The U.S. Department of Justice (DOJ) reported Feb. 1 that it had recouped more than $5.6 billion in settlements in connection with False Claims Act litigation (FCA) in 2021, with $5 billion of that amount derived from action against the health care industry.
The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.
Enforcement against false claims filed with federal health care programs continues to snare a number of testing clinics as demonstrated by the recent news that a clinical lab has come to terms with federal prosecutors over urine drug testing. MD Spine Solutions LLC, of Reno, Nevada, has agreed to pay up to $16 million to settle allegations that it performed unnecessary urine drug tests, a case brought to the attention of the courts not by a former employee, but by Omni Healthcare Inc., which has been active in the False Claims Act space, thus highlighting the hazards of third-party litigation to clinical lab operators.
A change of presidential administrations often brings a significant change in regulatory policy, and the Granston memo did just that shortly after the Trump administration took office in 2017. However, the Department of Justice (DoJ) has dismissed fewer whistleblower (qui tam) lawsuits against the private sector recently, a trend that Jonathan Phillips of Gibson Dunn said was evident before the Biden administration took over.
Qui tam litigation holds a dear place in the hearts of U.S. federal prosecutors and whistleblowers alike, but the volume of these cases ebbed as the COVID-19 pandemic swept across the nation. A report by Gibson, Dunn & Crutcher LLP makes clear, however, that despite the pandemic-induced drag, these cases are resuming their historical pace, and makers of drugs and devices are once again the most frequently targeted type of business.
Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.
