Cardiorentis AG v. Iqvia Ltd.

CourtSupreme Court of North Carolina
DecidedFebruary 28, 2020
Docket168A19
StatusPublished

This text of Cardiorentis AG v. Iqvia Ltd. (Cardiorentis AG v. Iqvia Ltd.) is published on Counsel Stack Legal Research, covering Supreme Court of North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cardiorentis AG v. Iqvia Ltd., (N.C. 2020).

Opinion

IN THE SUPREME COURT OF NORTH CAROLINA

No.168A19

Filed 28 February 2020

CARDIORENTIS AG

v. IQVIA LTD. and IQVIA RDS, INC.

Appeal pursuant to N.C.G.S. § 7A-27(a)(3) from an order and opinion on

defendants’ motion to stay all proceedings on forum non conveniens grounds entered

on 31 December 2018 by Judge Adam M. Conrad, Special Superior Court Judge for

Complex Business Cases, in Superior Court, Durham County, after the case was

designated a mandatory complex business case by the Chief Justice pursuant to

N.C.G.S. § 7A-45.4(a). Heard in the Supreme Court on 6 January 2020.

Robinson, Bradshaw & Hinson, P.A., by J. Dickson Phillips III and Jonathan C. Krisko; and Hogan Lovells US LLP, by Catherine E. Stetson, for plaintiff.

Brooks, Pierce, McLendon, Humphrey & Leonard, L.L.P., by Charles F. Marshall and Shepard D. O’Connell; Cooley LLP, by Michael J. Klisch, Joshua M. Siegel, and Robert T. Cahill for defendants.

PER CURIAM.

AFFIRMED. STATE OF NORTH CAROLINA IN THE GENERAL COURT OF JUSTICE SUPERIOR COURT DIVISION DURHAM COUNTY 18 CVS 2313

CARDIORENTIS AG,

Plaintiff,

v. ORDER AND OPINION ON DEFENDANTS’ IQVIA LTD. and IQVIA RDS, INC., PRE-ANSWER MOTIONS Defendants.

1. Plaintiff Cardiorentis AG is a Swiss biopharmaceutical company. Its

flagship drug, Ularitide, is a treatment for heart failure. In 2012, Cardiorentis

enlisted IQVIA Ltd. (“IQVIA UK”), an English contract research organization, to

perform a worldwide clinical trial of Ularitide with a view toward obtaining the

regulatory approvals needed to market the new drug. The trial was not successful.

According to Cardiorentis, the results were invalid, compromised by the inclusion of

hundreds of ineligible patients. Cardiorentis blames both IQVIA UK and its North

Carolina-based parent, IQVIA RDS, Inc. (“IQVIA NC”), asserting claims for breach of

contract and fraud, among others.

2. Neither IQVIA UK nor IQVIA NC has answered the complaint, instead

opting to file several pre-answer motions. Defendants first ask the Court to stay all

proceedings under N.C. Gen. Stat. § 1-75.12 on forum non conveniens grounds. (ECF

No. 19.) IQVIA UK separately asks the Court to dismiss the claims against it for lack

of personal jurisdiction. (ECF No. 17.) In the alternative, Defendants also seek to dismiss all claims on the merits pursuant to North Carolina Rule of Civil Procedure

12(b)(6). (ECF No. 21.)

3. For the following reasons, the Court GRANTS Defendants’ motion to stay

all proceedings under section 1-75.12. The Court DENIES as moot all other

requested relief.

Robinson, Bradshaw & Hinson, P.A., by J. Dickson Phillips III, Jonathan C. Krisko, and Morgan P. Abbott, and Hogan Lovells US LLP, by Dennis H. Tracey III and Allison M. Wuertz, for Plaintiff Cardiorentis AG.

Brooks, Pierce, McLendon, Humphrey & Leonard, L.L.P., by Charles F. Marshall, Charles E. Coble, and Shepard D. O’Connell, and Cooley LLP, by Michael J. Klisch and Robert T. Cahill, for Defendants IQVIA Ltd. and IQVIA RDS, Inc.

Conrad, Judge. I. BACKGROUND1

4. It is not clear when Cardiorentis began developing Ularitide, but by April

2010, the regulatory-approval process was underway. (See Compl. ¶¶ 18, 19, ECF

No. 3.) Though based in Switzerland, Cardiorentis hoped to market the drug widely.

It sought approvals from two of the world’s key regulatory agencies, the United States

Food and Drug Administration and the European Medicines Agency. (Compl. ¶ 19.)

Cardiorentis completed two preliminary clinical trials before selecting IQVIA UK, an

English company, to manage a Phase III trial designed to demonstrate Ularitide’s

safety and efficacy. (Compl. ¶¶ 1, 4, 20.)

1In this section, the Court draws from the allegations in the complaint, along with the briefs and affidavits in support of and opposition to Defendants’ motion to stay. 5. In August 2012, Cardiorentis and IQVIA UK (named Quintiles Ltd. at that

time) entered into a General Services Agreement (“Services Agreement”) that set out

the terms for a global, multi-year trial. (Compl. ¶¶ 1, 6, 21; Mem. in Supp. Mot. Stay

Ex. 2, ECF No. 20.3 [“Services Agreement”].) IQVIA UK agreed to design and run

the trial in its entirety. (Compl. ¶ 22.) Its duties included developing the protocol

that established the essential criteria for determining a patient’s eligibility to

participate. (Compl. ¶¶ 22(a), 30.) IQVIA UK was also required to select all trial

sites, to monitor each site to ensure compliance with the protocol, and to perform full

source data verification to ensure that reported data matched the patient’s original

medical records. (See Compl. ¶¶ 22(b), 22(f), 22(f), 37, 39; Defs.’ Reply Br. in Supp.

Mot. Stay Ex. 3 ¶¶ 18–19, ECF No. 81.4.) Other duties included data management,

statistical analysis, and medical advisory services. (See Mem. in Supp. Mot. Stay Ex.

5 ¶¶ 7, 9–12, ECF No. 20.6.) The Services Agreement is governed by English law and

allows IQVIA UK to use the services of its corporate affiliates, including its parent

IQVIA NC. (Services Agreement §§ 20.0; 28.0; Defs.’ Mem. in Supp. Mot. Stay 4, ECF

Nos. 20, 61 [“Mem. in Supp.”].)

6. Eight months after executing the Services Agreement, Cardiorentis entered

into a Clinical Quality Agreement (“Quality Agreement”) with IQVIA NC (named

Quintiles, Inc. at that time). (Compl. ¶ 24.) The Quality Agreement functioned as an

extension of the Services Agreement, outlining processes for effective communication

during the trial. (See Mem. in Supp. Ex. 3 § 1, ECF No. 20.4 [“Quality Agreement”].) If the Services Agreement and Quality Agreement conflicted in any way, the Services

Agreement would control. (Quality Agreement § 1.)

7. The trial appears to have been a mammoth undertaking, involving more

than a hundred trial investigators, thousands of patients, and hospitals in 23

countries. (See Compl. ¶¶ 7, 8, 34; Defs.’ Reply Br. in Supp. Mot. Stay 6, ECF No. 81

[“Reply Br.”].) Over a three-year period, IQVIA UK trained the investigators and

then collected, managed, and reviewed the trial data. (Compl. ¶¶ 22(c), 22(g).) Yet

the trial was unsuccessful. (Compl. ¶¶ 8, 82, 84.)

8. Cardiorentis now seeks to hold Defendants responsible for the failed trial,

claiming that both Defendants breached the Services Agreement and that IQVIA NC

breached the Quality Agreement. (Compl. ¶¶ 91, 99.) Cardiorentis alleges, among

other things, that Defendants provided inadequate training, failed to monitor the

trial sites, allowed hundreds of ineligible patients to enroll, and then concealed

deviations from the protocol. (See Compl. ¶¶ 46–49, 51.) These violations,

Cardiorentis alleges, were intentional—a conscious choice to withhold resources and

reduce trial costs for the purpose of inflating Defendants’ stock price before a merger.

(See Compl. ¶¶ 54–56.) In addition to its claims for breach of contract, Cardiorentis

asserts claims for fraud, tortious misrepresentation, and violations of North

Carolina’s Unfair and Deceptive Trade Practices Act. (Compl. ¶¶ 106, 120, 130.)

9. In their pre-answer motions, Defendants contend that this case has little

connection to North Carolina. They jointly seek a stay on forum non conveniens

grounds, and IQVIA UK separately contends that this Court lacks personal jurisdiction over it. In the event North Carolina is a proper venue, Defendants

contend that the case should be dismissed anyway because the complaint fails to state

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