By Susan Lasser, J.D.
A Philadelphia jury has awarded $13.5 million to a patient who was injured by a transvaginal tape product, Gynecare TVT, manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson. The jury found that the product was defectively designed and that the manufacturers failed to adequately warn of its medical risks. The verdict included $250,000 for the patient’s husband on his claim for loss of consortium. (Carlino v. Ethicon, Inc., February 10, 2016). The verdict is the second verdict against Ethicon by a Philadelphia jury in recent months. In December, a pelvic mesh patient was awarded $12.5 million in damages (seeProducts Liability Law Daily, December 23, 2015, analysis).
Complaint. In her complaint filed in 2013, the patient maintained that in 2005 she was implanted with one or more of the Johnson & Johnson pelvic mesh products to treat her pelvic floor prolapse and/or stress urinary incontinence. The product implanted was Gynecare TVT. Two years later, the patient underwent corrective surgery to revise and/or remove one or more of the pelvic mesh products/components. Three years after that, the patient underwent a third surgery for another revision/removal of the manufacturers’ implanted products. The patient alleged that as a result of having the pelvic mesh products and components implanted in her, she sustained permanent injury, underwent corrective surgery, and experienced, and will continue to experience, significant mental and physical pain and suffering, and financial or economic loss. The injuries she alleged to have sustained due to the pelvic mesh products/components included mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain, and recurrent urinary incontinence.
She further alleged that knowing the significant risk that the products and components would fail and/or imperil the health and welfare of the women in which they were implanted, the defendants failed to design the products/components for (and to establish) a safe, effective procedure for the removal of the products/components, rendering safe and easy removal impossible. The patient asserted a number of claims against the products/components manufacturers, including claims for strict liability defective manufacturer and design, negligence, strict liability failure to warn, common law fraud, negligent misrepresentation, gross negligence, and loss of consortium.
Jury findings. The jury first decided that the patient’s case was not barred by the applicable statute of limitations. It found that the patient did not know (nor should have known through the exercise of reasonable diligence) before June 26, 2011, that she was injured and that it was caused by the conduct of another person.
The jurors then determined that the TVT was defective in design and that the design defect was a cause of the patient’s injuries. Further, the jury said that Ethicon failed to adequately warn of the TVT’s medical risks and that the manufacturer’s failure to warn also was a cause of the patient’s injuries.
Thus, the jury stated that compensatory damages that fairly and reasonably compensated the patient for her injuries amounted to $3.25 million. In addition, the patient’s husband was awarded $250,000 on his loss of consortium claim. Finally, the jury found punitive damages were warranted and rendered a $10 million award in punitive damages for the patient.
The case is No. 03470.
Attorneys: Shanin Specter and Kila Baldwin (Kline & Specter PC) and Richard Freese (Freese & Goss) for Sharon Carolino. William Gage (Butler Snow Law Firm) and Laura H. Smith (Friday, Eldredge & Clark) for Ethicon Inc.
Companies: Ethicon, Inc.; Johnson & Johnson
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