In recent years, the volume and scope of government investigations and qui tam relator complaints concerning alleged “off-label” marketing by pharmaceutical, biological, and medical device manufacturers has skyrocketed.
Fraud and false claims
Allegations of injury to consumers, private insurers, and governmental entities such as Medicare and Medicaid arising from false claims, Civil RICO, and other deceptive practices often require careful economic analyses to establish or refute liability, causation, and damages. We support clients with such analyses in connection with complex civil litigation—including class action, parens patriae, and qui tam lawsuits—and governmental investigations. Our professionals support clients in connection with alleged False Claims Act and other fraud violations stemming from alleged kickbacks, off-label marketing, and noncompliance with state and federal statutes. We also provide our clients with policy recommendations and coordinate with them to present these recommendations directly to regulators.
- In United States ex rel. Steven May and Angela Radcliffe v. Purdue Pharma L.P., serving as a testifying expert on causation and damages on behalf of Purdue in connection with alleged False Claims Act (FCA) violations concerning alleged improper marketing of OxyContin to physicians, state Medicaid organizations, and Veteran’s Administration facilities.
- In United States v. Guidant Corp., served as a testifying expert on damages on behalf of a medical device manufacturer in connection with alleged FCA violations concerning certain implantable cardiac devices affected by a manufacturing change. Analyzed damages within the context of Medicare’s coverage and reimbursement policies for medical devices. Provided expert report.
- Served as consulting expert to evaluate issues of liability, causation, and damages on behalf of a major brand name drug manufacturer facing a government investigation into various allegations regarding its marketing practices. These allegations included off-label promotion, violations of the Anti-Kickback Statute, and violations of federal and state FCA laws. Analyzed millions of claim records submitted to Medicare and state Medicaid programs. Also analyzed the manufacturer’s pricing patterns and medical providers’ drug administration practices. Worked closely with counsel for several years throughout various phases of investigation and litigation to achieve a resolution.
- Retained as testifying expert on behalf of a specialty pharmacy in a matter involving allegations of Anti-Kickback Statute violations.
- Provided written, deposition, and trial expert testimony on behalf of a number of pharmaceutical manufacturers in expansive federal and state multidistrict Average Wholesale Price Litigation, in which public and private insurers allege that they overpaid for prescription pharmaceuticals as a result of inflated prices published by manufacturers. Representative cases include:
- In re Pharmaceutical Industry Average Wholesale Price Litigation
State of Illinois v. Abbott Labs., Inc.
State of Alabama v. AstraZeneca LP
- United States v. Dey, Inc.
- The State of Texas ex rel. Ven-A-Care of the Florida Keys, Inc. v. Mylan Inc.
- In Applied Medical v. Ethicon Endo-Surgery, on behalf of Applied Medical, investigated economic issues associated with the court’s consideration of injunctive relief regarding allegations of false advertising in markets for laparoscopic medical devices. Analyses focused on the impact of the challenged conduct on surgeon preferences and hospital procurements. Supported testifying expert’s report, deposition testimony, and preparation for trial.
- Computed damages arising from lost sales of a major antiviral pharmaceutical product. The dispute alleged breach of contract, specifically through the failure to provide adequate marketing and promotional support. Developed but-for scenarios, models of demand for antiviral pharmaceuticals, lost sales forecasts under hypothetical market outcomes, and prepared an expert report.
- Provided consulting expertise on issues of liability, causation, and damages on behalf of a pharmaceutical manufacturer alleged to have engaged in off-label marketing.