Herbert Tisher v. INSYS Therapeutics, Inc.

Superior Court of Delaware·Decided November 22, 2024·No. K18C-05-011 RLG·Published

Opinion

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE

HERBERT TISHER, JAMES ) STARLING, JR., and PAMELA ) STARLING, )

)

Plaintiffs, ) C.A. No. K18C-05-011 RLG )

INSYS THERAPEUTICS, INC., ) et al. )

)

Defendants. )

Submitted: August 9, 20241 Decided: November 22, 2024

MEMORANDUM OPINION AND ORDER On Defendant Kapoor’s Motion to Dismiss – GRANTED.

Philip T. Edwards, Esquire (argued) and Scott Himelein, Esquire, Murphy & Landon, Wilmington, Delaware. Attorneys for Plaintiffs.

David Anthony, Esquire; Peter C. McGivney, Esquire; Michael W. McDermott, Esquire; Brian T. Kelly, Esquire (PHV) (argued); and Mark T. Knights, Esquire (PHV), Berger McDermott LLP, Newark, Delaware. Attorneys for Defendant John N. Kapoor.

James E. Drnec, Esquire and Phillip M. Casale, Esquire, Wharton Levin Ehrmantraut & Klein, P.A., Wilmington, Delaware. Attorneys for Defendant Rodney Village Pharmacy.

GREEN-STREETT, J.

1 The transcript from the hearing in this matter was not received until September 30, 2024.

I. Introduction In 2012, Insys, a Delaware corporation, gained Food and Drug Administration (“FDA”) approval for Subsys, a fentanyl-based spray, as a treatment for “breakthrough cancer pain.”2 Defendant Dr. John Kapoor founded Insys, and served as its executive chairman when Subsys first debuted on the market.3 Unhappy with the volume of sales of Subsys, Dr. Kapoor and other Insys executives launched an aggressive campaign to push doctors to prescribe Subsys to more patients – and at higher doses.4 Many of the resulting prescriptions were illegal, and led to addiction problems for many patients.5 Dr. Kapoor and several Insys executives were prosecuted and found guilty in federal court on charges related to conspiracy to distribute Subsys improperly.6 Two patients prescribed Subsys improperly in Delaware – Herbert Tisher and James Starling Jr. – filed the instant complaint seeking compensation for the alleged damages they suffered due to their use of and resulting addiction to Subsys.

2 United States v. Simon, 12 F.4th 1, 15 (1st Cir. 2021).

3 Id.

4 Id.

5 Id.

6 Id.

Dr. Kapoor filed the instant motion under Del. Super. Ct. Civ. R. 12(b)(2), contending this Court lacks personal jurisdiction over him.7 Dr. Kapoor asserts “he has no meaningful contact with Delaware.”8 This Court held oral argument on Dr. Kapoor’s motion on April 14, 2023.9 The Court granted Plaintiffs the opportunity to pursue limited jurisdictional discovery regarding Dr. Kapoor.10 At the conclusion of that discovery, the parties submitted supplemental briefs, and Dr. Kapoor renewed his Motion to Dismiss.11 As Plaintiffs have not cited specific facts tying Dr. Kapoor to Delaware, his Motion to Dismiss is GRANTED. II. Factual and Procedural Background Dr. Kapoor founded Insys with the intention of developing a sublingual spray.12 The product he helped develop came to be known as Subsys, a sublingual spray utilizing fentanyl to provide pain relief.13 Subsys gained FDA approval as a

7 Def.’s Opening Br. in Supp. of Mot. to Dismiss, D.I. 104 (Aug. 30, 2022) (Dr. Kapoor’s motion also included argument about subject matter jurisdiction as to a claim for negligent misrepresentation. Plaintiffs conceded this Court lacks jurisdiction over that claim.). 8 Id. at 1.

9 D.I. 127 (Apr. 14, 2023).

10 Id.

11 See Def.’s Suppl. Reply, D.I. 184 (May 31, 2024); see also Pls.’ Suppl. Resp., D.I. 182 (May 13, 2024). 12 Simon, 12 F.4th at 15.

13 Id.

treatment for “breakthrough cancer pain” – spikes in pain for cancer patients who otherwise outpace cancer pain – and entered the marketplace shortly after gaining approval.14 Due to the highly addictive and dangerous properties of fentanyl, the FDA limited the initial dose of Subsys to 100 micrograms, and required any prescriber to participate in the “Risk Evaluation and Mitigation Strategy” program.15 To combat this low dosage cap, Insys employed an aggressive marketing strategy, including targeting doctors prescribing alternative fentanyl products and persuading those doctors to prescribe Subsys instead.16 Notably, many of the prescribing doctors were not oncologists and thus were unlikely to be prescribing Subsys for its FDA- approved use.17 Concerned with sales figures and the perception that many patients were only prescribed Subsys for a month before moving on to a different drug, Insys executives revamped their marketing approach.18 This new approach consisted of pressuring doctors to prescribe Subsys at higher doses; reward sales representatives for

14 Id.

15 Id.

16 Id.

17 Id.

18 Id.

successfully pushing higher doses; and a “speaker program,” in which doctors who prescribed high amounts of Subsys were rewarded with compensated speaking opportunities.19 These speaker events often had few attendees, and appear to have served mostly as a way for Insys to funnel money to doctors Insys perceived as “whales” – doctors writing a high volume of prescriptions for Subsys and at higher doses.20 Insys also formulated ways for prescribing doctors to get around barriers erected by insurance companies.21 The “Insys Reimbursement Center” led Insys sales representatives to contact insurance companies to help facilitate the approval of Subsys prescriptions.22 These sales representatives maintained a list of “diagnoses and conditions that historically had prompted particular insurers to approve Subsys.”23 Those conditions were utilized by physicians prescribing Subsys to gain insurance approval, even if the patient did not qualify for those conditions.24

19 Id.

20 Id.

21 Id.

22 Id.

23 Id.

24 Id.

Insys created a “super voucher” program, providing free samples of Subsys to patients whose insurance otherwise would not cover the medication.25 Eventually, Insys came under federal investigation and many of its executives were indicted on charges stemming from illegally pushing the sale of Subsys.26 Dr. Kapoor and the other defendants were found guilty in federal court, and their guilty verdicts were affirmed on appeal.27 In its decision affirming Dr. Kapoor’s conviction, the First Circuit Court of Appeals noted, “[t]he record is replete with support for the proposition that Kapoor intended physicians to write medically illegitimate prescriptions. Kapoor sought out pill mill doctors (that is, doctors who were notorious for their readiness to prescribe drugs regardless of medical necessity).”28 Plaintiffs filed the Amended Complaint on July 3, 2018.29 Plaintiffs allege Defendants, including Dr. Kapoor, executed “a reckless and negligent scheme” to

25 Id.

26 Id.

27 Id.

28 Id. at 24.

29 Am. Compl., D.I. 4 (Jul. 3, 2018); the parties agreed to stay the matter while criminal proceedings involving several Defendants, including Dr. Kapoor, resolved. See D.I. 38 (Oct. 22, 2018); the Court lifted the stay as to Dr. Kapoor on July 18, 2022. See D.I. 99; litigation was also stayed pending resolution of Insys’s bankruptcy filing. See D.I. 65 (Mar. 30, 2020).

push Subsys “to ensure huge financial gains.”30 Dr. Eva Dickinson, a Delaware- based physician, “prescribed Subsys to Plaintiffs at dangerous and unnecessary doses, resulting in their dependence and ultimate addiction to the drug.”31 Plaintiffs do not contend Dr. Kapoor ever interacted with Plaintiffs or spent any time physically in Delaware. Instead, Plaintiffs allege Dr. Kapoor, directly or through agents, managed Dr. Dickinson and directed her to overprescribe Subsys.32 Plaintiffs argue Dr. Kapoor exercised “tight control” over Insys, and directed sales representatives to persuade or pressure doctors into overprescribing Subsys.33 Plaintiffs point to the “speakers program” employed by Insys, which incentivized doctors to prescribe Subsys to patients who had no need for the drug, as an example of the tactics used by Insys to push sales of Subsys illegally.34 At the time of the events alleged in the Amended Complaint, Dr. Kapoor resided in Arizona, as did Insys’s headquarters.35 The Amended Complaint groups Dr. Kapoor into a category defined as the “Corporate Defendants,” but does not make

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Herbert Tisher v. INSYS Therapeutics, Inc., (Del. Ct. App. 2024).

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