Kenneth J. Nolan

When Icarus won the Academy Award for best documentary feature in 2018, Kenneth J. Nolan was credited as a co-executive producer. The documentary follows Grigory Rodchenkov, the Russian laboratory director whose disclosures exposed a state-run doping program. Nolan’s involvement accompanied his legal work representing whistleblowers from his practice in Fort Lauderdale.

A Yale graduate with a law degree from the University of Florida, Nolan began by representing nonprofits and consumers in litigation over fraud and deceptive practices. He helped lead the Florida Bar’s consumer protection law committee from 1997 to 2003, serving as chairman, vice-chairman, and continuing-legal-education chairman.

Trileptal, Botox, and the Sales Floor

Nolan represented three sales-force whistleblowers in litigation over Novartis’s marketing of Trileptal, an anti-seizure medication. Their allegations concerned promotion for unapproved uses and payments to health-care providers. In explaining the initial filing in Tampa, Nolan pointed to the local U.S. Attorney’s Office’s experience pursuing health-care fraud. He had assessed the volume of off-label sales and said that, if the allegations were true, the damages would be astronomical.

The sales representatives knew how the company marketed its products and paid prescribers. Nolan worked with his clients to present their information to the government, connecting their accounts to marketing documents, transactions, and claims paid by public health programs. The government alleged that Novartis promoted Trileptal for psychiatric and pain uses that those programs did not cover, and paid kickbacks to induce prescriptions of Trileptal and five other drugs.

In 2010, Novartis agreed to a $422.5 million resolution: a $237.5 million civil settlement and a combined criminal fine and forfeiture of $185 million, with a guilty plea to misbranding. The settlement resolved several whistleblower suits, including the litigation Nolan’s clients had brought.

That same year, Nolan represented two whistleblowers in the Allergan Botox litigation, part of a $600 million resolution comprising a $225 million civil settlement and a combined criminal fine and forfeiture of $375 million, with a misbranding plea. The allegations connected off-label promotion and payments to physicians with the billing instructions Allergan supplied. The government alleged that the company taught doctors and their staffs how to obtain reimbursement for uncovered uses, including through inappropriate diagnosis codes.

A Firm Built for One Kind of Case

Nolan founded Nolan Auerbach & White as a firm devoted to representing health-care fraud whistleblowers. His earlier clients included a psychologist in the Nova Southeastern University case, which resolved for $4.1 million over billing for psychological services, and four clinicians in the Lifeline Healthcare matter, whose allegations concerned home-health visits billed for patients who were not homebound. Those cases required examining the reimbursement rules governing the services, the accuracy of the claims, what the providers knew, and whether any misrepresentation was material to the government’s payment decision. The firm also had to establish the amount of public money lost.

The firm’s attorneys have continued that work with clients and the Justice Department across pharmaceutical, hospital, hospice, and medical-device cases. In the Schering-Plough matter, the firm represented two of three whistleblowers in a $435 million resolution: $255 million to resolve civil claims and a $180 million criminal fine. Its two clients received more than $12 million in relator shares. The firm’s representation of former Scios area manager Joe Strom led to a $184 million civil settlement with Johnson & Johnson and Scios over off-label promotion of the cardiac drug Natrecor. Scios had separately paid an $85 million criminal fine.

Other pharmaceutical clients brought information about a drug’s effectiveness and the incentives offered to prescribers. Former product manager Brian Shields’s case against Genentech and OSI Pharmaceuticals concerned the lung-cancer drug Tarceva and resolved for $67 million. Former sales representative Kathy Fragoules’s case against Daiichi Sankyo resulted in a $39 million kickback settlement. Her allegations concerned payments to physicians through speaking programs; the legal team reviewed tens of thousands of documents in pursuing the case.

Hospital billing required different evidence. The firm’s work included a $104.5 million Vencor and Kindred recovery involving cost reports, and a $36.9 million Dignity Health settlement over inpatient billing classifications. Dignity’s former director of medical management, Kathleen Hawkins, challenged claims for patients who could have received less costly outpatient care. In South Texas, the firm represented a whistleblower in a $27.5 million resolution with Universal Health Services and its hospitals over physician-referral arrangements.

The firm also represented a hospice executive director in a $25 million Odyssey Healthcare matter and a sales representative in a $16 million St. Jude Medical kickback settlement. Senior process analyst Amanda Wu pursued her Alere case for seven years before a $33 million resolution.

The Teacher’s Side of the Table

Taxpayers Against Fraud, the national organization of the whistleblower bar, named Nolan Lawyer of the Year, and he chairs its President’s Council. He has served as an adjunct professor of trial practice at Nova Southeastern University’s law school and on the faculty of the National Institute for Trial Advocacy. His civic work in Fort Lauderdale includes serving as vice-president of Florida Girls Giving Back. He is a past board member of ChildNet and the American Cancer Society and a past president of the Yale Club of Fort Lauderdale.

Nolan’s writing between 2000 and 2008 addressed health-care fraud and False Claims Act enforcement through particular problems: standing to sue, confidentiality when disclosing medical records, off-label sales, pharmaceutical kickbacks, and manufacturing standards. In 2001, he explained how a lawyer evaluating an insider’s account had to distinguish knowing false claims from mistakes, determine whether the government had suffered a loss, and examine how the agency responsible for payment understood the billing rules.

In a 2004 article for health-care purchasers, Nolan described preparing a disclosure memorandum with the whistleblower: assembling documents and witness accounts, and using consultants to test whether the suspected conduct could be substantiated. He urged employees to gather evidence lawfully and ethically, staying within company policy and the records they would encounter in their ordinary work. He described preparation that could take weeks or months before filing, as lawyer and client developed the information that investigators would need.