There were a spate of announcements last week about actions taken by U.S. attorneys – one that involves a guilty plea for misbranding a drug; one person getting a 51 month sentence for selling unapproved medical devices and one guilty plea for the fraudulent marketing of dietary supplements. Let's check that out.
- Criminal Charges for Misbranding a Drug - The Acting U.S. Attorney for the Northern District of New York announced that The Plastic Surgery Group of Albany New York entered a guilty plea for misbranding drugs and was ordered to pay restitution that amounted to $106,686 and $200,000 fine. Individuals associated with the plea were sentenced to probation with community service and also ordered to pay restitution and a fines ranging from $500 to $5000 and included physicians, the practice administrator and a nurse. What did they plead guilty to? According to the release, beginning in 2004 they began replacing FDA approved Botox with FDA not approved TRI-toxin into patients seeking treatments for facial wrinkles. No details were contained in the release as to what caused the investigation by the FDA Office of Criminal Investigations to begin to look into the matter.
- 51 Month Sentence for Selling Unapproved Medical Devices – In the most serious of the three actions, the U.S. Attorney for the Southern District of California in San Diego announced that an individual was sentenced to a 51 month term and a $250,000 fine following conviction on 26 counts related t the sale of unapproved medical devices. The court ordered the destruction of over 450 devices related to the crime. The defendant invented the devices which were marketed under various names and which were directed for patients to use to treat a variety of conditions including AIDS, diabetes, stroke, ulcers and worms. The device, a micro-current generator, was to be connected to the body of the patient. The device sold over $8 million over a period of 11 years. No information in the press release as to why the practice was able to go on for so long, or why there was finally intervention.
- Guilty Plea to Fraudulent Marketing of Dietary Supplements – It will be interesting to compare the sentence for this plea to the sentence for the sale of the unapproved medical devices. One case was in Albany, the next in San Diego, and this time from the heartland of Springfield, Missouri. Here was an Internet business that generated nearly $12 million, according to the release by the U.S. Attorney in the Western District of Missouri by making claims to prevent and cure diseases through the use of dietary supplements sold on the site. The supplements sold over various Internet sites were supposedly demonstrated by clinical trials to treat and prevent diabetes, IBS, gout, high cholesterol, high blood pressure, heartburn and diarrhea and promotional materials were said to include fraudulent customer testimonials using photo stock images. The Internet sites also produced a "sanitized" version of the promotion when it was detected that the Web sites were accessed from an IP address that was within the FDA network. No insight into how the FDA cracked this one or overcame the IP address issue.
All good action, but is it winning the battle or a drop in the bucket? I don't know the answer nor am I suggesting one, I'm only posing the question. What is the scale and scope of fraud out there? Hopefully actions like these will have some deterrent impact.