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Ethicon 06/05
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Boston Scientific Didn't Test Pelvic Mesh, Jury Told
May 6, 2015 | Law360
By Kat Greene
Boston Scientific Corp. failed to properly test a pelvic mesh implant and ignored warnings about the plastic used in the device, the attorney for a woman purportedly injured by the device told a California federal jury Tuesday during opening arguments in her product liability suit. -
Parties Dispute Jury Instructions as to Apportionment of Fault in Calif. Transvaginal Mesh Action
May 5, 2015 | Harris Martin Publishing
Parties in a California transvaginal mesh action are disputing jury instructions regarding the apportionment of fault to the plaintiff’s implanting surgeon.
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Boston Scientific Didn't Test Pelvic Mesh, Jury Told
May 6, 2015 | Law360
By Kat Greene
Boston Scientific Corp. failed to properly test a pelvic mesh implant and ignored warnings about the plastic used in the device, the attorney for a woman purportedly injured by the device told a California federal jury Tuesday during opening arguments in her product liability suit.
At the outset of the trial on Tuesday, Jim M. Purdue Jr. of Purdue & Kidd LLP told the jury that his client, Roseanne Sanchez, was never told by her doctor or Boston Scientific that the mesh that was being installed in her abdominal cavity hadn’t been tested before it was sent to market, even though it used a different form of plastic than earlier versions of the device.
The Pinnacle mesh that was implanted in Sanchez was a different shape than the mesh that had been used in previous models, and was made of a different formula of polypropylene, but the company hadn’t run human trials, Purdue said.
“She had no idea that no human testing had been done,” Purdue said. “The choices that Boston Scientific made are what brought us here today.”
And the plastic material Boston Scientific had used in the device came with a warning that it shouldn’t be permanently installed in human tissue, or in places where it would be exposed to bodily fluids, he said, warnings that Boston Scientific ignored.
“Here’s the reality: The design of this mesh is to go into the body permanently,” he said. “There was no exit strategy. It can’t be removed. It’s an irreversible device.”
Boston Scientific attorney Robert T. Adams of Shook Hardy & Bacon LLP told the jury that Sanchez was a nurse to chemotherapy patients who “knows how to have a conversation with a doctor about a serious medical condition,” and that she and her doctor were well aware of the risks of installing the mesh.
Sanchez’ symptoms, including pain and incontinence, are all listed side effects of the device that Sanchez and her doctor would have discussed, Adams said.
“She had made up her mind. She was willing to take whatever risks there was in order to get relief,” he said.
Adams also said that Boston Scientific admits that it didn’t conduct trials of the product before releasing it to the market, but that it hadn’t done so because the ingredients — the plastic mesh, the device used to install it, the circumstances in which it would be installed — all were the same. They were merely configured in a custom-cut shape, he said.
Sanchez filed suit in 2012, joining tens of thousands of plaintiffs suing pelvic mesh-makers over complications with the products, alleging the mesh, which is placed in women to manage stress urinary incontinence and pelvic organ prolapse, is responsible for a litany of injuries, including that the mesh breaks apart inside their bodies and causes complications.
Adams told the jury that before this lawsuit, no doctor had said that pelvic mesh was a problem. Sanchez’ problems with the mesh were severe, but her medical problems were severe before she installed the mesh, too, he said.
“Ms. Sanchez simply is unique,” he said. “We are not judging Ms. Sanchez. … We can all agree that Ms. Sanchez has been through a lot.”
Both attorneys worked to explain female anatomy to the jury in Tuesday’s trial, using slides and photographs to explain the mechanics of the pelvic floor and its role in holding up lower abdominal organs and controlling the flow of urine and bowel movements. Each showed the jury the mesh device, with Purdue using a water bottle to illustrate how the mesh would wrap around the organs to hold them up.
Listing the organs that could be impacted by prolapse, in which lower abdominal organs begin to fall through the pelvic floor and sometimes outside the body, Purdue described the uterus as “obviously used by the good Lord to help us conceive.”
Adams, meanwhile, described how Sanchez might have felt sitting on the “crisp, white paper” of her doctor’s table in December 2009 when her condition “had become embarrassing,” noting that she was leaking urine, had trouble with bowel movements and no sex life.
“We’re dealing with very sensitive, private information about the female body,” he said.
Representatives for the parties didn’t immediately respond to requests for comment on Tuesday.
Sanchez is represented by Jim A. Purdue Jr. of Purdue & Kidd LLP.
Boston Scientific is represented by Robert T. Adams, Eva M. Weiler, Lael A. Awong and William F. Northrip of Shook Hardy & Bacon LLP.
The case is Roseanne Sanchez et al. v. Boston Scientific Corp., case number 2:15-cv-01245, in the U.S. District Court for the Central District of California.
— Additional reporting by Emily Field. Editing by Ben Guilfoy. -
Parties Dispute Jury Instructions as to Apportionment of Fault in Calif. Transvaginal Mesh Action
May 5, 2015 | Harris Martin Publishing
Parties in a California transvaginal mesh action are disputing jury instructions regarding the apportionment of fault to the plaintiff’s implanting surgeon.
In an April 22 filing, the parties disputed two jury instructions regarding the apportionment of fault to Sanchez’s implanting surgeon, Dr. Kerri Wiltchik. BSC asserts the instructions are proper because it may present evidence at trial that the surgeon was negligent. The plaintiff, however, argues that BSC has presented no evidence that Dr. Wiltchik was negligent and therefore the instruction should not be given.
Trial began on May 5 in the U.S. District Court for the ...
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