Life Sciences False Claims Act Defense

Arnold & Porter's experience in defending manufacturers of pharmaceuticals, medical devices, and diagnostics equipment, as well as health care 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.

Experience Highlights

AbbVie in a qui tam suit filed in the District of Maryland alleging price reporting claims. Obtained dismissal of all claims, which was affirmed by the Fourth Circuit on January 25, 2022, and again en banc on September 23, 2022. Following remand based on a decision by the Supreme Court, on July 23, 2024, the district court again granted our motion to dismiss. United States ex rel. Sheldon v. Forest Lab'ys, LLC, Case No. CV ELH-14-2535, 2024 WL 4544567 (D. Md. July 23, 2024)
Bayer Corporation and Merck & Co., Inc. in defense of a qui tam suit in the District of New Jersey alleging misbranding and fraud in the inducement in connection with the antibiotic, Cipro®. The court has granted two motions to dismiss, most recently on March 28, 2024, this time with prejudice. United States ex rel. Bennett, 17 Civ. 4188 (ES-MAH).
Bristol-Myers Squibb Co. and Sanofi-Aventis, in securing DOJ’s declinations and winning dismissals of two FCA qui tam suits concerning Plavix® promotional activities.
Eli Lilly & Co., AstraZeneca, and UCB in three federal qui tam litigations filed in Texas, Washington, and Illinois, respectively, alleging violations of the AKS and FCA through the use of nurse educator and reimbursement support services. All cases have been dismissed. After Relator refiled the cases against Eli Lilly in New Jersey and Texas state courts, we obtained dismissal of the New Jersey state case and a stay of the Texas state case.
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 AKS and FCA through payment of service fees. Both cases were dismissed, and the dismissals were affirmed by the Second and First Circuits in December 2020 and January 2022, respectively.
Novartis 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, which was affirmed by the First Circuit. Relators then filed suits in Massachusetts and New York under state FCA statutes, and we successfully obtained dismissal of those cases.
Major pharmaceutical manufacturer in separate investigations by the Texas AG and the U.S. 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.
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.
Large New Jersey healthcare system and three of its hospitals in connection with a FCA investigation by the U.S. Attorney’s Office for the District of New Jersey, DOJ, and HRSA regarding federal COVID-19 Provider Relief Funds.

Five healthcare providers in Texas and Louisiana in a case brought in the Northern District of Texas under the federal, Texas, and Louisiana FCA statutes filed by a relator and the State of Texas relating to Texas and Louisiana’s efforts to terminate the providers from participating in their respective Medicaid programs where Plaintiffs seek nearly $2 billion in damages and penalties.