According to the law firm press release, the lawsuit alleges that IRadimed failed to disclose that: (a) the Company's infusion pump systems had been significantly modified which could significantly affect the safety or effectiveness of the devices; (b) as such under applicable federal regulations the Company's products are "adulterated" and "misbranded"; (c) the Company's mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850; and (d) the Company failed to disclose the material uncertainties and risks that their products were adulterated or misbranded.
On September 3, 2014, IRadimed Corporation shocked the market when it announced that it received a warning letter from the FDA. The warning letter requests that the Company immediately stop all activities that misbrand or adulterate its mRidium 3860 MRI infusion pump, mRidium 3850 MRI infusion pump, and the mRidium 3860+ MRI infusion pump, such as the commercial distribution of the device. This adverse news caused IRadimed Corporation's stock to fall $3.30 per share, or more than 30%, to close at $7.10 per share on September 3, 2014.
On December 11, 2014, the Court issued an Order appointing lead plaintiff and approving lead counsel. Lead Plaintiff filed an amended complaint on December 17.
On May 26, 2015, the Court issued an Order granting Defendants' Motion to Dismiss and closing this case.