Bayer AG May End Residential Glyphosate Sales in the U.S.

In May 2021, Bayer AG announced that it may end residential glyphosate sales in the United States. Glyphosate is the active ingredient in the popular weedkiller Roundup. The announcement came the day after U.S. District Judge Vince Chhabria rejected Bayer AG’s $2 billion settlement proposal to cover future claims that Roundup exposure led to victims’ cancer. 

The $2 billion deal intended to cover two groups of Roundup users: those who have been diagnosed with non-Hodgkin’s lymphoma but have not filed a lawsuit yet, and users who have been exposed to Roundup but haven’t developed cancer yet. Regarding the second group, Judge Chhabria said that the deal was “clearly unreasonable” for them because, in order to receive compensation, victims would have to make two major sacrifices: 

First, although victims could opt out of the compensation program and file a lawsuit against Monsanto, the victims give up their right to seek punitive damages against the company. Given the amount of damages awarded in the three previous Roundup trials, that could be a lot of money for victims to give up. Second, the deal calls for a panel of scientists to determine whether Roundup causes cancer and the results could be used by either party. Monsanto likely wants the science panel because it lost the previous three trials and the issue of current expert testimony regarding Roundup causing cancer weighs heavily in the plaintiffs’ favor. 

Judge Chhabria commented: “The deal would substantially diminish the company’s settlement exposure and litigation exposure at the back end, eliminating punitive damages and potentially increasing its chances of winning trials on compensatory damages. It would accomplish far less for Roundup users who have not been diagnosed with NHL- and not nearly as much as attorneys pushing this deal contend.” 

After the federal judge’s ruling, Bayer AG said: “We have legal and commercial options that together will achieve a similar result in mitigating future litigation risk, and we will pursue them as quickly as possible. Significantly, the weight of scientific evidence and the conclusions of all expert regulators worldwide continue to support the safety of glyphosate-based herbicides.”

Roundup Lawsuits Mount

Bayer AG wants to end the years of litigation that have led to approximately 125,000 claims that Roundup has caused non-Hodgkin’s lymphoma. The $9.6 billion settlement announced in June 2020 intends to resolve 96,000 of those claims. 

Three cases have already gone to trial and each has spelled disaster for Bayer AG. In August 2018, a California state court awarded $289 million to school groundskeeper Dewayne Johnson after determining that glyphosate caused his cancer. The jury determined that Monsanto had failed to adequately warn consumers about the risks. In March 2019, a jury in San Francisco federal court awarded Edwin Hardeman, a homeowner who used Roundup on his property, $80 million. In May 2019, a jury awarded more than $2 billion to Alva and Albert Piliod who argued that decades of Roundup usage caused their non-Hodgkin’s lymphoma. Although all three monetary awards were later reduced by judges and Bayer AG has appealed the verdicts, the losses are still staggering for the company.

How GoldenbergLaw Can Help You

If you or a loved one developed non-Hodgkin’s lymphoma after using or being exposed to Roundup, contact the Non-Hodgkin’s Lymphoma Attorneys at GoldenbergLaw. Our team has over 30 years of experience providing the Gold standard of advocacy to our clients. 

Valisure Discovers Benzene in Sunscreens

The online pharmacy and independent testing company Valisure discovered the presence of the human carcinogen N-nitrosodimethylamine (NDMA) in Valsartan and Zantac and recently alerted the FDA to the presence of the human carcinogen benzene in many popular sunscreens.

Valisure’s Citizen Petition

 On May 24, 2021, Valisure filed a Citizen Petition with the U.S. Food and Drug Administration about its findings. As a result of the alarming levels of benzene discovered in a wide variety of sunscreens, including sprays and lotions, Valisure requested that the FDA “issue regulations, request recalls, revise industry guidance, and take other requested actions.”

Valisure tested and detected high levels of benzene in specific batches of sunscreen products containing active pharmaceutical ingredients, including: 

  • Avobenzone
  • Oxybenzone
  • Octisalate
  • Octinoxate
  • Homosalate
  • Octocylene
  • Zinc oxide

The Centers for Disease Control and Prevention (CDC) stated that the Department of Health and Human Services (HHS) determined that benzene can cause cancer in humans. The National Institute for Occupational Safety and Health recommends that workers wear protective equipment if they are going to be exposed to benzene at a concentration of 0.1 ppm because exposure can occur through “inhalation, skin absorption, ingestion, skin and/or eye contact.”

 The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) classified benzene as a Group 1 compound, which means that it is carcinogenic to humans based on sufficient evidence that benzene can cause acute myeloid leukemia (AML). IARC also noted that benzene exposure has been linked to acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin lymphoma. Since benzene is associated with blood cancers such as leukemia, the fact that sunscreen’s ingredients are absorbed through the skin and into the bloodstream is especially concerning. The Citizen Petition stated: “The presence of this known human carcinogen in sunscreen products widely recommended for the prevention of skin cancer and regularly used by adults and children in large volumes makes this finding especially troubling.” 

The FDA also classifies benzene as a Class 1 solvent, stating that it “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity…However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted.” The current benzene restriction is two parts per million (ppm). Although the current benzene restriction is 2 ppm, Valisure’s test results revealed that many sunscreens contained amounts of benzene well in excess of this limit.

Valisure provided the results of its testing in its Citizen Petition and included a list of sunscreens which did not contain detectable levels of benzene, demonstrating that sunscreen can be and is produced without unsafe levels of benzene.

Sunscreens with Benzene

Valisure’s testing detected benzene in the following sunscreens from various retailers: 

Neutrogena ***Benzene detected at 2 ppm or higher 

  • Ultra Sheer Weightless Sunscreen Spray, SPF 100+
  • Ultra Sheer Weightless Sunscreen Spray, SPF 70
  • Beach Defense Oil-Free Body Sunscreen Spray, SPF 100
  • Invisible Daily Defense Body Sunscreen Broad Spectrum, SPF 60+
  • Beach Defense Spray Body Sunscreen, SPF 50
  • CoolDry Sport Water-Resistant Sunscreen Spray, SPF 70
  • CoolDry Sport Water-Resistant Sunscreen Spray, SPF 50
  • Ultra Sheer Body Mist Sunscreen Broad Spectrum, SPF 30 Spray
  • Ultra Sheer Body Mist Sunscreen Broad Spectrum, SPF 45
  • Ultra Sheer Dry-Touch Water Resistant Sunscreen, SPF 70
  • Sheer Zinc Dry-Touch Face Sunscreen, SPF 50 

CVS Health ***Benzene detected at 2 ppm or higher

  • After-Sun Aloe Vera Soothing Spray 
  • Body Mineral Spray Sunscreen, SPF 50
  • Ultra Sheer Broad Spectrum Sunscreen Lotion, SPF 100 
  • Ultra Sheer Lotion Broad Spectrum Sunscreen, SPF 45
  • 70 Beach Guard Sun Sunscreen, SPF 70
  • Sport Clear Spray Sunscreen, SPF 100+
  • Sheer Mist Spray Broad Spectrum Uva/Uvb Cont. Spray Sunscreen, SPF 70

Sun Bum ***Benzene detected at 2 ppm or higher

  • Cool Down Gel 
  • Oxy Free Zinc Oxide Sunscreen Lotion, SPF 50 
  • After Sun Cool Down Aloe Vera Spray 

Fruit of the Earth ***Benzene detected at 2 ppm or higher 

  • Aloe Vera Gel 

Walgreens

  • Sport Lotion Sunscreen, SPF 50
  • Broad Spectrum Sport, SPF 50 Sunscreen 
  • Sunscreen Sport, SPF 50
  • After Sun Gel 

SunBurnt

  • Advanced After-Sun Gel 

Goodsense

  • Sunscreen Lotion, SPF 30

Banana Boat 

  • Kids Max Protect & Play Sunscreen C-Spray, SPF 100 
  • UltraMist Deep Tanning Dry Oil Continuous Clear Spray, SPF 4
  • Ultra Sport Clear Sunscreen Spray, SPF 100
  • Protective Dry Oil Clear Sunscreen Spray with Coconut Oil, SPF 15 
  • Ultra Defense Ultra Mist Clear Sunscreen Spray, SPF 100 
  • Kids Sport Sunscreen Lotion Spray, SPF 50 
  • Simply Protect Kids Sunscreen Spray, SPF 50+ 

Max Block

  • Sunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant, SPF 30
  • Sport Sunscreen Lotion Water Resistant Blue, SPF 30 

Raw Elements

  • Eco Formula Sunscreen Lotion, SPF 30

TopCare Everyday

  • Ultimate Sheer Sunscreen Lotion, SPF 70
  • Ultimate Sheer Sun Lotion Sunscreen, SPF 55
  • Sport Sunscreen Lotion, SPF 70

EltaMD

  • UV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 45

Solimo

  • Sheer Face Sunscreen Lotion, SPF 55

Aveeno

  • Baby Continuous Protection Sensitive Skin Sunscreen Lotion Broad Spectrum, SPF 50

Coppertone

  • Whipped Sunscreen Lotion Spray, SPF 50

Ethical Zinc

  • Natural Clear Zinc Sunscreen SPF 50+

Babyganics

  • Kids Sunscreen Continuous Spray, SPF 50

La Roche Posay 

  • Anthelios Sunscreen Lotion Spray, SPF 60

Equate

  • Kids Broad Spectrum Sunscreen Lotion, SPF 50

Up & Up 

  • Clear Aloe Vera Gel 

Action Requested from the FDA

In their Citizen Petition, Valisure requested multiple actions from the FDA to amend the problem. Valisure requested that the FDA request recalls for the identified batches of sunscreens containing the benzene to protect public safety. In addition to the recalls, Valisure also wants the FDA to–at minimum–substantially lower the limit of 2 ppm of benzene because benzene should not be used at any point in manufacturing sunscreen. However, Valisure thinks that the FDA should go even further and revise the  rule to say that benzene “should not be employed in the manufacture of drug substances.” This would make it clear there is no acceptable level of benzene in consumer products such as sunscreen and after-sun care products. 

Currently, the FDA does not have any guidance on a permissible daily exposure for benzene in any drug product (including sunscreen) or cosmetic product (after-sun care products). Valisure urgently requests the FDA mandates a constant permissible daily intake or exposure limit due to the variability in product sizes and exposures per day that are common with an individual’s application of sunscreen and after-sun care products. This would guide users on the amount of sunscreen to use per application and how many daily applications are safe. 

Valisure requested that the FDA create rules or issue administrative orders requiring “independent batch-level testing and verification of sunscreen products” that are regulated as drugs by the FDA and/or revise the FDA’s proposed sunscreen rule in the Federal Register. In the meantime, Valisure urged the FDA to issue formal guidance recommending testing and verification to “serve public health and help protect Americans from adulterated drug products, an issue of growing concern.”

How GoldenbergLaw Can Help You

If you or a loved one have been harmed by a defective product, you need a legal team with the knowledge, experience, and compassion to help you get justice! Our team at GoldenbergLaw has been providing the Gold standard of advocacy for more than 30 years. Contact us today for a free consultation.

9th Circuit Court Upholds $25 Million Roundup Verdict

The U.S. 9th Circuit Court of Appeals upheld the first Roundup multidistrict litigation bellwether trial’s $25 million verdict and asserted that the failure-to-warn claims are not blocked by federal law.

Edwin Hardeman’s Roundup Case

In 2019, a jury awarded cancer victim Edwin Hardeman $5.3 million in compensation for his illness and $80 million in punitive damages against Monsanto due to their failure to warn about the dangers of glyphosate exposure to punish the company and deter future misconduct. 

A judge later reduced the punitive damages awarded to $25 million. 

Mr. Hardeman, 70 years old, developed non-Hodgkin’s lymphoma after regular use of Roundup on his Sonoma County property from the 1980s through 2012. The jury determined that Roundup substantially caused his cancer. 

Mr. Hardeman’s counsel, Leslie Brueckner of Public Justice, commented on the 9th Circuit’s ruling: “The Ninth Circuit decision squarely rejects Monsanto’s argument that these claims are wiped out by federal law and the decision holds that the jury’s verdict that Roundup causes non-Hodgkin’s lymphoma is supported by substantial evidence. This decision wipes Monsanto’s defense off the table.”

The Legal Rationale

The 9th Circuit determined that Edwin Hardeman’s California state failure-to-warn claims are not preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) since the laws’ requirements are mutually consistent. 

Under FIFRA, a pesticide label has to have a warning “adequate to protect health and environment” in order to avoid being labeled misbranded in violation of the law.” California’s common law requires that manufacturers warn about known risks or risks that a “reasonably prudent” manufacturer would know about. 

The panel stated that, “Because FIFRA’s misbranding requirements parallel those of California’s common law duty, Hardeman’s failure-to-warn claims effectively enforce FIFRA’s requirement against misbranding and thus are not expressly preempted.” 

The three-judge panel rejected Monsanto’s defense that because the U.S. Environmental Protection Agency (EPA) approved Roundup’s label without a cancer warning, failure-to-warn claims are preempted by federal law. Monsanto had previously argued that the 2019 letter sent by the EPA asserting that a warning label for cancer after exposure to glyphosate products (the active ingredient in Roundup) would render the product ‘misbranded.’ The 9th Circuit responded that the letter does not carry the force of law because the EPA did not follow the correct administrative procedures. 

The panel ruled that the EPA’s approval of a label does not automatically mean that the label is compliant with the FIFRA: “If mere EPA approval of a label were determinative of FIFRA compliance, then FIFRA’s misbranding provision and regulations imposing a duty to report additional factual information regarding unreasonable adverse effects would serve no purpose.” 

The panel also upheld the jury’s determination that Monsanto failed to warn users about the dangers of glyphosate exposure through Roundup. 9th Circuit Judge Ryan D. Nelson said, “Evidence of Monsanto’s conduct– downplaying concerns and failing to fully assess Roundup’s safety after being alerted to possible risks– supports that Monsanto acted with ‘indifference to or a reckless disregard of the health or safety of others.’” The panel also cited “various independent scientific studies linking glyphosate and cancer” that were released in 2012 and internal emails from Monsanto’s toxicologists indicating that the company was aware of the potential health risks of glyphosate exposure.

Bayer AG’s Response

Bayer AG’s spokesperson expressed the company’s displeasure with the verdict: “We are disappointed with the Court’s decision as the verdict in this case is not supported by the evidence at trial or the law. In particular, we believe the 9th Circuit decision is wrong on the issue of federal preemption as it is not possible for Monsanto to comply with federal law under which EPA has determined that a cancer warning is unwarranted and improper, and also comply with state law failure-to-warn claims seeking the very cancer warning EPA forbids. The company will pursue all legal options, including petitioning the U.S. Supreme Court to review this case.”

What does the 9th Circuit’s Ruling Mean?

This is the second appellate loss for Bayer AG over Roundup. It comes after the California appeals court upheld the $21 million jury verdict in 2020 in favor of school groundskeeper Dewayne Johnson. The ruling could spell disaster for Bayer in the Roundup MDL containing tens of thousands of cases. 

Last year, Bayer agreed to spend more than $12 billion to resolve legal claims that Roundup had caused non-Hodgkin’s lymphoma. Bayer also announced a separate $2 billion settlement to resolve future claims.

How GoldenbergLaw Can Help You

If you or a loved one was diagnosed with non-Hodgkin’s lymphoma after exposure to Roundup, contact our team at GoldenbergLaw today. We have more than 30 years of experience holding companies responsible for defective products. Leave the sleepless nights to us while we provide you with the Gold standard of advocacy.