Caveat Emptor . . . SERIOUSLY!

Average consumers generally trust the notion that the products they purchase “are what they say they are.” But that’s not always the case. Patients at a doctor’s office and home consumers buying medical devices or dietary supplements over the Internet continue to face the issue of misbranding and mislabeling. Recent examples of this disturbing trend abound.

On February 9, 2010, the United States Attorney for the Northern District of New York issued a press release wherein the Department of Justice recounted the sentencing of a group of plastic surgeons using a non-Food and Drug Administration approved TRI-toxin instead of the FDA approved drug, Botox. The sentencing included the following:

THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG’s plea of guilty to one felony count of misbranding drugs, in violation of Title 21,United States Code, Sections 331(k), 352(i)(3), and 333(a)(2) . . . .

Additionally, Doctors WILLIAM F. DE LUCA, Jr., DOUGLAS M. HARGRAVE, JEFFREY L. ROCKMORE, STEVEN M. LYNCH, and JOHN D. NOONAN, were sentenced to probation with community service, and ordered to pay restitution in the amount of $106,686, and a fine of $5,000. TPSG’s practice administrator, PETER M. SLATTERY, and supervisory nurse SUSAN F. KNOTT, were also sentenced and ordered to pay restitution in the amount of $106,686, and fines in the amount of $1,000 and $500, respectively. All individual defendants were sentenced in connection with their guilty pleas to one misdemeanor count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(1) . . . .

Just the day before, on February 8, 2010, the United States Attorney for the Southern District of California issued a press release regarding the sentencing of a man who sold thousands of unregistered medical devices that he claimed could treat anything from worms to AIDS. That man, James Folsom, was sentenced to 51 months and ordered to pay a fine of $250,000.

The evidence presented at Folsom’s trial indicated that he marketed the device under the names “NatureTronics,” “AstroPulse,” “BioSolutions,” “Energy Wellness,” and “Global Wellness.” The supposed medical device housed a digital readout that consumers could use to adjust the device to certain settings, as indicated in the accompanying manual, to treat a whole host of maladies including diabetes, strokes, ulcers, AIDS, and worms. The U.S. Attorney’s press release stated:

According to the testimony at trial, during the period from 1997 through August 2008, the defendant purchased over 9,000 units, which he sold to distributors for approximately $1000-1200, and to retail customers for $1995, with sales totaling over $8 million. The devices were manufactured by the defendant and others in a San Diego location, which he failed to register with the Food and Drug Administration (FDA) as a device manufacturing establishment. The defendant used the false name “Jim Anderson,” when selling the device and used post office boxes, self-storage units, and bank accounts opened in the names of others to conduct his business in an effort to avoid detection by the FDA.

The devices were adulterated in that they were marketed without a valid investigational device exemption, without pre-market approval, and in violation of an electrical performance standard set by the FDA, prohibiting lead wires that come into contact with patients from being able to come in contact with potentially hazardous voltages.

Finally, this past January, the FDA updated its earlier warning over an unapproved doppelganger of the FDA’s approved weight loss supplement, Alli. In that update, the FDA provided helpful information, including photos, to assist consumers in identifying the counterfeit drug which contained a non-approved dosage of the active ingredient found in Alli and other weight loss pills, sibutramine. As long as criminals suspect that they can profit from selling unapproved drugs and medical devices, they will continue to do so. As such, it becomes all the more important for consumers to exercise the old Latin adage – caveat emptor! This seems to beg the question: did the Romans have the same problem that we have today?

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