Monsanto Sues California Environmental Agency to Block “Probably Carcinogenic” Designation for Roundup

Agribusiness giant Monsanto Corporation has sued California’s Office of Environmental Health Hazard Assessment (OEHHA) to block the agency from adding glyphosate—the main ingredient in its herbicide Roundup—to the list of chemicals known to cause cancer.

The list of carcinogenic chemicals is authorized under California’s Proposition 65, a 1986 law to keep chemicals that cause cancer, birth defects, or reproductive harm out of the state’s drinking-water supply, Law360 reports. Monsanto said the listing was “virtually automatic” after International Agency for Research on Cancer (IARC) of the World Health Organization classified glyphosate as probably carcinogenic. Under Prop. 65, a business must post a warning when its operations or products will expose people to any of the chemicals on the list.  

Monsanto claims it was denied due process, that “OEHHA effectively elevated the determination of an ad hoc committee of an unelected, foreign body, which answers to no United States official (let alone any California state official), over the conclusions of its own scientific experts.” Phil Miller, Monsanto’s vice president for regulatory affairs, said OEHHA’s proposed listing is “contrary to science.” He said IARC’s designation is “erroneous, non-transparent and based on selectively interpreted data,” according to Law360.

Monsanto claims that the portion of the California Labor Code that cites IARC findings as a basis for Prop. 65 inclusion violates the California and U.S. constitutions. Monsanto told the court that during the 40 years Roundup has been in use, regulators and scientists who have not found an associated cancer risk. The OEHHA itself was one of the evaluators. The agency concluded in1997 and again in 2007 that glyphosate is not likely to pose a significant cancer risk to humans, Law360 reports.

Roundup is widely used commercially on crops such as corn and soybeans and also widely used use by landscapers and home gardeners. The Environmental Protection Agency (EPA) says that in 2007 farmers in the U.S. used about 185 million pounds of glyphosate, double the amount used six years earlier.

In 2015, the IARC deemed glyphosate “probably carcinogenic to humans,” the New York Times reported. The agency based its determination on studies of glyphosate exposure in the United States, Canada, and Sweden since 2001. “Probably carcinogenic” is more difficult to refute than the lesser designation “possibly carcinogenic.”

Glyphosate has been linked to the cancers leukemia (multiple myeloma, myeloma), and lymphoma (non-Hodgkin’s, Hodgkin’s), and also to Parkinson’s disease. In addition, glyphosate is associated with health problems including respiratory distress, impaired consciousness, pulmonary edema, arrhythmias, and renal failure, according to a study published in Toxicology Review in 2004. People exposed to glyphosate have also experienced blurred vision, coma, confusion, dizziness, hand tremors, headaches, insomnia, loss of appetite, stomach cramps, diarrhea, and loss of coordination.

After the IARC designated glyphosate a probable human carcinogen, France’s ecology minister, Segolene Royal, banned the sale of Roundup at garden centers. In a town in Argentina’s Entre Rios province, residents are demanding action on the high cancer death rates. They say that nearly half the deaths there in recent years have been cancer deaths. The national cancer death rate is 18 percent. Residents say the heavy use of Roundup on rice and soybean crops is responsible for the high cancer death rate.

Lawsuits filed against Monsanto allege Roundup caused the cancers of a Hawaiian farmer and a California field worker. Both suits mention the IARC probable carcinogen classification in support of the claims. Monsanto is seeking to have both cases dismissed, Law360 reports.

 

 

 

 

from Parker Waichman http://www.yourlawyer.com/blog/monsanto-sues-california-environmental-agency-to-block-probably-carcinogenic-designation-for-roundup/

Class Action Lawsuits Filed over Blistering, Bleeding, and Rashes from EOS Lip Balm

In January 2016, four proposed class action lawsuits have been filed over claims that EOS Lip Balm use leads to cracking, bleeding, and blistering lips.

San Francisco dermatologist Marie Jhin said the rashes could be contact dermatitis caused by a reaction to vitamin E, according to Your Health Magazine. Beeswax, an ingredient in the EOS lip balms, is an allergen, The Inquisitr notes. People sensitive to beeswax need to know if beeswax is in the cosmetics they use. The Inquisitr says EOS (Evolution of Smooth) does not fully disclosure the ingredients on EOS Lip Balm labels.

One of the women who filed a lawsuit alleges her lips felt like “sandpaper” within hours of using the EOS Lip Balm. When she applied more lip balm, her lips began to crack, flake, bleed, and blister, and she developed a rash. Her symptoms lasted for 10 days. The lawsuit seeks damages and corrective advertising indicating EOS Lip Balm may cause mild to severe rashes, dryness, bleeding, blistering, cracking, and loss of lip pigmentation that may last from a few days to a few months, or may potentially be permanent. A California plaintiff alleges violation of the Consumers Legal Remedies Act. A New York woman accuses EOS of false advertising and negligent product design, according to the firm representing the woman. One lawsuit was brought by a mother who bought EOS Lip Balm for her teenage daughter as an “age-appropriate” alternative to lipstick. Her daughter developed rashes and blisters from the lip balm.

Celebrity promoters of EOS Lip Balm include Kim Kardashian, Miley Cyrus, Ann Kendrick, Britney Spears, and Katie Perry. The EOS flavors involved in the lawsuits are Blackberry Nectar, Coconut Milk, Strawberry Sorbet, Blueberry Acai, Pomegranate Raspberry, Summer Fruit, Sweet Mint, Honeysuckle Honeydew, Lemon Drop, and Medicated Tangerine.

EOS posted this statement on social media: “Some of you may have seen reports of a lawsuit filed against our company. We wanted to be sure that you, our valued customers and fans, know that the health and wellbeing of our customers is our top priority. Our products are safe to use, are made with the highest quality ingredients and they all meet or exceed all safety and quality standards set out by our industry. An independent laboratory puts each of our products through a battery of rigorous testing to ensure this is the case. For these reasons, we firmly believe this lawsuit is without merit, and we will continue to create new and exciting products that delight our customers.”

The lawsuits allege violations of unfair business laws in different states. One case alleges that EOS breached express and implied warranties, committed consumer fraud, unjustly gained from the sales. Two of the lawsuits claim EOS failed to warn about skin reactions on the product itself or in the advertising material, and failed to commission a study on the adverse effects of its proprietary formula.

 

from Parker Waichman http://www.yourlawyer.com/blog/class-action-lawsuits-filed-over-blistering-bleeding-and-rashes-from-eos-lip-balm/

Class 1 Recall for Brainlab Cranial Image-Guided Surgery System Because of Navigation Inaccuracy

The Brainlab Cranial IGS (Image Guided Surgery) System has been recalled because inaccuracies in the navigation system display could lead to inaccurate medical procedures. This could result in life-threatening injuries or death.

Brainlab Cranial IGS System shows the surgeon the area being operated on and the position of an instrument relative to the patient’s anatomy to enable minimally invasive surgical procedures. The imaging system guides the surgeon through the procedure, helping to keep skull openings small and minimize damage to healthy brain structures, the company says.

The recall includes about 1021 units distributed nationwide from May 1996 to May 2015. All existing versions of the cranial navigation system before Cranial 3.0 are included in the recall. The Food and Drug Administration (FDA) has categorized this as a Class I recall, the most serious recall class. Use of the Brainlab Cranial IGS System may cause serious injury or death.

Brainlab notified customers of the display problem on April 22, 2013 and issued an update on May 29, 2015. The recall notice was updated again on January 15, 2016. Brainlab notified customers of the problem and said customers should adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the recalled IGS devices.

Brainlab will provide customers with an updated software version and schedule the update installation starting in September 2015.

Customers can direct questions to the Brainlab Customer Hotline at 1-800-597-5911 or they can send email to support@Brainlab.com.

 

from Parker Waichman http://www.yourlawyer.com/blog/class-1-recall-for-brainlab-cranial-image-guided-surgery-system-because-of-navigation-inaccuracy/

Kidney Problems Related to Heartburn Drugs

Medicines used in the treatment of heartburn, such as Prevacid, Nexium and Prilosec have been reviewed for potential ties to increased risks for kidney disease.

These drugs, in the drug class known as proton pump inhibitors (PPIs) reduce the production of acid by blocking the enzyme in the stomach wall that produces acid. Acid reduction helps to prevent ulcers in the esophagus, stomach, or duodenum. If stomach juice backs up into the esophagus, it would be less irritating and would allow for healing in the event of an ulcer, The New York Times wrote.

Studies in the use of PPIs, especially in long-term use, have linked PPIs to increases in bone fracture; pneumonia, and Clostridium difficile, a serious type of infection. For over 13 years, researches followed 10,482 people comparing those who used PPIs to those who took a non-PPI drug in the class known as H2 receptor antagonists, such as Zantac and Pepcid. The research appears in the American Medical Association’s (AMA) journal, JAMA Internal Medicine.

The study concluded that use of PPIs was associated with a 20 to 50 percent increased risk of developing chronic kidney disease. Use of the mostly over-the-counter (OTC) non-PPI medication was not associated with this risk. A kidney specialist at Johns Hopkins noted that patients using PPIs for a longer period of time, should be routinely monitored for their kidney function, according to The New York Times.

from Parker Waichman http://www.yourlawyer.com/blog/kidney-problems-related-to-heartburn-drugs/

Widely Used Herbicide Roundup Linked to Leukemia, Lymphoma, and Parkinson’s

Monsanto’s Roundup, one of the world’s most widely used herbicides, is linked to health risks, including cancers, Parkinson’s disease, and respiratory issues.

Roundup had been in use for decades in commercial farming, home gardens, and landscaping applications. The weed killer is crucial in the production of genetically engineered corn and soybeans, the New York Times reports.

Roundup’s main ingredient—glyphosate—has been associated with serious health issues such as respiratory distress, impaired consciousness, pulmonary edema, arrhythmias, and renal failure, according to a 2004 study published in Toxicology Review. Exposure to the toxic effects of Roundup has been seen in agricultural workers, nursery workers, landscape workers, and people who work at farm stands.

In 2015, the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) classified glyphosate as “probably carcinogenic to humans,” according to the Times. IARC’s determination was based on studies of glyphosate exposure in the United States, Canada, and Sweden since 2001. The report said that glyphosate had been found in food, water, and air following Roundup spraying. The IARC recommended that the Environmental Protection Agency (EPA) examine the dangers of glyphosate, but the EPA says it does not have the resources to do the testing.

The EPA reports about that 185 million pounds of glyphosate were used by farmers in the U.S. in 2007, which is double the amount used only six years earlier. And as weeds have developed greater resistance to Roundup, farmers have used more of the herbicide to counteract the resistance.

Glyphosate has been linked to:

• Leukemia: multiple myeloma, myeloma
• Lymphoma: non-Hodgkin’s, Hodgkin’s
• Parkinson’s disease.

People exposed to glyphosate may also suffer other significant heath problems:

• blurred vision with excessive tearing
• coma
• confusion
• dizziness
• fatigue
• hand tremors
• headaches
• insomnia
• loss of appetite associated with nausea, stomach cramps, diarrhea
• loss of coordination
• weakness
• weight loss

In 2011, Parkinsonism Related Disorders published a report of a case of a 44-year-old woman diagnosed with Parkinson’s symptoms after three years of glyphosate exposure in a chemical factory job. In 2014 Rodale Wellness reported a large increase in non-Hodgkin’s lymphoma cases in the last 30 years, and that year the International Journal of Environmental Research and Public Health published a review 44 scientific papers showing the effects of 80 active ingredients in 21 chemical classes on farm workers. According to IARC, exposure to glyphosate doubled the risk of developing non-Hodgkin’s lymphoma.

France banned Roundup in 2015 after glyphosate was classified as a probable carcinogen. Ecology minister Segolene Royal declared that “France must be on the offensive with regards to the banning of pesticides,” according to The Independent.

In May 2015, residents of a town in the Argentine province Entre Rios demanded an investigation into the town’s high cancer death rates. Nearly half the deaths in the town in recent years were caused by cancer, though the national average for cancer deaths is 18 percent. Residents point to the heavy use of weed killers on rice and soybean fields. Entre Ríos has increased production of rice and soybeans, with a corresponding increase in the use of pesticides and herbicides. The chemicals sprayed on fields are dangerous both to the workers doing the spraying and to nearby residents, who are exposed to drifting spray. There are also reports that discarded pesticide canisters have contaminated ground water in some neighborhoods, leading to residents’ glyphosate exposure.

 

from Parker Waichman http://www.yourlawyer.com/blog/widely-used-herbicide-roundup-linked-to-leukemia-lymphoma-and-parkinsons/

Senate Report Says FDA, Scope Makers Failed to Warn about Superbug Risk

A Senate report says that medical device makers, the U.S. Food and Drug Administration (FDA) and hospitals all share blame in the outbreak of several superbug infections linked to contaminated duodenoscopes. The devices, which are used to treat and diagnose disorders in the pancreas and bile duct, have been under scrutiny in light of the outbreaks, which took place over a three year period. The U.S. Food and Drug Administration (FDA) warned last year that the devices could spread antibiotic-resistant bacteria, even when cleaned according to manufacturer’s instructions. The agency said the complex design of the scopes may prevent them from being sterilized effectively.

Device maker Olympus controls most of the market for duodenoscopes in the United States. Duodenoscopes are also manufactured by Pentax and Fujifilm. In January 2015, Sen. Patty Murray’s office launched an investigation into the scopes. The Senate report stemming from that investigation revealed that Olympus knew its scopes could spread bacteria after cleaning as early as 2012. However, the report states, the company did not notify hospitals, patients or the FDA.

The report also criticizes the FDA for its delayed action. The agency learned of the scope-linked infections in 2013, but took an additional 17 months to warn the public. In the time it took the FDA to issue a safety alert, 68 patients in seven hospitals across the US were infected with antibiotic-resistant bacteria following procedures with a duodenoscope. “The failure of FDA’s device surveillance system to rapidly identify and respond to duodenoscope-related superbug and antibiotic-resistant infections serves as just one example of the fallacy of a system that is primarily reliant on hospitals and device manufacturers to self-report information to FDA,” the report states.

According to the report, hospitals also failed to take the necessary steps to prevent further superbug infections. The scopes were linked to infections at 16 different hospitals, but they failed to notify the FDA. The report states that at least 250 people became ill from 25 different superbug infections between 2012 and the spring of 2015.

The report found Olympus did not alert the FDA about the risk of spreading infection. The company learned of two independent lab reports showing bacteria could still be alive after cleaning in early 2013, but did not inform the FDA until February 2015. Additionally, the report says that Olympus, Pentax and Fujifilm all failed many regulatory requirements. “The duodenoscope manufacturers and Custom Ultrasonics failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues,” Sen. Murray wrote, according to Law360. “This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world.”

from Parker Waichman http://www.yourlawyer.com/blog/senate-report-says-fda-scope-makers-failed-to-warn-about-superbug-risk/

False Data Allegedly Reported Concerning Essure Birth Control System

A Yale study has reported that pregnancy was four times more likely in women treated with the Essure birth control system than more traditional laparoscopic tubal ligation.

The U.S. Food and Drug Administration (FDA) approved the Essure birth control system in 2002. Bayer now markets Essure, which was originally developed by Conceptus. Bayer disputes allegations that the product is unsafe.

Meanwhile, several women have died from complications associated with the device; non-fatal adverse events include metal toxicity, headaches, fatigue, and lifelong autoimmune problems.

According to a report from NBC News, several women involved in a clinical trial in 2000, indicated that their records were altered. One woman, after obtaining records related to the device in 2013, said her records were obviously altered. She was also quoted as saying that, when she reported pain, the information was crossed out in the records. Another woman reported that when she cited “sharp pain,” the researchers reported her comfort level as “excellent.” In other cases, patients reported being coached by researchers on how to describe their adverse reactions. There were also reports of women between the ages of 20 and 30 who were implanted with the Essure system who had to undergo total hysterectomies.

The FDA has cited Conceptus for multiple problems in 483 documents, including failure to disclose adverse events. There were a minimum of 41 reports of perforation, mostly of the uterus and fallopian tubes. The dates related to the tests were from July 12, 2012 to December 10, 201. There were 508 incidents of perforation as of January 6, 2010.

The FDA reported that an announcement concerning Essure will be made by the end of February.

from Parker Waichman http://www.yourlawyer.com/blog/false-data-allegedly-reported-concerning-essure-birth-control-system/