According to the law firm press release, Thoratec researches, develops, manufactures, and markets medical devices for circulatory support and vascular graft applications. The Company's products include a ventricular assist device, an implantable left ventricular heart assist device, a vascular access graft, and a coronary artery bypass graft. Thoratec also supplies whole-blood coagulation testing equipment.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose that the Company's HeartMate II Left Ventricular Assist Device had significant risk of pump thrombosis, causing numerous fatalities. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On April 4, 2012, U.S. regulators ordered a recall for the company's HeartMate II heart pumps for a potentially deadly defect. In a regulatory posting by the Food and Drug Administration, the agency stated that the recall "was initiated after Thoratec found that a component of the implanted device, which pumps blood for heart failure patients, may sometimes be improperly attached to the HeartMate II." On the news, Thoratec shares tumbled $1.52 or almost 4.5% to close at $32.83 on April 4, 2012.
On November 27, 2013, after the market closed, The New England Journal of Medicine released a study entitled, "Unexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis" concluding that the "rate of pump thrombosis related to the use of the HeartMate II has been increasing at our centers and is associated with substantial morbidity and mortality." On this news, Thoratec shares declined $2.75 per share or 6.5%, to close at $39.37 per share on November 29, 2013.
On April 21, 2014, the Court appointed Lead Plaintiff and approved their selection of Lead Counsel. Lead Plaintiff filed an amended complaint on June 20.
On November 10, 2015, the Court issued an Order granting the motion to dismiss without leave to amend.
On October 4, 2017, the Court of Appeals reversed the decision of the District Court and remanded.