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Judge Goodwin Expresses Confusion? 'Gold Standard' or Defective Pelvic Mesh?

 

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

*Editor’s Note~ MND editor has been the only reporter covering these trials so the comments by Judge Goodwin as the days testimony ended, were particularly noteworthy.

Jane Akre

Jane Akre

Judge Goodwin has shown a lighthearted spirit joking with the jurors and even the attorneys. Once calling a sidebar after an absence of one he said “I’ve missed you all.”

Certainly he has shown more of an upbeat attitude than he did during the other case against Ethicon he oversaw last February, Lewis v. Ethicon.  After the plaintiff rested its case, Judge Goodwin granted a J&J motion to end the trial in the company’s favor granting the directed verdict.

His comments today might indicate how thinks the case is going.

Judge Goodwin seemed to be grasping for words when he waved his hands in the air at the end of today and said he was thinking about the upcoming  jury instructions in this product liability case.  He asked both sides to write up something explaining two legal concepts at odds with each other:

How we can have a “Gold Standard” and a “Standard of Care”  meaning the TVT-O, transvaginal device used to treat incontinence,  and at the same time a  device that is “unreasonably dangerous” which it must be proven under strict liability law. How can a device when used by a physician be negligent in its design and manufacture?

 

Clearly Judge Goodwin is not aware that there is a divide among doctors, a growing voice of professionals that agree that polypropylene mesh represents an unreasonable risk, or is outright defective.  Here is a background story on Doctors Divide.

There’s  been an entire media blackout on reporting on these cases and women cannot make it here to Charleston because of injuries and instruction by law firms to stay away from speaking out. Jurors are not seeing the breadth of mesh-injuries in this trial.

Clearly Judge Goodwin and the jurors do not understand that an Institute of Medicine report issued in 2011 says the 510(k) approval process  should be abolished because it is putting too many patients at risk and that the FDA should start collecting information to build the new process, including post-market data for devices which should be enacted by Congress. Read the report here.

This case has not allowed in the FDA July 2011 Alert that says Risks may Outweigh Benefits in regard to mesh for pelvic organ prolapse. It is the same mesh. Here.

Judge Goodwin said : “Failure to warn is an easier thing to wrap your head around,” he said. “I’ve got that.”

He asked if there was a standard when a medical device that is extraordinarily dangerous such as the black box warning when a medication is found to be harmful to patients.

Both sides can offer explanations to the Judge  by tomorrow.  He must then take that into consideration in providing jury instructions.  The case for J&J should wrap up this week.

 

Readers of  Mesh News Desk… What would you say to the judge? How do you explain this apparent contradiction?

First of all- Was there any evidence of a “Gold Standard” or does calling it that make it so?

Secondly- Isn’t the 100-thousand lawsuits, and around the world, claiming mesh-related injuries, evidence that there are problems with polypropylene mesh devices not to mention similar problems expressed by hernia patients ?

Thirdly- Unlike pharmaceuticals, there is no FDA oversight  to assure the safety of the vast majority of medical devices before they are put on the market.  Essentially, the public tests the devices, good, bad, or otherwise.  Your thoughts? 

 

28 Comments

  1. msm says:

    In my opinion…

    Question 1.

    The term “Standard of Care” refers to one (but not necessarily the only)

    recommended protocol or treatment to be used in patient care.

    The treatment is predicated on the patient’s health not on the speed and

    ease of the procedure or its popularity.

    The term “Gold Standard” refers to an example against which all others are measured.

    To use TVT as the example by which all other treatments for SUI are measured, is presumptive.

    This is not a “one size fits all” issue. Too many variables exist to declare one treatment as THE best (Gold Standard).

    A few considerations that should be taken into account when selecting the best treatment follow:

    There are many variations of TVT.

    There are several techniques for implanting TVT.

    There are differences in the skills of the surgeons.

    There are differences in the amount of training required by the manufacturers to use their product.

    There are vast differences among patients (i.e age, body type, pre-existing conditions,

    lifestyle, activity levels of patients, scar tissue from previous surgery, etc.)

    I agrue that there cannot be a “Gold Standard” applied to treatment for SUI.

    ———————————————————-

    Question 2.

    There has been a lot said about lawyers driving up the number of complaints. These legal firms

    recruit for everything from hip replacements to cholesterol drugs.

    Why aren’t there more lawsuits for those devices and drugs?

    It is because fewer people are injured. It’s that simple. The women of the world

    didn’t get together and decide to subject themselves to the embarrassment

    and humiliation we have endured. We didn’t have a “hen party” and decide that

    hanging out in the O.R. having mesh removed is the latest and greatest spa

    treatment so we should all rush to our doctors. No woman wants to be splayed out

    on a table over and over again being examined, poked, prodded, injected, cut, stitched,

    manipulated, catheterized, packed full of gauze… I’ll stop there. I hope the judge and jury

    will truly put themselves in that position. These complaints are real.

    Fortunately, other countries have (or are considering) pulling all mesh, including TVT, off the market pending further investigation.

    Unfortunately, the U.S. favors the manufacturers over its citizens.

    ———————————————————-

    Question 3.

    It is barbaric to allow testing on human subjects without their knowledge.

    This is what happens with the FDA clearance process. The manufacturers rush to market

    to beat the competition and patient safety is the least of their concerns.

    The clearance process exists to avoid unnecessary delays in getting much-needed

    medical devices to patients. This works in a perfect world but profits drive the system.

    A genuine concern for improving the quality of life of patients was not on the minds

    of Ethicon when it rushed to market.

    • Jane Akre says:

      MSM- Your comments are always quite insightful! thank you. The FDA working in concert with manufacturers, they get a green light, they make money, hopefully people won’t be injured during the process. It didn’t work out that way.

    • danyelle robinson says:

      Msm… LOVE YOUR ANSWER TO QUESTION 2… as for Gold Standard, I think it’s simply a marketing term to peddle more mesh. In the cases of TVTs, it was it’s ease of use, they made it seem simple enough for any general surgeon to do what had once required a skilled specialist.

  2. Renee says:

    “Gold Standard” only equates to profitability and is no way (in regards to polypropylene medical devices) equatable to any type of health standard. Let the physicians, attorneys, and manufactures of these devices implant their mothers, sisters, and daughters with polypropylene medical devices – or better yet – themselves. Then, and only then, can they make any reasonable statements that relate mesh medical devices to any standard. They know better and would not allow it. Women and men have been used as living, human test animals without informed consent or compensation. Thousands of people are suffering to a degree that those who have not experienced it cannot possibly imagine. We were lied to and robbed of our lives and now we watch while our value as human beings is determined in a court of law – by people who unconscionably use the term Gold Standard when describing a lethal product. Gold Standard? I say double standard! We send people to prison for pointing a weapon at another human being with intent to rob yet this devastating thief is free to roam.

    • Jane Akre says:

      Gold standard is a handy marketing tool just like “minimally invasive.”

      Have we forgotten that tobacco was once considered so benign that doctors recommended it to their patients to calm their nerves. Then we found other differently. The same thing will happen here,….maybe one day.

    • Jane Akre says:

      Well put Renee. If there were only 50 women in the courtroom, judge and jury would see it first hand!

  3. Jane Akre says:

    Suzy cannot openly comment but she writes:

    Dear Jane

    “When I was having my 1st revision surgery the nurse asked why I was there and when I told her, she said oh! honey nobody is using those anymore! Its the gold standard if you are the one selling or being paid by the companies selling them. I was at Plano Baylor that has a great reputation and many drive to for excellent care which I did. My understanding is that they have other slings they are promoting.”

  4. Renee says:

    Is it just me? Or is there something really disturbing about Judge Goodwin’s lighthearted behavior? Are the people in the courtroom really that oblivious to what is going on?

    • Jane Akre says:

      Renee- He is just being friendly to the jurors… They are there doing their job as citizens. He is grateful as is the plaintiff or anyone who sits before their peers. The jury system is not perfect but it’s all we have. Honestly, he is just being kind and considerate to them making sure they have lunch brought in and that they can speak up if they need to. That’s my observation.

  5. Aaron Leigh says:

    Jane;

    Can you send her to me?

  6. Ginger says:

    Well here is another twist on GOLD STANDARD word used to promote products in commercial just like Johnson and Johnson a family company they are no family of mine ….. we are all VICTIMS of such GREED……twisted words that mean nothing except lies and mutilation of women all over the world… if this is a Gold Standard I want Platinum Standard …. lol I want Medical Doctors not to be used as puppets to gain monetary gain and women to be held to a higher standard than a meat market approach….

  7. Dear MSM……I could not have said it better….there are too many variables, too many differences in chemical recipes from different manufacturers to say there is a gold standard product …. and too little research into why the chronic FBR response to implant materials such a PP appears to initiate autoimmune disregulation post and during mesh complications ….. this is a newly emerging recognition that has little to no research done on it …. only with the advent of social media have women been able to share their observations to an audience that is willing to listen as they have the same problems and autoimmune problems ….. how can anyone say something is gold standard when there is no scientific research into why at least 30 % of the women who have TVT implants appear to be developing autoimmune disorders at a higher rate than the rest of the population…. under reporting, autoimune disregulation post mesh discovery in its infancy …… come on Judge Goodwin, mesh has already been found defective at trial…… many meshes were not tested on their own merit, this reminds me of the fairy story about the King and the weaver that spun golden threads that could not be seen by stupid people, the medical community followed experts who had ” invested interests” taught the gold standard sermon…..

  8. David says:

    Perhaps Judge Goodwin is not asking the right question. The question would be better rephrased as follows: Is it possible to have a reasonable assurance of safety and effectiveness when the industry’s “gold standard” of care is to indiscriminately abuse a surgical mesh device which performance cannot be predicted in any patient’s body?

    The root of the conundrum, I believe, is the assumption that the “failure to warn” is a separable or “an easier thing to wrap your head around” then negligent design and manufacture. And therefore, I believe, it is a fundamental failure of law that gives rise to Judge Goodwin’s confusion.

    As Jane reported in her article, Huskey v Ethicon Day 4- Huskey Takes the Stand:

    “Judge Goodwin interrupted a line of questioning about what Huskey had been told by her doctor. Under Illinois law, the learned intermediary is the doctor the manufacturer only has a duty to warn the doctor. A failure to do so is one of the elements of a defective product case.”

    The “failure to warn” and the physicians’ “gold standard” of own best practice, are at odds with a device not being understood by a patient as “unreasonably dangerous.”

    As Jane reported in her article, Renowned Urologist for the Plaintiffs Does Not Use Synthetic Mesh, under the subheading FAILURE TO INFORM:

    – Does the IFU or instruction for use warn adequately warn of the injuries Mrs. Huskey sustained? “It does not! said Blaivas.

    – Do you believe the medical consent form is consistent with information in the IFU? Objection!

    – Did Mrs. Huskey consent with full knowledge with what could happen to her? Objection!

    I think a device being fit for its intended use is inherent to the adequacy of a device’s IFU (instruction for use). The “unreasonably dangerous” risks making surgical mesh unfit for its intended use (non-inert materials and biocompatibility issues), therefore, must be mitigated with contraindications, to propagate responsible, real-world use (via a black box warning – the current failure of the IFU to adequately warn). And, thereby then, make the FDA reclassified (if possible), understood least risky surgical mesh devices fit for their surgical intended use, with restrictions (contraindications), to propagate a reasonable assurance of safety and effectiveness.

    I do not think it is possible for this industry to have its cake (it own, one-sided “gold standard”) and eat it too (self-promoted guidelines fixated upon a surgeon’s efficacy maximizing its profits). Industry’s “gold standard” of widespread, deceptive, systematic exploitation of unsuspecting patients is incompatible with the patient’s reality, for the lack of effectiveness, which follows its intent.

  9. charles says:

    I am impressed judge goodwin is addressing his confusion. I have been confused all along by the same question but didnt know how to word it. I am torn . I have had mesh in me for inguineal hernia since 2007 and ive never had any promlem at all . But i see all the problems my wife has had. Why???? Mesh was placed in me using a sterile procedure but vaginal mesh is placed thru the vagina which opens up huge possibilities for contamination. Why havent i had problems if mesh is eroding in me? How many women are like me and have no real problem? The questions really set up conflict and confusion in me. I applaude judge goodwin. Maybe these attorneys can shed some light tommorow. Ive no doubt the mesh is practically killing my wife and i mesh should be withdrawn and nautural fascia used and taught . The benefit does not exceed the risk but i am still confused

    • Jane Akre says:

      Agreed Charles- he is smart to address it. But the proof is in the 100-thousand lawsuits filed around the world…. these are mesh injured women, and to a lesser extent hernia mesh injured men who have filed lawsuits. They are the proof there is something wrong with the product aren’t they? They are real, not imagined injuries. How can the jurors deny Ms. Huskey is there for real reasons? We will see.

  10. Sarah says:

    Does anyone even realize that what is the golden standard today may not be tomorrow? This changes all the time because of research, complications ect. Often the more we use a product and find out what happens in time with a product we find it’s not safe, never was or something new and better comes along. Drug companies go to doctors and tell them it’s the new fast easy way to do something. Then like we did as kids one person says yeah it works great then another then another and then wow everyone is using it and it’s now considered th”golden standard”. Everyone is using it o it must be safe. Until it’s not! Until people like me and so many others no longer are alright. Until we finally have a voice and can speak out. But if the courts keep siding with big pharm then they kill our voice. Eventually there will be a new golden standard and people will look back and say how bad this was, just like smoking. I just hope it doesn’t take long!

    • Jane Akre says:

      Good point Sarah- cigarettes used to be the standard for relaxation… doctors told their patients to smoke to calm down… WE now know better. Imagine… the jurors do not know there are 66-thousand similar cases filed right under their nose! Very frustrating…

    • David says:

      Sarah,

      You mentioned smoking – the following are text excerpts from a NIH (National Institutes of Health) statement issued today on International FASD (International Fetal Alcohol Spectrum Disorders) Awareness Day (September 9), by George Koob, Ph.D., director, & Kenneth R. Warren, Ph.D., deputy director National Institute on Alcohol Abuse and Alcoholism:

      “Almost 40 years have passed since we recognized that drinking during pregnancy can result in a wide range of disabilities for children, of which fetal alcohol syndrome (FAS) is the most severe.”

      “For many years, the National Institute on Alcohol Abuse and Alcoholism has supported research to understand how alcohol exposure during pregnancy interferes with fetal development and how FASD can be identified and prevented.”

      “The message is simple, not just on Sept. 9, but every day. There is no known safe level of drinking while pregnant. Women who are, who may be, or who are trying to become pregnant, should not drink alcohol.”

      Applicable, I believe as well to surgical mesh, if the performance of surgical mesh cannot be predicted in a patient’s body, then restrictive guideline labeling is needed (on the FDA’s approved of the least risky mesh devices) to protect the public from the unreasonable risk of illness and injury resulting from indiscriminate surgeon abuse. The reality of patient need – not the illegitimacy of surgeon and manufacturer – should determine the real-world, responsible use of any long-term/permanently implanted medical device.

      http://www.nih.gov/news/health/sep2014/niaaa-03.htm

  11. Dean says:

    I get confused when the Judge knows how many cases which are building up just in the cases he’s handle ing and the Huskey team isn’t allowed to tell the Jurours this imformation how many there are.Also the FDA confirmed that it is a dangerous products and they put them at a different level.Also they can’t mention that it was found defective in a court of law already saying it is the Standard Gold everything new on the market in the health field is mostly called that until something goes very rong then it’s pulled which also isn’t being allowed to talk about with the meshes that have been pulled it seems that the Judge is saying to these lawyers well good luck how can one try to defend there client if they can’t tell the truth in the court room I thought the FDA where saying it was fast tracked and wasn’t approved at one time if the Jourous knew more of the truth I know I would not be worrying so much about the out come of this trial even the media is shut out of this case WHY?

  12. msm says:

    I just realized how Judge Goodwin’s approach differs from Judge Kottmyer in the Cardenas trial. In the Kottmyer court, jurors (with no medical background) were not given definitions of two technical medical terms used in testimony and were not allowed to look them up nor would the judge offer a definition. In many other trials, jurors ask for definitions and are allowed questions during deliberation. I suppose it is up to the judge.

    The number of procedures using TVT have increased exponentially in the last 5 years. The injuries will follow over the next 5-10 years. History will show all of the injustice’s . Judge Goodwin seems to be carefully considering the instructions he will give to the jury. I hope he delivers fair, clear and complete instructions before the jury deliberates.

    • msm says:

      Also, remember the Rizzo case where she was forced to pay over $14,000 when she dropped her lawsuit. 60,000 cases are not going to disappear.

      So, allow the evidence. Give the jurors clear and complete instructions. Allow questions during deliberation. Don’t force the jury to make a blind decision. Don’t let them walk away wondering if their decision was fair because they didn’t know the technical definitions presented from both sides. They deserve better than that for doing their civic duty.

  13. Kitty says:

    Hello Dean—Transvaginal mesh!!! Vaginal response—— Many people —believe it or not find this offensive—as did the Ob/GYN Docs in the days of Masters and Johnson research.(Human Sexual Response) This device is about woman’s sexuality–How shameful to have TV carry this report about the S—s and wh–es that can no longer have orgasms.

  14. Betty Scott says:

    First of all, I do not care for this judge!!!!!! Second, pray that the minds and hearts of these people will try to understand the problem and make the right choic. Sad what is being done to people today for money!!

  15. Kitty says:

    We will pray

  16. jade says:

    “Gold Standard” is not a medical term. It is a Marketing term. Plain and simple. PERIOD. It has nothing to do with the safety and efficacy of mesh, nor is it specific to mesh. It is also applied to other medical products and procedures, e.g. DaVinci Robotic Surgery (which is also under scrutiny and legal suits). Goodwin is not thinking clearly here. Quite frankly, I’m surprised at his confusion since he (if no one else) with his supposedly in depth knowledge of the TVM cases, should keenly be aware of the distinction.. Maybe one to many margaritas over Labor Day. But, as Cher said in Moonstruck “Snap out of it!”

  17. Disgusted says:

    I think that Judge Goodwin’s confusion goes directly to the issues with the 510k. It seems to me that he believes the FDA is doing it’s job and therefore; how could a product be defective and still be implanted into women on the market? I think he is starting to understand the difference between acute pain (caused by surgery and then healing occurs) and chronic pain (permanent pain caused by damage from the implanting surgery and the product implanted, that cannot be rememedied). The Gold Standard has not been adopted universally by all Dr.’s or institutions, there are many that have rejected using any mesh from the beginning. As others have said “Gold Standard” is a marketing term, as is “minimally invasive”. Minimally invasive disappears the moment erosion/extrusion/etc. start. I’ve seen reports that the success of the TVT/TVT-O are much higher than the Burch or the MMK, but also that the comorbitities are also much greater for the TVT/TVT-O than the Burch or the MMK. To say that other surgeries cause these same issues is ludicrous. Polypropylene is the only product that has been shown to cause erosion/extrusion/etc. whatever other name they come up with. To say that erosion/extrusion is manageable is a direct lie. There is nothing manageable about it. Partial removal of mesh is only a short term fix, it lasts as long as you’re in resting mode. Once movement begins the pain returns with a vengeance. Judge Goodwin need only to look to the 510K to see where the confusion started. The reason the 510k was put in place was to stop the “hold up” of getting valuable medical products on the market. Europe was getting life saving measures to the market much quicker. The problem in the thinking came in when someone decided that integrity would be used. The inability to understand that greed rules and comes before the hippocratic oath is what allowed this to take place in the first place. Combine that with the inability to hold corporations to a higher standard – individual responsibility for harming others – on purpose – knowing that the product would hurt people – is a recipe for disaster, which we are now seeing in force with so many different products out there.

  18. Pam says:

    Does anyone find it compelling that if this product is supposed to be safe, and very low adverse effects that there are less than a handful of skilled physicians with expertise to explant the Mesh? I’ve wandered why myself that if the company was aware that there could be FBR, and possible injury to nerves that there is “NO safe METHOD for removal, and that each surgery to remove is critical?” That alone is a Failure to Inform of defects in itself. Anyone can have adverse effects to peanut butter, so I find it hard to believe that all these Experts didn’t believe or chose to have deaf ears to all of us that are injured.

    In my own opinion I think that these companies and representatives were hoping that since this is such a private conversation that they were all hoping that “Meshed-Up Women” wouldn’t go public or come forward to anyone. Trying to deny the fact that they knew or could possibly wait until more adverse reactions were happening, so that they could then put the blame to the problem to all the “Adverse Reactions” and not the “Mesh”. Thankfully today with the Social Media that we are able to discuss our symptoms, and issues with one another going through the same, and sadly feel “Normal” and not crazy with all the issues that the “Mesh” has brought upon us.

    This is disheartening and a downright blatant injust to all of us that have been sentenced to a “Life of Mesh!”

  19. Anonymous says:

    At a recent osteopath visit, my doctor actually expressed to me that he wondered why women had such problems with mesh, when “it has been used for hernia operations for years”.He agreed that my body is trying to “reject the mesh”. I told him that perhaps it was partially due to it’s location.Intercourse would make it more difficult to recover from, and it’s location in such a bacteria prone area also might have something to do with it. I was amazed, that I had to express my opinion to my doctor, whom you would think would have much more common sense than I.Then he asked me if I was part of any litigation.He knows how I suffer, and I believe he is championing for me(but then I have trusted other doctors before).

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