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*Breaking News * Mesh-Injured Woman Pushes Against Caldera Mesh Settlement

Image, Linda Nylind for The Guardian

Image, Linda Nylind for The Guardian

Mesh Medical Device News Desk, April 20, 2016~ Twelve years ago today a grandmother was implanted with a Caldera Medical pelvic mesh used to treat incontinence, which she says she didn’t have.

Today she is urging a quiet revolution that threatens to implode the $11.7 million settlement the privately-held company has offered to get out of the domestic pelvic mesh business and end contentious mesh litigation with a looming April 25 deadline to object.

They entered our marriage, they mutilated my beloved wife. They never gave us a choice. I will never make love to her again. I watch her fade. I listen at night to her cry.  If this was the mutilation of American Men, the nation would be outraged.  Where are the leaders who can help us? 

They are all greedy, evil bastards who invented these devices and implanted so many helpless women. They are responsible for the slow death of my wife. ~ Husband of transvaginal mesh-injured woman

 

On October 14,  2003, Caldera Medical Inc. of Agoura Hills, California began introducing its product line of mesh to treat incontinence and pelvic organ prolapse in women.  Six months later, “Samantha” became one of its first recipients.building

Without knowing it, she was implanted with the T-Sling, a polypropylene mesh that did not yet have Food and Drug Administration (FDA) approval. She was implanted by a co-inventor of the implantation of the T-Sling mesh procedure, which he never disclosed.

It would be another 22 months before the T-Sling was approved for sale under the FDA’s 510(k) approval process.

Mesh News Desk’s editor knows “Samantha” (not her real name) who is represented and was advised not to go public at this time.

The Settlement

In February, the news hit Samantha hard. Caldera Medical announced an $11.75 million settlement for 2,100 women who had received Caldera pelvic mesh products. There would be no opt-out, no other options. Caldera said the $11.75 represents “virtually all of Caldera’s funds” which was whittled down from a $25 million insurance coverage provided by Federal Insurance Company, a subsidiary of the Chubb Group of Insurance Companies.caldera logo

Litigation between Federal and Caldera over the company’s remaining assets and coverage show the insurance coverage policy covered four years only from 2008 to 2012. See the document here.

Plaintiffs allege Caldera knew or should have known that its pelvic mesh products caused mesh erosion, infection, mesh contraction, scar tissue, dyspareunia, chronic pain and nerve damage, among other injuries.

Caldera denies any wrongdoing.

The company told women in a press release, take it or leave it. The average settlement would amount to roughly $5,000 per woman. The claimant release form would ensure confidentiality about the settlement.  If you opt-out you will not be able to sue Caldera.

Image from foreclosure fraud

Image from foreclosure fraud

Just Say No 

Samantha didn’t hesitate in saying no, partially because she was implanted in years before the insurance coverage claims to have been in effect. How could her claim be buried in with other policy years covered by Federal/Chubb Insurance?

Bringing her in with the other Caldera women would only lower the dollars available for everyone, she reasoned. Samantha suspected insurance fraud.

Introducers, Caldera

Introducers, Caldera

No American company can offer a settlement to women when it only had four years of insurance, not 14 years during which time the mesh was sold.  I believe there is a complex set of general liability policies that are accessible in additional litigation and the class action fails to produce discovery for all resources that could be available to Caldera victims,” she says.

Samantha learned those general liability policies would extend to the co-inventors of the Caldera mesh devices. They enjoy the shield of insurance, which protects their intellectual property – the creation of the mesh kit, the trocars, introducers, and the implantation method directions. None of that insurance was being tapped. There were at least four companies that shared the royalties for these tools and directions covered by at least 11 different patents so it stood to reason they should also share responsibility to women who were injured by those tools and implant directions.

Samantha followed the money trail. Many companies are affiliated. She found just last year, for example, American Medical Systems asked Caldera’s insurer to cover its litigation costs because Caldera medical pelvic mesh products were manufactured under a licensing agreement with AMS.   See the link here.   Samantha found intellectual property patent law specifically lists the inventor as having liability, therefore insurance coverage.

Samantha is now stirring the pot connecting with other Caldera implanted women on social media with this additional information.

They include:

  • One Caldera woman has been implanted with the T-Sling and is inoperable. The mesh sling is embedded in an SI joint and causes her mesh-related back and hip injuries, chronic infections and a general collapse of her health. An inventing physician caused her harm and she contends she was a human experiment and the inventors and at least three additional manufacturers should be held accountable for Caldera Medical victims.

  • A woman on the west coast, also implanted by an inventing physician, has had care both in the U.S. and Mexico. She and her husband have spent over a $100,000 plus her insurance on her care and she’s been told the mesh cannot be removed. Her life-altering injuries are numerous and she too believes the physician who implanted her should be held accountable because she was never told he was benefiting financially from his device he was putting in her body.

  • A 39-year-old woman has life-altering injuries, multiple surgeries, and is now facing mesh migrating into her colon. She is seeking a second opinion, not necessarily another surgery which has been suggested. This woman was also implanted by a co-inventor, without her knowledge of his conflict of interest.

  • A woman in Kentucky still is suffering after partial mesh removal and she has infections and cannot wear her pacemaker because of the chronic infections. She has had to downsize her home to endure the cost of this catastrophic health injury she says was caused by Caldera Medical, Inc. and those who inventing their devices and shared research.

  • Another woman, a 31-year-old mother, has had over 20 surgeries and she cannot void. Instead she must self-catheterize. She says she is destroyed physically and emotionally. Her father is an attorney and he is leading the fight for her justice. She says she has hope as she has been directed to leaders both in the healthcare field and legal field to gather their resources to help her gain a better quality of life and her justice.

 

She found many of Caldera’s implanted women are from the South and had no idea their implanting surgeon was also a co-inventor of the procedure who has separate insurance and legal responsibility to a patient.

patent co inventors

See the co-inventors listed in the patent for Caldera “Implants and procedures for treatment of pelvic floor disorders, July 2013,here.

“He saw me as sick, poor, he signed me up for Medicaid, then cancelled it. I never got any follow-up care,” says Samantha.   cm logo

Samantha believes there is now a way to help the more than 2,100 Caldera victims and she is encouraging women to object on the grounds there is additional insurance coverage that is being left on the table.

She and others plan to opt-out of the Caldera settlement and ask their cases be returned to Judge Joseph Goodwin, who is overseeing the federal pelvic mesh litigation, and allow him to remand all cases back to state courts.

 

“Until this litigation is fully fleshed out, and the person who has to be convinced of this is Judge Goodwin, monies will be left behind. We need Judge Goodwin to assign a special master for all manufacturers to pull all resources.  I really feel confident I’ve built the framework for insurance fraud for having constituted my own claim numbers.  If today you were hit by a car, they all partake in the injury, why would we accept an auto accident attorney who would let three cars walk away?

“I share this information so other women may have a better option to object. Print this article out and tell their attorney they are objecting because there are too many questions about other financial compensation. The policies in question in 2008 to 2012 are included in this document. “~Samantha

 

For those who do take the Caldera settlement, if they also receive government benefits, they may lose those benefits or have them reduced as a result of the additional income. Forming a Medical Needs Trust is the only way to accept monies and make them immune to a reduction in Social Security Disability or Medicaid dollars.

Meanwhile, Caldera, while claiming it is insolvent, announced plans in February to partner with IVUMed to implant one million third-world women with its pelvic mesh over the next ten years.

Background 

A cash settlement of $11.75 million has been proposed for those permanently injured by transvaginal mesh (“TVM”) devices manufactured by Caldera Medical, Inc. which includes at least 2,184 product liability claims.

The claims involve TVM marketed under the trade names T-Sling, Desara, Ascend, Hydrix, POPmesh and Vertessa. Manufacturers include Caldera, Biomedical Structures, Encision, Coloplast (on its own behalf and as successor in interest to Mpathy), Parker Hannifin and J-PAC LLC .

Allegations against Caldera include negligence, failure to warn of the defects of its TVM devices, the defective design of its TVM devices, breach of express warranties, deceit by concealment, negligent misrepresentation, fraud, and loss of consortium, among other charges.

Desara mesh, Caldera

Desara mesh, Caldera

Filing Deadlines

Women face an April 25, 2016 deadline to object to the settlement. Attorneys for injured women who have not joined the class action must file a request to appear by April 26, 2016 to participate in the final approval hearing which is scheduled before US District Judge Stephen V. Wilson for a final hearing on June 13 in Los Angeles where individuals can ask to speak in court about the fairness of the settlement.

Claim forms must be submitted by May 2, 2016.

Disallowing one’s access to a trial by jury appears to be a violation of one’s Seventh Amendment rights to federal trial.

The Caldera case is not involved in multidistrict litigation  in West Virginia federal court which involve mesh makers C. R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic. Link here.

In summary Samantha strongly urges women learn of their rights.

Pen drawing, Wellcome Trust, WikiCommons

Pen drawing, Wellcome Trust, WikiCommons

“The limited settlement chosen so far is an insult and victims and their families expect more. Every avenue to recover funds will be investigated. Women are brave and their families are braver.

We will not allow our daughters and granddaughters to be implant victims in the 21st century because these companies survive an anemic MDL process and we are left with nothing.”

 

 

LEARN MORE:

Federal Insurance v. Caldera Medical, U.S.D.C., Central District of California Case No. 2:15- cv-00393.
https://www.unitedstatescourts.org/federal/cacd/608750/1-0.html 

AMS and Caldera licensing agreement in Order Denying Transfer, August 7, 2015
http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2325-Order_Denying_Transfer-07-15.pdf


Notice of Proposed Class Action Settlement
http://settlement-alliance.com/assets/Claims-Notice-Counsel_CALDERA.pdf
 

More information is available at www.calderaclaims.com. 

Mesh Medical Device News Desk, February 22, 2016, Caldera Medical – Take $11.7 Mill Mesh Settlement or Nothing!
http://www.meshmedicaldevicenewsdesk.com/caldera-medical-take-11-5-mill-mesh-settlement-or-nothing/

IVUmed
http://www.ivumed.org/

Caldera – Launch of the Desara, August 2013
http://www.businesswire.com/news/home/20131015006880/en/Caldera-Medical-Introduce-Products-American-Urogynecologic-Society#.VZGZ8flVhBc

Mesh News Desk, Caldera Medical among 33 mesh manufacturers to follow-up on complications. See story here:
http://meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests

Chubb Insurance Group
http://www.chubb.com/businesses/cci/chubb15596.html

 

 

50 Comments

  1. Disgusted says:

    WOW! Whoever you are ‘Samatha” you have done an excellent job. Thank you for your hard undercover work in a way less than optimal state! (Can’t think of the words).

  2. Sharon Laakko says:

    No company should be allowed to do harm so many people. Clinical trials should be done by 3rd party with no possible monetary gain. FDA is not protecting people but they sure are good friends of big companies. Look how the women with essure were treated during Sept hearing and the treatment of Bayer. Prayers to the women and men with mesh that each person will be awarded according to the life time damage done by mesh.

  3. Mary Pat says:

    Wow!! Praise God!!!!!! Samantha you are amazing. Good job, no excellent job! My prayers are with you and God is on your side! Jane, thank YOU for bringing this great news to the world! You are the beacon of hope. You shine the light and the world is watching.

  4. Tickedoff says:

    Thank goodness for women like Samantha!!! I applaude you for standing up and saying NO! I do not have your mesh device but I do have one.
    I’m tired of the manufacturers trying justify their actions and their product!
    There is no excuse for what you have done to us and I bet my bottom dollar if it were your mother, grandmother, daughter, sister or friend, you would not let them suffer as so many of us have!
    Stand up and take responsibility for what you have done! Be honest with yourselves and us and admit your products have been epic failures!!! At least is you did that I would have more respect for you, I have no respect what’s so ever right now!
    I’m disgusted and outraged…I live a life of daily pain, can’t work, have mobility issues, acquired autoimmune diseases and have been pretty much rendered disabled.
    This was not the life I expected at only 54 and had I been given “informed consent” PRIOR to my surgery, you can be dam sure I would have run the direction as fast as possible!
    Everyday I wish I could take back that 45 minute surgery…I want my old life back!

  5. Hope Pagano says:

    Way to go Samantha. These companies are not only unethical they are above the law. Let’s put a stop to that today!
    Stay strong and keep fighting.
    I always say, I will quit when I am dead. If there are skeletons to be found may they be found now.
    Nice article Jane. On point as usual.

  6. Tammy says:

    I want to find other women around tampa, fl area to help me organize local protests, and contact influential women to help block approval of caldera’s class action lawsuit. Not only did I have desara mesh put in my body, I also have InteProY Sling. I guess I am double cursed. Have had trouble with both. Please give my email to anyone who can help me find others in my area. I am not very tech savvy. I just signed up with Facebook and don’ t know how to get people to friend me who have influence or the know how to start a mesh movement in my area. Please help. I know we don’t have much time (6/13/16) our fate will be decided regarding caldera.

  7. Kitty says:

    My question—where is the money coming from?

  8. Tammy says:

    But it says if I object I will still be a member of their class. Isn’t that like being on their side and agreeing? I would also like to give my Facebook acct. To be contacted by anyone who can inform me how to get a movement in tampa, fl area. Also need someone who knows media so we can send videos to anyone who needs them for their protests. My name is Tammy Ewers. They say there are 10 people with my name on facebook hopefully they don’t live around Tampa, fl and you contact me. My email is yooper4321@hotmail.com. please I need help, Tampa is a big area and there has to be some mesh victims like me.

  9. Janis Urban says:

    I salute you. Well done! We are bigger then our anger. It is a part of us. We are not part of it. Voices brings awareness, then action, then change! History has taught us that!!!

    • Jane Akre says:

      Thank you Janis.. You are also an outspoken one… I love you Tweets! Very creative. Can you do a story for Friday reminding folks about the Twitter party>>>>?? Thank you….

      • Janis Urban says:

        Sorry Jane…like I always say there is always a tomorrow….next Mesh Awareness Twitter Party is Friday April 29, 2012 8-11PM EST No Twitter Focus Topic Picked as of today. We have quite a few Gifted Tweeters but All Twee
        ters Doing a Great Job. They are really being Followed. Thanks Jane

  10. Karen says:

    Women With Vaginal Mesh Complications Have Increased Levels of Inflammation Around Implant: Study

    Amid tens of thousands of vaginal mesh lawsuits filed by women throughout the U.S. who have experienced problems following surgical repair of pelvic organ prolapse or female stress urinary incontinence, a new study indicates that women who experienced problems with pelvic mesh were more likely to have inflammation around the implant.

    In a study published this week in the American Journal of Obstetrics & Gynecology, researchers with the Magee-Womens Research Institute in Pittsburgh set out to evaluate reactions among patients undergoing vaginal mesh excision surgery after experiencing complications.

    Researchers found that inflammation and concentrations of white blood cells designed to attack foreign material were more commonly found among in women who suffered vaginal mesh complications like extrusion of the mesh through the vagina and other problems than those who simply reported pelvic pain.

    In July 2011, the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010. This led to an influx of product liability lawsuits against manufacturers of the devices, with about 100,000 women nationwide presenting claims for injuries and complications allegedly caused by the defective design of the mesh.

    Following a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse, and manufacturers of the devices have been ordered to conduct studies to evaluate the safety.

    Although the risk of complications from vaginal mesh have been a hot topic within the medical community for several years, researchers in this latest study note that few studies have been performed that focus on how women’s bodies respond to synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence.

    Researchers looked at 27 mesh-vaginal tissue samples from women who suffered complications and found that macrophages surrounded the implants. They found women who required mesh removal due to exposure, such as when the mesh penetrates the wall of the vagina, had 88.4% higher concentrations of macrophages than those explanted for pain.

    “In women with complications, mesh induces a pro-inflammatory response that persists years after implantation, the researchers found. They also determined that the types of white blood cells found in mesh explanted for exposure were associated with degradation, while the types around those removed for pain were more indicative of fibrosis.

    Several manufacturers of transvaginal mesh and bladder sling products have agreed to pay several billion in vaginal mesh settlements for women who have experienced problems, and thousands of cases are continuing to move forward through the court system. The transvaginal mesh litigation has been the largest mass tort in the United States over the past decade.

  11. Linda says:

    Jane,
    I was thinking when J and J destroyed the records many of us contacted US attorney General Eric Holder. Obviously with no response. We have not discussed sending letters to our new AG, who is also a woman. I went to the website and there is a form that can be completed on line. Maybe it will make a difference if we all write in. The fact that we have a case going to the Grand Jury is a first. I think we should educate her, if the mail gets to her.

  12. anna says:

    If we could get one high official in every city, who has the power to agreed with what women have suffered, because of TVT complications in the United States, we might be able to prove all the harm done to us. Not just Tampa, but all.

  13. K says:

    Judge Goodwin stop this craziness PLEASE!! I don’t have this product but I’ve been through this mesh hell! We have all spent so much of our own money trying to get better. We aren’t money hungry crazy women! We are injured hurt and in pain! Please have compassion and hold these millionaire asshole a accountable! Take away their yachts and extravagant vacations!! We can’t go on vacation because our stomachs are huge many have autoimmune diseases pain and no freaking money because of this its all spent on trying to get better. Many have lost jobs and some struggling to keep working! How is it they have no money but selling in third world countries!!! Are you kidding me stop this madness!!!!! STOP THE MADNESS!!!!

  14. Bejah says:

    Dear People, I was reviewing my symptom list before posting it and I found a site that was especially thorough and displayed a deep and perhaps even experiential knowledge of Vulvodynia, an excruciating disease that I found myself plagued by soon after implant in 2010 and NEVER had experienced before. I think it may be worth a read so have posted the link here. I will be interested in looking at the database we are working on to get a better sense of how many of us have this and have contracted it post implant. Hope ya’ll find it helpful. I believe they are in England. GOD bless…

    Bejah

    http://www.vulvalpainsociety.org/vps/

  15. Kitty says:

    Hi Bejah. Went to the site and it looks like VP is the same as Dyspuruinia. Not good

  16. Karen says:

    Former FDA commissioner Margaret Hamburg named in massive conspiracy and racketeering lawsuit involving Johnson & Johnson, a Wall Street hedge fund, and the Levaquin drug

    Learn more: http://www.naturalnews.com/053767_Margaret_Hamburg_FDA_commissioner_conspiracy_and_racketeering.html#ixzz46jKxa46w
    (NaturalNews) The former head of the FDA, Margaret Hamburg, used the federal agency to run a massive conspiracy of racketeering and fraud in order to generate millions of dollars in drug company profits for her husband’s hedge fund firm, alleges a damning lawsuit filed in the United States District Court for the District of Columbia.

    The lawsuit alleges that while acting as FDA commissioner, Margaret Hamburg engaged in a wide-ranging conspiracy to approve an extremely dangerous drug known to cause severe (and even deadly) side effects, in order to financially benefit her husband’s hedge fund which held very large financial positions in Johnson & Johnson, makers of the drug. “Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin,” says the complaint.

    “This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin,” reads the opening of the lawsuit. The conspiracy complaint also alleges that over 5,000 people died as a result of Hamburg’s conspiracy cover-up at the FDA:

    Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband’s financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg’s husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.’s holdings of Johnson & Johnson stock.

    To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg’s tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.

    “Both Alkermes and Johnson & Johnson stock value increased significantly during Hamburg’s tenure,” reports The Daily Caller.

    Margaret Hamburg “bought” her way into the FDA with financial contributions to Hillary Clinton and Barack Obama, alleges the lawsuit

    A fascinating finding in the lawsuit alleges that Margaret Hamburg bribed her way into the top position at the FDA by making large financial contributions to Hillary Clinton and Barack Obama:

    Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.

    …Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.

    …Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.

    From what we now know about the Clinton Foundation’s deep financial ties to Big Pharma and Wall Street hedge funds, none of this comes as any sort of surprise. In fact, while these allegations may have been easily dismissed as a “conspiracy theory” in 2008, so much more awakening has happened among the American public that they are now likely to be understood as an “actual conspiracy” being carried out among the political and financial elite who routinely conspire against the people in order to enrich themselves.

    Horrible side effects from the drug destroyed the lives of countless victims

    From the lawsuit:

    From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.

    Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.

    Highlights of the complaint

    You can read the complaint here, posted by the Daily Caller News Foundation. I’ve extracted some of the highlights of the complaint for reference, shown below.

    This Amended Complaint sets forth allegations that involve a conspiracy by Defendants, each and every one of them, to reap large financial returns by failing to disclose to Plaintiffs and the public at large the full extent of the devastating, life-threatening, and deadly effects of a highly dangerous pharmaceutical drug named Levaquin.

    Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation. During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown and the other Defendants named in this Amended Complaint, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest – specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.

    Once confirmed as FDA Commissioner, Dr. Margaret A. Hamburg acted as the instrumentality that all Defendants used to perpetrate their conspiracy and racketeering enterprise by having her act illegally and outside the scope of her authority as FDA Commissioner to suppress material information to Plaintiffs and the public that Levaquin was inherently dangerous and in fact, deadly. Had this information been disclosed to Plaintiffs and the public at large, her and her husband’s financial gain and net worth would have plummeted, since Dr. Margaret A. Hamburg’s husband, Peter F. Brown, reaped and continues to reap huge financial gain as a result of Renaissance Technologies, L.L.C.’s holdings of Johnson & Johnson stock.

    To further this conspiracy, Dr. Margaret A. Hamburg, acting in concert with each and every Defendant, jointly and severally, appointed officials of Johnson & Johnson to key FDA Advisory Committees and colluded with Johnson & Johnson and its officials and subsidiaries to suppress information about the dangerous and deadly effects of Levaquin. As a result, during Dr. Margaret A. Hamburg’s tenure as FDA Commissioner from 2009 to 2015, over 5,000 people died as a result of consuming Levaquin and other dangerous drugs promoted, manufactured, marketed, distributed and sold by Johnson & Johnson, suffered debilitating, life-threatening, and deadly illnesses and effects. This deadly harm is continuing as Plaintiffs and thousands of other people are suffering and dying from the highly dangerous effects of Levaquin.

    Because of the Defendants’ racketeering scheme and conspiracy to suppress warnings and other material information about the extent of the deadly effects of Levaquin, Plaintiffs were precluded from discovering the extent of their injuries until 2015, not coincidentally after Dr. Margaret A. Hamburg no longer held her position as FDA Commissioner in 2015 and material information about the full extent of the dangers of Levaquin were disclosed thereafter.

    Defendants, each and every one of them, profited handsomely from their racketeering conspiracy by their agreed-upon failure to disclose the harmful effects of Levaquin to Plaintiffs and the public at large. This case is thus of seminal importance not only for Plaintiffs, but also for the consuming public at large. It is a tragic testament to how corrupt companies like Johnson & Johnson and their officials bribe and illegally collude with government officials and line their pockets at the expense of persons such as Plaintiffs.

    Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to Hillary Clinton in 2005, 2006, 2007, and 2008 to induce Mrs. Clinton to recommend and push for Defendant Hamburg to be nominated by President Obama.

    Defendant Hamburg, on behalf of all of the Defendants as part of this racketeering conspiracy, gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.

    In and around May 26, 2009, Defendant Hamburg was forced to divest herself of several hedge fund holdings, as was her husband, Defendant Brown. This was done in order for her to take the position as the top food and drug regulator without any real or apparent conflicts of interest. However, the conflict of interest herein was never resolved. Neither Defendant Hamburg nor Defendant Brown, nor any other Renaissance Technologies executive had fully disclosed to Congress and other authorities that Defendant Brown, Defendant Hamburg’s husband at all material times, still held shares in – and benefits financially from – all of the stocks of Renaissance, via Renaissance Technologies profit-sharing, as explained in detail by Defendant Simons, regardless of whether Defendant Brown divested himself of a particular hedge fund, in furtherance of the racketeering enterprise and conspiracy.

    While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants’ racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin.

    As part of Defendant Hamburg’s pattern and practice of acting illegally outside of the scope of her authority as FDA Commissioner in furtherance of the racketeering enterprise and conspiracy, she counseled the FDA to also approved another highly dangerous pharmaceutical drug that Renaissance Technologies owns stock in, Zohydro, despite the fact that on December 7, 2012, an FDA Advisory Committee voted 11 to 2 against its approval. In or around March 2013, Defendant Hamburg personally testified to members of Congress that she supported Zohydro’s approval.

    Defendant Hamburg, as part of her pattern and practice of illegally acting outside the scope of her authority as Commissioner of the FDA, fraudulently used the U.S. mails and wires to commit overt acts in furtherance of the racketeering enterprise and conspiracy by willfully and intentionally and illegally preventing the FDA from issuing warnings about the devastating and life-threatening effects of Levaquin.

    On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally exposed to Plaintiffs, and the public at large, that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it did nothing to add this information to the Levaquin label and instead conspired with the other Defendants to fraudulently withhold it.

    From May 2009 to March 2015, Plaintiffs suffered mitochondrial toxicity, neuropsychiatric adverse events, and multi-system disability related to their consumption of Levaquin, including a constellation of medical issues related to the following body systems: neuromuscular, neuropsychiatric, peripheral neuropathy, senses, skin, cardiovascular, plus, endocrine, nutritional, metabolic and immunity; blood and blood forming organs; circulatory system; respiratory system; digestive system; genitourinary system; and connective tissue.

    Specifically, Plaintiffs suffer from a constellation of medical issues, including but not limited to widespread bodily pain, fatigue, muscle weakness, muscle twitching, muscle wasting, gait disturbances, severe balance issues, stiffness, spasms, joint pain, tendon issues, seizures, tremors, numbness, burning, tingling, fasciculation, spasticity, nerve damage, autonomic issues, voice issues, exercise intolerance, difficulty swallowing, slow digestive motility, abdominal pain, acid reflux, gastritis, nausea, constipation, diarrhea, colitis, cognitive impairment, memory impairment, cardiac issues, urinary issues, kidney damage, liver damage, pancreatic damage, thyroid abnormalities, hair loss, glucose issues, respiratory issues, emotional issues, depression, psychosis, depersonalization, dissociation, anxiety, insomnia, abnormal dreams, suicidal thoughts, thought alterations, agitation, fatigue, dizziness, inability to concentrate, panic attacks, difficulty communicating, forgetfulness, bruising, vision issues, hearing issues, tinnitus, dental issues, gum issues, skin issues, rashes, multiple chemical sensitivity, sexual dysfunction, reproductive issues, and DNA damage.

    Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin.

    Specifically, the purpose of Defendants’ racketeering enterprise included, but was not limited to, reaping large financial gain by willfully and intentionally suppressing material information, through the fraudulent use of the U.S. mails and wires, about the devastating, life threatening, and deadly effects of Levaquin. These Defendants form this association in fact for the common and continuing purpose described herein and constitute an enterprise within the meaning of 18 U.S.C. SS 1961(4) engaged in the conduct of their affairs through a continuing pattern of racketeering activity. As described in the foregoing paragraphs of this Amended Complaint, Defendants, each and every one of them, maintained an ongoing relationship during the course of their ongoing criminal enterprise.

    PREDICATE ACTS Bribery in Violation of 18 U.S.C. SS 201, Predicate Act No. 1
    From May 2009 to March 2015, Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen committed acts constituting indictable offenses under 18 U.S.C. SS 201(b)(1)(A)-(C) in that they directly or indirectly, corruptly gave, and offered and promised things of valuable, such as money, to Defendant Hamburg, who for the purposes of this predicate act was a public official as FDA Commissioner, with the intent to influence Defendant Hamburg to suppress material information about the devastating, life-threatening, and deadly effects of Levaquin. This is evidenced by Defendants Johnson & Johnson, Johnson & Johnson PRD, and Janssen’s pattern and practice of using gratuities and bribery to secure favorable treatment for its products, as described in paragraph 40 of this Amended Complaint. 109.

    Predicate Act No. 19
    From May 2009 to March 2015, Defendants Renaissance Technologies, Brown, Mercer, and Simons, in furtherance of the racketeering enterprise and conspiracy, transferred ill-gotten and illegal financial gains from Defendant Renaissance Technologies’ holdings of Defendant Johnson & Johnson stock to Defendants in order to continue to carry out Defendants unlawful conspiracy to conceal material information about the devastating and life-threatening effects of Levaquin.

    As set forth previously, in every quarter except one, from May 2009 to March 2015, while Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown’s employer, Defendant Renaissance Technologies, held significant amounts of Defendant Johnson & Johnson stock, including as much as half a billion dollars in Defendant Johnson & Johnson stock.

    Learn more: http://www.naturalnews.com/053767_Margaret_Hamburg_FDA_commissioner_conspiracy_and_racketeering.html#ixzz46jLoQS8Y

    • Still Standing says:

      Karen, thank you so much for this post. It about brings me to my knees thinking of all the layers and layers of deception that had to be in place. Sobering to say the least

    • Jane Akre says:

      I have to say Natural News is sometimes a little less than credible, in my opinion.,,,, Mike Adams is a big self-promoter and most journalists like to promote the story not themselves. That’s the bias I bring to reading his stuff. He connects dots that may not deserve to be connected. Regardless, here is the Complaint he refers to:

      https://www.scribd.com/doc/309957583/Amended-Levaquin-complaint

  17. sean says:

    Will this help out the lawsuits against Johnson and Johnson for transvaginal mesh at all. They have ruined my mother’s life. She is now on disability and can’t hardly leave the house. Why do the judges and Lawyers not care at all. They are all taking advantage of these women to cash in. But yet nobody seems to know anything. Johnson and Johnson ruined my mother’s life

    • Kitty says:

      Too many layers–too many crooks–“Jenny Jenny Jenny. Fee fi fennie oh jennie—but not tonight” Happy Nurses week

    • Barb says:

      SEAN, encouraging words!! Keep on your attorneys demand answere’s as you are entitled to and tell them If they don’t know who has answere’s for you tell them to find someone who does; I became a huge pain in the BUTT!! However I ended up sending one of the attorney’s an email demanding, i explained he did work for me and at the rate of the money they were going to recieve! I also mentioned that if I didn’t get a reply from someone who knew exactly how to answere my questions I would be contacting Judge Goodwin for miscommunication as Judge Goodwin did tell attorney’s they should be communicating with their clients. Get angry if need be this is YOUR mom and for her children to see/witness the affects of mesh is a horrible thing!! Keep on fighting my mesh friend, May God bless you and your mom!!

    • K says:

      Sean j&j doesn’t care about your mom. They don’t care about anyone they have harmed. It’s about money!!! Sad, I know but it’s the truth they do not care at all!!!

  18. sean says:

    Your very right way to many crooks. But the fda doesn’t seem to be there to prove products are safe. It’s just another way to line people’s pockets. I just can’t believe that this is how it all works. But it sure is. If these mesh makers cared they wouldn’t drag their feet as much as they do. It would be taken care of. It’s so sad

  19. ladeedah says:

    I wanted to share valuable information concerning AMS settlements. I finally received my package I’m going to break down the categories and the tiers with $ figures and percent of woman. I after 8 years of the unknowing has elected to take what was offered. I would also like you all to know that AMS has set up a hold back fund for those who had surgeries after the deadline. You can also write a letter to the Special master for catherization, pelvic pain, fistula,permanent disability, mesh related death, extraordinary loss of wages and other facts not mentioned to be considered for more monies from the hold back fund this process takes a much longer time. It appears that the age 65 are those who will not receive the same money as that of a 45 year old. This has been certainly a journey for us all and for me after reading the claims package, as it does explain it could be years for a court trial,the cost of the court itself, never knowing what the jury will go, and of course if found in favor for the Plantiff we the victims have to be prepared for all appeals. If you have had surgery after the deadline PLEASE make sure to send your Claims settlement package. The surgeries after the deadline will not be in your final settlement figure however it should be listed in your IVF! I have to say they did an amazing job and eveything was CORRECT!!

    • Mary Pat says:

      Would you mind getting my contact info from Jane. I would very much like to talk with you. Thank you for your post.

      • lola says:

        I will no longer be posting any information however if it’s okay with Jane If you contact her with questions she can ask me and I will try to answere as much as far as I know about the age, weight, smoking. I do have to be careful as to what I post however Jane has protected all and continues to!!

        • Jane Akre says:

          Please be careful…I can only protect you so far…. and I’ve done so, however,,,,

          • Jane Akre says:

            Lawyer letter from AMS says take down the information on Tiers and payouts by AMS. No sense in hurting yourself and violating the agreement you signed, unless you really don’t care. Think about that carefully. Thanks

    • k says:

      are they penalizing for weight and smoking? I wouldn’t think I would be considered overweight but just curious because they all seem to be using weight and smoking as an excuse.

    • Kitty says:

      Is age 65 at time of surgery?

      • Kitty says:

        What about the woman who had implant at age 55 and she now is 67?

        • Kitty says:

          How old is Samantha–it’s been years for her. Is she 65?…..precious years lost. Nothing for the old ladies. She will fight for the principle. “Do not caste me out in my old age or forsake me when my strength failith me”

          • cybil says:

            I’m starting to read this book:
            YOUR BEST AGE IS NOW
            Embrace an Ageless Mindset,
            Reenergize Your Dreams, and Live a
            Soul-Satisfying Life
            by Robi Ludwig

            I pray it will help me to get through.

  20. Karen says:

    There’s enough women here to have a different lawsuit against the FDA , AND THE MANUFACTURING INDUSTRY. We can call our organization the VAVM, VICTIMS AGAINST VAGINAL MESH . I’ve found 3 attorneys that have offered this lawsuit if we are a organization.
    Our attorneys are walking off with money our judges are walking off with tones of money in we are sitting in the dark while they dictate what happens .
    When was the last time women seen real justice with these case ? We are like sitting ducks waiting while attorneys are asking for a there fee up front .
    The UNITED STATES ALLOWS THESE BANK THAT OWN EVERYTHING THE CORPORATION THE PRODUCTS THE JUDGES . Lets play there game it chess if we all pull together and start our own organization then we come as a group. Think about this judge in West Virginia said he was going to put so many cases together. Read between the lines . That for us to get together for our selves. Right now nothing is happening there all going to lunch on our dimes . THESE CORPORATIONS ARE INSURED BY THE VERY BANKS THAT OWNS ALL THE INSURANCE. SO WHO ARE WE WAITING ONE THE FDA ?? LISTEN THE BANKS OWN EVERYTHING!!! The FDA is owned by the banks . Every case is LABELED different. Like everything else. Our VAVM WOULD BE A DIFFERENT LABEL CASE !!
    Please don’t give excuses about it takes a while for the courts . The corporations are milking the interest from there very own monies. We can start this are wait for this the judges to retire or die. I figured out a decision last night about a lot of my cases here if you appear to know as much as your attorneys you can go wrong . We have found out tons of informations on our own and with Jane we are good together .Women are extremely known as geniuses . Look at the facts we do it all but then we sit back again allowing others to Dictate . Im sure once something happen to the West Virginia judge then we have to start everything all over. All our cases will be lost . Our attorneys will have to file again and we will wait another 10 years to go to court against corrupted corporations like these !!! Sometimes God wants us to look ahead to what will make us better and right now we haven’t gotten anything done . BY THE WAY LADIES WHEN WAS THE LAST TIME AMERICA SHOULD US WOMEN ANY RESPECT?????

    • Still Standing says:

      Karen, I understand your frustration but a class action suit against the fda would definitely bring money to the lawyers,but very little money to the women, as all class actions do. By the time it would wind through the court system, women could get almost nothing except sweet revenge, which might help some women emotionally. Just a clarification about Judge Goodwin. He did not create this MDL on his own. Federal judges determine to set up an MDL when cases will share a great amiunt of pre trial discovery, thus theoretically reduce cost and move the cases through the court system. However, With the mesh, the system has just overloaded. Combined with the slow decisions companies are making to settle, it has just settled like concrete. The judges or the government cannot make companies settle, and, as stated in an earlier post, insurance companies that carry policies that cover the mesh are heavily invested in holding out as long as they can. Theoretically, once pre trial discovery is done,the cases move back to the states, but actually, most MDLs exist to move cases to settle. I don’t know how some cases that have gone to trial in state courts got there. Most of us did not have a choice of federal or state courts, so if anyone can clarify this, Im curious about the answer. Your case will not be dropped if Judge Goodwin retires or gets sick and leaves the bench. Other judges would move in to handle the load. One more question, have you had to pay your attorney his/her fee up front or are you representended on a contingency? If they dont get paid until you get paid, then they have probably spent money on your case that you might not have been able to do, so, of course, they will want to be paid according to your contract. We need to remember that many of them probably borrowed money, with interest, to fund our cases.

    • Kitty says:

      I just wanna know is it age 65 at implant? Or once the old lady hits 66 she goes out to pasture?—–and then they throw her a bowl of tankage

      • BB says:

        Kitty age does play a situation it doesn’t appear they considered age of implant I was 47 It appears the age comes in to play at the time of settlement, I really don’t have an answere I’m 54 now and it appears to me that they are figuring out $ at age when settled I may be wrong………..

  21. Still Standing says:

    Please be very cautious about discussing your settlement details on this site, other social networking or with friends or family. Settlements come with strict confidentiality agreements, you could loose your settlement dollars and you could have other financial and legal penalties if AMS figures out that you posted this information. My settlement stated very clearly to not disclose any information about any part of the settlement. My children and friends dont even know that I have resolved my case. None really even knew I filed a case. My husband is the only person who knows any details. Please ask your attorney before you post any other details of the settlement or talk with other members of the mesh community. We do have digital footprints and while Jane is very committed to protecting our privacy, you never know what they can discover online. There are even lawyers now who specialize in finding digital information on plaintiffs/ defendants. Just have an abundance of caution as you go forward to protect your settlement award.

    • Sissy says:

      Still Standing I’am aware abot the confident information but if you remember the categories and Tiers were published several months ago. Even some had $ figures and Tiers consisted injuries which was quickly taking down.

      • Still Standing says:

        I think I remember that but the settlements come with a strict confidentiality clause, one that each person who accepts the settlement legally signs. We have to keep our end of the agreement as we expect the companies to uphold theirs. We are dealing with a very flawed system, but in the end, flawed systems are made up by flawed anddeceptive individuals. We can all agree that it needs to change. I believe that if we hold ourselves accountable for keeping our word, it changes the system. Most people want top down change, but in reality the only person we can change is ourselves and how we move through the world. That is our personal responsibility. It matters to me.

  22. Karen says:

    The court entered PTO #231 (Initial Order Regarding Severance of Actions)
    The court entered PTO #230 (Initial Order Regarding Severance of Actions)
    Updated 04/25/2016

    The court entered PTO #229 (Initial Order Regarding Severance of Actions)
    The court entered PTO #228 (Defendants Johnson & Johnson and Ethicon, Inc.’s Motion for Protective Order Under PTO 205)

  23. darlene says:

    I had this implant many yrs ago.i had revised surgery.but the worst part for me was peeing when I had no feeling of it going to happen.the worst part was i bleed really for 6 yrs .I’m mean bled.they rupture my bowels when putting it in.no one could find where the blood was coming from.had one colon oscopy after another. As they were doing them they kept making it worse.so I found a doctor to do a hemroids ty and found a fisher so he fixed it.and no more bleeding. It not fair that I can’t include this.in the lawsuit……

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