Lawsuit Overview
October 28, 2015 - The U.S. Court of Appeals for the Eleventh Circuit granted the parties' joint motion to dismiss the appeal with prejudice.
June 22, 2015 - The lead plaintiff filed a notice of appeal.
May 26, 2015 - The court granted the defendants' motions to dismiss with prejudice.
January 20, 2015 - The defendants filed motions to dismiss.
December 17, 2014 - The lead plaintiff filed an amended complaint.
December 11, 2014 - The lead plaintiff and lead counsel were appointed.
November 10, 2014 - A lead plaintiff motion was filed.
September 10, 2014 - An investor in shares of Iradimed Corporation (NASDAQ: IRMD) filed a lawsuit in the U.S. District Court for the Southern District of Florida against Iradimed Corporation over alleged violations of Federal Securities Laws in connection with certain allegedly false and misleading statements made between July 15, 2014 and September 2, 2014.
According to the complaint the plaintiff alleges on behalf of purchasers of Iradimed Corporation (NASDAQ: IRMD) common shares between July 15, 2014 and September 2, 2014, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that Iradimed Corporation allegedly failed to disclose that Iradimed Corporation's infusion pump systems had been significantly modified which could significantly affect the safety or effectiveness of the devices, that as such under applicable federal regulations the Company's products are adulterated and misbranded”, that Iradimed Corp's mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850, and that Iradimed Corp failed to disclose the material uncertainties and risks that their products were adulterated or misbranded.
Iradimed Corporation reported that its annual Total Revenue rose from $7.69 million in 2012 to $11.34 million in 2013 and that its Net Income increased from $0.97 million in 2012 to $1.94 million in 2013.
On September 2, 2013, Iradimed Corporation announced that it received a warning letter from the U.S. Food and Drug Administration (“FDA”) relating to an inspection of the Company’s facility that took place in April 2014.
Iradimed Corporation said that the warning letter, among other things, states that a new submission is required under Section 510(k) of the Food, Drug and Cosmetic Act (the “FDCA”) for the Company’s IV infusion pump systems due to periodic updates of the software on the Company’s previously cleared infusion pumps, the mRidium 3860 and mRidium 3850, that the warning letter states that such updates are “significant” modifications that could significantly affect the safety or effectiveness of the devices and therefore the products being sold by the Company are “adulterated” and “misbranded” under the FDCA, and that the warning letter indicates that the mRidium 3860+ infusion pump requires separate FDA clearance from the mRidium 3860 and mRidium 3850.
Iradimed Corporation also said that the warning letter requests that Iradimed Corporation immediately cease activities that result in the misbranding or adulteration of the 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.
Shares of Iradimed Corporation declined from $10.40 per share on September 2, 2014 to as low as $6.26 per share on September 3, 2014.
On September 10, 2014, NASDAQ: IRMD shares closed at $7.65 per share.