The Vigna Law Group comments on recent discussions held in United States federal courts regarding safer design alternatives.
“… Because a reasonable alternative design is a required element of design defect and Plaintiffs have not pled that an alternative design exists in their Complaint, they have not stated a plausible claim for relief, and so Count I must be dismissed or the Plaintiffs must be given leave to amend”…Ducat, et al. v. Ethicon, Inc. (Civil Action No. 4:21-cv-10174-TSH)
Greg Vigna, MD, JD, national pharmaceutical injury attorney, practicing physician, and Certified Life Care Planner weighs in, “In the United States federal courts, there is a circuit split as to what exactly a safer alternative design means. There are circuits that require a safer alternative synthetic device when compared to polypropylene and there are circuits that will accept non-polypropylene alternative procedures as a safer alternative design for the treatment of stress urinary incontinence or pelvic organ prolapse. Regarding neurological complications caused by mid-urethral slings we have little concern at this point regarding this issue as we have evidence of safer alternative designs that utilize polypropylene and safer alternative designs for synthetic slings with non-polypropylene polymers that reduce the risk of neurological injuries and erosion type injuries.”
“We have safer alternative designs for polypropylene slings that avoid each neurological complication that these devices are known to cause.” — Dr. Greg Vigna
Dr. Vigna adds, “We are confident that polypropylene mid-urethral slings will be found defective under the law in every jurisdiction for even erosion type injuries because the scientific evidence relating to biomaterials provide evidence for a safer alternative design. Clearly, the medical literature has caught up with what the manufacturers have known about retropubic slings and trasobturator slings for years, that they cause serious life-altering pain. We have safer alternative designs for polypropylene slings that avoid each neurological complication that these devices are known to cause.”
Dr. Vigna concludes, “I have been very picky as it relates to the women we represent because these cases are very labor-intensive from paralegals to appellate attorneys. We represent those with the serious pain syndromes that have been recognized finally by the 2020 AUGS Joint Position Statement on the Management of Mesh Complications that cause disabling pain, loss of employment, and costly future medical care which are estimated at or above $500,000 per decade of life. Fortunately, the MDL is over and women have a pathway to the courthouse for the compensation that will allow them to obtain the care they deserve and compensation that will allow them to function in society.”
Dr. Vigna is a California and Washington D.C. lawyer who focuses on catastrophic neurological injuries caused by transvaginal mesh devices including pudendal neuralgia, obturator neuralgia, ilioinguinal neuralgia, and Complex Regional Pain Syndrome. His cases are filed around the country with Martin Baughman, a Dallas Texas firm. Ben Martin and Laura Baughman are national pharmaceutical injury trial attorneys in Dallas, Texas.
To learn more on the anatomical basis for TOT injury or irritation to the obturator and pudendal nerve and the treatments of obturator and pudendal neuralgia visit: https://vignalawgroup.com/ebooks/pelvic-mesh-pain/#page=59
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For articles, video resources, and information visit the Pudendal Neuralgia Educational Portal or https://tvm.lifecare123.com/.
Click on the following link for information regarding sling related complications: https://tvm.lifecare123.com/slingebook.html
Greg Vigna, MD, JD
Vigna Law Group
1155 Coast Village Rd., Suite 3, Santa Barbara, CA
Greg Vigna, M.D., J.D., Certified Life Care Planner
Academic Physician Life Care Planning
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