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 violations, off-label promotion, state and federal False Claims Act violations and other issues related to sales, marketing and pricing practices.

In addition, Ms. Ramer 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.

Experience

  • 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.
  • Major pharmaceutical company in qui tam litigation in two federal courts alleging violations of the AKS and FCA through payment of service fees to Pharmacy Benefit Managers. Both cases have been dismissed.
  • 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 qui tam suit brought in District of New Jersey by relator, alleging off label and kickback claims in connection with the 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.

Perspectives

Pharmaceutical and Medical Device Investigations and Enforcement Forum
Arnold & Porter Seminar, Short Hills, NJ
Too Swift a Dismissal? A Relator Asks the Supreme Court to Weigh In on Standard of Review for (c)(2)(A) Dismissals
Qui Notes: Unlocking the False Claims Act
Deskbook on Internal Investigations, Corporate Compliance, and White Collar Issues (2nd ed.)
Practising Law Institue
In Recent "Original Source" Decision, Relator's Pre-2010 "Secondhand" Claims Back-Handed by Third Circuit
Qui Notes: Unlocking the False Claims Act
Deskbook on Internal Investigations, Corporate Compliance and White Collar Issues (2nd Edition)
PLI Practising Law Institute
More

Recognition

Working Mother Magazine
Featured among the "Working Mothers of the Year" (2019)

Credentials

Education
  • JD, Georgetown University Law Center, 2005
  • BA, Tufts University, 2000, magna cum laude
Admissions
  • New York
  • New Jersey
  • US District Court, District of New Jersey
  • US District Court, Southern District of New York
Overview

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