Johnson & Johnson (NYSE:JNJ) this week held on to its win in the1st pelvic mesh bellwether to go to trial, but lost a $5.7 million decision in a California state court in a personal injury lawsuit filed over its Abbrevo pelvic mesh product.
A California jury yesterday hit J&J’s Ethicon unit with the verdict, after 3 days of deliberation, finding it liable for design problems and failure to warn, according to a lawyer for plaintiff Coleen Perry.
The Kern County Superior Court jury awarded Perry $700,000 in compensatory damages and an additional $5 million in punitive damages after deciding that Ethicon’s conduct amounted to "malice," her lawyer said.
It’s the 4th win for plaintiffs suing Ethicon over transvaginal mesh; more than 36,000 lawsuits have been filed against the division in state and federal courts over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse.
The FDA in 2010 cleared Abbrevo, 1 of Ethicon’s newer models of mesh products, for treating stress urinary incontinence. Perry, who was implanted with it in 2011, said she began experiencing a "pulling-type" pain almost immediately after surgery.
Perry said the mesh began to erode in her body, causing pain that she said she expects to last the rest of her life, according to testimony Reuters saw on Courtroom View Network. Peter de la Cerda, a lawyer for Perry, said the verdict sent a "clear message to Ethicon" about its "improper conduct in designing and marketing the Abbrevo."
Ethicon’s lawyers said the product was thoroughly vetted before it hit the market and that doctors considered the mesh used in the Abbrevo to be the "gold standard" for incontinence treatment. Ethicon spokesman Matthew Johnson said the company believed it has strong grounds for appeal. Ethicon stands behind the safety and effectiveness of the Abbrevo, as well as its development and marketing, Johnson added.
Appeals court upholds 1st bellwether win
In the other case, the U.S. Court of Appeals for the 4th Circuit upheld Ethicon’s year-old win in the 1st pelvic mesh bellwether to go to trial. Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia had issued a directed verdict Feb. 18, 2014, ordering the case dismissed and stricken from the record.
Plaintiff Carolyn Lewis was 1 of thousands of patients who’ve sued pelvic mesh makers including Ethicon, C.R. Bard (NYSE:BCR), Boston Scientific (NYSE:BSX), Endo Health Solutions (NSDQ:ENDP), Cook Medical and Coloplast (CPH:COLO B). Some of the cases in various federal courts have been consolidated into multi-district litigation under Goodwin.
"Plaintiff has failed to show by expert testimony that a defect caused her injuries, which is fatal to her design-defect claim, regardless of whether her claim is styled as one sounding in strict liability or negligence," Ethicon argued last year.
The appeals court, in a March 2 decision, found that Lewis failed to prove her failure-to-warn claims in arguing that the implanting physician, Dr. Muriel Boreham, relied on Ethicon’s warning label.
"When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury," the court ruled. "Accordingly, we agree with the district court that Lewis did not offer sufficient evidence to create a dispute as to material fact regarding whether a different warning would have changed Dr. Boreham’s decision to prescribe the TVT."
Goodwin was also correct in excluding expert testimony from Dr. Uwe Klinge linking the TVT mesh to Lewis’s injuries.
"The district court did not abuse its discretion in making these rulings. Dr. Klinge was a specialist in hernia surgery, not pathology or stress urinary incontinence. He did not receive training or board-certification in pathology. Dr. Klinge had never treated Lewis, performed surgery to treat SUI, or collected and studied mesh explants from SUI patients. The district court was clearly within its discretion in concluding that Dr. Klinge’s opinions regarding Lewis’s pain and mesh explant were beyond his area of expertise, and so did not abuse its discretion in excluding those portions of Dr. Klinge’s testimony," according to court documents. "We therefore agree with the district court that Texas law required Lewis to present expert testimony establishing a causal link between these alleged defects in the TVT and her injuries. We also agree with the district court that Lewis’s failure to present such expert testimony doomed her design defect claim. Not one of Lewis’s expert witnesses opined, let alone opined to a reasonable degree of medical certainty, that a defect in the TVT caused Lewis’s injuries."
Material from Reuters was used in this report.