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*Latest* J&J Wants New Trial in Huskey $3.27 Mill TVT-O Pelvic Mesh Case

Mesh News Desk, April 5, 2016 ~ Ethicon asks for new trial in the $3.27 million first TVT-O bellwether pelvic mesh case.  

Jo and Allen Huskey

Jo and Allen Huskey

An appeal brief was filed March 28, in the Us Fourth Circuit Court of Appeals No. 15-2118, by attorneys for mesh-injured plaintiff, Jo Huskey in Huskey et al, v. Ethicon (2:12-cv-05201).

Jo and her husband Allen filed a product liability case against Ethicon, a division of Johnson & Johnson, over its TVT-O (transvaginal tape obturator).  On September 5, 2014, the jury in the Charleston, WV federal court awarded the couple $3.27 million.

This was the in the first bellwether jury trial naming Ethicon in this multidistrict litigation before Judge Joseph Goodwin.
And it was also the first time a jury decided the TVT-O was defectively designed.  See the background on the case here.

J&J appealed after the Huskey verdict, initially asking Judge Goodwin for a directed verdict in its favor, which he denied.

The team for Huskey was also denied the ability to seek punitive damages. See here  .

J&J filed an appeal of the verdict.

Ed Wallace, attorney for Jo Huskey

Ed Wallace, attorney for Jo Huskey

Ed Wallace told MND
“The jury rendered its verdict in Jo Huskey’s case on September 5, 2014.  Ethicon appealed that decision.  Yesterday, we filed a brief on behalf of Ms. Huskey in the appellate court laying out the overwhelming evidence that the jury considered when it found in her favor. If you read the brief you will have an opportunity to know her story and how Ethicon’s mesh altered her life forever.  Jo Huskey stepped up and proved her claim.  Ethicon should step up and do the right thing by Ms. Huskey and all the women like her.  We suspect they will continue this appeal and we will do everything we can to end it.”  

 

BACKGROUND

TVT-O from beckenbodenzentrummuenster.de

TVT-O from beckenbodenzentrummuenster.de

Mrs. Huskey was implanted with a Johnson & Johnson, Ethicon TVT-O laser cut mesh to treat incontinence. TVT-O was first sold in 2004 and is considered a mid-urethral sling.  Using trocars, or stainless steel curved end hooks, doctors will stab a woman’s thighs to pierce the obturator membrane. Then a strip of synthetic polypropylene (PP) mesh is pulled through the obturator foramen, a nerve-rich area of a woman’s body before it is placed midway under the urethra.

There are two types of TVT-O one that is laser cut and the other than mechanical cut. The plaintiff had a laser-cut mesh, thought to smooth out rough, exposed plastic ends.

Dr. Gretchen Byrkit, ob/gyn

Dr. Gretchen Byrkit, ob/gyn

Ms. Huskey had her TVT-O implanted by Dr. Gretchen Byrkit Feb 23. 2011.  She experienced mesh erosion by March, also dyspareunia and she underwent a revision surgery where the doctor oversewed the exposed mesh. Another section was dissected but it retracted behind the public bone and it remains there today.

She is in pain,has dyspareunia, has been injected with countless drugs, and her SUI has reportedly returned.

At trial, the implanting physician also said she would likely not use TVT-O if it was contraindicated for athletic women and that information was contained in the product label or Instructions for Use (IFU).

Jo Huskey was an avid kayaker, liked to exercise, walk and work out regularly. At trial, Dr. Byrkit said if the warning was on the IFU  label that TVT-O should not be used in athletic women, she would have reconsidered using it on Mrs. Huskey.

Dr. Jerry Blaivas

Dr. Jerry Blaivas

Dr. Jerry Blaivas, brought in as the expert to testify for Mrs. Huskey, testified that active women should not be implanted with a TVT-O.

The jury returned a verdict based on Illinois Pattern Jury Instructions since she is from Illinois.  After a nine-day trial the jury returned a unanimous verdict in Plaintiffs’ favor on all four claims – strict liability design defect and failure to warn, negligent design and failure to warn.

 

Ethicon’s Appeal

The plaintiffs alleged there were six defects with the TVT-O:

* It’s made with Prolene mesh
* Prolene mesh undergoes oxidative degradation
* Prolene mesh shrinks
* Prolene mesh deforms
* Prolene mesh is too heavy and causes chronic foreign body reaction
* Prolene mesh is placed in the obturator space
* Prolene mesh was laser cut

Ethicon argued all of its surgical meshes the TVT and TVT-O are considered the standard of care, the “Gold Standard,” by medical industry organizations and therefore they cannot be defectively designed.

Ethicon relies on the learned intermediary, that is, the implanting physician as the end user. When a manufacturer of a drug or maker of a medical device gives adequate warning to physicians about the known dangers of such a product, that warning provides a shield from liability for the medical manufacturer under learned intermediary.

The plaintiffs’ brief says the exact nature of the dangers would have to be detailed to fully protect the seller.

Prolene mesh

Prolene mesh

“The learned intermediary doctrine does not shield Ethicon from liability because the warnings in the instructions for use were inadequate.” ~ appeal brief for Jo Huskey

 

What was missing?  Information about mesh degrading, cracking becoming embrittled or stiffening; mesh contracting and shrinking; mesh complications increasing with the more mesh used; more complications with the TVT-O; chronic or permanent pelvic pain; the potential for multiple surgeries, among other things not included in the IFU (Instructions for Use).

David Robinson, former Medical Dir. Ethicon

David Robinson, former Medical Dir. Ethicon

Ethicon’s own Associate Medical Director, Dr. Meng Chen, testified at trial Ethicon was aware of many adverse events which were being called into the company and she told Ethicon “These complications are not transitory.” Yet they did not make it to the IFU.

Dr. David Robinson, Ethicon’s Worldwide Medical Director, outlined many complications Ethicon never warned about including lifelong complications relating to foreign body reaction. He said the company was telling doctors the opposite, that there was no foreign body reaction.

And Ethicon did not warn that TVT-O was contraindicated in active women.

Illinois law does not require the plaintiff to show what the doctor would or would not have done if she had been adequately warned. The plaintiff is from Illinois.

Unavoidably Unsafe

Don’t you love a double negative?   An unavoidably unsafe product is one that has a benefit that far outweighs its known risks…. Like the rabies vaccine, says the appeal, which is quite incapable of being made safe (though one could always refuse the vaccine so is it really unavoidable?).

And if you are a trained lawyer, you have been schooled in something called comment k.

Comment k says that a product is not defective or unreasonably dangerous if you are properly warned about them.   It comes from prescription medicines that were dangerous but had some value when used only by prescription in the right hands. Should that doctor be legally liable for a dangerous product?  Comment k says it should be used as a defense of strict liability, or in other words, a shield to protect the company.  See Illinois law here:

Ethicon argued that TVT-O falls under the protection of comment k (unavoidably unsafe).  Judge Goodwin had decided comment k was not applicable because Ethicon had not met its burden to show that TVT-O was “unavoidably safe.”  In fact the opposite, at trial, Ethicon claimed TVT-O was perfectly safe.

It’s difficult to have it both ways.

 

Distinct Defect

Ethicon says the plaintiff was required to identify what about the TVT-O was defective and what caused her pain.  The plaintiff says that is not required under Illinois law, in fact, Illinois law does not require a plaintiff to pinpoint a specific defect in a product to recover under strict liability.

Meanwhile at trial Dr. Blaivas testified Ms. Huskey had the TVT-O removed because of chronic inflammation and a doctor who attempted a removal (Dr Siddique) testified that surgeries both implanting and attempting to remove the mesh were the probable cause of her pain.  Dr. Guelcher testified that polypropylene in the T VT-O degrades in the body and the oxidative process changes the structure of the mesh, the amount of mesh used affects foreign body response and that continues until the mesh is removed. Degradation of the mesh causes the mesh to become stiff, embrittled and crack and cause pain.

Bruce Rosenzweig MD from Rush U expert in lewis and huskey casesDr. Rosenzweig from Rush University testified the placement of the TVT-O in the adductor muscles can irritate the obturator nerve resulting in pain. He also said that the heavyweight laser-cut mesh in the TVT-O led to mesh shrinkage and contraction and foreign body response near muscles and nerves – all contributing to chronic pain.

 

New Trial

Christy Jones, Dave Thomas, atnys for J&J

Christy Jones, Dave Thomas, atnys for J&J

Ethicon in its appeal asked for a new trial based on the omission of FDA related evidence.  The fact that the FDA uses a 510(K) approval process was not included in the Huskey trial, just as it’s been omitted from the majority of these pelvic mesh trials (Cisson for example), which are on a tight time budget (the Huskey case was 9 days).

Ethicon never sought to have that admitted at trial, says the plaintiffs.

Ethicon also argues that comment k instructions should have been given to the jury and that the regulatory history of Prolene sutures, cleared by the FDA, should have been presented to the jurors.

Prolene sutures, approved by the FDA under the New Drug Application process in 1969, are not the same product as a boxed mesh kit containing the TVT-O, argued plaintiff attorneys.

Notes taken by Akre during this trial are available to those who subscribe to the Mesh News Desk newsletter (here) and members of law firms and legal content providers.  Please contact your editor, Jane Akre for rates to these any other links provided with newsletter stories.  Exceptions are granted to mesh-injured plaintiffs who need only write janeakre@meshnewsdesk.com for the copy. Thank you for understanding.   

 

 

21 Comments

  1. Sea says:

    Now, the loop holes of time, money, power, of our legal system really begins. And, since the WHOLE world is now looking to our judicial system to rule so other counties can follow and the amount of money these manufactures are making is at stake. Maybe every women who has been injured needs to flood letters to the judge?? with their own true horror stories??? or what to do now ??? Keeping the faith on the rights of women…..and any man who has also been injured by mesh. Putting on my warrior women suit to stand next to my sisters of the mesh mess …. Sea

    • Still Standing says:

      Sea, while it seems like a good idea to flood the judge with letters, that is a highly inappropriate thing to do when a case is in litigation. More than likely, the letters will be screened by an assistant and it will never reach the judge. I dont know about this court, but some might require that any correspondence that is sent is copied for attorneys on both sides. Please dont do this unless you get your attorney’s approval to do so. I doubt that they will give you the go ahead. I definitely agree with you wanting to get your story out there. It is very frustrating. Justice is definitely not swift in our cases.

      • Jane Akre says:

        My opinion is contacting the Judge en masse would be the worst thing you could do. He is aware you are out there. A court has never had this many cases consolidated in one court and it must be overwhelming. I’d ask you not to flood the judge with letters!

  2. Disgusted says:

    Give it up J&J. Your arguments are hollow. This “Gold Standard” you proclaim was coined by you, and not the industry. I have not heard one of over 11 doctors I have seen say this is the Gold Standard of the industry. What are you gaining by continually fighting? You either know you’re lying or you’re terribly deceived. Even your own employee’s were speaking up and were ignored. I don’t believe you were malicious and set out to purposely severely harm so many. I think you saw dollar signs and rationalized your actions. I think you’re actually shocked by how damaging this is. What I don’t understand is why you’re still trying to CYA. It’s been bared and civil juries have decided. STOP the MADNESS and do what’s right. Take your credo to heart and return to your original values. What is sad to me is that we are not being allowed to take this into the criminal law arena. Your original intentions may not have been criminal, but not standing by your product, apologizing and doing what is right, i.e. Taking it off the market, compensating those who have lost their lives as they knew them, has turned this into a criminal endeavor, including manslaughter and attempted manslaughter. As one who can no longer sit for more than 15 minutes without incredible pain, I can attest to the damage that has been done. Blaming the victim is a poor tactic. You used to be a great company, looked up to by many, and you did many great things. You are no longer in that category and you know it. You should be ashamed of yourselves. Incontinence is not the pariah you’ve made it out to be. I’m worse than incontinent now, anyway. How can continuing this product even be profitable at this point? I don’t get it. You’ve laid off 3000 employees and and are still paying lawyers at a phenomenal rate. You aren’t fooling anyone. Wake up and DO WHAT IS RIGHT!!

    • Still Standing says:

      Disgusted. There is a hidden factor in these lawsuits that we cant see and that is the fact that insurance companies are driving some of the corporate behavior. These corporations have many layers of product liability insurance. The insurance companies foot the litigation bills as they try limit their pay outs to plaintiffs. They have a right to do this. We dont know how the policies are written and what dollar limits the insurance companies put in the agreement. It could be possible that a corporation wants the litigation process to end, but the insurance company pursues it because of the financial liability they have in these cases.

  3. PLC says:

    The verdict was 20 months ago. How long did they have to appeal?

    I can see now how these trials no matter if you win or not can drag on for many years, and the courts allow this to happen?

    J&J is going to drag these cases out
    as long as they can and even then it
    will be next to impossible to have
    them pay up in the end.

    It is a shame the courts are not
    firmer on these companies, they are
    abusing the system and the Judges
    know this and yet keeps giving them what ever they want.

    I wish we knew what was on those
    thousands of documents that J&J
    destroyed. You never know as
    time goes on, there may be more
    information that comes to light that
    J&J may have been trying to hide.
    Look what happened to Boston
    Scientific with buying mesh
    overseas. I would not be surprised if the other mesh manufacturers were doing the same.

    I hope these two days of Judge
    Goodwin trying to see where the
    status of these cases is going ends
    up being more productive and from
    here on end letting the defendants
    know there will be zero tolerance
    from here on end of what the mesh manufacturers are trying to get away with.

    Maybe the Judges should allow more
    information into these trials like the
    destruction of documents etc……I bet
    some of these companies would
    think twice about everything if this
    was the case.

    If things keep going the way they
    have been we will be lucky to even see 100 cases get through the courts over the next 5 years with over 100,000 to go.

  4. Don't give up says:

    This is typical of J&J did you expect anything else these lawyers keep sending the message to them who work for them things will go our way this time you will see well J&J has it!…NO it hasn’t stop being fooled by your lawyers.
    Like what was said up above J&J was a house hold name bring it back to that stop already you had a product that went horribly wrong now fix the damages the product or products of mesh has caused.
    Why spend millions more trying to take a case back to court which was won nearly two years ago it does not make sense and hopfully the judge will see this.
    At first you thought this was going to be easy and just little mole hills to climb and conquer but you have made it become mountains in which you never thought it would come to,as these mountains are full of pain suffering and debilitating injuries for these poor women.
    So just do the right thing man up apologize and settle with descent settlements so these women with these debilitating injuries can get the help they need and try to live a somewhat more comfortable life as these issues for many of these women will NEVER go away.

    • Teresa Akridge says:

      I say we women and families start by hitting J&J and their counterparts where it hurts!!! In the pockets!!! We all ban the purchases of all products from this day forward of J&J and all their subsideries companies!!! Look them up, it’s amazing how many we go to and use daily!! They are making millions off all of us- while refusing to payout for damage their products have caused to our bodies!!!! This is the way to get their attention!!!!

  5. Debi says:

    Everything you just said is so true. I spoke with my attorney’s office this morning, and I was told that Johnson & Johnson is not going to offer any type of settlement, they are not going to work with any attorney, that J&J is going to fight this to the end. Unless the judges,the court,or the government steps in we are all living in a hell hole of insanity.

    • Jane Akre says:

      Do your attorneys have a crystal ball?

      • Debi says:

        I’m not sure about a crystal ball, but they had a big pit and pop my balloon. I spoke with them approximately a month ago and they were saying they were drafting a letter to J&J about starting settlement talks and it was all up to them. But when I called yesterday it was more stressful now. “J&J is not doing anything, we’re still trying they’re not”. Also, my attorney’s office is getting ready to go to court against J&J in Dallas or Austin end of this month, so let’s see how that goes.

  6. Teresa Akridge says:

    I myself have had 3 surgeries, and am in much worse pain now than in the beginning. My Md now states that we can’t even began to get this mesh out now. It is attached to my pelvic bone. I’m just waiting for it to cut through my euretha and colon. I can no longer walk without pain, sleep a whole night. I am a nurse and have had to stop working because cannot do my job because it requires standing, lifting, bending, walking, all of which I can no longer do. I’m taking a stand against J&J and Ethicon. I will no longer buy products produced by these companies or their co-companies. We can hit them hard this way if we all stand strong together!!! STAND STRONG AGAINST J&J!!! MAKE THEM PAY!!!

    • Don't give up says:

      Can someone put a list up of ALL of THERE PRODUCTS somewhere,I’m in just word to mouth and maybe others will follow.

    • Disgusted says:

      Hi Teresa,

      I somehow missed your comment.
      I’ve had 13 surgeries to date. I was in horrible pain after the third one. Don’t give up. My pain has decreased, of course not gone. I had removal with Dr. Raz after partial removals. He goes into no mans land. It took him almost 3 hours just to pry the mesh out of my pubic bone. Very difficult surgery. I highly suggest you go to him. You’re already in horrible pain, so what do you have to lose? Except financially. He is so worth it. I’m so sorry for your pain. Hang in there.

      The more I learn the madder I get. There wasn’t much foresight on the human side of things. The trocars were a new material, not used before and weren’t considered by premarket approval, let alone the 510k. The focus was on the mesh. The trocars go BLIND into the pelvis near many important nerves. Such a serious ball to drop. We were seriously considered numbers and revenue not people. SHAME ON ALL INVOLVED! A little common sense would have gone a long way. I know so much more about anatomy than I ever wanted to, but it is now clear the danger we were put into. And suffer with every day. If I had known then . . .

    • me says:

      mine was also attached to my pelvic bone. It broke in half and migrated on both sides. Dr. Veronikis in St. Louis removed mine and was able to remove most of it. He is excellent. You should give him a try.

  7. jan says:

    Sad to think Johnson &Johnson are filling an appeal..they know what they have done to all these women. .This company should be happy that the verdict was not 12mil..this amount is what they should pay all these women. .for all the medical past and present and fir the pain and suffering they have been going threw. .
    I have made it my personal goal not to have anything if Johnson &Johnsons because they will not do what’s right
    I pass the word to all mothers and mothers to be in my community churches, my grandchildrens school buddies..and anytime I see someone down a baby isle I put the mesh word out… it’s sad to think that this big corporation would rather make women suffer for there mistakes
    You just need to settle your cases SHAME on you

    • Jane Akre says:

      Their last attempt at an appeal will be to ask the State Supreme Court to hear it. So if the court denies that request…. the appeals process is over! is my understanding…

  8. Meshie says:

    https://annualsurveryofamericanlaw.files.wordpress.com/2015/01/589-hays.pdf

    I found this online and I find it rather interesting, not only are we Guinea pigs for the medical device community a side effect of that is that we are Guinea pigs for the legal system as well. I am not any anyway shape or form a legal person.

    There has to be a way to speed this up and I now believe it is with our Attorney’s… what would they do if we all called them and documented when and if they called us back. They need to make this happen now if not we need to have some avenue to reduce the amount per person they get even with a signed contact, I think this form might address that, but how do we make it happen… our Attorney’s… Judge Goodwin is trying to stay within the legal guidelines for everyone. The Gross trial survived every avenue of an appeal, well we need to start appealing and if we can’t say anything to anyone but our attorneys then so be it… Ready set… Call your lawyer every day, once a week, bi weekly we just need to say enough is enough… get this to court… they don’t have the staff to handle all of the clients they have… they need to feel the pressure we their clients are feeling.

    Again just my two cents….. HAPPY READING

    • Still Standing says:

      Meshie. It is common for people to blame the attorneys for the slow pace of the courts. However, try to understand that they WANT your case to succeed. After all, if they are in a contingency arangement with you, they are fronting the money for your case. The longer it goes on, the longer they must wait to be paid. Many firms borrow money to carry your case. It would not be helpful for you to barage your attorney with daily or weekly calls,for no reason. And, it may even cost you real money. Their settlement amount does not include the costs to bring your case to trial. It would be in your best interest to ask your attorney if they charge time for
      Phone calls, answering emails, etc. if so, these can add up rather quickly. When you do get a settlement or judgment, the attorney takes their percentage off the top, then they will give you an accounting of your case costs, which will be taken out of your percentagecase costs can be significant and taking up their time if you dont have valid questions may significantly eat into your award. Find out how they are billing your case.

  9. anna says:

    I think this companies were fast at teaching doctors to place the mesh, but did not think of training them for removals in cases of complication. I also, blame the doctors who should follow there code of ethic, and prepare themselves before taking a risk on women’s life’s. Now Doctors are not willing to say your suffering every day, because of your mesh. They are too busy, and don’t want to waste their time in a court trial. If you find them they are a drop in a bucket.

  10. Meshie says:

    Our Attorneys should also be pushing for autoimmune issues and make the companies prove it wrong.. again just my opinion. Each year that passes makes us stronger and the evidence stronger and this has to be pushed by Attorney’s sooner or later the public or Doctors will hear it because our Attorneys are fighting for us, or should be.

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