Pelvic mesh jury to decide if device is 'defective' and whether J&J should pay

HACKENSACK — A woman who is suing Johnson & Johnson over what she says was a faulty pelvic mesh implant finally got her day in court on Monday, more than nine years after the operation left her in chronic pain. 

Elizabeth Hrymoc came to Superior Court in Bergen County with her husband, Tad, and sat stoically during opening arguments of the civil trial before Judge Rachelle L. Harz.

Hrymoc, a 71-year-old research technician from South River in Middlesex County, is one of tens of thousands of women nationwide who have sued Johnson & Johnson after receiving pelvic implants between 2005 and late 2012, and are seeking damages in what is the largest tort claims litigation in history. 

Her attorney, Adam Slater, told the jury that Johnson & Johnson knew that one of the two pelvic mesh devices implanted in Hrymoc in 2008 was faulty, and that the company did not adequately inform patients of the potential risks. 

Slater reminded the jury of six men and four women that Johnson & Johnson is a corporation with an estimated worth of $70 billion, and that it should pay for its mistakes. 

"We know that the only language they speak is money," Slater told the jury at the end of his opening statement. "And the only way to deter them and to punish them is to make them pay." 

Although thousands of cases have been filed in New Jersey alone, this is only the second case to come to trial in the state. In the first trial, a jury awarded the plaintiff, Linda Gross, $11.1 million in punitive and compensatory damages. 

Jury awards in neighboring Pennsylvania have been quite large as well, ranging from $10 million to $20 million. 

The trial is expected to last at least until Christmas. Hrymoc is seeking compensatory damages for pain and suffering as well as punitive damages. 

The standard of proof is different in a civil case as opposed to a criminal trial. In a criminal trial, the jury weighs the evidence and decides whether a prosecutor's case was proved "beyond a reasonable doubt." 

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In a civil case, the jury decides by a "preponderance of the evidence," which means a civil jury weighs whether the evidence supports the claims made by the plaintiff.

As it has done in other cases, Johnson & Johnson continued to maintain that its pelvic mesh products aren't necessarily defective, even though one of them, known by the brand name Prolift, was taken off the market in August 2012.

One of three attorneys for the defense, Judy Wahrenberger, told the jury that Hrymoc, who received the Prolift device, had a long history of pelvic problems and had suffered from complications that, while unfortunate, were the natural risks of surgery, and not the result of a product defect. 

"In the real world, complications occur," Wahrenberger said. "It's not necessarily that the product is defective."

She added that the evidence would show that Hrymoc suffered from "complications, combined with pre-existing conditions."

Hyrmoc was 62 years old and was suffering from pelvic pain and incontinence when she had two pelvic mesh devices implanted in her vagina in June 2008. Like many women, Hrymoc suffered from a gradual weakening of the vaginal walls, which caused her internal organs to sag and bulge, a condition known as organ prolapse. 

The mesh devices she received were a Prolift and trans-vaginal tape, known as TVT. Both were developed in the early 2000s by Johnson & Johnson and its medical research subsidiaries Gynecare and Ethicon. 

As its first witness, the plaintiff called Scott Ciarroca, the project leader for Ethicon in 2003 when it was developing pelvic mesh products. Slater showed the jury documents that suggested the company was concerned about the potential for pelvic mesh devices to erode the vaginal wall, but put the product on the market nonetheless.

Doctors had been using mesh inserts, which are made of polypropylene, since the 1970s to treat hernias. Working with a French company, Gynecare set about making a mesh that could act as a sling that could be inserted into the vagina to help support sagging organs, which frequently caused incontinence. 

But Slater told the court that that once inserted, the mesh is frequently hardened by scar tissue, and in extreme cases it can erode and poke through the vaginal walls. Three surgeries meant to correct the problem were unsuccessful, and Hrymoc was left with chronic pain, unable to engage in sexual relations without extreme pain, he said. 

Slater said he will present documents and email correspondence proving that Ethicon knew that mesh had potentially disastrous side effects, but that the information was kept from Hrymoc's doctor. Slater said the products, which Johnson & Johnson began selling in 2004 and 2005, should never have been put on the market. 

"The defective design is unreasonably dangerous," Slater said. "It is a stupid idea." 

Johnson & Johnson says the doctor who implanted the devices in Hrymoc knew the potential risks and discussed them with her. Wahrenberger told the jury that in the coming weeks, a parade of doctors will testify before them, and all will agree on one thing.

"You will hear from every doctor that every surgery has the potential for complications," she said.