Maple Grove medical-device maker Vascular Solutions and its CEO Howard Root have been acquitted on all counts in a criminal case that had alleged a conspiracy to illegally promote sales of a device to treat varicose veins.
The case, unusual because it featured a CEO who opted to wage a vigorous counterattack against prosecutors, became a closely watched battle that could reshape the FDA's power to regulate medical device sales.
"I feel vindicated, but outraged by the obscene legal process that I had to endure and the public trashing that my reputation and my company had to take," Root said in a phone interview Friday afternoon, shortly after a San Antonio jury returned not-guilty verdicts on nine counts in the indictment.
The case turned on a somewhat arcane legal question about the Food and Drug Administration's approved label for Vascular Solutions' now-discontinued Vari-Lase Short Kit device. The jury deliberated for a day and a half, following weeks of testimony from prosecution witnesses.
Vascular Solutions said it spent $25 million building its defense, but ultimately chose not to call any of the 20 witnesses it had lined up.
The case is likely to draw industry scrutiny in part because of the trial judge's instruction to the jury that declared unequivocally that it is not a crime for a device company to provide doctors with truthful, non-misleading information about unapproved product uses. That's contrary to long-standing FDA legal theory about "off-label" promotion of devices and pharmaceuticals.
"Drug and device companies are following developments in this area very closely, and they will certainly welcome this," Minneapolis health care defense attorney Tom Beimers said.
A spokesman for the U.S. attorney's office in western Texas didn't respond to requests for comment Friday. Root accused government officials of malicious behavior in bringing the case against him.