The Wall Street Journal‘s Law Blog profiled a new trend in prosecutions for violations of FDA regulations that could pose serious risks for officers and attorneys in the health care sector and particularly those working in the pharmaceutical field.

The U.S. Department of Health and Human Services is once again invoking the “responsible corporate officer doctrine” to hold executives personally and criminally liable for corporate violations of U.S. food and drug laws. This doctrine allows prosecutors to reach executives of the violating company even if those executives were unaware of the violations.

The most alarming aspect of this trend for executives is the punishment that may follow if prosecutors invoke the doctrine successfully: exclusion from future participation in the Medicare and Medicaid programs. Prosecutors can even seek this penalty for misdemeanor violations, such as the misbranding of a pharmaceutical drug. The D.C. Circuit Court of Appeals will now decide whether such punishment is lawful.

If you are a corporate officer in the heath sector and have questions concerning your business’s compliance with administrative law, DLM Legal can help. Feel free to contact us at 216.635.0002 or info@dlmlegal.com.