Category: Litigation

African American Group Sues FDA For Inaction on Menthol

Photo: Miriam Doerr | Dreamstime.com
The African American Tobacco Control Leadership Council (AATCLC) and Action on Smoking and Health (ASH) are suing the U.S. Food and Drug Administration (FDA) for alleged inaction on menthol.
The plaintiffs have asked the court to compel the FDA to act on its own conclusion that banning menthol from tobacco products would benefit the public health.
The 2009 Family Smoking Prevention and Tobacco Control Act banned flavors in cigarettes but excluded menthol, subject to further research. In 2011, the FDA’s advisory committee concluded that the “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”
Despite this conclusion, and several statements of support in the interim, the FDA has not begun the rulemaking process of removing menthol from combustible cigarettes. The plaintiffs are asking the court to direct the FDA to act.
According to the AATCLC and ASH, smoking-related illnesses are the No. 1 cause of death in the African American community, and 85 percent of African American smokers consume menthol cigarettes.
“By continuing to delay, the FDA and the U.S. government are failing to protect the health of U.S. citizens, particularly African Americans, and the U.S. is also falling behind the global trend as countries around the world are increasingly banning menthol,” said Kelsey Romeo-Stuppy, managing attorney at ASH.
On May 20, the European Union banned menthol cigarettes.
“Our nation finds itself at a moment in time when action to eradicate systemic inequities and racism is crucial to fighting injustice, and this case is a perfect example of action which will elicit positive change,” said ASH in a statement.
Read the full complaint here.
June 18, 2020
Australia’s Plain Packaging Justified, Says WTO

Photo: Taco Tuinstra
The World Trade Organization (WTO) ruled on Tuesday that Australia’s plain packaging laws are justified, rejecting complaints by Honduras and the Dominican Republic that they are unfair restrictions on trade.
In December 2012, Australia became the first country to require tobacco companies to strip their products of all branding. Cigarettes have since been sold in drab, brown packs with large graphic health warnings but no logos or other distinguishing features. Brand names are printed in generic fonts.
Following the introduction of the measure, Cuba, the Dominican Republic, Honduras and Indonesia—all major tobacco-producing countries—challenged Australia’s measure at the WTO.
The complainants argued that Australia’s Tobacco Plain Packaging Act constituted an unjustified barrier to trade, but the WTO panel found Australia’s measures were not more restrictive than was necessary to achieve the public health goal of reducing smoking.
Honduras and the Dominican Republic appealed against the panel’s findings.
The World Health Organization’s (WTO) appellate body said on Tuesday that it had found no errors in the earlier panel’s conclusions and that it rejected the complainants’ request for Australia to change its packaging rules.
Anti-tobacco activists welcomed the WTO verdict. “This ruling is yet another victory for Australia and global health and a resounding defeat for the tobacco industry, which has fiercely fought plain packaging laws,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. “This ruling puts to rest any remaining questions about plain packaging under international trade law.”
Myers also suggested that the plaintiffs received technical and financial support from British American Tobacco (BAT) and Philip Morris International to bring their complaints.
The tobacco industry has long argued that plain packaging is an ineffective and disproportionate measure.
“Naturally, we are disappointed with the ultimate findings of the report,” said a spokesperson for BAT, which was not part of the case. “However, it is important to note that decisions from the WTO panel or appellate body do not set a global precedent when it comes to this measure and will only be binding to the parties involved in this dispute.”
BAT also noted that the report is not an endorsement on the effectiveness of plain packaging. “The appellate body actually dismissed the panel’s finding that plain packaging reduced the consumption of tobacco products,” the company wrote in a statement.
Plain packaging is now required in at least 15 countries, and many other governments are in the process of formally considering the policy.
Tuesday’s ruling was the last by the WTO’s appellate body, which serves as a supreme court in international trade disputes but has ceased to function after the United States blocked new appointments. The result is that the Geneva-based WTO can no longer effectively intervene to settle disputes.
June 10, 2020
Court to Hear Arguments Over Disputed Florida Settlement Payments

Photo: Michal Kalasek | Dreamstime.com
A U.S. appeals court will hear arguments today in a dispute about $100 million in payments related to a landmark legal settlement between the state of Florida and tobacco companies, reports Florida Politics.
R.J. Reynolds Tobacco Co. wants the 4th District Court of Appeal to overturn a ruling that said the company is responsible for making payments to the state related to the Salem, Winston, Kool and Maverick cigarette brands.
R.J. Reynolds was part of the 1997 settlement in which cigarette makers agreed to pay hundreds of millions of dollars a year to the state because of smoking-related health costs and, in exchange, received liability protections.
In 2015, Reynolds’ parent company sold the four brands to ITG Brands to gain regulatory approval for its acquisition of Lorillard Tobacco Co. As a result of the sale, R.J. Reynolds contends it is no longer responsible for making payments linked to the four brands.
A Palm Beach County circuit judge, however, ruled in 2017 that R.J. Reynolds remained responsible for the payments. Reynolds appealed that ruling, and its arguments will be heard today.
ITG Brands, which was not part of the 1997 legal settlement agreement, contends the appeals court should uphold the circuit judge’s ruling that R.J. Reynolds is responsible for the disputed payments.
June 9, 2020
South Africa Ordered to Overhaul Lockdown

Image by jessica45 from Pixabay
A South African court has found some coronavirus lockdown regulations imposed by the government “unconstitutional and invalid,” reports the BBC.
The high court in the capital, Pretoria, ruled that the measures were not connected to slowing the rate of infection or limiting its spread. The judge described rules around funerals, informal workers and amount of exercise as “irrational.”
Judge Norman Davis argued it was wrong to allow people to travel to attend funerals but not to earn their livelihoods by street trading, as many South Africans do.
South Africa initially had some of the world’s most restrictive lockdown measures, including a ban on tobacco sales.
Some restrictions were recently lifted but the ban on tobacco sales remains in place despite earlier indications that it, too, might be eased.
British American Tobacco and The Federation of International Trade Associations have mounted a legal challenge to the restrictions.
It was unclear if Judge Davis’ ruling also covered tobacco. The government was given 14 days to overhaul the regulations.
June 6, 2020
Juul Seeks Dismissal of Vaping Epidemic Lawsuits

Photo: Juul
Juul Labs has asked a U.S. federal judge to dismiss or pause hundreds of lawsuits alleging the e-cigarette manufacturer fueled a youth vaping epidemic, reports Reuters.
The company on Friday asked a federal judge in San Francisco to stay the lawsuits by consumers and local governments while the Food and Drug Administration determines whether it may continue to market its products.

June 3, 2020
Countermove: Altria Sues Reynolds Over Patent Infringement

Photo: Reynolds Vapor Co.
Altria Group has filed suit against competitor R.J. Reynolds Vapor Co. for patent infringement on e-cigarettes and associated products.
Earlier, Reynolds filed its own patent-infringement suit against Altria and Philip Morris International over their IQOS heat-not-burn cigarette, a competitor of Reynolds’ Eclipse.
Filed in the U.S. District Court for the Middle District of North Carolina, USA, Altria’s suit claims that Reynolds Vapor, owned by Reynolds American Inc. (RAI), violated nine patents held by Altria Client Services in producing its Vuse Vapor e-cigarette line. Altria contends that Reynolds’ Vuse brand of e-cigarettes uses heating technology, mouthpieces, batteries and liquid-filled pods covered by Altria’s patents for its Juul e-vapor products.
“Reynolds Vapor has infringed on Altria’s intellectual property, and we are seeking financial damages for each of these violations,” Altria Client Services spokesman George Parman said Thursday, according to the story.
Altria seeks unspecified monetary compensation but asks for “treble damages” for “defendant’s willful infringement” of the patents, as well as awards of compensation, supplemental damages after discovery cutoff and attorneys’ fees and expenses.
June 3, 2020
Health Labels Planned for October 2021

Image: FDA
The U.S. Food and Drug Administration (FDA) has set Oct. 16, 2021, as the new effective date for graphic health warning labels for combustible cigarettes.
The FDA signed off March 18 on a new set of 11 graphic warning labels for traditional cigarettes that are toned down considerably from its first attempt in 2012, which was abandoned after an industry legal challenge.
The new set of warnings contains images of diseased lungs, a man experiencing erectile dysfunction, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask. But there is no smoke coming out of a tracheal hole, no cadaver and no photo of a man who appears deathly ill, as the FDA proposed.
The labels must cover the top 50 percent of the front and rear panels of packages, as well as at least 20 percent of the top of advertisements. The messages must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.
The warnings were mandated by a federal judge for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.
Initially, the agency set a deadline for June 18, 2021. However, on April 3, Philip Morris USA, R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a joint motion requesting a preliminary injunction on implementing the labels and a ruling to prohibit enforcement. The manufacturers insist that the labels violate the First Amendment of the U.S. Constitution, which guarantees free speech.
On May 8, the FDA and the manufacturers filed a joint motion to extend the deadline by 120 days. The manufacturers said the pandemic has complicated their ability to meet the June 18, 2021, deadline.
Despite the postponement of the deadline, the FDA urged manufacturers to submit plans for compliance as soon as possible.
“Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner,” the FDA said.
May 29, 2020
BAT to Resume Legal Action Against South Africa’s Tobacco Ban

Photo: Sang Hyun Cho from Pixabay
British American Tobacco South Africa (BATSA) will resume legal action against the country’s government’s decision to extend the ban on tobacco sales during Level 3 of the nationwide lockdown, reports Polity.
“BATSA has made every effort to constructively engage with the government since the ban came into force, including making detailed submissions, along with other interested parties, to various ministers, as well as directly to the presidency,” the company said in a statement.
“To date, no formal response has been received from the government, and BATSA has also not been included in any of the government’s consultation processes so far.”
The Fair Trade Independent Tobacco Association has already taken the government to court to challenge the ban in a separate case.
Minister of Cooperative Governance and Traditional Affairs, Nkosazana Dlamini-Zuma, argued that, while Covid-19 is a relatively new disease, early studies support the view that using tobacco products increases not only the risk of catching the disease but also the risk of contracting a more serious form of the disease.
“This, in turn, increases strain on the public health system, by increasing the number of people who will need access to resources such as intensive care unit beds and ventilators,” she said.
BAT said the ban threatens the survival of South Africa’s legal tobacco sector, which employs thousands.
May 29, 2020
Shunbao Technology Banned From Selling IQOS ‘Knockoff’ in U.K.

Photo: PMI
A London judge has prohibited Shenzhen Shunbao Technology from marketing an alleged “knockoff” of Philip Morris Product’s (PMP) IQOS tobacco heating device in the U.K. because of European design protections.
High Court Judge Anthony Mann granted PMP’s request for default judgment in the case since Shunbao Technology had not participated in the proceedings.
He also granted PMP’s request to extend the intellectual property protections the company currently has for its product under a European Union registered community design so it will remain in effect in the U.K. after Britain leaves the bloc.
The smoking device dispute dates to November 2018 when PMP sued Shunbao Technology for infringement of its registered design.
Phillip Morris filed its claim in the U.K. shortly after discovering the rival company had created a “cheap knockoff” smokeless product called AMO that was already being marketed in China, according to its written arguments to the court.
May 18, 2020
PMI Investigated for Tobacco Heating Patent Infringement

Photo: R.J. Reynolds Vapor Co.
The U.S. International Trade Commission (ITC) has opened a probe into vapor products imported by cigarette giant Philip Morris USA (PM) after R.J. Reynolds complained that PM’s tobacco-heating system infringes Reynolds’ patents, according to a report by Law360.
The investigation will determine whether the IQOS tobacco vaporizers marketed by Philip Morris and parent company Altria use tobacco-heating systems and sticks that violate patents for R.J. Reynolds’ Vuse vaping system. R.J. Reynolds seeks cease-and-desist orders barring imports of the allegedly infringing products.
The patents describe a device that heats tobacco held in a removable cartridge to 350 degrees when vapors containing nicotine are released without producing smoke, according to R.J. Reynolds’ April 9 complaint to the ITC.
R.J. Reynolds, which is owned by British American Tobacco, said Philip Morris has sold the alleged copycat IQOS system in the U.S. since October 2019 and has imported the product from manufacturers in Italy, Switzerland and Malaysia for years to use in clinical testing.
“We believe the allegations are without merit, and we are fully prepared to defend ourselves,” Philip Morris spokesman Corey Henry told Law360 in a statement Wednesday, noting the company has spent $7 billion developing its smoke-free tobacco products over the past two decades.
R.J. Reynolds filed a suit accusing Altria and Phillip Morris of six counts of trademark infringement in Virginia federal court the same day R.J. Reynolds filed its ITC petition. In that case, the company seeks treble damages and court declarations that Altria and Philip Morris have infringed its intellectual property.

Photo: PMI
May 18, 2020