Tuesday, May 14, 2019

Agribusiness giant to appeal cancer decisions

Oakland jury hits Monsanto with a $2 billion verdict because Roundup weedkiller caused lymphoma

Although an Oakland jury awarded a couple more than $2 billion this week in their suit claiming a Monsanto weedkiller caused their cancer, the verdict is expected to be severely trimmed.

The large punitive damages, in the third consecutive trial that ruled against Bayer AG's glyphosate-based Roundup since August, "is likely to be reduced due to U.S. Supreme Court rulings that limit the ratio of punitive to compensatory damages to 9:1," according to a story by Tina Bellon of Reuters.
Alberta and Alva Pilliod. Photo courtesy
Baum, Hedlund, Aristei & Goldman

The jury in this case awarded only $55 million in compensatory damages to Alva and Alberta Pilliod, both of whom had contracted non-Hodgkin's lymphoma after using the weedkiller between 1975 and 2011.

Each were awarded $1 billion in punitive damages. 

The Reuters story reports that Alva was awarded $18 million in compensatory damages by the state court jury in Alameda, California; Alberta, his wife, $37 million — because Roundup purportedly was "defectively designed, that the company failed to warn of the herbicide's cancer risk and that the company acted negligently"

Bayer, which faces more than 13,400 U.S. lawsuits over Roundup's alleged cancer risk, had acquired the agribusiness giant Monsanto for $63 billion last year. An appeal is planned.

The Reuters story notes that Alberta Pilliod "called on Bayer to add a warning label to Roundup, saying she and her husband would not have used the product had it alerted them to a chance of risk. 'We've been fighting cancer for more than nine years now and we can't do any of the things we wanted to do. We really resent Monsanto for that,' Pilliod said."

The two prior San Francisco jury verdicts against Monsanto triggered steep declines in shares of Bayer; this decision is likely to cause a further dip. The earlier litigation wiped out some $33 billion from Bayer's market value.

The next suit to be adjudicated will be in Missouri state court in August, the first time a jury outside of California will hear a Roundup case. The trial will take place in St. Louis County, where Monsanto’s former headquarters are located. 

Lawsuits against the company so far have been based on the 2015 conclusion by the World Health Organization's cancer arm that classified glyphosate as "probably carcinogen to humans."

More information on verdicts in cases against manufacturers can be found in "Rollercoaster: How a man can survive his partner's breast cancer,"4 a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Thursday, May 9, 2019

Feds ignore complaints, fears of many women

FDA declines to ban breast implant that's linked to cancer but intends to increase information about risks

The FDA has decided not to ban a type of breast implant linked to a rare cancer — at least for now.

According to a story by Laurie McKinley in last week's editions of The Washington Post, the decision, which came a month after a dramatic hearing in which many women expressed fears, complained about the implants and called on the Food and Drug Administration to execute such a ban, the agency plans instead to "increase efforts to collect and disseminate information about risks involving the device."

A joint statement by Amy Abernethy, FDA principal deputy commissioner, and Jeff Shuren, director of the agency's Center for Devices and Radiological Health, maintains that the FDA doesn't believe the textured implant "meets the legal standard for being banned at this time, based on available data and information."

Other countries have either banned or restricted sales of similar products "because of concerns about what's called breast implant-associated anapestic large cell lymphoma, or BIA-ALCL," McKinley's story contends.

The FDA also notes that "while textured implants make up as much as 80 percent of the market share in some other countries, they represent only 10 percent or less of the implants sold in this country," the Post article continues.

Federal officials also say they don't have "definitive evidence" demonstrating that the implants cause  "'breast implant illness,' a constellation of auto-immune problems that includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing." But they do add, according to McKinley's piece, that evidence supports "that some women experience systemic symptoms that may resolve when their breast implants are removed."

Diana Zukerman, PhD
That admission has led Diana Zukerman, a PhD and president of the National Center for Health Research, to claim it's "the closest the FDA has come to acknowledging breast implant illness," which, she insists, is "definitely progress."

Historically, the agency tends to be reluctant to ban devices — having done so only twice, with powdered surgeons' gloves and prosthetic hair fibers.

The FDA has, however, "said it is considering requiring implants to carry what's called a boxed warning — the agency's strongest safety warning. And it may require doctors and patients to sign checklists of risks to make sure women have the necessary information to make an informed decision."

McKinley's story states that "bout 400,000 women a year get implants in the United States — 75 percent for cosmetic reasons and most of the rest for breast reconstruction about cancer surgery."

For more information on implants and reconstruction, check out "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Monday, April 29, 2019

Benzene found to cause lymphoma, leukemia

Jury awards $21.4 million in two cancer deaths against oil company that merged with Chevron 

A San Francisco Bay Area jury has awarded $21.4 million in the cancer deaths of two brothers who'd handled a deadly chemical.

The Contra Costa County Superior Court found Union Oil responsible for the deaths of Gary and Randy Eaves, who'd worked in a Texarkana, Arkansas, tire-manufacturing plant. 

Union Oil made the rubber solvent containing benzene, which the brothers were exposed to during their longtime employment.

Gary was diagnosed with non-Hodgkin's lymphoma in 2013 at age 59, and Randy was diagnosed with acute myelogenous leukemia in 2016, also at age 59.

The trial lasted more than four weeks; jury deliberation's took three days.
Attorney Mary Alexander
According to a statement by a San Francisco lawyer for the families of the brothers, Mary Alexander, "This oil company has been held accountable for their negligence in putting profits before people. This tremendous verdict will help ensure protection consumers as it sends a message that any company that fails to warn about toxic chemicals in the products they sell, such as benzene which causes cancer, will be held responsible."

The plaintiffs had alleged that the company knew the solvents contained benzene and "knew, or should have known, that exposure to it was extremely hazardous and cancer-causing," Alexander wrote.

The trial, according to a recent story by Lauren Hernandez in the San Francisco Chronicle, "was held in Contra Costa County because Chevron — which merged with Unocal, formerly known as Union Oil — headquartered in San Ramon," which is located in that county.

According to the lawyer, Hernandez's article notes, "the chemical sprayed onto [the brothers'] unprotected skin while handling the solvent…and Union Oil never told the plant or its workers to wear respirators or protective clothing, and never advised workers to handle the chemical inside of a ventilation booth."

In addition, Alexander was quoted as saying, "They did not ship the solvent with material safety data sheets or any other data that reflected the solvent contained benzene that cause cancer."

Chevron, the story says, "provide a one-sentence statement to The Chronicle in response to the decision, stating, 'We do not believe the Unocal had any role in the claimed injuries and we are evaluating the jury's decision and the court's rulings in this matter."

The newspaper's story said that Eaves families, who live in Arkansas, stayed in the Bay Area throughout the trial.

It also reported that Alexander "said Union Oil representatives are responsible for paying the $21.4 million bill as the primary defendant in the case, despite it technically not existing anymore."

Chevron paid Union Oil's trial costs, she said.

Details of other corporations being responsible for disease-related deaths can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Monday, April 15, 2019

Medicare coverage of costly drug being debated

Will Trump administration drop the restrictions on new type of blood cancer treatment? Stay tuned!

Will insurance companies be able to block expanded Medicare coverage of cancer care?

The answer is a positive maybe.

According to a story last week by by Robert Pear in The New York Times, insurers are pushing to keep existing restrictions against an expensive new type of treatment, CAR-T cell therapy. 

"Cancer patients, doctors and drug companies are urging the Trump administration to remove the restrictions," the story says.

The restrictions are intended to hold down costs of the treatment, which Pear explains "is manufactured specifically for each patient." 

Many more "such 'personalized medicines' are in the pipeline," he adds.

Medicare's final decision is expected in the next few weeks. 

According to the Times, the federal "Food and Drug Administration has approved two CAR-T products to treat certain blood cancers: Kymriah, made by Novartis, with a list price of $375,000 or $475,000, depending on the type of cancer, and Yescarta, made by Gilead Sciences, with a list price of $373,000."

Although CAR-T treatments "generate high costs up front…the benefits could last for years," Pear contends.

The treatments, he notes, "have been remarkably effective in some patients who had a dismal prognosis after exhausting other options."

Dr. Francis S. Collins
Pear's story quotes Dr. Francis S. Collins, director of the Centers for Medicare and Medicaid Services, as saying that "harnessing the power of a patient's immune system in this way was a 'marvel of modern medicine."

And Pear attributes to Kirsten A. Sloan, vice president of the American Cancer Society Cancer Action Network, the notion of favoring people having access to the treatment and letting "the doctor decide which patients should be eligible."

In CAR-T therapy, immune- or T-cells are removed from a patient's blood, sent to a lab to be "genetically engineered  to recognize and attack cancer cells, and then sent back to the hospital for infusion into the patient."

The problem is the over-all cost: The infusion, doctors' fees and hospital stays can add up to $750,000 or more.

A statement from one of the nation's largest insurers, UnitedHealth Group, expresses concern that CAR-T therapies could create significant financial risks for both the government and private Medicare Advantage plans.

More information about controversies over new treatments or drugs can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

Monday, April 8, 2019

FDA charged with not protecting patients

Women challenge risks of breast cancer implants at FDA meeting, but no changes are expected

Women linked to breast implants challenged plastic surgeons, regulators and implant-makers last week but apparently came away disappointed because no U.S. changes are in the offing.

Other countries, however, have taken steps to halt sales of the implants.

According to The New York Times, as cited in the Kaiser Health News Morning Briefing online, the women attended "an emotionally charged" federal Food and Drug Administration advisory panel meeting and called for a ban on at implants associated with a rare form of lymphoma.

In addition, they "asked implant-makers to disclose the materials used in the devices and also called for a 'black box' warning — a label that the FDA can require, noting heightened problems with a drug or device."

The Washington Post noted, as reported on KHN, that they told "searing stories about broken health, disrupted families and lost careers," and said they wanted the panel "to recommend more long-term research, bans or restrictions on certain products…and a beefed-up informed consent process so that women have a clear understanding of theorists and benefits of the devices before they opt for surgery."

Jamee Cook
Jamee Cook, a Texas paramedic who leads a group called Breast Implant Victim Advocacy, said "experienced chronic fatigue, numbness and migraines — symptoms that were resolved" when she had the implants removed, a story in The Wall Street Journal reported, according to KHN.

She charged that the FDA has not fulfilled its responsibility to protect patients."

The Journal also noted that nearly "three decades after the FDA first pulled silicone [gel] breast implants of the U.S. market [because of fear they might cause breast cancer or lupus] and then allowed some back on, women continue to report debilitating conditions to the agency. The FDA is revisiting the issue again this year and is grappling with efforts to study which issues are proven and which not proven."

By quoting the Associated Press, the KHN summary then showed what results evolved — and what didn't — from the meetings. It said that government medical advisers claimed "it's too soon" for any ban because "more information is needed to understand the problem."

The FDA panel, a day after reviewing the research presented, recommended no immediate restrictions on breast implants.

The bans imposed by other countries, however, came within days of the FDA's rejection of the idea of sales limitations.

In the United States, some 400,000 women get implants each year, 100,000 of them after cancer surgery.

According to a story by Marie McCullough last week in The Philadelphia Inquirer, health authorities in Canada and the Netherlands — "just days after France became the first country to ban sales of numerous brands of textured and polyurethane-coated implants" — announced plans to suspend sales.

That article notes that "since the first report of implant lymphoma in 1997, almost 700 cases and 17 deaths have been tallied worldwide, including 270 cases and nine deaths in the United States, according to the latest count from the American Society of Plastic Surgeons."

More data about implants, and reconstruction, can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Friday, March 29, 2019

Agribusiness 'negligent' about herbicide risks

Monsanto loses second consecutive case that finds Roundup causes cancer, this time for $80 million 

A federal jury in San Francisco slapped an $80 million judgment against Monsanto this week for causing a Sonoma man's cancer through Roundup.

The six-person jury deliberated only one day. 

Its verdict, that Monsanto had been "negligent by not using reasonable care" to warn of the risks of the herbicide, was unanimous. 

Edwin Hardeman
The award against Monsanto, now owned by Bayer AG, which intends to appeal, included $75 million in punitive damages, $5 million in compensation and $200,000 for medical expenses for 70-year-old Edwin Hardeman, a retiree who'd contracted non-Hodgkin's lymphoma, a blood cancer, after more than two decades of using Roundup to kill weeds on his 56-acre property.

According to an online story by Amanda Bronstad in law.com's The Record, Hardeman's attorneys, Aimee Wagstaff and Jennifer Moore, issued a statement after the verdict asserting that "it is clear from Monsanto's actions that it does not care whether Roundup causes cancer, focusing instead on manipulating public opinion and undermining anyone who raises genuine and legitimate concerns about Roundup."

The lawyers noted that "it speaks volumes that not one Monsanto employee, past or present, came live to trial to defend Roundup's safety or Monsanto's actions," the article continues.

Bayer, through a statement, claimed that "over four decades of extensive science and the conclusions of regulators worldwide…support the safety of our glyphosate-band herbicides," which the company continues to insist "are not carcinogenic."

The World Health Organization's cancer arm, however, has certified that glyphosate is "probably carcinogenic to humans."

The federal verdict, which may be as bellwether for 800 other lawsuits against Monsanto, follows a case in a San Francisco Superior Court in which jurors awarded $289 million, which was cut to $78 million by the judge.

Another case against the agribusiness was scheduled to start today in Alameda County Superior Court. Plaintiffs are Alva and Alberta Pilliod, both of whom contracted non-Hodgkin's lymphoma after decades of using Roundup.

Information on other verdicts against major corporations can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Thursday, March 21, 2019

2nd major ruling against Monsanto weedkiller

Unanimous U.S. court verdict labels Roundup as major factor in Sonoma man's non-Hodgkin's lymphoma 

In what might be a bellwether case, a six-person federal jury in San Francisco unanimously found this week that Roundup, Monsanto's weedkiller, was a substantial factor in a Santa Rosa man's cancer.

Or at least one active chemical ingredient in it — glyphosate — was.

The case could affect hundreds of others: Monsanto faces 9,000 similar lawsuits in the United States alone.

According to a story by Sam T. Levin in The Guardian, the 70-year-old plaintiff, Edwin Hardeman, said he'd used the herbicide for nearly three decades, had at least once gotten it on his skin, and "alleged that his exposure to [it] caused him to develop non-Hodgkin's lymphoma [NHL], cancer that affects the immune system."

In a second phase, the jury still must weigh liability and damage.

Hardeman, who was diagnosed with non-Hodgkin's lymphoma in 2015, has used Roundup to control weeds and poison ivy on his properties since the '80s.

A BuzzFeed News story notes that "Jennifer Moore, an attorney for the Sonoma County man, said Hardeman used Roundup regularly, spraying approximately 6,000 gallons of the herbicide over the course of 26 years."

The so-called bellwether trial, which means the verdict could possibly affect future litigation, followed a California state court verdict last August that Roundup caused the terminal cancer of Dewayne Johnson, a former school groundskeeper.

That jury, Levin's piece asserts, "said Monsanto failed to warn Johnson of Roundup's health hazards and 'acted with malice or oppression.'"

It awarded Johnson $289 million in damages, although that was later slashed to $78 million.

Monsanto, predictably, has appealed.

The Guardian story notes, however, that "Hardeman's trial has been more limited in scope. While Johnson's attorneys argued that Monsanto had 'bullied' scientists and fought to suppress negative studies about its product, the federal judge barred Hardeman's lawyers  from discussing Monsanto's alleged influence on research and regulations during the hearings."

Judge Vince Chhabria
Judge Vince Chhabria did, on the other hand, verbally flog the company on a procedural order during the trial by saying, "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."

Despite the latest verdict, Monsanto, which has been bought by Bayer for $63 billion, continues "to argue that Roundup is safe to use and does not cause NHL."

The Hardeman trial is in effect a test case for almost 800 others nationwide that were consolidated. At least six more trials, according to MarketWatch, are expected to start this year in federal and state courts.

Details on other court cases about products that cause disease can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.

Sunday, March 10, 2019

Stop sugary drinks and lessen your risks 46%

Yale study finds daily diet soda might lower risk of colon cancer recurrence — and death

Drinking diet soda every day can be particularly beneficial for those who've beaten colon cancer.

A new study by Yale University researchers, according to a story by Nyssa Kruse of The Hartford Courant a while ago, found that patients who drank it "were less likely to see a recurrence and less likely to die than those who didn't drink diet soda."

The study analyzed 1,018 patients, determining that "those who drank one or more 12-ounce artificially sweetened drink a day saw a 46 percent improvement in risk."
Dr. Charles S. Fuchs
Kruse's story quotes Dr. Charles S. Fuchs, director of the Yale Cancer Center, as calling the findings "exciting" — after noting that "artificially sweetened drinks have a checkered reputation in the public because of purported health risks that have never really been documented." 

The researchers attributed half the benefit of diet drinks "to patients substituting diet sodas for drinks full of sugar," the Times story indicated.

In a separate cancer study, unrelated to soda, Yale researchers found cancer patients who used complementary treatments (such as yoga, acupuncture and homeopathy) alongside traditional treatments such as chemotherapy "were more likely to die than those only using traditional treatments" — because they'd be likely to refuse a component of traditional treatment.

Details on other cancer research can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book that I, Woody Weingarten, aimed at male caregivers.