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Boston Scientific Must Pay Salazar $73.5 Million!

Obtryx II

Obtryx II

Mesh Medical Device News Desk, September 8, 2014 ~ A Dallas jury has returned a verdict in excess of $73.465 million for Martha Salazar in her product liability trial against Boston Scientific. That award includes $50 million in punitive damages.

See how it breaks down on Mesh News Desk.

Mesh News Desk had court watcher Joleen Chambers in the courtroom and she reported this tonight. At this hour there appears to be no other media coverage. The actual breakdown numbers should be available in the morning.

Salazar filed a product liability lawsuit against Natick, Mass.-based Boston Scientific. DrugWatch has more on the background of the company here.

Dallas District Court Judge Ken Molberg oversaw the trial (#DC 12 14349). Martha Salazar had filed an action against her implanting physician Dr. Jorge Lopez and Boston Scientific.

Dallas Judge Ken Molberg

Dallas Judge Ken Molberg

Salazar was implanted with a Obtryx® Transobturator Mid-Urethral Sling (MUS) System, a polypropylene mesh used to treat incontinence. Dr. Lopez did the 15 minute surgery January 17, 2011. Mrs. Salazar had testified she had SUI (stress urinary incontinence) symptoms only with active exercise or a cough or sneeze.

Salazar claims she was experiencing dyspareunia, pain, irreversible nerve damage to femoral and obturator nerve. Damage to adductor in right leg causes plaintiff to walk with limp. She just had 4th major surgery to remove mesh  recently which took hours.  More dangerous and invasive surgeries are to follow.

Salazar Alleged

– Warnings were inadequate to warn of the nature and extent of possible irreversible, permanent, catastrophic injuries. groin and pelvic pain. Dyspareunia, nerve damage, chronic debilitating UTI,

– The product is defective

– The risks outweigh the benefits.

-BSC did not adequately test the product on humans. Transvaginal implantation is not a sterilized field Bacteria with plastic initiates degradation, erosion, biofilm, shrinkage up to 50%. The middle of the Obtryx mesh is heat treated to make it stronger with no testing.   It becomes stiff and jagged edges form and effectively mechanically saw or dissect the urethra and other soft tissue.

-BSC ignored the MSDS issued by Phillips Sumika

-BSC withheld or concealed clinical trial information about these potential injuries

-the obturator approach is uniquely dangerous and needs more long term study

-BSC did not budget adequately for post-market surveillance and complaint investigation

 

WHAT WENT WRONG FOR BOSTON SCIENTIFIC

Peggy Pence P.h.D

Peggy Pence P.h.D

Chambers, who sat in the 10 day trial, says Boston Scientific played fast and loose with the evidence putting forth hours of studies and at one point claiming they had 2,000 studies that substantiated the safety of the Obtryx transvaginal pelvic mesh. When questioned about the data, the plaintiffs showed the studies were not about the Obtryx and good data, such as randomized controlled trials, were lacking. One study, for example,  only had three Obtryx patients.

Chambers says the evidence made the trial long and boring and what took ten days could have easily been summarized in four days.

The jurors often looked bored at the house of scientific studies. In one registry of data, funded by Boston Scientific, Chambers says according to testimony, the numbers were not going their way so they cancelled the study.

Peggy Pence, a toxicologist/pharmacologist consultant for the plaintiff who has been an expert in the Linda Gross case as well as Carolyn Lewis, testified that call center personnel were not well trained and did not pass on complaints coming in from customers. The call center had a huge backlog of 1,100 complaints that were not dealt with in a timely fashion.

Lawyers for Mrs. Salazar were Tim Goss (Freese and Goss), David Matthews ( Matthews Law), Richard Capshaw and Sheila M. Bossier from Mississippi. The jury of one dozen were about half men and women and racially diverse including white, black and Hispanics. The defense team was headed by Shook Hardy and Bacon, who also have represented the largest tobacco companies as well as the Sedgewick law firm from Dallas. Maria Karos.

Both sides had agreed no discussion of the Food and Drug Administration and its 510(k) process would be introduced. The feeling was it would bog down the proceedings.

One incident may have been significant. On Friday, a staff member of the Boston Scientific team told their photographer to take a picture of a juror who she believed was sleeping.   The judge, Ken Molberg admitted he sometimes closes his eyes but he is actively listening. The photographer was escorted out of the courtroom because it is the judge’s job to take care of his jurors and respect their privacy.

Boston Scientific sells Advantage Fit, Advantage, Lynx, Obtryx, Solyx, slings used to treat incontinence. The company is famous for making the first polypropylene mesh sling for incontinence, the ProteGen, which was removed from the market in 1999 over safety concerns. That did not stop it from being used as the “predicate” or equivalent device the Food and Drug Administration relies on as a basis for approval of new devices. See more here.

 

32 Comments

  1. Carmel Berry says:

    fantastic result! thanks Jane and Joleen.

  2. Nikki says:

    Thank The Lord!!!!! Finally !!!

  3. Jane R. says:

    Oh Holy Holy Day!

    I am so glad for Martha. Wow, 4 surgeries is scary.

    I can’t even imagine going through another surgery.

    One has ruined me for life.

    Thank you Martha. For leading the way for others.

  4. david tranter says:

    I have been following the mesh issue in New Zealand thanks largely to the efforts of the group representing the victims (Mesh Down Under). I am appalled at the attempts in New Zealand to cover up when matters go terribly wrong.

    I am thrilled with this news which will greatly help the fight all around the world. Well done to those who have stood up to the intimidating tactics used against them.

    David Tranter

    Health Spokesman

    New Zealand Democrats political party.

  5. Thank God. I feel for her. Same situation. I never walked right after surgery….and I now have to have a hip replacement at 50 : (

  6. Deb says:

    $65 million in punitive damages? Yes! It’s about time they started getting hit a little harder where it hurts them the most! All these greedy bastards care about it $$ – so, this is what needs to happen to make them stop. They obviously don’t care about all the lives being ruined … the pain and suffering they are causing… and for what? So someone doesn’t pee a little when they sneeze? ESPECIALLY when they can fix that anyway WITHOUT mesh!? No, it’s so they can make millions and millions of dollars, and that’s it. The risks of surgery with mesh FAR outweigh the benefits – and THEY KNOW IT! Maybe a few more cases like this will FINALLY make them think the risks of USING and SELLING defective products is also not worth the risk to them! Maybe. I hope this is the start of a landslide of cases with large punitive damages awarded!

    Thanks for reporting on this!!

  7. Susan Doyle says:

    So glad for u Martha like you I have also had 4 surgeries and totally understand the pain you have suffered any compensation will not ease your pain but will most certainly enable you a more comfortable lifestyle something you most certainly deserve hope all goes well in the future for you take care xx

  8. charles says:

    I feel as though lay people and juries are beginning to use intuition and visual imagery to for mental pictures of what is really happening with this mesh injury and i this is what has been needing to happen. The manner of ms salazars injury is explained so well in this trial . I actually feel as though the medical community will feel more comfortable addressing these injuries now that they are being publically uncovered.

  9. msm says:

    Absolutely fantastic. And to think that last week 5 of the manufacturers tried to get all cases thrown out together in Pennsylvania. Ha! I’m so happy for Ms. Salazar!

    • msm says:

      VERY disappointing that Texas severely limits punitive (exemplary) damages.

      Texas plaintiffs may only recover punitive damages that are less to or equal to twice the amount of economic damages, plus an amount equal to non-economic damage (up to $750,000 for the non-economic damages).

      § 41.008. LIMITATION ON AMOUNT OF RECOVERY. (a) In an

      action in which a claimant seeks recovery of damages, the trier of

      fact shall determine the amount of economic damages separately from

      the amount of other compensatory damages.

      (b) Exemplary damages awarded against a defendant may not

      exceed an amount equal to the greater of:

      (1)(A) two times the amount of economic damages; plus

      (B) an amount equal to any noneconomic damages

      found by the jury, not to exceed $750,000; or

      (2) $200,000.

  10. jade says:

    “Yes!” – Napoleon Dynamite

  11. Dean says:

    Holy Crap this might be the one we have all been waiting for first the victory for Mrs Huskey now this one they have been hot hard WOW

  12. Dean says:

    Hit hard.sory! my eyes poped out of my head reading this article

  13. All Meshed Up says:

    If I only had a dollar for every time a case had been settled and all of us mesh victims declare “Yes! This is the ONE! We finally have THE BREAK THROUGH!” But we do not a break through or a “Victory.”. How many of these cases have actually paid out the millions of dollars that are awarded. Or are they held up for another couple of years in appeal? “We” have not won anything. The manufacturers are still making, marketing and selling mesh products. The FDA is still allowing the 501(K) process to allow untested mesh on to the market. The Medical Community still stands behind most mesh products as the “Gold Standard”. We have not won a damn thing! Praise the Lord. For what? Are you still in pain? Can you have sex? Are Dr.’s still installing mesh into men and women TODAY? The day the the FDA comes out and stops the implants and the marketing of these supposed “benign” “Safe” products is the day we will have actually “won” something.

    And finally, will the Doctor who implanted her stop mesh implants all together? Will Boston Scientific stop marketing the products they have out now or will they continue making their mesh without change? This is no “Victory”. This is business as usual and another person will become a mesh victim today.

    Yes, Ladies I know I am harsh with my words but you cannot dispute my logic on this. Until Polypropylene Mesh is taken off the market and ALL mesh victims and survivors are compensated for the pain, suffering and loss they have experienced we have not actually won a thing. One or two “victories” does not end the war………

  14. All Meshed Up says:

    If I only had a dollar for every time a case had been settled and all of us mesh victims declare “Yes! This is the ONE! We finally have THE BREAK THROUGH!” But we do not a have break through or a “Victory.”. How many of these cases have actually paid out the millions of dollars that are awarded. Or are they held up for another couple of years in appeal? “We” have not won anything. The manufacturers are still making, marketing and selling mesh products. The FDA is still allowing the 501(K) process to allow untested mesh on to the market. The Medical Community still stands behind most mesh products as the “Gold Standard”. We have not won a damn thing! Praise the Lord. For what? Are you still in pain? Can you have sex? Are Dr.’s still installing mesh into men and women TODAY? The day the the FDA comes out and stops the implants and the marketing of these supposed “benign” “Safe” products is the day we will have actually “won” something.

    And finally, will the Doctor who implanted her stop mesh implants all together? Will Boston Scientific stop marketing the products they have out now or will they continue making their mesh without change? This is no “Victory”. This is business as usual and another person will become a mesh victim today.

    Yes, Ladies I know I am harsh with my words but you cannot dispute my logic on this. Until Polypropylene Mesh is taken off the market and ALL mesh victims and survivors are compensated for the pain, suffering and loss they have experienced we have not actually won a thing. One or two “victories” does not end the war………

    • Kitty says:

      All meshed up—Now simmer down young man. This has just come out—-it will take a little bit of time for this to get out. You are angry as we all are or have been. Justice will prevail

    • Dean says:

      All Meshed up: I understand your anger this verdict in my opinion is a victory then if more and more are won they are victories too we have to start somewhere and it’s been a good week with two casses and two verdicts with good outcomes Yes we all want to see a end to this Mesh harming people but would you rather see a win like this or it still at a stand still this shows the amount of suffering this women had to endure by the amount awarded hopefully this Will turn some heads but I do really understand your concerns we all have our opinions let’s Try to stay positive

  15. Aaron Leigh says:

    I couldn’t stop crying long enough last night even to call you!

  16. Jane R. says:

    Well the story is out on Bloomberg. And anyone considering this surgery might think twice about it.

    It’s going to make world news for sure. And it’s a big step to get this pulled off the market.

    It I ran the FDA, anything involved in a lawsuit would be pulled off the market. That would make sense.

    And I figured BS would appeal. Any company would with that kind of award. But the attention of

    the world is now on you BS. Hope the CEOs have good life vests.

  17. Ali says:

    So happy for her. I see a uro-gyno on Sept 25th to discuss removing the rest of it. That surgery will be my 4th also, I have severe low abdominal pain when standing from a sitting position after the sling sliced through my vaginal wall. Can’t wait to start feeling better. Money always helps… hope it takes away the sting of the future.

  18. Dawn says:

    I love how the FDA 510(k) process is always tabled.. I believe it would make a lot of sense to the jury to know that the polypropylene mesh that was used as a precedence was RECALLED after only 2 years on the market .. I believe it was the Progen, and all the meshes that followed are still on the market pretty much. Why would they not ALL BE RECALLED????

    • All Meshed Up says:

      You bring up a good point. The reason being is that the Court is usually petitioned by the Manufacturer to not allow the information about the 501(K) process nor any of the info from FDA’s MAUDE data base. Gosh! Why would that be? Could it be that the FDA does not want to admit that there are HUNDREDS of THOUSANDS of complaints in that data base? Which would bring up the question as to why there are no requirements that a “Bad Mesh” be sent to the FDA and the Manufacturer after it had to be removed. Many of the complaints are disregarded because there was no “product” to analyze. But if you have thousands upon thousands of mesh complaints, would you not want to know why?

      But it IS the FDA and gosh golly they cannot be wrong or biased or PAYED OFF. The FDA cannot bite the hand that feeds it. So unless you have some bad Chinese Dog Food, don’t bother the FDA. Best Wishes…..

  19. All Meshed Up says:

    First off Kitty, I am not “a young man” and simmering down is not what I am about. I am a Veteran, 57 years old, I have been in and seen war, and a mesh product took a great deal of my life away. DO NOT EVER refer to me as “young man”. And simmering down when all of this is happening to me and so many others? Do not be condescending to me, Kitty.

    I thought the Rhode Island verdict was “The Big Break Through”. That is until I realized that the mesh was not what was found to be the problem. And there have been more, before Jane Ackre starting reporting about mesh, but the difference is that those Court cases were about Hernia Mesh and mainly men.

    I am very happy about these verdicts but please tell me these women have received their Settlements. Do they have the monies they have fought for? Or are they still tied up in Court pending appeals? How much did they ACTUALLY receive if they did get it? Just asking. I have talked to a few that were involved in the RI MDL that are STILL waiting for maybe $5000!

    We are the Guinea Pigs and one or two Court verdicts does not end what you and I have had to endure because of a mesh product! Court cases have come and gone but mesh is still being re-invented, marketed and implanted. The Doctor that implanted Mrs Huskey or Salazar or even you, may still be implanting mesh, TODAY.

    YES! Rejoice, Praise the Lord and be Happy about these verdicts. But Please do not call it a Victory. Because that means an end to the conflict or the war. We are no where near that happy ending. Best Wishes……

  20. Karen says:

    Thank you jane !! Thank you Aaron !!! Have this information hit the new stations ?? Congratulation for both victories !!! I wish all our cases would come out as wonderful as this one did !!!

    • mom says:

      Karen :

      The thread below speaks volumes as to why we’re not likely to see news coverage on major networks. It comes back to $$$$$$$$$$$$$$.

      (Camille is coincidentally the last name of the President of AMS) (This is from CafePharma. Just search for “American Medical Systems”)

      “Anonymous

      02-20-2014, 09:48 AM

      Tick, tick, tick, tick, tick, tick, tick,….I can almost see Camille on 60 minutes, sitting between our attorneys, unable to answer the questions what did you know and when did you know it…

      Anonymous

      02-20-2014, 10:49 AM

      I would LOVE to see this on 60 minutes. Too bad main stream media is more worried about pissing off their sponsors than about real news or helping people.”

      • All Meshed Up says:

        Also Karen, when we approach a News Organization with our worries, complaints and injuries incurred by mesh, they have to investigate and check out our story. What is their first phone call? To the FDA. And that is where it STOPS. We are called disgruntled patients who want to sue to make money, we are drug addicts or mentally challenged. In short, we are not worth believing but you can trust us, the FDA. No reporter, other than Jane Akre, will proceed further than that. If the FDA say’s we are not worth listening to, why should they? So they do not.

        This story is SO Big that a reporter cannot grasp it. The FDA is protecting Manufacturers? No way. If our injuries are so bad, then we should be able to sue J&J, AMS, Boston Scientific etc, etc but we cannot for the most part because of the FDA? No way! The FDA is supposed to be the good guy! The FDA is there to protect US from the Manufacturers of bad medical devices and pharmaceuticals and of course they would do something about these mesh products but they are not, so WE the injured must be wrong. The FDA is the Trump card for the Manufacturers and so we can be portrayed as druggies and malcontents. And in that way our complaints are not considered worthy of comprehensive investigation or reporting from or by the mainstream media.

        It is very frustrating to me because I have been a witness to and a victim of this out and out conspiracy for almost 8 years. And it will continue…….

        • frank sharon says:

          I agree with you 100%—–the 510k program is about as effective as our Mexican border—and now they are allowing doctors to select implants that they benefit financially by using them—even though the product they select may not have the best track record.—then the scheme to have the patient pay for a 2nd surgery to remove broken implanted devices—-when titan spine announced that their neck implant devices were permanent and with a warranty that to me revealed a massive conspiracy to have the patient pay to remove broken hardware—– look how long they have allowed implanted screws that break or back out without being held accountable to victim.

  21. Jane R. says:

    Yes, I’m can now relate to Helen Keller here. It’s a tough go but the word is getting out so

    that can prevent others from having this surgery.

    I just got denied again my second SSDI claim. First one I didn’t have enough medical evidence to prove disability. SSDI acknowledge my complications from the Bladder sling surgery but I can walk and I can carry on a conversation so therefore I can work.

    Come follow me around in a day and see what I can do. I will appeal.

    • Disgusted says:

      I know! It is awful to be disabled and not recognized! We look normal but we are far from. I hope this nightmare ends sometime. Maybe some doctor will take up our cause and help us more than what is known now. We have been experimented on and it is so outrageous, that criminal charges should already be pending. It is so strange that a civil court can say a product is defective, but the criminal courts aren’t doing anything.

  22. Helen says:

    Fantastic result, it’s saying how wrong this disgusting mesh is, i have had 3 explant surgeries the last one was March this year, they still could not remove the anchors so the future is still uncertain.

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