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U.S. tells Minnesota company: Follow law or stop operations

By Dan Harkins | May 12, 2015

Shutterstock 155812997

The U.S. Attorney General's Office has sued to force a Minnesota medical device manufacturer to obey federal law in its operations.

The United States filed a lawsuit April 27 in U.S. District Court for Minnesota, against Medtronic Inc., S. Omar Ishrak and Thomas M. Tefft, seeking a statutory injunction.

According to the complaint, this statutory injunction would enjoin the defendants from 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.

The suit says through a series of inspections, the Food and Drug Administration found "numerous violations" of the QS regulation as recently as spring 2014 and as far back as inspections in 2006, 2007, 2011 and 2012. Inspectors made certain at a conference the defendants were well aware of the specific matters that had to change, but the defendants continued to operate in the same way, the suit says.

The government alleges, 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 (where many of the QS violations allegedly occurred) until it meets legal requirements.

The U.S. also asks that the FDA regularly inspects to keep the company complying, the complaint states. The plaintiff is represented by  U.S. attorney Andrew M. Luger, assistant U.S. attorney Chad Blumenfield and Ross S. Goldstein.

U.S. District Court for Minnesota case number: 15-2168.

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