J&J Faces first Defective Transvaginal Mesh Trial in Federal Court Monday

//J&J Faces first Defective Transvaginal Mesh Trial in Federal Court Monday

J&J Faces first Defective Transvaginal Mesh Trial in Federal Court Monday

Prolift, sold on eBay

Prolift, sold on eBay

The first federal trial accusing healthcare giant Johnson & Johnson (J&J)  of making defective transvaginal mesh will begin with jury selection Monday morning, February 10, in a Charleston, West Virginia courtroom. This is the first of 15,000 cases naming Ethicon, a division of J&J, consolidated before Judge Joseph R. Goodwin.

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Because there are 50,000 cases against six manufacturers consolidated in multidistrict litigation, Judge Goodwin has allowed four cases to be heard against each of the manufacturers. These bellwether trials, as they are known, are intended to get a reading on how jurors will respond to the presentations of each side. Too many losses and a defendant may decide to offer a settlement or continue fighting each case as Johnson & Johnson has vowed to do.

Plaintiff Carolyn Lewis was implanted with the Ethicon Gynecare TVT (tension free tape) transvaginal mesh to treat stress urinary incontinence in 2009. Her attorneys will president evidence that the mesh is defective in its design and in its manufacture. Punitive damages may also be awarded by the jurors.  Last February, a jury in state court in Atlantic City, New Jersey, awarded mesh-injured plaintiff Linda Gross $11.1 million dollars including $7.76 million in punitive damages for the damages caused by her Ethicon Prolift mesh. See background story here.

Lewis, like the other 15,000 plaintiffs claim they suffer from mesh erosion, mesh movement throughout the body, mesh contraction, infections, inflammation, painful scar tissue growth, organ perforation, chronic nerve damage and pelvic floor damage and an inability to have intercourse.

Transvaginal mesh is made of petroleum-based polypropylene and this may be the first time a complaint has listed autoimmune issues among the host of complications.

“Despite claims that polypropylene is inert, the scientific evidence shows that this material as implanted in the relevant female plaintiff set forth below is biologically incompatible with human tissue and promotes a negative immune response in a large subset of the population implanted with the Pelvic Mesh Products. This negative response promotes inflammation of the pelvic tissue and can contribute to the formation of severe adverse reactions to the mesh. When mesh is inserted in the female body according to the manufacturers’ instructions, it creates a non-anatomic condition in the pelvis leading to chronic pain and functional disabilities.” (Carolyn Lewis Doc #1 Complaint 2:12-cv-04301)

Thomas Cartmell, Wagstaff Cartmell

Thomas Cartmell, Wagstaff Cartmell


Christy Jones, attorney Butler Snow

Christy Jones, attorney Butler Snow

Attorney Christy Jones will represent Ethicon in the federal case. The Butler Snow attorney also represented Ethicon in the Linda Gross state trial in New Jersey.

Thomas Cartmell of Wagstaff Cartmell represents Ms. Lewis along with Renee Baggett of Aylstock, Witkin, Kreis & Overholtz who authored many of the motions in this case.

Renee Baggett, attorney Aylstock Witkin

Renee Baggett, attorney Aylstock Witkin

Failure to Warn
A product can be defective in its instruction to the end user, that is the physician or medical personnel who will use the device.  In the Gross case, the failure to warn her physician was presented to jurors, but in the Lewis case, Judge Goodwin has ruled there will be no failure to warn element of this product liability claim because her implanting physician said she had not read the product insert (Instructions for Use of IFU) since 2002.


In the first federal case against C.R. Bard, Judge Goodwin ruled that jurors could not hear about the FDA’s 510(k) approval shortcut which allows manufacturers to notify the agency it plans to sell  a product that is the “substantial equivalent” of one already on the market. Companies can then bypass any clinical trials to assure safety and efficacy. During the Gross case it was revealed that the Prolift was never tested on humans before it was approved for market.

Lost and Mishandled Documents
Last week U.S. Magistrate Judge Cheryl Eifert  ruled that Ethicon lost or destroyed documents that should have been preserved for litigation. She ruled that jurors should hear documents were destroyed on a case-by-case basis. Judge Goodwin will likely address that issue on Monday.

Ethicon is the second mesh manufacturer to face jurors in this courtroom. Last summer, jurors took 12 days to award C.R. Bard mesh-injured plaintiff Donna Cisson $2 million including $1.75 million in punitive damages. The second bellwether case settled, the third was dismissed by the Plaintiff and the fourth will not be heard until May 2014.

Charleston attorney Harry Bell of Bell Law tells the Sunday Gazette-Mail (here) that this is the largest multidistrict litigation ever filed based purely on the number of cases.
The defendant is Ethicon, a wholly-owned subsidiary of J&J located in Somerville, N.J., Ethicon Women’s Health and Urology, a division of Ethicon; Gynecare, a division of Ethicon.  The case is MDL No. 2327. #
By | 2014-02-09T19:26:35+00:00 February 9th, 2014|Legal News|7 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. kristine February 10, 2014 at 6:29 pm - Reply

    I hope for all the women like me who are suffering with this terrible mesh their will be justice. I feel like my life is over.

    • Shirley Dodson February 11, 2014 at 8:10 am - Reply

      It`s about time voices are heard as I am one of the victims who has gone through pain and suffering almost a decade this is so wrong for J & J gynecare to mishandle important documentation and hope justice is serveed in any manner under the laws that define corruption practices…Amen

    • Carin February 11, 2014 at 5:46 pm - Reply

      I know what you mean Kristine. I am sick of the pain and worse… the incontinence.Its so hard to try to live a normal life and who can you trust to talk too??? Even my doctors don’t get it. I never hear from my lawyer. I am not going to go around telling friends and family (haha… but I’ll tell you strangers) about my vag pain or that I piss my pants every 20 min. I feel very alone. Im too young to feel like my sex life is over, but I am sure it is. This sucks! I hope Carolyn Lewis and the other plaintiffs get the word out to that judge, and get huge awards.

  2. P williams February 11, 2014 at 7:43 pm - Reply

    I agree with all the comments that have been made regarding this “Awful mesh”!!! I don’t get any information from the lawyer that is suppose to be representing me or any satisfaction from the number of surgeries I have had to correct the incontience. I don’t leak anymore but now I am dealing with pelvic organ prolapse . I am not sure which situation is worse. I have attempted to have intercourse but it is either unsatisfying or it hurts. I am a 53 year old divorcee and it seems like my sex life is over. I wish I would have continued to leak, at least I was having sex and had a husband!!! Life does not look complete for me. We need help!!!!

  3. Maureen T February 12, 2014 at 6:00 pm - Reply

    The pain, the agony and mental anguish are enormous.

    The loss of consortium with my husband due to pain and shrinkage of the vagina after removal of the erosion.

    Life is just not normal and it gets worse each and every day.

    To read that J&J destroyed evidence shows how the American greed lives at the top of corporate America and not just few individuals.

    It is time for some justice.

  4. Deborah Boggs February 13, 2014 at 1:45 pm - Reply

    I am also one that the tvt has destroyed. My life is not normal by far.if I ever go out I do know where every restroom it, if not you ask first. Yes divorce, mental anguish, can’t sleep over a hr at a time. The money on pads. The pain and life sent 2002 has destroyed me. What kills me : They knew – THEY KNEW..

    • Barbara Dykes February 18, 2014 at 10:10 pm - Reply

      As I sit here and read these stories my eyes well up with tears. I had my surgery in 2008. I was at my son’s house 350 miles from home helping w/grandchildren. I started having pain in lower abdomen after bed so severe all I could do was toss and turn and worry if I would be able to get on the plane the next morning. I was taking antibiotics daily for urinary retention and recurrent infections.I did not sleep one minute. When my son and DIL got up I asked them to get me some Azo/Standard for the bladder pain. I think I took 3 times the dose as I rushed for my flight home to my hubby and dogs.God was flying with me because the pain subsided long enough for me to get home. I saw my implant MD the next day .She said “oh, you just have a little mesh that needs tacking back up, she walked out, came back said I don’t have anything on my schedule available. I will call you.OK? I am a RN, I get it. So went to the most well known OB/GYN next day. It took him 5 min w/his radar:)glasses to say YOU are TOTALLY eroded.I went to a female OB for compassion. oh wait, that doesnt always work.God Bless you all.

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