, Eyal Desheh, Robert Koremans, Michael Derkacz, Kåre Schultz, Michael McClellan, Brendan O’Grady, and Eli Kalif (collectively, the “Individual Defendants,” and together with Teva, “Defendants”) violated Section 10(b) of the Securities Exchange Act of 1934 and Securities and Exchange Commission Rule 10b-5 by making false and misleading statements and by failing to disclose material information about Teva’s drug Copaxone. (Doc. No. 1.) Plaintiff also claims that the Individual Defendants violated Section 20(a) of the Exchange Act because they knew or recklessly disregarded that Teva was making materially false and misleading statements and material omissions. (Id. ¶¶ 249–254.) Presently before the Court is Defendants’ motion to dismiss. (Doc. No. 66.) For the reasons below, Defendants’ motion is granted in part and denied in part. I. BACKGROUND A. Factual Background Taking the allegations in the Corrected Amended Complaint as true, the relevant facts are as follows. 1. Teva’s Business

Teva is a global pharmaceutical company that sells generics, specialty medicines, and over-the-counter products. (Doc. No. 64-2 ¶ 27.) One of Teva’s products is Copaxone (glatiramer acetate injection), an injectable drug used to treat patients with multiple sclerosis. (Id. ¶ 28.) Teva offers two dosages of Copaxone: a 20 mg/mL dose that is injected daily, and a 40 mg/mL that is injected three times a week. (Id.) Copaxone is “one of the leading” therapies for multiple sclerosis in the United States, and in the mid-2010s, it was responsible for nearly half of the revenue in Teva’s specialty medicines portfolio. (Id. ¶ 30.) 2. Shared Solutions Program Teva sponsors “Shared Solutions,” a program designed to increase patient access to

Copaxone. (Id. ¶ 41.) Through the program, Teva trains patients on how to inject the drug, offers patients injection devices to administer the drug, and assigns patients case managers who help patients secure insurance coverage for the drug. (Id.) In 2006, in connection with the Shared Solutions program, Teva contracted with Advanced Care Scripts, Inc. (“ACS”), a specialty pharmacy. (Id. ¶ 42.) Teva sent ACS prescriptions for patients participating in Shared Solutions who “either had or were eligible for Medicare Part D coverage.” (Id.) For the patients who did not already have Medicare Part D coverage, ACS assisted with the enrollment process. (Id.) And for the patients who already had Medicare Part D coverage and were eligible for co- pay coverage from a patient assistance program (“PAP”),1 ACS helped them apply for PAP assistance. (Id.) Teva also provided free Copaxone to low- or no-income patients; however, if those patients were eligible for Medicare Part D, Teva sent those patients to ACS for assistance enrolling in Medicare Part D and applying for PAP assistance. (Doc. No. 57 ¶ 43.) ACS referred Teva’s Copaxone patients to two PAPs for co-pay assistance: the Chronic

Disease Fund (“CDF”) and The Assistance Fund (“TAF”). (Id. ¶ 42.) Both CDF and TAF maintained funds dedicated to assisting multiple sclerosis patients, through which they “provided co-pay assistance to patients for, ostensibly, any of the [multiple sclerosis] drugs on the market.” (Id.) Teva regularly donated to both PAPs. (Id.) Under the applicable regulations, pharmaceutical companies may donate to PAPs; however, “the funds received through donations must be applied generally to all beneficiaries, and it is illegal for a Charitable PAP to apply the funds received to any particular drug.” (Id. ¶ 35.) The Department of Health and Human Services has cautioned that, if a pharmaceutical company makes a donation in order to “channel its financial support to copayments of its own products,” such conduct “would implicate the anti-

kickback statute.” (Id. ¶ 36.) Teva allegedly ran afoul of those regulations. (Id. ¶ 48.) Teva did not intend its donations to CDF and TAF to cover co-payments for multiple sclerosis treatments generally; rather, it intended its donations to CDF and TAF to cover patients’ co-pays on Copaxone specifically. (Id.) In fact, Teva executives regularly described the company’s donations to CDF and TAF as “Copaxone donations.” (Id.) Teva’s intentions bore out. (Id. ¶ 46.) For instance, in December 2009 and January 2010, Teva donated $15.7 million to TAF, “approximately 99% of

1 A PAP is a charitable program that provides financial assistance to help patients cover Medicare Part D co-pays. (Doc. No. 57 ¶ 35.) which was paid to Copaxone patients.” (Id.) Teva worked with ACS, CDF, and TAF “to ensure that the foundations would continue to cover all of [the] Copaxone patients’ Medicare co-pays in the following year.” (Id. ¶ 49.) ACS, CDF, and TAF provided Teva with information on the number of Copaxone patients enrolled in Medicare Part D, which Teva used to estimate the Copaxone patients’ total co-pays for the year and calculated its donations based on this estimate.

(Id. ¶¶ 50–52.) Specifically, at the beginning of each year, TAF closed its multiple sclerosis assistance fund “because it had committed all of its funding to existing patients who had renewed their annual co-pay grants.” (Id. ¶ 55.) But Teva, ACS, and TAF worked together to ensure that new patients could benefit from TAF’s funding throughout the year. (Id.) ACS would tell Teva how many Copaxone patients were awaiting Medicare co-pay assistance, and TAF would tell Teva the average co-pay per Medicare patient. (Id.) Teva would then calculate how much it would cost to pay each of those patients’ Medicare co-pays and donated that amount to TAF. (Id.) As soon as TAF received a donation from Teva, ACS would send a “batch file” of all the Copaxone

patients awaiting Medicare co-pay assistance to TAF. (Id.) Several of the Individual Defendants approved wire transfers for “Copaxone donations” to CDF and TAF. (Id. ¶ 48 (quoting from email from Defendant Desheh “approving a ‘Copaxone Donation payment’”); id. (quoting from an email to Defendant Koremans requesting “Approval for Copaxone donation payment”); id. ¶ 66 (quoting from email to Defendant McClellan requesting “to pay another $10M for Copaxone donations . . . a common payment we make each year”).) In all, Teva donated tens of millions of dollars to CDF and TAF annually to fund Copaxone co-pays. (See id. ¶ 53 (indicating that Teva made the following donations to CDF and TAF: $36,934,678 in 2012, $36,932,589 in 2013, and $34,774,070 in 2014).) Copaxone patients receiving Medicare co-pay assistance from CDF and TAF made up roughly 27% of patients on Copaxone. (Id. ¶ 62.) Teva recognized that if it stopped funding these co-pay assistance programs, these patients “may not fill Rx and go off therapy, which would result in a negative impact to the brand of $210-280M.” (Id.; see also id. ¶ 59 (quoting from email from Teva finance manager, stating that if donations to CDF and TAF were reduced

by $10 million, “the sales [of Copaxone] will decrease as well, as there will be Medicare patients out there that won’t be able to fill”).) While Teva was donating to CDF and TAF, it “raised the price of Copaxone at a rate . . . over 19 times the rate of inflation, from approximately $17,000 per year to $73,000 per year.” (Id. ¶ 69.) 3.

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HALMAN ALDUBI PROVIDENT AND PENSION FUNDS LTD. v. TEVA PHARMACEUTICAL INDUSTRIES LIMITED, Counsel Stack Legal Research, https://law.counselstack.com/opinion/halman-aldubi-provident-and-pension-funds-ltd-v-teva-pharmaceutical-paed-2022.