Headlines that Matter for Companies and Executives in Regulated Industries
During a recent interview commemorating the 50th anniversary of the enactment of the Anti-Kickback Statute, two prominent members of the False Claims Act (FCA) Bar offered a series of key insights into the current state of Anti-Kickback Litigation.
Among other key observations, Tycko & Zavareei LLP partners Renée Brooker and Eva Gunasekera (both US Department of Justice (DOJ) alumnae prior to their time in private practice) described DOJ’s preference for cases brought by corporate insiders with specific knowledge of problematic conduct within a company. Similarly, when asked about how DOJ decides which relator cases to focus on and intervene in, Brooker specifically pointed to DOJ’s limited resources and posited that the agency is beginning to shift its focus to pandemic-related fraud, as well as cybersecurity fraud.
Additionally, on the topic of off-label promotion, Gunasekera described DOJ’s focus on pharmaceutical manufacturers offering kickbacks to physicians and other prescribers to speak about off-label drug or devices indications. Gunasekera also posited that kickbacks to promote off-label uses have been used to enable older products to compete with newer ones.
Read together, the interview indicates that companies (particularly those operating in the pharmaceutical and medical device spaces) should ensure that they have robust compliance and oversight programs in place to make sure they...
Images of the Whitegate fuel protests earlier this month were altered to make it appear gardaí were violent towards protesters. The AI-doctored images were shared widely online, including by inter...