Monsanto Hit With $2B Verdict In 3rd Roundup Trial

From left, Alva Pilliod, lawyer Brent Wisner, Alberta Pilliod and lawyer Michael Miller appear at a news conference, Monday, May 13, 2019, in San Francisco, a few hours after an Oakland, Calif., jury ordered Monsanto Co. to pay the Pilliods $2.055 billion. The Pilliods, of Livermore, Calif., claimed Monsanto’s popular weed killer Roundup Ready caused the cancer each are fighting. Monsanto says it will appeal each verdict. (AP Photo/Paul Elias)

By Dorothy Atkins

Law360 (May 13, 2019, 5:04 PM EDT) — A California jury found on Monday that Monsanto‘s Roundup likely caused a couple’s cancer and awarded them a staggering $2.055 billion in damages, slapping the Bayer AG unit with a third consecutive Roundup trial loss.

From left, Alva Pilliod, lawyer Brent Wisner, Alberta Pilliod and lawyer Michael Miller appear at a news conference, Monday after a jury ordered Monsanto to pay the Pilliods $2.055 billion in damages. (AP)

After nearly two days of deliberating, five women and seven men found that it’s more likely than not that Roundup was a significant contributing factor in causing Alva and Alberta Pilliod’s non-Hodgkin lymphoma. The jury awarded the couple $55 million in noneconomic and economic damages and hit the agrochemical giant with $1 billion in punitive damages for each of the plaintiffs — a $2.055 billion total that doubled what the plaintiffs’ attorney suggested in closing arguments.

The verdict wraps a five-week trial over the Pilliods’ claims that decades of spraying Roundup on their four properties gave them both aggressive cancer. Alva Pilliod was diagnosed with diffuse large B-cell lymphoma, or DLBCL, in 2011 and his wife was diagnosed with primary central nervous system lymphoma, a type of DLBCL, in 2015.

The Pilliods’ case was the third to go to trial out of 13,400 pending that allege Roundup causes cancer.

Bayer said in a statement Monday that the company is disappointed with the jury’s decision and will appeal the verdict.

During the latest trial, the jury heard testimony from competing oncologists, pathologists and toxicologists who gave starkly different takes on the weedkiller’s skin absorption rates and the science backing claims that Roundup’s active ingredient, glyphosate, causes cancer.

The Pilliods’ experts pointed to animal studies, mechanistic data and epidemiological data showing that glyphosate is genotoxic, or DNA damaging, and 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.

The Pilliods’ expert toxicologist, Dr. William Sawyer, told the jury that Monsanto made glyphosate 50 times more toxic by selling its Roundup formula with polyethoxylated tallow amine — or POEA — which is a surfactant that is banned in Europe. He explained that the surfactants allow glyphosate to easily penetrate the skin.

Once inside, he said, the body stores it under the skin for days and delivers glyphosate doses to the bones, where lymphoma originates. Sawyer also accused Monsanto of manipulating its absorption studies by heating and then freezing skin samples before they were tested, leading to skewed results.

Other experts called by the Pilliods testified that the U.S. Environmental Protection Agency approved Roundup in the 1970s based on fraudulent studies done by Industrial Bio-Test Laboratories. They said the company kept selling the product, even after the fraud was exposed, and refused for decades to conduct certain studies of its Roundup formula, despite requests from the EPA and its own toxicologist.

During closings, the Pilliods’ counsel, Brent Wisner of Baum Hedlund Aristei & Goldman PC, argued 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.

However, Monsanto’s experts argued that the epidemiological data put forward by the decadeslong Agricultural Health Study shows that glyphosate doesn’t pose a cancer risk and that multiple regulatory agencies around the world, including Health Canada, the EPA and the Australian government, have repeatedly concluded that 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 the use of Roundup has increased significantly.

On Monday the jury sided with the Pilliods and 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 noneconomic damages and $3.2 million in economic damages, along with a combined $2 billion in punitive damages.

The Pilliods’ trial began on 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 culminated in August, when a state jury in San Francisco awarded former school groundskeeper DeWayne “Lee” Johnson a win and hit Monsanto with a $289 million verdict. Over multiple objections by the jurors, a state judge later slashed the verdict to $78 million, which Monsanto has since appealed.

The Pilliods are represented by Michael Miller of The Miller Firm, Brent Wisner and Pedram Esfandiary of Baum Hedlund Aristei & Goldman PC and Steven J. Brady of the Brady Law Group.

Monsanto is represented by Kelly A. Evans of Evans Fears & Schuttert LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP and Eugene Brown Jr. of Hinshaw & Culbertson LLP.

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

Monsanto Expert ‘Micro-Analyzed’ By Atty At Roundup Trial

By Dorothy Atkins

Law360, Oakland, Calif. (April 29, 2019, 10:45 PM EDT) — A hematologist-oncologist hired by Monsanto defended her expertise Monday while testifying against claims the weedkiller Roundup caused a couple’s cancer, noting that it’s her first time testifying as an expert witness and she hadn’t realized “every single word” of her deposition “would be micro-analyzed” by attorneys.

Dr. Celeste Bello, who works at the Moffitt Cancer Center in Tampa, Florida, was the first witness the Bayer AG unit called to testify in a trial that kicked off March 28. An attorney representing Alva and Alberta Pilliod attempted to discredit Bello by pointing out apparent contradictions in her testimony and holes in her expertise.

Brent Wisner of Baum Hedlund Aristei & Goldman PC noted that Bello initially said under oath that some pesticides, like DDT, are known causes of cancer. Bello replied that she had misspoken — she said actually thinks that exposure to those chemicals are cancer risk factors, but not known causes of non-Hodgkin lymphoma.

“I didn’t know every single word would be micro-analyzed,” she said.

The case was brought by Alva, 76, and Alberta, 74, who claim that decades of spraying the weedkiller on their four properties gave them both aggressive cancer. The Pilliod trial is the third case to go to trial out of approximately 11,200 lawsuits pending that allege Roundup causes cancer.

At the start of trial Monday, Wisner objected to Bello offering testimony on Roundup, arguing that she spends most of her time treating patients and she’s not an expert on chemicals that cause cancer. He also objected to Bello testifying on Roundup’s genotoxicity, or ability to damage DNA, because, he argued, her opinion wasn’t disclosed before trial. But Superior Court Judge Winifred Smith overruled both objections.

During her direct examination, Bello said she reviewed Alberta Pilliod’s medical records and depositions and concluded that Roundup was not a significant contributing factor to her non-Hodgkin lymphoma. Bello explained that there are only two known causes of the type of cancer Alberta Pilliod developed: HIV and a weakened immune system.

Bello said everything else, like pesticide use, age and weight, are merely risk factors. She added that the cause of 80% to 90% of non-Hodgkin lymphoma cases are unknown. Alberta Pilliod had Hoshimoto’s disease, she said, which indicates she had a weak immune system, and additional risk factors, including bladder cancer, diabetes and a smoking history.

Bello also refuted the Pilliods’ experts who said earlier in the trial that it is “common sense” that the couple must have gotten cancer from something in their environment, because they both developed it. She said studies show that couples aren’t at a higher risk of getting non-Hodgkin lymphoma.

“There’s more to it than just living together and being husband and wife,” Bello said.

But during her cross-examination, Bello conceded that she is not a pathologist, toxicologist or expert in chemicals that cause cancer. She also said she’s only conducted one epidemiology study when she was in graduate school and it didn’t involve cancer.

Wisner attempted to further cast doubt on Bello’s credentials by pointing out that she changed her testimony on the stand, testifying that she contributed to more than 20 peer-reviewed academic studies, instead of more than 50, which she gave in her deposition. Wisner noted that her resume only lists 25 papers and Bello hasn’t published papers linking pesticides to cancer. Bello defended her credentials, saying she doesn’t update her resume often and noting that she’s excluded from her resume some of her presentations.

Wisner then turned to Bello’s opinions, asking her whether being exposed to pesticides, like DDT, at extremely high levels is known to cause non-Hodgkin lymphoma. Although she wouldn’t concede the point, Bello admitted that the “magnitude of the risk drives a causal link.”

Bello also acknowledged that until she began working on the case, she wasn’t aware of the International Agency for Research on Cancer, which concluded in 2015 that Roundup’s active ingredient, glyphosate, is a “probable” carcinogen.

Wisner pointed out that IARC is an arm of the World Health Organization and wrote the publication on tumor classifications that Bello had claimed was “the Bible” and standard in her field. Bello replied that she didn’t know if IARC members were, in fact, authors of the tumor classification publication.

Wisner then pointed out that Bello reviewed only three studies to inform her opinion that glyphosate does not cause DNA damage. Bello took issue with Wisner’s characterization of her research, noting that she read the U.S. Environmental Protection Agency‘s report, which assessed multiple studies.

Wisner responded that at least one study in the EPA report was implicated in the wake of the IBT scandal in the 1970s and invalidated, which jurors had heard about earlier in trial. Bello replied that she has no reason to question the EPA’s statements and she wasn’t familiar with IBT.

The trial will continue Tuesday.

The Pilliods are represented by Michael Miller of The Miller Firm, Brent Wisner and Pedram Esfandiary of Baum Hedlund Aristei & Goldman PC, and Steven J. Brady of the Brady Law Group.

Monsanto is represented by Kelly A. Evans of Evans Fears & Schuttert LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP, and Eugene Brown Jr. of Hinshaw & Culbertson LLP.

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

Judge Recuses Self Over Views On Insurer‘s ’Barbaric’ Policy

By Nathan Hale

Law360 (April 29, 2019, 5:00 PM EDT) — A Florida federal judge stepped down Monday from a proposed class action claiming UnitedHealthcare improperly classified a certain cancer treatment as experimental to avoid providing coverage, saying his personal opinion prevented him from ruling fairly on what he called “immoral and barbaric” actions.

The suit, recently filed by prominent Miami attorney Richard Cole of Cole Scott & Kissane PA, alleges that up until changing its policy in January, Connecticut-based UnitedHealthcare Insurance Co. wrongly categorized proton beam radiation therapy as an “experimental or investigational” treatment for prostate cancer. The insurer, a subsidiary of UnitedHealth Group Inc., had used this classification despite the 30-year-old procedure’s medical advantages and longtime acceptance in the medical community, the suit says.

In a one-page order of recusal, U.S. District Judge Robert N. Scola Jr. recounted his own experience of being treated for prostate cancer in 2017 and shared a story of a friend who obtained reimbursement for proton radiation from UnitedHealthcare only after paying $150,000 out of pocket and threatening the insurance giant with litigation.

“It is undisputed among legitimate medical experts that proton radiation therapy is not experimental and causes much less collateral damage than traditional radiation,” Judge Scola said. “To deny a patient this treatment, if it is available, is immoral and barbaric. The court’s opinions in this matter prevent it from deciding this case fairly and impartially.”

Judge Scola said in his order that after he was diagnosed with prostate cancer in early 2017, he consulted with top medical experts around the country as to the best course of treatment. They all told him that if he opted for radiation treatment, proton radiation “was by far the wiser course of action,” he said.

“Although the court opted for surgery, rather than radiation, those opinions [are] still resonant,” the order said.

Judge Scola also noted that his friend was diagnosed with cancer in 2015 and opted to have proton radiation therapy in Houston, despite UnitedHealthcare refusing to pay for it. He was fortunate to have the resources to pay the $150,000 cost himself before managing to gain reimbursement after threatening to sue the insurer, the judge said.

The case had been transferred to Judge Scola last Thursday after U.S. District Judge Federico Moreno recused himself, citing his personal friendship with Cole. It will now be assigned to another member of the district’s bench.

Cole, who was diagnosed with prostate cancer in April 2018, is seeking to represent a class of all participants in UnitedHealthcare plans covered by the Employee Retirement Income Security Act who were denied coverage for proton radiation to treat prostate cancer based on the insurer’s policy prior to January 2019 that asserted it was experimental, according to the complaint.

Cole’s complaint says that in May 2018 his cancer doctor recommended proton radiation rather than the more traditional intensity modulated radiotherapy because of a likelihood of better results.

Proton beam radiation therapy, which uses protons to deliver a dose of radiation to cure a tumor, has potential advantages over the traditional method because the protons’ energy can be delivered over a smaller area than the photons used in intensity modulated radiotherapy. That allows patients to tolerate higher doses of radiation and reduces harm to healthy tissues and organs, the complaint says.

The U.S. Food and Drug Administration approved proton radiation for prostate cancer treatment in 1986, and it is recommended and used by many of the top cancer centers in the country, according to the complaint. Other insurers, including Medicare, cover the treatment and do not consider it to be experimental, the complaint adds.

Cole alleges that UnitedHealthcare breached its fiduciary duty under ERISA to act “solely in the interest of the participants and beneficiaries” in providing benefits because it was driven by a desire to avoid paying for the procedure, which the complaint says is significantly more costly than traditional radiation treatments in some parts of the country.

The suit seeks equitable relief, including disgorgement and surcharges, and an order that the insurer must reprocess class members’ claims under the insurer’s new policy that recognizes proton radiation as a proven, safe and effective treatment.

On Monday, UnitedHealthcare stood by its past actions.

“UnitedHealthcare bases its medical policies and coverage decisions — including for proton beam therapy — on the prevailing published clinical and scientific evidence,” the insurer said through a spokeswoman.

Cole is represented by Stephanie A. Casey, Dean Colson and Lazaro Fields of Colson Hicks Eidson.

UnitedHealthcare is represented by Peter Walsh of Hogan Lovells.

The case is Cole v. United Healthcare Insurance Co., case number 1:19-cv-21258, in the U.S. District Court for the Southern District of Florida.

Monsanto Faces Uphill Fight In Axing Punitives From Trial

By Dorothy Atkins

Law360, Oakland, Calif. (April 25, 2019, 9:54 PM EDT) — A California judge said Thursday she’ll likely allow jurors to consider awarding punitive damages in the third jury trial over claims that Monsanto‘s popular Roundup weedkiller causes cancer, after the Bayer AG unit argued that there’s no evidence its conduct was malicious.

During a hearing in Oakland, Monsanto’s counsel, Eugene Brown Jr. of Hinshaw & Culbertson LLP, argued that allegations Monsanto knew of Roundup’s cancer risks in the 1980s are “completely speculative.” Brown said that in order for punitive damages to be awarded, a defendant’s conduct must be vile and despicable.

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

But the counsel for the plaintiffs, Brent Wisner of Baum Hedlund Aristei & Goldman PC, noted that juries sitting on the two previous trials over claims Roundup causes cancer were asked to decide whether punitive damages were warranted and both juries awarded them. He said in this trial, there’s “considerably more evidence” that Monsanto’s conduct was malicious, including that Monsanto allegedly ghostwrote academic articles to intentionally mislead the scientific community about Roundup’s safety.

After oral arguments, Alameda Superior Judge Winifred Smith said her tentative ruling is that she will likely deny Monsanto’s motion to strike punitive damages, but she said she would read all the briefs before deciding.

The arguments came during a hearing without the jury present on jury instructions, the verdict form and Monsanto’s motion to strike punitive damages in a trial that kicked off March 28.

The case was brought by plaintiffs Alva and Alberta Pilliod, who are 76 and 74, respectively, and claim that decades of spraying the weedkiller on their four properties gave them both aggressive cancer. The Pilliods rested their case-in-chief on Tuesday, and Bayer will call its first witnesses Monday.

During the hearing Thursday, Brown said the few small studies that suggested Roundup’s active ingredient, glyphosate, might be carcinogenic weren’t published until the 1990s, and that there was no evidence that glyphosate could cause cancer until the International Agency for Research on Cancer concluded glyphosate is a probable carcinogen in 2015. Therefore, he said, the company couldn’t have been reasonably expected to warn consumers about Roundup’s potential risks, because it didn’t think it was dangerous and “no one else did.”

“The science had not evolved to the point to reach the conclusion that exposure to Roundup causes non-Hodgkin lymphoma,” he said. “At most, it’s a probable carcinogen.”

But Wisner said there’s evidence that Monsanto has repeatedly refused to conduct certain cancer studies on Roundup since 1983 and 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, Wisner said. Instead, the company continued to advertise Roundup using ads that showed people spraying the product without gloves, while wearing t-shirts and shorts, Wisner said.

Wisner said Monsanto’s conduct recklessly put people’s lives in danger and 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. Wisner said what the company knew about glyphosate’s cancer risks and when are being revealed through litigation, and that the process is akin to the Big Tobacco cancer litigation in the 1990s.

“We’re seeing that happen, we’re living through the history right now,” Wisner said.

In addition to 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, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP, said 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, Wisner argued that the tougher standard wasn’t warranted and that the other trials used the concurrent causation standard.

Judge Smith said she would look over the case law and decide the issue. She also noted that the verdict form should ask the jury to make separate findings for Alva and Alberta.

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

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

The first trial against Monsanto over Roundup’s links to cancer was held last summer in state court in San Francisco, and resulted in a $289 million verdict against Monsanto, including $250 million in punitives. A judge later slashed the total award to $78 million. Bayer filed its opening brief appealing the judgment in state appeals court Tuesday. The second trial, Ed Hardeman v. Monsanto, ended last month in federal court with an $80 million verdict, including $75 million in punitive damages, which Bayer has said it will appeal.

At the end of the hearing Thursday, Wisner said Bayer publicly released the names and contact information of jurors who sat on the first trial when the company filed its appeal Tuesday, and asked the judge to prohibit Bayer from releasing the names of the jurors in this case. Monsanto’s counsel, Kelly A. Evans of Evans Fears & Schuttert LLP, said he didn’t know the details of the appeal, but he said they “certainly agree” they wouldn’t release the names of the jurors in this case.

The Pilliods are represented by Michael Miller of The Miller Firm, Brent Wisner and Pedram Esfandiary of Baum Hedlund Aristei & Goldman PC and Steven J. Brady of the Brady Law Group.

Monsanto is represented by Kelly A. Evans of Evans Fears & Schuttert LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP and Eugene Brown Jr. of Hinshaw & Culbertson LLP.

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

Monsanto Appeals $78.5M Loss In First Roundup Trial

By Emily Field

Law360 (April 24, 2019, 8:12 PM EDT) — Monsanto asked a California appeals court Tuesday to reverse a $78.5 million verdict awarded to a school groundskeeper who claimed Roundup weedkiller caused his lymphoma in the first landmark trial over the herbicide’s alleged cancer risks.

The jury’s verdict of $289 million, later slashed to $78.5 million, to DeWayne “Lee” Johnson is inconsistent with both the law and sound science, Monsanto said. Although the jury found that Monsanto should have warned that its weedkiller caused non-Hodgkin’s lymphoma, the best scholarship available when Johnson was exposed to Roundup unanimously concluded there wasn’t enough evidence to link the cancer to the weedkiller’s active ingredient, glyphosate, Monsanto said.

Most of the trial hinged on a determination by the International Agency for Research on Cancer in 2015, several months after Johnson’s diagnosis, that glyphosate is “probably carcinogenic” at some unknown dose, Monsanto said.

But the U.S. Environmental Protection Agency and other regulators worldwide have found otherwise, Monsanto said.

“Given the worldwide consensus among health experts, there is no basis in law for a jury to find Monsanto liable based on the cherry-picked and unreliable evidence that was presented at trial,” Bayer AG, which now owns Monsanto, said in a statement.

Thousands of suits over Roundup have been filed in federal and state courts, and Monsanto last month lost the first federal bellwether trial when a jury awarded $80 million to a man who claimed the weedkiller caused his non-Hodgkin’s lymphoma.

A California state jury in August awarded Johnson $289 million in compensatory and punitive damages, finding that Monsanto’s weedkillers weren’t safe and were a substantial factor in causing his injury.

San Francisco County Superior Court Judge Suzanne Bolanos in October reduced the $250 million punitive damages award to $39.25 million under the U.S. Supreme Court’s 2003 ruling in State Farm Mutual Auto Insurance Company v. Campbell , which holds that punitive damages are limited by the Fourteenth Amendment.

There is no substantial evidence that Roundup caused Johnson’s disease, Monsanto said. At least 80% of non-Hodgkin’s lymphoma cases have no known cause, and Johnson’s experts failed to explain why his case wasn’t also idiopathic, Monsanto said.

Monsanto also said it was entitled to a new trial because the lower court excluded as hearsay reports by the EPA and foreign regulators that found glyphosate wasn’t carcinogenic, even though it allowed the IARC report to be admitted as evidence.

Johnson’s state-law claims are preempted by the Federal Insecticide, Fungicide and Rodenticide Act, which bars states from imposing different labeling restrictions than those required by the federal law, Monsanto said.

Additionally, Monsanto could not have changed the weedkiller’s active ingredient or added a cancer warning without the EPA’s approval, and there’s clear evidence that the agency would have rejected such a warning, according to the brief.

In a separate filing, Monsanto asked the appellate court to take judicial notice of jurors’ emails to the court sent after the trial, local news articles — including one penned by Neil Young and Daryl Hannah — and a full-page newspaper ad called “Dear Judge Suzanne Ramos Bolanos, What Is A Life Worth?” — which Monsanto said was meant to pressure the judge into rejecting a tentative ruling that she would likely toss the entire punitive damages award.

“Desperate times call for desperate measures,” Michael Miller, an attorney for Johnson, told Law360 on Wednesday. “Monsanto’s attempts to argue that a Neil Young editorial persuaded a respected jurist to change course is absurd on its face.”

Johnson is represented by Brent Wisner and Pedram Esfandiary of Baum Hedlund Aristei & Goldman PC, Michael Miller, Curtis G. Hoke and Jeffrey A. Travers of The Miller Firm LLC and Mark S. Burton of Audet & Partners.

Monsanto is represented by K. Lee Marshall of Bryan Cave Leighton Paisner LLP and David M. Axelrad, Jason R. Litt and Dean A. Bochner of Horvitz & Levy LLP.

The case is Johnson v. Monsanto Co. et al., case numbers A155940 and A156706, in the Court of Appeal of the State of California, First Appellate District, Division One.

FDA Orders Surgical Mesh Products Pulled From US Market

By Danielle Nichole Smith

Law360 (April 16, 2019, 6:52 PM EDT) — The U.S. Food and Drug Administration on Monday ordered Boston Scientific and Coloplast — the only two remaining manufacturers of surgical mesh meant for the transvaginal repair of pelvic organ prolapse — to stop selling those mesh products in the U.S.

The order stems from the agency’s reclassification of the devices as high-risk in 2016, which required their manufacturers to submit premarket approval applications to continue marketing them in the U.S., according to the FDA. The order covers Boston Scientific Corp.’s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast AS’ Restorelle DirectFix Anterior Mesh.

The two manufacturers will have 10 days to submit their plan for withdrawing the products from the market, the statement said. All other mesh products meant for the transvaginal repair of pelvic organ prolapse were removed from the market in 2018 when their manufacturers declined to submit premarket approval applications, according to the FDA.

Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, said the agency determined Boston Scientific and Coloplast had to show their mesh devices worked better to repair pelvic organ prolapse than surgeries that didn’t use mesh in order for those products to stay on the market.

“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Shuren said in a statement. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions.”

According to the statement, premarket approval applications are the FDA’s “most stringent device review pathway.” Ultimately, the agency found that the manufacturers didn’t give an “adequate assessment” of their devices’ long-term safety, or show they had an “acceptable long-term benefit” as compared to native tissue repair, which doesn’t use mesh, in their applications.

Boston Scientific said in a statement that the company would “work closely with the agency to understand its direction and determine next steps.”

“We are deeply disappointed by the FDA’s decision on our premarket approval applications for the Uphold Lite Vaginal Support System and the Xenform Soft Tissue Repair Matrix, and believe the inaccessibility of these products will severely limit treatment options for the 50% of women in the U.S. who will suffer from pelvic organ prolapse during their lives,” the company said.

The FDA and Coloplast each declined to comment Tuesday.

Boston Scientific has faced litigation over its manufacturing of other vaginal mesh devices, such as the Pinnacle Pelvic Floor Repair Kit. At the end of January, a federal judge said that the company had paid more than $7 billion to resolve tens of thousands of cases, and the company indicated in an annual report filed with the U.S. Securities and Exchange Commission that it was close to having resolved about 50,000 cases and claims related to its pelvic surgical mesh implants.

Bayer Exec Denies Knowing Of Ghostwriting At Roundup Trial

By Dorothy Atkins

Law360, Oakland, Calif. (April 16, 2019, 9:44 PM EDT) — Bayer Crop Science’s product safety team lead repeatedly said in a video deposition played for a California jury Tuesday that he “has no idea” whether Monsanto toxicologists ghostwrote multiple academic studies assessing Roundup’s cancer risks, but he conceded that it’s inappropriate if they wrote entire articles without attribution.

Bayer’s Michael Koch was the latest witness in a months long trial in Oakland, California, over claims by plaintiffs Alva and Alberta Pilliod against the Bayer unit that decades of using Monsanto’s popular Roundup weedkiller gave them both aggressive non-Hodgkin lymphoma.

During Koch’s examination, the Pilliods’ counsel pointed out internal Monsanto emails between Koch, Monsanto toxicologist Donna Farmer and William Heydens, who has held lead roles in Monsanto toxicology and product safety groups. The emails were sent around the time the World Health Organization’s International Agency for Research on Cancer was assessing whether Roundup’s active ingredient, glyphosate, causes cancer in 2015.

In the emails, Heydens wrote “this is getting huge” and suggested that the company “ghostwrite” papers and get authors to “just edit and sign their names,” which is what Heydens said the company did with glyphosate studies in 1999 and the early 2000s.

But Koch repeatedly said he didn’t know what Heydens meant by using the word “ghostwrite.” Koch said there are multiple definitions of ghostwriting and there is a “huge continuum” of what is considered acceptable. Koch said he’s not comfortable with people putting their names on papers they didn’t write, but he said he doesn’t know if Monsanto’s toxicologists did that.

“If that’s what indeed happened that would be inappropriate,” Koch added.

The Pilliods’ counsel, Brent Wisner of Baum Hedlund Aristei & Goldman PC, also pointed out that after IARC concluded in 2015 that glyphosate is a probable carcinogen, Monsanto had paid experts from the consulting firm Intertek Group $27,400. Those Intertek experts then contributed to a September 2016 paper published in the “Critical Reviews In Toxicology” peer-reviewed medical journal on long-term, glyphosate rodent studies, Wisner said. In the paper, the panel contradicted IARC’s findings and concluded the studies don’t show glyphosate poses a cancer risk, he said.

Wisner noted that when the paper was published, it said Monsanto wasn’t involved in its conclusions, but the journal later issued an apology and explained some Intertek experts had been paid by Monsanto. The journal also said it had not been given an adequate explanation for why Intertek’s relationship with Monsanto wasn’t initially disclosed, according to Wisner.

However, in his examination, Koch said it’s impossible to determine whether Heyden’s 2015 emails about ghostwriting were the “genesis” of the Intertek panel.

“That phrase is in [Heyden’s email], but I took that to mean a variety of things,” Koch said.

Aside from Koch’s deposition, the jury also heard from environmental scientist William S. Pease, who took the stand Tuesday to testify on the state’s Safe Drinking Water and Toxic Enforcement Act of 1986, or Proposition 65, which he helped get passed as a graduate student at University of California, Berkeley.

Please explained that when Proposition 65 was initially drafted, lawmakers incorporated IARC’s findings into the labor code, because IARC was considered the best source on carcinogenicity at the time, and it was the only organization with a “good and extensive track record” of assessing whether chemicals were carcinogenic. As a result of IARC’s 2015 finding, the state’s Environmental Protect Agency added glyphosate to its list of known carcinogens in July 2017, Pease said.

On cross, Please conceded that there are approximately 1,000 substances on the Proposition 65 list and that IARC is not a regulatory body. He also admitted that the state labor code doesn’t consider findings by other regulatory bodies like Health Canada, the European Chemicals Agency or the Australian government, which has each found glyphosate doesn’t pose a cancer risk. However, Pease said IARC’s “sole purpose” is to identify carcinogenic substances and to accelerate the process of carcinogenicity identification. Therefore, it doesn’t consider whether all regulatory bodies agree or have even assessed the chemical’s carcinogenicity, Pease said.

“IARC is basically the gold standard, because of its processes,” he said.

Trial will continue Wednesday.

The Pilliods are represented by Michael Miller of The Miller Firm, Brent Wisner and Pedram Esfandiary of Baum Hedlund Aristei & Goldman PC and Steven J. Brady of the Brady Law Group.

Monsanto is represented by Kelly A. Evans of Evans Fears & Schuttert LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP and Eugene Brown Jr. of Hinshaw & Culbertson LLP.

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