Boston Scientific Wins Second Defective Mesh Trial in Mass. Courtroom

//Boston Scientific Wins Second Defective Mesh Trial in Mass. Courtroom

Boston Scientific Wins Second Defective Mesh Trial in Mass. Courtroom

Maria Cardenas, Monday August 18

Maria Cardenas, Monday August 18

This is the second win in as many months in a Massachusetts  courtroom for pelvic mesh maker, Boston Scientific.

The Obtryx pelvic mesh implanted in Maria Cardenas of Utah was not defectively designed, the jury ruled Friday.

The company provided adequate warnings about its health risks as well, according to the jury.  A failure to warn about all of the potential risks of the pelvic mesh is one of three elements of a defective product case which include defective manufacture and defective design.

The warnings are intended to go to the physician, the end user, so he or she can provide a patient with true informed consent before they agree to a medical procedure.

Jurors deliberated for 17 hours before coming to their decision, reports Bloomberg.Cardenas claims the Obtryx sling caused her pain and permanent damage, according to her lawsuit.

She had it removed surgically but portions of the polypropylene mesh device remain behind.Boston Scientific is facing more than 12,000 similar lawsuits over its family of polypropylene mesh implants used to treat incontinence and pelvic organ prolapse.

Attorney Doug Monsour told Bloomberg (here), “We will continue to fight these cases, since the product at issue is made of mesh that is not intended to be inserted in the human body.”

The case is Cardenas v. Boston Scientific Corp., No. 12-02912, Middlesex County Superior Court, Massachusetts (Woburn).

According to Courtroom View Network, the testimony presented conflicting opinions on whether the Obtryx was safe and effective. The sales team at Boston Scientific pushed the product even though they knew it could shrink 20% or more inside the body.

The company offered testimony from experts that the polypropylene mesh has a history of safe use and there are more than 20 clinical studies demonstrating its safe design.

Boston Scientific is also facing thousands of cases in Charleston, West Virginia where more than 66,000 similar cases filed against six manufacturers have been consolidated before Judge Joseph Goodwin.

In other litigation, another defective product case naming Boston Scientific is underway in Dallas and the case of Jo Huskey in her claims against Johnson & Johnson has just rested the plaintiffs’ case.

The patients say they had no idea the risks of the implants which include chronic pelvic pain, chronic infection, painful sex (dyspareunia), nerve damage and systemic issues among others.  Most women attempt multiple surgeries to have the mesh removed, but they are intended to be a permanent implant, one that never underwent Food and Drug Administration approval for safety and efficacy.

That information is excluded from these trials as is the number of claims filed around the country. #

 

Learn More:
Cardenas V. Boston Scientific, Mesh News Desk here

Courtroom View Network coverage here.

By | 2014-08-29T15:02:15+00:00 August 29th, 2014|Legal News|14 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

14 Comments

  1. kristine August 29, 2014 at 5:58 pm - Reply

    If she has damage notated by a doctor then they should be held liable. No one ever told me that this damage would happen to me. I’m suffering terribly. This is not what we women deserve. I’m fighting to survive. I will live forever in pain. My life is destroyed. Mesh I call it a slow murder. Wow. Who wins the company so they can continue to destroy lives. we are victims.

    • Doris Bailey August 29, 2014 at 7:15 pm - Reply

      I can’t believe this !!! I guess we women need to start our own riot so we can get some news coverage and get the word out that these companies are killing us and getting away with cold blooded murders !!! How can anyone listen to the evidence of what this mesh has done to thousands of women from all over the world and still be able to say they are not at fought,,, I am beyond angry there are NO WORDS !!! I could express and it is very clear unless we fight we will not get justice !!!! so gag order or no gag order there are 60.000.00 women out there and we need our voices heard and I feel if thousands of women meet up and start to walk picket in front of the court houses and show the world what Johnson & Johnson and Boston Scientific and others have done and to us and all the evidence they destroyed and hide from the public and because of that there will be losses of mother’s sister’s wives, lover’s all because of more $$$$$$$$$$$$$$$ look at what the CEO and President’s of these companies took home every year in bonuses because they knew their products were going to kill our love one’s and so to insure there pockets stay full they destroyed pages and pages stating this product is NOT MADE FOR HUMAN consummation !!!!!!!!!!

  2. Dean August 29, 2014 at 6:52 pm - Reply

    Wow I don’t get or I do as there is hardly nothing in the media meaning Six O Clock News or these big time Dr shows on afternoon TV telling you what’s good for you and what’s not this needs way more MEDIA COVERAGE to let people know then maybe these Jurors might get it they are going in blind it maybe all over the net IF one looks for it but HARDLY NTHING is SAID on any news. Stations I’ve tried they won’t even respond WHY?

    • Jane Akre August 29, 2014 at 9:38 pm - Reply

      J&J is a big advertiser. The story is about women’s pelvic regions…. No pictures.= those would be tv reasons. No victims coming forward? I guess you have to walk into their stations en masse and say “We Are Here!”

  3. Kitty August 29, 2014 at 9:52 pm - Reply

    I am speechless at this point—Perhaps when the injustice gets bad enough like the Michel Brown case will we start demonstrating in mass.

    • Doris August 30, 2014 at 2:55 pm - Reply

      Amen !!! I am ready whenever anyone else is !!!! This is really pissing me off !!! Why or How is this happening ? We did not ask for this and I can’t believe nobody cares !!! Doctor’s Judges, Lawyers, This crap is killing us and we can’t even get our stories out there !!!! Please God don’t let us go down this way !! It should not matter if these woman were having other problems before the mesh was put inside them,, The mesh made all their problems even worse !!! The companies should have not won any of these cases,, They are Guilty !!!!! and they know it !!!

  4. Leslie August 30, 2014 at 2:11 am - Reply

    Some body needs to get a documentary crew on the case. Where is Lisa Ling when we need her! Why haven’t any of these woman on talk shows been talking about this!

    Our side is not being represented in the media. All people see are the mesh ads from lawyers. Most people think we are just suing to make a buck. Even if I were to win a settlement, it would be years before I received anything at all. The lawyers get paid first then the government gets their 30 pieces of silver (taxes) and I get left with peanuts. Peanuts are not going to reimburse me my vagina, nor will it give me back the ability to urinate normally. It will not compensate all the things my husband and family have lost. Why are these cases losing? How can polypropylene be safe when the company that sells it says it is not safe for use in humans. Where was that evidence! Something stinks and someone is getting rich off of our suffering and mutilation. My husband and I will no longer be able to enjoy our marital privileges because of what this poison mesh did to me. Nobody is listening and nobody cares!

  5. Maria Garcia August 30, 2014 at 4:25 am - Reply

    The problem with all the cases seems to be the fact that proving the products are defective in design or instructions for use (IFU) has kept the focus on the polypropylene mesh material but not the device anchor points.

    The anchors attach to ligaments which are too close to nerves and nerve bundles leaving many patients with permanent nerve damage. When ex-plants are performed, most of the mesh material is removed but the anchors cannot be without causing further nerve damage. The design flaw has to be the unrecoverable anchors and the continuing nerve damage they cause. Why are the attorneys not focusing on the unrecoverable nerve damaging anchor points instead of just the polypropylene material? It seems to me that it would be much harder for the defense to explain away or ignore the facts of a properly installed “Gold Standard” device when the installation anchor point locations and the damage they cause are proof of a defective design.

    • Jane Akre August 30, 2014 at 10:54 am - Reply

      In this case, jurors actually got to see a TVT-O taken out of the package. I hadn’t seen that before in these cases. Certainly it could be pointed out further how the device actually grows into the pelvis and anchors and that it is intended to be a permanent implant….Let’s hope the closing arguments point that out. There is a fine line- no one wants to be too graphic, but that is the reality, it’s no exaggeration- this is a horribly mutilating procedure, both going in, anchoring and coming out. Will keep you posted..~ ja

  6. Jane R. August 30, 2014 at 12:45 pm - Reply

    Just don’t get this. I was never told about any complications.

    There is a huge operating report and I didn’t sign anything to acknowledge

    there could be complications.

    If I was told there could be a slight chance of nerve damage to my legs

    I would not have had the surgery. Surely if you attach anything to a nerve

    you could have problems no? Mine TVT broke also twice during surgery

    and the doctor had to get a new one. My sling is not where it is

    supposed to be to work. It’s in the wrong place. So the doctor

    didn’t know how to implant it or never got instructions or because

    the thing broke?

    How did BS provide Maria with warnings?

    • Maria Garcia August 31, 2014 at 4:17 am - Reply

      I was commenting in general across all brands and cases that went to trial across the country not just Boston Scientific. The defense attorneys have been real successful at avoiding any conversation about nerves and the anchors that cannot be removed. Once the device or devices are ex-planted, the arms tied to ligaments are still installed causing chronic pain. It seems to me that regardless of the credentials of any Plaintiff experts, the defense has had too much success at being disrespectful and condescending. The plaintiff attorneys need to humanize the plaintiff and convey that to the jury. We need Adam Slater who represented Linda Gross in the NJ. Ethicon trial to take on all the cases… Yeah! I know… like that would ever happen.

  7. terri white August 30, 2014 at 5:45 pm - Reply

    WHY IS THE JURY NOT ALLOWED TO HEAR THAT THE MESH WAS NEVER APPROVED BY THE FDA ?? THAT IS THE MOST IMPORTANT FACT OF ALL !

  8. Jane R. August 31, 2014 at 11:33 am - Reply

    Why are these trials held in MA and some coming up in WV?

    So does the outcome of this trial sway the outcome of the next trials?

    Because mine is being held in WV. I’ve read alot on this site

    but this is the first time I’m hearing about the anchors for the

    sling. And it finally made sense to all I’m going through.

    • Maria Garcia August 31, 2014 at 7:25 pm - Reply

      If an attorney wants to file a case in any given city that a Patient lives they have to carefully word the filing a certain way to avoid becoming a Mufti District Litigation case (MDL) and consolidated to West Virginia. MDL cases are individual cases not class action by definition but to me they are a Hybrid. Take Merck & Co. and their drug VIOXX which was the largest MDL to ever come along at that time. A total of 16 bellwether trials were held and 11 of them were won by the defendant Merck & Co. and yet in 2007 Merck & Co. settled the MDL. Please read the details at this link which will give a clearer picture of the MDL process. Linda Gross from NJ won her case against Ethicon / Johnson & Johnson as the largest jury award to date of 3.35 million in compensatory and 7.76 million in punitive. Linda Batiste in Dallas won a 1.2 million verdict with no punitive against Ethicon Johnson & Johnson and found the TVT-O defective. These two awards have nothing to do with the range of settlement that will be offered if settlement ever takes place. Everything will be based on each individual plaintiffs case details. If you look at the VIOXX plaintiff awards in the five cases that won, the awards in two cases were huge then drastically reduced with one of them reduced to nothing. Look at PDF page 12 for the VIOXX MDL results in the link below.

      http://www.jpml.uscourts.gov/sites/jpml/files/Bellwether%20Trials%20in%20Multidistrict%20Litigation-Fallon_Grabill_Wynne-2008.pdf

      Even more info on VIOXX:

      http://www.bloomberg.com/news/2010-07-27/merck-paid-3-468-death-claims-to-resolve-vioxx-suits.html

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