Luckey v. Baxter Healthcare Corp.

• Decision Date: 20 April 1998
• Docket Number: No. 95 C 509.,95 C 509.
• Citation: 2 F.Supp.2d 1034
• Parties: Joan P. LUCKEY, Plaintiff, v. BAXTER HEALTHCARE CORP., Defendant.
• Court: U.S. District Court — Northern District of Illinois

2 F.Supp.2d 1034

Joan P. LUCKEY, Plaintiff, v. BAXTER HEALTHCARE CORP., Defendant.

No. 95 C 509.

United States District Court, N.D. Illinois, Eastern Division.

April 20, 1998.

As Amended, June 19, 1998.

COPYRIGHT MATERIAL OMITTED

Todd A. Smith, Devon C. Bruce, Powers, Rogers & Smith, Chicago, IL, for Plaintiff.

Javier H. Rubinstein, Lucia Nale, Bettina Getz, Ronald Philip Gould, Hugh R. McCombs, Jr., Mayer, Brown & Platt, Chicago, IL, William F. Pendergast, Alan M. Buie, Seyfarth, Shaw, Fairweather & Geraldson, Washington, DC, for Defendant.

MEMORANDUM OPINION AND ORDER

CASTILLO, District Judge.

Relator Joan Luckey, a former technician at the laboratories of defendant Baxter Healthcare Corporation ("Baxter"), brings this action on behalf of the United States pursuant to the qui tam provision of the False Claims Act ("FCA"), 31 U.S.C. § 3730(h). Count I of the complaint alleges that Baxter made false claims to the United States by (1) misrepresenting its testing of plasma and plasma based therapies was "adequate and effective"; and (2) misrepresenting compliance with federal regulations, in violation of 31 U.S.C. § 3729(a)(1). In Count II, Luckey alleges that Baxter wrongfully terminated her employment in retaliation for her pursuit of and investigation into Baxter's allegedly false claims, in violation of the anti-retaliatory discharge provision of the FCA, 31 U.S.C. § 3730(h).

The United States has declined to intervene in this action pursuant to 31 U.S.C. § 3730(b)(4)(B). Luckey, however, continues to litigate these claims as the Relator under the qui tam provisions of the FCA. Currently before the Court is Baxter's motion for summary judgment on all counts of Luckey's amended qui tam complaint. Baxter argues that Count I of Luckey's complaint fails as a matter of law because Luckey has not submitted evidence demonstrating that Baxter knowingly lied to the government to procure a benefit. Baxter similarly characterizes Count II as baseless, contending that the evidence shows that Luckey was terminated for harassing her coworkers and other inappropriate behavior. For the following reasons, Baxter's motion for summary judgment is granted in its entirety.

RELEVANT FACTS¹

1. Baxter's Plasma Testing

Baxter is one of the world's largest producers of plasma products. Baxter, through its subsidiaries, sells plasma products to hospitals, clinics, health maintenance organizations, doctors' offices, and other medical facilities. Baxter's customers include Medicare, Medicaid, Veterans Hospitals, and other hospitals receiving federal subsidies.

Baxter's plasma products are produced from plasma that is collected from paid members of the general public at donor centers. Plasma is a primary component of human blood and can potentially carry bacterial and viral contaminants, including HIV 1, HIV 2, Hepatitis B, Hepatitis C, Syphilis, and Creutzfeldt-Jakob disease. Prior to incorporating donor-center samples into its plasma products, Baxter sends donated plasma to its subsidiary, Baxter Biotechnology Screening Laboratory ("Baxter labs"), for product testing. Baxter labs conducts several tests to determine whether the donated plasma contains harmful contaminants.

The routine testing protocol includes the Alanine Amino Transfer test ("ALT"), which Baxter labs uses to determine, among other things, the donor's liver quality. Samples yielding low ALT results are subject to additional testing to make certain the samples actually consist of plasma. Baxter became aware that some donor centers were using inadequate plasma collection procedures that failed to prevent saline from mixing with plasma. The presence of excessive saline could impair the screening tests' ability to detect the existence of viral contaminants, causing "false negative results".

Prior to 1995, Baxter labs utilized the Color Inspection Test to evaluate the quality of suspect samples. Under this approach, technicians were directed to inform their supervisors when samples yielded a low ALT result. The supervisor then inspected the sample to determine whether it was clear, cloudy, or colorless. If the sample appeared colorless, the supervisor would order a Total Protein Test to determine whether proteins were present in the samples. The absence of proteins indicated that the sample could be saline diluted, and the sample would be rejected.

Baxter issued Protocol 93-019 to combat the saline problem in the spring of 1993. Protocol 93-019 conceded that samples improperly diluted with saline were presented for testing at Baxter labs. This protocol instructed workers in Baxter labs' customer operations division to examine and evaluate the samples when they first arrive at Baxter, prior to testing. Bychowski Dep. at 153. Baxter subsequently adopted Protocol 94-025 in the spring of 1994 to provide a method to test samples suspected of being diluted with saline. Bychowski Dep. at 163. This protocol enabled technicians to test suspect plasma samples for total proteins. Id. at 165. Following an audit by the Federal Food and Drug Administration, Baxter was directed to and did adopt a protocol requiring technicians to perform the Total Protein Test on all plasma samples yielding a low ALT result, regardless of whether the samples were colorless.

Once a sample is approved at Baxter labs, Baxter forwards the sample to another Baxter subsidiary, the Hyland Division of Baxter Healthcare ("Hyland"). Hyland pools plasma from various testing centers to create its plasma products. Hyland's combined pool contains approximately 20,000 liters of plasma.

2. Joan Luckey's Employment with Baxter

Luckey began working at Baxter labs as a Lab Technician III in December, 1991. Baxter places all new employees on probationary status for three months, and Luckey was no exception to the rule. As a probationary employee, Luckey was responsible for reviewing data and checking test results for accuracy. Charmaine Bychowski, Luckey's supervisor, evaluated Luckey's performance after 30, 60, and 90 days.² Luckey received "acceptable" ratings—the highest rating available—in all categories evaluated on her 30 and 60 day reviews. In Luckey's 90 day review, however, Bychowski downgraded her assessment of the quality of Luckey's work to "marginal", noting that "[Luckey] released a bundle ... without first submitting it for verification testing. Joan has a fair number of `missing signature/initials' type of documentation errors." Pl.'s Facts Ex. R. Baxter decided that "in an effort to raise [Luckey's] quality to acceptable, the probationary period will be extended to ten days." Id.

In the Spring of 1992, technician Candy Johnson tested and retested a plasma sample, achieving invalid results. Luckey examined the sample, noted that it looked like water or saline, and informed Bychowski of her discovery. Luckey suggested running a Total Protein Test to determine whether the sample was actually plasma. Luckey Dep. at 18. Luckey alleges that Bychowski responded that "we don't look" and "we don't ask questions." Luckey Dep. at 14. Luckey contends that she had continuing discussions with Bychowski regarding the saline incident and the need to use the Total Protein Test consistently. Id. at 24.

Bychowski completed Luckey's five month evaluation in May of 1992. Bychowski gave Luckey very middle-of -the road marks in all categories, but was generally pleased with Luckey's progress, stating that "the quality of work Joan completes is exceptional. She needs to ensure that all necessary precautions are being taken to maintain the highest quality of work, as well. Joan is a very dependable worker." Pl.'s Facts Ex. S. However, Bychowski found the accuracy of Luckey's work was inconsistent ("submits reports that occasionally are missing information"), and that Luckey's people sensitivity skills needed improvement ("occasionally reacts badly to others due to job pressures"). Id.

Luckey's one year evaluation showed some improvement. Luckey received high marks for her ability to gather and evaluate information, meet deadlines, and organize her work. Bychowski noted that Luckey was "very dependable", aspired to obtain a promotion, and had joined Baxter's Employee Team Committee ("ETC"), a volunteer committee that provided employees with a forum to voice their concerns. Id. However, Bychowski also found that Luckey's "work contains preventable errors. She occasionally does not detect discrepancies while verifying." Bychowski Dep. at 308. In addition, Bychowski noted that Luckey was "not always pleasant with her coworkers" or "considerate of others' feelings." Id. at 275. On at least four occasions when Bychowski discovered errors in Luckey's work, Luckey refused to accept responsibility and instead accused coworkers of sabotage. Id. at 308.

Unfortunately, Bychowski's warnings to eliminate preventable errors did not curtail Luckey's shortcomings in this area. On March 26, 1993, Baxter issued Luckey a verbal warning (documented in writing) for two laboratory errors. Def.'s Facts Ex. I. Luckey received an addendum to the verbal warning on April 9, 1993 for an additional laboratory error. Id. at Ex. J. Baxter labs' Quality Assurance department had discovered the errors before the incorrect results were released, and no additional action was taken against Luckey.

In November 1993, Baxter transferred Bychowski to the first shift, and promoted technician Dan Garrett to Bychowski's old position supervising the second shift. Initially, Garrett seemed impressed with Luckey's abilities. In evaluating Luckey's 1993 performance, Garrett found Luckey to be "outstanding" in the technical areas of her work. Garrett noted that Luckey initiated the "Pat on the Back" program, as well as the Health Support Group. Moreover, Luckey was "always looking for ways to improve things in the lab" (Pl.'s Rsp. at 24) and "discovers several errors that others have made and comes up with solutions so they will not occur again." Pl.'s...