Boston Scientific prevailed on a jury verdict today in a key Massaschusetts pelvic mesh suit against the company. Maria Cardenas v. Boston Scientific.

After two-and-a-half days of deliberations, jurors found Boston Scientific's Obtryx pelvic mesh device was not defectively designed and that the company adequately warned Maria Cardenas's treating physician of the possibility of erosion inside the body. Cardenas, who had the Obtryx pelvic mesh device implanted in 2008, sued Boston Scientific company after the device eroded inside her and had to be removed.

The verdict may signal a trend in Massachusetts suits against Boston Scientific and its pelvic mesh products. In July, the company prevailed in the the state's first suit against it and its Pinnacle pelvic mesh device. The company faces hundreds of potential lawsuits in Massachusetts alone over its pelvic mesh devices. Nationwide, there are more than 100,000 claims against Boston Scientific and other pelvic mesh manufacturers.

The week-long Cardenas trial turned on testimony surrounding the product’s design and conflicting opinions on its safety and risks. Cardenas's attorneys argued that Boston Scientific’s own internal documents pushed sales of the pelvic mesh device despite questions concerning its safety, and that the company failed to warn of device shrinkage of 20% or more inside the body. Her counsel also claimed that Boston Scientific's expert witness testimony conflicted with their own previously published articles questioning the mesh. "Maybe their experts are not shooting straight with you guys," Cardenas's attorney Doug Monsour told jurors in closing statements. "They're telling you Boston Scientific's story."

By contrast, Boston Scientific’s counsel offered testimony from experts that its mesh had a strong history of safe use, and that its directions for use clearly warned of the possibility of erosion. In closing arguments, Boston Scientific's attorney Susan Murphy reminded jurors of of more than 20 clinical studies on the pelvic mesh's safe design and expert testimony endorsing its use. "The community (of urologists) does not believe this product to be unreasonably dangerous. To the contrary, they believe it to be safe and effective," she said.

Outside Massachusetts, other manufacturers have fared worse in pelvic mesh litigation. In July, a New Jersey Superior Court upheld an $11.1 million verdict in Linda Gross v. Ethicon, one of the state’s bellwether pelvic mesh cases. That trial, recorded by CVN, led to a jury finding that Ethicon, a subsidiary of Johnson & Johnson, misrepresented its product and failed to warn Gross’s physician of its risks. Earlier this year, a Texas jury awarded Linda Batiste $1.2 million in her pelvic mesh suit against Ethicon. In August, manufacturer C.R. Bard agreed to settle more than 500 pelvic mesh suits pending in Texas.

Related Information

View the verdict.

View on-demand video of the case.

Read Plaintiff Testifies in Massachusetts's Second Pelvic Mesh Trial Against Boston Scientific.

Read Boston Scientific Wins First Jury Decision in Massachusetts Pelvic Mesh Suit.

On Wednesday, Maria Cardenas detailed the pain and medical complications she claims stemmed from the erosion of a pelvic mesh sling inside her body, concluding plaintiff’s case-in-chief in Massachusetts’s second trial against Boston Scientific and its pelvic mesh devices. Maria Cardenas v. Boston Scientific Corp.

Cardenas, who underwent pelvic mesh surgery in 2008, described pain and other health issues she said began more than a year-and-a-half after the mesh sling was implanted, and told jurors she wasn’t aware of the risks the procedure entailed.

“I did not appreciate how bad the mesh could harm me and cause permanent damage to my urethra,” she said.

Cardenas’s suit claims Boston Scientific’s Obtryx pelvic mesh device was defectively designed and that the company failed to adequately warn of its risks. The suit is one of more than 50,000 pelvic mesh actions against manufacturers nationwide. The suits typically allege that the mesh erodes into tissue, causing pain, infection, and other medical complications. In July, Boston Scientific prevailed in Massachusetts’s first trial involving the company's pelvic mesh devices. However, that suit involved a different product than the one at issue in Cardenas.

Cardenas testified on Wednesday that her surgeon implanted Boston Scientific’s device to treat her stress urinary incontinence. She said she began suffering from pain more than a year later and underwent a hysterectomy before doctors discovered the mesh’s erosion. Her physician, Dr. Lane Childs, ultimately removed most of the sling, though she said he told her that portions of the mesh could not be removed.

“I’m scared,” she said. “I don’t know if that could have any more complications, what kind of complications…. I just don’t want to go through any more surgeries.”

However, on cross examination, defense counsel sought to establish Cardenas's informed consent to the pelvic sling surgery and its risks. Cardenas acknowledged that, prior to surgery, she had signed a consent form that warned of a variety of complications, including reactions requiring the removal of the device. However, Cardenas testified that she could not recall actually discussing or reading specific warnings about the procedure.

Cardenas also told jurors that Childs, was “very surprised” that the pelvic mesh eroded. Cardenas acknowledged earlier deposition testimony where she said Childs “mentioned he’d had 100% success with his surgeries, and I was just that 1%.”

Related Information

View live and on-demand video of Maria Cardenas v. Boston Scientific Corp.

On Tuesday, CVN will begin live coverage of the second bellwether suit against Boston Scientific and its pelvic mesh products in Massachusetts. Maria Cardenas v. Boston Scientific Corp.