Surgical Implant Causes Allergic Reaction

Joseph O'Neill

Written by
— Updated on October 27, 2017

Hernia Mesh Expert WitnessThis case takes place in South Carolina and involves Composix surgical mesh, which was designed to assist with hernia repairs. The product combines a proprietary coating around a polypropylene mesh which provided structural integrity. There have been hundreds of reported incidents associated with the use of this implant involving severe allergic reactions to this proprietary coating. In most instances, patients developed a severe infection and foreign body response in rejection of the mesh once implanted. It is alleged that the implant’s manufacturer failed to warn implanting physicians about the risks associated with the mesh’s coating.

Question(s) For Expert Witness

  • 1. Have you ever been involved with the development of hernia mesh products? If so, please explain.
  • 2. Are you familiar with the use of this kind of coating in hernia mesh products? If so, please explain.
  • 3. Have you ever served as an expert witness on a case involving hernia mesh products?
  • 4. Do you have any experience dealing with the FDA with respect to new hernia mesh products?

Expert Witness Response E-007957

I have the experience and skill to support mesh litigation, to identify the research pathways and hidden skeletons in defendant’s activities, to outline and ask for the appropriate production, to assess and develop new thoughts, to evaluate the literature, the people and the regulatory and mesh legal history, and help you find the additional help that might be needed. No one individual will meet the complex needs of the litigation process as demonstrated by the long list of experts who have been brought forward by litigants in the New Jersey Centralized Management cases on vaginal mesh and in the Bard and Ethicon trials in the Multi District Litigations now ongoing in West Virginia. I have served those litigants with roughly 250 hours of support in the last five years, and believe I can best get you off the ground in this Atrium litigation. In 2009, I was hired as an expert in the emerging vaginal prolapse mesh cases then being collected in New Jersey, and for the next two years I actively guided the litigating firm in understanding the defendant’s people, processes and technology. This service continues through today at a much reduced level. It was understood from the beginning that my skills and experience gained as a research and development leader in closely aligned areas would prove useful, if not invaluable to the litigation. In 2013, I was retained by the lead attorneys in a benchmark case for MDL2327 in West Virginia and have provided support for the litigation in the same fashion as for the NJ case. This work brought me into contact with the full range of mesh activities, vaginal prolapse, stress urinary incontinence and hernia. As part of this I am familiar with and know many of the leading hernia surgeons and know the work of the European mesh scientists. The field of vaginal mesh and hernia mesh overlaps in the scientific sense; much of what is gleaned about one is applicable to the other. I understand you’re attempting to litigate on failure to warn issues. I have scanned Atrium’s “Instructions for Use,” which is the document often cited as the basis for failure to warn litigation. It is, as you must realize, rather brief and attracts appropriate attention. However, litigants should not ignore the design defect avenue here, as failure to warn is often judged as going through the learned intermediary, the physician, and is difficult to prove. The recent decision in Lewis v Ethicon in WV illustrates this; the judge did not allow testimony directed at failure to warn because the physician claimed she had not recently read those warnings.

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