Herbert Tisher v. INSYS Therapeutics, Inc.

CourtSuperior Court of Delaware
DecidedNovember 22, 2024
DocketK18C-05-011 RLG
StatusPublished

This text of Herbert Tisher v. INSYS Therapeutics, Inc. (Herbert Tisher v. INSYS Therapeutics, Inc.) is published on Counsel Stack Legal Research, covering Superior Court of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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

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. 1 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. 2 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.

3 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.

4 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.

5 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).

6 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.

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