Life Sciences False Claims Act Defense

In recent years, all participants in the drug, device, and healthcare fields have been under intense federal and state scrutiny for possible fraud and abuse. Given current governmental budgetary and oversight pressures, the number of investigations and prosecutions for violations of fraud and abuse laws—including False Claims Act cases at both the federal and state level—will only continue to increase. Our experience in counseling companies on federal and state fraud and abuse laws extends back for decades, and we are a well-recognized leader in helping pharmaceutical, medical device and healthcare companies respond to fraud and abuse investigations and False Claims Act matters. We have been involved in some of the most high-profile civil and criminal fraud and abuse and false claims cases, and our litigators are well schooled in the latest theories of claimants and prosecutors.

Our practice routinely advises drug, biotech, device, and healthcare companies on the full range of issues arising under the Medicare/Medicaid Anti-Kickback Act, the False Claims Act, and other federal and state fraud and abuse laws. We also assist our clients in formulating compliance strategies, performing self-evaluative audits, designing compliance and corrective action plans, and mitigating liability-where appropriate-through self-reporting. Every day, we help clients to structure commercial agreements to avoid violation of the Anti-Kickback Act and other fraud and abuse constraints, including with regard to the safe harbors for discounts, personal services, and group purchasing organizations, and we often develop written policies for clients in connection with sales, marketing, and pricing strategies. An integral part of our fraud and abuse work involves developing offensive and defensive strategies relating to the Centers for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), the Department of Health and Human Services, and the VA Offices of the Inspector General (OIG). Several of our partners have held high-ranking positions in these agencies.

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); aff'd 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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