FOR IMMEDIATE RELEASE – June 8, 2021
BALTIMORE, MD and COLUMBIA, SC—Janet, Janet & Suggs, LLC, a national plaintiffs’ law firm, is investigating patient injuries and deaths that may be due to a defective, and now, recalled heart pump system.
On June 3, 2021, Medtronic announced that it was stopping the sale of its HeartWare Ventricular Assist Device (HVAD)™ System due to safety concerns. According to a letter Medtronic sent to physicians, “[a] growing body of observational clinical comparisons demonstrate a higher frequency of adverse events and mortality with the HVAD™ system as compared to other commercially available durable left ventricular assist devices (LVAD).” Concurrently, the U.S. Food and Drug Administration (FDA) sent its own letter to physicians to advise them that the Medtronic HVAD™ System was being pulled from the market because:
- There is an increased risk of neurological adverse events and mortality associated with the internal pump, and
- There is a potential for the internal pump to stop.
Janet, Janet & Suggs, LLC is currently investigating legal action on behalf of clients with damages arising from pump failures and neurologic injuries associated with the Medtronic HVAD™ system.
“This is a medical device that was supposed to preserve health and prolong life, instead we are finding that it caused patient injuries and, according to the reports, patient deaths” said Gerald Jowers, an attorney with the firm. “We expect that there are other patients and families who have been affected by this product and are looking for answers, and so we are announcing our intention to investigate these claims and pursue legal action where appropriate.”
To assist patients and families looking for additional information, Janet, Janet and Suggs, LLC (JJS) has created a webpage that contains further information about the Medtronic HVAD™ system and its history of safety concerns. The webpage contains links to current and prior safety related product announcements from the company and the FDA.
About the HVAD™ System
The Medtronic HVAD™ System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
About Janet, Janet and Suggs, LLC
Janet, Janet and Suggs, LLC (JJS) is a national firm with offices in ten states and Washington D.C. The firm has decades of experience handling medical device cases and has won over three billion dollars in verdicts and settlements for clients across a wide range of serious and complex cases.
FOR MORE INFORMATION CONTACT:
Nicole Marion–Janet, Janet & Suggs