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Westlake Legal Group > Recalls and Bans of Products

Johnson & Johnson Recalls Baby Powder Over Asbestos Worry

Westlake Legal Group merlin_148254753_920dc85e-393b-480e-8f1d-4ce778d1fde8-facebookJumbo Johnson & Johnson Recalls Baby Powder Over Asbestos Worry Shopping and Retail Recalls and Bans of Products Johnson&Johnson Food and Drug Administration Asbestos

Johnson & Johnson, which has spent years insisting that its baby powder is safe, recalled 33,000 bottles of the product on Friday after the Food and Drug Administration discovered evidence of asbestos, a known carcinogen, in one of the bottles.

The recall, the first time Johnson & Johnson has pulled baby powder from store shelves over asbestos concerns, could undercut its defense against a swarm of allegations that its talc-based products caused cancer. It comes as the company, which reaches into the lives of millions of people through brands such as Tylenol, Band-Aid and Rogaine and reported nearly $82 billion in sales last year, is entangled in numerous legal battles over the safety of its products.

The company has settled some claims — and is still fighting others — involving its role in the nationwide opioid crisis. On Thursday, Johnson & Johnson agreed to pay $117 million in a settlement over the deceptive marketing of transvaginal pelvic mesh implants, and a jury this month ordered it to pay $8 billion to a Maryland man who accused the company of playing down the risks associated with the antipsychotic drug Risperdal. In total, the company faces more than 100,000 lawsuits over its products.

More than 15,000 of those are from people who say baby powder and other talc-based products caused them to develop cancer. Some have mesothelioma, an aggressive cancer that is considered the signature disease of asbestos exposure, while others have ovarian cancer.

The decision to pull the baby powder, sourced from China and distributed last year, is a “whopper” for a company as dependent on consumer trust as Johnson & Johnson, said David Noll, a law professor at Rutgers University.

“I can’t imagine an attorney for Johnson & Johnson standing up in front of a jury now and saying with a straight face that the product is safe,” Mr. Noll said. He added that “if people come to associate the company’s signature product with deadly diseases, there will be huge spillover effects for its ability to market other products.”

The recall was prompted by the FD.A.’s discovery of trace levels of chrysotile asbestos in samples from a bottle of baby powder bought from an online retailer. The company said it was informed of the results on Thursday and recalled bottles from lot number 22318RB out of an “abundance of caution,” though the F.D.A. advised consumers with baby powder from the affected lot to “stop using it immediately.”

But Johnson & Johnson also repeated its longstanding defense against cancer claims, saying that “thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos.” The company appeared to question the testing process, saying in a statement that it is working with the F.D.A. to “determine the integrity of the tested sample and the validity of the test results.”

Dr. Susan Nicholson, Johnson & Johnson’s vice president of women’s health, said during a short conference call with investors on Friday that the F.D.A.’s report showed “an extremely unusual finding” that was “inconsistent with our testing to date.”

In response, an agency spokeswoman, Gloria Sánchez-Contreras, said, “The F.D.A. stands by the quality of its testing and results.”

Analysts estimate the baby powder lawsuits could cost Johnson & Johnson $5 billion to $10 billion. The recall could lead to the company’s having to pay more in damages or to settle cases, said Erik Gordon, a University of Michigan business professor who studies corporate governance. Shares of the company closed down more than 6 percent on Friday.

Plaintiffs in the talc cases have accused Johnson & Johnson of failing to warn customers of the risks of asbestos contamination, despite being aware of concerns for decades. A New York Times investigation last year found internal memos and reports made public during litigation that document executives’ concerns about potential contamination that date back 50 years.

[Read our investigation into claims about asbestos in baby powder.]

Johnson & Johnson disclosed this year that it was being investigated by the Justice Department and the Securities and Exchange Commission over concerns about possible asbestos contamination of its talc-based products.

Johnson & Johnson is awaiting a major decision that could tilt the talc litigation in its favor. As part of pretrial proceedings for thousands of talc lawsuits consolidated in New Jersey, a federal judge is mulling whether to block testimony from expert witnesses hired by plaintiffs, a move that could cause many talc cases to be dismissed or dropped.

[Thousands of people who trusted Johnson & Johnson’s baby powder for decades are suing the company after developing cancer. “The Weekly,” our new TV show, investigates their allegations.]

Baby powder represents a tiny fraction of Johnson & Johnson sales but an outsize threat to its reputation.

Johnson & Johnson’s name is “so synonymous with their line of baby products,” said Alla Valente, an analyst with Forrester. But recently, she said, the company has started a “damage control campaign” that casts it as bigger than its baby powder, focusing on its slate of other products.

“It’s about trust: If a mother could trust a Johnson & Johnson product for their children, then that product must be safe,” Ms. Valente said. “But now, the dam is finally breaking, where consumers are saying that enough is enough.”

Talc is a natural mineral, formed in underground deposits under the same geological conditions as asbestos. In mines, veins of asbestos can intermingle with talc, geologists say.

Johnson & Johnson officials emphasized on Friday that the level of asbestos detected was very low, just a fraction of 1 percent of the sample. United States health agencies, however, say there is no known safe level of exposure to asbestos.

While health risks increase with heavier and longer exposure to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

Several earlier F.D.A. tests, including one in the past year and another about a decade ago, did not detect any asbestos in samples of baby powder.

The F.D.A. does not require safety testing for personal-care products and cosmetics before they are marketed, and tests products only occasionally, usually after complaints by consumers or advocacy groups.

The agency considered — and soon abandoned — a plan to monitor talcum products for asbestos in the 1970s, when concern about asbestos in household products captured the public’s attention. The F.D.A. commissioned tests of Johnson & Johnson powders back then, and the company successfully challenged their validity.

This year, after consumer tests found asbestos in makeup kits for children sold at Claire’s, the F.D.A. followed up with its own tests. It detected the carcinogen in half of 20 products, including Claire’s eye shadow and compact powder, JoJo Siwa makeup sold at Claire’s, and bronzers, blush and other makeup made by Beauty Plus Global City Color Cosmetics and sold in retail outlets. The products were eventually recalled.

The agency plans to test 30 more products containing talcum powder, including those popular on social media and others marketed to children, Ms. Sánchez-Contreras said. The products are a tiny percentage of the thousands of personal-care products available for sale.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Johnson & Johnson Recalls Asbestos-Tainted Baby Powder

Westlake Legal Group merlin_148254753_920dc85e-393b-480e-8f1d-4ce778d1fde8-facebookJumbo Johnson & Johnson Recalls Asbestos-Tainted Baby Powder Shopping and Retail Recalls and Bans of Products Johnson&Johnson Food and Drug Administration Asbestos

Johnson & Johnson is recalling a shipment of baby powder after the Food and Drug Administration discovered evidence of asbestos in one of the bottles, the company said on Friday, a move that undercuts its defense in a growing number of claims that its talc-based products were contaminated with the potent carcinogen.

The regulator found trace levels of chrysotile asbestos in samples taken from a bottle of baby powder purchased from an online retailer, Johnson & Johnson said. The company has, for years, denied that the carcinogen is, or ever was, present in its talc-based products.

This is the first time Johnson & Johnson has ever pulled baby powder from the market over asbestos concerns, a spokesman for the company said, and comes as Johnson & Johnson is battling thousands of lawsuits brought by people who say that baby powder and other talc-based products caused them to develop cancer. Some have mesothelioma, an aggressive cancer that is considered the signature disease of asbestos exposure, while others have ovarian cancer, which has also been linked to asbestos.

The recall will undermine defense claims against those suits, and could lead to the company having to pay more or to settle cases, said Erik Gordon, a University of Michigan business professor who studies corporate governance. Shares of the company fell 5 percent in early afternoon trading on Friday.

But in announcing the recall, the company also repeated part of its long-running defense against cancer claims, saying that “thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos.” The company said it was recalling the shipment out of an “abundance of caution.”

Though Johnson & Johnson said it has started “a rigorous, thorough investigation into the matter” it also appeared to question the testing process, saying in a statement that it is working with the F.D.A. to “determine the integrity of the tested sample and the validity of the test results.”

The recalled baby powder was produced and shipped last year. The recalled lot, #22318RB, involves 33,000 bottles sold by a retailer, which sold products online but may have shipped powder to stores, the spokesman, Ernie Knewitz, said. The F.D.A. has not responded to questions about the identity of the retailer.

A New York Times investigation last year found that Johnson & Johnson executives were aware for decades of the risks of asbestos contamination in talc but did not warn consumers. Internal memos and reports made public during litigation against the company document executives’ concerns about potential contamination that date back 50 years.

Earlier this year, Johnson & Johnson disclosed that it is being investigated by the Justice Department and Securities and Exchange Commission over concerns about possible asbestos contamination of its talc-based products.

The company is now entangled in litigation on multiple fronts. On Thursday, it agreed to pay $117 million to settle claims that it deceptively marketed transvaginal pelvic mesh implants. Earlier this month, a jury in Philadelphia ordered Johnson & Johnson to pay $8 billion to a Maryland man who accused the company of downplaying the risks associated with the anti-psychotic drug Risperdal. The company has also agreed to settle claims involving its role in the nationwide opioid crisis.

Lee Hambright, an analyst with Bernstein, wrote in a note to clients last week that Johnson & Johnson could face $5 billion in legal liability over the talc litigation. Of the 15,500 talc lawsuits the company has disclosed, Mr. Hambright estimated that 1,000 involved mesothelioma cases.

[Read our investigation into claims about asbestos in baby powder.]

Talc is a natural mineral that is mined from underground deposits, but asbestos can form under the same geological conditions that form talc, and geologists say veins of asbestos can intermingle with talc in underground mines.

Johnson & Johnson officials emphasized that the level of asbestos detected was very low, the amount being “two ten-thousands of a percent” of the sample. U.S. health agencies, however, say there is no known safe level of exposure when it comes to asbestos.

While health risks increase with heavier and longer exposure times to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

[Thousands of people who trusted Johnson & Johnson’s baby powder for decades are suing the company after developing cancer. “The Weekly,” our new TV show, investigates their allegations.]

This is a developing story that will be updated.

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Juul Replaces Its C.E.O. With a Tobacco Executive

The vaping powerhouse Juul Labs replaced its chief executive with a veteran of Big Tobacco on Wednesday, deepening the company’s turmoil and raising doubts about the very future of the e-cigarette industry.

The sudden announcement capped a relentless cascade of events that has called into question the safety of devices once billed as a promising alternative to cigarettes, one of the world’s leading preventable causes of death. Now, Juul is looking to that very industry for its survival as it faces a federal criminal inquiry, new bans on some of its products, and an onslaught of state and federal regulatory investigations into its marketing practices.

Early Wednesday morning, after frantic days of internal meetings, the company announced that its current chief executive, Kevin Burns, would resign as chief executive. His chosen replacement is K.C. Crosthwaite, a top official at Altria, the cigarette giant that bought a 35-percent share in Juul for $12.8 billion last December and has seen the company it invested in rocked by growing crisis.

In another sign of regulatory and business uncertainty, Altria and Philip Morris International said on Wednesday that they had ended talks to merge, dashing the chances of reuniting the two arms of what had once been the tobacco giant Philip Morris.

The e-cigarette industry — which Juul commands, with more than 70 percent of the market — is being threatened by twin public health crises: the rise of teenage vaping, which public health officials fear could create a new generation of nicotine addicts, and a surge of severe lung illnesses, including at least 11 deaths, linked to vaping.

Dr. David Kessler, a former commissioner of the Food and Drug Administration, said that in light of the epidemic of youth vaping, he doubted that any e-cigarette company could now prove that the benefits of its products outweighed the risks — a critical factor to win agency approval to stay on the market in the United States.

“In some ways the last several years has provided a record where it’s hard to see that these products could ever meet the ‘protection of public health standard,’” Dr. Kessler said. “And if they can’t meet that standard, they can’t be marketed.”

Testifying at a congressional hearing on Wednesday, the acting F.D.A. commissioner, Dr. Ned Sharpless, appeared to echo that sentiment, saying, “We really don’t think anyone should be using e-cigarettes, except perhaps a person who is using it instead of a combustible cigarette.”

Dr. Sharpless said the agency could have done more to keep the products away from teenagers. “In retrospect the F.D.A. should have acted sooner,” he said. “We’re going to catch up.”

In addition to the deaths, 530 cases of the lung sicknesses have been reported by the Centers for Disease Control and Prevention, causing public health agencies to warn most people to refrain from vaping any substance.

Many of the patients have said they had been vaping THC, the high-inducing ingredient in marijuana, when they became short of breath and grew sicker, officials have reported. But some said they were using just nicotine, or both.

Juul sells only nicotine products along with its sleek and popular vaping pens. Nevertheless, the company has become synonymous with vaping generally for much of the public.

“Juul is the face of the current public health crisis. Heads need to roll,” said Stefanie Miller, a co-founder of Sandhill Strategy, which consults with investment firms on regulatory policy, particularly tobacco-industry regulations. “To see the top head roll is a sign to public health, investors, to everyone that they know they need to make some changes.”

In announcing its change of leadership, Juul appeared to cave on issues that could be detrimental to its business. It said it would not fight a Trump administration proposal to ban most flavored e-cigarettes, which would slash its domestic sales. The company also said it would end one of its marketing campaigns, “Make the Switch,” which the F.D.A. warned could be construed as an illegal effort to portray its e-cigarettes as safer than traditional cigarettes.

A Juul employee said the company was also considering whether it should abandon its multimillion-dollar campaign on a ballot initiative to overturn an e-cigarette ban that is to take effect in San Francisco early next year.

ImageWestlake Legal Group merlin_161482992_d7bca353-1885-4105-bcb4-f2694ab1bfbf-articleLarge Juul Replaces Its C.E.O. With a Tobacco Executive Teenagers and Adolescence Smoking and Tobacco Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products Philip Morris Companies Inc Mergers, Acquisitions and Divestitures Juul Labs Inc Food and Drug Administration E-Cigarettes Crosthwaite, K C Burns, Kevin R Appointments and Executive Changes Altria Group Inc

Kevin Burns, the outgoing Juul Labs C.E.O., in June.CreditLea Suzuki/San Francisco Chronicle, via Polaris

Within the last week alone, several television networks decided to stop broadcasting Juul’s ads; Massachusetts announced a four-month ban on the sale of all vaping products; Rhode Island announced a ban on flavors; Walmart said it would stop selling all e-cigarettes; and the F.D.A. announced it had opened a criminal inquiry into the supply chain of vaping products and devices. The Federal Trade Commission also has been investigating Juul’s marketing practices. And the United States attorney for Northern California opened a criminal investigation into the company, a development first reported by The Wall Street Journal.

On Sept. 10, President Trump met with Dr. Sharpless and Alex M. Azar II, the health and human services secretary. After informing the president of another spike in teenage vaping, the two officials said they would issue the proposed ban on most flavored e-cigarettes within several weeks.

That would include mint and menthol, they said, although some vaping industry leaders have vowed to contest the inclusion of those two items. Juul has said mint and menthol now account for about 80 percent of its products and a ban on those would severely hurt its domestic sales.

All of this foreshadows a regulatory showdown at the F.D.A. that is slated to begin in May next year when the agency will determine what, if any, e-cigarettes can remain on the domestic market.

“The United States is moving toward asking vaping companies for permission to sell any products,” Ms. Miller from Sandhill Strategy said. “The people they’re asking, the F.D.A., have shown these products are killing people.”

The turn in fortunes for Juul, and perhaps e-cigarettes generally, culminates one of the biggest disagreements in public health in recent years: whether e-cigarettes would prove a benefit to society. Supporters of e-cigarettes have argued that these devices have the potential to save millions of lives and billions of dollars by providing a safer alternative to the nation’s leading killer, traditional cigarettes.

Some investment advisers pointed to the disarray with e-cigarettes as a potential benefit to traditional smoking. “The recent media scrutiny on vaping will help overall cigarette consumption,” Nik Modi, a tobacco-industry analyst for RBC Capital Markets, wrote in a message to investors.

In recent weeks, as Juul sales have slowed, sales of cigarettes declined at a slower pace with each passing week, according to Nielsen, a market-research firm.

But skeptics have said all along that not enough is known about the long-term health effects of e-cigarettes and assert that they, and Juul, in particular, have spurred heavy experimentation by teenagers.

The upshot may drive the market for e-cigarettes overseas, a market that Juul’s new chief executive, Mr. Crosthwaite, highlighted to employees in an all-hands meeting at the company headquarters on Wednesday morning.

“International expansion continues to be a huge opportunity given the number of smokers around the world,” he told employees.

But the company’s initial foray in China this month failed almost immediately, and last week India also said it would ban the sale of e-cigarettes.

Mr. Crosthwaite, in coming from Altria, brings to Juul the experience of working for one of the most regulatory-savvy companies in the world; the tobacco industry has navigated perilous straits in keeping its product on shelves and pushing internationally, despite cigarettes being a proven, addictive killer.

In a speech to a tobacco industry gathering in Washington on Wednesday, Howard Willard III, chief executive of Altria, said Mr. Crosthwaite would help Juul “urgently control, confront and reduce youth vaping,” and deal with the company’s other problems.

“This is a pivotal moment,” he said. “Vaping is at an inflection point.”

Dr. Ned Sharpless, the F.D.A. acting commissioner, testified about the threats of e-cigarettes to the public before a House subcommittee on Wednesday.CreditPete Marovich for The New York Times

Despite the public concerns, Altria invested $12.8 billion in Juul in 2018 for a 35 percent stake, valuing Juul at about $38 billion. Mr. Crosthwaite became a board observer at Juul.

As for the decision to end the merger talks between Philip Morris and Altria, the two companies said they would instead focus on rolling out the IQOS heated tobacco product in the United States. They emphasized that IQOS, which Philip Morris International sells abroad and which has received F.D.A. approval for sale in the United States, is not “an e-vapor product.”

IQOS is a penlike electronic device with a battery pack that resembles a cigarette case. It features a heating blade that warms a tobacco stick and emits a vapor with the taste of tobacco, but with fewer noxious chemicals than cigarette smoke. The F.D.A. has approved it for sale in the United States and said the product could help people to quit smoking. The agency is still weighing whether to permit Altria to be marketed as a reduced-risk product.

Investors had appeared largely skeptical of the potential deal, despite the companies arguing that reuniting could revive their fortunes amid a decline in cigarette sales.

On Wall Street, analysts said they were not that surprised by the abrupt end to the merger talks, especially given the steady drumbeat of negative headlines around vaping and Juul’s products. The stock of Philip Morris International ended Wednesday up more than 5 percent at $75.28, while Altria’s stock ended essentially flat at $40.56.

But Altria is likely to face a bumpier future amid the uncertainty around Juul.

Analysts said it was increasingly likely that Altria might have to write down the value of its $12.8 billion investment in Juul, given the recent developments and uncertainty surrounding the company.

“When the Juul transaction was done, it valued the company at around $37 billion,” said Garrett Nelson, an analyst at CFRA Research. “Juul’s valuation today is probably a fraction of that.”

Meanwhile, Altria’s debt levels more than doubled as it borrowed to buy the Juul stake, he noted.

Tim Hubbard, an assistant professor of management in the University of Notre Dame’s Mendoza College of Business, said it was not surprising that Mr. Burns was stepping down from the company as it had struggled to adapt to the swift change of perceptions, from a company that was providing an alternative to smoking to one that had been vilified.

“When compared to traditional tobacco products — which have remained on the shelves for decades despite being proven dangerous — e-cigarette makers have failed spectacularly,” Mr. Hubbard said in an email. “Bringing in a traditional tobacco executive who knows how to market and manage government relationships with deadly products matches the firm’s needs.”

Michael J. de la Merced and Katie Thomas contributed reporting.

Earlier coverage

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Juul Replaces Its C.E.O. With a Tobacco Executive

The vaping powerhouse Juul Labs replaced its chief executive with a veteran of Big Tobacco on Wednesday, deepening the company’s turmoil and raising doubts about the very future of the e-cigarette industry.

The sudden announcement capped a relentless cascade of events that has called into question the safety of devices once billed as a promising alternative to cigarettes, one of the world’s leading preventable causes of death. Now, Juul is looking to that very industry for its survival as it faces a federal criminal inquiry, new bans on some of its products, and an onslaught of state and federal regulatory investigations into its marketing practices.

Early Wednesday morning, after frantic days of internal meetings, the company announced that its current chief executive, Kevin Burns, would resign as chief executive. His chosen replacement is K.C. Crosthwaite, a top official at Altria, the cigarette giant that bought a 35-percent share in Juul for $12.8 billion last December and has seen the company it invested in rocked by growing crisis.

In another sign of regulatory and business uncertainty, Altria and Philip Morris International said on Wednesday that they had ended talks to merge, dashing the chances of reuniting the two arms of what had once been the tobacco giant Philip Morris.

The e-cigarette industry — which Juul commands, with more than 70 percent of the market — is being threatened by twin public health crises: the rise of teenage vaping, which public health officials fear could create a new generation of nicotine addicts, and a surge of severe lung illnesses, including at least 11 deaths, linked to vaping.

Dr. David Kessler, a former commissioner of the Food and Drug Administration, said that in light of the epidemic of youth vaping, he doubted that any e-cigarette company could now prove that the benefits of its products outweighed the risks — a critical factor to win agency approval to stay on the market in the United States.

“In some ways the last several years has provided a record where it’s hard to see that these products could ever meet the ‘protection of public health standard,’” Dr. Kessler said. “And if they can’t meet that standard, they can’t be marketed.”

Testifying at a congressional hearing on Wednesday, the acting F.D.A. commissioner, Dr. Ned Sharpless, appeared to echo that sentiment, saying, “We really don’t think anyone should be using e-cigarettes, except perhaps a person who is using it instead of a combustible cigarette.”

Dr. Sharpless said the agency could have done more to keep the products away from teenagers. “In retrospect the F.D.A. should have acted sooner,” he said. “We’re going to catch up.”

In addition to the deaths, 530 cases of the lung sicknesses have been reported by the Centers for Disease Control and Prevention, causing public health agencies to warn most people to refrain from vaping any substance.

Many of the patients have said they had been vaping THC, the high-inducing ingredient in marijuana, when they became short of breath and grew sicker, officials have reported. But some said they were using just nicotine, or both.

Juul sells only nicotine products along with its sleek and popular vaping pens. Nevertheless, the company has become synonymous with vaping generally for much of the public.

“Juul is the face of the current public health crisis. Heads need to roll,” said Stefanie Miller, a co-founder of Sandhill Strategy, which consults with investment firms on regulatory policy, particularly tobacco-industry regulations. “To see the top head roll is a sign to public health, investors, to everyone that they know they need to make some changes.”

In announcing its change of leadership, Juul appeared to cave on issues that could be detrimental to its business. It said it would not fight a Trump administration proposal to ban most flavored e-cigarettes, which would slash its domestic sales. The company also said it would end one of its marketing campaigns, “Make the Switch,” which the F.D.A. warned could be construed as an illegal effort to portray its e-cigarettes as safer than traditional cigarettes.

A Juul employee said the company was also considering whether it should abandon its multimillion-dollar campaign on a ballot initiative to overturn an e-cigarette ban that is to take effect in San Francisco early next year.

ImageWestlake Legal Group merlin_161482992_d7bca353-1885-4105-bcb4-f2694ab1bfbf-articleLarge Juul Replaces Its C.E.O. With a Tobacco Executive Teenagers and Adolescence Smoking and Tobacco Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products Philip Morris Companies Inc Mergers, Acquisitions and Divestitures Juul Labs Inc Food and Drug Administration E-Cigarettes Crosthwaite, K C Burns, Kevin R Appointments and Executive Changes Altria Group Inc

Kevin Burns, the outgoing Juul Labs C.E.O., in June.CreditLea Suzuki/San Francisco Chronicle, via Polaris

Within the last week alone, several television networks decided to stop broadcasting Juul’s ads; Massachusetts announced a four-month ban on the sale of all vaping products; Rhode Island announced a ban on flavors; Walmart said it would stop selling all e-cigarettes; and the F.D.A. announced it had opened a criminal inquiry into the supply chain of vaping products and devices. The Federal Trade Commission also has been investigating Juul’s marketing practices. And the United States attorney for Northern California opened a criminal investigation into the company, a development first reported by The Wall Street Journal.

On Sept. 10, President Trump met with Dr. Sharpless and Alex M. Azar II, the health and human services secretary. After informing the president of another spike in teenage vaping, the two officials said they would issue the proposed ban on most flavored e-cigarettes within several weeks.

That would include mint and menthol, they said, although some vaping industry leaders have vowed to contest the inclusion of those two items. Juul has said mint and menthol now account for about 80 percent of its products and a ban on those would severely hurt its domestic sales.

All of this foreshadows a regulatory showdown at the F.D.A. that is slated to begin in May next year when the agency will determine what, if any, e-cigarettes can remain on the domestic market.

“The United States is moving toward asking vaping companies for permission to sell any products,” Ms. Miller from Sandhill Strategy said. “The people they’re asking, the F.D.A., have shown these products are killing people.”

The turn in fortunes for Juul, and perhaps e-cigarettes generally, culminates one of the biggest disagreements in public health in recent years: whether e-cigarettes would prove a benefit to society. Supporters of e-cigarettes have argued that these devices have the potential to save millions of lives and billions of dollars by providing a safer alternative to the nation’s leading killer, traditional cigarettes.

Some investment advisers pointed to the disarray with e-cigarettes as a potential benefit to traditional smoking. “The recent media scrutiny on vaping will help overall cigarette consumption,” Nik Modi, a tobacco-industry analyst for RBC Capital Markets, wrote in a message to investors.

In recent weeks, as Juul sales have slowed, sales of cigarettes declined at a slower pace with each passing week, according to Nielsen, a market-research firm.

But skeptics have said all along that not enough is known about the long-term health effects of e-cigarettes and assert that they, and Juul, in particular, have spurred heavy experimentation by teenagers.

The upshot may drive the market for e-cigarettes overseas, a market that Juul’s new chief executive, Mr. Crosthwaite, highlighted to employees in an all-hands meeting at the company headquarters on Wednesday morning.

“International expansion continues to be a huge opportunity given the number of smokers around the world,” he told employees.

But the company’s initial foray in China this month failed almost immediately, and last week India also said it would ban the sale of e-cigarettes.

Mr. Crosthwaite, in coming from Altria, brings to Juul the experience of working for one of the most regulatory-savvy companies in the world; the tobacco industry has navigated perilous straits in keeping its product on shelves and pushing internationally, despite cigarettes being a proven, addictive killer.

In a speech to a tobacco industry gathering in Washington on Wednesday, Howard Willard III, chief executive of Altria, said Mr. Crosthwaite would help Juul “urgently control, confront and reduce youth vaping,” and deal with the company’s other problems.

“This is a pivotal moment,” he said. “Vaping is at an inflection point.”

Dr. Ned Sharpless, the F.D.A. acting commissioner, testified about the threats of e-cigarettes to the public before a House subcommittee on Wednesday.CreditPete Marovich for The New York Times

Despite the public concerns, Altria invested $12.8 billion in Juul in 2018 for a 35 percent stake, valuing Juul at about $38 billion. Mr. Crosthwaite became a board observer at Juul.

As for the decision to end the merger talks between Philip Morris and Altria, the two companies said they would instead focus on rolling out the IQOS heated tobacco product in the United States. They emphasized that IQOS, which Philip Morris International sells abroad and which has received F.D.A. approval for sale in the United States, is not “an e-vapor product.”

IQOS is a penlike electronic device with a battery pack that resembles a cigarette case. It features a heating blade that warms a tobacco stick and emits a vapor with the taste of tobacco, but with fewer noxious chemicals than cigarette smoke. The F.D.A. has approved it for sale in the United States and said the product could help people to quit smoking. The agency is still weighing whether to permit Altria to be marketed as a reduced-risk product.

Investors had appeared largely skeptical of the potential deal, despite the companies arguing that reuniting could revive their fortunes amid a decline in cigarette sales.

On Wall Street, analysts said they were not that surprised by the abrupt end to the merger talks, especially given the steady drumbeat of negative headlines around vaping and Juul’s products. The stock of Philip Morris International ended Wednesday up more than 5 percent at $75.28, while Altria’s stock ended essentially flat at $40.56.

But Altria is likely to face a bumpier future amid the uncertainty around Juul.

Analysts said it was increasingly likely that Altria might have to write down the value of its $12.8 billion investment in Juul, given the recent developments and uncertainty surrounding the company.

“When the Juul transaction was done, it valued the company at around $37 billion,” said Garrett Nelson, an analyst at CFRA Research. “Juul’s valuation today is probably a fraction of that.”

Meanwhile, Altria’s debt levels more than doubled as it borrowed to buy the Juul stake, he noted.

Tim Hubbard, an assistant professor of management in the University of Notre Dame’s Mendoza College of Business, said it was not surprising that Mr. Burns was stepping down from the company as it had struggled to adapt to the swift change of perceptions, from a company that was providing an alternative to smoking to one that had been vilified.

“When compared to traditional tobacco products — which have remained on the shelves for decades despite being proven dangerous — e-cigarette makers have failed spectacularly,” Mr. Hubbard said in an email. “Bringing in a traditional tobacco executive who knows how to market and manage government relationships with deadly products matches the firm’s needs.”

Michael J. de la Merced and Katie Thomas contributed reporting.

Earlier coverage

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Walmart to End Sales of E-Cigarettes as Vaping Concerns Mount

Walmart said on Friday that it would stop selling e-cigarettes at its stores in the United States, responding to growing concerns over the health effects of vaping and its soaring popularity among teenagers.

“Given the growing federal, state and local regulatory complexity and uncertainty regarding e-cigarettes, we plan to discontinue the sale of electronic nicotine delivery products,” the nation’s largest retailer said in a statement on Friday.

Walmart will continue selling e-cigarettes until its current inventory is exhausted, which could last until January. A company spokesman said the retailer would continue to sell traditional cigarettes.

The decision by Walmart underscores the way parents, doctors and government officials are increasingly treating e-cigarettes, marketed as smoking-cessation devices, as addictive and potentially dangerous products.

And it also represented a significant business move for Walmart. Although vaping products do not make up a large portion of the company’s overall revenue, e-cigarette shoppers tend to be younger and more loyal customers, who shop regularly and often buy other items when they come to replenish their vaping supplies.

“The e-cigarette shopper is a very important shopper for Walmart,’’ said Burt Flickinger, a managing director of the retail consulting firm Strategic Resource Group.

Walmart is not the first retailer to stop selling e-cigarettes. Rite Aid, one of the country’s biggest pharmacy chains, said in April that it would stop selling e-cigarettes and other vaping products over concerns that they were fueling tobacco use among middle and high school students across the United States.

In recent weeks, mounting medical concerns about the effects of vaping have prompted government investigations and warnings from medical groups.

On Thursday, medical authorities said that the number of vaping-related lung illnesses had risen to 530 probable cases, and a Missouri man became the eighth person to die from the mysterious ailments. Public health officials have said that many of the people who became sick were vaping THC, the ingredient in marijuana that induces a high, although some people have reported getting ill from vaping nicotine through e-cigarettes, too.

No one product or ingredient has been identified as the cause of the illnesses, and health experts say there may be multiple devices or ingredients involved.

Investigations are underway by the Centers for Disease Control and Prevention, the Food and Drug Administration and state health departments.

Much of the concern about vaping has focused on use among teenagers. Federal officials said on Wednesday that teenage vaping continued to increase this year, suggesting that campaigns to curb e-cigarette use among minors were not working.

Joshua Raffel, a spokesman for Juul Labs, the most popular e-cigarette company in the country, declined to comment. Last week, after the Trump administration said it would ban the sale of most flavored e-cigarettes, Juul said it strongly agreed “with the need for aggressive category-wide action on flavored products.”

David Sutton, a spokesman for Altria, which owns 35 percent of Juul, said, “We respect a retailer’s right to determine what products they want to sell.”

Walmart had raised the minimum age for tobacco products to 21 earlier this year, and said in May that it would also no longer sell “fruit- and dessert-flavored electronic nicotine delivery systems.”

The retailer’s decision to end e-cigarette sales entirely comes as it also grapples with its connections to the gun industry in the wake of the shooting in August at one of its stores in El Paso.

Earlier this month, Walmart said it would stop selling ammunition that could be used in military-style assault rifles, discourage its customers from openly carrying guns in its stores and call on Congress to increase background checks and consider a new assault rifle ban.

Michael Corkery and Sheila Kaplan contributed reporting.

Walmart Raises Minimum Age to Buy Tobacco Products to 21

May 8, 2019

Westlake Legal Group merlin_146750595_132ca16f-e184-4edc-bbb0-0f81ca005dd7-threeByTwoSmallAt2X Walmart to End Sales of E-Cigarettes as Vaping Concerns Mount Walmart Stores Inc Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products E-Cigarettes
Vaping Illnesses Increase to 530 Probable Cases, C.D.C. Says

Sept. 19, 2019

Westlake Legal Group 19VAPING1-threeByTwoSmallAt2X Walmart to End Sales of E-Cigarettes as Vaping Concerns Mount Walmart Stores Inc Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products E-Cigarettes
Is It Time to Quit Vaping?

Sept. 19, 2019

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Walmart to End Sales of E-Cigarettes

Walmart said on Friday that it would end sales of e-cigarettes at its locations in the United States, as medical concerns about the effects of vaping rise along with sicknesses and deaths seemingly linked to the habit.

“Given the growing federal, state and local regulatory complexity and uncertainty regarding e-cigarettes, we plan to discontinue the sale of electronic nicotine delivery products,” the nation’s largest retailer said in a statement on Friday. The company will continue to sell the devices until its current inventory of e-cigarettes is exhausted.

Walmart’s decision came a day after medical authorities said that the number of vaping-related lung illnesses had risen to 530 probable cases, and a Missouri man became the eighth to die from the mysterious ailments.

Investigations are underway by the Centers for Disease Control, the Food and Drug Administration and state health departments.

On Sunday, Gov. Andrew M. Cuomo of New York announced emergency regulations to quickly ban the sale of flavored e-cigarettes, and state health officials approved the ban on Tuesday. Michigan announced this month that it would also prohibit such products.

Last week, the Trump administration said it would move to ban the sale of most flavored e-cigarettes.

Walmart had raised the minimum age for tobacco products to 21 earlier this year, and had said in May that it would also no longer sell “fruit- and dessert-flavored electronic nicotine delivery systems.”

Juul, the most popular e-cigarette company in the country, did not immediately respond to a request for comment.

The move by Walmart is the most recent example of the retailer responding to widespread concerns about its products. In the wake of the shooting at one of its own stores in El Paso in August, Walmart said it would stop selling ammunition that could be used in military-style assault rifles.

This is a developing story. It will be updated.

Walmart Raises Minimum Age to Buy Tobacco Products to 21

May 8, 2019

Westlake Legal Group merlin_146750595_132ca16f-e184-4edc-bbb0-0f81ca005dd7-threeByTwoSmallAt2X Walmart to End Sales of E-Cigarettes Walmart Stores Inc Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products E-Cigarettes
Vaping Illnesses Increase to 530 Probable Cases, C.D.C. Says

Sept. 19, 2019

Westlake Legal Group 19VAPING1-threeByTwoSmallAt2X Walmart to End Sales of E-Cigarettes Walmart Stores Inc Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products E-Cigarettes
Is It Time to Quit Vaping?

Sept. 19, 2019

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Trump Administration Plans to Ban Flavored E-Cigarettes

WASHINGTON — Trump administration officials said on Wednesday they want to ban the sale of most flavored e-cigarettes, at a time when hundreds of people have been sickened by mysterious vaping-related illnesses.

Sitting in the Oval Office with Alex M. Azar II, the secretary of Health and Human Services, and Dr. Ned Sharpless, the acting Food and Drug Administration commissioner, President Trump acknowledged that there was a vaping problem, and said, “We’re going to have to do something about it.”

Mr. Azar said that the F.D.A. would outline a plan within the coming weeks for removing most flavored e-cigarettes from the market.

The move follows increasing pressure by lawmakers, parents and educators, who have been overwhelmed by the popularity of vaping among youths, and felt powerless to keep e-cigarettes out of their schools.

Details were sparse, but officials said the proposal may include a ban on menthol and mint flavored e-cigarettes, which have been the among the most popular flavors for the industry. Research has shown that these flavors are very appealing to youths and to nonsmokers, although some vaping advocates note that they hold great appeal for smokers who want to use e-cigarettes to quit.

The first lady, Melania Trump, also attended the White House meeting. “She’s got a son,” the president said of their teenage child, Barron. “She feels very strongly about it,” he said of Mrs. Trump’s interest in the vaping issue.

What You Need to Know About Vaping-Related Lung Illness
Coughing, fatigue and shortness of breath are warning signs for anyone who has vaped within the last 90 days.

Sept. 7, 2019

Westlake Legal Group merlin_160293528_5b0b0b27-3c5e-49cf-b7eb-bb1ddce4646d-threeByTwoSmallAt2X Trump Administration Plans to Ban Flavored E-Cigarettes your-feed-healthcare Trump, Donald J Smoking and Tobacco Sharpless, Norman E Recalls and Bans of Products Nicotine Marijuana Juul Labs Inc Food and Drug Administration E-Cigarettes

Just this week, Michigan became the first state to prohibit the sale of flavored e-cigarettes. New York Gov. Andrew Cuomo also called for a ban, and Massachusetts and California are considering similar measures. San Francisco approved an e-cigarette ban earlier this year, which Juul Labs, the dominant seller in the United States, is lobbying to reverse through a ballot initiative this November.

Last week, Senator Dick Durbin, Democrat of Illinois and a longtime opponent of tobacco and e-cigarettes, warned Dr. Ned Sharpless, the acting commissioner of the Food and Drug Administration, that if the agency failed to remove e-cigarette flavors from the market, he would call for the commissioner’s resignation. After Kansas reported a sixth vaping-related death on Tuesday , Senator Durbin again slammed the F.D.A. for failing to take decisive action to protect the public from e-cigarettes.

Pressure also began to mount as Michael R. Bloomberg, the former mayor of New York, decided to step in by announcing a $160 million push to ban flavored e-cigarettes. Long an opponent of traditional smoking, the former mayor said his organization, Bloomberg Philanthropies, would seek prohibitions of flavored e-cigarettes in at least 20 cities and states.

In New York, Governor Cuomo also directed state health officials to subpoena companies that market or sell so-called thickening agents, which are sometimes added to illicit vaping products. A state laboratory, which detected the agents in vaping products collected from New York’s patients, found that they were nearly pure vitamin E acetate oil, which officials have said is a potential cause of some of the illnesses.

Hospitals and health officials in nearly three dozen states have reported nearly 500 cases of vaping-related illnesses since the beginning of the summer. Doctors have said that many patients appear to have vaped some THC or cannabis-related products, although others have reported using e-cigarettes as well. No one has singled out a particular company, device or product as the possible culprit.

Deaths have been reported in Illinois, Kansas, California, Indiana, Minnesota and Oregon. The patients’ ages ranged from the 30s to middle-aged or older, and some had underlying lung or other chronic conditions, health officials said.

ImageWestlake Legal Group 11ECIGARETTES-articleLarge Trump Administration Plans to Ban Flavored E-Cigarettes your-feed-healthcare Trump, Donald J Smoking and Tobacco Sharpless, Norman E Recalls and Bans of Products Nicotine Marijuana Juul Labs Inc Food and Drug Administration E-Cigarettes

Various flavors of Juul e-cigarettes in a store in Manhattan.CreditJeenah Moon for The New York Times

Months ago, public and agency pressure forced Juul to yank its flavored pods — which were considered to appeal particularly to youths — from store shelves. The F.D.A. said at the time that it would seek to have retailers curb access to products to keep them away from minors.

Since Dr. Scott Gottlieb resigned as F.D.A. commissioner in April, the agency has appeared to be more sluggish in its efforts to control the epidemic of youth vaping. Although Dr. Sharpless had said he planned to continue the agency’s work to reduce both cigarette and e-cigarette use, not much moved forward. Dr. Gottlieb’s proposal to ban menthol in cigarettes, for example, has languished, as has his call for reducing nicotine in cigarettes to non-addictive amounts.

That appears to have changed this week. On Monday, the F.D.A. took action against Juul, sending a warning letter accusing the company of violating federal regulations by promoting its vaping products as a healthier option than cigarettes.

There is little conclusive research on the long-term safety of using Juul or other e-cigarettes. The company’s flavor pods have a higher level of nicotine than cigarettes do, which is of concern because of the impact nicotine can have on the still-developing teenage brain.

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Coverage of flavored e-cigarettes

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Trump Administration Weighs Ban on Flavored E-Cigarettes

WASHINGTON — Trump administration officials said on Wednesday they would move toward a ban on the sale of most flavored e-cigarettes, at a time when hundreds of people have been sickened by mysterious vaping-related illnesses.

Sitting in the Oval Office with Alex M. Azar II, the secretary of Health and Human Services, and Dr. Ned Sharpless, the acting Food and Drug Administration commissioner, President Trump acknowledged that there was a vaping problem, and said, “We’re going to have to do something about it.”

Mr. Azar said that the F.D.A. would outline a plan within the coming weeks for removing most flavored e-cigarettes that are not tobacco products from the market.

The move follows increasing pressure by lawmakers, parents and educators, who have been overwhelmed by the popularity of vaping among youths, and felt powerless to keep e-cigarettes out of their schools.

The first lady, Melania Trump, also attended the White House meeting. “She’s got a son,” the president said of their teenage child, Barron. “She feels very strongly about it,” he said of Mrs. Trump’s interest in the vaping issue.

What You Need to Know About Vaping-Related Lung Illness
Coughing, fatigue and shortness of breath are warning signs for anyone who has vaped within the last 90 days.

Sept. 7, 2019

Westlake Legal Group merlin_160293528_5b0b0b27-3c5e-49cf-b7eb-bb1ddce4646d-threeByTwoSmallAt2X Trump Administration Weighs Ban on Flavored E-Cigarettes your-feed-healthcare Trump, Donald J Smoking and Tobacco Sharpless, Norman E Recalls and Bans of Products Nicotine Marijuana Juul Labs Inc Food and Drug Administration E-Cigarettes

Just this week, Michigan became the first state to prohibit the sale of flavored e-cigarettes. New York Gov. Andrew Cuomo also called for a ban, and Massachusetts and California are considering similar measures. San Francisco approved an e-cigarette ban earlier this year, which Juul Labs, the dominant seller in the United States, is lobbying to reverse through a ballot initiative this November.

Last week, Senator Dick Durbin, Democrat of Illinois and a longtime opponent of tobacco and e-cigarettes, warned Dr. Ned Sharpless, the acting commissioner of the Food and Drug Administration, that if the agency failed to remove e-cigarette flavors from the market, he would call for the commissioner’s resignation. After Kansas reported a sixth vaping-related death on Tuesday , Senator Durbin again slammed the F.D.A. for failing to take decisive action to protect the public from e-cigarettes.

Pressure also began to mount as Michael R. Bloomberg, the former mayor of New York, decided to step in by announcing a $160 million push to ban flavored e-cigarettes. Long an opponent of traditional smoking, the former mayor said his organization, Bloomberg Philanthropies, would seek prohibitions of flavored e-cigarettes in at least 20 cities and states.

In New York, Governor Cuomo also directed state health officials to subpoena companies that market or sell so-called thickening agents, which are sometimes added to illicit vaping products. A state laboratory, which detected the agents in vaping products collected from New York’s patients, found that they were nearly pure vitamin E acetate oil, which officials have said is a potential cause of some of the illnesses.

Hospitals and health officials in nearly three dozen states have reported nearly 500 cases of vaping-related illnesses since the beginning of the summer. Doctors have said that many patients appear to have vaped some THC or cannabis-related products, although others have reported using e-cigarettes as well. No one has singled out a particular company, device or product as the possible culprit.

Deaths have been reported in Illinois, Kansas, California, Indiana, Minnesota and Oregon. The patients’ ages ranged from the 30s to middle-aged or older, and some had underlying lung or other chronic conditions, health officials said.

ImageWestlake Legal Group 11ECIGARETTES2-articleLarge Trump Administration Weighs Ban on Flavored E-Cigarettes your-feed-healthcare Trump, Donald J Smoking and Tobacco Sharpless, Norman E Recalls and Bans of Products Nicotine Marijuana Juul Labs Inc Food and Drug Administration E-Cigarettes

From left, Dr. Norman Sharpless, the acting F.D.A. commissioner, Melania Trump, President Trump and Alex M. Azar II, the health and human services secretary, discussing flavored e-cigarettes in the Oval Office on Wednesday.CreditKevin Lamarque/Reuters

Months ago, public and agency pressure forced Juul to yank its flavored pods — which were considered to appeal particularly to youths — from store shelves. The F.D.A. said at the time that it would seek to have retailers curb access to products to keep them away from minors.

Since Dr. Scott Gottlieb resigned as F.D.A. commissioner in April, the agency has appeared to be more sluggish in its efforts to control the epidemic of youth vaping. Although Dr. Sharpless had said he planned to continue the agency’s work to reduce both cigarette and e-cigarette use, not much moved forward. Dr. Gottlieb’s proposal to ban menthol in cigarettes, for example, has languished, as has his call for reducing nicotine in cigarettes to non-addictive amounts.

That appears to have changed this week. On Monday, the F.D.A. took action against Juul, sending a warning letter accusing the company of violating federal regulations by promoting its vaping products as a healthier option than cigarettes.

There is little conclusive research on the long-term safety of using Juul or other e-cigarettes. The company’s flavor pods have a higher level of nicotine than cigarettes do, which is of concern because of the impact nicotine can have on the still-developing teenage brain.

[Like the Science Times page on Facebook. | Sign up for the Science Times newsletter.]

Coverage of flavored e-cigarettes

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Before Fisher-Price’s Rock ’n Play Recall, Safety Fears and Dubious Marketing

The thousands of images of Fisher-Price’s Rock ’n Play sleeper posted on Instagram include many of babies snuggled serenely in the cloth-covered cradle, free of its harness and surrounded by blankets and stuffed animals.

To sleep-starved parents, the photos and videos seemed to underscore the Rock ’n Play’s ability to lull fussy infants into a peaceful slumber. But the posts also suggest something else: that the risks long associated with the sleeper did not register with many consumers.

Doctors, safety groups, and now several lawsuits say Fisher-Price and its parent company, Mattel, should have done more to fix that.

When Fisher-Price agreed last week to recall all 4.7 million Rock ’n Plays on the market, it said it was not at fault for the more than 30 infant deaths the Consumer Product Safety Commission had linked to the sleeper.

Instead, the company said the reported deaths stemmed from the sleeper being “used contrary to safety warnings and instructions” to buckle babies in with the harness and avoid putting other items in the sleeper. (The safety commission advises that it should not be used once children reached 3 months or show signs of being able to roll over.)

But Fisher-Price’s marketing materials for the product had long included phrases like “baby can sleep at a comfy incline all night long” that were at odds with pediatricians’ longstanding recommendation that infants sleep on flat surfaces without restraints.

Consumer safety watchdogs criticized Fisher-Price for waiting years to initiate a recall after first hearing about suffocations linked to the sleeper. Instead, they said, the company let the government issue vague warnings that got little attention.

“This is just not a safe way for babies to sleep,” said Nancy Cowles, the executive director of Kids in Danger, a nonprofit organization focused on the safety of products for children.

Fisher-Price said in a statement that the Rock ’n Play had “always met all applicable regulations and safety standards” in the United States and that it “included very specific and conspicuous product usage instructions and warnings that we urged parents and caregivers to read and follow carefully.” The company also said it had shared safety information about the sleeper with the government commission “from the moment it was introduced.”

Fisher-Price’s marketing claims are among the issues cited in lawsuits now being brought against the company.

On Thursday, Samantha Drover-Mundy and Zachary Mundy, the parents of a 12-week-old girl who died in September after a few minutes in a Rock ’n Play, sued Fisher-Price, Mattel and Amazon, where the girl’s grandmother bought the sleeper, in federal court in New York.

Fisher-Price, the suit says, gave Rock ’n Plays to online reviewers after it “determined that the most effective form of advertising for its baby-related products was through word-of-mouth and through ‘mommy bloggers.’” The company’s marketing language promoted “dangerous features as selling points,” emphasizing the product’s soft padding and angled positioning, the suit says.

The family also accuses Fisher-Price of lobbying government officials to skirt regulations that could have blocked it from being sold, an issue explored by Consumer Reports in a recent investigation that helped prompt the Rock ’n Play recall.

The safety commission is now investigating all so-called inclined sleepers, which 26 companies sold in the United States as of August. At least one report has been filed linking another inclined sleeper, the Ingenuity Moonlight by Kids II, to a child’s death.

Inclined sleepers prop babies up at an angle. Many parents say they help soothe infants with gastroesophageal reflux, which can cause spitting up and irritability. But the safety commission said it had received more than 700 reports since 2005 about injuries associated with the sleepers. There were at least eight recalls before mid-2018 linking inclined sleep products to concerns about strangulation, suffocation, falls and entrapment.

In 2012, the commission and the Food and Drug Administration warned customers to avoid sleep positioners for babies. By then, such products had been linked to at least 13 deaths over 15 years, officials said.

About 3,500 infants die in the United States each year from sleep-related causes like sudden infant death syndrome, according to the American Academy of Pediatrics. That number declined in the 1990s after a national campaign to raise awareness about safe-sleeping techniques for infants.

ImageWestlake Legal Group merlin_153722970_5efca197-6bef-4870-8c34-158ba72c907f-articleLarge Before Fisher-Price’s Rock ’n Play Recall, Safety Fears and Dubious Marketing Suits and Litigation (Civil) Sudden Infant Death Syndrome Social Media sleep Recalls and Bans of Products parenting Infant Mortality Cribs (Baby Beds) Consumer Protection Children and Childhood Babies and Infants Advertising and Marketing Accidents and Safety

Stuart Brazell posted this photo of her son, Asher, in a Rock ’n Play on Instagram as part of a Fisher-Price social media campaign. She said she was instructed to place the sleeper on a level surface and to strap him into his harness.CreditStuart Brazell

The pediatricians’ group objects to infant-sleep products that are set at an incline or require restraints. Babies should rest on their backs on a firm, bare sleep surface without soft bedding, the group says.

The Rock ’n Play, created in 2009, never met those guidelines. But it quickly drew rave reviews. The price — $40 for some models — made it attractive to parents who could not afford to skip work after being kept up all night by colicky infants, one baby sleep consultant told NPR this month.

But problems soon emerged.

Pediatricians and parents said some babies who spent time in the sleeper developed torticollis, a condition that twists the head to one side. Others said it was flattening parts of some infants’ skulls. In 2013, Fisher-Price recalled 800,000 Rock ’n Plays after complaints about mold that could cause respiratory illnesses and infections.

But there were more serious concerns. Consumer Reports linked the Rock ’n Play to 32 deaths, including one in 2011.

A 2012 complaint described a 5-month-old girl falling out of a Rock ’n Play despite being restrained and then dangling upside down from the harness. A complaint last year said a 6-month-old boy who weighed less than the 25-pound maximum set by Fisher-Price had died after rolling over in the sleeper.

Nonetheless, long after authorities in Canada and Australia had blocked it from being marketed as a sleeper, the Rock ’n Play remained popular in the United States.

Anna Weiss, a child and family therapist in New York, described it as “one of those things that almost every parent swears by.” Her daughter Emery, now 9 months old, used it “all the time in the beginning,” she said.

The recall was the first Ms. Weiss had heard about the suffocation concerns.

“It’s very surprising, the talk about flat heads was all over the place when I was looking at products,” she said. “The rolling over didn’t come up anywhere.”

In August, Ann Marie Buerkle, the safety commission’s acting chairwoman, responded to a congresswoman’s inquiry about inclined sleepers with a letter saying the agency had “ratcheted up the resources and senior staff attention being devoted to” the products. Ms. Buerkle cited a 2018 consumer alert that said the agency knew of deaths associated with the sleepers but did not name specific products or companies.

“The warning wasn’t written to gather attention,” said Ms. Cowles of Kids in Danger. “No parent ever calls the Rock ’n Play an ‘inclined sleep product’.”

This month, before the recall, Mattel worked with the safety commission to issue a new warning about the sleeper. Safety experts say consumers pay far less attention to warnings than they do to recalls.

Joseph Martyak, a safety commission spokesman, said alerts were useful.

“It’s better to give people a heads-up in these situations,” he said. Deciding on whether a recall is needed “takes time,” he said.

“The agency has to get the company to agree to the voluntary recall for it to happen,” he added.

Soon after the Rock ’n Play was introduced, Natasha Burgert, a pediatrician in Kansas City, Mo., began to warn parents against it, often unsuccessfully.

“Most families believed that since the product was from a reliable company, our concerns as pediatricians were seen as alarmist and overzealous,” she said. “The box specifically suggested ways of safe use and parenting blogs galore were touting its utility and ‘lifesaving’ sleep help.”

Stuart Brazell, an actress and blogger in Los Angeles, described her experience with the Rock ’n Play as “amazing.” She began using it the day she brought her son, Asher, home from the hospital last year.

Ms. Brazell, who has 157,000 followers on Instagram, said she heard that Fisher-Price was seeking mothers for a Rock ’n Play social media campaign. She signed up through an agency that links so-called social media influencers to brands.

The agency gave her specific instructions for her post — the sleeper had to rest on a level surface and her son had to be buckled into the harness — and approved the image and caption before she published it in November, she said. The post earned more than 4,000 likes.

“The power of social media is major for moms,” she said. “A lot of the time, we’re stuck at home and sometimes the only contact we have with other people is online.”

Asher is now 9 months old. Ms. Brazell stopped using the Rock ’n Play when he began to roll over.

“We kept the Rock ’n Play in the garage for baby No. 2 if we had another one,” she said, “but I’m completely torn now as to what to do.”

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