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Commentary: One Hand Tied Behind Their Back

judge mallet 200Commentary: What Jurors Never Got to See in the Lewis v. Ethicon Trial

In an effort to streamline the proceedings Judge Joseph Goodwin had early on told the court that he would move these cases through his federal courtroom. He certainly did that with a directed verdict in favor of Ethicon on February 18, six days after the start of the Carolyn Lewis trial and on the eve of the defense’s case.  What were the jurors thinking? We will never know because Judge Goodwin did not allow the proceedings to move on to that phase.  As the only reporter sitting in the courtroom during the trial I thought a very good case had been made even with one hand tied behind their back.  The following is an Opinion/Editorial of what I saw and what I knew going into the case. Apologies for the interpretation of a non-lawyer of the proceedings. Others are invited to submit their more learned interpretations.

What Jurors Never Saw- 50,000 Cases Filed

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Defendants brought forward and Judge Goodwin granted several motions in limine on February 5. They included Ethicon’s motion to exclude evidence of other TVT lawsuits. Judge Goodwin agreed with attorneys for Ethicon that such “Evidence of other lawsuits is likely to confuse and mislead the jury from that task, and it is highly prejudicial to Ethicon. Accordingly, Ethicon’s motion on this issue is GRANTED.”

Never mind that it’s true.

There are currently 16,825 (as of March 3) cases filed against Ethicon, now more than any other mesh manufacturer with over 53,000 filed against six manufacturers.

This is just one federal court where cases have been amassed in multidistrict litigation (MDL), which groups cases together that have a similar cause of action.  This does not count the hundreds if not thousands of other cases of mesh injuries that are filed in individual state courts around the country.

Of course jurors never heard that the Linda Gross case one year earlier in an Atlantic City courtroom had yielded an $11.1 million verdict in favor of the plaintiff including $7.76 million in punitive damages against Ethicon.

 

What Jurors Never Saw- Spoliation

On Thursday Feb 13th, the lawyers for Lewis tried again to put before the jurors the issue of the spoliation or destruction of evidence. Whether it was intentional on the part of Johnson & Johnson or just sloppy record keeping, jurors might want to know that thousands of pages of documents, computer hard drives and videos never made it into evidence. Sometimes those inner office notes yield the “smoking gun” everybody seeks.

In plaintiff’s Trial Brief in Support of her Request to put on evidence of Defendants’ Spoliation filed February 13,  Doc #278 (here) is a trial brief to response to the Courts invitation that it would consider allowing plaintiff to submit evidence of Ethicon’s spoliation of documents to the jury.  Plaintiffs want to play the deposition of James Mittenthal, Ethicon’s corporate representative on spoliation issues which was taken earlier in the week.

Adam Slater

Adam Slater

Attorney Adam Slater (attorney for Linda Gross, first Ethicon case in NJ, $11.1 million) had conducted a videotaped deposition of Mr. Mittenthal.  The jury never saw it. Judge Goodwin did not allow the videotape to be shown.

“Plaintiff will be significantly prejudiced if the jury does not hear about the missing evidence, so that the jury may draw its own conclusions.” Plaintiffs say they would like access to the missing data so they could counter the claims by defendants in the opening that clinical trials have supported the safety and efficacy of the TVT product. Christy Jones praised the TVT as widely used by doctors around the world. “But because of the missing data from Medscand, none of the data from the clinical trials conducted by TVT inventor Ulf Ulmsten are unavailable to Plaintiff. [sic] they mean available].   The plaintiffs are disadvantaged if they cannot see the TVT studies that form the “cornerstone” of the campaign that sold TVT to doctors in the first place.  There is no doubt that the “hard drive of the five-year worldwide president which was destroyed in 2010, would have had information about not only the TVT product, but about other products and about possible changes to the design.”

In addition the Plaintiffs say they lack important information about any financial payments to the authors of the study that support the use of TVT ie, Ulf Ulmsten and C G Nilsson.

Ulf Ulmsten, founder of TVT

Ulf Ulmsten, founder of TVT

It’s tough to prove what you don’t have.

Doc #278-1 here is the deposition of James P. Mittenthal, the designated corporate representative to testify on the subject. He was hired by the company and paid $400 an hour. It’s estimated his firm made hundreds of thousands of dollars to review the lost documents.

For its part, Ethicon objected to the deposition on the grounds of relevance and on February 7, 2014 motioned to exclude evidence and arguments related to the spoliation allegations. Ethicon objected to questioning custodians whose documents would not be relevant to design, safety and efficacy of the TVT, the basis of a defective product case. Ethicon objected on the grounds that it violates the court order prohibiting references to other pelvic mesh litigation.

The deposition was held in New York  February 10 in the matter of Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation, MDL Number 2327.  The examination was conducted by attorney Adam Slater.

He shows Mittenthal a document entitled Johnson & Johnson law department document preservation notice not to destroy specified documents. It said “Do not discard, destroy, or alter in any way any of the documents, electronic or paper, described below.” The notice was issued May 22, 2003 by the Johnson & Johnson law department to preserve papers and documents in connection with current or future litigation.

A companywide hold notice for mesh documents was issued April 30, 2007.  Mr. Mittenthal said actually since 2003 there had been a defined policy. The employee is provided with a checklist and along with their manager they go through it to make sure “the departing employee’s obligations are complied with prior to his or her leaving the company, and that includes records retention or obligations.” The policy has now been revised to take into account technology he said. “

For my last question,” said Slater, “… you don’t expect people to actually tell you they did that in direct violation of a policy right?”

 A: I ask at every interview if information was destroyed.  I have spent several years now looking at this company and have understood the climate by which information is managed, the information, the systems in place, and the general attitude and demeanor of the employees. And I have no reason to believe that anyone has withheld information from me or been false with me.”

Q: “There’s no way for you to know,, for you to know what happened, right?”

A: “There’s no way for me to be absolutely certain. I would agree with you.”

In a motion filed by Ethicon February 12, 2014, (Doc #273 here) the company argued that documents from MedScand, the Swedish company that initially made the TVT should be barred from trial. Ethicon argues the only relevant MedScand materials concerning the inventor of TVT, Ulf Ulmsten and his research, were destroyed in a 2009 fire at a third-party storage facility over which Ethicon had no control.

In a ruling by Magistrate Judge Cheryl Eifert February 4, 2014, (PTO#100 here) plaintiffs should be allowed to put on spoliation evidence in every case.  That never happened.

What the Jurors Never Saw- Failure to Warn

Part of a defective product case is defective in its manufacture, in its design and in its instructions for use (IFU). A manufacturer has no obligation to warn the patient. The end user is considered to be the doctor so any warnings would come in the form of the product label or Instructions for Use (IFU).

Plaintiffs had argued that the defendants were negligent in failing to use reasonable care to label their pelvic mesh products and a failure to do so led to an avoidable risk of harm to women.  The burden falls on the plaintiff to show a proper warning would have changed the doctor’s decision to use the TVT.

Judge Goodwin ruled the plaintiffs failed to provide evidence that any inadequate warning caused the injuries to Lewis. (Doc #194 here). That’s because Dr. Boreham said she had not read the IFU since 2002 and did not rely on it in prescribing the TVT.  Because of all of the above the plaintiffs Motion to Reconsider and Clarify Summary Judgment order and Daubert Order (Doc #205) was denied.

Of all of those elements, the plaintiffs were left with a defective design action alone.

What had Carolyn Lewis been told in advance of her surgery about the dangers? Did she have true informed consent? Dr. Muriel Boreham testified in her deposition (Doc #180-1  here) that she gave patients brochures which fail to include information about the potential for permanent pelvic damage and long-term chronic pain, nerve entrapment, dyspareunia, mesh erosion, infection, repeated attempted removal surgeries.

Jurors never heard Dr. Boreham received product updates from industry-sponsored symposiums, the American Urogynecologic Society peer reviewed journals and from sales reps and the brochures they dropped off. No one at Ethicon was monitoring whether older versions of the brochures were still being distributed or whether they had been replaced with newer versions, presumably with more information.

They never heard that Dr. Boreham has now switched to using the TVT Exact which has smaller trocar needles used in the blind passage into the pelvis to place the mesh.

They never heard that Dr. Boreham told patients a 92 percent cure rate was calculated on the return of stress urinary incontinence. If one had chronic pain or painful sexual relations she would still be considered cured.

Jurors never heard that ten percent of her surgeries are revision (removal) surgeries.

They never heard that toxicity studies on rats conducted by manufacturers of the resin used to make polypropylene mesh had shown sarcomas (cancer) developing at the site of mesh implantation, information Dr. Boreham agreed was important and something she would have liked to have known. (Her deposition page 109). The TVT IFU has never mentioned that the TVT has cytotoxic potential something the company studied back in 1979.

In (Doc #246  here) – Feb 3, 2014 – Judge Goodwin found that an inadequate warning in the product Instructions for Use is not relevant to the design defect claim in the Lewis case.  The “user” of the product is the doctor not the patient and is considered the “learned intermediary” since she is a medical professional (they are in a better position to understand the risks involved), therefore the duty to warn only extends to her doctor not Lewis. Texas not yet adopted the learned intermediary rule and Lewis is from Texas so the case cited by the plaintiff has no or little relevance in this case ruled Goodwin.

The judge says Texas law only makes the warning relevant to defective design when they include instruction on how to make a device safer for the user. In the case of TVT the warning (IFU) there were no instruction that included the safer use of the product. Either the doctor used it or not and the IFU informed of some of the product’s risks (as we know from the Gross trial the IFU is inadequate in its warnings). Since the warning does not include a safe way to use the product, including evidence of an inadequate warning has the potential to confuse and mislead the jury into believing there is a failure to warn claim.

What Jurors Never Heard – The FDA

Mesh used to treat hernias, incontinence and pelvic organ prolapse does not undergo any clinical trials for safety and efficacy. It simply is not required under the FDA’s 510(k) approval process so unlike drugs that must undergo a premarket approval (PMA), the most stringent required by the agency, the majority of medical devices get on the market after the manufacturers notifies the FDA it plans to market the device and assures the agency it is the “substantial equivalent” of a device already being sold.  It’s really that simple, costs a few thousand dollars and can be accomplished in a matter of weeks.

The jurors never heard that Ethicon never completed a controlled study on live women before marketing the TVT device beginning in the EU in 1997 and in the U.S. in 1998.

The FDA began to get wind of the dangers of transvaginal mesh and in 2008 issued its first Safety Alert that adverse events were being reported.  Since the FDA receives only an estimated 1 to 10% of actual adverse events, it is hardly a reliable barometer of what is happening in the real world.

In 2011, another FDA Safety Alert (here) was issued after the FDA noticed a five-fold increase in complications from transvaginal mesh. This one was much more strongly worded and said that complications are “not rare” and that the risks of mesh for prolapse repair might outweigh the benefits.  That doctors should evaluate their patients carefully and that even multiple surgeries to repair complications may not resolve the issues.

Jurors never heard about the FDA’s 510(k) approval process or the predicate for the TVT mesh cited by many other meshes as a “predicate” was the Boston Scientific ProteGen, recalled by the company for being “misbranded” and “adulterated” and “does not appear to function as intended.” In fact, for the Carolyn Lewis trial Ethicon filed Motion in Limine No. 14 Motion to Exclude Evidence of Recall of the ProteGen Sling. Ethicon argued that the recall of the ProteGen does not speak to the safety of efficacy of the TVT and therefore is irrelevant.

Isn’t the failure of the 510(k) to assure safety, no matter what medical device, exactly on point? Judge Goodwin granted Ethicon’s motion in limine.

What Jurors Never Heard- Science

Dr. Uwe Klinge

Dr. Uwe Klinge

Jurors never heard the Ethicon marketing materials stated that TVT mesh had ‘large pores” in direct contradiction to what scientists on the stand said about the Prolene mesh.

On December 12, 2013, the defense had filed a motion (Doc #132 here) to limit the opinions and testimony of Dr. Uwe Klinge.  Dr. Klinge, a scientist from Germany who has studied Prolene mesh used for hernia repair in patients, who at one time was a consultant to Ethicon offered opinions that were “unreliable, will not assist the jury and far exceed his qualification and the bounds of permissible expert testimony.”

The defense asked the court to enter an order precluding Dr. Klinge from testifying about Ethicon’s corporate ethics and about its documents; that TVT is susceptible to case an increase risk of infection; that TVT degrades and undergoes particle loss; do not mention pore deformation of mesh as its in the body; and not to mention that PVDF mesh was a feasible alternative to polypropylene mesh; and not to offer any opinion or testimony about the pelvic mesh explants.

His expert report (Doc #132-1 here) states that implantation of TVT mesh, a heavy weight “over-engineered” mesh deforms, collapses and leads to fibrotic bridging, scar plate formation, mesh shrinkage leading to chronic pain erosion, dyspareunia and a need for reoperation making it unsafe for its intended purpose. He testified in his expert report that Ethicon’s Medical Director Piet Hinoul deferred to Dr. Klinge and Dr. Klosterhalfen and their expertise.

Among the 485 pelvic floor mesh explants they collected in Germany at the Institute for  Pathology, Duren, they found severe fibrosis in 60% of the TVT Prolene meshes explanted, about 50 percent of Prolift and 30 percent of Prolift +M (Ultrapro mesh) along with considerable shrinkage in the TVT of 40 percent.

Both medical directors Dr. Hinoul and his colleague Charlotte Owens testified they knew prior to the launch of pelvic meshes in the U.S. that some women would suffer severe, chronic, life-altering inflammatory response to its pelvic meshes.

“Ethicon has performed no appropriate studies in order to determine in which women, serious, life-altering complications may occur due to implantation of TVT slings.”  Ethicon has failed to act as a “reasonable manufacturer” in this regard, Dr. Klinge concludes.

Dr. Klinge did appear on the stand Thursday, February 13 but jurors did not hear that the largest maker of polypropylene in the country is in Kenovah, They also did not hear from Dr. Klinge’s Expert Report (Doc #132) that the compounding resin hasn’t changed much since hernia mesh was first made.

“Ethicon’s use of polypropylene as a suture material dates to the late 1960’s when it began purchasing polypropylene resin for its Prolene sutures from the Montecatini Company at their Novamant Plant in Kenovah, West Virginia. The mixing and compounding of the resin has not changed since that time – same composition; same molecular weight; and same molecular weight distribution. The individual component additives to the resin are Santonox (antioxidant); calcium stearate (lubricant); dilauralthiodipropionate (antioxidant); Procol LA-10 (lubricant); and CPC pigment (colorant to enhance visibility). After the extruded resin material leaves. the compounder in pellets for shipping to Ethicon.”

The West Virginia-based Braskem America’s Neal Plant was purchased from Sunoco in 2010 and makes 70 different types of PP.  1.4 million lb/day in this 24 hour operation.  Background story is here:

In Doc #250 Opinion and Order (here) February 5, 2014 – Judge Goodwin was asked to reconsider excluding some opinion of Dr. Klinge regarding secondary infection. They tend to appear when mesh remains in the body he said (Doc #195). The plaintiffs argued since Ms Lewis has some mesh remaining, Judge Goodwin says secondary infections were not a fact in issue for Ms Lewis so Klinge’s opinion was excluded.  Judge Goodwin determine Dr. Klinge’s analysis of 485 mesh explants from the Institute for Pathology in Duren were unreliable because Dr. Klinge did not explain how he selected those explants, and whether or not they constitute the entirely of his collection of pelvic floor explants.   Judge Goodwin says he has no information on the “Potential rate of error” (Doc #246 here).

Plaintiffs’ motion to reconsider and Clarify summary Judgment Order (Doc #205) is denied because information about Dr. Klinge’s methodology is left unanswered and Judge Goodwin denies the motion to reconsider.

What the Jurors Never Heard- Material Safety Data Sheets

Recall in the C. R. Bard cases, lawyers showed the MSDS issued by the companies making the raw polypropylene. In the case of Bard it was Chevron Phillips MSDS for Marlex Polypropylene mesh which clearly said the materials were not to be used for implantable medical devices.   This is as close as one can come to a “smoking gun” in making a case, especially when the evidence then showed internal company discussion to intentionally distance themselves from the supplier by creating a middleman company, Red Oak, to purchase the materials.

Motion in Limine (Doc #250) No. 15 by Ethicon tries to avert a similar revelation for Ethicon. The supplier of the polypropylene for the company was Sunoco and Braskem. Both companies issue a MSDS for the C4001 polypropylene homopolymer.  The warning not to use for any implantable device does NOT appear on the MSDA by those companies but the suppliers to warn of carcinogenicity or whether polypropylene causes cancer.  Ethicon says the risks discussed in the Sunoco and Braskem MSDSs are irrelevant “as they relate to injuries that Ms. Lewis did not suffer,”  that being the development of cancer.

Judge Goodwin agreed to grant the motion excluding all MSDSs that are not an Ethicon supplier.

What Jurors Never Heard – Ethicon’s Own Admissions

Doc # 180-24 (here) is a report  The (clinical) argument of lightweight mesh in abdominal surgery by Boris Batke, Ethicon Research & Development

Ethicon’s own literature extolling the virtues of lightweight mesh- a smoking gun, heavyweight contracts up to 40 percent, lightweight 10-20 percent. Heavyweight creates bridging fibrosis and a scar place that causes shrinking. Ethicon then launched a new line of lighter weight hernia meshes. The TVT relied on the old standby, heavyweight, small pore Prolene mesh that had been used for hernias.

B. Todd Heniford, MD

B. Todd Heniford, MD

Motion in Limine No. 13 in Doc #250  states that a DVD featuring Dr. Todd Heniford entitled “The Benefits of Lightweight meshes in Ventral hernia Repair” should be excluded. According to Ethicon the video features the Kugel Composix Hernia Mesh made by C.R. Bard (Doc #208) in which Dr. Heniford, then working as a consultant for Ethicon, discusses heavyweight hernia mesh and the development by the company and advantages of using a lighter-weight mesh for use in the abdomen.  Heniford says the lightweight polypropylene mesh allows for better tissue ingrowth and improved vascularization of the mesh.

Dr. Heniford was withdrawn as a testifying expert in the matter December 11, 2013   because the company thought plaintiffs might try to impeach his current positive views regarding Ethicon’s product.  Goodwin granted Ethicon’s Motion provided Heniford did not testify at trial.

Piet Hinoul, Ethicon from Linda Gross trial

Piet Hinoul, MD, Ethicon from Linda Gross trial

What Jurors Never Heard- Crude References

Emails from within the company (Doc #207) showed that the company was considering a registry of Prolift and provide that information to physicians on a CD-Rom.  In an email chain between Medical Director Dr. Piet Hinoul and Aaron Kirkemo, Hinoul said that if physicians were not provided a CD-Rom “then they could not use it as a pessary when the mesh fails.”

A pessary is removable device used to hold back prolapsing organs. #

23 Comments

  1. Paula says:

    Makes me SICK…..!!!!!!

  2. stopmeshimplants says:

    These facts are unbelievable! I cannot understand how this has happened and no one is there to stop this madness. Someday, before I die,I hope to have answers from this judge about these cases and what he was thinking when he made these decisions that have such a negative impact on so many lives. Thank you, Jane. I am grateful for your investigative skills and for your documenting all of it so we can better understand exactly what has occurred with this case. It is absolutely disgusting.

  3. Richard Howden says:

    J&J/Ethicon has more money than we have Lawyers and more Lawyers than we have money. None of this surprises me anymore. When the FDA can ignore their own MAUDE data base’s number of complaints by calling them “Inconclusive” for one reason or another but is now investigating Testosterone??!! Or they are investigating a Blood Thinning Compound because “Bleeding” has occurred! But just browse through the MAUDE data base and look at the thousands of complaints about Mesh of what ever make or model and you have to come to the conclusion that there is something wrong. Not according to the FDA and that is where we as a group are being screwed. Until they are forced, kicking and screaming, to finally admit that ALL Mesh is bad we will not get a fair shake in court. And Ethicon and all the rest can buy the best Judges money can buy. There is just too much money involved to stop hurting people. Can there be any other explanation? I think not……..

  4. Annie says:

    This pains me to know that its because of this product I now have nerve damage, pelvic pain so severe I cannot stand up at times. I’m terrified that I will die from this mesh. I just found out I have pelvic floor damage. I will be having a partial removal but what does that do it still leaves part of that mesh in me. I’m told their is no way to remove the arms. The only doctor who can do it is just way to expensive for me to afford his care. I will need the money to remove the arms. I don’t care about money for me but at least they should cover my costs. Suffering is no fun.

    • Victoria Lake says:

      I also have your problem, mine is still wrapped around my bladder unyielding to anyone who will remove it. I feel that the lawsuits were the only way to hold these companies accountable for the damages. But it is not happening and the next move is for the women to find someone who can reach the judge and at least have our day in court with a jury

  5. Consumers Union -Safe Patient Project- has just begun a campaign to demand product warranties on implanted medical devices from the manufacturer. The first effort/focus is for hip/knee replacements, but as harmed mesh patients and advocates you can join as allies! Watch for local media stories on this issue and comment on how it relates to the catastrophic surgical mesh failures and subsequent medical medical and legal purgatory you have experienced. We (collectively) have a lot of work to do to counteract the powerful profiteers who blatantly ignore patient harm and have contorted our justice system so deviously that we no longer have protections from outlier medical predators.

    • Jane Akre says:

      Joleen- thanks so much for reminding us of this important campaign. If your car and television come with a warranty- why can’t your permanently implanted medical device? Makes so much sense….. thank you..

  6. HE says:

    How can anyone of these people look in the mirror at themselves and then sleep soundly? It still amazes me that so many people are being hurt by this. There is so much mounting evidence to the contrary that these products “are the gold standard of the industry.” There are more than 60,000 known cases in the court systems. This does not include those who’ve been hurt and are not pursing justice or those who’ve yet to find out what we already have. That the national news programs will highlight case after case of single individuals hurt by someone, go into detail and spend a lot of air time on it. That so many are hurt and no one who has great power to cause change seems to care, and allows this to continue. That Dr.’s, even though they see how injured some women are in their practices – continue to use this product. That regulations concerning human beings are inferior to the regulations for many other industries – automobiles, animal care, electronics and household products. A crib causes 3 deaths and there are immediate recall notices. I am not saying this should not be – it should and it is horrifying that happened. These are good regulations that are saving lives and emotional devastation that will last a lifetime. Where are these protections for the medical industry? I believe that Judge Goodwin is at best ignorant, or at the worst in bed with the pharmaceuticals – I don’t understand the law, but even I can see that there was undue prejudice. I am tired of the helpless feeling that we have – getting someone to listen and believe us! We are victims as yet unidentified. I believe there will be justice one day that this is not the end. Thank you Jane for being strong and stretching yourself so much for us. You cannot be repaid for all you’ve done and what you are continuing to do for us. I wonder if the human rights organization would be interested in this story?

  7. Mike Patrick says:

    Everyone needs to write, call or send a letter to the Honorable Judge Godwin to ask him to be Honorable and to be Just in his actions as this is affecting tens of thousands of US citizens and makes one think there is some sort of shenanigans being done behind closed doors in his courtroom with the big Medical companies. IF this were a move it would seem that the overall theme of this move was to placate the big companies and give them an out.

    Interesting…………. Also if anyone knows how to contact Jon Stossel or Greta Van Sustern at FOX or Dr Sanjay Gupta at CNN or others on NBC and CBS and ABC. or send a letter to the Doctors show to ask them to investigate and make it public. We really need to bring this and other things to light through the mass media chain, others will then follow fairly quickly. Why aren’t Oprah, and other women daytime shows addressing this? What about Dr. OZ. Mention names and the injustice of what has been going on and the suffering of those inflicted.

    In any contact or letter, be nice, respectful and appreciative. But also be factual, loud.and continually forceful in our endeavor for true Justice and not arbitrary rulings or opinions.

    Does anyone know if this Ethicon vs Lewis case ruling is being appealed over his head?

    Here is Judge Joseph Goodwin’s court information:

    Honorable Joseph R. Goodwin, Judge

    Phone Number:

    304/347-3192

    Mailing Address:

    P. O. Box 2546

    Charleston, WV 25329-2546

    Street Address:

    7009 Robert C. Byrd United States Courthouse

    300 Virginia Street East

    Charleston, WV 25301

    Staff Information

    • Jane Akre says:

      I do not think it is wise to call Judge Goodwin and do not endorse it. I will approve your comment regardless.

      • carol says:

        Jane,

        What can we do. This is so frustrating. Why is this not being run by major networks. Whu does no media outlet care about this ongoing healtj issue for women. I want to do something. It feels hopeless at times.

  8. carol says:

    This is all very disgusting. IT STINKS!!!!! we have all been raped by these companies now the judical system is doing it.

  9. Mary pat says:

    I encourage every mesh injured person to file a consumer protection complaint with your state Attorney Generals Office. You can also file a complaint with your state Medicaid Fraud Control Office. You can also file a complaint with the Office of Inspector General (OIG) Federal Agency that investigates the FDA. DO IT!!!!!! These are three powerful government agencies that can go up against the pharmaceutical companies like David versus Goliath. I see lots of whining and complaining from mesh victims yet they don’t even sign a petition against mesh. I implore you to TAKE action and file complaints. The petition on “we the people” didn’t even get enough sigmatures to be an active petition! Why not???? Why didn’t you all sign it? If you really want to stop the use if mesh, TAKE ACTION!

  10. Mary pat says:

    So sorry. I did not mean to offend anyone. The petition was on the MDND facebook Hardly anyone signed it and that was heartbreaking for me. When I experience extreme pain days that literally drown me I have to fight my way out of it and I tend to get fired up. I truly did not mean to offend anyone. So sorry.

  11. Victoria Lake says:

    How many more women are going to suffer from the companies who want to use us as pawns in their games to win? We are the ones who have to deal with all the exams, urinary tests, countless lawyer meetings, and the husbands or partners who will never be able to have sexual counters. Where is the justice for us? The judge was wrong or he was just too tired to care.

  12. Bejah Notrettu says:

    Dear People, Do you still believe you live in a Democracy? Do you still believe we have freedom of the press, of assembly, of speech….do you still believe the Constitution is abided by in the halls of power? Why do you think this issue is not covered at all by major media. Could it be because the power in this nation owns those media corporations and has prevented coverage quietly behind the scenes? If so, do we really have freedom of the press? Do we still live in a nation where government is of, by and for the people? Or is it of, by and for corporations? Goodwin’s peformance is shameful and we can expect more of the same. He has been bought and paid for and is an enemy of the people. The plantiff’s defense teams must view him in that light in future. This is heartbreaking and I know that so many of you, like me, were deeply depressed for days beause of the outcome of this trial. My heart goes out to the woman who suffered this additional abuse of her spirit but I would ask her to remember that we are doing battle with pure evil and remember to be thankful for the good things in her life and not dwell on this horror. The rest of us continue to fight for justice for her. We will not forget.

  13. Bill Thompson says:

    If you strip away all of the emotion and horror of each case and look at Carolyn Lewis on the merits of the case itself, as a matter of law the case was weak. She never went back to see the implanting doctor not even once yet had seen many doctors repeatedly for her other health conditions. How could any law firm actually take the case with such fundamental flaws in the facts of the case? Does this change the fact that Carolyn had the same defective mesh implanted as any other woman that did see their doctor after mesh complications began?This issue should not be about how proactive a woman has been with her response to her body and symptoms rather what the law will do to determine if the product is defective and hold the companies liable. If a woman is suffering, compensation should have nothing to do with how proactive she was compared to anyone else. If the product was defective for Linda Gross then it’s defective for Carolyn Lewis.

  14. NJ Ansted says:

    Until we march in the streets, show up on TV and in news papers . Until they see our real numbers we will never get justice. I have had it with being in pain and No one caring. We deserve a Fund be set up for us, We should not have to be sick and struggle to get a lawyer and never get our day in court. The Senate the FDA and Congress are all failing us.

    • Jane Akre says:

      I talked to a woman today who went to her Congresswoman from Washington state. There an aide told her she thought the whole mesh litigation was made up by trial lawyers… Really.

  15. GA Guest says:

    Jane,

    I was instructed by my attorney (and signed an agreement) to not discuss my situation online or to anyone except medical professionals whom I seek for assistance. Isn’t that reason enough not to sign petitions, go on TV talk shows, etc?

    • Jane Akre says:

      Some lawyers would agree with that. Others say unless your case will appear before a jury, it may not make a bit of difference. Others feel if you stick to the facts of your case then what is the problem? Ultimately it is between you and your counsel.

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