Trinity Medical Services, LLC v. Merge Healthcare Solutions, Inc.

District Court, M.D. Louisiana·Decided March 19, 2020·No. 3:17-cv-00592·Unknown

Opinion

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF LOUISIANA TRINITY MEDICAL SERVICES, L.L.C., ET AL CIVIL ACTION VERSUS NO, 17-CV-592-JWD-EWD MERGE HEALTHCARE SOLUTIONS, INC.

RULING Before the Court is Merge Healthcare Solution, Inc.’s Motion In Limine to Exclude the Opinions and Testimony of Plaintiffs’ Expert Chris Harol brought by defendant Merge Healthcare Solution, Inc. (“Merge” or “Defendant”). (Doc. 82.) It is opposed by plaintiffs Trinity Medical Services, L.L.C. (“Trinity”), Performance Labs, L.L.C. (“Performance Labs”), and Prestige Worldwide Leasing, L.L.C. (“Prestige”) (collectively, “Plaintiffs”). (Doc. 97.) Defendant filed a reply brief. (Doc. 130.) For the following reasons, the motion is denied. BACKGROUND Trinity is a Louisiana holding company and the sole owner of Performance Labs and Prestige. Performance Labs was a laboratory located in Mandeville, Louisiana that performed toxicology tests. Prestige provided employee leasing and laboratory management services to Performance Labs and other labs, including Pathway Diagnostics, LLC (“Pathway”). Blake Bourque is the only owner of all three Plaintiff companies. Pathway, which is not a party to this suit, is a laboratory owned by insiders of Trinity that performs toxicology tests and is located in Mississippi. Merge is a developer and manufacturer of clinical laboratory software systems, including the Merge LISTM software (“Merge LIS Software”) at issue in this case. As a toxicology laboratory, Performance Labs was subject to the Clinical Laboratory Improvement Act (“CLIA”). To be able to run tests on live patient samples, Performance Labs needed to be certified by the Centers for Medicare and Medicaid Services (“CMS”). (CMS’s certification was based on compliance with regulatory and statutory mandates to ensure patient health and safety. In June 2015, Performance Labs failed an inspection by the Louisiana Health

and Hospitals Department (“LHHD”) and CMS. The state and federal regulators found “condition-level noncompliance” that “posed an immediate jeopardy to patients.” (July 31, 2015 Letter from CMS to Performance Labs at 4, Doc. 77-7.) As a result of Performance Lab’s noncompliance, it was required to submit plans of correction to state and federal regulators and agreed to cease testing patients on two sets of equipment. (Id. at 5.) During an on-site visit in the fall of 2015, state and federal regulators again concluded that Performance Labs “demonstrated continued systemic and pervasive problems through the laboratory which has led to findings of continued immediate jeopardy.” (December 23, 2015 Letter from CMS to Performance at 4, Doc. 77-9 at 4.)

Due to these findings, Performance Labs was sanctioned by the state and federal regulators and as a result: (a) barred from accepting live patient samples (Doc. 77, December 30, 2015 Emails from CMS at 3); (b) precluded from accepting payments from Medicare and Medicaid (Id.); (c) required to notify all clients who ordered patient testing that the results were not accurate or reliable (Doc. 77, January 12, 2016 Plan of Correction at 20, 46); and (d) had their CLIA certificate suspended, prohibiting Performance Labs from performing patient testing. (Doc. 77, January 14, 2016 Email from CMS to Performance Labs.)

Facing this pressure from federal and state regulators and hoping to get Performance Labs back into compliance, Trinity negotiated with and on January 11, 2016, signed a Sale Order with Merge to lease the Merge LIS Software to use at Performance Labs and Pathway. As a result of the sanctions, Performance Labs also reduced their equipment and personnel to a barebones operation, employing only a technical supervisor and a lab technician (M. Spruill Dep., at 117:17-19, Doc. 77-16.) Also, in January 2016, Blake Bourque’s brother in law, Kyle Mouton, along with Trinity’s in-house counsel, Phil Martinez, opened Pathway in Mississippi. (K. Mouton Dep., at

17:19-22, 18:22-20:3, Doc. 77-22.) Pathway is not owned by Trinity. (K. Mouton Dep., at 18:24- 19:7, Doc. 95-19; B. Bourque Dep., at 127-28, Doc. 95-12.) Most of Performance Lab’s staff and equipment was moved to Pathway. (Mouton Dep. at 120:3-15, 30:9-10, 91:2-12, Doc. 77-22.) Trinity provided Pathway with start-up capital to pay expenses as well as management and IT services. (Id. at 106:12-19, 87:9-88:3.) Trinity allowed Pathway to use the Merge LIS Software. (Id.) In June 2016, Pathway began testing patient samples and billing clients using the Merge LIS Software. (M. Spruill Dep., at 154:23-155:5, 217:11-15, Doc 77-16.) However, to prove compliance and become recertified under the CLIA, Performance Labs only performed validation and establishment studies until August 24, 2016, when CMS

allowed Performance Labs to begin doing screening tests. (August 24, 2016 Email from CMS to Performance Labs, Doc. 77-28.) During this time, it was under heightened scrutiny from federal and state regulators. (C. Howell Dep., at 188:10-189:2, Doc. 95-5.) Performance Labs began with a small panel of tests and had an agreement with Pathway to reference any tests not offered for $85/sample. (B. Bourque Dep., at 150:20-21, 203:18-204:11, 406:5-6, Doc. 95-12; R. Poe Dep., 125:12-22, 144:2-145:21, Doc. 95-2.) On January 17, 2017, CMS permitted Performance to start conducing confirmatory testing. (October 14, 2016 Email from CMS to Performance Labs, Doc 77-29.) On January 20, 2017, Performance Labs began accepting patient samples from one clinic. (M. Spruill Dep. at 189:8-19, Doc. 77-16.) In February 2017, Performance Labs identified an issue with the tracking of quality control data in the Merge LIS Software and voluntarily ceased patient testing. (March 6, 2017 Correspondence from Performance Labs to CMS, Doc. 77-32.) Performance Labs formulated a “work around” for the issue and indicated to CMS that the issue did not cause Performance Labs or Pathway to submit any incorrect testing results. (Id.) In March 2017, Performance Labs also

reported other issues with the Merge LIS Software to CMS. (March 17, 2017 Email from CMS to Performance Labs, Doc. 77-33.) Despite these reported issues with the Merge LIS Software, in August 2017, Performance Labs’ suspension was lifted, it was recertified under the CLIA, and could bill Medicare and Medicaid following a successful onsite inspection in June 2017 by state regulators. (January 24, 2017 Email between CMS and Performance Labs, Doc. 77-30; August 9, 2017 Correspondence from CMS, Doc. 77-34.) Plaintiffs allege that the Merge LIS Software contained numerous defects but focus on two alleged defects, the Duplicate Container Defect and the Trojan Horse Defect. The Duplicate Container Defect allegedly resulted in the Merge LIS Software creating duplicate container

numbers for patients. Therefore, Plaintiffs maintain that when the Duplicate Container Defect occurred, the software created duplicate records for a single toxicology test, which eventually could result in the software deleting both entries in error. Plaintiffs claim that this compromised laboratory reliability and testing accuracy because it increased the risk that the testing laboratory would fail to perform the requested toxicology test. The Trojan Horse Defect resulted in passwords and other security information being discoverable on Google. As such, Plaintiffs assert that the evidence shows that Plaintiffs were not able to use the Merge LIS Software and be HIPAA compliant. Defendant’s expert witness testimony controverts that the alleged defects were present in the Merge LIS Software installed at Performance Labs. Plaintiffs allege that “Performance Labs worked with Merge for months to get these defects resolved but they remained unresolved until 2018. These defects prevented Performance Labs from reopening its laboratory given the level of regulatory scrutiny Performance Labs was under.

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Trinity Medical Services, LLC v. Merge Healthcare Solutions, Inc., (M.D. La. 2020).

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