995 F. Supp. 2d 357
E.D. Pa.2014Background
- Relator Bergman, a former Abbott sales representative (1999–2008), sues Abbott under FCA for off-label marketing of TriCor and kickbacks to physicians.
- Relator alleges TriCor was marketed for off-label/medically unnecessary uses (diabetes first-line therapy; with statins) despite FDA labeling.
- Relator claims the off-label marketing, plus kickbacks, caused physicians to submit false reimbursement claims to Medicare, Medicaid, TRICARE, FEHBP.
- Abbott moves to dismiss under Rule 12(b)(6) and 9(b), arguing off-label uses were reimbursable and marks/AKS claims lack specificity.
- Complaint pleads alleged schemes including misrepresentation of TriCor efficacy/risks and payments to physicians; government intervention declined.
- Court takes allegations as true for purposes of the motion; rules split on scope and pleading standards for such FCA theories.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| FCA liability based on off-label marketing survives 12(b)(6)? | Bergman argues off-label marketing caused false claims. | Abbott contends off-label uses were reimbursable under payment rules. | Partially survives; off-label theory plausibly links to payments under 12(b)(6). |
| AKS-based FCA claims meet 9(b) particularity? | Bergman asserts kickback scheme details show causation. | Abbott argues 9(b) failure to plead who/what/when/where/how. | Counts based on kickbacks survive 9(b) under district practice (relaxed specificity). |
| First Amendment defense to marketing statements? | Relator contends statements were false/misleading and not protected speech. | Abbott argues truthful commercial speech is protected. | First Amendment defense rejected at 12(b)(6) stage; claims proceed where alleged false statements. |
| Statute of limitations/WSLA tolling impact? | Relator seeks WSLA tolling to reach conduct pre-2003. | Timeouts bar earlier conduct; non-intervention factors apply. | Counts narrowed; some pre-2003 claims dismissed; others survive with later conduct. |
Key Cases Cited
- United States ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295 (3d Cir. 2011) (two FCA false-claim categories: factually vs. legally false; express/implied certifications)
- U.S. ex rel. Conner v. Salina Reg’l Health Ctr., Inc., 543 F.3d 1211 (10th Cir. 2008) (explains false certification theory distinctions)
- U.S. ex rel. Quinn v. Omnicare, Inc., 382 F.3d 432 (3d Cir. 2004) (relies on relaxed 9(b) standards in some FCA claims)
- United States ex rel. Streck v. Allergan, Inc., 894 F. Supp. 2d 584 (E.D. Pa. 2012) (discusses non-specificity relaxing 9(b) for AKS/claims)
- Underwood v. Genentech, Inc., 720 F. Supp. 2d 671 (E.D. Pa. 2010) (permitting off-label/AKS FCA claims to survive 9(b) with broad allegations)
- Galmines v. Novartis Pharms. Corp., 2013 WL 2649704 (E.D. Pa. 2013) (detailed off-label marketing rationale; reliance cited for specificity)