Cancer Patient Urges High Court To Ignore Monsanto Appeal

A California man who successfully claimed that repeated exposure to Monsanto’s Roundup led to his cancer diagnosis asked the U.S. Supreme Court to ignore the company’s appeal of a Ninth Circuit ruling that affirmed a jury verdict awarding him $25 million, saying the ruling abides by precedent against the company’s claims.

Plaintiff Edwin Hardeman questioned Monsanto’s arguments that his state of California’s failure-to-warn claims are preempted by federal law and that experts testifying on Hardeman’s behalf were allowed to do so under a “uniquely lenient” standard in district court.

In May, the Ninth Circuit ruled that California’s failure-to-warn claims were not preempted by the Federal Insecticide, Fungicide and Rodenticide Act as the requirements of both state and federal laws were similarly consistent. According to the Ninth Circuit’s ruling, under the federal law, manufacturers must provide label warnings “adequate to protect health and environment,” and California law mandates warnings about dangers that a “reasonably prudent” manufacturer would know about.

In a writ of certiorari filed in August, Monsanto argued that the experts who testified on behalf of Hardeman were admitted into court under a “uniquely lenient” standard with potential “consequences for tens of thousands of pending Roundup cases.” Hardeman, in the opposition brief, points out that other jurisdictions with purportedly “stricter” standards have supported rulings similar to that of the Ninth Circuit.

Since Monsanto filed its appeal to the high court, seven legal and trade groups, including the pro-business nonprofits Washington Legal Foundation and Retail Litigation Center Inc., filed amicus briefs in support of Monsanto’s request.

In March 2019, a unanimous, six-person, California jury found that Monsanto was liable on a failure-to-warn claim, a negligence claim and a design defect claim in a federal bellwether trial.

While the jury awarded Hardeman about $80 million in future, past and punitive damages, the federal judge overseeing the case cut down the punitive damages award to $20 million.


J&J, Ethicon Beat Pa. Woman’s Untimely Hernia Mesh Suit

A Pennsylvania federal judge handed Johnson & Johnson and Ethicon Inc. a win in a woman’s lawsuit alleging that she was injured by the companies’ pelvic mesh implants that aim to treat hernias, finding that the patient’s lawsuit is untimely under state law.

Nancy Yelinek alleged in her October 2017 suit that her mesh implant manufactured by Johnson & Johnson and its subsidiary Ethicon led to pain, discomfort and other complications.

Senior U.S. District Judge Nora Barry Fischer ruled that Yelinek waited too long to sue over her alleged injuries given that Yelinek’s doctor who removed the mesh implant told her in 2008 that the mesh “didn’t work.”

The judge said Yelinek received notice for her cause of action once her doctor, Brent Angott, communicated this news on Dec. 12, 2008. The judge concluded that Yelinek’s right to sue expired six years later “under the most generous limitations period Pennsylvania provides.”

Yelinek had her bladder surgically removed and an Ethicon hernia mesh implanted in July 2008 to repair a hernia. But the hernia came back, and a different surgeon had to repair it and remove the mesh in December 2008.

Yelinek did not sue her doctors, and she didn’t sue Ethicon until 2017, some time after seeing a law firm’s television commercial about pelvic mesh mass tort litigation. Her case had originally been filed as part of a pelvic mesh multidistrict litigation but was transferred out because it involved a different product.

Ethicon moved for summary judgment in May, arguing that the two-year statute of limitations started running with Yelinek’s mesh removal surgery in 2008.

Pennsylvania law maintains a two-year limitation period to sue for matters related to tortious conduct, while all other civil actions “face a six-year statute of limitations,”.

During a September video hearing, counsel for Yelinek said that as a layperson, she didn’t realize she had even had a hernia mesh put in five months earlier, let alone that its alleged defect was the cause of her injury after a different surgeon removed it and told her it did not work.

Yelinek’s attorney continued that it should be up to a jury to weigh the testimony in the case and decide whether her conversations with the second surgeon were enough to put her on notice and start the countdown for her claim, or whether the TV commercial years later constituted that notice. As a layperson without any medical expertise, she would not be expected to know how much of her discomfort was attributable to her previous operations.

But Judge Fischer ruled in favor of J&J and Ethicon, finding that Yelinek’s claims are time-barred under Pennsylvania law since the “clock began to run” once she had the mesh removed.


J&J settles most Risperdal lawsuits, with $800 million in expenses

Johnson & Johnson said it has settled most of the lawsuits it faced by thousands of men who claimed its antipsychotic drug Risperdal caused them to develop excessive breast tissue and disclosed that it recorded $800 million in expenses in connection with the agreement.

J&J said in a filing with the U.S. Securities and Exchange Commission on Friday that it reached a settlement in principle in September to resolve “substantially all” of the roughly 9,000 cases that the New Brunswick, New Jersey-based drugmaker faced over Risperdal.

The company said it reached the agreement with lawyers handling cases including a lawsuit in state court in Philadelphia by Nicholas Murray, a Maryland resident who a jury awarded an $8 billion punitive damage award in 2019 that a judge later reduced to $6.8 million.

J&J said it accrued $800 million in legal expenses in the third quarter related to the settlement.

The lawsuits generally accused J&J of failing to warn of the risk of a condition called gynecomastia associated with Risperdal, which they said the company marketed for off-label, unapproved uses with children. J&J denied the allegations.

The U.S. Food and Drug Administration approved Risperdal in 1993 to treat schizophrenia and bipolar mania in adults, but it was only in 2006 that its use was approved for irritability associated with autism in children.

The company separately agreed in 2013 to pay $2.2 billion to settle U.S. criminal and civil probes into its marketing of Risperdal and two other drugs.


8th Circ. Sends Civilians’ 3M Earplug Suits To State Court

The Eighth Circuit sent to state court civilians’ claims that they were not warned about the alleged dangers of earplugs originally designed for the military by a company now owned by 3M Co., saying the military’s specifications did not constrain what warnings the company put in the commercially sold models.

The three-judge panel affirmed the remand of claims by several plaintiffs who had brought claims in Minnesota state court, but found that those plaintiffs who bought the earplugs through the military must stay in federal court.

The opinion consolidated appeals in 14 actions, which alleged that the users of the Combat Arms Earplugs Version 2, or CAEv2, made by Aearo Technologies and sold by 3M suffered hearing damage or tinnitus as a result of 3M’s failure to provide adequate instructions and warnings on how to use the earplugs.

The cases led by Christopher Graves all contain civilian purchasers, while the cases consolidated under the one led by Casey Copeland include an unknown number of military contractor plaintiffs.

Aearo, which was bought by 3M in 2008, made the earplugs to the specifications of the U.S. Army, and on the Army’s request, shipped the earplugs to the military in bulk, without instructions, because the military intended to provide its own training and instructions.

When Aearo decided to sell a version for commercial use, it drafted instructions and sent them to the Army’s program manager of hearing conservation — who had originally commissioned the earplugs for the military — for feedback. Aearo then incorporated the feedback into the packaging.

After the Graves and Copeland suits were filed, 3M removed the cases to federal court, saying that the earplugs had been designed in conjunction with the military for military purposes, which allows it to take the federal contractor defense. But the district court later granted the plaintiffs’ motion to remand, saying the company failed to demonstrate a conflict between its obligation to design the product to the military’s specifications and its state law duty to warn civilian purchasers, and 3M appealed.

Eventually, the panel agreed that the civilian purchasers who bought the product commercially could keep their claims in state court, noting that they are not making design defect claims, but only failure to warn ones. Voluntarily soliciting feedback from the military about the proposed instructions for a commercial product does not show that 3M was carrying out or assisting in the government’s duties, so it cannot be said to have been “acting under” an officer or agency of the U.S. in that capacity.

However, an “uncertain number” of plaintiffs in the consolidated appeals worked for defense contractors and received the earplugs from the military, and in those cases, 3M has shown that its warnings were the result of military specifications, so it has a reasonable federal defense in the government contractor defense that must go before the federal court.

As such, the panel reversed the remand order as to those plaintiffs, and noted that the courts must sort out which of them worked for defense contractors.


Atrium Wins Quick Verdict In Chicago In 1st Hernia Mesh Trial

A Chicago federal jury has returned a verdict in favor of Atrium Medical Corp. in the first trial over its hernia mesh products in a suit brought by a man seeking $12 million in damages over an allegedly contaminated mesh product.

Randy Africano had hernia repair surgery in December 2013 and was implanted with a ProLite mesh made by Atrium, which he claimed was contaminated at an Atrium manufacturing site.

His attorney, James Benak of James D. Benak Attorney LLC, asked the jury to award $20,000 in medical expenses, $500,000 for pain and suffering, and $100,000 a year for future pain and suffering, with a multiplier of five for enhanced damages,

In his 2017 suit, Africano said that after his implant surgery he suffered increasing pain and that a 2015 ultrasound revealed that fluid had started to collect at the site, or what’s called a seroma, but was told there was no satisfactory treatment.

He claimed that the mesh was contaminated with bacteria at Atrium’s manufacturing facility in New Hampshire and that Atrium failed to tell his doctor about a warning letter sent by the U.S. Food and Drug Administration that all of the products made at the New Hampshire facility were adulterated.

“We’re disappointed in the jury’s verdict, which we believe was due to the trial court’s improper exclusion of important evidence that the jury should have considered, including the FDA complaint against Atrium in February 2015,” Benak told Law360, “We have another case pending in New Jersey and look forward to a fuller presentation of the evidence in that case.”


Florida Man Awarded $15M Over Exploding E-Cig Battery

A South Florida jury has awarded more than $15 million in damages to a man who suffered burns when a spare electronic cigarette battery exploded in his pocket.

Jurors found that Broward County resident Manuel Ortega suffered $5 million in past damages for pain and suffering and will suffer another $10 million in future damages. They also determined that he should recover about $21,000 in medical expenses related to the 2016 incident.

Ortega filed suit in 2017, alleging that he suffered third degree burns throughout his lower extremities after the spare battery exploded, resulting in it leaking acid and causing his leg to catch fire.

He said he had only used the battery for about a month and had not subjected it to overuse or abuse prior to the March 2016 incident.

The battery was made by Shenzhen Battery Company Ltd., which sold it to Hollywood, Florida-based EcigRus, which in turn sold it to Vapor Life’s store in Plantation, Florida, for retail sale.

Ortega’s suit claimed there were several defects in the design and manufacture of the battery, including an absence of adequate thermal protection, but the complaint did not name Shenzhen Battery as a defendant.

Instead, it held that the other defendants had certain duties when making the product available to consumers.

The suit brought claims of strict liability and negligence against the defendants.


RJ Reynolds Hit With $2M In Punitive Damages In Death Suit

A Florida jury has awarded the family of a deceased cigarette smoker $2 million in punitive damages from R.J. Reynolds Tobacco Co., bringing an end to a yearslong Engle progeny case.

The jury reached its verdict on October 19th, finding that the evidence warrants the $2 million in punitive damages against the tobacco company to be awarded to the family of Jose Ledo, following a prior trial that had awarded compensatory damages to the family.

In 2016, the jury had found that Jose Ledo was addicted to cigarettes and that R.J. Reynolds’ cigarettes were defective, and awarded $2 million in compensatory damages to Ledo’s wife, Mirtha, and $4 million to his son, Carlos, over the smoker’s death of laryngeal cancer at age 58 in 1996. The total was reduced to $2.94 million, as the jury had found R.J. Reynolds 49% at fault for Jose Ledo’s death.

The jury at the time did not award punitive damages, because the judge had granted R.J. Reynolds a directed verdict on punitive damages. In 2019, an appeals court found that the directed verdict was in error and remanded for another look at punitive damages.

The jury in the punitive damages trial was bound by the first’s findings as to liability.

The punitive damages trial, however, was delayed by the COVID-19 pandemic, but two weeks ago it began, with counsel for the Ledo family saying that while the company’s leadership may have changed, its “legacy” of hiding the dangers of tobacco should be punished.

The Ledo family’s attorney told the jury it should award punitive damages to punish past conduct and to deter future similar conduct by the $24.9 billion company, while R.J. Reynolds’s counsel said its products were not responsible for Ledo’s death.

The case is one of the thousands stemming from the landmark Engle class action against tobacco companies.

The Florida Supreme Court had decertified the Engle class in 2006 and overturned a $145 billion verdict, but allowed up to 700,000 people who could have won judgments to rely on the jury’s findings to file suits of their own. Those findings include conclusions that smoking causes certain diseases and that tobacco companies hid the dangers of smoking.



A New Jersey state judge refused to preemptively block Johnson & Johnson from engaging in a bankruptcy maneuver, the so-called Texas Two-Step, that cancer patients say would unlawfully shield company assets from claims its talcum powder products caused their illness.

In rejecting their application for a temporary restraining order and preliminary injunction against the pharmaceutical giant, Superior Court Judge John C. Porto said that plaintiffs Brandi Carl and Diana Balderrama want him “to assume the defendants intend to conduct a fraudulent transaction” but that he “cannot make that leap.”

Under the hypothetical scenario derided by Carl, Balderrama and similar plaintiffs around the country, J&J would use the Lone Star State’s “divisive merger” statute to split off its talc liabilities into a separate entity that would then file for bankruptcy, while the bulk of the company’s productive assets would remain in a different entity, court documents state.

The bankruptcy proceeding would likely result in “J&J paying mere pennies on the dollar for the injuries”. 

However, Judge Porto repeatedly stressed that no such transaction had occurred.

Carl and Balderrama failed to show “by clear and convincing evidence there was any actual fraudulent transfer that was consummated or transacted by the defendants or that the plaintiffs would suffer any immediate irreparable harm”. J&J has enough money to cover potential judgments in favor of the women.

As for possible transactions in the future, the women neither offered “any clear and convincing proof” that J&J had decided to move forward on the controversial maneuver nor presented “the terms of an actual transaction that would undermine the present situation or disrupt the status quo”.



The makers of the Paragard birth control device asked a Georgia federal judge to toss the master complaint in multidistrict litigation comprising almost 500 plaintiffs who say the device is defective, saying it’s a shotgun pleading without specificity.

Teva Pharmaceuticals USA Inc. and The Cooper Cos. Inc. said the plaintiffs bluntly lobbed 16 counts against them and various subsidiaries over the Paragard intrauterine device, accusing all defendants of all alleged wrongdoings without breaking down the allegations against the companies.

The plaintiffs say the Paragard devices broke inside their bodies without warning and despite assurances that the birth control method was safe. Claims include negligence, fraud, warranty breach, failure to warn, strict liability and violation of consumer protection laws.

Plaintiffs contend that the Paragard label is insufficient to warn users about the potential for it to break; the warning section of the label didn’t even contain the word “break” until 2019.

The U.S. Judicial Panel on Multidistrict Litigation consolidated more than 100 cases and transferred them to Judge May in December, after hearing arguments from counsel about who should take the consolidated suits. Judge May decided lead counsel in the MDL in February.



An untested legal maneuver could help Johnson & Johnson wipe out billions of dollars in claims over its allegedly cancer-causing talcum powder, but pending legislation and likely fraud allegations may block a move plaintiffs’ lawyers deride as a “Texas two-step.”

The company is facing pressure to shake up its legal strategy after losing a series of trials in cases alleging it concealed cancer risks, including a $2.1 billion verdict that the U.S. Supreme Court declined to review this summer. Attorneys for some plaintiffs have said J&J is considering what’s known as a “Texas two-step,” which would involve using the state’s “divisive merger” statute to split off its talc liabilities into a separate entity that would then file for bankruptcy.

The maneuver, which bankruptcy law professor Samir Parikh described as a “corporate mitosis,” could help J&J minimize payouts as it faces nearly 35,800 open claims in federal multidistrict litigation and even more cases in state courts. But it’s far from guaranteed to work.

Talc plaintiffs in various jurisdictions are doing what they can to stop it. A group of claimants in the bankruptcy of Imerys Talc America, a longtime J&J partner, unsuccessfully sought an injunction to block J&J from the move. A group of Missouri plaintiffs filed a similar motion before dismissing it voluntarily, while a third injunction bid was made in New Jersey state court.

The flurry of motions shows the plaintiffs “are scared,” said Parikh, and that’s likely what J&J wants. Just the threat of a Texas two-step can serve J&J by moving the plaintiffs closer to a settlement figure that the company could stomach.

The company last year set aside $4 billion for talc settlements and other legal costs.

A bedrock principle of bankruptcy law is that a company seeking the protections of bankruptcy cannot hinder, delay or defraud creditors. Moving money before bankruptcy in order to avoid paying back debts is the quintessential fraudulent transfer.

Observers agree there’s a good chance J&J will face such a challenge if it executes a Texas two-step. But the ultimate outcome is hard to predict because no two-step has yet been seen through to completion in the few years they’ve been tried.

Besides the energetic pushback from plaintiffs, J&J could see more trouble on another front.

A group of congressional Democrats has introduced legislation that, on its face, is unrelated to J&J. But in the bankruptcy context, it could make a difference, since the legislation would block “third-party nonconsensual releases.”

In English, it would mean that the bankruptcy process could not block litigation by people who were never part of the bankruptcy and never agreed to have their claims erased.

The legislation currently sitting in each chamber’s Judiciary Committee, and neither is currently showing a hearing scheduled on it.

At stake are the claims of a legion of cancer patients — and in some cases, their surviving family members — who used talcum powder and then, some time afterwards, were found to have cancer.

The company took talc powder off U.S. shelves, but it remains available in other markets.

J&J has not settled yet, and for the time being is content to keep fighting the litigation.