by Paul Alan Levy
Many groups at Public Citizen issue hard-hitting reports, but we are scrupulous about reviewing reports about particular companies and individuals to ensure their accuracy, not to speak of avoiding the prospect of libel litigation. This was certainly true with respect to letters to the FDA back in July, asking why it had not completed a criminal inquiry into RevecoMed, and asking it to force the removal from the market of the “LipoTron” machine that supposedly uses radio waves to melt away fat, a liposuction without surgery that can be marketed to credulous patients desperate to lose weight. In a second letter to the FDA, we also urged pursuit of “Advanced Aesthetic Concepts," a firm that offers a “comprehensive cash flow program” for doctors who can’t make enough of a living from honest work, through the sale of the Lipotron for prices ranging from $35,000 to $95,000.
Evidence of Illegal Marketing
Our evidence showed that the FDA’s criminal investigators had known about the companies' activities for more than two years, and also knew that they had not done enough to bring the manufacturer and distributor to heel. And we knew that the manufacturer had avoided rules requiring FDA approval for the marketing of a machine for such purposes, by listing the device with the FDA as an electronic massager used to relieve minor pain, but then promoting the machine for fat reduction. (Tellingly, this page was taken down after we wrote to the FDA.) The firms knew full well that being able to say that they had FDA approval was a key to their ability to get doctors to pay top dollar for the machines, and that great care was needed in crafting marketing language to characterize the machines while avoiding legal trouble. Other documents showed an awareness that the machines could cause burns in patients, including one poignant email from an Advanced staff member showing how his own mother got burned.
The manufacturer expressed apprehension that machines that it had “illegally sold” could be pulled from the market by the FDA, and indeed that FDA intervention could land it in “not civil but crime court.” Similarly, one of the principals at Advanced showed how acutely aware he was of the criminal law consequences of what the firms were doing, because during a deposition in a business dispute he repeatedly asserted the Fifth Amendment privilege against self-incrimination in refusing to answer questions about the sale of LipoTron machines, his understanding of the FDA approval process regarding the Lipotron, and related matters.
Still, the firms had no compunction about promoting the “LipoEx equipment” as allowing doctors to multiply their income tenfold by employing technicians who pull in fees of $350 to $450 per hour as an alternative to liposuction for “bodysculpting” to ”achieve a more contoured look.” And yet Advanced claims what it was not marketing the machines illegally (what did they think, nobody would get the message that a machine called “LipoTron,” used for these purposes in a program called “LipoEx”, was intended for fat reduction)?
At the same time, there was growing attention from bloggers who wondered whether the FDA was ready to respond to such an obvious challenge to its regulation of the advertising of off-label uses. If RevecoMed and Advanced could deliberately misclassify a medical device as a way to continue an impermissible use, without repercussions from the FDA, why shouldn’t every other manufacturer? (One of the bloggers that made this point was also sued for libel.)
DIstributor Sues for Defamation
But as so often happens, it is the plaintiffs with the weakest claims that push forward into court. Advanced not only filed a libel suit against Public Citizen and others who published unfavorable opinions, but sought a temporary restraining order. To justify ex parte hearing, its lawyer certified (see page 32 of document linked above) that he had no idea what lawyers would be representing Public Citizen so that it could be represented at a hearing (In fact, I had written to the lawyer who signed the certification, two weeks before he signed it, promising a response to his libel demand letter after the main author of our letters to the FDA got back from vacation.)
Given how frivolous the libel suit was, I have to assume Advanced felt that it had no choice. It was receiving hard questions from some doctor customers, and sometimes the targets of criticisms decide that their denials will not receive full credence unless they sue for defamation, no matter how well the accusations may be supported. To this day, Advanced’s marketing director Jayne Wilks can be found online responding to critical stories on medical spa industry sites by insisting that RevecoMed “is in diligent pursuit of other indications of use.” (that is, FDA approval of the machine for fat-melting use).
Distributor Backs Down
We therefore set to work drafting an opposition to the motion, pointing to our evidence. Thanks in part to the new Texas anti-SLAPP statute, one of the top media lawyers in the state expressed interest in signing on as our local counsel. However, as soon as we notified Advanced's lawyer that we were ready to appear at any TRO hearing, so that he could not get an injunction without any opposition, Advanced’s lawyer called to say that he was going to dismiss the lawsuit against Public Citizen, although the individual whistleblowers remain defendants for now.
At least we can hope that the FDA will move forward. In the meantime, we can take some pleasure in the fact that increased attention flowing from our letters to the FDA and to state regulatory authorities, is inducing some medical providers to rethink use of the device.