If you think medical device advertising is immune from criminal prosecution, look to the current charges against the CEO of Vascular Solutions.
This medical device maker and its CEO are facing conspiracy and other charges, around their sales pitches to physicians.
The issue is basically this: how far can a company veer from the intended use for which it received 510k medical device clearance from FDA?
The device at the center of the dispute was called the Vari-Lase Short Kit, which used laser energy to seal off diseased blood vessels that lead to varicose veins. The company has said it voluntarily pulled the $300 device off the market in 2014 after it sold only 1,800 kits nationwide in seven years.
The device had FDA approval to block off superficial veins near the surface of the skin, but prosecutors say it was never approved to seal off the short, twisty “perforator” veins that connect with blood vessels deeper in the legs.
Sealing off perforators can create blood clots that can travel toward the lungs and cause a potentially life-threatening pulmonary blockage, prosecutors say, though they don’t name any affected patients. The two sides disagree about the safety findings from a company-sponsored 2007 clinical trial….
In court filings, the company acknowledges that doctors had already started using longer versions of the Vari-Lase line of devices “to treat short vein segments, including perforator veins.” So around 2007, Vascular Solutions says it began developing its “short kit” to treat short vein segments. Prosecutors argue that the company deliberately created the meaningless phrase “short vein segments” to get around explicit warnings from the FDA.
We know that physicians can recommend medical devices for off-label use, as this is considered clinical innovation and within the practice of medicine — which is regulated by the states, and outside FDA purview. But companies can be held liable for promoting and advertising their medical devices for off-label purposes (i.e., purposes not cleared by FDA under the 510k or PMA process).
The question is how far companies can go under the banner of Free Speech in marketing their medical devices, before these claims will get the companies (and their chief executives) in legal hot water.
Not very far, according to FDA.
From a lawyer’s perspective, this case challenges the view in the 2nd Circuit (U.S. Court of Appeals) Caronia case that a salesperson had a First Amendment right of free speech to speak truthfully about the drug Xyrem, even for conditions not approved by FDA. Other courts since have disagreed with Caronia.
From a marketing perspective, the Vascular Solutions case is a warning shot by FDA.
For the ordinary consumer, whether something is marketed for “superficial” varicose” veins or “twisty perforator veins” may be a bit arcane.
However, companies must remember that FDA is charged with protecting public safety; and, either FDA or FTC (or state attorneys general or private plaintiffs) can bring an action for claims they find false, deceptive, or misleading.
Perhaps here, the company should have been counseled by its FDA attorneys to be more cautious regarding the claims around the medical device, given that there is a medical distinction between treating superficial veins and treating “perforator” veins.
It’s unclear whether using the phrase “short vein segments” was indeed a clever ploy to “get around” FDA rules by injecting “meaningless” language into the marketing. FDA can allege what it wants – we’re not mind-readers, though.
It is clear that medical device makers should have FDA legal counsel review all marketing material — including websites and scripts to be used by salespeople – so as to mitigate risks of FDA enforcement, which can include criminal prosecution of the company’s executives. Ask your healthcare and FDA law firm to review your medical device marketing in light of current FDA enforcement hot buttons, and with an eye toward risk mitigation.