Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and Accountability Act (HIPAA).   See HERE for that previous post.

That physician has now been convicted of the HIPAA violation, as well as an unrelated charge of obstructing a federal health care investigation.  The US Attorney’s Office in Boston made the announcement late last month.

The Warner Chilcott settlement involved illegal drug promotion.  Specifically, sales reps were accused of flagging patient medical records with product brochures and filling out the provider’s prior authorization forms in advance for specific patients.  All of this required impermissible access to patient records.  The physician’s criminal liability stems from providing these sales reps with access to her patients’ records.  In some cases, the reps were even allowed to take the records home with them!

We are often reminded through settlements with the HHS Office for Civil Rights that HIPAA violations are taken seriously and can include hefty fines and corrective action plans (see HERE, HERE and HERE for just a few examples).  This case serves as fair warning that intentional misuse of protected patient information can lead to jail time.  When this physician is sentenced, she could be looking at up to a year in prison, a $50,000 fine, and a year of supervised release.  If you picture a sales rep combing through your personal health issues in his or her living room to determine whether you might be a sales target, it shouldn’t be so surprising that this conduct can rise to the level of criminal liability.

Written by: Laurence J. Freedman and Samantha P. Kingsbury

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food and Drug Administration (FDA); and (2) conspiring to defraud the U.S. government by concealing their illegal activities.  This case is pending in the U.S. District Court for the Western District of Texas.  In July 2014, VSI entered into a civil settlement agreement with DOJ under which it agreed to pay $520,000 to resolve allegations under the False Claims Act regarding this conduct.

Under its consumer protection criminal authorities, the Civil Division charged Mr. Root and VSI each with one count of conspiracy and eight counts of introducing adulterated and misbranded medical devices into interstate commerce in connection with a sales campaign related to VSI’s Vari-Lase product line.  The Vari-Lase system was designed to treat varicose veins by sealing them with a laser (“ablation”).  The indictment alleges that the Vari-Lase system was only approved by the FDA for the treatment of superficial veins, not perforator veins (which connect the superficial vein system to the deep vein system). 

Continue Reading Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices