Blog Tag: VSI
The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices. The same charges were also brought against VSI. According to its website, Minneapolis MN-based VSI makes medical devices for diagnostic and interventional vascular procedures.
According to the United States Department of Justice, the indictment alleges that VSI and Root ran an off-label promotion scheme to market VSI’s Vari-Lase product for the ablation of perforator veins, which connect superficial veins to deep veins. According to its 510(K) summary, the FDA cleared the Vari-Lase for treatment of superficial veins. As the Department of Justice notes, the FDA did not approve the Vari-Lase for treating perforator veins due to higher risks associated with perforator veins’ contact with deep veins. Yet, as stated by the indictment, VSI and Root continued to promote and sell Vari-Lase for treating perforator veins even after failing to obtain FDA approval.
The Department of Justice reports that VSI and Root continued off-label promotion of the Vari-Lase even after a whistleblower complained to Root in 2009 and the government told VSI about its investigation in 2011, and VSI and Root continued to deceive the FDA by using code words and misleading investigators. The Star Tribune states that Vari-Lase was eventually voluntarily pulled from the market in July 2014 when VSI agreed to pay $520,000 to resolve civil allegations related to the same alleged off-label promotion.
Following the indictment, VSI issued a press release stating that “[t]he indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation.” The case is now pending in the U.S. District Court for the Western District of Texas.
On May 15 and 16, 2014, Boston Scientific Corporation and Boston Scientific Scimed, Inc. (collectively, “Boston Scientific”) filed a total of five petitions with the Patent Trial and Appeal Board requesting inter partes review of three U.S. Patents. The first petition (the ’759 Petition) seeks review of U.S. Patent No. 8,142,413 (“the ’413 Patent”). The second and third petitions (the ’760 Petition and the ’761 Petition) seek review of U.S. Patent No. 8,048,032 (“the ’032 Patent”). The fourth and fifth petitions (the ’762 Petition and the ’763 Petition) seek review of U.S. Patent No. 8,292,850 (“the ’850 Patent”). The petitions state that “all three patents are closely related and directed generally to the same subject matter,” and request that the petitions be assigned to the same Board.
All three patents are entitled “Coaxial Guide Catheter For Interventional Cardiology Procedures,” and list as inventors Howard Root, Greg Sutton, Jeffrey M. Welch, and Jason M. Garrity. According to the patents, the ’850 Patent issued from an application that was a divisional of the application that issued as the ’413 Patent, which was a divisional of the application that issued as the ’032 Patent.
The ’413, ’032, and ’850 Patents state that they relate to “methods and apparatus for increasing backup support for catheters inserted into the coronary arteries from the aorta.” Figure 7 from the patents is shown below:
The ’759 Petition seeks review of claims 1, 4, 9, 10, and 13 of the ’413 Patent on various grounds. The ’760 Petition seeks review of claims 1-4, 8, 11, 13, and 17 of the ’032 Patent on various grounds, and the ’761 Petition seeks review of claims 1-4, 8, 11, and 13 of the ’032 Patent on alternative grounds. The ’762 Petition seeks review of claims 1-4, 8, 12, 14, and 18 of the ’850 Patent on various grounds, and the ’763 Petition seeks review of claims 1-4, 8, 12-14, and 18 of the ’850 Patent on alternative grounds.
The petitions disclose that one or more claims of the ’413, ’032, and ’850 Patents have been asserted against Boston Scientific by Vascular Solutions, Inc. (“VSI”) in a lawsuit originally filed on May 16, 2013 in the U.S. District Court for the District of Minnesota. VSI’s first amended complaint, filed on May 28, 2013, alleges that Vascular Solutions is the owner by assignment of the ’413, ’032, and ’850 Patents. The complaint further alleges that “VSI’s cause of action arises directly from Boston Scientific’s infringing actions by manufacturing, marketing and selling the infringing Guidezilla™ product in the State of Minnesota. . . .”