JAIME L.M. JONES is global co-leader of the firm’s Healthcare practice and serves on the firm’s COVID-19 Task Force. She represents leading pharmaceutical and device manufacturers and institutional providers in healthcare fraud and abuse and food and drug enforcement and litigation matters. Jaime has defended numerous civil, criminal, and administrative enforcement actions involving allegations of healthcare fraud and abuse and off-label promotion and other violations of the Food, Drug, and Cosmetic Act. She has handled the defense of such matters conducted by the Department of Justice’s Consumer Protection Branch and Civil Fraud Section, FDA Office of Criminal Investigations, the Department of Health and Human Services Office of Inspector General, various U.S. Attorneys’ Offices, and State Attorneys General. She has negotiated significant Corporate Integrity Agreements with HHS-OIG and has substantial experience counseling clients on compliance and CIA-related issues.
Jaime also has significant experience defending civil litigation in both state and federal courts, with an emphasis on False Claims Act cases and whistleblower retaliation claims. She has successfully defended qui tam claims brought against pharmaceutical and device manufacturers and institutional healthcare providers, in both federal and state courts.
Jaime leverages her experiences in enforcement and litigation matters to effectively and efficiently conduct confidential internal investigations and compliance audits concerning, among other things, drug and device promotional practices, including potential off-label promotion and pre-selling, and anti-kickback, pricing and reimbursement, and Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) issues and compliance program effectiveness. She routinely counsels life sciences companies on these and other compliance issues.
Jaime is recognized on Law360’s list of top life sciences attorneys under 40 and has been named as a Rising Star in the Euromoney LMG 2015 Guide.
Representative Engagements:
Representative matters handled by Jaime include the following:
Enforcement Matters
- Represents a major pharmaceutical company in a DOJ criminal investigation involving allegations off-label promotion and risk minimization.
- Representation of a biologic manufacturer in a parallel civil and criminal investigation of alleged off-label promotion.
- Representation of a pharmaceutical manufacturer in a criminal investigation into alleged violations of cGMP regulations.
- Represented GE Healthcare in connection with an investigation of the company’s pricing and promotion of a radiopharmaceutical product.
- Represented a major pharmaceutical company in a civil investigation by DOJ and the U.S. Attorney’s Office in Chicago involving allegations of off-label promotion. The result was the closure of the investigation without any government action.
- Represented a major pharmaceutical company in a civil and criminal investigation by the U.S. Attorney’s Office in Los Angeles involving allegations of off-label promotion and kickbacks. The result was the closure of the investigation and a declination to intervene in the underlying qui tam.
- Represented a medical device manufacturer in an investigation by FDA’s Office of Criminal Investigations of manufacturing quality issues. The government closed the investigation.
- Represented a major pharmaceutical company in an investigation by the U.S. Attorney’s Office for the Southern District of New York into allegations related to sampling practices and government price reporting.
- Representation of a major pharmaceutical company in connection with investigations related to product diversion.
- Represented an institutional healthcare provider in OIG investigations, qui tam matter, and other enforcement and compliance-related matters based on alleged quality of care and coding and billing issues.
- Represented a food manufacturer and distributor in connection with a seizure action and criminal investigation. The seizure action was resolved with a consent decree without injunctive provisions.
Corporate Integrity Agreements
- Led the negotiations for DaVita of its groundbreaking corporate integrity agreement.
- Represented an institutional provider in corporate integrity agreement negotiations.
- Successfully convinced OIG that a corporate integrity agreement was not warranted in connection with a significant civil settlement.
- Represented a pharmaceutical manufacturer in negotiations to amend its existing corporate integrity agreements.
- Assists companies with investigations into potential CIA violations and counsels companies on compliance with CIA obligations.
State AG Investigations
- Represented a major pharmaceutical manufacturer in state attorneys’ general investigations regarding fraudulent marketing practices and risk minimization in violation of the states’ consumer protection laws.
- Represented a major pharmaceutical manufacturer in state attorneys’ general investigations regarding alleged kickback violations.
- Represented a large academic medical center in connection with an investigation of state qui tam claims related to alleged non-compliance with applicable quality of care regulations.
Qui Tam Litigation
- United States ex rel. Kennedy v. Aventis Pharmaceuticals Inc. – defense of a pharmaceutical manufacturer in a qui tam action alleging off-label promotion and anti-kickback violations. Qui tam claims based on inpatient services, reimbursed under a prospective payment system, dismissed.
- United States ex rel. Grant v. Thorek Hospital – defense of a hospital in a qui tam action alleging government program fraud. Claims dismissed with prejudice.
Prior to joining the firm, Jaime clerked for the Hon. Gerald B. Tjoflat, United States Court of Appeals for the Eleventh Circuit, from 2001–2002. Jaime received her J.D. in 2001 with high honors from Duke University School of Law, and her B.A., cum laude, from the University of Notre Dame.