The Court ruled that Dr. Margolis’ opinions as to cause of the injuries were admissible because of the lack of facts in the medical records.

On February 19, 2020, the honorable Senior U.S. District Judge Lawrence E. Kahn, excluded specific causation opinion and testimony from Michael Margolis, MD as the basis of his opinions were not supported in the medical records (Case 3:19-cv-01372-LEK-ML). The case involves the most common injury in the West Virginia Multidistrict Litigation caused by the vaginal mesh including vaginal erosion, dyspareunia, and recurrent urinary incontinence. Post-revision surgery the injured woman continued to have incontinence as well as pain during intercourse.

Testimony by the revision surgeon was that there was not “any excessive contraction or scarification around the mesh” during the vaginal exam. Testimony of the injured woman was that she did not suffer from “generalized pelvic pain or pelvic pain outside of intercourse.”

Dr. Margolis’ qualifications as an expert were not challenged by Ethicon. The company, however, challenged the case data as being insufficient to serve as a basis for his opinion. Dr. Margolis reasonably stated that to “a reasonable degree of medical certainty, [the injured woman’s] pelvic injuries were caused by the defective TVT device” and that “future surgeries will be far more complicated because of the dense scar tissue caused by the sling and more likely than not will increase scarring, related pain, and tissue damage.”

“Pain is just pain unless it is explained to the pain generator.” – Dr. Greg Vigna

The Court ruled that Dr. Margolis’ opinions as to cause of the injuries were admissible but stated that these opinions could be attacked on cross examination because of the lack of facts in the medical records or witness testimony to support his opinions.

Unfortunately for the injured victim, the Court struck the specific causation testimony of Dr. Margolis because the Plaintiff failed to “show that the defectively designed product caused his (her) injury” understanding that the “mere use of the product and subsequent injury…are not a sufficient basis from which to infer causation.”

Dr. Greg Vigna, MD, JD, practicing physician, national pharmaceutical injury attorney, and Certified Life Care Planner explains, “Pain is just pain unless it is explained to the pain generator. Logic and reason leads to the conclusion that if you implant something into the vagina it may cause pain and it may even cause erosions. That does not make a product defective in the eyes of the law. However, when pain is explained in the medical record down to the pain generator
specific, causation can be proven. In other words, is the pain explained by muscle spasm from direct injury to the muscles and soft tissues of the pelvis or direct injury to the nerves? With the specific diagnosis to the pain generator the effects of the above, decision by the Court can be avoided.”

Dr. Vigna adds, “Unlike attorneys in the MDL, the vast majority of the women I represent have specific injuries to the pudendal nerve, obturator nerve, and ilioinguinal nerve so we don’t have any issues with respect to specific causation, and our clients are trying to obtain care for their specific injuries. These are horrific injuries with life-time disabling pain.”

Greg Vigna, MD, JD, operates a California and Washington DC law firm and has teamed up with Martin Baughman, a national pharmaceutical injury trial law firm from Dallas, Texas, and together they represent women with catastrophic pain syndromes caused by transobturator slings including the Ethicon TVT-O and Abbrevo, Coloplast Altis and Aris, and Boston Scientific Obtryx and Solyx and are proceeding down the path to justice.

For articles, video resources, and information, visit the Pudendal Neuralgia Educational Portal ( or Click here for information regarding sling related complications:

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