Philip Morris International and three of its top executives have been named as defendants in a class action being brought on behalf of anyone who purchased Philip Morris stock between February 8, 2018 and April 18, 2018, according to a story by Nickeesha Swaby in Courthouse News.
The action has been filed by lead plaintiff, the City of Westland Police and Fire Retirement System, in the US District Court for the Southern District of New York.
CEO Andre Calantzopoulos, CFO Martin G. King, and COO Jacek Olczak are named as defendants along with the cigarette multinational.
According to the complaint, PM was experiencing lower sales for years attributed to a decline in smokers worldwide, but throughout the period in question, investors were assured that ‘new sales initiatives’ and ‘favourable sales trends’ were working to combat the issue.
The class is represented by Samuel H. Rudman of Robbins Geller Rudman & Dowd LLP in Melville, N.Y., with David C. Walton and Brian E. Cochran in San Diego and Thomas C. Michaud of Vanoverbeke, Michaud & Timmony in Detroit.
Meanwhile, the Rosen Law Firm, a global investor-rights law firm, announced on Saturday the filing of a class action lawsuit on behalf of purchasers of the securities of Philip Morris International from February 8, 2018 through April 18, 2018, both dates inclusive (Class Period). The lawsuit seeks to recover damages for Philip Morris investors under the federal securities laws, according to a Business Wire report.
The lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Philip Morris was experiencing a faster decline in overall cigarette and e-cigarette (or “heated tobacco”) sales volumes during the first quarter of 2018 than investors had been led to believe; (2) Philip Morris’ much-lauded sales initiatives had stalled; (3) Philip Morris was experiencing adverse sales headwinds in key markets; and (4) as a result of the foregoing, defendants’ statements about Philip Morris’ business, operations, and prospects, were materially false and/or misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.
Tag: United States
Investors in class actions
Graphic warnings on order
A US federal court yesterday ordered the Food and Drug Administration (FDA) to issue expeditiously a final rule requiring graphic health warnings on cigarette packs and advertising, as mandated by a 2009 federal law, according to a statement posted on the Campaign for Tobacco-Free Kids website.
The statement was attributed to the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids and the Truth Initiative
The ruling by district judge Indira Talwani of the district court for the District of Massachusetts was said to have been in response to a lawsuit filed in October 2016 by eight public health and medical groups and several individual pediatricians.
‘Judge Talwani agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic warnings,’ the statement said.
‘Judge Talwani set a deadline of September 26, 2018, for the FDA to “provide to this court an expedited schedule for the completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of final graphic warnings rule in accordance with the Tobacco Control Act.’
The statement described the ruling as a major victory in the fight against tobacco use, which was said to be the nation’s number one cause of preventable death.
‘In accordance with the court’s order, we urge the FDA to quickly issue, finalize and implement a rule requiring graphic cigarette warnings,’ the statement said. ‘The current US cigarette warnings, which are printed on the side of cigarette packs and haven’t been updated since 1984, are stale, unnoticed and a major impediment to greater progress in reducing cigarette smoking.
‘Studies around the world have shown that graphic warnings are most effective at informing consumers about the health risks of smoking, preventing children and other non-smokers from starting to smoke, and motivating smokers to quit.
‘Requiring graphic cigarette warnings in the US will protect kids, save lives and reduce tobacco-related health care costs, which total $170 billion a year.’The rules rule
The US Food and Drug Administration, which has come under criticism for its cumbersome processes and which is fighting a lawsuit over its August 2017 Guidance Document, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, says it is spotlighting tobacco regulations as part of its Understanding Tobacco Regulation and Guidance series.
In a note issued through its Center for Tobacco Products, the FDA said that in 2009, the Family Smoking Prevention and Tobacco Control Act (TCA) amended the Food, Drug, and Cosmetic (FD&C) Act, establishing FDA’s authority to regulate the manufacture, distribution, and marketing of tobacco products. ‘FDA implements the FD&C Act by issuing regulations (commonly referred to as rules) and guidances,’ the statement said. ‘A regulation is a government statement that carries out or explains a law or policy. Regulations can also describe the agency’s organization or procedures. FDA regulations are created through a formal notice-and-comment rulemaking process and have the full force and effect of federal law.’
The FDA said it went through a number of steps that invited participation from the public as it considered, developed, and finalized a regulation.
For instance, the agency might choose to issue an Advance Notice of Proposed Rulemaking (ANPRM) before issuing a proposed rule. An ANPRM, the FDA said, was a document published in the Federal Register that generally described the regulatory action the agency was considering, explained the underlying issues, and asked for public comment on specific questions.
A Proposed Rule (also known as a Notice of Proposed Rulemaking or NPRM), meanwhile, was an official document published in the Federal Register that announced the agency’s proposal of a new rule or regulatory change. It explained the need and authority for the proposed rule and the issues involved, and it provided also a period for the public to comment. A proposed rule and accompanying public comments shaped the final rule.
A Final Rule was a regulation published in the Federal Register that explained the basis for the rule, described and responded to public comments received on the proposed rule, explained any changes from the proposed rule, contained a variety of analyses of the rule’s potential impacts, and provided a specific date on which the rule became effective. A final rule was law.
A more detailed overview of the federal rulemaking process is available here. And it is possible to explore FDA’s searchable list of ANPRMs, proposed rules, and final rules here.
The FDA included information in its statement on its ‘public health mission’.
‘As a science-based regulatory agency, FDA examines areas of its legal authority under the FD&C Act and prioritizes issues for rulemaking in accordance with the agency’s public health mission,’ it said. ‘FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco products. When FDA develops certain regulations, the TCA requires the agency to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use. FDA also considers the impact of the regulation on the regulated tobacco industry.’
In addition, the FDA said, when considering a new tobacco regulation there were many other factors involved in the process, ‘some of which may include the following’:- ‘New technologies or data related to the issue;
- Subject matter expertise, research findings and recommendations of agency staff;
- ‘Concerns arising from accidents or other health risks affecting the public;
- ‘Recommendations from congressional committees or federal advisory committees;
- ‘Requests from other agencies;
- ‘Petitions from interest groups, corporations, and members of the public;
- ‘Lawsuits filed by interest groups, corporations, states, and members of the public;
- Presidential directives.
Young forsaking cigarettes
The US’ young adult cigarette smoking rate is at an all-time low of about 10 percent, a more than 20 percent drop in a year, according to a Truth Initiative statement.
Young adult smokers are defined as people 18-24 years of age who report having smoked more than 100 cigarettes in their lifetime and who now smoke every day or some days.
In 2017, 10.4 percent (more than three million) of young adults smoked cigarettes, according to the latest data on cigarette use from the National Health Interview Survey by the Centers for Disease Control and Prevention.
That marks a 21 percent decline since 2016, when the young-adult smoking rate was 13.1 percent, and a 45 percent decrease since 2011, when 18.9 percent of young adults smoked.
The statement said too that the ‘youth’ smoking rate had dropped also to an historic low. Now, 5.4 percent (about 1.3 million) of US teens smoked, down from 5.9 percent in 2016.
‘These declines underscore the importance of proven public health strategies, including well-funded and well-executed public education campaigns, like truth®,’ the statement said.
‘Research published in the International Journal of Environmental Research and Public Health concluded that truth prevented more than 300,000 US ‘youth’ and young adults from becoming smokers in just one year from 2015-16.
‘Youth and young adults are most at risk of starting to smoke cigarettes. Nearly all – 99 percent – of smokers start smoking by age 26.’It's time for action
The US Food and Drug Administration has failed to approve a single reduced-harm nicotine product in the past year, despite having unveiled a new ‘roadmap’ in July 2017 that emphasized the role such products can play in reducing tobacco-related illness, according to a piece by Michelle Minton at cei.org.
‘That lapse does a huge disservice to millions of smokers who could benefit from switching from cigarettes to a far less harmful product,’ Minton said.
‘A year ago, the FDA claimed it would balance regulation against encouraging the development of harm-reducing products. But with each passing week it’s become clear that the biggest roadblock on the path to tobacco harm reduction is the agency’s own cumbersome product approval process.’
Minton pointed out that it would be easy for the FDA to encourage the development of less harmful nicotine products for smokers. The market already provided alternatives in the form of e-cigarettes, smokeless tobacco, and heat-not-burn devices, she said. All that was needed to make these products available and viable as smoking cessation tools was for the FDA to establish a regulatory structure that made it easier and cheaper for manufacturers to earn FDA approval to sell the products and advertise them as being of lower risk than combustible cigarettes.
But the FDA seemed to have done nothing to reform its pre-market tobacco approval gauntlet. During the past two years, the agency had received 367 premarket tobacco applications, which are required for the products to be sold legally in the US. None had been approved. The agency had received also 35 Modified Risk Tobacco Product applications (MRTP), which would allow tobacco products to be advertised as lower risk. The agency had not approved any such application, ever.
Minton pointed out that snus had helped Sweden get its smoking rate down to five percent, lower by far than any other EU nation and the US; and, as a result, Sweden had one of the lowest incidences of lung cancer and oral cancers in the EU.
While snus could be sold in the US, it could not be advertised as being of lower risk than cigarettes, even though it was. Consequently, US consumers saw little reason to switch from smoking to smokeless tobacco.
So far, the FDA had considered MRTPs from several snus companies, including Swedish Match, which submitted an application in 2014 and was denied two and half years later. Currently, R.J. Reynolds, which submitted an MRTP in March 2017, was still waiting on a decision from the FDA.
[In December 2016, the FDA announced a partial ruling offering Swedish Match two years to submit an amended application, and TR understands that the company is finalizing its amendment and plans to submit it soon.]Smoking incidence down
The overall cigarette smoking rate among US adults has hit an all-time low, according to a story at medicalxpress.com quoting the US Centers for Disease Control and Prevention.
Preliminary data from the National Health Interview Survey is said to have shown that smoking rates declined from 15.5 percent in 2016 to 13.9 percent in 2017.
“Cigarette smoking among adults has been on a downward trajectory for decades,” said Brian King, deputy director for research translation in the CDC’s Office on Smoking and Health.
“It’s the lowest percentage we’ve seen since we started monitoring smoking rates in 1965.”
Still, the preliminary 2017 data indicates 34 million Americans smoke, according to King. And an estimated 480,000 Americans die each year due to cigarette smoking and second-hand smoke exposure, according to the latest CDC data.Switching to vaping
The Serendipitymommy.com website is offering some advice on switching from smoking to vaping that could be useful to a wider audience than perhaps the website normally attracts.
It gives, among other things, five tips for making the switch:- Invest in a better device because one of the most common reasons why vapers have difficulty completely giving up tobacco cigarettes is down to the type of device that they are using.
- Find the right balance because, when choosing your ‘kit’, the trick is to strike the right balance between ease of use and an experience that provides the satisfaction that you need.
- Explore new flavors by thinking about what flavors you like in other products, because there’s bound to be a suitable vape juice for you.
- Give yourself time to make the adjustment once you have chosen your kit and flavors.
- Consider dual use because many vapers don’t make a straight switch immediately.
What price truth?
The US Food and Drug Administration is being urged by The Heartland Institute to recognize the reduced harm of Camel Snus products
The FDA recently issued a ‘public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Company’.
In a comment to the FDA, Lindsey Stroud, state government relations manager at the Institute said the Institute had researched the effects of smokeless tobacco and tobacco harm reduction products for more than 20 years.
‘According to our research, the smoke in combustible cigarettes poses the biggest threat to smokers,’ Stroud said. ‘Therefore, smokeless tobacco can deliver nicotine more safely. Evidence indicates snus products, including Camel Snus, deliver nicotine effectively without the associated harms of combustible cigarettes.
‘FDA recognizes a continuum of risk among tobacco products: Combustible cigarettes are the most harmful and smokeless tobacco and snus are less harmful. However, despite this acknowledgement, FDA regulations prevent snus manufacturers from marketing their products as less harmful than combustible cigarettes. In fact, the warnings required on snus products misinform the public.
‘Therefore, The Heartland Institute urges FDA to regulate Camel Snus products and combustible cigarettes differently.
‘Because FDA has recognized and accepted the continuum of harm posed by different tobacco products, FDA should approve the modified risk tobacco product application. Approving the application would clarify the health effects of different tobacco products and hopefully incentivize smokers to quit using combustible cigarettes.’Making the connection
The findings of new US research will surely feed into the debate about whether it is better to take your cannabis neat, as generally in North America, or mixed with tobacco, the European way.
According to a story at sciencedaily.com, researchers at the Center for BrainHealth® at the University of Texas, Dallas, investigated the effects on the brain of concurrent cannabis and nicotine use, versus the use of solely cannabis and solely nicotine.
The results, recently published in the journal Brain Structure and Function, apparently show that not only were the effects in these three categories different, but also that the group using both nicotine and cannabis more closely resembled the control (non-user) group in brain connectivity. The isolated nicotine and isolated cannabis users showed equally less connectivity in general.
‘Previous research in rats has suggested that nicotine may be a ‘gateway drug’ leading to cannabis and other drug use,’ the story reports.
‘Studies performed with rats exposed to THC – the main psychoactive compound found in marijuana – demonstrated an increased likelihood to self-administer nicotine that was not observed with rats exposed to heroin or cocaine, suggesting that there is something unique about the cannabis-nicotine interaction.’
“Most of the literature to date has focused on associations of isolated cannabis and nicotine use, even though concurrent cannabis and nicotine use is more prevalent in society than cannabis use alone,” said the study’s lead author, Dr. Francesca M. Filbey, the Bert Moore Chair in BrainHealth at UT Dallas. “Our findings confirm the limitations of existing research.”
While the outcome of the study could be, in part, due to the opposing effects nicotine and cannabis have on the brain, the difference in the brains of concurrent users versus isolated users of each product begs for further research in functional connectivity metrics in these populations, Filbey added.Altria to webcast discussion
The Altria Group is due to webcast its participation in the Barclays Global Consumer Staples Conference in Boston, Massachusetts, US, from about 09.00 Eastern Time on September 5.
The live, audio-only webcast, which will be in listen-only mode, will feature a discussion with Billy Gifford, Altria’s vice chairman and CFO, and Murray Garnick, executive vice president and general counsel.
Pre-event registration is necessary at www.altria.com/webcasts.
An archived copy of the webcast will be available on altria.com or through the Altria Investor App. The free app is available for download at www.altria.com/irapp or through the Apple App Store or Google Play.
