If you do not have women involved in the intake of Transvaginal Mesh (TVM) cases in your law firm, you are making a large, large mistake. Women do not want to talk to men initially about these issues. As you’re running your shop and as you’re trying to deal with these TVM patients, train females in your office to be involved in the intake.
In my office, we have two lawyers, three nurses, and one senior paralegal—all females and all have been trained to understand what is going on with these women and to talk to them.
A typical intake interview will take three to four hours in my office. And by the time it’s over, my senior paralegal says that she has learned everything that has happened between the knees and the navel in that woman through her entire life.
But something else we have learned in our experience here is that some of the social issues and side issues may be as important in these cases as the physical issues are. There are psychological issues that may or may not be related to the mesh, but they do impact the cases. Remember, you’re taking on extremely serious cases. These are not simple cases and quite frankly they are not easy cases. They are complex cases—but for the women who have been affected by this material, it is extremely serious and in many of their lives it is life altering.
The process by which these products came to the market was a clearance process, not an approval process. The defendants want you to think that the FDA approved their products and approved the safety of their products. That’s absolutely untrue. They have not been approved—they have been cleared for marketing. That’s another aspect you’ll learn in these cases; the marketers control the companies. It’s not the scientists, it’s not the researchers, it’s the marketers who decide what’s coming to market, under what circumstances and when.
The original basis for many of these pelvic organ prolapse products is hernia mesh. Now let’s think about that for just a moment. The areas affected by a hernia are totally different than in the female pelvis. Every woman would agree, there’s nothing similar in the pelvis to the abdominal area or areas where you use abdominal mesh. What the companies did—and we’ll be able to prove this—is they generally took hernia mesh and they said, “hey look at these statistics—the number of women who have incontinence or prolapse are staggering, it’s a great area to market. So, let’s create kits containing mesh so it can be used in the pelvis to treat these problems.”
There was no real research done by the companies to look at what is vitally important, that is, the dynamics in the pelvis compared to the dynamics of the areas that the mesh is designed to handle. The mesh was designed to deal with hernias and the forces that exist to keep things from protruding through the abdomen. It was also designed to go into a much thicker muscular structure, which did not have motion such as you have in the female pelvis. We are finding—and this is important—the mesh itself degraded. If you look at the patents, you would find that for polypropylene and for some of the patents on mesh, the companies brag that the material is totally inert and does not degrade. However, the scientific literature doesn’t support that—it never supported that.
Polypropylene is a petroleum product that was frankly a waste product and some scientist figured out we can take it and we can use it for something—they didn’t figure out you could use it for mesh, but they figured out it had a use. So, now you’ve got a petroleum waste product that is being placed in the pelvises of women. And the big thing from industry is to say, “well, if you use the mesh, the frequency of re-occurrence is less than if you had done it by one of the old native tissues or one of the old sacrocolpopectic procedures.”
What’s interesting is that when you look at how industry’s analyzed their claims, they are looking to see which procedure gives the best anatomical appearance. But, what about the subjective result? What does the woman who had the procedure say? How comfortable is she? How satisfied is she? From that perspective, you don’t see a real difference in utilization of mesh versus native tissue or sacrocolpopexy and I think that is one of the things we’re all going to have to be tuned into as lawyers in this litigation.
Henry Garrard is a trailblazer in the area of transvaginal mesh litigation, having investigated and pursued these cases since 2006. He was previously lead counsel for the plaintiffs in the Mentor ObTape MDL in the Middle District of Georgia, and he presently serves as lead counsel for the plaintiffs and a as a member of the plaintiffs’ steering committee in the Bard Women’s Pelvic Repair Mesh MDL in the Southern District of West Virginia. His firm is currently handling hundreds of transvaginal mesh cases in various courts throughout the country. Garrard is a frequent lecturer about surgical mesh-related injuries and litigation, sharing his experience and expertise with other attorneys. He was a faculty member at HB’s Transvaginal Mesh Litigation Conference in Amelia Island, Florida, on October 4, 2011.