7th Circuit Upholds $20 Million Verdict Against Ethicon in Pelvic Mesh Case

Casting aside Ethicon’s “broad-spectrum attack on the judgment,” the 7th US Circuit Court upheld a $20 million verdict to a woman who was permanently injured by the company’s Prolift pelvic mesh device.

Ethicon appealed in Barbara Kaiser v. Johnson & Johnson and Ethicon, Inc., No. 18-2944. An Indiana state jury had awarded $35 million to Barbara Kaiser on March 8, 2018 for negligent design defect and negligent failure to warn about the dangers of the mesh. The trial judge reduced the verdict to $20 million.

It was the latest in a long string of jury verdicts.
Kaiser had the mesh implanted in January 2009. Afterwards she experienced severe pelvic pain, bladder spasms and pain during intercourse. Although she underwent revision surgery to remove the device, it could not be completely extracted.

Kaiser sued in March 2012. She claimed the defendants offered exaggerated and misleading information about the safety of Prolift. The device was later taken off of the market in 2012 following years of complaints and U.S. Food and Drug Administration scrutiny.

Ethicon’s “Kitchen Sink” Appeal faces

The company threw in every legal argument plus the kitchen sink in its appeal, a “broad-spectrum attack on the judgment, starting with an argument about federal preemption and moving through several issues of Indiana product-liability law, a claimed evidentiary error, and challenges to the compensatory and punitive damages,” the court said.

The 7th Circuit was not impressed, criticizing Ethicon’s “flurry of arguments,” and “its highly generalized statements fall far short of satisfying the legal standard.”

“One issue in particular warrants special mention upfront,” Circuit Judge Diane Sykes wrote for the 7th Circuit, that the plaintiff does not have to produce evidence of a reasonable alternative design for the product. It applied TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d 201, 209 (Ind. 2010), which specifically rejected an alternative-design requirement.

The court also held that the plaintiff’s state-law judgment was not preempted by federal law. Ethicon started marketing Prolift in 2005 and in 2007 submitted a 510(k) premarket application for Prolift when the FDA demanded one. The trial judge rejected Ethicon’s argument that the federal regulatory scheme preempted Indiana law, and the 7th Circuit affirmed.

The 7th Circuit ruled that “On this record a reasonable jury could conclude that Prolift was unreasonably dangerous.”

“Ethicon conceded that it hadn’t conducted any human trials before releasing Prolift, so it couldn’t present a safety record. Instead, it offered testimony that Prolift was generally an improvement over its predecessor.”

Ethicon’s many losses in the courtroom

A total of 1,213 lawsuits against Ethicon have been consolidated before US District Judge Joseph R. Goodwin in MDL 2327, IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation.

Of all the mesh manufacturers, J&J’s Ethicon has been the slowest to offer settlements, despite many losses in the courtroom, most notably a 2019 verdict from a Philadelphia jury that awarded $120 million:

  • In February 2013, Johnson & Johnson lost the first bellwether trial involving its transvaginal mesh implants. A New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. Linda Gross claimed that she required 18 revision surgeries after receiving the mesh implant.
  • In September 2014, Johnson & Johnson’s Ethicon Inc. unit lost a $3.27 million verdict to a West Virginia woman who claimed she was injured by the company’s Gynecare TVT Obturator, or TVT-O, transvaginal mesh device.
  • In December 2015, Johnson & Johnson lost a $12.5 million verdict to a woman who claimed she was injured by the company’s Prolift implant. Patricia Hammons claimed complications from the device forced her to have multiple revision surgeries.
  • In August 2017, Peggy Engleman filed a lawsuit against Ethicon and claimed the company’s TVT-Secur mesh caused serious complications including infections, bleeding and severe pain. A jury awarded her $20 million.
  • In December 2017, a New Jersey jury awarded $15 million to Elizabeth Hyrmoc. The jury awarded $4 million for pain and suffering, $10 million for punitive damages and $1 million for loss of consortium.
  • In January 2019, a Philadelphia jury awarded $41 million to Suzanne Emmett and her husband, Michael. The award included $25 million in punitive damages. She had Ethicon mesh implanted in 2007 and had multiple revision surgeries for bleeding, infections and painful sex.
  • In April 2019 a Philadelphia jury awarded $120 million to Susan McFarland, including $100 million in punitive damages. McFarland had a strip of TVT-O mesh implanted in 2008. She had surgery that did not alleviate pain and constant urinary tract infections. She has not been able to have sex since she received the implant.
  • In May 2019, a Philadelphia jury awarded $80 million to Patricia Mesigian, $50 million of which was for punitive damages. Mesigian had a Prolift implanted in 2008. The mesh eroded tissue and caused pelvic pain, inflammation and infections.

Ethicon does have some success in court. In April 2014, Linda Batiste won a $1.2 million state lawsuit against Johnson & Johnson. A Texas jury found that the mesh bladder sling that Batiste received was defective. Batiste claimed the sling eroded inside of her, causing severe pain and medical problems. An appeals court judge later overturned the verdict, saying Batiste failed to prove that the sling caused her injuries.

Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Attacking and Lying, Johnson & Johnson is Battered by Talcum Powder – Cancer Litigation

Ten years into the nationwide litigation over talcum powder, Johnson & Johnson is bleeding billions of dollars in settlements, legal fees, jury verdicts, and stock valuation. The company faces 15,299 cases nationwide in federal court, but all of the action so far has been in state courts.

The U.S. Justice Department started a criminal investigation in July 2019 into whether Johnson & Johnson lied to the public about the possible cancer risks of its talcum powder. A grand jury in Washington, DC, is examining documents related to what company officials knew about any carcinogens in their products.

The FDA announced on October 18, 2019, that over 33,000 bottles of Johnson’s Baby Powder were voluntarily recalled after testing positive for asbestos. Johnson & Johnson voluntarily recalled one lot of baby powder, after a sample tested positive for asbestos.

Johnson & Johnson has known about cancer-causing asbestos in its talc products since 1957. But in a deny-and-attack litigation strategy, the company has lied about it to consumers and the government, has faked research, has covered up its own findings about asbestos in talc, has bullied independent researchers and has stonewalled litigants.

Juries in state courts, where all the trials took place, have held J&J liable for failing to warn consumers that its baby powder causes fatal ovarian cancer and mesothelioma.

Through it all, J&J implausibly contends that its baby powder and talcum powder is “safe” – a claim that has been proven wrong. Meanwhile, scientists urge consumers not to use baby powder because of the cancer risk.

Plaintiff strategies

Attorney Mark Lanier of Houston, who won a $4.7 billion talc verdict against Johnson & Johnson this summer, told CNBC in December that the recent $50 billion plunge in shares of J&J plays into his hands in seeking a settlement with the company.

“This litigation, these problems can be resolved [for] much, much less than” than the $50 billion loss in J&J’s stock market value, Lanier said. “It serves my purposes as a litigator to say, ‘Yes, get their attention; keep driving the stock down.’”

Lanier represented 22 women with ovarian cancer who proved that J&J’s talc-based products, including its baby powder, contain asbestos and caused them to develop ovarian cancer. In August 2019, a Missouri judge affirmed the nearly $4.7 billion jury award.

“If the company continues to handle [the litigation] wrongly, then I think the company is going to continue to have problems that cost it two, three, four, five times what it should,” Lanier said. “Every case ultimately settles. Every case finds resolution. At some point, it’s a business decision for the litigants as well as for the company. And smart minds can prevail on that.”

The key turning point in the litigation came in 2018 when J&J finally complied with discovery requests, which disclosed damning revelations that its own tests have found asbestos in its talc for 60 years and that the company lied to the FDA about it.

Since then plaintiff lawyers have introduced the internal documents into evidence with devastating results at trial. Most of the standing verdicts have involved plaintiffs with mesothelioma.

  • $4.7 billion awarded in December 2018 to 22 women with ovarian cancer. A Missouri state jury made the award after it heard that Johnson & Johnson has known for decades about the risk of asbestos contamination in its talc.
  • $325 million awarded in May 2019 in New York to Donna Olson, whose mesothelioma was caused asbestos-laced Johnson & Johnson baby powder. The company’s damning internal documents were used as evidence.
  • $117 million awarded by a New Jersey jury in April 2018 to Steven Alonzo, who has mesothelioma.
  • $40.3 million awarded by a California jury in October 2019 to Nancy and Phil Cabibi because the company’s baby powder was tainted with asbestos. In 2017, Nancy was diagnosed with mesothelioma.
  • $37.3 million awarded by a New Jersey jury in September 2019 to four plaintiffs claiming they developed mesothelioma from inhaling asbestos allegedly present in Johnson & Johnson’s cosmetic talc products. The judge actually struck the closing argument by defense lawyer Diane Sullivan for accusing the plaintiffs’ attorneys of creating evidence and being sinister.
  • $29.4 million awarded by a California jury in a March 2019 trial involving a Teresa Leavitt, who proved that her mesothelioma is tied to her regular use of Johnson & Johnson’s talcum powder.
  • $25.75 million awarded by a California jury in May 2018 to Joanne and Gary Anderson. She was diagnosed with mesothelioma and proved that Johnson & Johnson was negligent and did not warn consumers about possible health risks from its Baby Powder.
    • Several additional verdicts are in the $25 to $20 million range. Linda O’Hagan was diagnosed with mesothelioma after using asbestos-laced baby powder and she filed suit in Oakland, CA.

Johnson & Johnson finally began settling cases in 2019, but most are hidden because the company forces plaintiffs to sign a confidentiality agreement. One settlement that went public was for $2 million on January 6, 2020.

Lawyers who won the plaintiff verdicts include Mark Lanier, Eric Holland, Christopher Placitella, Tim Meadows, Joseph Satterley, Jerome Block, David Greenstone, Mark Robinson, and Michael Miller – plus an army of others.

Defense successes

Defense attorneys are led by Peter Bicks of Orrick, Herrington & Sutcliffe and include Allison Brown of Skadden, Morton Dubin of Orrick, and Diane Sullivan of Weil, Gotshal & Manges.

Johnson & Johnson has found courts to overturn large plaintiff verdicts, but they are based on a jurisdictional issue – and not on the merits of the case. Most of the reversed cases are in Missouri, where an appeals court ruled that 1,000 out-of-state plaintiffs could not bring suit in the state.

The company has successfully used the June 19, 2017, US Supreme Court ruling in Bristol-Myers Squibb Co. v. Superior Court of California, 137 S. Ct. 1773. The Court held that California courts lacked personal jurisdiction over the defendant on claims brought by plaintiffs who are not California residents and did not suffer their alleged injury in California.

This led to several reversals of ovarian cancer verdicts:

  • A trial judge in California overturned a $417 million talc cancer verdict in October 20, 2017. Relying on the Bristol-Myers Squibb case, the judge reversed the 2016 award to Eva Echeverria, who developed ovarian cancer.
  • A Missouri appeals court threw out a $110 million verdict in October 2019, awarded to Lois Slemp, who got cancer from the company’s baby powder. The court said she should not have been allowed to bring her ovarian-cancer lawsuit to trial in St. Louis because she is a resident of Virginia.
  • A $72 million verdict in 2016 in favor of the family of a woman whose death from ovarian cancer was reversed by the Missouri Court of Appeals, Eastern District in October 2017. The court said the case over Alabama resident Jacqueline Fox’s death from ovarian cancer should not have been tried in St. Louis.
  • Plaintiffs have also suffered dismissals, hung juries and mistrials in mesothelioma and ovarian cancer cases.

Andreas Saldivar has been a leading defense expert for Johnson & Johnson, testifying up to 30 trials. The company was shocked when his lab found asbestos in Johnson’s Baby Powder in September 2019. This prompted the humiliating recall of over 33,000 bottles of Johnson’s Baby Powder in October 2019.

The lab, AMA Analytical Services, Inc. was working under a contract with the FDA, which stood by the finding. When plaintiff lawyer Nate Finch asked an Indianapolis judge to let him tell the jury about it, J&J quickly settled the case with a confidentiality agreement.

Meanwhile, when plaintiff experts testify, they lead to spectacular verdicts like the $4.7 billion award in December 2018 in Missouri state court.

They include Dr. William Longo of Suwanee, GA, who has testified for talc plaintiffs for 30 years. He is a material scientist/electron microscopist who specializes in the analysis of asbestos-containing materials. In 1983, he founded Micro Analytical Laboratories.

Other experts include James R. Millette Ph.D. of Cincinnati, an engineer who is a Fellow of ASTM-International and serves as Vice-Chair for Air Quality. He is also a Fellow of the American Academy of Forensic Scientists.

Another witness is Dr. David Egilman, who served as the editor of a journal that published his 2014 article that lawyers frequently cite as the foundation for opinions talc contains asbestos. Egilman, a clinical professor of family medicine at Brown University, said he was first retained in a talc case two years ago and has billed $1 million in the litigation since.

The litigation will continue for years to come because talc and asbestos are found together in talc mines. The elemental structure of talc and chrysotile asbestos are nearly identical. Both Talc and Chrysotile Asbestos are formed from the same four basic elements: magnesium, silicon, hydrogen, and oxygen.

“It is unlikely that any naturally occurring talc deposit would not also contain some asbestos. Combine the foregoing with the fact that there is no practicable and economical means by which to separate asbestos from talc, it is reasonable to conclude that, it is more likely than not, that all talc contains asbestos,” writes John Ray, who has been a leading consultant to the Mass Tort industry for more than a decade.

Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

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If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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JUUL Vaping Litigation Could Be as Big as Opioid Actions

Plaintiffs in the mounting JUUL mass tort litigation docket are pursuing the same successful legal theories against the maker of addictive nicotine vape pens that are being used against the pharmaceutical companies that made addictive opioids.

With the creation of a JUUL MDL (multi-district litigation docket), the litigation is on its way to being as big as the opioid MDL.
Plaintiffs in the opioid litigation recovered $465 million in November 2019 in State of Oklahoma v. Johnson & Johnson. JUUL, just like J&J, engaged in:

  • Deceptive marketing about the benefits of its products.
  • Downplayed the addictive risks by saying the vape pens were “totally safe.”
  • Caused a public nuisance worse than the opioid crisis.

Opioids were involved in almost 400,000 overdose deaths from 1999 to 2017, according to the U.S. Centers for Disease Control and Prevention. In comparison, 5.3 million youth were current e-cigarette users in 2019, up from 3 million students in 2017, according to the 2019 National Youth Tobacco Survey.

In the JUUL litigation, plaintiffs are similarly alleging the vaping giant created a public nuisance, violated deceptive trade practice laws and RICO laws, was negligent and is strictly liable for defective design and manufacturing of its “nicotine delivery systems.”
JUUL lawsuits also allege fraudulent concealment, conspiracy with tobacco companies, intentional misrepresentation, and infliction of emotional distress.

Tobacco company influence

The JUUL litigation is also about promoting a habit-forming product that turns customers into addicts. The FDA and Surgeon General both described the underage use of e-cigarettes as an “epidemic.”

JUUL’s market value is $24 billion (down from $38 billion), and there is a deep pocket in the litigation: the cigarette company Altria, which has a $92 billion market capitalization. Altria bought a 35% stake in JUUL in December 2018, paying close to $13 billion.

A few months later the CEO of JUUL stepped down and he was replaced by a top executive from Altria. Altria discontinued its own e-cigarette products and gave JUUL prime shelf-space with its traditional Marlboro cigarettes.

It is no surprise that JUUL’s marketing and advertising targeted minors, following the classic playbook of the tobacco companies. Colorful JUUL ads depicted young people dancing, portrayed the nicotine device as cool and rebellious, and offered kid-friendly flavors like Mango, Fruit, and Crème.

Reaching critical mass

JUUL litigation is in the “litigation phase” now that the MDL was created on October 2, 2019. Many attorneys will seek clients at this point in the litigation because it has reached critical mass, and there are scores of product liability lawsuits filed in federal courts nationwide.

The Judicial Panel on Multidistrict Litigation has recognized that there are common factual issues that are sufficiently complex to merit centralized treatment. The Panel created MDL 2913, JUUL Labs, Inc., Marketing, Sales Practices, and Products Liability Litigation. It designated U.S. District Judge William H. Orrick, III of the Northern District of California to hear the cases in San Francisco, where JUUL is headquartered.

JUUL is the primary defendant because it has a 75% market share of the vaping market. However, there are eight additional defendants: Beard Vape, Direct eLiquid, Electric Lotus, Electric Tobacconist, Eonsmoke, Juice Man, Tinted Brew, and VapeCo.

When it created MDL 2913, there were only 10 cases filed in federal court in 5 states. Now there are 182 cases from across the country. Plaintiffs include school districts, states, counties and individuals.

  • School districts had to divert dollars away from classroom instruction and instead spend it on counseling and programs to help inform students of the dangers of vaping.
  • Individual customers suffered addiction, respiratory system damage, permanent brain damage, mood disorders, stroke, heart attack, and other cardiovascular injuries. The mother of an 18-year old in Florida has filed a wrongful death action, Lisa Marie Vail, individually and on behalf of the Estate of Daniel David Wakefield, deceased vs. JUUL Labs, Inc., in US District Court in the Northern District of California.

Separately, Siddharth Breja, a former senior vice president at JUUL sued the company in October 2019, alleging that JUUL sent to market at least “one million mint-flavored e-cigarette nicotine pods that it admits were contaminated, and against Mr. Breja’s insistence and protests, refused to recall those contaminated pods or even issue a product health and safety warning.”

Harvard researchers announced on January 3, 2020 that they found the microbial toxin Glucan in JUUL pods. Glucan is a component of fungal cell walls that can cause inflammation in the airways and can lead to long-term lung damage, according to the researchers.

Anemic response from the government
A Congressional hearing in July 2019 produced testimony that JUUL said in a school that:

  • JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
  • JUUL was “totally safe.”
  • A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
  • “FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”

The Trump administration’s response has been anemic. The FDA merely issued a warning letter “expressing concern” and saying the agency was “troubled.” In September 2019 the FDA said, “JUUL has ignored the law,” but then it only requested documents and threatened further action.

How JUUL is more dangerous than cigarettes

Just as tobacco use of teens dropped to 5% in 2017, the launch of JUUL has pushed the number of high schoolers using tobacco products back up to nearly 30%.

“Julling” is much more dangerous and insidious than smoking cigarettes. The JUUL pods are easily hidden from parents and teachers because they look like USB drives. A JUUL pod is far less conspicuous than a pack of cigarettes and a lighter. JUUL vapor smells far less than the pungent odor of burning tobacco. Students can exhale the JUUL vapor under their shirts to avoid detection.

The JUUL vapor is much less harsh than tobacco smoke, making JUUL easy to start using. Students call JUUL the “iPhone of vapes” because of its sleek and minimalistic design.

And then there is the JUUL high.

An interview with a 15-year-old describes the kick like this:

“The first time was in the lunchroom. Everyone else was hitting it and I was like “alright, I want to try that.” I guess I knew there was nicotine in it, but I had no idea that it had so much. When I hit it for the first time it was, like, really crazy. I felt a really big buzz off of barely anything.”

“It hurt my throat more than anything else I’ve done. I hit it and coughed immediately. At first, it was just fun and it was something that you could do anywhere. It’s so easy. Then it just became something I was doing nonstop, but I still felt a buzz. Now, I go crazy if I don’t have it. I don’t even feel a buzz anymore.”

The JUUL punch comes from a mega-dose of nicotine. One JUUL pod contains at least as much nicotine as a pack of cigarettes, or 20 cigarettes.

Nicotine is a neurotoxin that is one of the most addictive chemicals in the world. Nicotine is particularly dangerous to young people, whose brains are still developing through age 25. Nicotine is not only addictive but also permanently alters the structure of the brain and causes permanent mood changes and other cognitive disorders.

The Surgeon General concluded that “The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe.”

Marketing JUUL to Kids

JUUL was first launched in summer 2015 in schools, on social media and even billboards in New York City’s Times Square. The company put up YouTube videos, advertising in Vice Magazine, sponsorship of music events, and 50 highly stylized launch parties with free JUUL starter kits.

Just as the opioid companies paid doctors to shill their addictive product, JUUL paid social media influencers to promote its e-cigarette. JUUL’s ad agency said the 2015 “Vaporized “campaign “created ridiculous enthusiasm” for the campaign hashtag, #DoIt4JUUL.

By 2017, JUULing had taken off among America’s young people.

The marketing campaign came to a crashing halt after the FDA raided JUUL’s headquarters in October 2019, seizing more than 1,000 documents about the company’s sales and marketing practice. The JUUL MDL was created the same month.

Now that Juul had a huge base of young, addicted customers, it stopped selling candy flavors, pulled down all of its social media, limited sales to its website at www.JUUL.com, claimed that buyers must be at least 21, and asserted that “JUUL was developed as a satisfying alternative to cigarettes” for adults.

The website has “age verification” screening questions, which are easily spoofed with a parent’s driver license. The age verification is easily avoided by online resellers like eBay and Craigslist that have no age verification.

A starter kit sells for $35, JUUL pods cost $10 to $16, and the device costs $15 to $20. Exactly like cigarettes, the current flavors are Virginia tobacco, classic tobacco and menthol.

Today the company says, “JUUL was developed as a satisfying alternative to cigarettes.” But the lawsuit filed by the state of North Carolina alleges, “In reality, JUUL products are doing exactly the opposite of what JUUL claims, serving not as an “off-ramp” from traditional cigarettes for experienced smokers, but as an enticing “on-ramp” for young, inexperienced, and frequently underaged users.

Once again, it is up to America’s trial lawyers to hold a giant corporation accountable for its dangerous and damaging product.

Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Can the Trump/Barr Justice Department Aid Monsanto/Bayer in the RoundUp Litigation?

The news that the Trump/Barr Justice Department and EPA are attempting to come to the rescue of Monsanto in the Roundup litigation emboldened stockholders and caused concern among Roundup plaintiffs and their attorneys. Bayer stock saw its first significant uptick since the beginning of the Roundup litigation and the market reacted with general optimism after the December 20th Amicus brief was filed by the Hardeman v. Monsanto Company et. al. Trump/Barr DOJ/EPA. Apparently, Bayer stockholders are not familiar with the now common axiom “Everything Trump Touches, Fails”.

This article will clarify why Bayer stockholders have nothing to be cheer about and why Roundup Plaintiffs and there counsel should not be overly concerned with the fact that the most corrupt administration in our history has for some reason decided to come to the aide of Monsanto/Bayer.

EPA Amicus Brief: https://usrtk.org/wp-content/uploads/bsk-pdf-manager/2019/12/EPA-amicus-brief-supporting-Monsanto-in-Hardeman-appeal.pdf

Appeal: https://usrtk.org/wp-content/uploads/bsk-pdf-manager/2019/12/Hardeman-appeal-by-Monsanto.pdf

Monsanto’s appeal in the Hardeman case raises numerous issues however, it appears to MTN that Monsanto’s ultimate goal is to use the highly questionable EPA Statements from August of 2019 to argue that all plaintiffs failure to warn claims (all cases arising under all State laws) are preempted as a result of the August of 2019 EPA action.

This article will focus on dispelling the concept that the August of 2019 EPA action could serve as a “litigation killer” and dispose of all plaintiffs’ cases currently on file alleging that Roundup caused them to suffer from Non-Hodgkin’s Lymphoma.

As a preliminary matter, any attempt to use the August of 2019 EPA Statement to dispose of all plaintiffs cases would have to rely on arguments sounding in “The EPA would not have approved the label (warnings) change plaintiffs claim were needed, if Monsanto had actually filed a formal request with the EPA to add the dispute warnings language”. Arguments sounding in what a Federal Agency would or would not have done had a manufacturer actually attempted to effectuate the disputed label change were recently foreclosed on in Merck Sharp & Dohme Corp. v. Albrecht (Fosamax). Without regard to the SCOTUS ruling in Albrecht specifically, we will focus on why any “global” failure to warn defense sounding in Federal Preemption of State Law failure to warn claims fails.


Below is an exact quote from the EPA Statement (link previously provided):

Exact Quote: The EPA will no longer approve (emphasis added) product labels claiming glyphosate is known to cause cancer – a false claim that does not meet the labeling requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Note: The EPA has the power to disapprove statements (on label) that are false and misleading, the EPA does not have the power to determine that a statement that is factually true as stated is a false claim simply because the EPA disagrees with any conclusion that might be drawn from the otherwise truthful statement.

The EPAs own statements provide clear and convincing evidence that the EPA would have approved some form of cancer warning on the Roundup label prior to August of 2019 had the company requested to make such an addition to their label. Any argument by the Monsanto /Bayer defendant that the EPA would not have approved any form of cancer warning prior to August of 2019 fails in as much as the EPA did in fact approve warnings on Glyphosate products prior to August of 2019. Below are three examples, two of these examples contain language that that could not be deemed to be false and misleading and the other would likely be preempted post August of 2019.


May 6, 2015 Label Excerpt:

“Carcinogenicity / Chronic Health Effects: Prolonged overexposure to glyphosate may cause effects to the liver. EPA has given glyphosate a Group E classification (evidence of non-carcinogenicity in humans). In 2015, IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals.”

Comment: This Statement remains true and accurate and could arguably continue to be cited by Plaintiffs as an example of a more adequate warning that the warning provided on the label of Monsanto Products. The , The Statement that “The IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals “ remains true to day in that the IARC did in fact make (and continues to make) the statement to this date. The fact that the EPA disagrees with the IARC statement does not render the fact that the IARC made the statement false and misleading. The Statement made on the above label example remains true to this date, the Statement is not false and misleading nor does the statement constitute a “false claim”. The IARC made the Statement, the label states that the IARC made the Statement. The label does not offer an opinion on the Statement, the label simply informs the user of the fact that the IARC made the Statement.

It would arguable be far falser and more misleading to exclude the IARC Statement, given the fact that the IARC is a worldwide recognized authority on the subject of cancer, than it would be to include the Statement. The label also includes the EPAs statements which contradict the IARC. When contradicting opinions exist between authorities, how would the end user of a product be better served (better warned) by including one authorities conclusion to the exclusion of another’s?


Page 6 1/10/2017 Label

Excerpt: “California Proposition 65: This product does not contain substances known to the state of California to cause cancer and/or reproductive/developmental effects.”

The above is an example of a warning that would be impacted by the August 2019 EPA action however, any argument that the EPA would not have allowed (preempt) this warning be provided to individuals who were exposed to a Monsanto Product label fails as the EPA did in fact allow this warning prior to August 2019.


Page 4 May of 2015

Exerpt: Carcinogenicity / Chronic Health Effects: Prolonged overexposure to glyphosate may cause effects to the liver. EPA has given glyphosate a Group E classification (evidence of non-carcinogenicity in humans). Canada PMRA has classified glyphosate as non-carcinogenic. In 2015 IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals. Imazapyr did not cause cancer in laboratory animals. EPA has classified imazapyr as a Group E (evidence of non-carcinogenicity for humans) carcinogen.

Comment: Again, the warning that “In 2015 IARC classified glyphosate as a probable human carcinogen Group 2A based on limited human evidence and some evidence in animals” is an absolutely true statement and therefore cannot be considered false and misleading. Had the IARC not made such statement, including this language in the warning label would be false and misleading, but this is not the case.

Monsanto is likely to continue to press the relevance and importance of the August 2019 EPA Statements by attempting to conflate the doctrine(s) of Field Preemption with the Doctrine of Express Preemption under “impossibility preemption” theories. These attempts should fail in that Congress having empowered the EPA to preempt (foreclose on) States from passing laws imposing additional labeling requirements (beyond those imposed by the EPA) does not equate to Congress having Expressly Preempting Plaintiffs from arguing that a given defendants could have (it was possible) sought approval to add different, stronger, better or more adequate warnings than those the defendant actually sought to have approved by the agency.


Field occurs when Congress, without expressly declaring that state laws are preempted, nevertheless legislates in a way that is so comprehensive as to occupy the entire field of an issue.

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. Through the passage of FIFRA Congress did expressly declare that no State could impose labeling requirements in addition to those imposed under FIFRA. California’s right to impose additional labeling requirements (beyond those imposed by the EPA, is arguably foreclosed on under FIFRA.

Notwithstanding the foregoing, and as expressed by SCOTUS in the seminal case of Wyeth v. Levine, 555 US 555 – Supreme Court 2009, the maker of a Federally Regulated (as to warning labels) always remains the “master of their label”. Plaintiffs remain free to argue that the manufacturer should have submitted a label to the EPA for approval which contained a different (stronger or better) warning than that contained in the label the manufacturer submitted for approval and that their failure to do so renders the warnings provided on the label which was submitted for approval inadequate under State Law. https://www.scotusblog.com/case-files/cases/wyeth-v-levine/

The only exception to the jurisprudence found in Wyeth v. Levine arises when a manufacturer submits a specific label for approval and the EPA (or the FDA) and the agency formally rejects the change sought by the manufacturer. See Merck Sharp & Dohme Corp. v. Albrecht (Fosamax Ruling). We find no argument put forth by Monsanto sounding in “ We requested the label change plaintiffs assert was necessary to “adequately warn” and the EPA rejected our request.” See: Merck Sharp & Dohme Corp. v. Albrecht (Fosamax)


1. California (or others) Plaintiffs in which exposure to RoundUp occurred after August 2019 may not want to cite the language of California Prop 65 (related to Glyphosate) as an example of a more adequate warning.

2. The EPAs action of August 2019, should have no impact on cases in which exposure occurred before August 2019 without regard to California Prop 65 (relevant to the Hardeman case) as the EPA clearly did approve labels with warnings related to California Prop 65 prior to August 2019, including the time period in which Mr. Hardeman was exposed.

The argument that the EPA would not have approved any form of cancer warning prior to 2019 fails for the following reasons:

A. The language of the EPAs August 2019 statement is conclusive of the fact that the EPA would have approved some form of cancer warning prior to August 2019.
B. The EPA did in fact approve labels containing cancer warnings prior to August 2019 on labels submitted for EPA approval, when the manufacturer requested such approvals.

3. Warnings approved by the EPA for other glyphosate products prior to August 2019 which remain factually true, (not false nor misleading) taking into consideration the EPAs August 2019, remain available to plaintiffs to cite as “more adequate” than the warnings provided by Monsanto.


We do not argue that juries should not be allowed to consider any and all Statements made by the EPA. Of course, plaintiffs should also be allowed to conduct discovery to uncover any possible corruption, malfeasance or mistakes relevant to the EPAs statements and conclusions.

We do argue that there is no support under the law for any conclusion that once a Federal Agency makes a statement, expresses an opinion or conclusion, that litigants are foreclosed on entering evidence that contradicts the agency statements, conclusions or opinions under the circumstances relevant to this matter. The concept of “I have thus said, and therefore that which I sayeth is true” is the province and privilege of Kings. American citizens are free to challenge our own government’s lies and misrepresentations. The trier of fact holds the power to determine what is true and what is not.

We do not argue that the FIFRA (via the August 2019 action by the EPA) may not foreclose on the State of California’s right to impose the specific stronger label requirements than imposed by the EPA. We simply argue that the EPA could not (because it was not delegated the authority by congress) issue any Statement that could foreclose on all possible (stronger) warning language a plaintiff might allege would be required to render a label adequate under a given States laws, without the EPA having first having considered and rejected the exact language claimed by Plaintiff as necessary to provide an adequate warning.

We further argue that the two label examples, previously approved by the EPA, remain truthful (in no way false or misleading ) to this day and any plaintiff that puts forth this exact language as that which was needed to render the label adequate would not be arguing that the defendant be required to make a false and misleading statement and therefore the EPA is without the power to intercede on behalf of the defendant claiming that the agencies power to restrict manufacturers from making false and misleading statements extends to restricting statements that are factually true.


How desperate does Monsanto/Bayer have to be to turn to the Trump Administration for help. Then again, both Monsanto and Bayer have a history of being on the wrong side of things.

Bayer stockholders should all be hoping for a Trump re-election. If the U.S. elects a legitimate president later this year, the EPA could easily reverse course shortly thereafter.

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