United States ex rel. George v. Boston Scientific Corp., 864 F. Supp. 2d 597

Background

Relator Elaine George sues Boston Scientific and Guidant for off-label promotion of the FlexView device and FCA false-claims liability; amended complaint adds FCA retaliation and Illinois public policy claims, which were dismissed but leave to amend granted; George files second amended complaint alleging FCA retaliation only; court denies motion to dismiss.
The FlexView device was approved for tissue ablation; off-label promotion to treat atrial fibrillation is alleged; FDA approvals and labeling govern marketing restrictions.
George was hired as a Guidant sales representative in 2006 during the Boston Scientific transition and was fired in September 2006 amid alleged off-label marketing concerns and internal scrutiny.
In July–August 2006, George attended trainings where off-label marketing restrictions were discussed; she was reprimanded for asking about legality and later warned she might not be cut out for the job; she was subsequently subjected to harassment, a Performance Improvement Plan, and termination.
George alleges Boston Scientific learned of her protected activity and fired her, creating a causal link supported by multiple retaliatory conduct allegations and timing.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether second amended complaint plausibly pleads protected activity under FCA	George’s questions about legality of off-label promotion constitute protected activity.	Mere questioning does not constitute protected FCA activity.	Yes; allegations show protected activity.
Whether employer had notice of protected activity	Management knew of her questions and conduct; supervisor present at meetings.	No explicit notice established.	Yes; employer on notice.
Whether retaliation was causal or mere temporal proximity	Allegations show reprimands, warnings, harsher treatment, and pretextual termination.	Temporal proximity alone insufficient; no causation shown.	Causation plausibly alleged; not precluded at motion to dismiss.
Whether statute of limitations bars FCA retaliation claim	Texas choice-of-law governs limitations; more than one state could apply.	Texas 90-day period applies; but two-year personal injury limit may apply per circuit.	Not a basis for dismissal; claim timely under applicable limits.

Key Cases Cited

Graham Cnty. Soil & Water Conservation Dist. v. United States ex rel. Wilson, 545 U.S. 409 (U.S. 2005) (most closely analogous state limitations period applies to FCA retaliation claims)
Bell Atl. Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (pleading must contain plausible claims under Rule 8(a))
Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (pleading must be plausible, not merely possible)
Harrington v. Aggregate Indus.-Ne. Region, Inc., 668 F.3d 25 (1st Cir. 2012) (internal complaints can constitute protected activity; notice may be inferred)
Sanchez v. Lymphatx, Inc., 596 F.3d 1300 (11th Cir. 2010) (internal reports can alert to fraudulent government claims)
McKenzie v. BellSouth Telecomms., Inc., 219 F.3d 508 (6th Cir. 2000) (internal reporting must reasonably lead to a viable FCA action)
Yesudian v. Howard Univ., 153 F.3d 731 (D.C. Cir. 1998) (protected activity includes investigations or other activities concerning false claims)
Patton v. Shaw Servs., L.L.C., 418 Fed.Appx. 366 (5th Cir. 2011) (protective internal complaints recognized; unpublished is cited but not controlling)
Sikkenga v. Regence Bluecross Blueshield of Utah, 472 F.3d 702 (10th Cir. 2006) (notice can be shown by employer’s knowledge of protected activity)
Williams v. Martin-Baker Aircraft Co., 389 F.3d 1251 (D.C. Cir. 2004) (employer need not know filed/ contemplated suit; must know of protected activity)
Fanslow v. Chicago Mfg. Ctr., Inc., 384 F.3d 469 (7th Cir. 2004) (internal complaints may suffice to constitute protected activity)
Shirley v. Chrysler First, Inc., 970 F.2d 39 (2d Cir. 1992) (causation and timing considerations in retaliation)