Life Sciences/Healthcare Investigations & Defense

In recent years, federal and state authorities have devoted ever-increasing resources to investigate and prosecute life sciences companies, healthcare providers, executives, and directors. With increased civil penalties, criminal sentences and fines, it is more important than ever to retain legal counsel with a proven track record in defending companies and individuals against aggressive criminal prosecution and civil enforcement. Successful representation in these cases requires an in-depth understanding of not just the regulatory regimes but also the government's investigative and litigation methods, as well as experience coordinating ongoing parallel criminal, civil qui tam and administrative matters. Our team has the experience that corporate boards, senior management and practitioners trust to gather the facts, evaluate the options and obtain results. We’ve handled hundreds of life sciences and healthcare cases in federal and state courts around the United States—from government and internal investigations and criminal and civil pretrial litigation to trials and appeals up to the US Supreme Court.

Experience Highlights

National hospital system, with 70+ in-patient facilities across 25 states, in connection with 14 qui tams filed across 10 different judicial districts. Qui tam cases involving allegations of False Claims Act, Anti-Kickback Statute, and Stark Law violations including alleged upcoding, incorrect admission status, cost-report fraud, and lack of medical necessity, among others. For example, US, ex rel. Dennis v. University Medical Center, No. 3:09-cv-00484 (MD TN) (declined and dismissed); and US, ex rel. Williams v. HMA, et al., Case No. 3:09-CV-130 (MD GA) (dismissed).
Dermatologic surgeon in winning a complete acquittal after a five-week federal criminal jury trial involving 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 (ED Va. Nov. 30, 2015); US ex rel. Hoffman v. Skin & Laser Surgery Center PC, No. 1:15-CV-1601 (ED Va.).
A Democratic Party donor, as lead trial counsel in a 10-week federal criminal trial in the District of New Jersey involving charges of bribery and honest services fraud. Pursuant to our R29 motion, the court acquitted co-defendants US Senator Robert Menendez and Dr. Melgen of all political contribution counts following a mistrial in which jurors were hung 10-2 in favor of acquittal. DOJ dismissed all remaining charges with prejudice.
Medical device manufacturer in successfully dismissing all claims in a complex fraud case in the US District Court for the District of Delaware alleging client bribed Brazilian physicians and hospitals to use their devices.
Former owner of sleep study businesses as lead trial counsel in a three-week federal criminal trial in the Eastern District of Virginia involving allegations of healthcare fraud, wire fraud and tax evasion.
Wanaque Center for Nursing and Rehabilitation in its response to a deadly viral outbreak by conducting an independent investigation of the facility's response, responding to investigations, reviews, and enforcement action by multiple law enforcement and regulatory agencies, representing the facility in ongoing litigation with the Centers for Medicare and Medicaid Services, and coordinating the overall response to the media and the state legislature.
Newark Beth Israel Medical Center and its parent RWJBarnabas Health in conducting an independent investigation, responding to multiple enforcement investigations and regulatory reviews, and overseeing the response to extensive media scrutiny and congressional and legislative inquiries following allegations in the national press that patient care in the hospital’s heart transplant program was compromised to improve survival statistics.
Novartis Pharmaceuticals Corporation and Novartis Corporation in successfully defending 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.
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). All of the cases have been dismissed.