Thoratec shareholder seeks class action over recall, blood clot study

January 28, 2014 By Brad Perriello Leave a Comment

Thoratec shareholder seeks class action over blood clot recall

An owner of Thoratec (NSDQ:THOR) stock is suing the heart pump maker on behalf of himself and other shareholders, accusing the medical device company of failing to warn investors about a blood clot problem with its HeartMate II implant implicated in a Class I recall.

The FDA in 2012 classed a Thoratec field correction as a Class I recall, saying an improperly connected component may result in deformation or tearing of the device’s outflow conduit, creating the risk of serious injury or death. Last year a study, published in the New England Journal of Medicine, documented a sharp increase in the rate of blood clots with the HeartMate II left ventricular assist device. Each episode pushed THOR share prices down.

That’s prompted Bradley Cooper to sue on behalf of anyone who bought the stock between April 29, 2010, and Nov. 27, 2013. Cooper alleges that Thoratec misled investors about the risk of thrombosis, or blood clots, in the HeartMate II device. He bought a total of 460 Thoratec shares between July 2010 and July 2013, according to court documents; a block of 200 shares July 27, 2010 for $44.29 apiece; another 30 shares at $42.80 the next day; and a final 230-share block for $31.21 apiece on July 15, 2013.

The stock was trading at $34.34 per share as of about 11:35 a.m. today, down 0.1%.

"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.

The Pleasanton, Calif.-based device maker issued a correction notice in February 2012, warning physicians that a small portion of the HeartMate II devices’ sealed outflow graft bend reliefs, designed to prevent a connector between the pump and the aorta from kinking, were not properly connected.

The issue was reported in less than 1% of 3,200 devices and most cases were discovered in X-ray images or during surgical procedures. It may have been a contributor to at least 1 patient’s need for replacement surgery. Detached bend reliefs can cause low or fluctuating pump flow, hemolysis, varying speed and/or power or worsening symptoms of heart failure, and "may cause serious adverse health consequences, including death," according to the FDA.

"The firm states that the device labeling has been revised to provide instructions on how to verify the bend relief is fully engaged with the sealed outflow graft at the time of implant and new caution statement regarding the bend relief connection are included," according to the FDA warning. "Clinicians have been instructed to follow the revised instructions for use that clarify the recommended procedure for securing the bend relief to the outflow graft."

Then, last November, the NEJM article reported a sharp increase in rates of blood clots in patients implanted with the HeartMate II, using data from 3 centers that implanted more than 830 of the devices from January 2004 through May 2013. Data from 3 centers that implanted 895 HeartMate II LVADs in 837 patients from January 2004 through May 2013 showed a total of 72 confirmed cases of pump thrombosis in 66 patients and another 36 cases of suspected pump thrombosis. Of note were a drastic increase after March 2011, according to the study, when rates jumped from 2.2% at 3 months to 8.4% by January 2013. The study also revealed a sharp decrease in the amount of time from implantation with the HeartMate II device until blood clots developed.

Earlier this month Thoratec CEO Gary Burbach said the NEJM study, involving by then year-old data from only 3 centers, obscured the fact that adverse events associated with the HeartMate II are down.

"The broader context is that survival has actually improved since the clinical trial, quite significantly here in the commercial experience," Burbach said at the J.P. Morgan healthcare conference in San Francisco. "We’ve also seen significant improvements in other areas – adverse events, stroke, bleeding and infection, in particular."

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston

At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.

Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.

REGISTER NOW

FDA panel: Neuronix Alzheimer’s therapy fails to prove efficacy
An FDA advisory panel has recommended against granting de novo clearance to Neuronix’s NeuroAD system intended to slow the progress of mild to moderate Alzheimer’s disease. NeuroAD is approved for use in Europe, Australia and Israel, but the panel found that while it met FDA safety standards, clinical studies did not prove that it is… […]
Instron launches biomedical testing online training course
Instron (Norwood, Mass.) recently announced that it is foddering an online training program, “The Essentials of Biomedical Testing.” The course is designed to give an introduction and foundation to biomedical testing. It is an hour long course geared toward lab managers and test machine operators who work in the biomedical industry as well as test… […]
Linak touts new touch screen control for hospital beds
Linak has launched a new touch screen control for advanced hospital bets. The new touch screen is a large screen for the ACT controller to give users a view of all functions through an easy-to-use format. The controller also offers three levels of operation, which includes care mode for patients and relatives, extended care… […]
Myomo inks Italian sales deal
Myomo recently announced that it has signed a sales and service agreement with Progettiamo Autonomia Robotics (PAR) to market the MyoPro in Italy. Myomo is a wearable medical robotics company that gives functionality to people who have neurological disorders and upper limb paralysis. PAR is also focused on neurological pathologies and delivering devices for orthopedic… […]
Artificial intelligence and medicine: Is it overhyped?
Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver? AI could possibly fuel the future of medtech, enabling such thrilling innovations as implanted devices that instantly react to minute changes, software that can identify the best treatment options for individuals facing life-threatening conditions and fully-functioning autonomous surgical systems.… […]
ACell signs South Korean distribution agreement
ACell (Columbia, Md.) announced that it has signed an exclusive distribution agreement with MyungMoon Bio to market ACell’s wound matrix devices in South Korea. “South Korea is one of the largest healthcare markets in the Asia Pacific, and this agreement will meet a growing unmet need for innovative wound management solutions in the country,” Nino… […]
VisionCare wins approval for CentraSight implant in Australia
VisionCare (Saratoga, Calif.) recently announced that it has received regulatory approval from the Australian Department of Health Therapeutic Goods Administration for its Implantable Miniature Telescope. The miniature telescope is designed to improve the visual acuity in patients who are 55 years or older and have bilateral moderate to profound central vision impairment because of age-related… […]
Millstone Medical appoints new EVP of sales and business development
Millstone Medical announced that it has appointed Richard Worthen as its executive VP of sales and business development at its Massachusetts headquarters. Prior to joining Millstone Medical, Worthen served as VP of North American sales at Clozex Medical where he helped launch the company’s Class I skin closure device. He has also held a number… […]
SMC expands Wisconsin facility capabilities
SMC recently announced that it is expanding is drug delivery device capabilities by adding a pharmaceutical class 7 cleanroom at its Somerset, Wisc. facility. “As we continue to experience growth in the pharmaceutical market, we realized the need for additional clean room capabilities in our Somerset, Wisc. location,” Chetan Patel, CEO of SMC, said. “The… […]
March 2019 Issue: Can AI truly transform medicine?
Medtech is going digital: So how do we keep it real? One of medtech veteran Mir Imran’s biggest claims to fame is that, as a young engineer in the early 1980s, he played a pivotal role in the development of the first implantable ICD. Imran told me a startling fact a few years ago: FDA… […]
NE Ohio biomedical industry investments on the rise
Investment in the northeast Ohio biomedical sector totaled nearly $294 million in 2018 with 71 regional companies receiving funding, according to regional healthcare trade group BioEnterprise. Those figures make this region the third largest for total healthcare investment in the Midwest, following Minneapolis ($664 million) and Chicago ($551 million). These were among the findings of… […]