Life Sciences False Claims Act Defense

Arnold & Porter's experience in defending manufacturers of pharmaceuticals, medical devices and diagnostics equipment, as well as healthcare providers, in False Claims Act investigations and litigation is unparalleled. From the initial receipt of a subpoena or civil investigative demand through litigation against the government and relators, we have successfully represented manufacturers and providers in many high-profile FCA cases. We have unique experience representing manufacturers in cases in which the government has intervened, and we have litigated against the government all the way through discovery, motion practice and up to the eve of trial. Our lawyers have not only defended life sciences clients in FCA suits, but we also have extensive experience as federal prosecutors investigating and bringing FCA cases on behalf of the government.

Our experience on both sides of the aisle provides clients with valuable insight and strong capabilities in defending against FCA allegations, helping them fully assess all of the direct and collateral consequences that could result from such claims. We also regularly partner with colleagues in our Life Sciences & Healthcare Regulatory practice, who bring unique perspective and significant subject matter knowledge of even the most complicated regulatory issues to investigations and litigation against manufacturers.

Read our blog for insightful commentary and the latest news on FCA recoveries as they happen.
Qui Notes Blog

Experience Highlights

  • Novartis Pharmaceuticals Corporation and Novartis Corporation in the successful defense of a qui tam suit brought in the District of Massachusetts by multiple relators, alleging off-label and kickback claims in connection with the asthma medication Xolair®. On a motion to dismiss, we obtained dismissal with prejudice of all claims. United States ex rel. Garcia et al. v. Novartis Pharmaceuticals Corporation et al., 06 Civ. 10465 (WGY), which was affirmed by the First Circuit. United States ex rel. Kelly et al. v. Novartis Pharmaceuticals Corporation et al., 827 F.3d 5 (1st Cir. 2016). Relators then filed suits in Massachusetts and New York under state FCA statutes, and we successfully obtained dismissal of those cases.
  • Sanofi-Aventis and Bristol-Myers Squibb Co. in winning dismissals of two False Claims Act qui tam suits concerning promotional activities, US ex rel. JKJ Partnership 2011, LLP v. Sanofi-Aventis US Inc., et al., 315 F. Supp. 3d 817 (DNJ 2018); US ex rel. Dickson v. Bristol-Myers Squibb Co., et al., 332 F. Supp. 3d 927 (DNJ 2017); and in defending against related state attorney general consumer protection actions.
  • Allergan in the successful defense of a qui tam suit in the District of Maryland alleging price reporting claims in connection with various medications. On a motion to dismiss, obtained dismissal of all claims. United States ex rel. Sheldon et al v. Forest Laboratories LLC, 14 Civ. 2535 (ELH).
  • Pfizer in FCA cases filed in the Southern District of New York and District of Rhode Island by the same relator against numerous pharmaceutical manufacturers and pharmacy benefit managers, alleging violations of the Anti-Kickback Statute and FCA through payment of service fees. US ex rel. John R. Borzilleri, MD et al. vs. Abbie, Inc., et al., 15 Civ. 7881 (S.D.N.Y.); US ex rel. John R. Borzilleri, MD et al. vs. Bayer AG, et al., No. 14 Civ. 00031 (D. R.I.). Both cases were dismissed.
  • Alcon Laboratories and Alcon Inc. in the successful defense of a qui tam suit brought in the District of New Jersey by a relator, alleging off-label and kickback claims in connection with ocular medication Vigamox®. On a motion to dismiss, we obtained dismissal with prejudice of all claims. United States ex rel. Lampkin v. Alcon Laboratories, Inc., et al., 08 Civ. 05362 (JAP).
  • Novartis Pharmaceuticals Corporation in an intervened FCA case filed by the US Attorney's Office for the Southern District of New York alleging violations of the AKS and FCA through speaker programs. United States of America ex rel. Oswald Bilotta v. Novartis Pharmaceuticals Corp., 11 Civ. 0071 (PGG).
  • Large national healthcare provider in federal investigations by DOJ, HHS-OIG and US Attorney's Offices across the country; in proceedings before the Judicial Panel on Multidistrict Litigation; and in individual False Claims Act qui tam suits alleging medically unnecessary procedures and violations of the Stark Law and Anti-Kickback Statute. See In re Health Management Associates Inc. Qui Tam Litigation, MDL Nos. 2442 & 2524; US ex rel. Williams v. HMA Inc., et al., No. 3:09-CV-130 (M.D. Ga. June 22, 2015) (dismissing claims against clients); US ex rel. France v. HMA, Inc., et al., No. 8:13-CV-1264 (M.D. Fla. May 27, 2015) (dismissing case); US ex rel. Dennis v. HMA, Inc., et al., No. 3:09-CV-00484, 2013 WL 146048 (M.D. Tenn. Jan. 14, 2013) (dismissing case).
  • Dermatologic surgeon in winning a complete acquittal after a five-week federal criminal jury trial on charges of healthcare fraud and aggravated identity theft, and securing a full dismissal of related FCA allegations. US v. Bajoghli, No. 1:14-CR-278 (E.D. Va. Nov. 30, 2015); US ex rel. Hoffman v. Skin & Laser Surgery Center, P.C., No. 1:15-CV-1601 (ED Va.).
  • Eli Lilly & Co., AstraZeneca and UCB in three federal qui tam litigations filed in Texas, Washington and Illinois, respectively, alleging violations of the Anti-Kickback Statute and FCA through the use of nurse educator and reimbursement support services. US ex. rel. Health Choice Alliance, LLC, et al. v. Eli Lilly and Company, Inc., et al., Civ. Action No. 5:17-CV-123; US ex rel. SCEF, LLC v. AstraZeneca PLC, Civ. Action 17-CV-1328; US ex rel. CIMZNHCA, LLC v. UCB, INC., No. 17-CV-765-SMY-MAB). The three cases have since been dismissed.
  • Major pharmaceutical manufacturer in separate investigations by the Texas AG and the US Attorney's Office for the Eastern District of Pennsylvania regarding allegations of off-label promotion and kickbacks with respect to a blockbuster dermatological medication. After production of documents and presentations, the federal government closed its investigation and declined to intervene. After discovery and presentations, we reached a resolution with the Texas AG.
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