After designation of a Class I recall over the HeartMate II left ventricular assist device, a Thoratec shareholder just brought a lawsuit and is seeking class action status. The HeartMate II is a heart device in the medical device category of products known as left ventricular assist devices, or LVADs. The HeartMate II is constructed […]
After designation of a Class I recall over the HeartMate II left ventricular assist device, a Thoratec shareholder just brought a lawsuit and is seeking class action status.
The HeartMate II is a heart device in the medical device category of products known as left ventricular assist devices, or LVADs. The HeartMate II is constructed with a pump that continuously pushes blood through the heart, The New York Times previously wrote. The device is used to treat patients who have been diagnosed with advanced heart failure.
In 2012, a Field Correction issued by Thoratec was classified as a Class I recall by the U.S. Food and Drug Administration (FDA). The recall was implemented over an improperly connected component that might have led to deformation or tearing of the device’s outflow conduit. According to MassDevice.com, this defect might create a risk of serious injury or death. In 2012, a study published in the New England Journal of Medicine (NEJM) indicated that a significant increase in blood clots associated with the HeartMate II LVAD was seen.
Following publication of the NEJM study, shares of Thoratec Corp. dropped.
Now, a Thoratec stockowner is suing the device maker on behalf of himself and other shareholders. The lawsuit accuses Thoratec of not warning investors about a blood clot problem with the HeartMate II that was implicated in the Class I recall, MassDevice.com wrote. The stockholder purchased 460 Thoratec shares from July 2010 and July 2013, according to court documents.
Brought on behalf of anyone who bought Thoratec stock between April 29, 2010 and November 27, 2013, lawsuit allegations include that Thoratec misled investors about thrombosis or blood clots risks associated with the HeartMate II device. “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the company’s securities, plaintiff and other class members have suffered significant damages,” according to the lawsuit, MassDevice.com reported.
In February 2012, Thoratec issued a correction notice warning physicians that a small portion of the sealed outflow graft bend reliefs, created to prevent a connector between the pump and the aorta from kinking, were improperly connected in the HeartMate II, according to MassDevice.com.
Last November, the NEJM article reported that a sharp increase in blood clots was seen in those patients who were implanted with the HeartMate II, according to data from three centers that implanted more than 830 devices from January 2004 through May 2013, wrote MassDevice.com. Data from three centers that implanted 895 HeartMate II LVADs in 837 patients from January 2004 through May 2013 revealed 72 confirmed cases of pump thrombosis in 66 patients and another 36 cases of suspected pump thrombosis. According to the study, a significant decrease was seen from implantation with the HeartMate II device until a blood clot developed. The three centers were the Cleveland Clinic, the Washington University Barnes-Jewish Hospital, and Duke University Medical Center.
In 2012, Cleveland Clinic physicians began noticing issues with the HeartMate II, according to a prior The New York Times report. The number of patients diagnosed with thrombosis after being implanted with the HeartMate II was increasing. Researchers sought to understand why and the results were alarming, The New York Times reported.
The incidence of blood clots seen in HeartMate II patients implanted after March 2011 was nearly four-fold greater than in those who were implanted with the device prior to March 2011, according to The New York Times. For those patients who did not die, pump-related clots dictated the need for emergency measures and, typically, heart transplants or device replacements. “When we got the data, we said, ‘Wow,’” Dr. Randall C. Starling, a cardiologist at Cleveland Clinic, told The New York Times.