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Huskey V. Ethicon- Case Survives Summary Judgment

Jury selection August 22. Pelvic mesh trial to start August 25.

TVT-O from TVT Mums website

TVT-O from TVT Mums website

The case of Huskey v. Ethicon (Johnson & Johnson) has survived a summary judgment motion and will continue to federal court in Charleston, West Virginia.

Jo Huskey is a 54-year-old woman who was implanted with a TVT-O pelvic mesh device in February, 2011 to treat incontinence.

Jury selection in her case is set for August 22 with the trial commencing in the federal court August 25. The case number is 2:12-cv-05201.

Huskey filed a product liability action that alleges the polypropylene mesh is defective in its design and manufacture as well as its directions for use and that the company made false and fraudulent promises to the public and to the doctors. Her implanting physician was Gretchen L. Byrkit, MD Ob-Gyn. See here

The Huskey lawsuit is just one of 20,072 product liability lawsuits facing Ethicon in this federal court.

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

The Husky case might not have gone forward except for a ruling July 8 by federal Judge Joseph Goodwin who is overseeing actions filed against seven manufacturers and 62,691 federal transvaginal mesh cases. Ethicon tried to have the Huskey case dismissed on the basis of federal preemption. Federal preemption essentially means if you are injured by a medical device, that was approved by the U.S. Food and Drug Administration’s Premarket Approval (PMA), you should not be allowed to sue. The device maker has immunity.

As most readers of Mesh News Desk know, pelvic and hernia mesh never underwent the FDA’s more stringent PMA. Instead it was approved under the fast-track 510(k) approval which does not require clinical trials before it is marketed.

Riegel v. Medtronic

Decided February 2008 by the U.S. Supreme Court, the famous case Riegel v. Metronic established that Charles Riegel and his wife Donna Riegel should not be allowed to sue over the Medtronic catheter that ruptured in Riegel’s coronary artery while he underwent heart surgery. It later killed him.

See Riegel v. Medtronic here.

Why not?

Because the Medical Device Amendments of 1976 created federal oversight for medical devices. States cannot challenge federal Premarket Approval or PMA. The Riegels had sued under New York state law.

The bottom line- 510(k) approved devices can face defective product litigation while devices approved by the FDA under the PMA cannot.

Ethicon moved for the partial summary judgment (Doc #178), arguing that PROLENE mesh, the proprietary name for J&J’s polypropylene that makes up the TVT-O, underwent the Food and Drug Administration’s “rigorous premarket approval process, rather than the less stringent 510(k) clearance process.”

Readers of Mesh News Desk know hernia and pelvic mesh were approved under 510(k).

Ethicon argued the Prolene suture which is a “component part of the TVT-O” made it to market under PMA, therefore the entire device also should be considered a PMA-approved device. That argument had been made previously in the Lewis v. Ethicon case in the same court.

Judge Joseph Goodwin said that Ethicon ignored the fact that the TVT transvaginal mesh and Prolene sutures are two entirely different medical devices.

Prolene mesh

Prolene mesh

The TVT mesh, made of Prolene is as woven from knitted Prolene filaments.The Prolene suture is a single filament of polypropylene. 

Other differences- the average suture is a few inches long, the TVT is .5 inch by 16 inches, in other words, a lot more polypropylene.

The suture is not intended to adhere to human tissue but the TVT is designed to integrate with the body. Suture is designed to be removed from the body, easily pulled out, while the TVT is a permanent medical device and cannot be removed” without invasive surgery.”Ethicon  200

The FDA’s approval of the Prolene suture it said it was safe and effective “for use as recommended in the submitting labeling.” The FDA did not approve Prolene in a larger format in a knit material or in a permanent transvaginal mesh implant.

Judge Goodwin ruled just because they are the same material “It does not automatically follow that the material is safe in both devices.”

Ethicon’s motion for a partial summary judgment based on preemption was denied. #

13 Comments

  1. kristine says:

    I pray she wins her case. The mesh in my body is painful and destroying my body. I understand all to well the suffering and mental sadness this mesh brings.

  2. Paula says:

    GOOD.

  3. Dean says:

    I pray she wins and will win because the truth will come out again and again and again

  4. Kitty says:

    Hi Pam——are you the Pam from Tennesee? You sound so mellow today. Be well my friend.

  5. Barbara says:

    I understand all of the pain, the worry and anxiety of this great travesty done to so many women. Which also affects husbands, children, grandchildren. I was active and happy but the day to day pain, incontinence, anxiety I have gone through since my first implant in 2008…are beating me down and the more I learn about J&J, the sicker I get because they knew, and they only worship at the alter of the Almighty dollar.(J&J and Others).So many days I won’t get back spent at home in bed or on the couch. As an RN, I always hoped when I retired, I would help seniors with chores, etc. But I can’t get to far from home or a bathroom! Much less Volunteer.God bless you all.

  6. R.E. says:

    Will there be a point where enough cases have been heard and J & J will or won’t be forced to settle all cases?

    • Jane Akre says:

      Settlement is purely up to them. They said they would never settle the DePuy metal hip cases. they did. ~ ja

  7. Dean says:

    They know they have to settle they are just trying to drag it out to see what happens with these trials they know they are guilty and it’s nothing that can change that I just hope they come to there senses and settle so these pore SORY not pore hurt and injured and taken advantage of just like my wife it’s dragging on to long for them just help these unfortunate women that have gone through devastating life changes because of your product changing there lives in such an awe full way SETTLE IT and admit your wrong doing

  8. I am still in pain after going through hernia surgery on Oct 25, 2010, then back in hospital because of an infection caused by the mesh. Doctor didn’t care, he seen me in ER Nov 3 with high fever, heat coming out of my chest 5″ away. I went into my appointment on the 4th of Nov, even though I was there the day before, they gave me a IV of antibiotics and sent me home, even though the “suction bubble” looked like DIRTY POND WATER WITH FISH SCALES in it…. I woke up NOV 5th with a FOOTBALL sized hole, where they took the mesh and everything that was infected out. I had a sponge connected with a VAC unit (suction) on. It killed me every time they ripped that sponge out of a wound measuring 2″x 4″x 7″. So bad that it smelled like a dead animal on the side of the road. I have had a lawyer on this, she must not have cared very much, she tried to get the doctor for malpractice while I set in pain, severe pain still as I write this letter I want to cry… the doctor knew that I didn’t have any back muscles because another doctor royally ‘SCREWED UP MY BACK”, even though there was nothing wrong with it, that doctor didn’t look at my chart or do the right tests, when the 2 back surgeries were done it was

  9. I am still in pain after going through hernia surgery on Oct 25, 2010, then back in hospital because of an infection caused by the mesh. Doctor didn’t care, he seen me in ER Nov 3 with high fever, heat coming out of my chest 5″ away. I went into my appointment on the 4th of Nov, even though I was there the day before, they gave me a IV of antibiotics and sent me home, even though the “suction bubble” looked like DIRTY POND WATER WITH FISH SCALES in it…. I woke up NOV 5th with a FOOTBALL sized hole, where they took the mesh and everything that was infected out. I had a sponge connected with a VAC unit (suction) on. It killed me every time they ripped that sponge out of a wound measuring 2″x 4″x 7″. So bad that it smelled like a dead animal on the side of the road. I have had a lawyer on this, she must not have cared very much, she tried to get the doctor for malpractice while I set in pain, severe pain still as I write this letter I want to cry… the doctor knew that I didn’t have any back muscles because another doctor royally ‘SCREWED UP MY BACK”, even though there was nothing wrong with it, that doctor didn’t look at my chart or do the right tests, when the 2 back surgeries were done it was my AORTA, I didn’t have blood flow down to my legs from my heart….. now that I have the pain taken care of with nerve blocks in my spine, my chest hurts from my ribs to what is left of my belly, I don’t have belly button anymore because that went with the muscles of my chest…. please contact me , I have pictures of what my wound was without the sponge in it….my last surgery was April 2011 when a plastic surgeon fixed my chest after the others let my chest grow back together, which was so big I couldn’t see my feet… being 5’8″ tall and never over 156 even after 2 kids, he has pictures of what that looked like…. please contact me

  10. Agnes P says:

    I was implanted with Ethicon mesh in 2008. I began having issues that couldn’t be explained. I was in pain all the time and was passing small pieces of white and then blue pieces of soft material. In 2015 I had to have the mesh removed during a 4 &1/2 HR surgery. I am 76 years old and had to endure reconstruction of my pelvic floor. Rectocelse & cystic else repair as well. I have had 7 surgeries since due to permanent nerve damage, acute sinusitis, days of not being able to walk without the ability to straighten my legs etc……I was a very active person prior to the surgery and now I’m mostly confined to my home or going to the doctors. I have suffered with having 3 sets of ipedural steroid injection therapy which did not help and I am at the present going to therapy 4 days a week. I am scheduled for more surgery in September . There is not a day goes by that I am free of pain. Will the compensation for all this suffering be available to those of us who may not be healthy enough to use it if the good Lord sees it in His will to keep us around. My husband of over 50 years has been affected by my condition as well.
    Regards

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