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Jury has Boston Scientific Obtryx Pelvic Mesh Case

Obtryx IIAt this hour the jury has the case of Tyree v Boston Scientific (2:12-cv-08633) filed in federal court in West Virginia.  

Four women have had their cases consolidated in this federal proceeding.  All were implanted with the Obtryx Midurethral sling to treat incontinence. Their trial has entered its third week in federal court in Charleston, where 67,000 cases are consolidated against seven mesh manufacturers.

The women claim the Obtryx was defectively designed and manufactured and the company was negligent in marketing the defective product.

Boston Scientific argues its mesh implants were properly designed and that doctors were given complete information about their use and the potential for risks.

Bloomberg reports company lawyer Robert Adams says plaintiffs are trying to “demonize the mesh like it’s some kind of dangerous product.”

The case is being heard before U.S. District Judge Irene Berger. The plaintiffs include Jacquelyn Tyree, Carol Campbell, Jeanie Blankenship and Chris Rene Wilson.  All women were treated for incontinence with the Obtryx transvaginal mesh, a ribbon of polypropylene mesh placed under the urethra.

Boston Scientific, a Massachusetts-based company is facing 23,000 defective product lawsuits over its family of pelvic mesh products, some of which have been quietly removed from the market.

One week ago in a federal courtroom in Miami, Boston Scientific suffered another loss when a jury of nine decided its Pinnacle Pelvic Mesh Repair Kit was defectively designed and awarded four plaintiffs $27.6 million.

Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

Both cases are part of the same consolidated multidistrict litigation and some of the same experts appeared at both trials.

The plaintiffs claim Boston Scientific rushed to market its pelvic mesh products without proper testing, said plaintiffs’ attorney Scott Love (Clark, Love Hutson) during closing arguments after lunch Wednesday afternoon. The company was “desperate to sell more slings and protect its business,” the same argument made to the Miami jury over the Pinnacle product.

 

Miami Pelvic Mesh Trial 

The Tyree trial mimics the same plaintiffs’ arguments before the jury even using some of the same expert witnesses. See Mesh News Desk coverage from Day One. 

The first bellwether trial to test legal theories, the Miami trial of Enghnayem Dortes, Nunez and Betancourt, showed jurors that the mesh degrades over time, is not inert and can fold, migrate, shrink and become hardened like plastic. The Material Data Safety Sheet shown jurors warns against using the raw polymer resin, that makes up the polypropylene, in any implantable medical device.

A jury award  of $26.7 million was announced Thursday, November 13.

Expert witnesses in the Tyree case included Peggy Pence, Jimmy Mays and Dr. Bruce Rosenzweig. Dr. M. Tom Margolis appeared by videotape for the plaintiffs in both cases.

Meanwhile, the company says complication complaints about the Obtryx were less than one percent.

The Obtryx II remains on the market while the Pinnacle was removed in May, 2011. The FDA issued an IMMEDIATE RECALL and a letter announcing the Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

 

Courtroom Victories and Losses so Far for BSC

Boston Scientific (BSC) had two successful outcomes earlier this year in a Massachusetts courtroom.

In the trial of Maria Cardenas, the jury decided that BSC provided adequate warnings about its Obtryx product.  The jurors were not allowed to see the Material Safety Data Sheet during the proceedings, which carried a warning the polypropylene plastic was not to be used to make medical devices.

In July, the Pinnacle Pelvic Floor Repair Kit trial of Diane Albright was won by Boston Scientific in Middlesex Co. in Massachusetts, where Boston Scientific is headquartered. See background story here.

An unprecedented $73.5 million jury award in the Martha Salazar v. Boston Scientific  Obtryx mesh sling case broke the Boston Scientific winning streak last September in a Dallas courtroom. That jury award has since been reduced by half due to caps on awards in Texas.

The Tyree case is the second bellwether filed in a federal court to test legal theories in hopes of determining a settlement amount.

 

Boston Scientific

Boston Scientific still sells a number of mid-urethral slings for the treatment of incontinence including:

Advantage Fit (transvaginal mid-urethral sling)

Lynx – transvaginal mid-urethral sling

Obtryx II (transobturator mid-urethral sling)

Solyx (single-incision sling system).

The ProteGen was the first mesh sling to be manufactured by any mesh maker but it was pulled from the market in 1999. That did not stop other companies from naming it as a “predicate device” on which to base their own mesh products.

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20 Comments

  1. sandy says:

    let’s all pray

  2. Pam Wise says:

    Praying that God will see that Justice is served for all injured Mesh Victims. That’s certainly good that this jury was able to hear more truth with just the MSDS alone! So thankful that these Pharmas are getting less and less prejudice than before.

  3. Pamela says:

    First let me say Thank You! Let me tell u a little about myself, I was implanted March of 08, I’ve been in hospital almost 6 times, not including the countless emergency room visits where they treat u as if ur crazy! I’m a widow age 38 now was implanted at the age of 32 lost my husband and left with 2 teenage boys 2 raise on my own! They loose their Dad tragically & have to loose the mother I used to be due to pain, surgeries, sickness, just all over the map misery! As I watch the fear in my son’s faces of are we gonna loose her to, as my son comes to me and expresses his anger and hurt that he had to loose 2 parents in 2009 one to death & one to being bed ridden in pain, sickness, weightloss, autoimmune, no energy, no insurance, & trying to take care of them their needs & pay to keep me alive to the best of my ability! Eventually all the funds run out and u sit here wondering when this will end, how will this end! They keep implanted death in us all cause even those who have not died, your life becomes taken from u to the point u feel dead inside, helpless, worthless, well so much it’s hard to describe! One day your living a decent life, have a career, spend time with family-friends, vacations, then it’s all u can do to make it out of bed!! I feel like not only was my life ripped from me but my kids, my family, & friends have all paid & suffered in one way or another watching this take the life outta the ones they love! Idk what to do anymore but pray they have to pay so that we can get the help we need! Hard enough to find someone to help period but with no insurance no one will help period! It’s not about the money God knows I’d give anything to not have made the decision to have a simple procedure that was safe and the recovery time was minimal & I would no longer be incontinent! Never the slightest warning of risk or any of this!! I’ve lost control of bodily functions before 35, unbearable pain, no chance of intimacy, or a partner, less than 100 pds soaking wet, my career, my life, revisions that only brought more pain, reconstruction with protrusion all over again! I could go on & on! THE HARDEST PART OF ALL IS WATCHING 2 AMAZING SONS, THAT’S LOST THEIR DAD, & ME MINE, WONDER & SEE COMPLETE FEAR IS THEIR MOM GONNA WAKE IN THEIR MORNING!! WHAT IT’S TAKING FROM THEM HOW THEY’RE SCARED TO BE GONE TO LONG, OR ONE OR THE OTHER NOT BE HERE TO LOOK AFTER ME! IT’S SUPPOSE TO BE THE OTHER WAY AROUND! I’ve gone on long enough but It’s the first time I’ve written & believe me I could write for days! Thank each and everyone for your time to let me know I’m not alone! To keep me informed & to know I’m here in any way I can be! I do understand! May these companies have to pay dearly not just for what they’ve done to us, but what they’ve taken & done to the ones we love and love us!

  4. PLC says:

    Was there also a J&J trial in San Antonio that started First week in November as well?

  5. Jane R. says:

    I am hopeful.

  6. Disgusted says:

    I am praying. I’m sick over this. How anyone, even a defense attorney can say plaintiffs are trying to “demonize the mesh like it’s some kind of dangerous product.” is insulting. It is a dangerous product. 1%, even if it were true, which it isn’t, is unacceptable. Loss of life as we knew it and living in constant pain over an annoying problem like incontinence after a 1/2 hour outpatient surgery; how can this even be defended? They should be ashamed of themselves, instead of boldly claiming “the product is still on the market”. I would like to know how the defense is allowed to claim this, when the truth of the 510K isn’t allowed into testimony and if the product has been taken off the market this isn’t allowed in. What happened to the whole truth??

  7. msm says:

    The “demons” are the people who put mesh on the market and FDA that allowed it.

  8. mary l. says:

    Well said disgusted. I agree 100 % .How can they sleep at night.

  9. David says:

    In the October 20, 2008 “FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence,” it stated (in the form of a letter to alert healthcare practitioners and not patients): “Although rare, these complications can have serious consequences.”

    The FDA’s July 13, 2011 “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication” stated (for the audience of “Hospital surgical staff, OB/GYN physicians, other healthcare professionals” and again not patients): “serious complications associated with surgical mesh for transvaginal repair of POP (Pelvic organ prolapse) are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008.” (This FDA change also did not specifically, now UPDATE, “…and Stress Urinary Incontinence.”)

    What was the difference between “although rare” in 2008 and “are not rare” in 2011? The risk to patients is still 100% because a surgical mesh device’s performance cannot even be predicted in a patient’s body. And, why are there still no performance standards applicable to surgical mesh? Could it be the former reason: because both the FDA and the mesh industry, even after “more than 20 years,” still cannot predict the performance of a non-inert surgical mesh device in any patient’s body? And, if you cannot predict the in vivo performance of surgical mesh (outside of it packaging), a mesh defendant’s lawyer will still try (but fail) with an attempt to claim that mesh is safe and fit for its intended use after human implantation? Could it be that it is the long overdue TRUTH, not around 100,000 Plaintiffs, which is seeking to “demonize the mesh,” like the dangerous product that it is?

    While “Adams countered that the rate of complaints about the Obtryx insert was less than 1 percent and noted the device was still being used by doctors across the U.S.” (as stated in the November 19th Bloomberg story), where did Mr. Adams get, or where else could one find, this 1% adverse event rate needed to make a claim at past safety and effectiveness?

    In the FDA’s April 1996 Medical Device Reporting for User Facilities manual it stated: “Although manufacturers and importers of medical devices have been required since 1984 to [only] report to the FDA all device-related deaths, serious injuries [verified by surgical intervention], and certain malfunctions, numerous reports show widespread under reporting. A 1986 General Accounting Office (GAO) study showed that hospitals report less than one percent of problems with medical devices and, the more serious the problem with the medical device, the less likely it was to be reported.”

    What value is there for those profiteers off human suffering to keep this understood underreporting of adverse events at a one percent rate (or specifically the “complications [that] can have serious consequences” for U.S. women implanted with transvaginal mesh indicated for the repair of both POP and SUI), if not to make further false marketing claims about the safety and effectiveness of a “substantially equivalent” medical device’s past use (aka: “the [510(k)] predicate device”)?

    This one percent statistic (as it relates specifically to the general hospital reporting of adverse events) was still found to be true in a 07/19/2012 (date stamped) Office of the Inspector General letter, from Stuart Wright, Deputy Inspector General for Evaluation and Inspections to Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services.

    With regards to Mr. Adams’s rationale (for something) that “…the device was still being used by doctors across the U.S.”; what else can a doctor do when he/she can only indiscriminately abuse a dangerous, non-inert surgical mesh device…but choose to believe that this 1% rate is relevant to a reality that would still sustain an understanding that “…mesh had been used safely for more than 20 years in medical settings”? After all, it is the regressively trained surgeon the mesh manufacturer uses to market the benefits of mesh to unsuspecting populations of patients targeted by their best practices. Perhaps if a doctor is found still using a defectively designed surgical mesh device, the rationale should be that they should be charged with medical malpractice.

    The reality remains: “The more serious the problem with the medical device, the less likely it [is] to be reported.” Why?…Because societies formed between device manufacturers and leading industry doctors are willing to gamble with the lives of unsuspecting patients – for the commingling of own self-serving benefits – to narcissistically maximize profits upon the mutual self-gratification of one-sided, (maybe not even heightened) surgeon efficacy.

  10. Tami Goodson-Porter says:

    Maybe we can see someone at the end of the tunnel with a candle. I know we have all been through so much due to the negligence of others. Since my surgeries I have lost everthing, my home, husband, job. Also had a 3.98 GPA that started dropping after my original surgery, so it has been temporarily put on the back burner. I know we all wish we had not had our surgeries that caused this downward spiral that all our lives have taken. God bless and keep us all safe and let these companies have to admit there negligence.

    • Jane Akre says:

      I’m so sorry Tami- unfortunately, your story is not uncommon AND these devices are still on the market. Please be sure to tell your surgeon so he/she can never say to someone else “You’re the only one” and be sure to make your report to the FDA. ~ ja

    • Jane Akre says:

      Would you let us know where you live… there may be others in your area you can connect with… and I’m growing a list of doctors who might be able to help if you haven’t yet found competent medical help!

  11. Michelle says:

    I had 6 surgeries but they are not counting all of them. They only count the removals but the lSt surgery was a 3 parter , once in it was too embedded and they had to go back in and couldn’t close me up as I had to heal for a few months ,I was totally on cather and wS trying to get back to work and take care of my grandchildren as I have custody as their mom has terminal cancer , then they had to take a strip of my stomach to use as like the mesh did for support, but since that was repair and the mesh was out this all doesn’t count. It was embarrassing for as young as I am and it hurt very much . Also it disfigured me.

    So to have so say it’s only cause of painful sex , it is not . This was suppose to be a simple surgery on your day off and return to work in a few days , I had the first repair within a week of the implant anyway good luck to all .

  12. Sandra says:

    My first surgery was March 2007. I was 45 years old and in considerable good health, minus the bladder and rectal protrusions. Surgery was to only take 1 hour…ended up lasting 8 hours. I’ve never been in so much pain…I couldn’t walk for several days due to damage of nerves in my left groin area. Was out of work for 3 months and nearly lost my job. I was single during this time and needed my job…I went to the Dr at least every 2 weeks for 3 more months. Had infection after infection… This kept going on then surgeries started again and again…mesh kept working through the tissue walls. Then I remarried.. My husband could feel “something” during sex. More surgery needed..but this time I was sent to UAB in Birmingham. Some of the crystalized mesh was removed but there will be other surgeries to remove the remaining pieces and parts. I ended up getting terminated from my job after a surgery in 2011, due to high absences. (All due to Dr appts or surgery!). My immune system is shot…no energy and I’m at my wits end….hope these people can sleep at night when I’m up and down trying to go to the bathroom!

  13. charrie e says:

    I have had 2 mesh devices implanted in me how do I find out if my mesh has propolyne ???

    • Jane Akre says:

      You could ask your doctor or check your medical records. Please, always ask for a copy of your medical records after a procedure- ALL of them including doctor and nurses notes….. More than likely your implant is made of polypropylene, which in itself does not mean you will have a bad reaction. Some people do not, at least in the short run. Maybe you will be one of them.

  14. Tina says:

    Has anyone had problems with the Obtryx ii? I’m due to have my miniarc sling removed if possible (it failed). I’m nervous.

    • Jane Akre says:

      Tina- please only go to an experienced mesh removal doc…. don’t let someone do a partial, hacking away at portions of the mesh……the fewer surgeries the better we are learning from these trials…..Let me know if you need a referral…..

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