MINNEAPOLIS (Legal Newsline) – The U.S. Attorney General’s Office is asking a federal court to force a Minnesota medical device manufacturer to obey federal law in its operations.
According to a lawsuit filed on April 27 in U.S. District Court for Minnesota, the United States of America has filed a complaint for a permanent injunction against Medtronic Inc., S. Omar Ishrak and Thomas M. Tefft.
U.S. Courthouse in Minneapolis
The U.S. seeks an injunction to enjoin the defendants from allegedly continuing to violate federal law concerning the “quality system regulation” for devices that require companies to make, pack, store and install products in a safe and effective manner.
Over a series of inspections, the Food and Drug Administration found “numerous violations” of the QS regulation, the lawsuit states, as recently as spring 2014 and as far back as inspections in 2006, 2007, 2011 and 2012.
Inspectors made certain at a conference that the defendants were well aware of the specific things that had to change, but the defendants continued to operate in the same way, the suit claims.
The government believes that, unless court-ordered, the defendants won’t adhere to the law, so it seeks an injunction to make them stop violating interstate commerce shipping laws and to stop manufacturing its SynchroMed II implantable infusion pumps (in which many of the QS violations allegedly occurred) until it meets the legal requirements.
The government also asks to ensure the FDA regularly inspect to keep the company complying, the complaint states.
U.S. District Court for the District of Minnesota case no. 15-2168
