Pharmaceutical Fraud, Waste, and Abuse

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DiCello Levitt represents consumers, fraud victims, whistleblowers, and government agencies against pharmaceutical companies for fraud, waste, abuse, and deceptive practices in the manufacture, marketing, and sale of drugs and devices. Our breadth of expertise and experience in this area includes successfully litigating cases asserting claims under the Food, Drug, and Cosmetics Act; the Controlled Substances Act; the Medicare Act; the Anti-Kickback Statute; the Stark Law; and a panoply of state consumer protection laws. Given the firm’s extensive array of practice groups, we bring unrivaled acumen to the many legal issues implicated in pharmaceutical fraud cases, including antitrust, breach of contract, and unfair competition.

An exemplar of our industry-leading work in this space is our representation of whistleblowers in qui tam actions under the False Claims Act and related federal statutes on behalf of various states against pharmaceutical and medical device manufacturers and distributors, pharmacy chains, pharmacy benefit managers, hospitals, and medical labs. Whistleblowers play a critical role in exposing and preventing pharmaceutical fraud and in ensuring that fraudulently procured revenue, including treble damages in some instances, is returned to taxpayers.

DiCello Levitt represents whistleblower clients including consumers, pharmacists, doctors, hospital administrators, and pharmacy auditors. Our whistleblower cases involve the misuse and abuse of opioids and other controlled substances, Medicare and Medicaid billing fraud, pharmaceutical and medical device kickbacks, fraud and abuse in the administration of prescription drug benefit programs, the manufacture and prescription of defective and unapproved medical devices, electronic health records fraud, and much more.

DiCello Levitt also represents individual consumers, consumer classes, organizations, and state attorneys general in a range of cases under federal and state consumer protection laws against drug companies that make false or misleading claims about their products. For example, DiCello Levitt represents the State of New Mexico and its Attorney General in a case against Abbvie and the other makers of AndroGel, a testosterone replacement drug. The case, which is still pending, alleges that Abbvie and the other drug makers violated New Mexico’s Unfair Practices and False Advertising Acts when they overstated the drug’s efficacy by deceptively convincing middle-aged men that they suffered from a disease called “andropause” and claiming that the drug cures the natural incidents of aging, all while materially understating the drug’s cardiovascular risks.