United States ex rel. Palmieri v. Alpharma, Inc.
928 F. Supp. 2d 840
D. Maryland2013Background
- Palmieri, a relator, sued Alpharma (Alpharma, Inc. and Alpharma Pharmaceuticals, LLC), King, and Pfizer under the False Claims Act and analogous state statutes.
- Flector Patch, approved by FDA for acute pain from minor injuries, was marketed for off-label and excessive use according to Palmieri.
- Plaintiff alleged a comprehensive marketing scheme including kickbacks to physicians to induce off-label, excessive prescriptions.
- Relator claimed off-label and excessive prescriptions were submitted to federal/state programs for reimbursement, generating false claims.
- Amended Complaint filed October 25, 2011; defendants moved to dismiss on first-to-file and Rule 9(b) grounds; government plaintiffs declined intervention.
- Court holds jurisdiction exists but the Amended Complaint fails under Rule 9(b); first-to-file not a bar; dismissal without prejudice with leave to amend is appropriate.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether first-to-file bars this case | Palmieri argues Littlewood pending at filing bars remained claim | Defendants contend Littlewood bars related action | First-to-file does not bar this Amended Complaint |
| Whether Amended Complaint meets Rule 9(b) particularity | Palmieri argues allegations sufficient to infer presentment | Clausen/Nathan require specific presentment details | Nathan controls; Amended Complaint lacks plausible presentment allegations; must dismiss |
| Whether dismissal should be with or without prejudice | Amendment possible with additional facts | Dismissal should be with prejudice if futile | Dismissal without prejudice with leave to amend within 28 days; if no amendment, then prejudice results |
| Whether court has subject-matter jurisdiction and potential FCA/AKS theory | Court has jurisdiction; claims arise under FCA and AKS theories | Challenge to jurisdiction and sufficiency under 9(b) | Court has jurisdiction; under Nathan, pleading failure to state a claim warrants dismissal |
Key Cases Cited
- Nathan v. Takeda Pharms. of N. Am., Inc., 707 F.3d 451 (4th Cir. 2013) (adopts Eleventh Circuit’s Clausen standard; presentment required with reliability indicia)
- Clausen v. Lab. Corp. of Am., Inc., 290 F.3d 1301 (11th Cir. 2002) (Rule 9(b) requires presentment of actual claims or reliable indicia of presentment)
- LaCorte v. Wagner, 185 F.3d 188 (4th Cir. 1999) (first-to-file implications; pending status tied to related actions)
- Chovanec v. Apria Healthcare Gp. Inc., 606 F.3d 361 (7th Cir. 2010) (first-to-file rule; dismissal without prejudice; original-source considerations)
- In re Nat. Gas Royalties Qui Tam Litig., 566 F.3d 956 (10th Cir. 2009) (first-to-file scope and pending status guidance)
- Rockwell Int’l Corp. v. United States, 549 U.S. 457 (U.S. 2007) (jurisdictional relevance of amended complaints for jurisdiction)