Josey v. Impulse Dynamics (Usa) Inc.
Josey v. Impulse Dynamics (Usa) Inc.
Opinion of the Court
Plaintiff Lori Josey ("Plaintiff") brought this matter against Defendants Impulse Dynamics (USA), Inc. ("Impulse"), and Insperity PEO Services, L.P. ("Insperity") (collectively, "Defendants") raising a single claim of retaliation in violation of the federal False Claims Act ("FCA").
I. BACKGROUND
This case concerns reports of alleged irregularities during clinical testing of the Optimizer, an investigational medical device used to treat chronic heart failure. Impulse, the Optimizer's developer, remains in the final stages of the FDA approval process. (Doc. 1, Compl. ¶¶ 3, 8.) Insperity is Impulse's human resources provider. (¶ 4.) Clinical testing of the Optimizer in the United States began in 2005, with the FIX-HF-5 study. (¶ 9.) When FIX-HF-5 failed to reach its primary efficacy endpoint, Impulse designed and sponsored a second study, FIX-HF-5C, to prospectively confirm its results. (¶¶ 9-12.) FIX-HF-5C's development included the submission of protocols to the FDA. (¶ 13.) The FDA approved, and Impulse affirmed that it would conduct the trial in accordance with those protocols. (Id. ) Among other things, the protocols prohibited Impulse employees from directly recruiting or administering testing to study participants. (¶ 14.) The protocols also included a metric, known as the Minnesota Living with Heart Failure Questionnaire ("MLHFQ"), used to measure the Optimizer's effect on quality of life. (¶¶ 15-16.)
On January 1, 2016, Plaintiff began working for Defendants as a Senior Field Clinical Engineer. (¶ 20.) One of Plaintiff's duties included the removal of barriers impeding site enrollments for FIX-HF-5C. (¶ 21.) This involved advocating for potential subject recruitment at clinical sites and helping to increase randomization of subjects for trial participation. (Id. ) Plaintiff trained site investigators and coordinators on the study protocols, provided case support for site surgeons and staff during implants, and followed up with subjects. (¶ 23.)
*606Plaintiff's retaliation claim concerns an incident at a clinical site in Mesa, Arizona. On August 9, Plaintiff witnessed another clinical engineer, Jason Kindler, verbally administer the MLHFQ to a subject and record the subject's responses. (¶ 26.) The protocols provided that a clinical site coordinator would administer the test, with the subject writing his or her answers on the questionnaire. (¶ 27.) Concerned that administration of the MLHFQ by an Impulse employee might skew test results, Plaintiff reported it to her supervisor, Anthony Caforio, who had also witnessed the incident. (¶¶ 28-29.) After Plaintiff said this "was not right," Kindler observed, "You do what you have to do to get patients randomized." (¶ 29.) Caforio did not respond. (Id. )
Plaintiff later learned that a site coordinator had also complained to Angela Stagg, Implulse's Clinical Manager, about Kindler. (¶ 30.) The site coordinator claimed that Kindler had pressured her to rush subjects through testing to get subjects randomized more quickly. (Id. )
Plaintiff believes she was subject to increased scrutiny and criticism for reasons unrelated to her job performance after she reported Kindler. (See ¶¶ 34-44.) On September 28, Caforio sent an email to Plaintiff placing her on a 30-day disciplinary notice period stating that failure to improve would lead to further disciplinary action or termination. (¶ 40.) The notice cited Plaintiff for insubordination related to expense reports, failure to split a $ 1,500 client dinner bill with Kindler, and unprofessional comments and behavior during that dinner. (¶ 40.) Copying members of upper management, Plaintiff responded with an email to Cafario disputing the underlying allegations. (¶ 42.)
Plaintiff then elevated her concerns to upper management at Impulse. On September 29, Plaintiff called Vice President of Human Resources Nitsan Mor. She reported that Caforio and Kindler had failed to follow applicable protocols at the Mesa site and that Caforio had since retaliated against her for reporting the issue. (¶ 45.) They also discussed the details of the 30-day warning. (Id. ) She raised the same issues in a discussion with Vice President of Clinical Operations Norbert Clemens on October 4. (See ¶ 46.) Clemens told Plaintiff they would discuss the issue further in person. (¶ 47.) On October 12, Plaintiff sent another email to Clemens, Mor, and Chief Executive Officer Simos Kedikoglou describing her concerns about Kindler and Caforio's protocol violations and reiterating her belief that Caforio was retaliating against her for reporting them. (¶¶ 48-49.) Plaintiff reported these concerns because she believed Impulse would submit unreliable data to the FDA for approval of the Optimizer. (¶ 50.) Clemens responded on October 19, stating that Impulse took her complaints seriously and would handle them with care. (¶ 51.)
Insperity Human Resources Specialist Erin Lau followed up with Plaintiff on November 9. In a phone call, Plaintiff and Lau discussed the conduct witnessed August 9, her immediate complaint to Caforio, her concerns about the impact of Kindler's conduct, and the alleged retaliation she experienced thereafter. (¶ 52.) The following day, Plaintiff met with Clemens and an outside auditor hired by Impulse to ensure all FDA-required paperwork was complete. (¶ 54.) During their conversation, Clemens suggested that Plaintiff's concerns were "made up." (Id. ) Clemens also concluded that the allegations underlying Caforio's 30-day warning were unfounded. (¶ 56.) Plaintiff is unaware of the extent of the auditor's investigation, though she questions its sufficiency. (See ¶¶ 57-60.)
Plaintiff was terminated on December 9. In a phone call, Caforio and Mor told Plaintiff she was being terminated in part *607for reporting false accusations about Caforio and Kindler. (¶ 63.) A termination letter dated December 12 and signed by Lau reiterated that a reason for termination included "[f]alse reporting of serious accusations" against Caforio and Kindler. (¶ 64.) On February 22, 2018, Plaintiff filed this matter alleging that Defendants violated the FCA's anti-retaliation provision. (See generally Compl.) Defendants now seek dismissal.
II. DISCUSSION
Defendants' motion focuses on a single issue-namely, whether Plaintiff's reports about protocol violations constitute protected activity under the FCA. Defendants think not. Defendants argue that (1) to the extent Plaintiff alleges Defendants' protocol violations run afoul of FDA regulations, Plaintiff's failure to specify a regulation is fatal to her claim; and (2) more fundamentally, Plaintiff has not shown that her complaints relate to conduct one might reasonably consider an FCA violation. The Court disagrees.
A. Legal Standard for Rule 12(b)(6) Motions
A motion to dismiss pursuant to Rule 12(b)(6) challenges the legal sufficiency of a complaint. Cook v. Brewer ,
The Court must interpret facts alleged in the complaint in the light most favorable to the plaintiff, while also accepting all well-pleaded factual allegations as true. Shwarz v. United States ,
B. Retaliation Under § 3730(h) of the False Claims Act
"Congress added
*608about which her employer was aware and (3) for which the employer retaliated.
"An employee engages in a protected activity by 'investigating matters which are calculated or reasonably could lead to a viable [False Claims Act] action.' " United States ex rel. Campie v. Gilead Sciences, Inc. ,
C. Reporting Protocol Violations as Protected Activity
Plaintiff alleges that she engaged in protected activity by reporting Kindler's protocol violations. (Compl. ¶ 67.) Plaintiff does not merely allege that Kindler's conduct ran afoul of FDA regulations. (¶ 68.) She says she reported that "Impulse's agents engaged in conduct that would lead it to misrepresent or omit data that Impulse would submit to the FDA for approval of its medical device." (¶ 69.) If left uncorrected, Plaintiff argues, these protocol violations could reasonably be expected to result in ill-gotten gains-first in the form of FDA approval, then as government payment made possible by that approval. (Opp'n at 7.) No doubt, a plausible theory, as explained below.
The submission of inaccurate data to the FDA could reasonably be linked to an FCA violation. See Campie ,
That FDA approval was then and remains pending bears little significance.
Defendants correctly note that reports of regulatory violations alone are insufficient. See Campie ,
Defendants' attempts to distinguish Campie are unavailing. They argue that the plaintiffs there, who alleged FCA violations based on false statements made to *610secure FDA approval, "alleged far more" than Plaintiff does here. (Mot. at 10.) This is true. The Campie plaintiffs alleged "false statements permeating the regulatory process."
Defendants' reliance on this Court's decision in Nelson v. Millennium Laboratories, Inc. is similarly misplaced. See No. 2:12-cv-01301-SLG,
III. CONCLUSION
Defendants are correct: the FCA is not an all-purpose whistleblower protection statute. See Hopper ,
Accordingly,
IT IS ORDERED denying Defendants' Motion to Dismiss (Doc. 9).
The Court finds that the issues have been fully briefed and oral argument will not aid in its decision. See Fed. R. Civ. P. 78(b) (permitting resolution of motions without oral hearings); LRCiv 7.2(f) (same).
Because § 3730(h) does not require a showing of fraud, Rule 9(b)'s heightened pleading standard does not apply here. See Mendiondo v. Centinela Hosp. Med. Ctr. ,
Neither case Defendants cite in suggesting that reports of prospective fraud are not protected activity recognizes such a rule. (See Mot. at 13.) In United States ex rel. Uhlig v. Fluor Corporation , what the Seventh Circuit deemed lacking was not a completed fraudulent act, but an objectively reasonable connection between the plaintiff's reported observations and possible fraud. See
Other district courts in this circuit have adopted a similar view. See, e.g., Boyd v. Accuray, Inc. ,
Reference
- Full Case Name
- Lori JOSEY v. IMPULSE DYNAMICS (USA) INCORPORATED
- Cited By
- 3 cases
- Status
- Published