Elizabeth Berry frequently counsels pharmaceutical and medical device clients in matters involving advertising and promotion issues, fraud and abuse enforcement, federal anti-kickback laws, the negotiation and implementation of corporate integrity agreements, and False Claims Act defense. In addition, Ms. Berry conducts due diligence in connection with life sciences and health care industry transactions.
Representative matters include:
- a specialty pharmaceutical company in securing the settlement and resolution of an investigation by the U.S. Department of Justice (DOJ) regarding the company’s sales and marketing practices;
- a specialty pharmaceutical company in an investigation by the DOJ related to the company’s relationship with copay assistance charities;
- a specialty pharmaceutical company in connection with negotiations with the Office of the Inspector General for the U.S. Department of Health and Human Services, related to a corporate integrity agreement;
- a pharmaceutical manufacturer in criminal and civil investigations by the DOJ relating to the marketing of opioid medications;
- a medical device manufacturer in securing the settlement and resolution of a DOJ claim alleging the company sold medical devices not approved by the FDA;
- a pharmaceutical company in connection with an internal investigation related to sales and marketing practices;
- several pharmaceutical manufacturers in providing strategic advice regarding reimbursement and patient support services; and
- due diligence counseling on multiple dealings, including related to a health care data integration software company, a telehealth entity and a pharmaceutical manufacturer.
Ms. Berry also has an active pro bono practice, which has included representation of clients in a quiet title action and a successful compassionate release proceeding.