Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of an issue in order to evaluate how best to remediate and guard against future occurrences of a potentially harmful event. From industry-specific concerns, such as those related to quality and safety, product labeling and promotion in compliance with the Food, Drug and Cosmetic Act, federal and state healthcare program reimbursement, False Claims Act matters, HIPAA protections, supply chain compliance, or more general corporate concerns equally applicable to the entire life sciences industry, such as import/export controls, Foreign Corrupt Practices Act compliance, product liability issues, data breaches, environmental catastrophes, or human resource issues, there are more than enough landmines in today’s legal and regulatory environment to keep any general counsel up at night. While not all issues may be avoided, having a playbook in place for conducting an internal investigation that facilitates the identification and remediation of issues is an important step in feeling prepared for whatever may come. Further, following that playbook helps a company to meet the expectations of enforcement authorities, such as the Department of Justice and Department of Health and Human Services Office of Inspector General, which can materially mitigate potential enforcement efforts and penalties.
When a developing situation requires an internal investigation, a general counsel faces a series of decisions, sometimes in rapid succession. Beyond first protecting the integrity and quality of patient care and safety and public health, many constituents must stay top of mind as the situation moves forward. Click here to view the full decision tree.