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Rabiola Trial Rescheduled to 2016, First Trial for TVT-Secur

TVT Secur, Megamed Service, RU

TVT Secur, Megamed Service, RU

October 27, 2015 ~ The Josephine Marie Rabiola v. Ethicon trial, scheduled for Monday, October 26 in Austin, Texas has been rescheduled to February 2016 at the Austin court’s request.  The judge is not set in this rotating docket. The case is expected to be rescheduled one more time at a later date, perhaps mid-2016.

Rabiola is represented by the Matthews Law Firm as well as Freese and Goss.

The case was remanded from multidistrict litigation in Charleston, WV to Austin, Texas – Josephine Marie Rabiola v. Ethicon, 53rd Judicial District Court, Austin TX. Case no. D-1-GN-13-002039.

Ms Rabiola, of Austin, Texas, was 63 years old when she was implanted with two meshes – first the Gynecare TVT Secur System to treat stress urinary incontinence (SUI) on May 24, 2010. She was then implanted with Gynecare Prosima Pelvic Floor System to treat pelvic organ prolapse (POP) on November 2, 2011.

TVT Secur tip, Neuman Urology, Israel

TVT Secur tip, Neuman Urology, Israel

The meshes are made by Ethicon, a division of Johnson & Johnson and include polypropylene mesh tethered in place with two arms that extend up through the buttocks.  They were approved through the FDA’s 510(k) approval process.

Both meshes were removed from the market in 2012.  See the Mesh News Desk story here.

Even though they were voluntarily removed, a quick online search fines one can purchase the TVT-Secur for a suggested price of $900 here.  (No date of this post is given.)

A legal victory was just handed to Ethicon this month in the Dallas trial of Cavness v. Ethicon. She was implanted with the Prosima mesh for pelvic floor repair.

Rabiola has included her implanting doctors in the action – Tomas G. Antonini M.D. of Lone Star Urogynecology and Continence Center, Seton Healthcare Family of Hospitals including its Medical Center, Johnson & Johnson and Ethicon.

 

THE COMPLAINT

The complaint says despite the claims polypropylene mesh is inert, scientific evidence shows the material is “biologically incompatible with human tissue and promotes an immune response.”  In addition,  it degrades, causing severe adverse reactions to the mesh including shrinkage from 30-50%, erosion and bacteria harbored in the small weave.  Polypropylene is impure, the complaint says.

mesh particlesThere is no such thing as pure polypropylene. Polypropylene contains about 15 additional compounds which are leached from the polypropylene and are toxic to tissue which enhances the inflammatory reaction and the intensity of fibrosis.”

Mesh anchors are likely to pass through and injure major nerve routes in the pelvic region. Welding of the mesh during its production creates a toxic substance that contributes to the mesh degradation, says the complaint.

These mesh products were marketed to the public through aggressive campaigns despite the high failure and complication rates, according to attorneys for the Plaintiff who add that J&J and Ethicon have consistently under-reported and withheld information about the propensity of its products to fail and cause injury.

Injuries include mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and prolapse of organs.  Many women must undergo repeat surgeries, pain control, injections, explant surgeries and repair surgeries in an attempt to rebuild what has been damaged.

She suffers physical pain and mental anguish, now and likely in the future; disfigurement; physical impairment and medical expenses, both now and in the future.

Tomas Antonini, M.D.

Tomas Antonini, M.D.

Ms. Rabiola was implanted on May 24, 2010 by Dr. Chris Hart with the TVT Secur to treat stress urinary incontinence.  Dr. Antonini owns the medical group and he knew or should have known the pelvic mesh products had a high failure and injury rate, failed to perform as intended, and often required additional surgeries.

Ms. Rabiola went to Dr. Antonini to consult on the TVT Secur System and he recommended the Gynecare Prosima Pelvic Floor Repair System be implanted.  He failed to inform her of all of the risks involved, according to her complaint.  Had she known, she would not have consented to the implantations. On November 2, 2011, she had the products implanted to treat SUI and POP.

 

CAUSE OF ACTION

The causes of action include Negligence– J&J and Ethicon failed to use reasonable care in designing, manufacturing, marketing labeling and packaging its pelvic mesh products.

The doctor and hospital failed to select the proper treatment for SUI and POP patients and improperly selected her as a candidate for such products.

Other cause include Strict Liability, Design Defect – Dr. Hart and Antonini were in the business of supplying these products, which were defectively designed when they were sold and were unreasonably dangerous. The Plaintiff was not warned about the risks.  This was proximate cause the damage and injuries to the Plaintiff.

Breach of Implied Warranty – The Plaintiff relied on the implied warranty of merchantability of the Defendant, which they breached because the products were not suited for their intended use.

Breach of Express Warranty – The Defendant made assurances to the public, to hospitals and doctors about the safety and fitness of their pelvic mesh products.  Ms. Rabiola relied on those promises.

 

BACKGROUND ON TVT-SECUR

This will be the first trial of the TVT-Secur System, a mini-sling that mimics the TVT-Obturator placement.   See European Urology tvt secur neuman urogynecology  here.

The only other trial of the TVT-Secur involved the case of Stacey Wilkins which was settled in a Joplin, Missouri State Court in May 2014 for an undisclosed amount. Adam Slater was her attorney.  See the Mesh News Desk story here. 

The TVT-Secur was intended to be the third generation and an improvement on TVT (transvaginal tape).  In the case of a similar product, the Abbrevo mini-sling, Plaintiff Coleen Perry received a $5.7 million jury award in March 2015.  #

 

10 Comments

  1. Greg Vign says:

    I would expect Mr. Mathews to be prepared.

  2. janet says:

    Sad

    I guess thus is how our judges and attorneys deal with solving important issues they keep pushing it back in hopes it will go away

    This is not fair we all have been waiting for justice many many years now

    And here we sit many many years later and we are still know where with any of it

    When will it be enough for us women to get what is due to us because these manufacturers butchering women and getting by with it

    • Advocate says:

      Janet,

      Often times, when the court requests that a trial be set back, it’s because of other cases in line before it, have tumbled backwards. That differs from a delay request by plaintiff or defense, which is usually due to discovery not being complete or some such thing as, witness testimony scheduling problems.

      The state courts will be scrambling to find judges to hear these trials, since the cases are an increase to the loads already scheduled. Look at the the number of federal judges in your state. You can find them on your state website. Understand, these judges listed, have a full calendar of cases to be heard before them. Your state allocates judges, based on expected case loads and factoring in vacations and illness, just like any other business would. Suddenly, these state courts find all these cases being sent back.

      Imagine a theater with it’s limited seats for a movie release. More people show up than the theater can hold nor they expected for the movie. Now they have to get an additional screen and all the people it takes to be functional for the over flow. Although overly simplistic, this example is the problem the state courts will incur, when cases begin flowing back in. A lack of judges, courtrooms and staff, could push trials back months at the very least. Some states may be able to absorb the cases, because they are few. Other states that have more litigants, like a CA., TX. or FL., could have a disaster waiting if they have a few hundred cases sent back.

  3. Barb says:

    Jane, Why is it that those who don’t get to have their say in court are not being awarded for infections of any type, No IC?? These infections have already been stated by the FDA and been in cases in court!! I spoke to another attorney firm they don’t suggest changing as they will put a lien on your settlement if ever awarded plus a new law firm and government insurance hold back of 20-25%! They encourage us all to seek medical treatment however why should we continue to if they are not compensating for fixing SUI, infections or POP. My attorney firm tried telling me I did not have organ prolapse after implant I had it before I told them read my medical records and you will see I was not diagnosed till 2011-2012!! If I had those issues 8 plus years ago it would have been taken care of after all these years, grade 2 on rectocele/cystocele operation will be grade 3!! I still have not been told what figures that are putting on the tiers within the categories! I still have no idea after 3 revisions what that is worth and will have to appeal for surgery performed in July 2015! I want to know exactly what they are taken in consideration of injuries, we who have AMS will never walk away with enough!! I would be much happier if I was walking away with $300, 000 after all deductions however no one will!! 1.6 million they have allready paid over 1 million!! I’m going to demand to know how much money is awarded for pain and suffering, loss of intimacy, I cannot believe that having 2 defective devices doesnt play any role!! They seem to be trying to put alot of our issues on the implanting doctor;s!! I was never given any information pertaining to risk, a 20 minute procedure vaginally and being 47 at time of implant, 1 year to the date of the first implant the TVT-O was inserted 2 days later emergency because urine back-up so adjustment needed, yes that does happen. I also feel they are putting much responsibility on us saying we did not do the research prior too!! My surgery from July was over $16, 000 I don’t know what I will have to pay and if we had SUI/POP prior too which we al had a reason to have this done also they are not compensating my feelings IF THEIR PRODUCTS WERE NOT DEFECTIVE IN THE FIRST PLACE, IF OUR DOCTOR’S WERE PROPERLY INFORMED IT WOULD HAVE BEEN PASSED ONTO US!! Is it just government insurance being reimbursed or do other insurance companies have their hands out as well?? I have been referred to a urologist to see if Im a good candidate for collagen injections since mesh will/cannot be used but Im camcelling my appointment! I don’t believe medicare will consider covering plus 2-3 injections usually needed, usually under anthesia and would have to have someone drive me home!! They say seeking medical help for our injuries issues helps build our cases stronger but why bother when they are not compensating for what is medically needed to be done!! I feel betrayed, fro any AMS Client my feeling is after they came to a settlement they should have sent us all information on how/what was being included in our cases if they had done this no way would so many people have signed on the dotted line, I would not have~~~

    • Jane Akre says:

      Barb- Apparently the more procedures, the more valuable your case. All of your questions are good so they are ideally answered by your law firm which will have no problem collecting its 40% from you when the time comes! Also if insurance wants to be reimbursed, is it for a reduced amount? Can you receive a return of the premiums you paid in order to be insured? It seems everyone has their hands out indeed… I continue to believe this is nothing short of an atrocity on the unsuspecting and an entire generation of women is wiped out from this “minimally-invasive” experiment. Shame on them.

      • Advocate says:

        Jane,

        All insurance will probably be required to be reimbursed if they put in for reimbursement. In usual 3rd party injury, they recover their outlay of payment only. Meaning, they only get that amount that they actually paid. They don’t usually reduce that money. Premiums paid by the insurance subscriber are never reimbursed. The insurance company never wants to be out money when their subscriber was not at fault for the injury. That’s an expense of the tortfeasor(defense).

        The nature of mass settlements, is what makes the situation difficult for Barb and others to understand. Barb will never get a breakdown as to how much, each aspect of injury was worth. The reason is, it’s a global injury offer, not a specific injury payment. Most people think in this way… I have three different injury symptoms to my mesh injury. I should be compensated X for the first, Y for the second and Z for the third. That all adds up to my total award of $.

        The settlements are not done on all individual symptoms though. For instance, each defendant has designated a signature injury(s) (an injury that is supported clearly with science, clear causation and that it exists in every single case, although varied by degrees.) that makes the baseline for settlement offers. If a plaintiff doesn’t have one of the signature injuries, the chances are they’ll receive little to nothing, regardless of how many other symptoms they may demonstrate. Not all clients have loss of intimacy or infections or some other symptoms that are still not scientifically linked to the mesh, today. The defendant won’t give any credit to those in settlement. Only those they deemed signature (thus the importance of surgical procedures as a signature confirmation) by looking at hundreds of cases and maybe some small bumps for these “other” symptoms. These settlements, while reviewed case by case, do not have a great deal of difference in monetary value. One woman may get X on a level 1 signature and another may get Y on a level one signature, but the total dollars of the level never changed. I know that attorneys have presented their case inventories for valuation (each case reviewed for signature injury) and then been left to figure out which of their clients would get how much out of each wave award. So 10 cases are settled for 1 million dollars and then the attorney figures out how much each client will get in those 10 cases, until the million dollars are gone. Simple math says… if they give 110,000 to one client, another will only get 90.

        As we’ve said a thousand times on the blog, anyone can turn down the money offered. Some are better positioned financially to “wait out” the process. Others not so much. This much I am sure of. The offers will not climb much higher globally, for any of the defendants attempting to settle. The defense incentive for settling is for only one of two reasons. First is money, if that money makes sense to them. Secondly, if it affected their overall business channels, and it won’t. Damage will be contained to their mesh business arms only. So the plaintiff is saying no to the settlements and that means in a few months, 3-6, the judge might send those cases back to the states for trials. The plaintiff can figure 18 -24 months before they get on the calendar for trial and probably at least one motion and more like two, to postpone for various reasons. Time becomes the issue for most.

        If our victims face 3 years for trial and then end up with a negative verdict like Cavness…well, I don’t know how that will work in the end.

        • Jane Akre says:

          However, advocate- far more women have had positive outcomes from their state court trials…. in the hundreds of millions of dollars. Yes two recent losses to Defendants, but the odds are in the Plaintiff’s favor if the past is any indication …..

          • Advocate says:

            You are correct Jane. The cases tried to date, have done well and we hope they continue along that path. But these cases are representative of the “best” the plaintiff attorneys have in the litigation and the best litigation teams in the country, trying those cases. They also contain the defense belief of the “worst” of cases, or certainly those that are questionable.

            It is my opinion, based on conversations I’ve had with attorneys that you and I both know and respect, the breakout of cases in any group that are clean and capable of trial, is somewhere in the 35% range. Keeping it simple, 3.5 cases of every 10, are well documented medically, have all of the signature injuries and the client is compliant. There is another 3 to 3.5 cases of every 10, where elements of the first 3.5 are missing. Still, the attorneys are confident that despite the deficiencies, they have a chance to prevail at trial.

            That leaves a final 3 to 3.5 cases the attorneys brought in, but never wanted to expose to a trial. In fact if they knew they would be trial cases, they theoretically, would not have signed them. That’s not to say these women are not injured, just there are a great many impediments to be taking them to trial.

            Our concerns about winning are always pinned on the strength of the medical documentation, the causation that is provable and the likability of the client. Above all else to be considered, is the strength and experience of the attorney walking into that court room. Inexperienced attorneys, will bring about the worst results, with even the best cases.

    • Still Standing says:

      Barb, from what I have tried to glean from this process is that there are no clear answers on how insurance companies lay claim to your settlement dollars. There are a few states that have what are called “anti-subrogation” laws. Subrogation is the process where private health insurers get reimbursed for what they paid out in your medical care related to your personal injury claim. The states that prevent subrogation are: Arizona,Connecticut, Kansas ,Missouri, New Jersey, New York, North Carolina, Virginia. I may be missing one but you can look online for states with anti-subrogation laws. Some of these laws have been upheld in the Supreme Court but I still dont understand even a fraction of this process. The reasoning for anti-subrogation is that private insurers charge you a monthly premium based on the anticipation of risk across their insured population and they can’t then claim that they should get any settlement $$ since the cost is spread across all the insured. I do know that federal law can trump the state laws. If you are on Medicaid/Medicare it is another ball game and of course they will have a lien on your settlement. There are other technicalities where private insurers can make claims but I am at the end of my knowledge base on this one. You can do an online search abour subrogation and come up with lots of confusing information. Im sure there are other readers who understand this better than I do, but maybe this will start an interesting conversation.

      I do know that the law firms involved in settlement distribution are required to hold back the 25% while the Settlement Master does a comprehensive lien search and reaches some compromise with your insurers. If your liens are not as much as what is held back, then you will get the rest of your money at some time. Fortunately, my law firm is very responsive to my questions so I have to give them a nod for being willing to educate me about this process. It must be frustrating to be left in the dark. Pretty unprofessional on their part. Maybe if we all contribute our knowledge we can come up with a more complete picture.

      Now just a quick comment on the collagen injections. I have a couple of friends who have tried this because of their fear of surgical repair based on my experience. Both did not have good outcomes. It just didnt work for very long. It would be interesting to have some input on this as well.

      You seem so frustrated and rightlyfully so. Emotional stress can increase physical pain, so I am hopeful that you have some ways to release your frustration. I have done mosaic art over the years. Buying old dishes at garage sales, then smashing them to bits to use in my design is very therapeutic! And who says you have to use the pieces for art. Maybe a psychological mosaic is reason enough. I wish you well.

    • Nora says:

      Let me know what you find out. It’s all what i am going thru now. Laying in bed,as i type this in pain from rectocele surgury.ihave had over@least four surgeries ..Jane hasbeen a Godsend

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