Chalk one up for the truth-tellers. And one big black eye for sellers of dubious medical devices who try to use the courts to bully skeptics.
Late last month, Advanced Aesthetic Concepts, a medical device distributor, filed a libel claim against FairWarning, an investigative journalism organization, and Public Citizen, a consumer advocacy organization. The company claimed that they had made false statements about its “fat-melting device” called LipoTron 3000, causing economic harm.
The company also claimed that after the article was published, Public Citizen defamed it in letters to the FDA and state medical boards encouraging them to take enforcement action.
In addition to the organizations, two whistleblowers were targeted in an earlier lawsuit. One is a former LipoTron distributor who provided sales records and other documents to an agency investigator. The other was a marketing consultant accused of disparaging the product on the Internet and through social media. That lawsuit was amended to add the libel claims against the organizations.
Little more than a week after it filed the claim, Advanced said, essentially, “Never mind.” It dropped the lawsuit against FairWarning and Public Citizen. And it won’t say why.
After Advanced filed a one-paragraph dismissal, its lawyer declined to explain. “A suit was filed, and a suit was dismissed, and that’s the way we’re leaving [it],’’ he told FairWarning.
But it’s not dropping its claims against the whistleblowers, who were sources for the FairWarning story after they had been sued by Advanced for defamation for documents given to the FDA in 2010.
The LipoTron supposedly eliminates fat using radio frequency waves instead of invasive surgery such as liposuction or a variety of bariatric surgical procedures to reduce stomach capacity. It’s distributed by Advanced and manufactured by RevecoMED.
The libel/defamation lawsuit claimed the defendants have falsely stated that the LipoTron has been marketed without FDA approval; that the feds are conducting an investigation; and that the defendants inaccurately equated the LipoTron with the Lipo-Ex program, which involves multiple treatments and devices, including the LipoTron.
But FairWarning has documents and interviews with insiders supporting its conclusion that the FDA is investigating LipoTron sales. The FDA has declined comment. FairWarning reported that the LipoTron has not been cleared or approved by the FDA for weight-loss treatments, which would make it illegal to market it for that purpose. It was registered last year, after years of sales, for a different use.
Twice Reveco tried unsuccessfully to get FDA clearance. In 2011, the Texas State Department of Health Services issued a warning letter to Texas-based Advanced for marketing the LipoTron without FDA clearance.
About the same time, Reveco registered the LipoTron as an electronic massager, which is classified by the FDA as a Class 1 device. That category doesn’t require agency review because it represents low-risk equipment, such as elastic bandages. (See our explanation of FDA device classifications and our blog, “Protecting Yourself from Dangerous Medical Devices.")
Allison Zieve, general counsel of Public Citizen, offered one reason for Advanced’s abrupt change in legal strategy: “Maybe they realized they screwed up,’’ she said, and decided to steer clear of those “they thought most likely to put on a good defense.”
One of the whistleblowers called the lawsuit a face-saving move, and that Advanced knows “the truth’s been told about them all along.” She thinks the company is going after her and the other individual because they’re “considered the weakest link because they think we can’t pay for a defense.”
Sounds plausible when a loser desperately wants to look less pathetic.