Despite the recent filing of multiple lawsuits involving a recalled Medtronic device, the company maintains it acted responsibly and is anticipating the launch of a new product.

Eleven new lawsuits were filed against Medtronic over deaths related to its recalled implantable cardioverter defibrillator (ICD) Sprint Fidelis leads.

Medtronic misrepresented the safety of the leads and distributed them as secure devices to be used with ICDs, according to four identical suits filed Sept. 9 by individuals represented by Texas firm Provost & Umphrey in the US District Court for the Eastern District of Texas. That same week, seven related suits were filed in the US District Court for the Eastern and Western Districts of Tennessee.

“Medtronic designed, manufactured, marketed, promoted, sold, and distributed four models of defective leads,” one suit says. “As a result of this defective design and manufacture, the Sprint Fidelis Leads can cause serious physical trauma and/or death. Medtronic knew and had reason to know of this tendency and the resulting risk of injuries and deaths, but concealed this information.”

This is not the first time users of Medtronic’s Fidelis leads have sued the company over injuries from the devices. Approximately 290 lawsuits regarding the Fidelis leads had been filed against the company as of Aug. 28, including 33 alleged class action suits reflecting 760 individual personal injury cases, according to Medtronic’s Sept. 3 quarterly earnings report.

SOURCE: FDANEWS

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