Class action suit filed against Framingham company
Troubles with HeartWare's MVAD pump are cited in a new class action lawsuit.
A class action lawsuit has been filed against HeartWare International, alleging that company officials misled shareholders as to the viability of a new technology by saying that the company had adequately addressed concerns by U.S. Food and Drug Administration revolving around their technology.
The lawsuit, filed by Robbins Arroyo LLP of San Diego, alleges that HeartWare shareholders were misled about the commercial viability of the company’s new ventricular assist device (VAD). According to the complaint, HeartWare officials said that the new device would revolutionize the VAD market and be the key driver for HeartWare's future growth.
However, the suit alleges that the company failed to adequately address concerns raised by the U.S. Food and Drug Administration surrounding HeartWare’s products even though company officials told shareholders that they were being addressed. These concerns included issues at the company’s Florida manufacturing facility as well as the company's alleged failure to take proper corrective action regarding 27 complaints that included reports of “2 deaths and 4 serious injuries” related to HVAD, according to a letter from the FDA sent on June 2, 2014. On June 10, 2014, according to the suit, HeartWare publicly assured investors that it was addressing its regulatory failures and that those failures posed no risk to timely MVAD approval.
The suit alleges that the company never adequately addressed FDA concerns and on Sept. 9, 2015 announced it was halting the enrollment of the HVAD in a trial because of the same issues raised by the FDA in 2014. Since that announcement, shares have dropped from a Sept. 10, 2015 high of $65.24 to a low on Jan. 13 of $24.46.
In response to a request for comment, a Heartware spokesperson said that it is company policy to not comment on legal matters.
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