Robbins Arroyo LLP: HeartWare International, Inc. (HTWR) Misled Shareholders According to a Recently Filed Class Action
January 29 2016 - 7:05PM
Business Wire
Shareholder rights law firm Robbins Arroyo LLP announces that a
class action complaint was filed in the U.S. District Court for the
Southern District of New York. The complaint alleges that officers
and directors of HeartWare International, Inc. (NASDAQGS: HTWR)
violated the Securities Exchange Act of 1934 between June 10, 2014
and January 11, 2016, by making materially false and misleading
statements about HeartWare's business prospects. HeartWare, a
medical device company, designs, develops, manufactures, and
markets miniaturized implantable heart pumps or ventricular assist
devices ("VADs") for the treatment of advanced heart failure. The
company currently has one commercial product —the HeartWare
Ventricular Assist System ("HVAD"), which provides patients with
additional blood flow in order to manage congestive heart failure.
The company was in the process of developing a new device- the
MVAD- based on HVAD technology but less than one-half HVAD's size.
According to the complaint, HeartWare officials represented that
MVAD would revolutionize the VAD market and be the key driver for
HeartWare's future growth.
View this information on the law firm's Shareholder Rights Blog:
www.robbinsarroyo.com/shareholders-rights-blog/heartware-international-inc
HeartWare International Accused of Lying About Its
Products
The complaint alleges that on June 2, 2014, the U.S. Food and
Drug Administration ("FDA") issued a Warning Letter to HeartWare,
identifying several manufacturing and regulatory failures at its
Miami Lakes facility in Florida that were connected to reports of
death and serious injuries. On June 10, 2014, HeartWare publicly
assured investors that the company was addressing its regulatory
failures and that those failures posed no risk to timely MVAD
approval.
Contrary to HeartWare officials' statements, HeartWare failed to
adequately address the issues the FDA identified, which caused an
indefinite delay in commencing clinical trials of MVAD. On
September 1, 2015, HeartWare announced a highly dilutive
acquisition of Valtech Cardio, Ltd., which, according to the
complaint, led investors to question HeartWare's confidence in its
regulatory compliance and MVAD's commercialization prospects. Then,
on September 9, 2015, HeartWare disclosed that it had identified
manufacturing problems with the device's controller—the same device
component that the FDA had tied to previous deaths and injuries in
HVAD users—and was halting enrollment in the MVAD trial. 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, and that the MVAD trial would be delayed
indefinitely. HeartWare stock declined 72% from its class
period high to close at $26.50 per share on January 12, 2016.
HeartWare International Shareholders Have Legal
Options
Concerned shareholders who would like more information about
their rights and potential remedies can contact attorney Darnell R.
Donahue at (800) 350-6003, DDonahue@robbinsarroyo.com, or via the
shareholder information form on the firm's website.
Robbins Arroyo LLP is a nationally recognized leader in
shareholder rights law. The firm represents individual and
institutional investors in shareholder derivative and securities
class action lawsuits, and has helped its clients realize more than
$1 billion of value for themselves and the companies in which they
have invested.
Attorney Advertising. Past results do not guarantee a similar
outcome.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160129006006/en/
Robbins Arroyo LLPDarnell R. Donahue619-525-3990 or Toll Free
800-350-6003DDonahue@robbinsarroyo.comwww.robbinsarroyo.com
Heartware International, Inc. (MM) (NASDAQ:HTWR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Heartware International, Inc. (MM) (NASDAQ:HTWR)
Historical Stock Chart
From Apr 2023 to Apr 2024