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.
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.
We will never know what the jury decision would have been. They never got that chance.
This case was as remarkable for what was left out as what was presented. The jurors were not allowed to hear about the number of cases amassed in one court – 50,000 cases of defective transvaginal mesh products made by six manufacturers, Johnson & Johnson just one of them.
Judge Goodwin also did not tell jurors about the mishandling of thousands of pages by Johnson & Johnson, something called spoliation. Whether it was intentional or just sloppy record-keeping, the fact remains that even though there was an order to preserve documents for litigation, that in-house order was ignored and thousands, if not hundreds of thousands of pages, as well as videotapes and computer hard drives, disappeared. Some of the most compelling evidence sometimes comes from e-mails exchanged within a company.
In the future, any company wanting to avoid embarrassing e-mails might just decide to trash the damaging evidence since spoliation seemed to work in J&J’s favor here. Judge Goodwin did not grant any sanctions for the mishandling of documents and the jury never heard about the issue.
Nor did Judge Goodwin allow the fact that the FDA issued a warning to the medical community in July 2011 that the risks of mesh likely outweigh its use; that the FDA’s own 510(k) approval process does nothing to guarantee safety and efficacy; that the agency has ordered mesh manufacturers to conduct three years of post-approval monitoring of the health of women already implanted; that the instructions for use inadequately warn the implanting doctor as to the dangers; that J&J has taken off the market four of its worst offending meshes and in doing so, avoids having to conduct any post-market testing. The list goes on and on.
This was just the first Ethicon case scheduled in this court. There are three more naming J&J as well as four each against four other manufacturers and one defective case pending against C.R. Bard. They are all scheduled to be heard in front of this judge who has promised he will get through the cases quickly. He certainly did. Needless to say an appeal is planned.