Drug & Device News

The litigation, In re Pelvic Mesh/Gynecare Litigation, No. 291, encompasses thousands of suits claiming injuries from the Gynecare Prolift pelvic mesh product, created by Somerville, NJ-based Ethicon to treat organ prolapse and urinary incontinence, and marketed beginning in 2002. It was designed for minimally invasive implantation through the vagina, and J&J has maintained that the products are safe. But the plaintiffs claim they have a high failure rate, cause serious complications and necessitate corrective surgeries, despite their billing as safer than other surgical methods. The products allegedly erode into organs and vaginal walls, causing chronic pain, pain during sexual intercourse, scar tissue and other injuries.

Suits were first filed in 2008, shortly before the federal Food and Drug Administration (FDA) first announced that complications were being reported.

Linda Gross of Watertown, SD, sued in November 2008, claiming she underwent 18 surgeries to correct injuries caused by a Gynecare Prolift mesh implant. After five days of deliberation, the jury found in a 7-2 vote that Ethicon failed to warn Gross' doctor about possible side effects, and made fraudulent misrepresentations to Gross. The jury unanimously found no cause of action on Gross' defective design claim and voted 7-2 that there was no cause of action on a fraudulent misrepresentation claim as to Gross' doctor. The jury's compensatory damages award was made up of $1.1 million for pain and suffering, $1 million for future medical expenses, $500,000 for future lost wages, $385,000 for past medical expenses, $180,000 for past lost wages, and $185,000 for a per quod claim. Days later, in the ensuing punitive damages trial, the panel delivered a 7-2 verdict awarding an additional $7.76 million.

Judge Higbee denied Ethicon's motions for a new trial and judgment notwithstanding the verdict, dispensing with Ethicon's claims that there was insufficient evidence to support the verdict. The evidence “not only was sufficient, but it was extremely strong in support of the plaintiff's position,” Higbee said, according to the preliminary transcript. She cited evidence that Ethicon was aware of the medical complications associated with Prolift. That testimony “could have been believed, and apparently was believed by the jury … that the defendant knew about this problem, that [it was] told about this problem, that [its] own doctors were warning [it] about this problem, that [its] own studies were showing this problem … and therefore, that the defendant had a duty to warn about the problem,” Higbee was quoted as saying in the transcript.

Higbee also relied heavily on testimony of the physician who performed the implanting procedure for Gross. He testified that he was not fully aware of the risks and probably wouldn't have recommended the product to Gross, a young patient at age 41, had he been informed, according to Higbee. The doctor was not named in the transcript. Higbee noted that punitive damages claims are typically barred in pharmaceutical cases, but Gross' injuries occurred before any FDA approval was obtained. ' David Gialanella, New Jersey Law Journal

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NJ Judge OKs $11 Mil. Award in Pelvic Mesh Mass Tort

A Johnson & Johnson subsidiary has lost a bid to upend an $11.1 million verdict in the first bellwether trial over allegedly harmful pelvic mesh implants. Atlantic County, NJ, Superior Court Judge Carol Higbee recently denied motions by Ethicon for a new trial and judgment notwithstanding the verdict that would have struck a jury award of $3.35 million in compensatory damages and $7.76 million in punitive damages from early last year. At trial, “there was strong evidence presented and multiple sources of evidence that in fact there were many problems with this product,” Higbee said in court, according to a preliminary transcript.

The decision “only marks the start of the appeals process,” Ethicon spokesman Matthew Johnson said in a statement. “We will be filing an appeal in this case as we believe the jury's verdict and damage awards were not supported by the evidence presented at trial.”

The litigation, In re Pelvic Mesh/Gynecare Litigation, No. 291, encompasses thousands of suits claiming injuries from the Gynecare Prolift pelvic mesh product, created by Somerville, NJ-based Ethicon to treat organ prolapse and urinary incontinence, and marketed beginning in 2002. It was designed for minimally invasive implantation through the vagina, and J&J has maintained that the products are safe. But the plaintiffs claim they have a high failure rate, cause serious complications and necessitate corrective surgeries, despite their billing as safer than other surgical methods. The products allegedly erode into organs and vaginal walls, causing chronic pain, pain during sexual intercourse, scar tissue and other injuries.

Suits were first filed in 2008, shortly before the federal Food and Drug Administration (FDA) first announced that complications were being reported.

Linda Gross of Watertown, SD, sued in November 2008, claiming she underwent 18 surgeries to correct injuries caused by a Gynecare Prolift mesh implant. After five days of deliberation, the jury found in a 7-2 vote that Ethicon failed to warn Gross' doctor about possible side effects, and made fraudulent misrepresentations to Gross. The jury unanimously found no cause of action on Gross' defective design claim and voted 7-2 that there was no cause of action on a fraudulent misrepresentation claim as to Gross' doctor. The jury's compensatory damages award was made up of $1.1 million for pain and suffering, $1 million for future medical expenses, $500,000 for future lost wages, $385,000 for past medical expenses, $180,000 for past lost wages, and $185,000 for a per quod claim. Days later, in the ensuing punitive damages trial, the panel delivered a 7-2 verdict awarding an additional $7.76 million.

Judge Higbee denied Ethicon's motions for a new trial and judgment notwithstanding the verdict, dispensing with Ethicon's claims that there was insufficient evidence to support the verdict. The evidence “not only was sufficient, but it was extremely strong in support of the plaintiff's position,” Higbee said, according to the preliminary transcript. She cited evidence that Ethicon was aware of the medical complications associated with Prolift. That testimony “could have been believed, and apparently was believed by the jury … that the defendant knew about this problem, that [it was] told about this problem, that [its] own doctors were warning [it] about this problem, that [its] own studies were showing this problem … and therefore, that the defendant had a duty to warn about the problem,” Higbee was quoted as saying in the transcript.

Higbee also relied heavily on testimony of the physician who performed the implanting procedure for Gross. He testified that he was not fully aware of the risks and probably wouldn't have recommended the product to Gross, a young patient at age 41, had he been informed, according to Higbee. The doctor was not named in the transcript. Higbee noted that punitive damages claims are typically barred in pharmaceutical cases, but Gross' injuries occurred before any FDA approval was obtained. ' David Gialanella, New Jersey Law Journal

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