HeartWare investors may receive additional information about the case by clicking the link "Join this Class Action" above.
According to the complaint, HeartWare is a medical device company that develops and manufactures miniaturized implantable heart pumps to treat patients suffering from advanced heart failure. The company presently produces one commercialized product, the HeartWare Ventricular Assist System (“HVAD”), which provides patients with additional blood flow in order to manage congestive heart failure. HeartWare has developed a new device, named MVAD, which is based on the same technology as HVAD, but is less than one-half HVAD’s size. MVAD devices are manufactured in HeartWare’s Miami Lakes, Florida (the “Miami Lakes Facility”).
According to the complaint, on June 2, 2014, the FDA issued a Warning Letter (the “Warning Letter”) to HeartWare concerning the Miami Lakes Facility, which identified several manufacturing and regulatory failures that were connected to numerous reports of death, serious injuries, and other complaints.
The Class Period begins on June 10, 2014, when HeartWare spoke publicly to assure investors that remedying the problems that the FDA identified was the company’s “Number 1 priority,” and that the defendants would ensure that the company was “super-squeaky clean,” “pristine,” “perfect,” and “bulletproof.”
The complaint alleges that contrary to the defendants’ public statements, HeartWare failed to adequately address the serious manufacturing-related issues that the FDA identified. On September 9, 2015, HeartWare disclosed that it had identified manufacturing problems with the device’s controller and, as a result, was halting enrollment in the MVAD trial. Then, on October 12, 2015, HeartWare disclosed that patients in the MVAD trial had suffered adverse events, and the MVAD trial would be put on hold until 2016 at the earliest. Finally, on January 11, 2016, HeartWare confirmed that nearly half of all patients in the MVAD trial had suffered “serious adverse events” as a result of software issues with MVAD, including significant blood clotting problems. As a result, HeartWare admitted that there would be indefinite delays for the MVAD trial, and that a redesign of MVAD requiring an entirely new MVAD trial may be required.
Following the final disclosure, HeartWare shares fell over 35%, from $40.84 on January 11, 2016 to close at $26.50 per share on January 12, 2016, on extraordinarily high volume. In total, on January 12, 2016, HeartWare stock closed 72% below its Class Period high.
If you are a member of the class described above, you may no later than March 22, 2016, move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP.
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq.
Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
1-888-299-7706 (toll free) or 1-610-667-7706