HIV Drug Lawsuits filed over Tenofovir

Gilead’s TDF Drugs cause Serious Side Effects

Men claim HIV drug caused bone and kidney problems. Lawyers have also filed a related class action lawsuit against Gilead.

(May 15, 2019) Two California men living with HIV filed a personal injury lawsuit last May against Gilead Sciences. The men claim Gilead intentionally delayed the development of a safer version of the HIV medicine called tenofovir. Tenofovir disoproxil fumarate (TDF) – the original form of the drug – is sold under the brand name Viread. It is found in Truvada, Atripla, Stribild, and Complera.

Gilead HIV Drug Kidney & Bone Injuries

The LA Times reported that the lawsuit also claims Gilead hid the risks of the less-safe version of tenofovir while letting people with HIV take the more dangerous medicine which harmed their kidneys and bones.

Related: Truvada Lawsuit

AIDS Healthcare Foundation (AHF), which operates HIV clinics around the world, is funding the two men’s lawsuits. An AHF press release read: “[A] class action lawsuit against Gilead by two other Californians living with HIV who suffered bone and kidney damage from taking TDF was filed on behalf of all persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.”

AHF also filed a previous lawsuit against Gilead over tenofovir. A judge who heard a similar case in 2016 ruled that Gilead did not illegally manipulate the patent system, but an appeal is pending.

What is Tenofovir?

The FDA approved Gilead’s TDF as an HIV med in 2001. The FDA approved TAF in 2015 as part of Gilead’s single-tablet combo pill Genvoya. Since then, TAF has been included in other HIV single-tablet regimens, such as Biktarvy and Descovy

At issue, says the lawsuit, is that Gilead had already begun research on an improved version called tenofovir alafemanide fumarate (TAF).  Gilead wrongly withheld that research and delayed the release of TAF. According to the Times, the lawsuit claims, “[B]y holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in 20 years.”

The Times reports that both men named in the lawsuit took the older tenofovir and developed related health issues. Michael Lujano of Los Angeles County took TDF from 2004 to 2015. He  developed osteopenia and osteoporosis of the spine, neck and hip. Jonathan C. Gary of San Diego County took TDF for 10 years starting in 2001. In 2010, he was diagnosed with the rare kidney disorder Fanconi syndrome, and last year was also diagnosed with osteopenia and osteoporosis.

“A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the ‘Miracle Drug’ and using other deceptive marketing strategies,” Mr. Lujano said in the AHF press release. “Gilead shelved a far safer drug, TAF, simply to increase its long-term profits. I’m bringing this lawsuit to try to hold Gilead responsible for their reckless focus on profits over patient safety.”

Rebuttal?

In related news, one recent analysis found that the updated version of tenofovir may not offer any more safety benefits than the first version. Please see the POZ feature: “Is Gilead’s Entire HIV Enterprise Built on a False Promise?

HIV Drug Lawsuits filed over Tenofovir

Plaintiffs’ attorneys are filing lawsuits for people with HIV who took one or more of Gilead’s tenofovir disoproxil fumarate (TDF) drugs –Truvada, Viread, Atripla, Complera, and Stribild –and then allegedly suffered kidney disease and/or bone density loss.

Nearly 20,000 people with HIV were allegedly diagnosed with kidney disease after taking TDF-based antiretroviral drugs. Studies have also shown TDF drugs may increase the risk of bone fractures. Nearly 6,000 bone breaks are alleged to be linked to the drug compound.

What Gilead Knew and When

Gilead allegedly knew that TDF could cause serious side effects as early as 2001. In 2002, the company allegedly tested a new formula – tenofovir alafenamide fumarate (TAF), later marketed as Genvoya and Odefsey – that achieves the therapeutic effect of TDF but uses a safer, lower dose. Plaintiffs believe the new formula isn’t linked to the same risk of kidney and bone injuries as the earlier version. Lawsuits are being considered for those who took Gilead’s Tenofovir drugs and then developed problems that include:

Kidney Injuries

  • Chronic kidney disease (CKD) or declining kidney function
  • Acute kidney injury (AKI) or acute renal failure (ARF)
  • Fanconi syndrome
  • Tubular dysfunction

Bone Injuries

  • Osteopenia
  • Osteoporosis
  • Bone fractures

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Monsanto loses $2B Verdict in Third Roundup Trial

Married Couple both have Lymphoma

(May 13, 2019) Monsanto lost the third Roundup trial in dramatic fashion today when a California jury found that the company’s Roundup likely caused a married couple to both develop a similar cancer. The jury awarded the two $2.055 billion in damages. It was Monsanto’s third straight loss in three trials. Some 13,400 Roundup cancer lawsuits are still pending against Monsanto. All the cases allege that Roundup causes cancer.

The jury of five women and seven men deliberated for nearly two days before finding that Roundup was a significant contributing factor in causing Alva and Alberta Pilliod to develop a type of non-Hodgkin lymphoma. The jury awarded the pair $55 million in non-economic and economic damages, then hit Monsanto with $1 billion in punitive damages for each person.

Punitive Damages

In ordering punitive damages, the jury had to find that Monsanto “engaged in conduct with malice, oppression or fraud committed by one or more officers, directors or managing agents of Monsanto” acting on behalf of Monsanto.  The total of $2.055 billion doubled what the plaintiffs’ attorney suggested in his closing arguments.

During the five-week trial, the Pilliods’ claimed that decades of spraying Roundup on their four properties gave them both diffuse large B-cell lymphoma.  Alva Pilliod was diagnosed with DLBCL in 2011. His wife Alberta was diagnosed in 2015 with a type of DLBCL called primary central nervous system lymphoma.

The jury heard testimony from competing oncologists, pathologists and toxicologists from each side. Different experts gave different opinions over Roundup’s skin absorption rates and the science regarding claims that Roundup causes cancer.

The Pilliods’ experts pointed to animal studies, mechanistic data and epidemiological data that showed glyphosate is genotoxic, or DNA damaging. They offered evidence that Roundup causes oxidative stress which can cause cancer mutations. They also cited the International Agency for Research on Cancer’s 2015 finding that glyphosate is a probable carcinogen.

Glyphosate vs. Roundup
The Pilliods’ expert toxicologist, Dr. William Sawyer, testified that Monsanto made glyphosate 50 times more toxic by selling its Roundup formula with polyethoxylated tallow amine – or POEA –a surfactant banned in Europe. Dr. Sawyer explained that the surfactants allow glyphosate to easily penetrate the skin, just as they are designed to penetrate plants.

Dr. Sawyer said the body stores POEA under the skin for days and delivers glyphosate doses to the bones, where lymphoma starts. He also accused Monsanto of manipulating its absorption studies by heating and then freezing skin samples before testing them, a process which leads to skewed results.

US EPA used Fraudulent Data
Other experts called by the Pilliods testified that the U.S EPA approved Roundup in the 1970s using fraudulent studies. Industrial Bio-Test Laboratories, which was convicted of fraud, performed the studies later proved to be fraudulent, but EPA allowed the ruse to continue anyway. They said Monsanto kept selling Roundup even after the fraud was exposed, and refused for decades to conduct certain studies of its own Roundup formula, despite requests from the EPA and its own toxicologist.

The Pilliods’ counsel also argued in closing that Monsanto spent decades suppressing science linking its products to cancer by ghostwriting academic articles and feeding the EPA “bad science.”  He asked the jury to “punish” Monsanto with a $1 billion punitive damages award.

Carey Gilliam of U.S. Right To Know reported that the trial showed:

* Monsanto never conducted epidemiology studies for Roundup and its other formulations made with glyphosate to evaluate users’ cancer risks.

* Monsanto was aware surfactants in Roundup were much more toxic than glyphosate alone.

* Monsanto spent millions of dollars on covert public relations campaigns to finance ghostwritten studies and articles aimed at discrediting independent scientists whose work found dangers with Monsanto’s herbicides.

* When the US Agency for Toxic Substances and Disease Registry sought to evaluate glyphosate toxicity in 2015, Monsanto engaged the assistance of EPA officials to delay that review.

* Monsanto enjoyed a close relationship with certain EPA officials who repeatedly backed Monsanto’s assertions about glyphosate’s alleged safety.

* Monsanto’s worker safety recommendations called for wearing a load of protective gear when using glyphosate but did not warn the public to do the same.

Monsanto Rebuttal

Monsanto’s experts argued that the epidemiological data put forward by the decades-long Agricultural Health Study shows that glyphosate doesn’t pose a cancer risk. Monsanto lawyers argued that several regulatory agencies around the world, including the US EPA, Health Canada, and the Australian government have repeatedly concluded Roundup doesn’t pose a cancer risk. They also noted that the rate of non-Hodgkin lymphoma has plateaued over the past two decades, while Roundup use has increased. They argued that if the plaintiffs’ side were correct in alleging that Roundup caused the Pilliods’ cancer, NHL rates should coincide with the rise in Roundup’s ubiquitous blanketing of the earth.

Monsanto loses $2B Verdict in Third Roundup Trial

The California jury found Monsanto liable for failure to warn claims, design defect claims, negligence claims, and negligent failure to warn claims. They awarded the Pilliods’ $52 million in non-economic damages and $3.2 million in economic damages, along with a combined $2 billion in punitive damages.

The Pilliods’ trial began March 28, one day after a separate California federal jury ordered Monsanto to pay a California man $80 million after it agreed that Roundup exposure caused him to develop NHL. The first Roundup cancer trial concluded in August 2018 when a San Francisco jury in state court awarded a former school groundskeeper $289 million verdict that was later reduced – over the jury’s repeated objections – to $78 million. Monsanto has also appealed that reduced award.

The case is Pilliod v. Monsanto Co., case number RG17862702, in the Superior Court of the State of California, County of Alameda.

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Third Roundup Case Jury told to punish Monsanto with $1B Verdict

(May 9, 2019)  The thirdB Verdict"> jury to hear a Roundup case this year was told by the plaintiffs’ attorney yesterday to punish Monsanto with a $1 billion verdict.  In the five-week-long trial which wrapped yesterday after closing arguments, an attorney for Alva and Alberta Pilliod told the jury that Monsanto needed to be punished for misleading the couple and the world about the dangers of Roundup. Both Alva and Alberta Pilliod developed non-Hodgkin’s lymphoma after decades of using Monsanto’s Roundup. Their attorney said Roundup caused them to develop NHL; Monsanto’s attorneys argued that it had not.

The Pilliods’ attorney told the jury they should find that Monsanto failed to warn his clients of Roundup’s cancer risks, and award them $1 billion in punitive damages and $55 million in combined economic and noneconomic damages. He said that if the Pilliods had known Roundup could cause cancer, they would have never touched it.  He argued that the jury needs to send Monsanto a message.

The Pilliods’ case is the third to go to trial out of 13,400 lawsuits pending that allege Roundup causes cancer. Their trial began March 28, a day after a separate California federal jury handed down an $80 million verdict against Monsanto in favor of Ed Hardeman.

The first trial concluded in August 2019 when a state jury in San Francisco awarded former school groundskeeper DeWayne “Lee” Johnson a $289 million verdict against Monsanto.  A state judge later slashed the verdict to $78 million, despite multiple pleas from the jurors to leave their full award in place.  Monsanto has also appealed that entire verdict

On May 8, closing arguments in the Pilliods’ trial drew a crowd of people into the small state courtroom, including DeWayne Johnson, Bobby Kennedy, Jr., Oliver Stone, and a juror from Mr. Johnson’s trial.

Roundup Born in Fraud
In the Pilliods’ closing argument, their attorney Brent Wisner described decades of Monsanto executives’ attempts to cover up or suppress science that linked Roundup to cancer. He said the weedkiller was “born in fraud,” because the U.S. EPA approved it in 1974 based on fraudulent studies conducted by Industrial Bio-Test Laboratories.  The EPA discovered the lab’s fraudulent work in 1976, but Monsanto was nevertheless allowed to keep Roundup on the market. Monsanto also repeatedly refused to conduct certain cancer studies in the 1980s and 1990s even after the EPA and its own toxicologist told Monsanto it needed to conduct those tests.

Monsanto spent years, meanwhile, trying to manipulate the scientific literature by ghostwriting academic articles while also feeding the EPA those same articles and others based on “bad science,” according to Mr. Wisner.

The Pilliods’ attorney said Monsanto executives also adopted a corporate strategy to combat the finding of the International Agency for Research on Cancer on Roundup’s active ingredient, glyphosate. The IARC concluded that glyphosate is a probable carcinogen in 2015, and Mr. Wisner reminded the jury that they had seen evidence of how Monsanto was moving to discredit the IARC even before the scientists had issued their finding.

US EPA captured by Industry
Mr. Wisner said Monsanto’s “bad science” included the fraudulent Industrial Bio-Test studies as well as the ghostwritten studies that “permeate” scientific literature today. He said the EPA is still citing those studies in its findings because the government has been captured by the industry. He also argued that Monsanto continued to sell Roundup with polyethoxylated tallow amine (POEA), a surfactant that makes glyphosate 50 times more toxic than glyphosate alone and is banned in Europe.

Roundup/Glyphosate and Lymphoma
Meanwhile, said Mr. Wisner, Monsanto refused to conduct cancer tests on Roundup and ignored studies showing it is easily absorbed through the skin, stored, then transported to the bones where lymphoma develops.

Mr. Wisner also argued that not one of Monsanto’s experts in this trial was an expert on chemicals that cause cancer.  He said they focused only on epidemiological data, and ignored animal studies and mechanistic data showing Roundup’s cancer links.

Monsanto Rebuttal – A Lawyer’s Charade

Monsanto’s attorney said during closing that the Pilliods shouldn’t be awarded anything. He said Mr. Wisner had performed a “charade” in a “rehearsed routine” in front of the jury with the plaintiffs’ toxicologist Dr. William Sawyer. He said Dr. Sawyer is a seasoned expert who has testified in 300 cases.  The Monsanto attorney said that during Dr. Sawyer’s testimony, Mr. Wisner and Dr. Sawyer planned an exchange in which the expert warned the lawyer to wear gloves when he picked up an open Roundup bottle, even though they both knew it contained only water. Monsanto’s attorney said the stunt was meant to mislead the jury about Roundup’s danger. He said the men disrespected the jury’s intelligence and the justice system.

Monsanto’s attorney also argued that Mr. Wisner and the Pilliods’ experts gave “wildly misleading” Roundup exposure estimates throughout the trial. He said Roundup doses given mice in cancer studies were 2 million times more Roundup than what the Pilliods had been exposed to.

In reality, argued Monsanto’s attorney, the couple both had years of health issues and a lengthy smoking history that together weakened their immune systems and put them at a higher risk of developing non-Hodgkin lymphoma. He noted that Alva Pilliod had 22 instances of skin cancer since the 1970s, five brain infections from the herpes virus, and genital warts. He said Alberta Pilliod had Hoshimoto’s disease and bladder cancer.

Monsanto’s lawyer argued that Roundup is safe to use. He said multiple regulatory agencies around the world, including Health Canada, the U.S. EPA and the Australian government have repeatedly concluded that Roundup doesn’t pose a cancer risk. He said the Pilliods are asking the jury to “throw out” 40 years of EPA findings.

The Monsanto attorney also said the Pilliods’ case doesn’t meet the heightened burden of proof to warrant a punitive damages award. He admitted that some of the language in Monsanto’s internal emails “probably” didn’t use the right phrases, but said the Pilliods’ attorneys were “cherry-picking” phrases from hundreds of Monsanto’s internal emails to make the company look bad.  He also defended the ghostwritten scientific articles by saying they don’t address the issues at hand.

Mr. Wisner attempted to counter the Monsanto accusations that he had played a charade with Sawyer to manipulate the jury, but the judge stopped him, saying, “knock it off.”

After the Pilliods’ closings, Monsanto’s counsel asked the court to declare a mistrial, arguing that Wisner had made multiple arguments that were off-limits. But Alameda Superior Judge Winifred Smith denied the motion and refused Monsanto’s request to give a curative jury instruction.

The jury began its deliberations this morning.

Third Roundup Case Jury told to punish Monsanto with $1B Verdict
The case is Pilliod v. Monsanto Co., case number RG17862702, in the Superior Court of the State of California, County of Alameda.

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Uloric Gout Drug Lawsuits

Uloric Cardiovascular Injuries – Heart Attacks & Strokes

Gout drug lawsuits are being filed over Uloric, a medication designed to help treat chronic gout. A Uloric gout drug lawsuit alleges the maker of Uloric failed to warn users of the increased risk of heart attacks and strokes. Our law firm is representing people who have suffered cardiovascular issues while taking – or after taking – Uloric for at least 30 days.

Uloric Drug Lawsuits

Uloric (Febuxostat) is a xanthine oxidase inhibitor prescribed for the management of chronic hyperuricemia (excess uric acid) in adult patients suffering from gout. Takeda Pharmaceuticals brought Uloric to the market after it received FDA approval in February 2009.

When the FDA approved Uloric in 2009, the agency required a warning label to include the information that it raised risk of cardiovascular events. The FDA also required Takeda to perform a mandatory post-marketing cardiovascular safety study.

The 6,000-patient safety trial saw its results published in the New England Journal of Medicine on March 12, 2018. The study’s authors found a statistically significant increased risk of cardiovascular death for users of Uloric compared with users of allopurinol.

Gout Symptoms & Causes

Gout is a form of arthritis characterized by sudden, severe attacks of pain, swelling, redness, tenderness in the joints. Pain and swelling often manifest in the  in the feet and toes.  The pain and swelling are caused by elevated uric acid levels in the bloodstream.

Patients with hyperuricemia and gout already face an elevated risk of cardiovascular events.  The cause is not entirely understood, but may be linked to chronic inflammation associated with the underlying disease process. Most gout patients also suffer from various comorbidities which are also associated with an increased risk for cardiovascular events.

Gout is a disease state for which only a few medical therapies are available. Allopurinol has long been the standard of treatment. Brought to market first by Casper Pharma LLC in 1966, allopurinol has an established safety profile and has been available in generic form since at least September 1984.

Uloric Indications

Uloric is indicated only for those patients with severe renal dysfunction or those who cannot tolerate allopurinol. By comparison, allopurinol is at least as efficacious as Uloric, if not moreso, and it costs far less.

Uloric Lawsuit Compensation

For those who have experienced a heart attack or stroke while taking Uloric, we pursue damages for several losses. They include:

  1. Past and future medical and funeral expenses resulting from injuries.
  2. Past and future pain and suffering for injuries, treatment and recovery processes.
  3. Past and future wage loss, and loss of estate.
  4. Past and future loss of earning capacity.
  5. Past and future loss of enjoyment of life.
  6. Punitive damages, if applicable and warranted.

FDA Science regarding Uloric

On November 15, 2017, the FDA issued a Drug Safety Communication to the public:

“[P]reliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol” and noted it would be conducting a comprehensive review of Uloric’s safety.

The FDA held a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on January 11, 2019, during which the safety of Uloric was discussed. While the committee agreed that biological plausibility for cardiovascular death was unclear, they “agreed that there is a consistent signal of cardiovascular death associated with febuxostat”.

Most committee members agreed Uloric should no longer be designated as a first-line therapy for gout. Most agreed Uloric should be reserved for patients who cannot tolerate allopurinol or who found allopurinol ineffective. Most members also noted Uloric should not be used in the general gout population or in patients with a history of cardiovascular events or those at high risk for cardiovascular events.

Uloric Boxed Warning

The FDA issued a second Drug Safety Communication re: Uloric on February 21, 2019. The agency announced there was an increased risk of death associated with Uloric when compared with allopurinol. Consequently, the FDA required the addition of a boxed warning for cardiovascular death. It also required a Limitation of Use, which reserved treatment only for those patients with symptomatic hyperuricemia.

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FDA won’t Ban Implants Linked to Cancer

(May 2, 2019)   The U.S. FDA said yesterday that it won’t ban a certain textured breast implant linked to a type of cancer.  The agency has, however, strengthened warnings on textured breast implants.

Related: Breast Implant Lymphoma Warning

The FDA announcement followed a March 2019 safety hearing over breast implants linked with breast implant-associated anaplastic large cell lymphoma.  BIA-ALCL is specifically associated with textured breast implants. The FDA said that based on all currently available data, it doesn’t believe these breast implants meet the legal standard to require their banning under the Food, Drug and Cosmetic Act.

Some other countries, however, have banned or restricted sales of some textured breast implants due to BIA-ALCL concerns. According to FDA, implants sold in those markets aren’t sold in the United States.

By comparison, some 80% of breast implants sold outside the U.S. are textured, according to FDA, compared to less than 10% of breast implants in the U.S..  In addition, the type of textured implants banned or limited by foreign regulators represents less than 5% of domestic breast implants.

Cancer, Chronic Fatigue, Joint & Muscle Pain
The FDA vowed it will take steps to improve information about the risks of breast implants and BIA-ALCL with textured implants.  The agency also said it will investigate reports of chronic fatigue and joint and muscle pain symptoms some women report from textured breast implants.

Breast Implant Illness
Some women have told the FDA they are concerned about how their immune systems react to their implants.  Some women have experienced a variety of symptoms sometimes called “breast implant illness,” said the agency. The FDA, however, said it doesn’t have definitive evidence that implants cause these symptoms, though current evidence supports the notion that these symptoms may be resolved with the implants’ removal.

The FDA said it will explore ways to include product information on the implants’ labels that patients can understand.

Lymphoma Testing, Boxed Warning, Report Filings
The FDA announced, “We also plan to work with the pathology community to educate pathologists about testing for this lymphoma specific to breast implants.”  The agency further said it will work with stakeholder groups on any labeling changes, including a possible boxed warning. The agency also said it is changing how breast implant makers file medical device reports. They will now file individual reports with the FDA instead of “alternative summary reporting.”

The FDA said, “This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks.”

The “alternative summary reporting” program, said the FDA, was established in 1997 to review adverse events for well-established risks, but not patient deaths or unusual adverse events. In  the case of breast implants, that includes BIA-ALCL, which means the agency was not getting all of the actual data that it really needs to oversee the safety of these implants.

According to the FDA, these individual reports will now be available in the agency’s public database for medical device reports.  In addition, the FDA said it will be making past reports public in the coming weeks.

FDA won’t ban Implants linked to Cancer

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the FDA said.

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Several states may ban pesticide linked to lower IQ, ADHD

(May 2, 2019) Several states are trying to ban a pesticide – chlorpyrifos – that some US EPA executives are fighting to keep on the market, despite the fact that the EPA’s own scientists have called for its banning. Kaiser Health News reported last week that lawmakers in several states are trying to ban a widely used pesticide that the Environmental Protection Agency inexplicably supports.

Chlorpyrifos

A  pesticide derived from nerve gas used in WWI, chlorpyrifos kills insects by attacking their nervous systems.  It also causes a host of problems for human beings, especially young children, pregnant women, people working in fields or living in areas sprayed with the poison, or anyone eating the pesticide-contaminated fruits and vegetables. Many, if not most, non-organic fruits and vegetables are sprayed with this poison.

Kaiser Health News reported last week that several studies have linked prenatal exposure of chlorpyrifos to lower birth weights, lower IQs, ADHD, and other developmental problems, including autism spectrum disorder. Nevertheless, in 2017, top EPA officials closely aligned with pesticide industry lobbyists ignored the conclusions of the EPA’s own scientists. The compromised EPA officials rejected a proposal made during the Obama administration to ban chlorpyrifos in fields and orchards.

States Move where EPA Fails

Consequently, some states have been forced to take matters into their own hands. Hawaii was the first to act, banning chlorpyrifos last year.  California, Oregon, New York, and Connecticut are now trying to do the same thing.

If California, the country’s largest agricultural state, is successful at banning the poison, many other states could follow suit, according to Virginia Ruiz, director of occupational and environmental health at the Washington, D.C.-based nonprofit organization, Farmworker Justice.

In light of the EPA’s inaction on the matter, which has continued for at least a decade, Congressional Democrats introduced bills earlier this year to ban chlorpyrifos nationally.  But  given typical beltway acrimony and political prostitution arranged with millions of dollars in lobbying money from pesticide makers, states may have a much better chance at succeeding than Congress.

Presidential candidate Sen. Kirsten Gillibrand (D-N.Y) introduced a separate bill last week that would prohibit schools from serving fruits and vegetables sprayed with chlorpyrifos.

Three Dozen Studies show Chlorpyrifos Dangers

“I don’t see this as something we should still be debating,” said Irva Hertz-Picciotto, an epidemiologist and director of the Environmental Health Sciences Center at the University of California-Davis. Ms. Hertz-Picciotto testified during a California Senate Health Committee hearing April 10 on California’s bill to ban chlorpyrifos. She said more than three dozen studies have demonstrated a connection between prenatal exposure of chlorpyrifos and developmental disabilities, including symptoms of autism.

“No study has identified a level at which we can consider it safe,” she told lawmakers. And therein lies the EPA problem with breaking its own rules, which state that it cannot green light a pesticide which has not been shown to be safe.  With chlorpyrifos, the opposite applies.

In 2000, the EPA, which is charged with regulating pesticides at the federal level, ordered chlorpyrifos for residential use off the market. But the poison is still used liberally on many crops that include citrus fruits, grapes, and almonds. It’s also sprayed on golf courses and in other non-agricultural settings.

In 2015 under the Obama administration, the EPA proposed a complete ban of chlorpyrifos, citing evidence of health risks.  But in 2017, President Trump’s EPA administrator, the disgraced industry apologist and partner Scott Pruitt, refused to ban it.

“Despite several years of study, the science addressing neurodevelopmental effects remains unresolved,” the EPA says on its website. The agency did not return requests for comment. But the EPA rules are clear that this pesticide should be pulled entirely, that it should have been pulled 20 years ago when the agency banned it for home use.

US Court Orders Chlorpyrifos Off Market

Last summer, the 9th U.S. Circuit Court of Appeals ordered chlorpyrifos completely off the market, but the EPA is now fighting that decision.

EPA Averse to its own Science & Scientists?

“The EPA is contradicting the findings of its own scientists,” declared Aseem Prakash, the director of the Center for Environmental Politics at the University of Washington. Mr. Prakash accused the EPA of serving the interests of the chemical industry over people’s health.

“It’s bizarre,” he said. “We have the research.”

Lorsban, Dursban from Dow AgroSciences

Several companies make chlorpyrifos products. The most recognized brand names in the US are Dursban and Lorsban, made by Corteva Agriscience, formerly known as Dow AgroSciences.

Pesticide Makers Respond

Industry “experts” paid by pesticide makers tell a different story. A former Dow Chemical Company employee Carol Burns, who now works as an epidemiologist for Corteva Agriscience, which profits from chlorpyrifos, argued that during the California Senate hearing that many studies link neurodevelopmental problems in children with the chemical compounds known as organophosphates.  However, she said, they don’t link with chlorpyrifos specifically.

Ms. Burns claimed the science is not as clear cut as the EPA scientists and others have said that it is.

“Chlorpyrifos is an organophosphate, but not all organophosphates are chlorpyrifos,” said Ms. Burns.  She added that some of those studies focused on children born in the late 1990s and early 2000s. Since then, children face less exposure to the chemical as a result of increasing restrictions on its use.

Chlorpyrifos, Chlorpyrifos Everywhere

Like Monsanto’s cancerous glyphosate, chlorpyrifos goes everywhere.  It can be inhaled during application.  It can drift into nearby areas.  It can be ingested as residue on food. It can also run off and fields and contaminate drinking water.

Brief exposure can result in dizziness, nausea and headaches, while more acute poisoning can cause vomiting, tremors and loss of coordination, according to the National Pesticide Information Center.

But the most harmful exposure appears to be long-term exposure, even at low levels, for young, developing brains. A 2014 study by Hertz-Picciotto and other UC-Davis researchers found that pregnant women who lived near fields treated with chlorpyrifos, primarily during their second trimester, had an elevated risk of giving birth to a child with autism spectrum disorder.

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Monsanto faces Punitive Damages in Third Roundup Cancer Trial

(April 26, 2019) Monsanto faces punitive damages in the third Roundup cancer trial, unless a California judge in the case changes her mind.  The judge said yesterday that she will likely allow jurors to consider punitive damages if they find that using Monsanto’s Roundup caused both a husband and wife to develop non-Hodgkin’s lymphoma. If this jury does find Roundup caused the couple’s lymphoma, they will be the third jury in three trials to find Roundup causes cancer and that Monsanto knew or should have known it does.

The question of punitive damages would not have arisen at this stage of the trial – which began on March 28 and is not yet complete – except for the fact that Monsanto’s attorneys motioned to have punitive damages excluded from this trial. Monsanto’s attorneys’ aggressive move to make this motion appears to be ill advised. Its end result is to invite this and similar stories to be written, all of which further shed light on Monsanto Propaganda vs. the Truth of Roundup’s Carcinogenicity. It also sheds light on the recent litigation history of Monsanto’s repeated failures to buffet Roundup’s safety profile.

Monsanto Roundup Lawsuit Update:  13,400 Cases

Bayer AG’s CEO on Friday, April 26, said Monsanto faces 13,400 lawsuits over Roundup. He made the announcement to shareholders while defending Bayer’s $63 billion acquisition of Monsanto in 2018.

Monsanto Vile, Despicable, Malicious?

Bayer AG, which acquired Monsanto for $63 billion last year, alleged that no evidence exists to show Monsanto’s conduct was malicious, a prerequisite for punitive damages. A Monsanto attorney called the notion that Monsanto knew of Roundup’s cancer risks in the 1980s “completely speculative.” He also said a defendant’s conduct in such a case must be “vile and despicable.”

Those adjectives do present a pretty high bar (or rather a low one, in this instance) for a judge’s granting of punitive damages.

The Monsanto attorney said, “There is absolutely no evidence that its conduct rises to that level,” he said.

The plaintiffs’ attorney, however, noted that both juries in the previous two Roundup trials awarded punitive damages over claims that Roundup causes cancer and Monsanto knew that it did, yet failed to warn Roundup users.  In this trial, he said there is “considerably more evidence” Monsanto’s conduct was malicious.  In this trial, evidence has come in which includes Monsanto’s ghostwriting of academic articles in scientific journals which misled the scientific community about Roundup’s safety profile.

Judge Winifred Smith

Alameda Superior Judge Winifred Smith said her tentative ruling was to likely deny Monsanto’s motion to strike punitive damages.  She did say, however, that she would read all the briefs before deciding.

The arguments over punitive damages came during a hearing on jury instructions, the verdict form, and the Monsanto motion to strike punitive damages.

Husband and Wife both have cancer

Plaintiffs Alva (76) and Alberta Pilliod (74) brought the Roundup lawsuit after they were both exposed to decades of spraying Roundup on their four properties.  They both now suffer from aggressive non-Hodgkin’s lymphoma cancer. The Pilliods rested their case-in-chief on April 23. Monsanto/Bayer will call their first witnesses Monday.

Monsanto’s lawyer claimed yesterday that the few small studies that suggested Roundup’s active ingredient, glyphosate, might be carcinogenic weren’t published until the 1990s. He argued no other evidence showed glyphosate could cause cancer. He claimed the first real evidence didn’t surface until the International Agency for Research on Cancer (IARC) concluded glyphosate is a probable carcinogen in 2015. He said, therefore, that Monsanto couldn’t have been reasonably expected to warn consumers about Roundup’s potential risks.  He claimed Monsanto didn’t warn people because the company didn’t think it was dangerous and “no one else did.”

Monsanto’s main trial attorney further claimed “the science had not evolved to (reach) the conclusion (Roundup) causes non-Hodgkin lymphoma. At most, it’s a probable carcinogen,” he said.

The plaintiffs’ attorney said, however, that evidence shows Monsanto repeatedly refused to conduct certain cancer studies on Roundup since 1983.  He said Monsanto refused to change its Roundup formula to replace the ingredient polyethoxylated tallow amine, which has been banned in Europe and allegedly makes glyphosate 50 times more toxic.

Monsanto also didn’t warn consumers to take extra safety precautions when using the product, said the plaintiffs’ trial attorney. Instead, Monsanto continued to advertise Roundup with advertising that showed people spraying the product without gloves, while wearing t-shirts and shorts.

Monsanto’s conduct recklessly put people’s lives in danger, said the plaintiffs’ attorney.  That conduct constitutes malice under the law.  He added that there wouldn’t be any lawsuits if the court accepted Bayer’s argument that no one knew about glyphosate’s cancer link in the 1980s. He said what Monsanto knew about glyphosate’s cancer risks and when are being revealed through litigation.  He compared the process to the Tobacco cancer litigation in the 1990s.

Besides the punitive damages arguments, the parties also argued over whether the jury should be instructed using the “but for” causation standard — meaning, a harm would not have happened if not for a party’s actions — or the less-demanding “concurrent causation” standard that can hold more than one party liable for causing a disease.

Monsanto’s counsel claimed the court should use the but-for standard, because the Pilliods’ experts refused to concede that there could have been other contributing factors that caused the Pilliods’ cancer. However, the Pilliods’ lawyer argued that the tougher standard wasn’t warranted and that the other trials used the concurrent causation standard.

Judge Smith said she would examine the case law before deciding the issue. She also said the verdict form should ask the jury to make separate findings for Alva and Alberta Pilliod.

“I think it’s important that [the jury] understand these are two separate cases being decided together,” she said.

11,200 Roundup Lawsuits
The Pilliod trial is the third case to go to trial out of approximately 11,200 lawsuits pending that allege Roundup causes cancer.

1. The first trial against Monsanto over Roundup’s links to cancer was held last summer in state court in San Francisco. That jury reached a $289 million verdict against Monsanto, including $250 million in punitives. A total later cut to $78 million. Bayer filed its opening brief appealing that judgment in state appeals court April 23.

2. The second Roundup cancer trial was Ed Hardeman v. Monsanto. It ended last month in federal court with an $80 million verdict which included $75 million in punitive damages. Bayer, of course, said it would appeal the verdict. 

More of Bayer/Monsanto’s Dirty Pool

The Pilliod’s attorney told the judge yesterday that Bayer/Monsanto released the names and contact information of the jurors in the first Monsanto Roundup trial.  He asked the judge to prohibit Monsanto from releasing the names and contact information of the jury in this case. The Monsanto attorney told the judge Monsanto wouldn’t release the names of the jurors in this case.

The case is Pilliod v. Monsanto Co., case number RG17862702, in the Superior Court of the State of California, County of Alameda.

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* Monsanto Lawsuit Lawyer | Attorney

* Monsanto loses $80 Million Verdict

* Monsanto loses $289 Million Verdict

* California Winephosate

* Monsanto earns Monsatan Moniker

* Monsanto faces Punitive Damages in Third Roundup Cancer Trial

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J & J settles 3 More Talc-Mesothelioma Lawsuits

(April 25, 2019) Johnson & Johnson settled three more talcum powder-mesothelioma lawsuits this week.  All three cases were in the midst of trials brought by women who claimed they were exposed to asbestos while using J&J’s Baby Powder products. Their lawsuit petitions said that exposure led to their developing mesothelioma. Though Johnson agreed to pay the women’s suits, a company spokesman claims they were a “one-off” (though they seem more like a “three-off”) and still denies there was ever asbestos in J&J talcum powder.

The settlements come as New Jersey-based giant Johnson & Johnson faces thousands of talcum powder mesothelioma lawsuits filed by plaintiffs who claim to have developed mesothelioma or ovarian cancer from the products.

The three latest settlements:

  • Plaintiff Sharon Pipes reached a settlement as her Oklahoma jury had begun deliberating after a two-and-a-half-week trial.
  • Plaintiff, Gail Koretoff reached a settlement agreement after jurors had deliberated for two days on her case.
  • Plaintiff Jenny Shulman reached a settlement as her case was scheduled to begin trial this month. She was diagnosed with peritoneal mesothelioma after using J&J’s talcum powder for feminine hygiene. An expert witness was set to testify about finding talc and asbestos in her ovarian and fallopian tissue. Peritoneal Mesothelioma

Peritoneal Mesothelioma

All three plaintiffs had developed peritoneal mesothelioma and claimed to have used J&J’s talc powder products for long periods of time, mostly for feminine hygiene.

Johnson officials have denied rumors that J&J is shifting its talc powder litigation strategy. The company told Bloomberg News that these settlements were “one-off situations.”

J&J maintains its talcum powder products do not contain asbestos. Several juries have nevertheless found J&J responsible for some plaintiffs’ ovarian cancer and mesothelioma.

More than 20 talcum powder trials are scheduled this year in the U.S. Virtually all of the cases involve plaintiffs with a mesothelioma diagnosis.

In December 2018, J&J and Imerys SA, the company’s talc supplier, came to a $1.5-million settlement in a similar mesothelioma case. Imerys later declared bankruptcy which the company said was brought on by all the talc cancer litigation in the country.

Related

•  Talc Mesothelioma Verdict $29 Million against J&J

•  Talcum-Mesothelioma Cancer Lawsuit

•  Imerys seeks Bankruptcy over Talc Lawsuits

•  J & J settles 3 More Talc-Mesothelioma Lawsuits

 

 

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NYC Leaders Move to ban Roundup

(April 22, 2019) NYC leaders have moved to ban Roundup (with glyphosate) in city parks.  Two councilmen are working to stop the city park system from using the carcinogenic weed killer which raises the risk of non-Hodgkins lymphoma. They’ve introduced legislation that would ban city agencies from spraying glyphosate-based weed killers and other pesticides in parks and other public spaces.

Environmental Health News reports that the NYC council action is the latest in a series that shows a growing concern over pesticide use, particularly the products made by Monsanto. It is another indication of a groundswell of people, homeowners, educators, farmers, business leaders and others who are rejecting Monsanto – and now Bayer – assurances that glyphosate-based pesticides are safe.

Growing Movement to Ban Glyphosate

Cities, school districts, and suppliers across the US are increasingly halting use of Monsanto pesticide products. Residents in Leesburg, Virginia called on the town’s officials last week to stop using glyphosate along area stream banks, and local school children also petitioned for a ban.

Since the World Health Organization declared glyphosate, the main listed active ingredient in Roundup and other Monsanto concoctions, a probable carcinogen, Monsanto has lost every jury verdict over its best-selling poison.  In the last year it has been ordered to pay Roundup non-Hodgkin’s lymphoma victims $289 million (later reduced to $78 million) and $80 million, with a third Roundup trial now in progress in California.

Discovery in the lawsuits against Monsanto has uncovered a trove of internal Monsanto emails in which company executives discuss ghostwriting articles for academics like disgraced corporate apologist Henry I. Miller and others.  The Monsanto Papers have shown how hard the company has worked and how much money it has spent, to spin all studies over Roundup in its favor, regardless of the toxicity and the links to cancer that many studies not sponsored by Monsanto have found.

Trial evidence has also shown Monsanto worked closely with the Environmental Protection Agency to block a toxicity review of glyphosate by a separate government agency. See Monsanto EPA Collusion?

Monsanto Defense

Monsanto has claimed in all of the trials, and in full page propaganda missives published in the New York Times and elsewhere, that hundreds of studies and decades of Roundup use have proven it safe. Monsanto has also been accused by plaintiffs’ attorneys of “geofencing,” specifically targeting San Francisco juries’ zip codes in social media ads and notices, as well as peppering them with pro-glyphosate propaganda in local newspapers.  Court testimony has shown that virtually all of Monsanto’s studies were too short term to be relevant, or were skewed in their design for one reason or another, always erring on the side of exonerating glyphosate and Monsanto. The company also spent millions — trial evidence has shown — trying to marginalize and discredit the WHO after it determined in 20015 that glyphosate is a probable carcinogen.

Many corporations have also been paying attention to the trials and their results.

Retail giant Costco has stopped selling Roundup. A Florida-based golf and landscaping supply store called Harrel’s stopped offering Monsanto’s Roundup on March 1 this year. CEO Jack Harrell, Jr. said the company’s insurance supplier will no longer insure it.  In addition, Pike Nurseries, a large independent company, said it would no longer stock Roundup due to declining sales.

More than 11,000 cancer victims are suing Monsanto, alleging exposure to Roundup and other glyphosate products the company sells caused them to develop non-Hodgkin lymphoma.

Longtime Monsanto researcher Carey Gilliam of US Right To Know, reported that Susquehanna Financial Group analyst Tom Claps has warned shareholders to brace for a global settlement of between $2.5 billion and $4.5 billion. “It’s not a matter of ‘if’ Bayer will reach a global Roundup settlement,” Claps told investors in a recent report. “It is a matter of ‘when.”

Monsanto MDL Judge Orders Mediation

U.S. District Judge Vince Chhabria has ordered Bayer to enter into mediation, to discuss just such a potential settlement of the Roundup litigation. He put the next Monsanto trial in his court on hold to give mediation a chance to work for a settlement.

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FDA Recalls Mesh Products for Women

(April 17, 2019)  The US FDA announced yesterday that it was recalling all remaining surgical mesh products used on women to treat pelvic organ prolapse (POP).  The FDA said it determined that Boston Scientific and Coloplast, makers of those plastic mesh products, had failed to demonstrate a reasonable assurance of their safety and effectiveness.  That assurance is the premarket review standard that had applied ever since the agency reclassified POP meshes as class III (high risk) in 2016.

That reclassification meant POP mesh makers were henceforth required to submit and obtain approval through premarket approval (PMA) applications.  PMA is the  FDA’s most stringent device review path for marketing medical devices in the US.

The agency said BSC and Coloplast now have 10 days to submit a plan to withdraw their products from the market.

FDA Announcement of April 16, 2019:

“The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.”

Transvaginal Mesh not FDA Approved

Plastic mesh to treat POP and SUI was never formally approved by the FDA in the usual PMA process.  These meshes were, rather, “cleared” under the auspices of the agency’s 510k program, which allows some devices to reach the market if the agency determines the product in question is substantially equivalent to a product already approved.  In the case of transvaginal mesh (TVM), that comparison has always been shaky at best. Polyurethane or plastic mesh was first used in hernia repair surgery in the mid 1970s, and even then it was shown to cause problems in some people.  The company that made the oil-based plastic product is on record as saying it should never be implanted in the human body, but medical device companies used it anyway, and continue to use it.

FDA Dr. Jeffrey Shuren

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”

100,000 + TVM Lawsuits

A multi district litigation court was created to handle more than 100,000 transvaginal mesh lawsuits filed over the plastic devices used to treat POP and SUI.  It was the largest ever MDL ever assembled. Jury trials resulted in several large verdicts for plaintiffs, and several thousands of cases were quietly settled for injured women.  Hundreds of TVM lawsuits are still on file, and more trials are ongoing.

FDA Recalls Mesh Products for Women

One lawyer, David Matthews, who won a large jury verdict in a TVM case and later settled several others, said: “The FDA has finally done what the mesh industry would not do on its own. The adverse event reports, which reflect less than 10% of actual injuries to the women implanted with this product, coupled with multiple large jury verdicts based on expert opinions, has shown the risks of these products far outweigh their benefits, if any. This is yet more evidence that the clearance process for these dangerous products is inadequate.  As lawyers who have been represented those injured by these defective products for more than eight years, we thank the FDA for declaring these plastic devices unfit for use.”

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