A New Jersey appeals court affirmed an $11 million damages award to a woman who claimed a defective vaginal mesh product produced by Johnson & Johnson caused unbearable nerve pain.
Defendant Johnson & Johnson was aware that the Prolift vaginal mesh could disintegrate in the vaginal wall and cause pain from the mesh arms. The court cited the company’s series of ill-considered choices for failure to include adequate safety warnings in affirming the award.J&J ignored warning
A French physician notified the company of the defect before marketing materials were sent to doctors across the country. However, Johnson & Johnson decided not to add the warnings to the label because the printing job was already at the printer.
The plaintiff, Linda Gross, had the Prolift product inserted in 2006. Her doctor described her reaction to the mesh as catastrophic.
Within two months of the surgery Gross complained of pelvic pain. After six months with the mesh, the doctor performed a second surgery to remove the mesh and found a “wrinkled bulge” and discovered that the mesh had shrunk overtime.
Physician Kevin Benson testified he trusted Johnson & Johnson to provide fair, balanced, and truthful information about Prolift. He further testified that he would not have recommended the procedure had the additional warnings been present.
Gross continued to suffer complications even after multiple surgeries for the mesh. She was unable to have an intimate relationship with her husband, lost her job as a nurse, and suffers from severe depression and anxiety.
On appeal, the defendant argued that under the intermediary doctrine the lower court erred by:
1. Failing to bar Gross’ claim for deceit as a matter of law; and
2. Misapplying the learned intermediary doctrine to the failure to warn claim.
Learned Intermediary Doctrine & Deceit
The learned intermediary doctrine imposes a duty on a manufacturer to warn physicians of any risks involved with its products. The physician becomes the intermediary between the manufacturer and communicates warnings to patients.
The purpose of the doctrine is to allow patients to make well-informed decisions and balance the benefits against the risk of procedures. Johnson & Johnson failed to notify the physicians of the issues until years after Gross sustained complications from the mesh.
Regarding J&J’s claim of deceit, the court stated the plaintiff is required to prove the manufacturer intentionally concealed or misrepresented of a fact which the plaintiff would rely and caused the injury.
Johnson & Johnson staff testified they were aware of the risk and issues with the Prolift before it went onto the market. But, the risk were ignored because they believed surgeons were responsible for fixing the issues.
Further, the impetus to have the product on the market and reluctance to reprint marketing materials was more important. The court held there was sufficient evidence to show Johnson & Johnson failed to inform physicians and the intermediary doctrine does not bar the deceit claim.
Failure to Warn Claim
The defendant argued the lower court erred in its jury instruction for the failure to warn claim. Johnson & Johnson stated the instructions allowed the jury to find causation based on reading the patient brochure.
There were multiple opportunities for the jury to make inferences that course of treatment for Gross would have been altered had appropriate warnings were provided.
The opinion states that Benson relied on the pamphlets and instructions for use provided with the mesh kits. Gross herself testified if all the risks, including information about multiple surgeries, chronic pain, and difficulty of removal was present, she would have declined the surgery.
The three-judge panel disagreed with the defense argument and ruled the plaintiff presented enough evidence for the jury to determine an inadequate warning was provided.
This case is Linda Gross and Jeffrey Gross v. Gynecare, Ethicon Inc, and Johnson & Johnson, Case No. A-0011-14T2, Superior Court of New Jersey
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Amid tens of thousands of vaginal mesh lawsuits filed by women throughout the U.S. who have experienced problems following surgical repair of pelvic organ prolapse or female stress urinary incontinence, a new study indicates that women who experienced problems with pelvic mesh were more likely to have inflammation around the implant.
In a study published this week in the American Journal of Obstetrics & Gynecology, researchers with the Magee-Womens Research Institute in Pittsburgh set out to evaluate reactions among patients undergoing vaginal mesh excision surgery after experiencing complications.
Researchers found that inflammation and concentrations of white blood cells designed to attack foreign material were more commonly found among in women who suffered vaginal mesh complications like extrusion of the mesh through the vagina and other problems than those who simply reported pelvic pain.
In July 2011, the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010. This led to an influx of product liability lawsuits against manufacturers of the devices, with about 100,000 women nationwide presenting claims for injuries and complications allegedly caused by the defective design of the mesh.
Following a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse, and manufacturers of the devices have been ordered to conduct studies to evaluate the safety.
Although the risk of complications from vaginal mesh have been a hot topic within the medical community for several years, researchers in this latest study note that few studies have been performed that focus on how women’s bodies respond to synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence.
Researchers looked at 27 mesh-vaginal tissue samples from women who suffered complications and found that macrophages surrounded the implants. They found women who required mesh removal due to exposure, such as when the mesh penetrates the wall of the vagina, had 88.4% higher concentrations of macrophages than those explanted for pain.
“In women with complications, mesh induces a pro-inflammatory response that persists years after implantation, the researchers found. They also determined that the types of white blood cells found in mesh explanted for exposure were associated with degradation, while the types around those removed for pain were more indicative of fibrosis.
Several manufacturers of transvaginal mesh and bladder sling products have agreed to pay several billion in vaginal mesh settlements for women who have experienced problems, and thousands of cases are continuing to move forward through the court system. The transvaginal mesh litigation has been the largest mass tort in the United States over the past decade.