Lawsuit Overview
Settlement Overview
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December 12, 2018 - The court preliminarily approved the settlement.
November 13, 2018 - A stipulation of settlement was filed by the parties.
March 16, 2018 - The court denied defendants' motion to dismiss.
August 30, 2016 - Defendants filed a motion to dismiss.
June 29, 2016 - An amended complaint was filed.
January 22, 2016 - An investor in shares of HeartWare International Inc (NASDAQ: HTWR) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by HeartWare International Inc in connection with certain allegedly false and misleading statements made between June 10, 2014 and January 11, 2016.
According to the complaint the plaintiff alleges on behalf of purchasers of HeartWare International Inc (NASDAQ: HTWR) common shares between June 10, 2014 and January 11, 2016, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that after the U.S. Food and Drug Administration ( FDA ) issued a Warning Letter identifying numerous manufacturing and other regulatory failures at the Company's sole manufacturing facility, Defendants falsely assured investors that the Company had addressed those problems, and that they therefore posed no risk to the clinical trials or timely approval of MVAD, a pump that HeartWare International Inc is presently developing. The plaintiff says that the truth concerning the Company's failure to remediate the regulatory failures identified by the FDA and its impact on the viability of MVAD was revealed through a series of disclosures. HeartWare International Inc reported that its annual Total Revenue rose from $110.92 million in 2012 to $278.42 million in 2014 and that its respective Net Loss declined from $87.72 million to $19.37 million.
On September 1, 2015, HeartWare International Inc announced the acquisition of Valtech Cardio, Ltd., a manufacturer of medical devices used to treat heart disease. The Complaint alleges that this disclosure revealed significant obstacles to the timely approval of MVAD.
On September 9, 2015, HeartWare International Inc disclosed that it had paused its MVAD clinical trial to address an MVAD controller manufacturing process issue.
On October 13, 2015, HeartWare International Inc announced that following the company's investigation of causes of reported adverse effects in certain clinical trial patients, HeartWare International Inc might not re-initiate enrollment in the MVAD clinical trial in November as it had previously planned.
On January 11, 2016, HeartWare International Inc provided corporate updates and announced preliminary revenue expectations for the fourth quarter of 2015. The plaintiff says that the announcement revealed that problems with MVAD had resulted in serious adverse events in nearly half of the patients so far implanted with the device, and that the trial would be delayed indefinitely. Shares of HeartWare International Inc (NASDAQ: HTWR) declined from $90.71 per share in late July 2015 to as low as $25.02 per share on January 12, 2016.
On January 22, 2016, NASDAQ: HTWR shares closed at $34.50 per share.