The Times They Are A’Changing – Or Are They? DOJ Announces It Will Move To Dismiss Qui Tam Complaints That Lack Merit
Client Alert | 1 min read | 11.13.17
After months of signaling that a change to the Department of Justice’s qui tam practices was imminent, Michael Granston, Director of the Civil Fraud Section, announced the change during a presentation at the Health Care Compliance Association’s Health Care Enforcement Compliance Institute on October 30. The Department of Justice will now move to dismiss a qui tam complaint when it concludes that it lacks merit. Although announced as a means of conserving judicial and litigant resources, we also wonder if the apparent change is spurred by a concern over the creation of bad law under Escobar’s materiality standard is a driving force behind this decision. Given that DOJ rarely exercises its statutory authority to move to dismiss a qui tam complaint, it should not be difficult to ascertain whether DOJ’s announcement is, in fact, a sign of a real shift in its enforcement tactics.
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Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.
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