Medicalgorithmics, SA v. AMI Monitoring, Inc.

CourtCourt of Chancery of Delaware
DecidedAugust 18, 2016
DocketCA 10948-CB
StatusPublished

This text of Medicalgorithmics, SA v. AMI Monitoring, Inc. (Medicalgorithmics, SA v. AMI Monitoring, Inc.) is published on Counsel Stack Legal Research, covering Court of Chancery of Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Medicalgorithmics, SA v. AMI Monitoring, Inc., (Del. Ct. App. 2016).

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

MEDICALGORITHMICS S.A., ) ) ) ) Plaintiff, ) ) v. ) C.A. No. 10948-CB ) AMI MONITORING, INC. d/b/a ) SPECTOCOR and SPECTOCOR LLC, ) ) ) Defendants. ) ) v. ) ) MEDICALGORITHMICS S.A., ) ) Counterclaim Defendant. )

MEMORANDUM OPINION

Date Submitted: May 10, 2016 Date Decided: August 18, 2016

Philip Trainer, Jr. and Marie M. Degnan, ASHBY & GEDDES, P.A., Wilmington, Delaware; Madlyn Gleich Primoff, Daniel Reisner, Michael Lynn and Kyle D. Gooch, KAYE SCHOLER LLP, New York, New York; Attorneys for Plaintiff.

Blake Rohrbacher, Kelly E. Farnan, Robert L. Burns, Rachel E. Horn, Thomas R. Nucum and Brian F. Morris, RICHARDS, LAYTON & FINGER, P.A., Wilmington, Delaware; Attorneys for Defendants.

BOUCHARD, C. In 2011, Medicalgorithmics S.A. and AMI Monitoring, Inc. entered into a

Strategic Alliance Agreement under which AMI received an exclusive license to

market and distribute in the United States a cardiac monitoring device that

Medicalgorithmics invented. A critical term of the agreement, which was updated

in 2014, prohibited AMI from seeking or developing a product to replace the

Medicalgorithmics device unless AMI first provided a notice of termination, which

would begin a two-year period at the end of which the remaining obligations under

the agreement would expire. The purpose of this provision was to deter AMI,

Medicalgorithmics’ exclusive licensee in the United States, from seeking to

develop or use a competing device and to afford Medicalgorithmics a two-year

runway to transition to another distributor if it did.

In this post-trial decision, I conclude that AMI materially breached the

Strategic Alliance Agreement by no later than April 2014 by secretly seeking to

develop a device for use in the United States to replace the Medicalgorithmics

device without first providing the required notice to Medicalgorithmics. Because

of AMI’s material breach, Medicalgorithmics’ later termination of the agreement

was valid, and it is entitled to damages, although significantly less than it sought at

trial. Medicalgorithmics also is entitled to recover its attorneys’ fees and costs for

this litigation under an indemnification provision in the agreement, and to

judgment in its favor dismissing AMI’s counterclaims.

1 I. BACKGROUND

The facts recited in this opinion are my findings based on the stipulations of

the parties, documentary evidence, and testimony presented during a five-day trial

during which seven fact and three expert witnesses testified. I accord the evidence

the weight and credibility I find it deserves.

A. The Parties

Plaintiff and counterclaim defendant Medicalgorithmics S.A. is a public

company incorporated and headquartered in Poland. 1 Medicalgorithmics is the

developer and manufacturer of a remote cardiac monitoring system known as the

PocketECG, a medical device marketed in the United States under a premarket

clearance from the United States Food and Drug Administration.

Medicalgorithmics holds the intellectual property rights to the PocketECG.2

Marek Dziubinski, the founder and CEO of Medicalgorithmics, 3 invented the

PocketECG technology. 4

1 PTO ¶ 10. 2 PTO ¶ 13-14. 3 Tr. 5 (Dziubinski). 4 Tr. 7-8 (Dziubinski).

2 Defendant and counterclaim plaintiff AMI Monitoring, Inc. (“AMI”) is a

privately held corporation incorporated and headquartered in Texas. 5 Joseph

Bogdan (“Joe”) founded AMI in 2002 and serves as its President. 6 Defendant

Spectocor LLC is a limited liability company organized under Nevada law and

headquartered in Texas. Joe is Spectocor’s sole managing partner. 7 AMI and

Spectocor run cardiac monitoring centers known as independent diagnostic testing

facilities.8 At the times relevant to this action, Joe owned and controlled both

Spectocor and AMI, which were operated in a coordinated fashion as a single

business. For simplicity, I generally refer to both entities interchangeably as

“AMI.”

Non-party Medi-Lynx Cardiac Monitoring, LLC is a competitor of AMI that

was formed in 2013 after disagreements arose between Joe and his brother,

Andrew Bogdan (“Andy”), who were the original co-owners of AMI. Andy

currently serves as President of Medi-Lynx. 9

5 PTO ¶ 11. 6 PTO ¶ 11. I refer to the Bogdan brothers in this opinion by their first names to avoid confusion. No disrespect is intended. 7 PTO ¶ 12. 8 Tr. 28-29 (Dziubinski). 9 Tr. 855 (Andy).

3 B. The PocketECG Technology

The PocketECG is a system for diagnosing heart arrhythmia that

Medicalgorithmics sells to its licensees around the world.10 Medicalgorithmics has

manufactured two versions of the PocketECG: the PocketECG II and the

PocketECG III.11 The PocketECG II is a Bluetooth device that a patient wears. It

transmits electrocardiography (“ECG”) 12 data digitally via Bluetooth to an off-the-

shelf smartphone, which then processes the ECG signal using an algorithm

designed by Medicalgorithmics and uploads the data to a remote server.13 The

PocketECG III contains the smartphone technology within the device, avoiding the

need for a separate off-the-shelf smartphone device. 14

The PocketECG devices are known as 3-in-1 devices because they offer

three types of cardiac monitoring services: Holter, event monitoring, and mobile

cardiac telemetry (“MCT”). 15 Holter is the oldest of the three methods and the

most commonly used method worldwide. Holter involves recording a continuous

ECG signal for 24 to 48 hours and downloading the data to a computer for 10 Tr. 5-6 (Dziubinski). 11 PTO ¶ 15. 12 Tr. 1243 (Scher). 13 Tr. 10 (Dziubinski). 14 Tr. 12 (Dziubinski). 15 Tr. 19 (Dziubinski).

4 subsequent analysis. Event monitoring is a longer process, lasting up to 30 days,

during which time the device transmits only certain fragments of the ECG signal

arising during noteworthy events or symptoms, and discarding the remaining data.

MCT also provides intermittent monitoring but frequently sends transmissions,

which are then classified as being an arrhythmia or not an arrhythmia. 16 The 3-in-1

designation is a creature of the United States healthcare insurance market, in which

all three methods are reimbursable. Mobile cardiac telemetry is largely unknown

elsewhere in the world. 17

Cardiac monitoring services using the PocketECG and similar devices are

provided through independent diagnostic testing facilities such as AMI, which

receive the data and have cardiac technicians provide diagnostic reports to the

patient’s physician.18 Private insurers or Medicare reimburse these facilities for

providing the device and the diagnostic services to the patient. 19 The amount of

reimbursement depends on which of the three services is used, with mobile cardiac

telemetry receiving a significantly higher level of reimbursement. 20

16 Tr. 19-21 (Dziubinski); Tr. 321-24 (Moss). 17 Tr. 21 (Dziubinski); Tr. 320-21, 376-77 (Moss). 18 Tr. 325 (Moss); Tr. 23-25 (Dziubinski). 19 Tr. 24-25 (Dziubinski). 20 Tr. 25-26 (Dziubinski) (noting that telemetry is reimbursed at a rate of approximately ten times the reimbursement rate for Holter monitoring).

5 C. Medicalgorithmics and AMI Enter into Business Together

In May 2009, Medicalgorithmics received approval from the FDA to market

the PocketECG in the United States under Section 510(k) of the Food, Drug, and

Cosmetic Act. 21 After receiving this approval, Medicalgorithmics contacted

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Medicalgorithmics, SA v. AMI Monitoring, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/medicalgorithmics-sa-v-ami-monitoring-inc-delch-2016.