What types of cases will the DOJ pursue?

From our experience the DOJ is interested in a wide range of topics. Just to name a few, any fraudulent activity involving the prescription of opioids, federal frauds involving kickbacks or any illegal enumeration, specialty pharmacy fraud and patient assistance programs not following proper guidelines. Also, any fraud that directly harms patients are always a high priority.


Some legit whistleblower issues from the standpoint of the actual whistleblower are usually the fear of retaliation or keeping one’s anonymity when reporting a fraud. All whistleblower programs have provisions to protect a whistleblower from retaliation while only the SEC program protects the identity of the whistleblower throughout the entire process.


Adverse event fraud refers to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. These frauds waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries. Any misreporting of adverse events is taken seriously by the FDA.


The Sunshine Act is designed to increase transparency around the financial relationships between physicians, teaching hospitals and manufacturers of drugs, medical devices and biologics. Any misreporting may run afoul to the CMS guidelines for reporting such payments and may violate the anti-kickback statute. Aslo, any misreporting of expenses may trigger a separate SEC or IRS violation.