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Defective Pelvic Meshes Remain on the Market

Byrd federal court, Charleston WV

Byrd federal court, Charleston WV

Mesh Medical Device News Desk, September 8, 2016 ~ Pelvic meshes found detective in a court of law remain on the market even though the Food and Drug Administration says it can take action against defective devices.

Does the difference lie in the definition of “defective”?

The U.S Food and Drug Administration has been in the news lately for action taken – against antimicrobial soap!antimicrobial-soap

The final rule on antimicrobial soaps was not a recall but a regulation establishing that over-the-counter antiseptic products intended for use with water are not generally recognized as safe and effective (GRAS/GRAE) and are considered misbranded.  See the final rule on antiseptic soap.

While we can wash our hands of that problem, there are still a half dozen transvaginal pelvic meshes that remain on the market that have been found to be “defective” by impartial juries in a court of law.

It’s not that the FDA can’t issue a recall.

Statutorily it has the authority if, “There is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death,” Health and Human Services (FDA) can issue a recall. See (21 U.S.C. § 360h(e)(1));

The problem with the regulation of transvaginal surgical pelvic mesh is that the FDA has never issued a recall even though it claims it will take action, “When a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.”

 

How Does the FDA Define Defective?

In civil litigation, juries have found seven pelvic meshes to be “defective” in their design and or manufacture.

But the jury standard for “defective” may not be the FDAs.

Deborah KIotz, FDA media relations, tells MND, “defective” is not determined in civil litigation.

“I don’t think there’s a specific definition for the term “defective,” in the regulations, but in practice, a medical device is defective if it fails to meet all required specifications.”

The thinking is reflected in this guidance, Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements 

It’s just that the government, whether the FDA or the Consumer Product Safety Commission (CPSC) finds protracted litigation doesn’t get the job done, it’s better to work cooperatively with the very industries it’s is regulating.

Two that have been found defective have been removed voluntarily and quietly by the companies –  Prolift by Ethicon, and Avaulta by C.R. Bard.

With little fanfare, they went away.

Pinnacle was removed from the market voluntarily by Boston Scientific in May 2011 three years after it was launched. The company told the FDA “The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”

 

Defective Pelvic Meshes Remain on the Market

So aside from the disappearing act of a number of pelvic meshes, at least four pelvic meshes that have been found to be defective in a court of law remain on the market.

They include:

TVT, Wisbech Standard, UK

TVT, Wisbech Standard, UK

Carlino v Ethicon – TVT made by Ethicon- February 10, 2016. A Philadelphia jury found Johnson & Johnson made a defective pelvic mesh and awarded Sharon Carlino $13.5 million, which includes $10 million in punitive damages.  Philadelphia Court of Common Pleas, Case No. 1306-03470 before Judge Kenneth J. Powell Jr.

Outcome: TVT, made by Ethicon, a division of Johnson & Johnson, remains on the market and is referred to as the “standard of care” or the “gold standard.”

 

bs logo

Stevens v. Boston Scientific Corp – all mesh made after 2012. A complaint filed in January in federal court in Charleston WV by the Mostyn Law firm accused the Massachusetts-based company of smuggling polypropylene resin in from China under regulators eyes in both countries. The material has already been tested to be substandard, yet earlier this year, the FDA indicated it would let Boston Scientific investigate its own products to see if they were substantially similar to pelvic mesh made from its older Marlex.

Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia (Charleston).

Outcome: Boston Scientific still sells polypropylene mesh, made from the substandard raw resin from China. The company confirmed to Scottish reporter, Marion Scott, that all mesh products they have made in the past three years contain the Chinese resin.  If you consider the requirement to “meet required specifications,” Boston Scientific’s pelvic mesh made after 2012 could all be recalled. The FDA is letting Boston Scientific determine if its own mesh is substandard. See LINK

 

Prolift for POP repair

Prolift for POP repair

Hammons v. Ethicon, Prolift made by Ethicon.  In December 2015 a Philadelphia jury ruled in favor of Patricia Hammons and awarded her $5.5 million in damages over its defectively designed Prolift pelvic mesh. The jury later added $7 million in punitive damages to bring her total jury award to $12.5 million. Patricia L. Hammons v Secant Medical, Ethicon, in the Philadelphia Court of Common Pleas, Case No.  2:13-cv-04086.  

Outcome- Prolift was quietly removed from the market voluntarily in mid-2012 along with three other meshes that were giving the company problems in terms of consumer complaints.

 

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Linda Batiste v. Ethicon, April 3, 2014, TVT-O.  In this Dallas trial, the jury found the TVT-O (transvaginal tape obturator) made by Johnson & Johnson was defective and awarded Ms. Batiste $1.2 million. Batiste v. McNabb, case number. 12-14350, District Court for the 95th Judicial District, Dallas County Texas.

Outcome – Ms. Batiste has since died of cancer. In November 2015, a Texas appellate court reversed her win arguing she didn’t adequately prove an alleged defect in the product caused her injuries. Ethicon still markets the TVT-O.

 

Huskey v. Ethicon, September 2014, TVT-O.  Jo and Allen Huskey were awarded $3.27 million in September 2014 due to her injuries from the Ethicon TVT-O.  There were no

punitive damages. It was the first bellwether jury trial naming Ethicon in the MDL in Charleston, WV and the first time a jury decided TVT-O was defectively designed.  Huskey et al, v. Ethicon (2:12-cv-05201), in the U.S. District Court for the Southern District of West Virginia.

Outcome – J&J asked for a new trial and in August 2015 Judge Goodwin denied a Motion for Judgment or for a new trial.  TVT-O remains on the market.

 

Ms. Perry

Ms. Perry

Perry v. Ethicon, March 5, 2015, TVT Abbrevo Midurethral Sling. Coleen Perry won her product liability trial against Ethicon and was awarded $5.7 million. She had been implanted with J&J’s Abbrevo mini-sling as a treatment for incontinence.  The award includes $5 million in punitive damages.  Abbrevo mini-sling was found defective in its design and in its instructions to doctors.
California case is Perry v. Luu, 1500-CV-279123-LHB, Superior Court of California, Kern County (Bakersfield).  

Outcome – The Abbrevo sling which was an improvement over previous treatments, was introduced in 2010 and expected to bring $1.7 billion a year by 2017.  Abbrevo remains on the market.  J&J announced at the time of the verdict that it planned an appeal.

 

Cisson v C.R. Bard, June 2013, Avaulta Pelvic Support System, Avaulta Plus.  Donna Cisson was awarded $2 million in her claim against mesh manufacturer C.R. Bard over the Avaulta Plus surgical mesh she had implanted.

Outcome – The Cisson $2 million in compensatory and punitive verdict against C.R. Bard was upheld by an Appellate court in January 2016. Avaulta was taken off the market by Bard in July 2012.

Christine Scott 200

Christine Scott v C.R. Bard, Bard Avaulta. July 2012. The jury was instructed on negligence theories, specifically negligent design.
The jury found Bard was negligent in the design of the Avaulta Plus and that the defect caused Scotts’ injury. Christine Scott et al. v. C.R. Bard Inc.,
case number F066039, in the Court of Appeal of the State of California, Fifth Appellate District.

Outcome– In November 2014, a California Appeals Court affirmed the $5.5 million verdict against C.R. Bard and the gynecologist. This was the first case to reach a
verdict and after exhausting all appeals, Bard had to pay Scott and her husband $3.6 million since the jury assigned 40% of the blame on her physician.

 


logoEghnayem et al v Boston Scientific
, November 2014, Pinnacle Pelvic Mesh Repair Kit.  A Miami jury decided November 13, that the Pinnacle was defectively designed and its instructions to physicians were also defective and the company had failed to warn adequately about the dangers of the Pinnacle. Four women were plaintiffs in this case who were awarded $26.7 million or about $6.7 to $6.7 million each. No punitive damages were awarded. (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 14-24061, S.D. Fla.).

Outcome – Pinnacle was removed from the market by Boston Scientific May 2011 three years after it was launched after a growing body of adverse events or complications were reported. It was a Class 2 or moderate risk Device Recall under FDA rules. The reason for the recall – “The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.”

 

Tyree v Boston Scientific, November 2014, Obtryx midurethral sling. In November 2014, four plaintiffs proved theircase against Boston Scientific and were awarded a total of $18.5 million over damages suffered after they were implanted with the Obtryx midurethral sling used to treat incontinence. This was the second federal case in multidistrict litigation. Jurors decided the OBtryx was defectively designed and the company was negligent in its manufacture and design of Obtryx. The case is Tyree v Boston Scientific (2:12-cv-08633)

Outcome – Obtryx II remains on the market. Boston Scientific continues to train doctors on the use of its mesh products through its Pelvic Floor Institute. http://www.bostonscientific.com/en-US/medical-specialties/female-pelvic-medicine/pelvic-floor-institute.html

 

Obtryx IISalazar v Boston Scientific, September 2014. Obtryx Transobturator Midurethral sling system.  A new record was reached in this $73.5 million award over her defective Obtryx TVT-O midurethral sling.  Dallas District Court Judge Ken Molberg oversaw the trial (#DC 12 14349). 

Outcome – The Salazar case remains the highest award ever in transvaginal mesh litigation even after it was slashed in half in October 2014 due to tort reform.

 

11 Comments

  1. Lois S says:

    It is so unfair,the way the cases have been heard,I know they are so many injured I am one of them,should have been settlements from all the company’s so each woman could have a decent amount for our horrible surgeries we had that destroyed our life we are sick !!! One person should not get 75 million dollars and other women only 4 000,15000it is not right every one cannot afford a big time lawyer should have to be a global settlement and each woman receive the same amount,the injured all have the same damage to our bodies ,plus the pain and suffering we endure every day!!!!!!!????

    • J Maxwell says:

      Lois,
      That’s exactly correct and a court advocate who is making more than I’m getting in settlement is going to tell me that after two surgeries; worse than before I had surgery to correct a problem and missing work, etc. that I’m getting $10,000 that’s beyond ridiculous! That won’t even pay for my time off and loosing clients because I was down for months after second surgery. Can’t sit at my desk for long periods of time due to pain, can’t even carry out the trash or bring in grocery sacks because it is painful. Needless to say the more we read the more upset we should be! Let’s appoint someone to investigate the FDA.

  2. J Maxwell says:

    Isn’t it interesting that the FDA received Billions of $$$$ to investigate and make right the mistakes of an industry and the very industry that they are investigating is the one that paid them $$$billions. Isn’t that sorta of a conflict of interest of ‘pay to continue to play’ by continuing to market Ethicon TVT. Which is the product that still can’t be removed from me after two surgeries because it’s so imbedded that I will never be rid of this stuff and J & J will make another 17 billion by keeping it on the market while the FDA makes up it’s mind on a wording technicality……..seriously?

  3. Sea says:

    It’s only money which does not fix the problem …..it should be a high amount of money and then put the companies out of business …and the hospitals and doctors should pay also ….still in pain ….guess I always will be ….

  4. charrie e says:

    My case has been on file in west Virginia since 2013 I had to move in with my sister this past August… Because I am just too painful for me to work or stand long. I just have no idea what I am suppose to do. Ii am still going to doctors / therapy for my pelvic pain. My sister takes me. I have to pay these bills now all I can do is pray they can get to my case soon… I had my surgery in 2009 & 2011 I have to realized I will never have a relationship again I can’t have sex my doctor said that is not an option. If I stand too long its feels like my pelvic bones are breaking or if I sit it’s the same, can’t make to the bathroom in time… So all these years I have had to endure this pain and its Not going to go away ever.. I’m 52 years old now… How am I going to have a full life at my age in dept..I will just keep praying that’s all I can do

    • Jane Akre says:

      Charrie-

      Can your law firm help you find a doctor? You shouldn’t have to continue to suffer so. I know you don’t have funds, but some doctors do cases at low cost… please don’t give up.

    • Charrie, Im so sorry for your pain and how it has impacted your life. What kind of doctor is managing all of your mesh complication systems? Mesh triggers a host of pain syndromes and each one must be dealt with individually. Even small changes, small steps, can change your level of pain. Have your told your doctor every single place that is hurting? I mean being really specific ( i used permanent marker to record every place that felt pain. Also, keeping a pain diary helps your physician)because every pain trigger feeds into a hypersensitive neurological reaction. For example, constipation, while not a vaginal issue per se, can play a big part in your pelvic pain. Leg pain, buttock pain ( by the way, be sure you have what I call my happy ass cushion. I had one from the IC website but found another one I prefer at Bed, Bath, Beyond. I will check the name when I get in my car tomorrow and post it. Do NOT get a donut cushion. These put pressure on the wrong areas) . The right cushion can help a great deal. I could not sit at all for quite a long time. Fear of not getting to the bathroom can also contribute to pain as you more than likely brace, or try to hold in your urine. This bracing leads to shortened muscles, which generate more pain. It becomes a viscious cycle that reinforces and increases your pain. What you eat plays a big part in this as well. Certain foods drive inflammation and inflammation is what causes pain. Dairy and sugar are the major offenders but there are also specific foods that should not be eaten if you have bladder pain/ urinary frequency. Certain supplements can help if you are deficient, especially vitamin d and magnesium. Magnesium plays a role in muscle relaxation and most adults are deficient. I use a powdered magnesium drink I get online. Quality of sleep is important. If you are not sleeping, your muscles stay tense, creating more pain. What are you doing for neuropathic pain, have you been assessed for depression, which can increase your pain. Vitamin d is essential to fight depression. How do you breathe? Sounds like a strange question. But, pain promotes more shallow breathing. Shallow breathing reduces the amount of oxygen that is needed for tissue repair and healing.

      This is just a small snapshot of a large picture of what you need to assess in order to get some control over your pain. I will be glad to share other things that I have learned , with the help of a great urogynecologist, physical therapist, psychologist, psychiatrist, and holistic physician. I needed lots of help. It’s hard work, but it can lead to better days.

      Sorry for the length and detail, but it needs to be a very detailed evaluation. Also,since you have limited access to doctors, maybe you can try some of the things I have been taught without having to have the cash outlay.

  5. Toni says:

    Charrie can you get disability even if they take your money if we ever get any. At least you will have medical attn and a little income to survive. I am now close to losing everything myself. Mine was implanted in 2006 the prolift and TVT and I had 4 surgeries in 3 yrs. The last one he got 85% of it out and I had Chronic UTI ‘s following. I now need another surgery to correct my incontinence. Problem is I no longer have ins or my career. Can’t miss that much work and keep a job. I drained my retirement surviving the last 10 months. I am now in the process of selling my house I’ve owned and raised my boys in for 22 yrs. I am on my last leg and will be financially ruined very soon. I am 51 and I have worked my whole life to loose it all to a surgery that as my doctor told me was supposed to make me a new woman. Now my primary doc says get used to the new normal. Which is daily pain no energy infection and wetting myself. I barely feel enough energy some days to do the minimal housework and don’t leave my home sometimes for days. Not what I signed up for. I will be applying for disability soon as I can’t sustain much longer as well as being homeless.

    • Jane Akre says:

      Toni- do you have a decent relationship with your law firm? Do they know what this has cost you? Do they have all of your records? I”m so sorry…. if you let us know where you are located, maybe there are others in the same boat nearby and you can pool resources..

  6. Diva 64 says:

    Since C. R. Bard took their product off the market in 2012, why is it so difficult for the attorneys to make settlements.
    Like the lady who has lost her home. Most are struggling. I found a loan firm that would only charge 2% interest. My attorneys refused to sign off on this, I am really sick not only pain, but the Lupus from Polypropylene. I went without AC in Fl, finally I had to give in and skip the house payment and car payment to get AC. I am having a difficult time accepting the fact that the attorneys both sides are racking up billable hours in negotiations , while we lose everything, Stress certainly does not help our pain or other illnesses caused by the polyurethane.
    I also found a correlation to the date I made my complaint to FDA, and the date my doctor dropped me as his patient. Is there no profession that won’t bend over to the almight dollar while the 100,000 ++women in the US suffer, then start adding numbers to that count from the ladies outside the US.. I sorta here about me hoarding paper work to but today when I was lying in bed going through what I could do away with , the facts jumped right out on the question of why my doctor chose to discontinue to provide me medical care after all the years of trying to find a qualified doctor , getting sicker all the time.

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