J&J was found by the Court to have used systematic deceptive marketing and is liable under California’s Unfair Competition Law and False Advertising Law.
As a matter of law, Johnson & Johnson (J&J) lied to consumers regarding the safety and efficacy of their transvaginal mesh product as pronounced in a major ruling by the Honorable Eddie C. Sturgeon in the Superior Court of the State of California in San Diego County, Central Branch, ordering civil penalties in the amount of $343,993,750 to be paid by J&J. Though the company seeks to blame doctors for its misdeeds, it may be more difficult now for J&J to blame them for failing to warn patients of the risks associated with the implantation of their devices via the Learned Intermediary Doctrine. Simply stated, J&J was found by the Court to have used systematic deceptive marketing and is liable under California’s Unfair Competition Law and False Advertising Law.
The California Court found that all of J&J’s “sales training materials and outward-facing marketing materials about J&J’s mesh products-including doctor-directed sales aids, professional education training materials, and patient-directed marketing materials” were approved by the company’s medical, regulatory, and legal management. Unfortunately, for a generation of women, the California Court found that J&J marketing “concealed what they knew about the risks and downplayed FDA warnings.”
“The door is closing on the mesh manufacturers…as their devices are defectively designed and the risk of severe debilitating pain does not justify their use and the warning is still inadequate.” – Dr. Greg Vigna
The California court found that since 2000, a mere two years after the TVT launch, “J&J did not include the risk of or potential need for removal of pelvic mesh in its IFUs until 2015,” and in fact affirmatively acted multiple times to conceal known risks of their transvaginal mesh product lines. An example of this includes in 2005, “Ethicon instructed marketing employee, Kimberly Hunsicker, to remove dyspareunia data from the abstract of a presentation about Prolift because including that information “IS GOING TO KILL US.”
As a Matter of Law, the California Court found that J&J “knew about the risk and dangers of their pelvic mesh devices.” The Court was unconvinced by J&J expert testimony of Dr. Peter Rosenblatt, Dr. Charles Nager, and Dr. Karyn Eilber that “mesh does not cause or pose additional dangers aside from vaginal exposure and erosion.” In fact, the court found that the defense experts’ opinions contradicted the company’s own internal documents “that these mesh properties can lead to multiple serious and long-term complications.”
Not only did the California court find J&J experts’ testimony unconvincing, it found that their testimony was biased, noting that Dr. Rosenblatt has implanted “over 3,000 mesh devices over his career [and] he has also been a paid consultant for almost every U.S. mesh manufacturer for the past 18 years” with compensation “somewhere in the range of $2.2 million to $5.5 million from mesh manufacturers.”
Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner states, “The door is closing on the mesh manufacturers, even with the change in warning, as their devices are defectively designed and the magnitude of the risk of severe debilitating pain does not justify their use and the warning is still inadequate. We are investigating cases involving retropubic slings causing ilioinguinal neuralgia and transobturator slings causing obturator and pudendal neuralgia including those mesh implants inserted by J&J’s unconvincing and biased experts.”
For articles, video resources, and information, visit the Pudendal Neuralgia Educational Portal (https://tvm.lifecare123.com/pudendal-portal.html) or https://tvm.lifecare123.com/. Click here for information regarding sling related complications: https://tvm.lifecare123.com/slingebook.html