Ethicon Media Monitoring 4/5/2018

Online Sources

1. Bard Meshes Didn't Harm Woman, Harvard Doctor Tells Jury

   Apr 6, 2018 | Law 360

   By Daniel Siegal
   
   
   A Harvard assistant professor and gynecological surgeon told a New Jersey jury Thursday that a woman suing C.R. Bard over allegedly defective pelvic mesh implants cannot blame the products for her post-procedure complaints, saying the woman’s preexisting conditions and later surgeries are the true culprits.

Online Sources

1. Bard Meshes Didn't Harm Woman, Harvard Doctor Tells Jury

   Apr 6, 2018 | Law 360

   By Daniel Siegal

   A Harvard assistant professor and gynecological surgeon told a New Jersey jury Thursday that a woman suing C.R. Bard over allegedly defective pelvic mesh implants cannot blame the products for her post-procedure complaints, saying the woman’s preexisting conditions and later surgeries are the true culprits.
   
   Mary McGinnis has alleged that C.R. Bard Inc. knew its Avaulta Solo Support System and the Align Trans-Obturator Urethral Support System were unsafe and failed to warn about the potential risks, and that the products have caused her to suffer debilitating pain.
   
   On Thursday, Bard called to the stand Dr. Peter Rosenblatt, an assistant professor at Harvard Medical School who practices as female pelvic medicine and reconstructive surgery specialist at the affiliated Auburn Hospital in Cambridge. Under questioning by Bard attorney Lori Cohen of Greenberg Traurig LLP, Rosenblatt went point-by-point through several demonstrative slides used by McGinnis’ counsel during opening statements, tackling a slew of claims about the safety of the Bard products.
   
   Rosenblatt testified that he disagreed with a demonstrative listing several purportedly safer alternative treatments for McGinnis’ vaginal prolapse, dismissing the different procedures as either ineffective or less safe than using the Bard products.
   
   Rosenblatt then testified that the benefits of the Bard products “clearly” outweighed the risks, and that McGinnis’ continued discomfort after she had them implanted was due in part to her preexisting conditions including spine and disc issues, and in part to the failure of a surgeon who operated on her to treat that discomfort to fully address problems with the mesh.
   
   “These devices did not cause her harm,” he said.
   
   McGinnis, who filed the lawsuit in 2011 along with her husband, Thomas, had the devices implanted in March 2009. She underwent the Avaulta Solo procedure to support her bladder, and the Align system was designed to treat stress urinary incontinence, court documents state.
   
   Before McGinnis' procedure, however, Bard knew about problems with the devices, Adam Slater of Mazie Slater Katz & Freeman LLC, representing McGinnis, said during opening statements on March 19.
   
   Slater said that Bard went through “stoplights” related to alleged defects with the devices, and that Bard did not perform clinical studies on the devices and asserted that internal company documents would show that “Bard knew that there were unsafe aspects of these products.”
   
   A surgeon has said she would not have implanted the devices in McGinnis if Bard had warned the physician about certain risks, according to Slater.
   
   On Thursday, Rosenblatt said that based on his review of the medical literature and internal resting and research done by Bard, he did not think the company needed to have done a clinical study of the Avaulta Solo before bringing it to market.
   
   “There was plenty of clinical data available, there were devices that had come on the market that were very similar, there was also the Avaulta Classic on the market which was very similar to the Avaulta Solo,” he said.
   
   Rosenblatt also testified that the warnings given by Bard were “very reasonable,” and said that many of the risks the plaintiffs said she should have been warned of, such as excess scarring, would have been common sense for experienced surgeons at the time.
   
   “Every surgeon knows when you do surgery you get scar tissue,” he said. “Scarring is known.”
   
   During cross-examination, Slater questioned Rosenblatt about his work for medical device manufacturers, asking him to confirm that he had received roughly $300,000 in payments from medical device and pharmaceutical companies from 2013 through 2016, and that he’s never testified that a pelvic mesh device has caused any injury to a woman.
   
   Rosenblatt assented to both questions.
   
   Mary and Thomas McGinnis are represented by Adam Slater and Cheryll A. Calderon of Mazie Slater Katz & Freeman LLC.
   
   Bard is represented by Lori G. Cohen and Cliff Merrell of Greenberg Traurig LLP and Melissa A. Geist of Reed Smith LLP.
   
   The case is Mary McGinnis et al. v. C.R. Bard Inc. et al., case number L-17543-14, in the Superior Court of New Jersey, County of Bergen.
   

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