Johnson & Johnson announced Tuesday that it would stop selling the talc-based Johnson’s Baby Powder in the United States amid consumer concerns about the safety of the product. The company said that consumer demand for the product had declined “due in large part to changes in consumer habits and fueled by misinformation around the safety of the product and a constant barrage of litigation advertising.”

J&J has faced a barrage of lawsuits from consumers saying that its talc-based products, including Baby Powder, caused their cancer. As of March 2020, around 19,400 plaintiffs had filed suits in U.S. courts against J&J, claiming that its talc products caused ovarian cancer and mesothelioma.

The company has denied the allegations against it, maintaining that its products are safe. While the company has prevailed in some suits, it has lost some substantial verdicts. This past February, a jury in J&J’s home state of New Jersey ordered J&J to pay $750 million in punitive damages after it found that the company had failed to warn consumers about dangers of Baby Powder. While the state court judge in the New Jersey case reduced the award to $186.5 million, the case marked the fifth loss for J&J in 2019.

This won’t be the first time that J&J has pulled Baby Powder from store shelves. Late last year, the company recalled 33,000 bottles of Baby Powder after the U.S. Food & Drug Administration reported that it had found trace amount of asbestos in a bottle.

J&J will continue to sell its cornstarch-based version of the product.

The impurity, N-Nitrosodimethylamine (NDMA), is commonly ingested in the human diet. NDMA is present in low levels in food and water. But the FDA discovered that the NDMA in Zantac increases over time, especially when the product is exposed to higher temperatures during distribution and consumer handling of the drug. These increases in NDMA can expose those that take the drug to high levels of NDMA, which may increase the risk of cancer.

The FDA has now advised all manufacturers of Zantac and other ranitidine drugs to pull their products from the market. Many large pharmacies, like Walgreens, Rite Aid, and CVS, have already removed the products from their shelves. Sanofi, the manufacturer of brand-name Zantac, said that it recalled all its products last October and that it continues to work the FDA to assess safety risks with the product.

The agency also says that consumers should stop taking the drug if they are taking an over-the-counter version and speak to their health care professional about alternatives if they are taking a prescription version of the drug. The FDA says that it has not found NDMA in Pepcid, Tagamet, Nexium, Prevacid, or Prilosec, drugs which the agency has approved for the same or similar uses as Zantac. Nexium and Prilosec have problems of their own, however, as studies have linked those drugs to chronic kidney disease.

The FDA continues to investigate the issues with Zantac and encourages health care professionals and patients to report problems with the drug.

As we strive to limit the impact of COVID-19, we continue to closely monitor all CDC and governmental announcements, guidelines and recommendations to ensure we do our part in protecting the public from further spread of COVID-19. We appreciate your patience and understanding as we all get through this.

If you have any questions, please contact us.

Thank you.

Links: CDC WHO

The trial is the first to come to judgment in the United States on the issue of whether Bayer and BASF should be held liable for damage attributed to their herbicide. Farmers across the country have brought lawsuits against the companies, saying that the herbicide can drift for miles when applied and damage cropland far from the site of application. In late 2018, the U.S. Environmental Protection Agency validated some of these concerns, imposing restrictions on the use of dicamba over worries that it could damage nearby crops.

The jury in Bader’s case awarded the farm $15 million in actual damages and $250 million in punitive damages. Both Bayer and BASF have expressed disappointment in the verdict and have vowed to appeal the jury’s decision. The companies say that dicamba herbicides are safe when used correctly.

Lawyers representing farmers say that this verdict is promising for other dicamba plaintiffs. The Missouri jury awarded $50 million more in punitive damages than the plaintiff’s legal team asked for. And the jury acted quickly. It only took thirty minutes to decide on the $250 million punitive damages award.

Lawyers also say that Bader’s case was a difficult one and that other cases could be easier to prove. In Bader’s case, Bayer was able to argue that the peach trees were not damaged by dicamba. But that defense is more difficult to argue in soybean cases. Soybean leaves damaged by dicamba have a “cupped” look, which should make it harder for Bayer to deny that there was any exposure.

Dicamba lawsuits are not the only legal challenges Bayer is facing over their herbicide products. The company is currently in mediation to try to settle thousands of lawsuits claiming that Roundup weed killer causes cancer. More than 40,000 plaintiffs say that Roundup causes a cancer called non-Hodgkin’s lymphoma. People familiar with the Roundup cases say that the settlement in those cases could top $10 billion.

Both the Roundup and dicamba lawsuits have Bayer investors worried. In 2018, Bayer acquired Monsanto, the producer of both Roundup and dicamba, for $63 billion. Since that acquisition, Bayer has lost three Roundup trials and now one dicamba trial. Investors have responded. Bayer shares have fallen since that acquisition and activist investors are calling for the company to split its pharmaceutical and agriculture divisions.

But the agriculture division is not the only part of Bayer causing headaches for investors. Bayer is also set to face trials concerning its Essure birth control devices. Women in those suits say that the devices cause pain, bleeding, autoimmune disorders, and a host of other problems.

For now, Bayer’s heels are dug in on dicamba. Bayer says that it plans to file post-trial motions in Bader’s case within the next month and ask the judge to overturn the jury’s verdict. If that fails, it plans to take its efforts to the Missouri appellate courts.

JUUL has increasingly come under fire after a string of deaths linked to e-cigarettes or vaping products. The U.S. Centers for Disease Control has, as of October 22, linked 34 deaths to use of the products and has received reports of lung injury in users in 49 states and the District of Columbia. The New York Times found that over 1,600 cases of vaping illnesses have been reported in the United States. These injuries, combined with evidence that JUUL marketed their products to children, have led several consumers to file lawsuits against the e-cigarette company.

On October 16, JUUL was hit with a wrongful death suit brought by a Flordia woman whose 18-year-old son died in his sleep. Lisa Vail said that her son had become addicted to JUUL products and was hospitalized three times for lung and breathing complications that she attributes to vaping. School districts are also suing the company, claiming that the products endanger their students and divert school resources to battling nicotine addiction.

These suits and broader criticism of JUUL have led to internal shakeups in the company. Top executives are out and the company plans to lay off 10 to 15% of its staff. Breja’s suit is likely to bring more attention to the company, which remains under investigation by the U.S. Food and Drug Administration, the Federal Trade Commission, state attorneys general, and several congressional committees.

JUUL says that Breja’s suit is baseless and says it will defend itself against his claims.

The couple, Alva and Alberta Pilliod, had used Roundup for decades on their California property. Now both in their 70s, the Pilliods learned within the past few years that they shared a diagnosis: non-Hodgkin’s lymphoma.

Previous verdicts against Monsanto had awarded $159 million to plaintiffs that claimed that Roundup caused their cancer. In August 2018, a San Francisco jury awarded $289 million to Dewayne Johnson, a school groundskeeper who had developed non-Hodgkin’s lymphoma after using Roundup for his job. A judge later slashed that verdict to $78 million. In March 2019, another California jury ordered Monsanto to pay Edwin Hardeman $80 million after determining that Roundup was a “substantial factor” in causing his cancer.

The size of the present verdict was a deliberate strategy by plaintiffs’ lawyers to encourage the company to change their practices. In closing arguments in the Pilliods’ case, lawyer Brent Wisner asked for $1 billion in punitive damages, a number based on the $892 million in profit recorded by the agricultural chemicals division of Monsanto in 2017. “That is a number that changes things,” Wisner said.

The numbers have been changing things for Bayer, who acquired Monsanto late last year. Since purchasing Monsanto for $63 billion, Bayer shares have fallen more than 45 percent. Investors have revolted. In a nonbinding vote, investors refused to absolve Bayer’s management of responsibility for their actions in acquiring Monsanto. Commentators have suggested that dramatic action, like splitting up Bayer’s agriculture and pharmaceutical divisions might be necessary to mitigate losses. Others have said that Bayer should explore settlement options.

Bayer CEO Werner Baumann has hinted in the past that a global settlement might be on the table. The company still faces over 13,000 lawsuits linking Roundup to cancer. Moody’s, the credit reporting agency, said in a report that Bayer could settle the lawsuits for $5.6 billion without affecting their credit rating. But despite Baumann’s earlier signals, Bayer continues to say that Roundup is safe.

The principal ingredient in Roundup is glyphosate, the world’s most widely used herbicide. In 2015, the International Agency for Research on Cancer, an arm of the World Health Organization, classified glyphosate as “probably carcinogenic to humans.” The U.S. Environmental Protection Agency disagrees. The agency said late last month that “EPA continues to find that there are no risks to public health when glyphosate is used in accordance with its current label and that glyphosate is not a carcinogen.”

Bayer is likely to rely on the EPA’s determination in their appeals. Lawyers for Bayer say that the scientific evidence is on their side and that they should have been able to introduce more recent studies at trial. Bayer also says that the EPA’s position that Roundup is not dangerous would have made it impossible to change Roundup’s label to provide an adequate warning.

Not everyone at the EPA appears to agree about the agency’s determination, however. Documents unsealed in 2017 showed that Monsanto had ghostwritten scientific studies and that federal officials at the EPA had worked to prevent review of glyphosate. Internal documents at Monsanto have told a similar story. Following the $2 billion verdict, Wisner said in a statement, “The jury saw for themselves internal company documents demonstrating that, from Day 1, Monsanto has never had any interest in finding out whether Roundup is safe.”

Analysts say that this is an unusual move for J&J, a company not known for quickly settling claims about its products. A move to settle claims in quick fashion may indicate that the company has shifted its strategy toward the litigation over whether its talc products, like Baby Powder and Shower-to-Shower, cause cancer. J&J denies that there has been any such shift in its strategy and maintains that the products are safe. A Reuters report late last year revealed that company officials knew for decades that asbestos, a compound linked cancer, was present in its products and sought to conceal that fact from U.S. regulators.

The pharma company currently faces thousands of lawsuits across the country that say that its talc products are responsible for ovarian cancer and mesothelioma. Though J&J has won reversals and verdicts in a few cases, the litigation has seen large plaintiff verdicts, including a $4.7 billion verdict for 22 women in Missouri. In that case, the judge had remarked that J&J’s behavior was “particularly reprehensible.” More recently, a California jury awarded a mother of two $29 million on her claim that J&J’s talc products were a substantial contributing factor to her cancer.

The cases that have settled so far all involve mesothelioma. J&J will face more trials this year, most of which also involve mesothelioma.

The jury found for Hardeman on his defective design, failure to warn, and negligence claims against Bayer last week. The company disputes the verdict. Bayer, who acquired Monsanto and Roundup for $63 billion last year, says that the verdict is against the weight of the scientific evidence and will appeal. Scientific experts at the International Agency for Research on Cancer found in 2015 after review of about 1000 studies that glyphosate, the prinicpal ingredient in Bayer’s Roundup, was “probably carcinogenic to humans.”

The latest verdict only represents one of the more than 11,000 cases Bayer faces nationwide making similar claims about Roundup’s carcinogenicity. One case last year initially awarded a California groundskeeper $289 million after he successfully argued that Roundup caused his cancer. But Hardeman’s case may prove more significant than this earlier trial. The judge in Hardeman’s case, Vince Chhabria, is currently overseeing hundreds of Roundup cases and has designated Hardeman’s case a “bellwether” trial. Historically, bellwether trials serve as benchmarks for eventual settlements.

Late last year, after the first California verdict, Bayer CEO Werner Baumann suggested that the company might be eyeing settlement in the Roundup cases. Certainly, settlement is likely on the minds of Bayer executives after shares in the company slid 12 percent in one day of trading following the most recent verdict.

Chhabria has scheduled two more Roundup cancer trials to occur this year, one in May, and another later this year. Bayer will also face additional lawsuits in state courts this year.

Bayer stock dipped in early morning trading on Wednesday following the verdict. “We are disappointed with the jury’s initial decision, but we continue to believe firmly that the science confirms that glyphosate-based herbicides do not cause cancer,” the pharmaceutical company said in a press release following the verdict. The company said that it believes that they will prove in the second stage that their conduct does not merit liability or damages.

This is the second jury verdict in a matter of months that has gone against Bayer. In August 2018, a San Francisco jury awarded a California school groundskeeper $289 million in case making similar claims about the connection between Roundup and cancer. Though the award in that case was diminished as a matter of law, it still marked a significant loss for Bayer. Some commentators have begun to question whether the German Bayer AG should have acquired Monsanto in the first place, calling Monsanto a “symbol of unbridled greed” and the “embodiment of a misguided form of agriculture.”

Bayer promises to continue to challenge the lawsuits in the United States. Though Bayer’s CEO Werner Baumann had earlier floated the idea of settling the lawsuits, Baumann now appears committed to fighting the Roundup cancer lawsuits, saying that the new suits will be handled by a more experienced litigation team. Nevertheless, the company is facing increased pressure from investors and has been cutting jobs and selling off parts of the company.

Bayer still faces over 11,000 lawsuits from home gardeners, farmers, and other users of their products claiming that glyphosate-based herbicides like Roundup cause cancer. Six more trials will start this year in federal and state courts over the Roundup cancer claims.

Teresa Leavitt, the woman at the center of the case, argued that Johnson & Johnson’s Baby Powder was a substantial contributing factor in causing her mesothelioma. Because of her cancer, the mother of two is not expected to live past 2020. Though Ms. Leavitt testified that she stopped using J&J’s Baby Powder decades ago, recent tests revealed that she had asbestos in her lungs. J&J argued that there was no credible evidence that their products caused Ms. Leavitt’s cancer and that the asbestos could have come from other sources.

A jury in the Alameda County Superior Court ultimately agreed with Ms. Leavitt and found Johnson & Johnson liable for harm that Leavitt suffered due to her cancer.

J&J disputes the verdict, citing “serious procedural and evidentiary errors,” and plans to appeal. In a statement issued Wednesday, the company continued to maintain that its products are safe: “We respect the legal process and reiterate that jury verdicts are not medical, scientific or regulatory conclusions about a product.” A Reuters investigation of J&J’s internal documents in December 2018 suggested that the company has known for decades that its talc products contained asbestos and failed to disclose that information to the public. J&J has refused to place any kind of warning label on their products.

This verdict marks J&J’s seventh trial loss in claims related to its talcum powder products. The company’s stock has responded in kind, dropping nearly two percent in after-hours trading following the latest verdict. More than two dozen additional trials are scheduled for this year over J&J’s talc products.