The makers of a pelvic floor repair system are being sued for fraudulent misrepresentation by a Texas woman who claims the manufacturers knew their products were not safe.
Nancy Feidler and Kenneth Feidler filed suit against Johnson & Johnson Inc. and Ethicon Inc. on Dec. 8 in the Eastern District of Texas, Beaumont Division.
The lawsuit argues that the defendants' negligently designed and marketed the defective products Gynecare Proflit and TVT, which are used to treat pelvic organ prolapse.
In order to treat her pelvic organ prolapse, Nancy Feidler was implanted with one of the defendants' products on Dec. 12, 2006. Feidler states that she has since undergone corrective surgeries.
According to the lawsuit, the FDA issued a warning in 2008 that the transvaginal placement of mesh device systems, including the defendants' products, could lead to complications such as erosion of the material, infection, pain, urinary complications and recurrence of prolapse or incontinence.
Causes of action filed against the defendants include negligence, strict products liability, breach of express and implied warranties, fraudulent misrepresentation and loss of consortium.
The plaintiff is asking for an award of damages for mental and physical pain and suffering, medical expenses, lost wages, punitive and treble damages, attorney's fees, court costs and interest.
Feidler is represented by William M. Moreland and Scott A. Love of Clark, Burnett, Love & Lee GP in Houston.
U.S. District Judge Ron Clark is assigned to the case.
Case No. 1:11-cv-00702