The evidence seemed overwhelming.
The transvaginal tape (TVT made by Ethicon, a division of Johnson & Johnson) had caused a foreign body reaction inside Carolyn Lewis of Texas, the woman suing the healthcare giant. Her trial began February 10 and was the first federal case to be heard against Johnson & Johnson (J&J) in a West Virginia court where more than 16,000 cases of transvaginal mesh injury naming J&J have been consolidated.
The mesh is a medical device permanently implanted to treat stress urinary incontinence and/or a prolapse condition.
Here is an image of how polypropylene is weaved. Note the porous nature of the mesh.
Judge Joseph Goodwin listened to the evidence along with the ten jurors. Lawyers for Ms. Lewis brought a scientist from Germany to the stand to talk about the small pores in the polypropylene mesh that cause it to scar over with tissue that tightens and contracts. In the body, especially the delicate pelvic area, that causes shrinkage of the mesh by 30 to 50 percent. By the way, this scientist also worked as a consultant to Ethicon for a number of years but has decided to speak out.
Ethicon’s own documents acknowledged that the shrinking mesh was a problem – it caused pain, entrapped nerves and was difficult if not impossible to remove. Ethicon was working on an alternative with larger pores and a lighter weight which didn’t seem to incite the same problems.
The company knew about this as early as 1992 but the mesh used in the TVT implant, Prolene, the marketing name for polypropylene, hadn’t changed since the product was approved for use in this country in 1998 for TVT mesh and since it was first used for hernia mesh in 1974.
But on the eve of the case to be presented by the defense, Judge Joseph Goodwin cut the legs off of the plaintiff’s case – he directed a verdict in favor of Johnson & Johnson. Anything can happen in court and in this case it did. The defense had made a motion for a directed verdict saying that the other side failed to show the mesh was a defective product, even though that’s exactly what they had showed.