Paula Ramer | People | Arnold & Porter

Paula Ramer represents pharmaceutical and medical device manufacturers in internal investigations, criminal and civil government investigations and litigation against the government and private relators involving allegations of healthcare fraud, including Anti-Kickback Statute (AKS) violations, off-label promotion, state and federal False Claims Act (FCA) violations and other issues related to sales, marketing and pricing practices.

In addition, Paula has developed fraud and abuse training for clients and advises companies on their compliance programs. She has written on individual liability and exclusion arising from healthcare fraud prosecutions and First Amendment issues relating to the promotion of pharmaceutical and medical device products.

Paula serves as Co-Chair of the firm's Women's Initiative for Success & Empowerment (WISE).

Focus Areas

Experience

AbbVie in a qui tam suit filed in the District of Maryland alleging price reporting claims. Obtained dismissal of all claims, which was affirmed by the Fourth Circuit on January 25, 2022, and again en banc on September 23, 2022. Following remand based on a decision by the Supreme Court, on July 23, 2024, the district court again granted our motion to dismiss. United States ex rel. Sheldon v. Forest Lab'ys, LLC, Case No. CV ELH-14-2535, 2024 WL 4544567 (D. Md. July 23, 2024).
Major pharmaceutical company in high profile qui tam litigation in federal court alleging violations of the AKS and FCA through the use of nurse educator and reimbursement support services. The case has been dismissed.
Pfizer in FCA cases filed in the Southern District of New York and District of Rhode Island by the same relator against numerous pharmaceutical manufacturers and pharmacy benefit managers, alleging violations of the AKS and FCA through payment of service fees. Both cases were dismissed, and on appeal the dismissals were affirmed by the Second and First Circuits in December 2020 and January 2022, respectively.
Major pharmaceutical company in a qui tam litigation in federal court alleging violations of federal price reporting requirements and the AKS in connection with the marketing of its medications.
Medical device manufacturer in a federal criminal investigation involving alleged manufacturing deficiencies.

Alcon Laboratories and Alcon Inc. in the successful defense of a qui tam suit brought in District of New Jersey by relator, alleging off label and kickback claims in connection with ocular medication, Vigamox®. On a motion to dismiss, obtained dismissal with prejudice of all claims. United States ex rel. Lampkin v. Alcon Laboratories Inc., et al., 08 Civ. 05362 (JAP).
Major brand name prescription drug manufacturer in qui tam litigation brought in Southern District of New York by government and relator, alleging kickbacks to specialty pharmacies in connection with various medications.
Major brand name prescription drug manufacturer in qui tam litigation brought in Southern District of New York by government and relator, alleging kickbacks to physicians through speaker programs in connection with various cardiovascular medications.
Five Healthcare Providers in Texas and Louisiana in a case brought under the federal, Texas, and Louisiana FCA statutes filed by a relator and the State of Texas relating to Texas and Louisiana’s efforts to terminate the providers from participating in their respective Medicaid programs where Plaintiffs seek over $1 billion in damages and penalties.