Free Case Evaluation
Connect
With Us

The Mesh Trials: Mullins is Off, Huskey Appeal Over and Boston Sci Trial to Begin

Bryd federal courthouse, Charleston, WV

Mesh Medical Device News Desk, February 24, 2017 ~ One needs a scorecard to track the court happenings in transvaginal mesh litigation. While the March 6th trial of Mullins has been continued, the Huskey case appeal has concluded. March 13th is a Boston Sci trial in Philadelphia.  


MULLINS 

Judge Joseph Goodwin who is overseeing multidistrict litigation (MDL) in his West Virginia court has been busy.  With tens of thousands of transvaginal mesh cases filed before him, he has vowed to move them along and out of the MDL.

This week has been very busy for the Mullins v. Ethicon et al  case (Case No. 2:12-cv-02952), a trial of 24 or so women who live in West Virginia who were all implanted with the Ethicon TVT.  It was to be the largest trial so far of mesh-injured women consolidating the proceeds into one large trial.

It has been continued and has not yet been rescheduled, according to the court. Mullins  Order Doc.#1884 Continuing case, Feb 23 2017

Protesters, fed court Charleston WV

Ed Wallace of Wexler Wallace law firm, who had three women in the Mullins MDL, is not aware why the case was continued.  “We were ready to go and looking forward to proceeding, but we respect the court order,” he told Mesh News Desk. 

Judge Goodwin, has sealed under court order the juror list and qualifying juror questionnaires and supplemental juror questionnaires for the Mullins trial.  That court order is dated February 23, 2017. Mullins Doc # 1882, Juror Questions, Feb 23 2017

 

TVT, Wisbech Standard, UK

IS THERE A SAFER TVT?

Judge Goodwin was busy Thursday issuing an Order, this one on alternative designs.   Under West Virginia law, the plaintiffs must show there were alternatives to the transvaginal mesh treatment for incontinence. Mullins Doc #1881, Memo and Opinion, Feb. 23, 2017, Alternative Design 

“Evidence that a surgical procedure should have been used in place of a device is not an alternative, feasible design in relation to the TVT,” writes Judge Goodwin.

Logically if polypropylene is a huge component of defective design, as many contend, changing the shape of the mesh or detanging its edges would not make any difference. But a non-mesh repair does nothing to inform the jury on a feasible design for the TVT, according to the judge. The jury must be informed how TVT’s design could have been made safer to eliminate the risks that caused the plaintiffs injuries under the West Virginia theory of product liability.

(Both Prolene suture and the tension-free tape (TVT) are made from polypropylene. The average Prolene suture is a few inches long, the TVT measures one-half inches by 16 inches containing much more woven material made from knitted Prolene filaments. The more mesh the more mess, according to mesh removal expert M. Tom Margolis. Also Prolene suture is not intended to adhere to human tissue, while the TVT is designed to adhere to human tissue, making its removal difficult, if not impossible.)

Plaintiffs have argued polypropylene sutures should be considered an alternative, feasible design for the TVT, in other words, a non-mesh repair. The defense too has relied on suture argument, informing the court that sutures underwent premarket approval, therefore Ethicon is immune from prosecution under federal preemption. (See Riegel v Medtronic)

Judge Goodwin finds both arguments lack merit.

J&J’s Prolene Mesh

And that “polypropylene suture is not an alternative, feasible design for the TVT device as a matter of law.”  The plaintiff have to provide evidence of an alternative, feasible design for the TVT, a comparable product or design concept that was in existence at the time of TVT’s manufacture.  That then becomes the factual question that can be submitted to the jury.

Any other argument about alternative surgeries concerns the medical judgment of the doctors using the TVT device not on design defect.

In a lawsuit against the product manufacturer, the jury must decide on product liability under strict liability, negligence and warranty, each element must be proven by the plaintiffs.

The plaintiffs do not need to prove an alternative design to prove the product malfunctioned under West Virginia law, or to find negligence.

 

Jurors

DO JURORS GET TO HEAR ABOUT THE FDA?

What role the FDA plays in clearing medical devise for market under the 510(k) process will not be presented to jurors.

On one hand, the FDA clears most medical devices with an exchange of paperwork relying on the honesty and integrity of the manufacturer that it’s done its due diligence on safety and effectiveness testing.  On the other hand, the defense contends the FDA clearance implies safety.

Since the clearance of medical devices for market does not speak to safety or efficacy, A Motion in Limine, granted by Judge Goodwin means neither side can interject any discussion of the FDA and its role in regulating medical devices. Mullins Motion in Limine Doc. #1880,  Feb. 23, 2017

 

HUSKEY V ETHICON 

Huskey and Christy Jones, art by J. Akre

The Fourth Circuit Court of Appeals on February 22, 2017 issued an order denying Ethicon’s petition for rehearing and rehearing en banc.  No judge requested a poll on the petition for rehearing.

Now Ethicon can petition the  U.S. Supreme Court to take up the case, however, the nation’s highest court historically hears cases where there are conflicted lower court rulings, which is not the case with Huskey.   Appeal 15-2118.

 

Philadelphia Court of Common Pleas

SULLIVAN V BOSTON SCIENTIFIC

The trial of Sullivan v. Boston Scientific (Case No. 2:14-CV-18000)has been moved to March 13th in the Philadelphia Court of Common Please. Lee Balefsky of Kline Specter is the attorney for Ms. Sullivan.   ###

49 Comments

  1. Kitty says:

    Jane …u are a very good journalist indeed …thanks

  2. Lana Keeton says:

    Excellent news for all the Ethicon Plaintiffs in West Virginia! Now I will file oONLY a Motion to Take Judicial Notice to include all the information for the Amicus Curiae Brief for Huskey v. Ethicon and additional factual evidence only I have from my August 22, 2014 meeting with the FDA. I presented scientific evidence related to the inherent defects of the manufacture of all polypropylene. I met with 5 biomedical engineers, a toxicologist, a microbiologist, a general surgeon, an obgyn and a materials engineer, all senior personnel. THEY ASKED ME what the difference was between the safety profile of a polypropylene suture and polypropylene mesh saying “Your critical thinking on this question is very valuable.” Now I will rebut ALL info in the Ethicon Petition for Re-hearing before the 4th Circuit Court of Appeals in Huskey v. Ethicon 15-2118. They played their “best” hand which has zero basis and now It will all be re-butted before Judge Joseph Goodwin for all the thousands of cases that follow. That’s great!! http://www.lanakeeton.com Medical Mesh Talk, a Legal Forum (link to follow}

    • Jane Akre says:

      Sorry if it wasnt clear but the Fourth Circuit denied their second request for a rehearing en banc. It’s done for Huskey at the appellate level, unless the SCOTUS takes it up,, it’s over.

    • Jane Akre says:

      Please help support Lana, she’s been at this for a long time and needs a little support from many people…. thank you.

    • UpsetProlift Victim says:

      Thank you Lana!! Will do my best to send you money.

    • Holmly says:

      I just wanted to thank Lana and Jane for all the hard work you put in for us. It’s nice to know that someone cares about us and we aren’t just a bunch of misfits from medical device island. Lol!

    • K says:

      I know that we all want to bitch and the press is at your heels, many if not most have signed non-disclosure agreements. Don’t forget that these are the main sites looked at and you are forbidden to say anything negative, derogatory, threatening, you get the point. You are usually allowed to speak with your counsel and what is considered “advisors”, but I am positive about posting on the internet. I will be deleting this post as fast as humanly possible. Chew on your words before you spit them out. Just a friendly reminder to make sure that you want that on the internet before you hit post. It literally can change your life.

      • Jane Akre says:

        You can certainly post anonymously or with a fictitious name. Please do not use your real name here, first and last. Thank you.

  3. Rene says:

    I am waiting for Boston Scientific to reach their their threshold…this is what my lawyer is waiting for ..I signed my papers last september for my settlement…I do not understand what waiting for a threshold means and how long it takes…please let me know your take on it

    • Jane Akre says:

      It may mean they are waiting for 90 to 95% of potential participants to agree to the settlement, but that is an excellent question for your lawyer. That’s why they make the big bucks!

  4. Angela S says:

    Hi Jane. I just received an email from my attorneys regarding Bill 598 being introduced to Congress which could end MDLS and also be retroactive? Do you have any information on this? They are asking all to contact their Congress representative and vote NO on Bill 598. Thanks for any info.

  5. asr says:

    That would be HR 985 regarding MDL.

  6. Mart says:

    Boston scientific is slow in settling there claims that they know there liable for if you have good attorneys that know what there doing then this shouldn’t be to much of a hassle unlike my attorney I wish I would of thought twice before hiring them to take my case

  7. Mart says:

    Why don’t they just leave the huskeys alone and move on they’ve suffered enough already

  8. Pat says:

    Jane,just read MDL orders for Goodwin’s court in W.Va that motions are filed regarding the 400 oldest Ethicon/J&J to start preparing for trial.Dates are set for depositions,motions,etc.Might want to check it out

  9. steve wheeler says:

    not a surprise ,yet another delay..perhaps they are waiting to see if house bill h r 985 gets passed.the corporate immunity act.just filed this year in the house.would elimate americans right to seek redress in court system,through class actions or mdl. efforts.if passed seeks to have retroactive application which could elimate cases already filed or pending in mdl for years.. write your congress person with your story and urge them to vote no on this bill.

  10. Deborah s says:

    Upon reading the article regarding Mesh Trials, two things stand out clearly. 1) The idea that there MUST be a safer TVT design to rule that a patient was injured by mesh is ludicrous!! There is no safe, alternate design for a mesh product. The problem goes much deeper than that. Look into the chemicals these products are made of. There are less damaging procedures, but there is no such thing as a safer synthetic mesh product. What a crock!! 2) Ethicon is contending that the suture material underwent premarket approval and therefore is immune from prosecution. I challenge you to dig into the FDA’s ‘approval’ of these sutures. There were ALWAYS complications…even with one synthetic suture. It doesn’t take a freakin’ genius to figure out that if ONE tiny suture caused enough inflammation and complications for the FDA to put off approval for years…then it SHOULD go without saying that millions of tiny sutures, produced from the SAME chemicals, combined to form a synthetic mesh would have DEVASTATING RESULTS!! They are foreign bodies made of toxic chemicals. OF COURSE the body is going to reject it!! 3) The FDA has a specific role in society. When they approve a product, regardless if it’s a drug or device, it is understood that the product is safe for public consumption. If they are no longer responsible or accountable for ensuring the safety of the American public, what IS their damn job?
    The fact is manufacturers put the almighty dollar ahead of patient’s well-being. There was NEVER any doubt that there would be complications. Surgeons have only recently had an opportunity to view the very complicated and catastrophic results of these products. It’s not the surgeon’s skills but the chemical makeup of the product that is the risk. STILL they aren’t privy to the information that Lana and I discovered during our many all-nighters to find out what the hell just happened to us. There are MSDS reports floating around that explicitly state that these products are NOT to be used in the human body, either temporarily or permanently, for ANY purpose. NOT EVER!!
    Now, Lana Keeton has busted her ass to help ALL VICTIMS of these mesh-related cases hold those accountable for their ongoing, debilitating injuries since I’ve known her. She’s crisscrossed the country to make meetings with the FDA, to DC on multiple occasions to meet with various Senators and Congressmen in an effort to get these products off the market!! She’s made this her Mission in Life!! Until recently she’s managed to do all this pretty much on her own. She’s a highly intelligent and capable woman. But the legal team she’s been assisting has elected to deny her fees, even though they’re contractually bound. As a result, she’s behind on everything and in desperate need of funding. A mere $20 from each of us should get her over the hump and back in the business of ‘Stopping the Mesh Madness’ that has become our new ‘tortuous’ normal. I am pleading with you to do whatever you can to assist the one who has put the welfare of each mesh victim at the forefront of her life. God Bless you all.

    • Jane Akre says:

      Agreed. Lana has done a great deal for everyone. If all give a small amount it doesn’t mean much to you but a great deal to her. As far as the safer design, that is West Virginia law, an issue that must be met to prove product liability. Agreed, in this case it makes no sense because it ignores the basic premise of the material!!!! For those of you interested in more… Here is a paper on product liability laws in WV
      http://www.dinsmore.com/files/upload/West%20Virginia%20Products%20Liability%20Monograph.pdf

      • Deborah says:

        There’s so MUCH more work to be done, so many injured patients and more evidence to present. Lana has been instrumental in getting us where we are today but the journey has just begun in earnest. Please try to help support this champion for women. Donate here to keep the fight going.
        http://www.lanakeeton.com

  11. bejah B says:

    Hello Jane and everyone, I finally got my laptop back with new HD and I am in process of reloading everything, very time consuming and problematic at least for me. Outlook Express will not work right per Frontier tech so I am advised to contact Microsoft which I will do. I will need to upgrade soon at least to V7…I hear V10 has problems but do not know if this is so.

    I will begin reviewing all articles and comments here soon trying to get up to speed and hoping for good news. I REALLY missed ya’all.

    Bejah

  12. Waiting for Justice says:

    Just what I expected another delay for the trail of 24 women in West Virginia. If Judge Goodwin really wants to move things along why does he keep allowing these trails to be postponed? Do the injured and suffering a favor Judge and send our cases back to our states to be tried, we are not getting anywhere in the MDL!!! So frustrating!!!

  13. Waiting for Justice says:

    Spelling correction for above post. The word is trial not trail or trails. Sorry but I am very frustrated at this take forever pace of the mdl. It is obvious that Johnson & Johnson / Ethicon are dragging their feet and Judge Goodwin is just letting them have their way! What about us who are hurting? Don’t you care Judge Goodwin? If you do I’m sorry but show us you care and get this long process moving!

  14. Waiting for Justice says:

    Just what I expected also Steve another delay for the trial of the 24 women from West Virginia. If Judge Goodwin really wants things to move along why does he keep allowing these trials to be postponed? This is rediculous! Do us a favor Judge and send our cases back to the State Courts to be tried. We are not getting anywhere in this take forever MDL. Please Judge if you really care about justice stop playing right into the hands of Ethicon and Johnson & Johnson. They are sitting back laughing at all of this while the injured and hurting continue to wait and suffer!

  15. K says:

    Imagine that! I knew the Mullins case would be postponed.

    • Jane Akre says:

      You were right! I’ve heard it settled, but that is not confirmed. It may be in the process…. You called it!!!

      • K says:

        If it settled I am happy for them but it really doesn’t help with what the cases are worth in the MDL. I really don’t believe the MDL works.

  16. Tami says:

    I’m in the Boston scientific battle and have been since 2011. I never hear anything from my lawyers. They returned 1 out of several calls abt 2 months back because I sent a email.
    Bottom line, I’m sick or the wait and lack of correspondence.

  17. Waiting for Justice says:

    Jane what settled? I am a little confused. Also can you shed any light on this hr985? Thank you!

    • Jane Akre says:

      I got one unconfirmed report that a woman was offered a mesh settlement, she was part of Mullins. If a mass offer was made to settle one case,,, it would have to be confirmed by the plaintiffs so it would take awhile to get that confirmation…. In that case continuing the case would be wise.

  18. Waiting for Justice says:

    If HR985 effects class action and the Mdl cases can we the plaintiffs withdraw from the Mdl and file individual suits against ethicon?

    • Still Standing says:

      I don’t think we can individually withdraw from the MDL in process. Most of us didnt elect to get here. You can petition to be remanded to state court, but if your case is not air tight, you may not be able to find an attorneynto take it on contingency. MDL placement is determined by federal judges. The bad thing now is that if you withdraw and hire a new attorney, you still have to pay for your current attorney’s fees from any settlement you receive in the future. They would in essence, have a lein on your settlement. Then, your new attorney would be at a clear disadvantage unless he/she has access to the shared MDL discovery. It is very complicated for sure.

  19. Still Standing says:

    HR985 was introduced in the house on February 9 then it was sent to judiciary committee that same day. It is still in committee and it appears that there has not been any action taken yet. Nothing has been passed. It will stay on committee to be marked up, sent back to the house, maybe back to committee again until house takes it up for full vote. . Then, it has to go to Senate and through a long process there. This bill does NOT take away our rights to file suit. Follow it on Congress.gov. The biggest impact is on class action law suits, which do need overhaul. It limits what attorneys can get paid utntil after claimants get paid. Im sure class action lawyers dont like it because, generally, class actions suck alll the money out of settlement and claimants receive pennies. For MDLs, it does change the percentage of money attorneys can receive in relation to plaintiff. That could also be unpopular with product liability attorneys. Read the bill and ask questions before you call to ask that it not be supported. Not sure what it is going to do at this point and by the time the house and senate committees get through marking it up, it may look entirely different from the one that gets voted on. In any case, it would be better to wait to see the final bill before you lobby against it.

  20. Waiting for Justice says:

    Still Standing: Thank you very much for the info, it really helps clear things up. Thanks again!

  21. Anonymous says:

    Why can’t news organizations report this. I have to quote this instead of finding it in the news!

    4th Circ. Backs $3M Pelvic Mesh Verdict
    By Emily Field

    Law360, New York (January 26, 2017, 5:18 PM EST) — The Fourth Circuit on Thursday upheld a $3.27 million jury verdict handed down two years ago in a bellwether trial over Johnson & Johnson subsidiary Ethicon Inc.’s allegedly defective transvaginal pelvic mesh implants, finding that the woman who brought the suit showed sufficient evidence that the mesh caused her injuries.
    In a published opinion, the Fourth Circuit rejected Ethicon’s argument that Jo Huskey had failed to prove there was a specific flaw in the design of her TVT-O sling, finding that the record belied that assertion as she offered sufficient evidence for a reasonable jury to find that the company’s use of heavyweight polypropylene mesh in the sling caused her severe scarring and pelvic pain.

    “We’re very pleased with the ruling and excited for Jo Huskey and the team that worked on the case,” Edward A. Wallace of Wexler Wallace LLP told Law360 on Thursday. “Given the length that the court went to explain its reasoning, we hope it can be used to demonstrate to Ethicon that it needs to go ahead and resolve all of these cases for all of these women.”

    Huskey’s expert witnesses had testified about the body’s reaction to heavyweight polypropylene. One witness was also a former Ethicon employee, Dr. Brigitte Hellhammer, who testified that she had no reason to believe that lightweight mesh couldn’t effectively treat stress urinary incontinence.

    “Drawing all inferences in the Huskeys’ favor, a reasonable jury could conclude from this expert testimony that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect that caused Mrs. Huskey’s inflammation and pelvic pain,” the panel said.

    Huskey sued Ethicon in 2012, claiming the polypropylene mesh in her TVT-O sling eroded, causing her severe, ongoing pain as the mesh could not be entirely removed through surgery. Her husband, Allen, also sued for loss of consortium.

    The suit was the first bellwether case to go to trial in the massive multidistrict litigation against Ethicon over its mesh implants. The trial concluded on Sept. 5, 2014, with the jury deliberating for about three hours before returning its compensatory damages verdict.

    U.S. Judge Joseph Goodwin solidified the jury’s verdict in August 2015, refusing to throw out the verdict as a matter of law, or alternatively to allow a new trial, finding that the plaintiffs had brought sufficient evidence that Ethicon failed to warn Huskey’s doctor of certain risks in implanting the company’s TVT-O polypropylene mesh product, and even stronger evidence that there were defects in the product’s design.

    The panel also rejected Ethicon’s argument that a product liability doctrine known as “comment k” — which holds some products, such as vaccines, are unavoidably unsafe though not unreasonably dangerous — provided a shield from Huskey’s claims.

    Huskey is an Illinois resident and courts in that state determine on a case-by-case basis if a specific product is covered by that doctrine, the panel noted.

    Much of the same trial evidence that indicated the use of heavyweight polypropylene mesh constituted a design defect also suggested that “comment k” doesn’t shield Ethicon, the panel said.

    For one, a jury could reasonably infer from Hellhammer’s testimony that if Ethicon had used a lightweight mesh, the TVT-O would have stayed effective and patients would have a lower risk of reacting to the mesh, the panel said.

    “Taken together, the expert testimony allowed the jury to infer that Ethicon could have designed the TVT-O with lightweight mesh without sacrificing any performance,” the panel said.

    A spokeswoman for Ethicon told Law360 that its company is reviewing its options.

    ” The verdict in the Huskey trial was not supported by the evidence and we believed we had strong grounds for this appeal,” the spokeswoman wrote in an email Thursday. “Ethicon’s TVT-O midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development, and marketing of this device for the treatment of stress urinary incontinence.”

    Huskey is represented by Edward A. Wallace and Mark R. Miller of Wexler Wallace LLP, Fidelma L. Fitzpatrick of Motley Rice LLC, and Jeffrey Kuntz and Adam Davis of Wagstaff & Cartmell LLP.

    Ethicon and J&J are represented by Christy D. Jones of Butler Snow O’Mara Stevens & Cannada PLLC, David B. Thomas and Philip J. Combs of Thomas Combs & Spann PLLC and Charles C. Lifland, Stephen D. Brody and David K. Roberts of O’MELVENY & MYERS LLP

    The case is Huskey et al. v. Ethicon Inc. et al., case number 15-2118 in the U.S. Court of Appeals for the Fourth Circuit.

    –Additional reporting by Steven Trader. Editing by Kelly Duncan.

    https://www.law360.com/articles/885170/4th-circ-backs-3m-pelvic-mesh-verdict

  22. Anonymous says:

    QUOTE
    “We’re very pleased with the ruling and excited for Jo Huskey and the team that worked on the case,” Edward A. Wallace of Wexler Wallace LLP told Law360 on Thursday. “Given the length that the court went to explain its reasoning, we hope it can be used to demonstrate to Ethicon that it needs to go ahead and resolve all of these cases for all of these women.”
    END OF QUOTE

    PLEASE Dear God, let Ethicon move on with it already! They ruined my life. I have been waiting in NJ court roll for 5 long years!!!

  23. Anonymous says:

    Also: The NJ GYNECARE TVT MESH cases management conference calendar; has always updated quickly and has not from the end of Feb.

    http://www.njcourts.gov/mass-tort/pelvicmesh/calendar.html

  24. Anonymous says:

    Wasn’t Mullins the TVT consolidated case where they asked the women to go to a doctor?

    Were the women ever made to go to a doctor? This is ridiculous as this can’t prove chronic pain and suffering. Surgical records for revision and removal should be all that is needed…

    • Jane Akre says:

      It is required that you go to a doctor of the defendants choosing, in case you are not being truthful They get to make their professional assessment.

  25. Kitty says:

    Section 5 speaks of transvaginal mesh MDLs

  26. Waiting for Justice says:

    A doctor of the defendants choosing? I know how that diagnosis will turn out. This women is lying! She is not in pain as they shove the hush money in their pockets!

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This news website is designed by NextClient.com.