X-Rated, Misbranded Medical Device Winner a Loser

Nov 23rd, 2011 | By | Category: Legal News

This true story will help you enjoy your holiday. Not to have a laugh at someone else’s expense, but when they are so wrong, why not?

In this case a Mr. Gary Winner (his real name), 49, from Buffalo Grove, Illinois, owned a company called Planned Eldercare which allegedly supplied durable medical equipment to the elderly.

Calling for Dollars

From 2005 to 2009, Winner and his merry band of boiler room mates would make unsolicited telemarketing calls to the elderly and ask if they suffered from diabetes and/or arthritis. Pretty good chance you might get a ‘yes’ to one or both of those conditions. The elderly would be asked to provide their Medicare and physician information and they would receive “at no cost to you” certain products whether they needed them or not. The boiler room employees were told to order as many “products” as possible whether or not the beneficiaries asked for them or had a medical need. The elderly were told to put the items “under their sink” if they didn’t need it.

What kind of products?  This is where it begins to sound like a Carl Hiaasen novel.

Erectile Pump

An elderly male who was called was told, if he suffered from diabetes, that an “erectile pump” was good for prostate problems and would help the blood circulate in the prostate region. According to the indictment, announced by the FDA’s Office of Criminal Investigations, Winner would order “penis enlargers from an x-rated website for $26.00 each, repackaged them with an information sheet stating that regular use of the enclosed “erectile pump” helps with bladder control, urinary flow and prostate comfort, and then ship them to recipients.”

But Winner charged Medicare an average of $284 per item. And he asked the recipient to wave co-payments, assuring they would not report the problem to Medicare.

Medicare requires a medical device be a necessity and prescribed by a doctor.

Big Trouble for Winner

Last September, Mr. Winner pleaded guilty to two counts of health care fraud and one count each of money laundering and the introduction of an adulterated and misbranded medical device into interstate commerce, according to a November 17, 2011 news release here.

Gary Winner is looking at a maximum of 33 years in prison, a fine of $760,000, a $2 million forfeiture of money he obtained by fraud, and supervised release when he’s sentenced in February of next year.

The case is being prosecuted by Assistant U.S Attorney Dulce Donovan of the United States Attorney’s office in Rhode Island and was investigated by Health and Human Services, the FBI, IRS, and the FDA.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.