Monday, December 10, 2018

Dr. Anne Weber Details Alleged Defects in Pelvic Mesh, Setting Up $68M Verdict

The Trial: McGinnis v. CR Bard, a products liability trial in which plaintiff claims defects in two pelvic mesh implants manufactured by the defendant caused her chronic pain.

The Expert: Dr. Anne Weber, an obstetrician and gynecologist, testifies to the alleged link between the pelvic mesh and plaintiff’s chronic pain.

The Verdict: $68 million, including $33 million compensatory damages and $35 million in punitives.


 By Gary F. Gansar, MD, FACS; Senior Medical Director, AMFS

 

Dr. Anne Weber, a Pennsylvania-based obstetrician and gynecologist, supports a plaintiff’s claim that two pelvic mesh implants manufactured by CR Bard Inc. and used to treat her bladder prolapse were defectively designed and caused her intractable chronic pain.

In this clip, Weber details plaintiff’s pudendal neuralgia, pain caused by damage or irritation to the pudendal nerve. This condition causes constant, chronic, burning pelvic pain, painful muscle spasms of the pelvic floor, pain on sitting and pain with sexual intercourse. In addition to pain, the plaintiff also suffered from motor function problems seen in pudendal neuralgia. These include dysfunction of the urethral sphincter as it attempts to empty the bladder, leading to urinary retention with its accompanying discomfort and risk of infection.

Weber connects these symptoms with the mesh’s implantation. These symptoms, she explains, are a consequence a foreign body reaction, mesh distortion, and an inflammatory reaction that produces the buildup of scar tissue occurring very close to the anatomic position of the pudendal nerve and its branches. As the body attempts to rid itself of the mesh, enzymes are released that damage the tissues nearby. Eventually the buildup of scar tissue and collagen, combined with the mesh’s contraction, work to damage tissue and the pudendal nerve. .

The expert goes on to explain the internal mechanism causing the patient’s pain when she sits, and how it worsens when she stands. Sitting, she tells jurors, is uncomfortable due to the proximity of the pudendal nerve to the bony structures on which she sits. Six muscles attach to the obturator foramen, where arms of the mesh were placed. These muscles, which affect hip and thigh function, were also affected by the body’s reaction to this mesh and led to the documented worsening of the pain on standing from a sitting position.

This patient had been treated with Trileptal, a drug used to improve neuropathic pain. When the patient stopped using this medication due to a side effect, her pain became much worse, and when she restarted it, the pain improved. The doctor felt that this series of events, in combination with the symptoms previously recognized, confirmed that the pain was indeed neuropathic.

Weber noted that mesh contraction discovered by a urogynecologist who examined the plaintiff was related to the patient’s pain as well. When the treating physician pressed upon the “guitar-like” cords of the mesh, the patient was brought to tears. “That tells us that this is clearly the mesh causing her pain,” she emphasizes. The effect of the contraction, she explains, is that the mesh arms pull and become more like a cord and less like a mesh.

This degradation to a cord-like effect led to the expert’s criticism of company claims that the mesh’s arms were designed to mimic “natural tissue bridges.” Weber plainly states “There are no natural tissue bridges that go through the obturator foramen.” She explains that the arms of the mesh are only used to guide the mesh into place, and provide no support whatsoever. Instead, these arms eventually contracted and led to the pain that the patient experienced. Since there is no tissue channel created by the needle used to place the arms, the spaces within the mesh arms collapse, creating the cord. This occurs on both sides, pulling the central body of the mesh tight as well, and collapsing its spaces. This is “completely unsafe” according to the expert, and using the arms is of no benefit in treating prolapse.

Weber’s easily understood explanations, her calm and self-assured demeanor, and definitive remarks regarding causation connected the defects in the design of this mesh to the patient’s pain and dysfunction in an irrefutable way. The jury agreed, awarding the plaintiff $68 million.

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Gary Gansar, MD, is residency trained and Board Certified in General Surgery. He previously served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Mercy Hospital and Touro Infirmary in New Orleans, LA. Dr. Gansar also served as Clinical Instructor and Professor of Surgery at Tulane University. He received his MD and served as Chief Resident at Tulane University Medical School. Dr. Gansar joined AMFS as a consulting medical expert in 2011 and has served as Medical Director since Nov. 2015. In this capacity, Dr. Gansar provides consultation, review and guidance to attorney clients.