TRENTON, N.J — A federal judge in New Jersey reportedly allowed a plaintiff to amend their design defect claim against the device manufacturer of a power morecellator.
Judge Joseph Dickson ruled on Aug. 8 that “finding a question of fact exists as to whether a reasonable alternative design existed that would have prevented the plaintiff’s injuries.”
Harris Martin Publishing first reported the ruling in early September.
“(The) plaintiff only needs to provide enough factual content in the proposed Amended Complaint to allow this court to draw the reasonable inference that Defendants ‘knowingly withheld or misrepresented information required to be submitted under the agency’s regulations’ in order to rebut the presumption of adequacy,” Dickson explained, according to Harris Martin.
The plaintiff, Sumaira Khan, reportedly filed a lawsuit against Karl Storz Endoscopy-America Inc., Karl Storz Endovision Inc., Karl Storz GMBH & Co. KG, Dr/ Howard H. Jones, Dr. Noah A. Goldman, and the Valley Hospital Inc., on Oct. 30, 2015, claiming she developed Stage 4 cancer after her doctors used Karl Storz’s Rotocut Power Morcellator during a laparoscopic myomectomy procedure for the treatment of uterine fibroids, according to Harris Martin.
Khan’s legal team alleges another reasonable alternative may have existed that would have prevented the plaintiff’s injuries.
“Defendants knew that use of the tissue bag could prevent the spread of malignant cells to healthy tissue in the body cavity, yet failed to require concomitant use of the bag, or warn that failure to use the tissue bag may result in the dissemination of cancerous cells throughout the body,” Khan’s amended complaint reads, according to Harris Martin.
Karl Sortz argues New Jersey Products Liability Act prevents Kahn’s claims for failure to warn and punitive damages because they do not overcome the FDA’s presumption of adequacy.
The defendant also stated Kahn must allege specific facts that they deliberately concealed information from the FDA.