Monsanto attacks Honest Scientists & Science

More evidence has emerged to show how Monsanto attacks honest scientists and even science itself.  The chemical company giant has long worked to “neutralize” or discredit individuals and organizations when their findings threaten Monsanto profits.

Time and again, Monsanto’s actions behind the scenes impugn the chemical company’s endless “on- message” claim that Roundup is safe, doesn’t cause cancer, and no evidence exists anywhere to show that it does cause cancer.

The big message problem for Monsanto is that its own duplicitous conduct is well known on many fronts.  It begs the simple question:  If Roundup is as safe as advertised, then why has Monsanto worked so very hard to attack any scientists and any scientific findings showing Roundup causes non-Hodgkin’s lymphoma?  Monsanto’s messaging problems abound and grow by the day.  Here is just a small sampling:

  • Why has Monsanto hired ghost writers like Henry Miller, the bogus Stanford academic, to attack organic foods and organic farming in mainstream publications like Newsweek?
  • Why does Monsanto secretly attack anti-GMO Activists?
  • Why did Monsanto try to destroy French researcher Dr. Giles Seralini after he performed a rat study which showed GMO corn gave rats hideous tumors?
  • Why did Monsanto use its press minions to attack Carey Gilliam, a brave and honest writer who has published a superbly-researched book on Monsanto titled, “Whitewash — The Story of a Weed Killer, Cancer and the Corruption of Science.
  • Why has Monsanto worked behind the scenes with EPA regulators to quash at least one Roundup safety study?
  • Why did a Monsanto executive feed a Reuters reporter fake news that defamed the International Agency for Research on Cancer and one of its scientists, after the IARC declared glyphosate a probable carcinogen?
  • Why has Forbes magazine had to pull fake news stories (on at least two occasions) that maligned, misrepresented, and attacked researchers who pointed out the dangers of Roundup?
  • Why did Monsanto use an industry hack named Geoffrey Kabat to attack research which showed Roundup increases non-Hodgkin’s lymphoma risk by 41 percent? Kabat accused the authors of cherry-picking data, and he made other patently false statements, all while failing to disclose his ties to the industry.
  • Why has Monsanto attacked those who prove that the industrial farming methods Monsanto promotes strip soil of nutrients that form the most basic building blocks of environmental, human, and animal health?

Forbes magazine – which has published several articles defending Monsanto – published Mr. Kabat’s scathing review of the meta-analysis showing Roundup increased cancer risk, and then later pulled the article.  Why did Forbes pull the piece?  Because it was full of falsehoods, like so much of Monsanto’s propaganda that its press minions get paid to fling.  It was the second time in recent memory that Forbes was forced to pull Monsanto propaganda which Forbes had initially represented as “news.”

There was nothing honest about Geoffrey Kabat’s diatribe, just as there is nothing honest about Monsanto’s position that glyphosate is safe and no studies prove otherwise.  Even a federal judge who has shown himself more than sympathetic to Monsanto’s arguments – curiously “bifurcating” the first federal Roundup trial – was forced this week to admit the plain truth.  The judge denied a request from Monsanto’s lawyers to grant a summary judgment which would have ended the trial in Monsanto’s favor.

Yes, even the federal judge who had favored Monsanto by severely handicapping the plaintiff’s side with “bifurcation” wrote:

“[T]he plaintiffs have presented a great deal of evidence that Monsanto has not taken a responsible, objective approach to the safety of its product. (Although) the evidence that Roundup causes cancer is quite equivocal, there is strong evidence from which a jury could conclude that Monsanto does not particularly care whether its product is in fact giving people cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about the issue.”

Those are strong words from a judge who had once worked for a law firm that defended Monsanto.  His bifurcation of the trial meant the jury was not able to hear about Monsanto’s reckless attitude toward safeguarding the public.   They were unable to hear trial evidence of how Monsanto had more interest in manipulating public opinion than getting at any underlying truths.  The jury did not hear evidence of how Monsanto was most interested in undermining anyone with “genuine and legitimate” concerns about Roundup.

The six jurors will be allowed to hear some of that evidence of Monsanto’s propagandizing and reckless disregard only if they decide unanimously that Roundup caused the plaintiff’s non-Hodgkin’s lymphoma.  The jury began deliberations on March 13, 2019.  They will resume deliberations again on Friday, March 15.

One can only hope now that the bifurcated trial arrangement will not hinder the jury’s arriving at the truth of the matter, despite being allowed to hear only a fraction of the whole story in this first phase of the trial.

In this first phase, only if all six jurors unanimously agree that Roundup was the principal cause of the plaintiff’s non-Hodgkin’s lymphoma, will they then be allowed to move to a second, damages phase.  If and only if they make it that far, will they then be allowed to hear at least some of the truth behind Monsanto’s behind-the-scenes manipulations, of Monsanto’s attacks on honest scientists, of its never-ending maneuvers to manipulate the actual reporting of the science itself.

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Monsanto Roundup likely Caused Cancer, Pathologist testifies

(March 7, 2019)  Monsanto’s Roundup likely caused a California man’s cancer, a pathologist testified in a federal courtroom yesterday.  Dorothy Atkins reported for Law360 that the pathologist testified that it is “more likely than not” that Monsanto’s Roundup weed killer poison caused a man to be diagnosed with non-Hodgkin’s lymphoma (NHL). The testimony refuted Monsanto’s claim that hepatitis C, weight, and age caused the (now 70-year-old) plaintiff’s cancer.

Dr. Dennis Weisenburger explained to jurors in San Francisco that plaintiff Ed Hardeman was treated for hepatitis C within a year of contracting it.  Dr. W. said that early treatment significantly reduced Mr. Hardeman’s risk of developing non-Hodgkin lymphoma from the virus.  Dr. Weisenburger also testified that any cells damaged by the Hep-C virus would have died off when the man was cured of that disease in 2006.  He rejected Monsanto’s claim that Mr. Hardeman’s 2015 NHL diagnosis was caused by hepatitis.

NHL Diagnosis Nine Years Too Late for Monsanto

“If he was going to get lymphoma, he would have gotten it when he had the infection, not nine years after he was cured,” Dr. Weisenburger testified.

Dr. Weisenburger is one of the last experts to testify before Mr. Hardeman’s attorneys rest the first part of his case in the controversial bifurcated trial arrangement which District Judge Vince Chhabria agreed to assemble at the request of Monsanto’s attorneys and against the strong objections of the plaintiff’s side.

Related: MonsantoLawsuit.com

Arcane Bifurcated Arrangement Censors Plaintiff’s Side

In the arcane “bifurcated” arrangement of this first federal trial in the Monsanto Roundup litigation, the plaintiff’s side may not bring to the jury’s attention any of the mountain of evidence which shows Monsanto’s behind-the-scenes moves to censor or attack any research or organization deemed a threat to Monsanto profits.  That arrangement severely handicaps the plaintiff’s side.  One cannot fairly present Monsanto’s brand of “science” without simultaneously showing how the company manipulates it, promotes the views of its own paid scientists, and attacks with its well-paid media minions any scientist or organization that questions Roundup safety.

Bifurcation in this case means that the jury will not hear about any of Monsanto’s behind-the-scenes manipulations unless the jury first rules, solely on the basis of “scientific” grounds, that Roundup caused Mr. Hardeman’s NHL.  Without any doubt, censoring all the damning information that we now know about Monsanto’s real actions to manipulate science and public opinion decidedly favors the company.  It allows Monsanto lawyers to repeat the company’s default defense that “hundreds of studies” prove Roundup is safe enough to drink, or that Roundup is as safe as table salt (a false, claim along with many others, that Monsanto was forced to retract in New York state.  Because virtually all of those Monsanto studies were short-term and were virtually all sponsored by Monsanto, the WHO refused to include them in its evaluation which concluded in a 2015 assessment that Roundup is a probable human carcinogen.

The Monsanto Papers

A mounting pile of evidence from internal documents revealed in “The Monsanto Papers” and elsewhere has shown how Monsanto propaganda clouds and poisons – like mustard gas in WWI trenches – the worldwide fight over Roundup.  Monsanto or its proxies have been shown to manipulate news outlets like Reuters, Newsweek, Fortune, and others around the world; email secretly with EPA regulators to derail or influence Roundup safety studies; hire bloggers to attack anyone or any organization that questions the safety of Monsanto’s products; entice academic ghostwriters and blogger goons to put their names on pro-GMO propaganda; move Monsanto employees through a revolving employment door between the FDA and the company, compromising regulatory agencies with industry monies.

Ed Hardeman’s case is the first to go to trial where hundreds of similar lawsuits have been filed in the multidistrict litigation court overseen by U.S. District Judge Vince Chhabria.  Claimants all share the same injury, non-Hodgkin’s lymphoma, and all claim that injury resulted from their exposure to Monsanto’s Roundup and Ranger Pro herbicides, which are classified as pesticides by EPA.

Mr. Hardeman testified on March 5, 2019 that he used Roundup to kill weeds and poison oak on his 56-acre property in Santa Rosa, California.  He said he used it for 25+ years, between 1986 and 2012.  The spray’s mist often fell on his skin and face, he testified.  Mr. Hardeman was diagnosed at age 66 with stage 3 cancer on Feb. 14, 2015.  He has undergone cancer treatment.

Dr. Weisenburger, who took the stand March 6, has published more than 50 research papers on causes of non-Hodgkin lymphoma. He noted during his direct examination that less than 1 percent of patients with chronic hepatitis C develop non-Hodgkin lymphoma in 10 years.  He said those patients have a “much higher” risk of getting liver cancer. He said that age and being overweight are minor risks for developing NHL. He added that obesity increases the risk of getting the cancer by 30 percent “at most.”

Monsanto Attorneys Cross Examination

In cross-examination, Monsanto’s attorney, Brian L. Stekloff, tried to discredit Dr. Weisenburger’s testimony.  Mr. Stekloff asked him what doctors and pathologists know about the biological impact of having hepatitis for decades.

Dr. Weisenburger said there’s no way to tell by looking at a damaged cell if the damage is due to Roundup exposure.  He further conceded that the “vast majority” of patients’ diagnosed with NHL don’t get it from Roundup exposure. The doctor also admitted that he could not completely rule out that Mr. Hardeman’s decades-long chronic hepatitis B could have contributed to his NHL.

Mr. Stekloff also tried to cast doubt on studies that showed links to Roundup exposure and NHL. He pointed out that test subjects who developed NHL were diagnosed a few years after Roundup came on the market in 1974, not 20 years later, which Dr. Weisenburger claims is the cancer’s latency period following Roundup exposure.  However, Dr. Weisenburger responded that the 20-25 year latency period is just a guess, as it’s the median; so that all the test subjects in the studies at issue still fell within the bell curve.

Dr. Weisenburger also said he didn’t know the cause of cancer for 70 percent of the 1,000 NHL patients he has treated.  But the pathologist said repeatedly that doctors don’t look at the history of patients closely.  He said physicians often don’t know the cause of cancer, because they don’t pursue it in detail.

“Physicians don’t ask about Roundup,” said the pathologist. “They don’t even ask about pesticides.”

Monsanto’s own health assessment “will be inaccurate”

After Dr. Weisenburger’s testimony, Mr. Hardeman’s attorneys showed a video deposition clip of Monsanto’s corporate representative Bill Reeves. Mr. Hardeman’s attorney questioned Mr. Reeves about a 1997 letter from an in-house Monsanto epidemiologist who wrote that the exposure assessment in a decades long agricultural health study “will be inaccurate.”  Monsanto has used the study to counter Mr. Hardeman’s allegations.

Mr. Wisner also pointed out a 1986 document in which the US EPA told Monsanto its mouse study testing the safety of glyphosate was based on insufficient data and needed to be redone.

The trial is expected to last into at least the middle of next week if Monsanto wins this first phase, and there will be no second phase for damages in the bifurcation arrangement if the plaintiff fails to win this first truncated round.

Though this is the first trial against Monsanto for Roundup in a federal court, there has been one previous Roundup trial in a state court, last summer in California.  In that case last summer, a state jury hit Monsanto with a $289 million verdict.  It was later slashed by tort reform to $78 million and is on appeal.  Monsanto has yet to pay out any monies over Roundup.

The case is Hardeman v. Monsanto Co. et al., case number 3:16-cv-00525, and the MDL is In re: Roundup Products Liability Litigation, case number 3:16-md-02741, both in the U.S. District Court for the Northern District of California.

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Monsanto Trial Judge rips Plaintiff Attorney’s “Steely” Composure

(Feb. 27, 2019)  A California judge running the first federal court trial in the Monsanto Roundup litigation ripped into a plaintiff’s attorney for her “composure” after he repeatedly interrupted her during her opening argument Monday.  Judge Vince Chhabria (unpronounceable) interrupted the plaintiff’s attorney Amy Wagstaff over and over again as she attempted to open her client’s case for the jury.  The judge later criticized her “steely composure” in responding to his interruptions, and finally he threatened to issue sanctions against the woman as well as her law firm.

Steely Composure proves actions in bad faith and intentional
Judge Chhabria said that Ms. Wagstaff’s actions were in bad faith and intentional. How did the judge know her actions were in bad faith and intentional? Because, the judge said, the woman showed “steely” composure in reacting to his interruptions.

(Editor’s Note: We relate this story directly from the record as it was reported by Dorothy Atkins for Law 360, a publication which, like Judge C., tends to weigh – and share – most evidentiary matters decidedly in favor of Monsanto.)

Bifurcation Blues
The judge’s prior ruling to bifurcate this Roundup cancer trial – at the request of Monsanto’s lawyers – was the clear catalyst for this messy opening scene of the first Roundup trial to be heard in a federal court.  Judge Chhabria ruled before the trial began that it would proceed differently than the first trial, which didn’t work out well for Monsanto.  The first Roundup trial last summer in California brought a former groundskeeper a $289 million verdict (later reduced to $78 million) against Monsanto, though that entire verdict is still (of course) on appeal.

For this second Roundup-Lymphoma trial and the first in a federal court, Judge Chhabria agreed with Monsanto lawyers to split the proceedings into two parts, the first for causation, the second for damages.   In this rare and controversial (to say the least) setup, the jury will first hear only those arguments which relate directly to the science of causation. (That seems fair, at first blush, but wait and hear the whole story.)  If, looking only at the causation “science,” the jury determines that Roundup caused the plaintiff’s non-Hodgkin’s lymphoma, then they will also be allowed to hear – in a potential second phase of the trial – about some of Monsanto’s machinations to manipulate the “science” and propagandize to sway public opinion.

In the first trial, the jury was allowed to hear “the whole story” – both the plaintiff’s whole story and Monsanto’s whole story – from the start.  Why did this judge decide to change that simple formula?

Science Divorced from Reality
While bifurcating the trial into two parts – divorcing the science from Monsanto’s behind-the-scenes manipulations – might seem like a fair approach in some sense, the overarching problem with the bifurcation ruling is that the science of Roundup safety cannot be divorced from Monsanto’s machinations to manipulate that “science.” And this is why we need to put that word in quotation marks the rest of the way.  “Science” cannot be divorced today (if it ever could) from politics, or from the considerable money that works so hard to control “scientific findings.”

The jury in the first trial was able to hear, from the start, from the plaintiff’s attorney, the simple question:  “If Monsanto’s Roundup is so safe and the science behind its safety is as strong as Monsanto says it is, then why did the company need to work so hard to ghostwrite articles for academics to sign; hire editors at ostensibly objective publications who could then work as gatekeepers to deny space to anyone showing the danger of Monsanto’s products; retract peer-reviewed and published information when it threatened Monsanto’s business model? Why did Monsanto need to secretly contact EPA employees and secure the quashing of safety studies?  Why does Monsanto hire bloggers and internet trolls to attack citizen researchers who uncover evidence of the dangers of Roundup?  Why does Monsanto continue to feed fake news to Reuters and other worldwide publications to defend its products and attack its detractors? Why does Monsanto spend millions of dollars to defeat food labeling bills?

The Impossibility of Bifurcation
Though this jury may never hear any of them, examples of Monsanto’s behind-the-scenes manipulations of “science” are legion.  Just one case alone will serve to show just how Monsanto poisons the well of honest scientific discourse and research into the safety of its products.

Monsanto Manipulation and Dr. Giles Seralini


Monsanto’s work to discredit and neutralize Dr. Giles Séralini is instructive of how the biotech giant does business. Dr. Séralini found that Monsanto’s GM maize caused massive tumors in rats, and he published those findings in a peer-reviewed science journal. Rats from all over the world at the behest of Monsanto then attacked Dr. Séralini and his study, and a Monsanto minion secured an editorial post at the publication and then had the threatening paper retracted. That retraction then caused an uproar from honest scientists everywhere, so that the paper was then re-peer-reviewed and then re-published in another science journal.

A French Member of the European Parliament and France’s former minister for the environment, Corinne Lepage, explained that the Séralini study exposed the weakness of industry studies conducted for regulatory authorization. The GM maize had previously been judged safe by regulators around the world, including the European Food Safety Authority (EFSA).

Institute for Responsible Technology

The Institute for Responsible Technology (IRT) explains that Dr. Séralini became the center of an “[E]pic struggle between independent science and corporate hegemony. The scientific journal, Food and Chemical Toxicology, which first published his study, had retracted the article following an orchestrated campaign by thinly disguised biotech promoters. The article was later re-published in June 2014 in the journal, Environmental Sciences Europe.”

IRT notes also that another Monsanto minion of a scientist, “[F]ormer chairman of France’s Biomolecular Engineering Commission, Marc Fellous, was then exposed in a libel trial that he lost to Dr. Séralini just last year for using or copying Séralini’s signature without his agreement to argue that Séralini and his co-researchers were wrong in their reassessment of Monsanto studies. The Séralini team’s re-assessment reported finding signs of toxicity in the raw data from Monsanto’s own rat feeding studies with GM maize (corn).”

Monsanto Trial Judge rips Plaintiff Attorney’s “Steely” Composure

The Dr. Séralini story proves – definitively, and all by itself – that there is simply no way for U.S. federal Judge Vincent Chhabria, or anybody else, to “bifurcate” a trial that separates science and causation from Monsanto’s propagandizing machinations.  Monsanto’s actions have proven again and again that science and propaganda are inextricably linked. That IS the story of Monsanto’s Roundup, and why any jury that hears these cases needs to be given both and all sides of the entire story, in order to decide for themselves what real “science” does and does not say.

Let us, the American people, hear the whole story, Judge. We’re as smart as you, and we deserve to hear the whole truth, and then decide for ourselves what is right, and what is not.  The truth of Monsanto’s rat experiments on us all will not be silenced by you or anybody else.

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Monsanto Poison Glyphosate contaminates Wine and Beer

(Feb. 26, 2019)  A Monsanto poison contaminates most of the wine and beer sold in the United States, according to a recent study by U.S. Public Interest Research Groups (PIRG).  Glyphosate, the main active ingredient in Roundup – which impairs human gut health and is linked with non-Hodgkin’s lymphoma and a host of other maladies – was found to contaminate every conventionally produced wine and beer tested in a recent study, as well as most organic beer and wine samples.

Glyphosate Contamination Epidemic

PIRG tested 20 different wine and beer samples in the U.S., finding glyphosate contamination in 19 of them, including most organic wine samples.  Just one product they tested, an organic beer, was found to have no glyphosate contamination.  Some mildly good news for organic wine and beer lovers is that the organic beer and wines tested were found to have far less glyphosate than conventionally-produced beverages.

Good news was hard to come by in this study. Is anyone paying attention? Why would anyone pay $100 for a bottle of glyphosate-contaminated California wine, or even $10 for that matter?

Glyphosate Poison Everywhere

The presence of glyphosate pesticide even in organic products proved once again just how widespread glyphosate contamination is in the country.  Organic beer and wine producers do not intentionally use any glyphosate in their products, and they do their best to avoid the chemical, for obvious reasons.

The Findings

Wines

  1. Sutter Home Merlot – 51.4 ppb
  2. Beringer Estates Moscato – 42.6 ppb
  3. Barefoot Cabernet Sauvignon – 36.3 ppb
  4. Inkarri Estates Malbec (Organic) – 5.3 ppb
  5. Frey Organic Natural White –4.8 ppb

Beers

  1. Coors Light –  1 ppb
  2. Tsingtao Beer – 49.7 ppb
  3. Miller Lite – 29.8 ppb
  4. Budweiser – 27.0 ppb
  5. Corona Extra – 25.1 ppb
  6. Heineken – 20.9 ppb
  7. Guinness Draught – 20.3 ppb
  8. Stella Artois – 18.7 ppb
  9. Stella Artois Cidre – 9.1 ppb
  10. Ace Perry Hard Cider – 14.5 ppb
  11. New Belgium Fat Tire Amber Ale – 11.2 ppb
  12. Sam Adams New England IPA – 11.0 ppb
  13. Sierra Nevada Pale Ale – 11.8 ppb
  14. Samuel Smith’s Organic Lager – 5.7 ppb
  15. Peak Beer Organic IPA – no detected level

Glyphosate at 1 ppt is Problematic

Human tolerance for glyphosate may be much lower than the U.S. EPA claims, especially as one considers the secret and not-so-secret relationships some EPA officials, U.S. politicos, judges, and journalists share and have shared with Monsanto executives.

The levels of glyphosate found in these latest beer and wine tests were below EPA risk tolerances for beverages (for what that’s worth from a captured agency).   However, in one study, scientists found that 1 part per trillion (ppt) of glyphosate has the potential to stimulate the growth of breast cancer cells and disrupt the endocrine system.  German scientists have shown that 0.1 ppb of glyphosate has the potential to destroy beneficial gut bacteria while pathogenic gut bacteria were resistant.  Furthermore, 0.1 ppb of glyphosate has also been shown to stimulate the proliferation of certain types of breast cancer cells.

PIRG calls for Glyphosate Ban

In short, no safe level for glyphosate has ever been proven.  The researchers recommend that the EPA ban the use of glyphosate unless and until it can be proven safe.

Public Interest Research Groups

Founded by consumer advocate Ralph Nader  in 1971, PIRG’s motto is “Standing up to Powerful Interests.”  PIRGs are a federation of non-profit U.S. and Canadian organizations that use grassroots organizing and direct advocacy with the goal of effecting political change.

Someone needs to do this important work to safeguard our health, because it is not currently being done by the government institutions we entrust to do it – the EPA and the FDA.  Both of those agencies continue to show a fealty to Monsanto that comes at the considerable expense of people, animals, birds, bees, plants, and other living things throughout the world.

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Breast Implant Lymphoma Warning from FDA

(Feb 6. 2019)  The FDA issued a letter today which warns that breast implants may increase the risk of Associated-Anaplastic Large Cell Lymphoma.  The agency sent the letter to health care providers alerting them to the problem and the potential risks to their patients of breast implants.

 All Breast Implants Included

The letter stated that the FDA “wants to increase awareness about an association between all breast implants [emphasis ours], regardless of filling or texture, and Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).”

The agency said it had received reports indicating that patients with breast implants face an increased risk of developing this disease within the scar capsule adjacent to the implant.

The FDA wrote:  “We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy.  We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.”

Associated-Anaplastic Large Cell Lymphoma

BIA-ALCL is not a cancer of the breast tissue but a type of lymphoma.  Breast implants are inserted behind the breast tissue or under the chest muscle (see photo).   A fibrous scar called a capsule then develops around the implant, separating it from the rest of the breast.  Cases of BIA-ALCL have typically been found adjacent to the implant and contained within that fibrous capsule.

The FDA says a significant amount of medical literature has been published since its 2011 report on BIA-ALCL.  It includes more case histories and comprehensive reviews of the natural history and long-term outcomes of BIA-ALCL.  Current literature reports various estimates for the incidence of BIA-ALCL.  These estimated incidence rates range from 1 in 3,817 patients to 1 in 30,000 (Clemens et al, 2017; Loch-Wilkinson et al, 2017; De Boer et al, 2018).

 Textured vs. non-Textured Implants

Most patients who develop BIA-ALCL have received textured implants, but BIA-ALCL reports have also involved patients with smooth-surfaced implants, and many diagnostic reports do not detail the implant’s surface texture.

660 MDRs for BIA-ALCL, 9 Deaths

The FDA said it has received a total of 660 Medical Device Reports (MDRs) of BIA-ALCL.  The agency has reviewed the “660 MDRs to remove duplicate reports and to control for MDRs in which a BIA-ALCL diagnosis was confirmed by: a physician, positive pathology/cytology test results, or positive for biomarker CD30 and negative for biomarker ALK. The FDA’s additional data analysis identified 457 unique MDRs for BIA-ALCL, including the death of nine patients which may be attributable to BIA-ALCL. However, it is important to note that at the time of diagnosis, patients may have their original breast implants or they may have had one or more replacements.”

Risk Factors for BIA-ALCL

Recent journal articles explore possible risk factors for developing BIA-ALCL, including the methods used to create the textured surface of the implant and the possible role of biofilm.

Treatment for BIA-ALCL

Most of the published information regarding treatment involves removal of the implant and the capsule surrounding the implant, and in some patients, treatment with chemotherapy and radiation.

 1.5 Million Breast Implants Yearly – Increased Risks

Though FDA says the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide each year, confirmed data and published information that the agency has reviewed  suggests patients with breast implants have an increased risk of BIA-ALCL.

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Judge limits Monsanto Trial Evidence

(Jan. 4, 2019)  A Monsanto Christmas wish was granted this week by a judge in the Roundup cancer litigation.  California Judge Vince Chhabria ruled for Monsanto in its lawyers’ requests that the jury in the next Roundup cancer trial not hear evidence of how Monsanto worked to influence regulators and manipulate public opinion.

Unlike the first trial – in which a jury awarded a $289 million verdict that stated Monsanto’s Roundup caused a California groundskeeper’s cancer – the judge ruled to split the second trial into two parts.  That decision could have far-reaching consequences for the entire Roundup litigation.

New Trial Arrangement favors Monsanto

In the new two-part trial arrangement, the plaintiff’s attorneys will first have to convince the jury that Roundup caused the plaintiff’s non-Hodgkin’s Lymphoma. They will need to do so without any reference to Monsanto’s now well-documented attempts to influence the EPA, other regulators, and the public at large.  Plaintiff’s attorneys will also not be able to show Monsanto’s secret funding of ostensibly “scientific” research projects that established outcomes which virtually always favored the company that funded them.

If – and only if – the plaintiff’s attorneys are able to convince the jury that Roundup caused the plaintiff’s lymphoma, will they then be able to reveal the full scope of Monsanto’s efforts to keep  the public from discovering that Roundup was not as safe as the company advertised.

If Roundup Were Safe

If Roundup were as safe as advertised, why would Monsanto be so concerned with manipulating public opinion?  Why would it spend countless hours and monies to attack or “neutralize” honest researchers like Giles Seralini?  If Roundup were safe, why would Monsanto feel the need to hire academic stooges like Berkeley’s Henry I. Miller to put his name on propaganda penned by Monsanto executives?  If Roundup were safe, why would Monsanto need to cajole and massage EPA employees like Jess Rowland to get them to do the company’s bidding and squelch honest inquiry into Roundup safety?

Scope of Ruling

Judge Chhabria’s Jan. 3 order applies to Edwin Hardeman’s case, which is scheduled for trial on Feb. 25.  The ruling also applies to two other bellwether trials which will help determine the range of damages and define settlement options for the rest of the 620 Roundup cases before Chhabria.

Mr. Hardeman’s lawyers contend that the exluded evidence, including internal Monsanto documents, show the company’s misconduct.  They believe that evidence was critical to an August 2018 California state court jury’s $289 million award in a similar case, though that verdict was later reduced to $78 million and is under appeal.

Under Judge Chhabria’s order, evidence of Monsanto’s alleged misconduct would be allowed only if glyphosate were found by the jury to have caused Mr. Hardeman’s cancer.   If that happens, the trial can proceed to a second phase to determine Monsanto’s (Bayer’s) liability.

Monsanto and Bayer face more than 9,300 U.S. lawsuits over Roundup’s safety in U.S. state and federal courts.

A Bayer statement welcomed the judge’s decision:  “The court’s decision to keep the focus of the trial on the extensive science relevant to human health is encouraging,” the company said.

The attorney for Mr. Hardeman said that even without the evidence of Monsanto’s influence peddling, she feels confident the jury will be able to understand that Roundup caused her client’s lymphoma.

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FDA warns Genetech over Stem Cell Contamination

Liveyon recalls all Genetech Products

(Jan. 2, 2019)  The FDA warned Genetech, Inc. and its president Edwin N. Pinos on Dec. 20, 2018 for marketing stem cell therapies without FDA approval.  The FDA warning letter said the company – based in San Diego, Calif. – also committed “significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients.”

The FDA letter said “Genetech processed umbilical cord blood into unapproved human cellular products” distributed by Liveyon, LLC.

Dangerous, Unapproved Stem Cell Products

The FDA warning also put other stem cell providers on notice.  It was pointedly titled:  “FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice.”

In September 2018, Liveyon suspended shipment of all product pending an FDA inquiry into the source of adverse reactions reported last year.  Liveyon also recalled all Genetech products it may have distributed.

E.coli Stem Cell Contamination

The recall came too late for some.  FDA reported on Dec. 20 that at least 12 people have suffered bacterial infections from contaminated stem cell therapy.  FDA said it was aware of a dozen patients who had received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli).

The FDA and the CDC have both received “numerous reports of safety issues including those involving microbial contamination,” according to the FDA’s Dec. 20 warning letter.

The infections FDA found were described in a Morbidity and Mortality Weekly Report (MMWR) titled “Notes from the Field:  Bloodstream Joint Infections in Patients after Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions – United States, 2018.”

Significant Deviations

The FDA said that during its inspection it documented evidence of “significant deviations” from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products.  Those deviations included:

  • Deficient donor eligibility practices
  • Unvalidated manufacturing processes
  • Uncontrolled environment
  • Lack of control over components used in production
  • A lack of defined areas or a control system to prevent contamination and mix-ups

The FDA requested a response from Genetech within 15 working days of the letter’s release.  (That would be on or around Jan. 4, 2018). The response letter should detail how the deviations noted in the warning letter will be corrected.  FDA said deviations not corrected by companies and owners can lead to enforcement action such as seizure, injunction, or prosecution.

FDA:  Report Adverse Events

The FDA warning letter also said health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products, or other stem cell treatments.

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J&J knew Asbestos contaminated Baby Powder

(Dec. 12, 2018) A Reuters story this week shows Johnson & Johnson knew for decades that its baby powder was contaminated with asbestos.  Newly unearthed records show the company typically did not know – and plaintiff’s lawyers in several talc cancer lawsuits have argued the company did not want to know – exactly how much asbestos was contained in each batch.  Nevertheless, this latest Reuters research strongly suggests, and some would say “proves,” what several plaintiffs’ lawyers have argued in the courts – that J&J knew some of its talcum batches were contaminated with carcinogenic asbestos.

Though the company has successfully turned back some talc-cancer lawsuits, it has lost more jury verdicts than it has won. Going forward, the difference now may be that Reuters has turned up the evidence that some juries have found lacking in some of the talc-cancer trials against Johnson & Johnson.  The company has thus far been able to keep  juries from seeing most of this latest uncovered evidence of its internal communications regarding asbestos-tainted talc.

A Potential Game Changer

The internal documents Reuters just unearthed present a potential game changer for talc litigants. The documents which Reuters turned up show that J&J has known of its talc-asbestos contamination problem for at least 60 years.  The documents show J&J has been aware – at least since the late 1950s – of an asbestos-contaminated talcum problem.

In addition, the internal documents show J&J officials knew their talcum powder was sometimes tainted with carcinogenic asbestos, yet they kept that information from regulators and the public.

J&J documents Unavailable to Plaintiff
In one lawsuit directed against J&J for alleged talc-related ovarian cancer, 52-year-old Darlene Coker filed suit against the company.  Ms. Coker believed her mesothelioma was caused by her longtime use of J&J talcum powder.  She hadn’t worked in ship building, mining, manufacturing, or in any other industry which employs people prone to developing the deadly disease.  Ms. Coker ran a massage school in Lumberton, Texas.  How had she been exposed to asbestos?

Darlene Coker sued Johnson & Johnson in 1999, alleging “poisonous talc” in the company’s flagship product gave her mesothelioma, which would eventually kill her at age 63.

J&J denied the claim.  Its attorneys argued that J&J Baby Powder was asbestos-free.  As the case progressed, company attorneys were able to convince the judge not to make them hand over talc test results and other internal company records which the plaintiff demanded. Without that  evidence, Ms. Coker was forced to drop her lawsuit.  Without those documents, her lawyer could not establish the burden of proof placed by law on every plaintiff.

Nearly 20 years later, the evidence Ms. Coker needed is emerging.  J&J has now been compelled to share thousands of pages of company memos, internal reports and other confidential documents with plaintiffs’ lawyers who represent some 11,700 plaintiffs who claim J&J talc caused their cancers. Thousands of those women have ovarian cancer.

J&J Talc Tested Positive for Asbestos

Reuters examination of many of those documents, as well as deposition and trial testimony, show that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, though the company tested just a tiny portion of its powders.  Meanwhile, J&J executives, mine managers, scientists, doctors, and lawyers fretted over the problem and how to address it.  And all the while they failed to disclose their concerns to regulators or the public.

J&J silenced Regulators

The documents also show J&J’s successful efforts to influence U.S. regulators’ plans to limit asbestos in cosmetic talc products, and limit scientific research on the health effects of talc.

Previous Trials lacked this evidence
Lawyers for plaintiffs in several talc-cancer trials so far have been able to present only a small portion of the documents the Reuters study has unearthed. J&J has been able to keep many documents from public view by court orders that allowed the company to turn over thousands of documents it designated as “confidential.”

They are confidential no more, at least not to the public. Reuters reports much of their contents for the first time. Reuters found that J&J first mentioned talc-asbestos contamination in 1957 and 1958 reports from a consulting lab. Those reports described contaminants in talc from J&J’s Italian supplier as fibrous and “acicular,” or needle-like, tremolite. Tremolite is one of the six minerals classified as asbestos in their naturally occurring fibrous form.
From those late 1950 to the early 2000s, reports by scientists at J&J, outside labs and J&J’s supplier found similar results. Those reports identified contaminants in talc and finished powder products as asbestos or describe them in terms typically applied to asbestos, such as “fiberform” and “rods.”

J&J Fails to Inform FDA of Talc-Asbestos Contamination
In one more bombshell from the documents, when the FDA was weighing limits on asbestos in cosmetic talc products, J&J assured FDA that no asbestos was “detected in any sample” of talc produced from December 1972 to October 1973. J&J failed to tell FDA that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc – in one case at levels reported as “rather high.”

Whether this newly released information will find its way into the court rooms in this litigation is uncertain. For now, it is enough to give those litigants hope who believe their ovarian cancer or mesothelioma was caused by exposure to J&J talc products.

Johnson & Johnson Response

Johnson & Johnson, meanwhile, says that releasing these documents shows the care the company takes to ensure its products are asbestos free.  J&J says it will appeal the recent verdicts against it. The company has maintained in public statements that its talc is safe.  It says years of the best tests available show its talc is safe.

J&J has blamed its losses on juror confusion, “junk” science, unfair court rules, plaintiffs’ attorneys.  J&J’s vice president of global media relations, Ernie Knewitz, emailed a response to Reuters’ findings: “Plaintiffs attorneys out for personal financial gain are distorting historical documents and intentionally creating confusion in the courtroom and in the media.  This is all a calculated attempt to distract from the fact that thousands of independent tests prove our talc does not contain asbestos or cause cancer.  Any suggestion that Johnson & Johnson knew or hid information about the safety of talc is false.”

Reuter’s reported that it tried for more than two months to have Johnson & Johnson executives comment further for this latest article.  The executives refused.  J&J did tell Reuters it would have one of its experts contact the news agency, but no J&J expert contacted Reuters for nearly a week. Finaly, one J&J expert said that he would not comment.

Johnson & Johnson referred all inquiries to its outside litigation counsel, Peter Bicks. In responses emailed to Reuters, Mr. Bicks rejected the new agency’s findings as “false and misleading.”

“The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc,” wrote Mr. Bicks.  “This is true even if – and it does not – Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.” Mr. Bicks dismissed tests cited in this article as “outlier” results.

Talc Asbestos Cancer Lawsuits

Nearly 12,000 talc asbestos cancer lawsuits have now been filed across the country.

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Valsartan BPM contains Carcinogen

(Oct. 18, 2018)  The FDA announced in July 2018 that Valsartan blood pressure medicine contains a probable human carcinogen.  The agency has recalled products containing N-nitrosodimethylamine (NDMA).  Since that initial Valsartan recall, the FDA has continued to expand the list to include lots from more and more manufacturing facilities. The FDA recall list for Valsartan continues to expand.   You can find that list here.

Valsartan BPM contains Carcinogen

Valsartan is a commonly-prescribed high blood pressure medication that contains NDMA, a probable human carcinogen. Researchers found tumors in the bodies of mice and rats after they were exposed to NDMA.

Free Legal Consultation

Matthews & Associates is accepting cases in which a person took Valsartan and was then diagnosed with cancer of the digestive tract,  including liver, kidney, colorectal, stomach, pancreatic, and bladder cancer.  Call 713-522-5250 or email us now for a free legal consultation.

FDA Approved Drugs Kill 106,000 People Yearly

The Valsartan debacle is no exception for anyone paying attention to how the FDA works (or doesn’t) in tandem with Big Pharma drug makers.  The agency approves more and more drugs each year despite those drugs killing at least 106,000 Americans each year.

Here’s a fact which should be headline news in every TV news show and newspaper in the country:  More than 105,000 people are killed each year by FDA-approved drugs. (Another 119,000 Americans are killed yearly by errors committed in hospitals.)

These facts have been well known since at least July 26, 2000, when the Journal of the American Medical Association (JAMA) published a review by Dr. Barbara Starfield titled:  “Is US health really the best in the world?”  The answer to that question, easily proven by statistics, was a most emphatic, “No!”

Let’s recap the Dr. Starfield U.S. Health System Review:

  • The US medical system kills 225,000 Americans per year.
  • 106,000 deaths per year come from FDA-approved medical drugs.
  • 119,000 deaths per year come from treatment errors in US hospitals.

Drug Industry pays FDA to Approve its Drugs

In an email interview with No More Fake News writer Jon Rappoport, Dr. Starfield wrote:  “Even though there will always be adverse events that cannot be anticipated, the fact is that more and more unsafe drugs are being approved for use.  Many people attribute that to the fact that the pharmaceutical industry is required to pay the FDA for reviews [of its new drugs], which puts the FDA into an untenable position of working for the industry it is regulating. There is a large literature on this.”

U.S. Healthcare System Broken by Vested Interests

Mr. Rappoport asked Dr. Starfield whether her work was an indictment of the FDA.

Dr. Starfield would not blame the FDA directly.  She said,  “They [the death statistics] are an indictment of the US health care industry: insurance companies, specialty and disease-oriented medical academia, the pharmaceutical and device manufacturing industries, all of which contribute heavily to re-election campaigns of members of Congress. The problem is that we do not have a government that is free of influence of vested interests. Alas, [it] is a general problem of our society — which clearly unbalances democracy.”

Dr. Starfield also noted that the figures she found were accepted by virtually all those who study them, with the lone exception of one  former medical school dean who has received lots of attention for claiming the US health system is the best there is. That lone apologist for the broken system has a vested interest in medical schools and teaching hospitals, so his outlier criticism is highly suspect.

Virtually every study similar to the one Dr. Starfield published in 2000 has found much higher numbers of deaths caused by legal drugs and deaths by medical mistakes.

We must first identify a problem before we can properly fix it.  The U.S. healthcare system is not the best in the world.  It is badly corrupted by money and the vested interests of interlocked corporations with parallel interests in profits, not people or their health.  The health system’s vice-like grip on our personal finances (forcing us into expensive and restrictive insurance policies) and its monetary control of our health choices (they’ll pay the rotten system for expensive chemo which fails 97% of those it poisons; but they won’t pay for a vitamin B-12 shot or the treatment of your choice) will continue unabated, unless we do something about it.

More than 225,000 deaths per year by legal drugs and medical mistakes is an awfully steep price to pay for a broken system of “healthcare.”

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FDA Gadolinium Warning

(Oct. 15, 2018)  The FDA issued a warning about gadolinium-based contrast agents in December 2017.  The agency’s Drug Safety Communication concerned gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) for diagnostics.  The FDA alerted health care professionals and patients about the dangers of gadolinium retention.   The FDA announced that a new class warning would be required for all GBCAs concerning gadolinium remaining in the body for months or years  following the drug’s injection for an MRI.

Related:  Gadolinium – MRI Dye Lawsuit

FDA Calls for Gado Dye Safety Tests

FDA also announced that GBCA makers must conduct human and animal studies to further assess the safety of gadolinium contrast agents. The agency is also requiring a patient medication guide be given prior to a patient’s receiving any GBCA.  The FDA says gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the agency “has  concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.”

All People at Risk from Gadolinium

ScienceDaily writes:  “Previously gadolinium was thought to accumulate only in patients with impaired kidney function. New evidence now shows that all patients are at risk. The authors call for urgent retrospective and prospective studies to assess the clinical effects on patients who have been exposed to gadolinium-based contrast during MRI scans.”  See:  ScienceDaily.com

Gadolinium Dangers can outweigh Benefits

Despite the FDA’s pronouncement that gadolinium benefits outweigh risks, one might be wise to consider Science Daily’s pronouncement as well as the example of the actor Chuck Norris’ wife.  The FDA warning over gadolinium and nephrogenic systemic fibrosis (NSF) states that only those with diagnosed kidney problems should avoid gadolinium-based contrast agents.  Mr. Norris’ wife had no known kidney problems when she was given GBCA before several MRIs. The couple have charged in several lawsuits against the makers of GBCAs that gadolinium caused Mrs. Norris grievous personal injuries.  And the Norris family is not alone in believing that GBCAs can cause undue harm.

Gadolinium deposition disease is real for many people who were injected with gadolinium prior to an MRI despite their having not been diagnosed with kidney problems beforehand.  Many forums can be found on the web with anecdotal reports from people who say they were injured by gadolinium dye.

Symptoms of gadolinium deposition disease — GDD — can start from within a few minutes to one month after administration of a gadolinium-based contrast agent (GBCA).

Gadolinium Deposition Disease (GDD) Symptoms:

  1. Intense burning of the skin and skin substrate may be felt overall in the entire body, though it may be localized to the trunk area or the distal extremities.
  2. Intense boring pain in bones or joints can arise early after GBCA exposure and affect any bones or joints. Joint pain may be peripheral and also affect large joints such as the knee or hip.  Any bones may feel some severe point pain, but rib pain is distinctive for GDD.
  3. Brain fog or mental confusion can also arise early after GBCA exposure.  Brain fog is also a prominent feature of lead toxicity, another heavy metal malady.
  4. Muscle vibrations (muscle fasciculations) and skin pins and needles/tingling may represent part of the same process that is causing brain fog. Muscle vibrations/twitching and pins and needles skin sensations generally reflect nerve disease or neuropathy.
  5. Head pain or headache, of variable degree, are a very common occurrence.  GDD sufferers describe it as a head pain unlike any head-ache they’ve ever experienced.  Some describe it as a burning pain or an extreme tightness  — like feeling a tight bathing cap on the head.
  6. Distal arm and leg skin/skin substrate thickening, discoloration, pain can arise in the subacute stage at 2 + weeks after GBCA exposure.  This can be similar to the principal features of NSF, but generally less severe.

GadoliniumToxicity.com says, “This symptom complex should be expected.”

Gadolinium Lawsuit

Maybe those symptoms should be expected for gadolinium deposition disease, but the makers of GBCA owe a duty to people to warn them of the real dangers of gadolinium contrast dye.  Our law firm is handling gadolinium lawsuits for people adversely affected by gadolinium dye.  Contact us for a free legal consultation if you or a loved one was injured as a result of being injected with gadolinium prior to an MRI.  You may be entitled to significant compensation for any gadolinium-related injuries.

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