Life Sciences False Claims Act Defense

Arnold & Porter's experience in defending pharmaceutical and medical device manufacturers 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 in many high-profile FCA cases and have been at the forefront of the most cutting-edge FCA issues and Government enforcement trends.

We represent manufacturers at both the federal and state level in responding to CIDs and subpoenas in investigations involving an array of issues that implicate the FCA, in addition to representing manufacturers in an array of FCA cases in which the government has declined to intervene and the relator has opted to pursue the case. We also 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.

More generally, our lawyers have not only defended large and small pharmaceutical and medical device clients in FCA suits, but 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 our clients with valuable insight and strong capabilities in defending against FCA allegations, and helps our clients to fully assess all of the direct and collateral consequences that could result from such claims.

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.
  • 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 Eli Lilly and AstraZeneca cases have been dismissed.
  • 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.).
  • Radiation oncology practice in winning dismissal of a False Claims Act qui tam suit alleging violations of Medicare requirements for supervision of medical procedures. US ex rel. Parker v. Space Coast Medical Associates, L.L.P., 94 F. Supp. 3d 1250 (MD Fla. 2015).
  • 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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