WASHINGTON – A pair of U.S. Senators have called out the Department of Justice, seeking answers stemming from the department’s unsuccessful criminal pursuit of Vascular Solutions, a medical-device maker in Minnesota.
On May 19, Senators Chuck Grassley, R-Iowa, and Mike Lee, R-Utah, sent a letter to Deputy Attorney General Sally Quillian Yates, inquiring about the “questionable actions of federal prosecutors” involved in the case.
Both senators are members of the Senate Judiciary Committee.
As previously reported, the DOJ’s Civil Division accused Vascular Solutions of marketing its Vari-Lase Short Kit to treat veins deep in the leg when the FDA had only approved the device for treatment of veins closer to the skin’s surface.
The company maintained the plain language of the FDA approval gave authorization to treat a general category of varicose veins, as all varicose veins include perforator varicose veins.
In the summer of 2014, Vascular Solutions, with no admission of liability, agreed to a $520,000 settlement. The DOJ’s Criminal Division then jumped in and a few months later a San Antonio grand jury indicted Vascular Solutions for promoting off-label uses of the kit, accusing the company of misbranding.
Vascular Solution’s CEO, Howard Root, maintained there were no falsehoods in its marketing and took the case to trial, spending a purported $25 million on its defense.
Root has been very vocal on his feelings that he and his company were falsely charged, publically accusing prosecutors of acting unethically to obtain the grand jury indictment.
The company, which ran the risk of losing its federal dealings if convicted, was vindicated in late February when a jury returned not-guilty verdicts on all counts.
Prior to the trial, Vascular Solutions sought to dismiss the indictment, asserting the government endeavored to distort the evidence, court records show.
The senators’ letter requests answers for allegations that, according to court documents, the government:
- Characterized a group of witnesses’ testimony as the “same line of sh**” given by others who refused to admit “the obvious truth,” and warned that witnesses must “fix” their testimony or face criminal prosecution;
- Told one witness that if he wants to “be safe from prosecution,” his testimony needs to be “consistent with” the testimony of others;
- The government told another witness that her testimony was “pissing them off,” and that the government could seek to have her fired;
- The government warned another witness that if she did not “fix” her testimony to be consistent with the others, she would face criminal charges, loss of employment, and referral for exclusion from participation in federal health care programs, effectively ending her career; and
- Warned another witness that he was a “coat of paint away from perjury,” explained that the “poor f***er just on principle may be indicted,” and demanded that the witness return “on bended knee” to admit that he misled the government.
"We write regarding the questionable actions of federal prosecutors in connection with the prosecution," the letter states. "As we have previously noted, prosecutors must be held to the same standards as the general public and are accountable for their conduct as representatives of the United States."
The trial court denied the motion but instructed the jury that it’s “not a crime for a device company or its representative to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”
Vascular Solutions had annual revenues of more than $100 million dollars from 2007 to 2014. The total amount of sales for the kit exceeded a little more than $500,000 over that seven-year period.
No patient was harmed because of the kit.
Vascular Solutions has little recourse in recouping the millions spent fending off the DOJ’s charges.
The lead DOJ prosecutors in the case were Timothy Finley of the Consumer Protection Branch and Walter Paulissen, an Assistant U.S. Attorney for the Western District of Texas.