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2016 – The Mesh Year in Review

Christmas cactus, 2016

Mesh Medical Device News Desk, December 29, 2016 ~ It may not seem like much has happened in the world of polypropylene mesh implants this year, but a review of 2016 tells otherwise.

There have been changes and shifts in litigation and research, albeit moving much too slowly for the 100,000 or so mesh-injured patients waiting for some resolution.

Here are some highlights from 2016:

 

Prolift, MedTech Marketing

PROLIFT FOUND DEFECTIVELY DESIGNED – It was the last trial of 2015, the Hammons trial in Philadelphia Court (here) of Common Pleas found Prolift was defectively designed and awarded Ms. Hammons $5.5 million in compensatory damages.

The jury returned to award $7 million in punitive damages. MND coverage here.

This marks the first time document destruction by Johnson & Johnson (Ethicon) was brought before a jury.

J&J quietly removed Prolift from the market in mid-2012, but it remains one of the most injurious pelvic mesh devices ever made.

The Philadelphia court then yielded a $13.5 million verdict for plaintiff Sharon Carlino concerning her TVT tape, also made by Ethicon.  That award contains $10 million in punitive damages intended to punish the company for wrongdoing.

Judge Robert M. Scheiber, 16th Judicial Circuit Court, Missouri

BOSTON SCIENTIFIC AND C.R. BARD TRIAL  – In February, 2016, jurors, in the only pelvic mesh trial to name two defendants, handed Boston Scientific and C.R. Bard a victory in a Kansas City, Missouri courtroom in the Sherrer case.

See coverage here.

The trial had been extended and interrupted throughout the holiday season, and at 40-days, was the longest in pelvic mesh litigation history.

This is also the trial Mesh News Desk became part of the story when a  disparaging comment by a reader, (Maria.Garcia) led to defense attorney Lori Cohen’s complaint to the judge. He decided MND should lose its access to the trial.

Even when MND filed an appeal, MND was excluded from the Courtroom News camera access.

 

JOHNSON & JOHNSON OFFERED FIRST TRANSVAGINAL MESH SETTLEMENT  – At $120 million, J&J and its Ethicon subsidiary, offered to pay $120 million to settle anywhere from 2,000 to 3,000 defective product lawsuits. The average award in the vicinity of $50,000 varied depending on the severity of injury.

J&J offered its second pelvic mesh settlement of $112 million to 1,000 women in September of 2016. See coverage here.

Yimao Plastic Molding, Guangdong Province, China

 

CHINESE RESIN IN BOSTON SCIENTIFIC MESH – Judge Joseph Goodwin, the federal judge overseeing thousands of pelvic mesh lawsuits consolidated in his court, decided to let the U.S. Food and Drug Administration (FDA) deal with the question of whether or not Boston Scientific (BSC) pelvic mesh was made from adulterated polypropylene smuggled into the U.S. from China.

In January 2016, the Mostyn law firm uncovered the finding in court documents and filed a RICO lawsuit (Stevens v. Boston Scientific 2:16-cv-00265) in Judge Goodwin’s court alleging racketeering in the sale of the allegedly substandard mesh and representing the 55,000 women who had received BSC mesh since 2012.

The Mostyns

Mostyn said BSC acted like a drug dealer to hide 37,000 pounds of the substandard resin from customs agents in the U.S. and China.

See MND coverage here Here is the RICO lawsuit.

Another case over Chinese mesh from BSC was filed in the Eastern District of New York in November, alleging 13 violations including violation of federal anti-racketeering law, negligence, strict liability, unjust enrichment, breach of warranty, all elements of organized crime. Under RICO, damages can be tripled.

More MND coverage here.

Judge Goodwin refused to restrain Boston Scientific from marketing, selling or importing its mesh devices containing the allegedly counterfeit resin, those made since 2012.

BSC was forced to source polypropylene resin from China when its supplier, Phillips Sumika, stopped selling to the company to make its pelvic mesh medical devices. Technically, any variation in the device approved by the FDA is supposed to undergo another approval, which never happened.

In February 2016, a Grand Jury was convened in West Virginia to look into criminal charges against Boston Scientific over counterfeit mesh.

Scotland called for criminal investigations into the counterfeit mesh allegations against Boston Scientific. MND coverage here and here.

 

Linda and Jeff Gross, from PBS Need to Know

LINDA GROSS CASE SURVIVES APPEALS – In March 2016, the pelvic mesh case of Linda Gross survived a three judge appellate panel.

Ms. Gross and her husband were awarded $11.1 million in February 2013 in her defective product liability trial against J&J over her injuries from a Prolift mesh. J&J immediately appealed.

In November, the company’s last chance at an appeal to the New Jersey Supreme Court was denied. According to her attorney, J&J can appeal that denial and try again to get to the high court in New Jersey, but at this writing, the company has exhausted all appeals in the Gross case. See MND coverage here.

Scottish Mesh Survivors

 

SCOTLAND HALTS PELVIC MESH PROCEDURESScottish Mesh Survivors spoke directly to a parliamentary committee in that country and in June, Health Secretary Alex Neil suspended surgeries using transvaginal mesh for pelvic organ prolapse and to treat stress urinary incontinence.

The country promised a national review. Mesh would still be available to those who requested it.

 

CALDERA DENIED SETTLEMENT OPTION – Caldera Medical had claimed it was insolvent and offered women injured by its pelvic mesh a few thousand dollars.

At the same time, the company announced it would expand its operations, joining with another company to offer mesh implants to one million third world women.

With about 4,000 women awaiting some Caldera settlement, in July, the judge overseeing the proposed Caldera Medical settlement denied the company claim that it was insolvent and denied its final settlement (here).

Meanwhile, more settlement funds were whittled away as Caldera fought Federal Insurance (Chubb). Most of the remaining Caldera Medical assets went to lawyers for the two companies fighting each other.

At this writing, the Caldera Mesh settlement has not been approved.

“Samantha” filed her own objection to the Caldera settlement, pro se, and the issue is still not resolved. See MND coverage here and here. 

Federal Insurance v. Caldera lawsuit here.

KY AG Beshear

 

ATTORNEYS GENERAL FILE SUIT AGAINST J&J – By May 2016, both California and Washington State attorneys general had filed lawsuits against Johnson & Johnson for deceiving the public about the safety of its pelvic mesh implants, a violation of state consumer protection laws. Kentucky later joined in filing its own lawsuit against J&J.

All three states seek to be reimbursed for each woman who was implanted with J&J mesh and to seek costs, fees and restitution.  The fines could reach tens of millions of dollars for J&J. At this writing, the AG actions remain open.

See the MND coverage here.

J&J denied it did anything wrong and called the lawsuits unjustified.

Here is the Washington State complaint.

 

 

UCLA RESEARCHES AUTOIMMUNE MESH LINK – A link between polypropylene mesh implants and autoimmune reactions has long been suspected among hernia mesh and pelvic mesh recipients. Some suffer unexplainable autoimmune reactions to their mesh implant.

No one was acknowledging much less looking at the connection until August, when UCLA announced it was beginning an autoimmune registry of mesh complications.

Opened to men and women, in the U.S. and globally, it will add to the UCLA research on biofilms and is the first official recognition that there may be a link.  Those experiencing autoimmune issues since their implant are asked to add their experience. It can be done anonymously.

The link to the registry is in this MND story.

 

Bear at Denver Conv. Center

AUGS CALLS OUT MESH-INJURED MOVEMENT –  When your editor attended the 2016 meeting of the American Urogynecologic Society (AUGS), she was  surprised to see a number of things- the president of the society called the mesh-injured community an “anti-mesh movement,”  some doctors said mesh injured women were “looking for a payday,” while some were not really injured, others concluded.

One opinion expressed by some in attendance was that trial attorneys had targeted urogynecologists and many were unfairly being brought into the pelvic mesh litigation.

At the same time, AUGS stood by its mid-urethral slings as the gold standard and a “treatment worth protecting,” though some doctors who have been sued, have given up the use of polypropylene mesh.

Those members of AUGS who have been shown at trial to be those most influential as “preceptors” to other doctors, were again, representing device companies, teaching sessions at AUGS on new medical devices to fellow urogynecologists. Patient presence was absent from the gathering in Denver, while a plethora of manufacturers shared their wares in the trade show exhibit hall.

The only session specifically scheduled to discuss litigation issues was abruptly cancelled the day it was to be held.

See MND coverage here and here and here.

Judge Diane M. Kottmyer

 


BOSTON SCIENTIFIC PINNACLE PELVIC MESH VERDICT OVERTURNED
– A decision by a Massachusetts Appeals Court in September 2016, meant a mesh injured woman from Ohio will receive a new trial against Boston Scientific.

Diane Albright claims she was injured by the Pinnacle Pelvic Floor Repair Kit. A jury in 2014 concluded her mesh was not defective and the warnings to her doctor were adequate.

Motley Rice, the lawyers for Albright, immediately filed an appeal on the basis that key evidence was omitted from trial by Judge D. Kottmyer, specifically the Material Safety Data Sheet, a document that details environmental hazards of raw polypropylene. It says the material is not to be used to make implantable medical devices.

Jurors also could not see an FDA letter that ordered post-approval surveillance of Pinnacle, a mesh kits that Boston Scientific took off the market in May 2011.

See MND story here.  The case has not yet been rescheduled.

###

As 2016 wraps up, some of the oldest J&J pelvic mesh cases are being readied for trial in West Virginia.

All of the pretrial proceedings should be completed by May, 2017. Mullins et all and its 31 plaintiffs from West Virginia, is scheduled to begin March 6, 2017.

The Sullivan v. Boston Scientific case is set for February 27, 2016 in Philadelphia.

The Smith TVT-O case set for January 9, 2017 in Bergen Co. New Jersey has just been resolved. See the documents here.  

Enjoy the remaining days of 2016!  May health and peace be yours in 2017!  

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18 Comments

  1. stopmeshimplants says:

    From someone who has been here for years, this is progress. I appreciate you and your efforts more than you know. Thank you for taking the time to help us understand legally there are some good things happening, with this mesh mess, even though we suffer every single day. Wishing you a very Happy New Year!

  2. Shannon says:

    Happy New New ear may 2017 bring us some relief in our medical symptoms some relief in our love relationships and our children who suffer along with us
    Many blessings stay strong and keep believing that your hhos is standing beside you

  3. jan says:

    It might be progress I have been in the battle since 09.. still need more surgeries insurance will not send me to one of the best Dr.V are Dr. RAZ.. I have gad 4 surgeries still Mesh in my body UTI’S are so bad the infections have put my heart into overdrive. . Every day is a battle to just try to move… I can no longer do anything. . I am a prisoner in my own body. .
    We have all been injured we should all be compensated the same.. I have lost my home belongings vehicle. . I am 160thousand debit.. I have to live place to place I had to bring up a child during all the heart aches and breaks..
    We need to know our lifes matter to the government and to these companies because it did not matter when the made the mesh…we need fair settlements to take care of us..

  4. Cathy says:

    Thank you Jane! You do so much for the mesh injured. We appreciate it. Happy New Year and many blessings for 2017.

  5. Thank you Jane for your tireless efforts in bringing us updated…it’s all so unfair that after so many years…so many of us continue the physical and mental anguish from the roots of greed…
    HAPPY NEW YEAR to you and all who suffer from this unfortunate situation…hopefully the new year will bring justice and closure to the mesh injured. You give us hope…thanks again.

  6. Nora says:

    Why is it that cases in the beginning were being awarded amounts in the millions? Now, it seems that people who have suffered longer and filed earlier are still waiting on news.

    • Jane Akre says:

      Nora- Because they were the bellwether cases, they were the test cases to estimate the value of litigation. Plaintiff law firms then pushed for settlements, but companies resisted…. AMS was first but the settlement dollars were small….. a few others offered little amounts…. Basically the corporations that make mesh are stubbornly refusing to sell for the value of the cases as established by the trials… ie in the millions! That requires law firms to get tough but guess what? They want to get paid too…. so they are settling for less in an effort to move this litigation along. You end up with less… that’s my understanding as a non attorney. Anyone else?

  7. Lori says:

    I have been waiting almost 7 years…3 surgeries and lots of health issues…truly upset that i never hear from my attorney…since they get 40% of any settlement it is a shame that i get my updates from you…i call my attorney occassionally after reading ur updates and they always tell me nothing new…how can that be…i often think they are just piggybacking other attorneys for the money and at my expense

    • Jane Akre says:

      Lori- If they are not working up your case, that is, staying on it, filing motions, etc. in other words if you are past of the Mass Tort, they are piggybacking on another law firm to do the heavy lifting and shuffle your papers into the settlement firms for consideration. They will take a portion of your settlement, part of the 40%. I’m not an attorney but that is my understanding. I’m sorry.

  8. Only Just Begun says:

    I’d like to know what Law Firm and specific attorney both Jane Akre and Still Standing are or have used. I have not filed a suit or anything yet. I had prolapse surgery July 2, 2015. I began infection 4-5 weeks out from surgery. I had Boston Scientific ‘ s Upsylon Mesh Kit used. It is attached to vagina & cervix and anchored to my sacrum. My urogyenocologist tried estrogen and steroid but still had infection. He did biopsies himself and checked it himself and said I had no diseases that showed up. He sent me to Allergist who put pieces of mesh on my back to see if I would break out. Nothing happened. He sent stitching material and it came back showing nothing. Uno said he wanted me to try a compound steroid but it was going to be expensive. This was December 23, 2015. My insurance rejected it because of it being compound. I hadn’t bought 1 Christmas present yet so concerned with it going to cost me $500 out of pocket and insurance not willing to cover also worried me that it may not be safe. I decided not to do that. End of Jan., 2016 I got 2nd opinion with another urogyenocologist. She said looked as if I had desquamative vaginitis and referred me to a gynocholigist she new who did the research on this type of vaginitis. Hoever, this gyno moved to Washington DC and was in private practice. Way too costly. Oh the 2nd opinion urogyenocologist also said she believed it was caused from the mesh. She did an ultrasound on my bladder and it was fine no erosion, yet anyway. She said I could try to maintain the vaginitis or have mesh taken out. She would do it but would have to cut clear across my abdomin as she didn’t feel she could go through me vaginally as it probably wouldn’t heal since I was a mess. So, this began my journey into the ‘mesh jungle’. I finally found a gynocholigist at Ohio State U. at Columbus, OH. As soon as she saw my vagina she knew what it was. She sent off biopsies to N.Y. which confirmed I had lichen planus. She sent me to a colleague at OSU ‘ S Oro thopathology Dept., who confirmed it was also in my mouth. I am being treated for both now along with an area 4-5″ on my on mid to lower spine of what is either eczema or lichen planus also. I had to use steroid ointment just to heal a potion of my vagina to where I can put my finger in to try to stretchout my vagina and oopen it back up as the lichen planus or mesh has caused scarring inside vagina in a circular motion shrinking my vagina opening. She now wants to do surgery to go in and open up my vagina and then I will have to use a dialater 20’s per day to keep it open til it heals. She said we’ll need to be agressive with all of it and after to make sure I get no other infections. After reading a lot of these posts I’m wondering if it will hurt my case, if I decide to file one, if I have another surgery if any kind. I don’t want defense side to be able to use it against me or shoukd I go see Dr. Raz first and have his team examine me and the mesh and see what he says. I know he does some type of ultrasound so he can actually see the mesh. Also, the gynecologist I have been working with at OSU don’t feel my lichen planus is caused from the mesh because she says, “It is an auto immune disease.” Therefore, based in her knowledge of how one gets an auto immune disease, she isn’t believing it’s caused by it. She is a great gynocholigist and so many people have told me she’s the best up there but I know that I know this is caused from the mesh period. I was healthy never had issues except UTI ‘ s a few years before, then periods stopped in Oct. 2014, then prolapse began in Jan. Feb. if 2015. I saw a Urologist in Aug./ Sept. of 2014 who opened my urethane tube and that stopped any leakage from sneezing or coughing and never had another uti. The prolapse didn’t come until after that as said Jan./Feb. 2015. I went for follow up with Urologist at end of May first of June 2015 and he advised since my periods had stopped the previous Oct. 2014 that I could have a Urogynecologist do a hysterectomy and the prolapse surgery. This was so the chances if me having another prolapse would be less as it would take lots if pressure off the bladder and vagina. So, does anyone who’s been through ir going through the fight have any advice for my next best steps and the attorneys or best firms who will actually keep in contact with me. I understand fully their job and how much they get etc. My reason for fighting the manufacturer is to help with what I’m dealing with now, the past & for my unknown future and that of my family esp. my husband. I haven’t been able to even attempt to have intercourse yet. And yes, I was told the mesh being used was the goid kind snd he had never had a problem with it. After the fact he kept saying over and over every time zone had an office visit that he just could figure it out. He had never seen anything like this. He even took a picture of my vagina after doing my biopsie, he did ask, but I was desperate. There were 2 nurses in the room. Sorry so very long but I felt it was needed so you know why I’m asking questions that may seem trivial. Nothing with this mesh has been trivial. Thank you to all my sisters in our journey.

    • Jane Akre says:

      I have not had a mesh implant, I just report on it. If you can get to Dr. Raz, he is a good bet, but there is a bit of a wait….

      • Kitty says:

        Dear only just begun. It seems like u have a very good Dr. It is disturbing that many of us will need continuous care for various afflictions nerve damage which will exhaust our resources. I would tell u to take your records and head to Dr Raz if u can afford to.

    • Still Standing says:

      Only just, Im so sorry to hear your heartbreaking story. It sounds a lot like mine. Different company and I had posterior and anterior transvaginal mesh in 2008. First advice, get your lawsuit filed. If you had your mesh implant in Ohio, you only have two years from your implant date to file a defective device lawsuit. It is very important for you to get this on the books before your 2nd implant anniversary. I was very pleased with my attorney. I don’t want to put their name out here or they might be overwhelmed with calls. jane knows who I used and she has my permission to send it to your email. They were very kind and professional.

      Now, it is unusual that you have lichen planus. I was diagnosed with erosive lichen planus three years ago and it has been awful to manage. Mouth sores, ulcerations on one foot, terrible vaginal and vulvar ulcers. Nothing has really stopped it. Last year, the vaginal ulcerations were so bad my doctor removed the most damaged half of my vagina and used a pig bladder graft. It is amazingly healthy. Now, the vulvar ulcerations are so bad that next week, my doctor will start a process to laser burn off all my vulvar skin hoping that it will grow back healthy. It will take 4-5 treatments over several months. A very few doctors have been researching this for lichen planus and this will be the first time my doctor gives it a go. I will keep you posted on how it goes. Here is something I started doing a few days ago. I have been putting coconut oil there. It has helped a lot with the pain and discomfort. It has high anti-inflammation properties so,I decided what the heck. Better than the $50 lidocane gel that lasted a few weeks.

      Now, get your surgery that you need. It is important to get better. The longer you go with high pain, it is more likely that you will develop chronic pain. Im curious about the surgery to open your vagina. I go to pelvic floor physical therapy and that has almost completely gotten rid of two large restrictive bands of scar tissue. Have you tried that yet? It would certainly be preferable than another trauma from surgery. I have had seven surgeries and they do take a toll on your mind and body.

      Only, just keep asking questions, communicating clearly with your physician, and intentionally caring for your body and soul every day. That is hard to do. It took me a long long time to get there. You are worthy of that care.

      • Kitty says:

        What is the name of your law firm SS?

        • Still Standing says:

          Kitty, I have been asked that question before and I choose not to put my lawfirm’s name out in this forum. If they want new mesh clients, they can pay to advertise for them. I think it could cause an overwhelming number of calls to the firm that they would have to handle and I don’t want to do that to them. Also, it appears they have settled all of their cases for Bard, Boston Scientific, Coloplast, J&J and AMS so I doubt that they are taking new clients. You can go to the West Virginia court page and pull up the seperate MDLs and probably figure out what firm I have. They have had a leadership role in all of them. I am very grateful for the professional and client-friendly way they handled my case. I wish all of the attorneys who represent mesh women could have taken a page out of their playbook.

  9. jan says:

    Is it possible to put liens on their companies? Liens where they cannot manufacturer or sell trade or do any type of dealings until they settle the correct and right way
    We are injured because of them we are now physically trapped in bodies that do not and can not function correctly. .

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