Di Donato v. Insys Therapeutics Incorporated

CourtDistrict Court, D. Arizona
DecidedSeptember 20, 2019
Docket2:16-cv-00302
StatusUnknown

This text of Di Donato v. Insys Therapeutics Incorporated (Di Donato v. Insys Therapeutics Incorporated) is published on Counsel Stack Legal Research, covering District Court, D. Arizona primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Di Donato v. Insys Therapeutics Incorporated, (D. Ariz. 2019).

Opinion

1 WO 2 3 4 5 6 IN THE UNITED STATES DISTRICT COURT 7 FOR THE DISTRICT OF ARIZONA 8 Richard Di Donato, individually and on No. CV-16-00302-PHX-NVW 9 behalf of all others similarly situated, ORDER 10 Plaintiff, 11 v. 12 Insys Therapeutics, Inc.; Michael L. 13 Babich; Darryl S. Baker; John N. Kapoor; and Alec Burlakoff, 14 Defendants. 15 16 17 Before the Court are Lead Plaintiff’s Motion for Class Certification (Doc. 159) and 18 Defendants’ Motion for Leave to File Sur-Reply in Further Opposition to Lead Plaintiff’s 19 Motion for Class Certification (Doc. 170). 20 On June 10, 2019, Defendant Insys Therapeutics Inc. (“Insys”) commenced a 21 voluntary case under chapter 11 of title 11 of the United States Code (11 U.S.C. § 101 et 22 seq.) in the United States Bankruptcy Court for the District of Delaware, and this action is 23 automatically stayed with respect to Insys. (Doc. 230.) This action is not stayed as to the 24 proceedings against the Defendants other than Insys. (Doc. 258.) This Order, therefore, 25 applies only to Defendants Michael L. Babich, Darryl S. Baker, and John N. Kapoor. 26 Claims against Defendant Alec Burlakoff were dismissed. (Doc. 107 at 41.) 27 28 1 I. BACKGROUND 2 Insys is a publicly traded1 pharmaceutical company headquartered in Arizona that 3 makes and sells Subsys, a very expensive sublingual fentanyl spray approved by the Food 4 and Drug Administration to treat breakthrough pain in adult cancer patients already taking 5 opioid pain medication. Babich, Baker, and Kapoor served as high-level executives at 6 Insys during 2014 through 2016. During that time, Insys reported increasing revenues each 7 quarter and attributed most of its upward trajectory to the sale of Subsys. Insys touted its 8 unique programs within the oncology setting for increasing sales and claimed that it was 9 taking market share from competing products for breakthrough cancer pain by building 10 awareness among oncologists. However, as alleged, Insys actively discouraged promoting 11 Subsys for cancer patients, less than 1% of Subsys prescriptions were written by 12 oncologists, and Insys paid doctors bribes and kickbacks in exchange for prescribing 13 Subsys off-label. 14 Company executives publicly attributed the drug’s success to vigorous marketing 15 efforts and the company’s diligent negotiations with pharmacy benefit managers, third- 16 party payers, and insurers. Insys created an “Insurance Reimbursement Center,” 17 sometimes called the “Prior Authorization Unit,” ostensibly to interact with third-party 18 payers to obtain prior authorization and insurance coverage for Subsys prescriptions. 19 Employees of the “Insurance Reimbursement Center” allegedly falsified patient diagnoses, 20 lied to insurance companies, and posed as employees of the prescribing doctors. 21 Plaintiff alleges that Defendants made the following materially false and misleading 22 statements: 23 268. More specifically, Defendant Babich stated: 24 I think Q4 is a great indication of what we can do with the product moving forward, as well. I think that is important for 25 folks—our sales force expansion was based on opportunity. 26 We keep hitting new highs in the number of new doctors that we activate on a weekly basis. We have some very unique 27 28 1 During the Class Period, Insys common stock traded on the NASDAQ.

-2- programs within the oncology setting that we continue to 1 execute on and any growth that we see in this overall TIRF 2 class is specifically coming from Subsys. 3 So we feel that this is our market to continue to grow and to continue to dominate, like we are doing at this point with our 4 market share. I’ve always talked about, from a market share, 5 our next total is 50% market share. You can see that in Q4 the Actiq generic continued to decline, so we continued to take 6 market share from the generic. And I think that’s a testament 7 to the fact that we have a clinically superior product to the Actiq generic out there. So I think long term we can 8 eventually get to that 60% market share for this product. 9 .... 10 272. Furthermore, with respect to the continued growth of Subsys, the FY14 Form 10-K also explained: 11 some of the key factors in generating continued growth in 12 Subsys usage include taking market share from other 13 competing TIRF products and expanding the usage of Subsys for BTCP by building awareness among oncologists of its 14 rapid onset of action, improved bioavailability, most complete range of dosage strengths and ease of administration relative 15 to other TIRF products. 16 (Doc. 77 at 103-05; see Doc. 107 at 41.) “TIRF” refers to “Transmucosal Immediate- 17 Release Fentanyl.” “BTCP” refers to “breakthrough cancer pain.” 18 Plaintiff also alleges that Insys stock prices declined because of news or 19 announcements to investors that revealed the company’s prior statements to have been false 20 or misleading. On November 4, 2015, CNBC published an article on its website revealing 21 that the Department of Health and Human Services classified Subsys as commonly 22 prescribed for unintended uses. In the context of publicized fraud allegations against Insys 23 employees and collaborating healthcare providers, the article constituted a partial 24 disclosure of the company’s underlying fraud. On December 3, 2015, and January 25, 25 2016, the Southern Investigative Reporting Foundation partially disclosed fraud by Insys 26 in articles about the company’s “Prior Authorization Unit” and Babich’s resignation. 27 28

-3- 1 Plaintiff seeks to certify a class (the “Class”) pursuant to Federal Rules of Civil 2 Procedure 23(a) and 23(b)(3) consisting of all persons and entities who purchased or 3 otherwise acquired Insys common stock during the period from March 3, 2015, through 4 January 25, 2016 (the “Class Period”), and were damaged thereby. Excluded from the 5 Class are Defendants; present and former directors or executive officers of Insys and 6 members of their immediate families; any of the foregoing individuals’ or entities’ legal 7 representatives, heirs, successors, or assigns; and any entity in which any Defendant has or 8 had a controlling interest or which is related to or affiliated with any Defendant. 9 Count I of Plaintiff’s Second Amended Complaint alleges against all Defendants 10 securities fraud in violation of Section 10(b) of the Exchange Act, 15 U.S.C. § 78j(b), and 11 Rule 10b-5 promulgated thereunder by the SEC, 17 C.F.R. § 240.10b-5. Count II alleges 12 control-person liability for Defendants Babich, Baker, and Kapoor under Section 20(a) of 13 the Exchange Act. (See Docs. 77, 107.) 14 II. DEFENDANTS’ MOTION FOR LEAVE TO FILE SUR-REPLY 15 Defendants move for leave to file a sur-reply to respond to arguments and evidence 16 included for the first time in Plaintiff’s reply in support of his motion for class certification. 17 (Doc. 170.) Defendants respond not only to “new” arguments and evidence included in 18 Plaintiff’s reply, but also to issues that were “not addressed in any meaningful detail” in 19 Plaintiff’s opening brief. Plaintiff contends that each of the arguments Defendants describe 20 as “new” is a response to arguments or concessions Defendants did not make until they 21 filed their response to the class certification motion or to Defendants’ attempt to rebut the 22 presumption that proposed class members relied on Defendants’ misstatements. 23 Defendants attached their proposed sur-reply to be filed if leave were granted. Plaintiff’s 24 opposition brief responds both to the motion and the content of the proposed sur-reply.

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Di Donato v. Insys Therapeutics Incorporated, Counsel Stack Legal Research, https://law.counselstack.com/opinion/di-donato-v-insys-therapeutics-incorporated-azd-2019.