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Pfizer Chantix Adulterated with N-Nitroso-Varenicline Class Action

One of Pfizer, Inc.’s most popular products is the varenicline-containing drug (VCD) Chantix. Chantix is designed to help people stop smoking, and, unlike many other products for this use, it does not contain nicotine. However, the complaint for this class action alleges that the drugs have recently been contaminated with N-nitroso-varenicline, and possibly other substances as well. The complaint alleges this renders the drugs unfit for their intended use and worthless.

The National Class is all entities in the US and its territories and possessions who paid any amount of money for a varenicline-containing drug, for personal or household use, that was made, distributed, or sold by Pfizer. A Minnesota Subclass has also been defined, for those in the above class in Minnesota.

Pfizer received approval from the Food and Drug Administration (FDA), the complaint alleges, “to sell Chantix as a first of its kind treatment in May 2006.” The complaint alleges it quickly became one of the company’s fastest-growing products. “For example,” the complaint alleges, “from its launch through 2015, the number of Chantix prescriptions for Medicaid beneficiaries increased 13,277%.”

The price has also grown, the complaint alleges, beginning at $113.98 for a thirty-day supply, then increasing to $254.50, and finally to $485 in 2018.

However, the complaint alleges that Pfizer has disregarded the standards required for producing Chantix and instead has “knowingly and fraudulently” been making and selling adulterated and misbranded VCDs instead.

What’s wrong with the purported but misbranded Chantix? The complaint alleges that it has experienced “contamination with a probable human carcinogen known as N-nitroso-varenicline. Additionally, [Pfizer] was on notice of other potential contamination from nitrosamines such as N-nitrosodimethylamine (‘NDMA’) and N-nitrosodiethylamine (‘NDEA’).

The complaint alleges that this occurred because Pfizer did not maintain current good manufacturing practices (cGMPs) or adhere to other proper practices and regulations when it produced the drugs.

The complaint claims, “According to FDA testing, [Pfizer’s] VCDs contained nitrosamine levels many times higher than the FDA’s updated interim limits for nitrosamine impurities.” It claims that the FDA and other authorities regard nitrosamines as “dangerous probably human carcinogens.”

Pfizer began recalling the drugs in July 2021, the complaint alleges, with the recall including all Chantix products by September 2021.

“On information and belief,” the complaint alleges, “N-nitroso-varenicline contamination of [Pfizer’s] VCDs dates back many years, at which point [Pfizer] had actual or, at minimum, constructive notice of the contamination.” The complaint claims that Pfizer has been unjustly enriched by the sales of these contaminated drugs.

Automated Pet Care Telemarketing Texts Florida FTSA Class Action

Automated Pet Care Products, LLC sells products like the litter robot, feeder robot, and cat furniture. But the complaint for this class action takes issue with how the company chooses to sell its goods. It claims that Automated sends consumers telemarketing text messages without their prior express consent, in violation of the Florida Telephone Solicitation Act (FTSA).

The class for this action is all persons in Florida who (1) were sent a telephone sales call about Automated Pet Care Products goods or services, (2) using the same equipment or type of equipment used to call the plaintiff in this case, (3) without the proper express consent as defined by Fla. Stat. § 501.059(1)(g), (4) on or after July 1, 2021.

The plaintiff in this case, Leutrim Topalli, is a resident of Florida. On or after July 1, 2021, the complaint alleges, he received telephone sales calls in the form of text messages to his telephone, while he was physically present in Florida.

Exhibit A to the complaint shows three screenshots of the text messages. They carry these promotional messages:

  • “Litter-Robot: Never Scoop Cat Poop Again | Take $30 off when you purchase a Litter-Robot bundle! Bonus: Free Shipping*…”
  • “Litter-Robot: Truly innovative pet care | Litter-Robot solves problems—for you and kitty! Start your 90-day trial…”
  • “Litter-Robot: Sharing is Caring | Give your friends $50 toward their Litter-Robot, and you’ll get $25!* Share now…”

The purpose of the text messages, the complaint alleges, “was to solicit the sale of consumer goods and/or services.” According to the complaint, their sending “involved an automated system for the selection or dialing of telephone numbers or the playing of a recorded message when a connection is completed.”

The complaint quotes FTSA specifications for the “prior express written consent” agreement it requires before a business can place telemarketing calls. For example, it must carry “the signature of the called party” and “the telephone number to which the signatory authorizes a telephonic sales call to be delivered[.]” The complaint also quotes the law as saying that it must present “a clear and conspicuous disclosure informing the called party” that they are agreeing to receive telemarketing via an automated system” and must not require consumers to sign the agreement “as a condition of purchasing any property, goods, or services.”

The complaint alleges that Topalli had not given his prior express consent to receive such calls, but that Automated made the calls or knowingly allowed the calls to be made even without that consent.

Zillow Session Replay Code and Illinois Eavesdropping Act Class Action

Zillow Group, Inc. is responsible for the Zillow website, which the complaint for this class action calls “the leading online homebuying marketplace” in the country. But the complaint also claims that Zillow has third-party vendors, such as Microsoft, embed Session Replay Code in its website that allows Zillow to intercept and record the communications of visitors to the website, in alleged violation of the Illinois Eavesdropping Act and other laws.

The class for this action is all natural persons in Illinois whose website communications were captured with the use of Session Replay Code embedded in www.zillow.com.

At Zillow’s request, the complaint alleges, companies like Microsoft “embed snippets of JavaScript computer code (‘Session Replay Code’) on Zillow’s website, which then deploys on each website visitor’s internet browser for the purpose of intercepting and recording the website visitor’s private electronic communications with the Zillow website…”

The recordings including the visitor’s “mouse movements, clicks, keystrokes (such as text being entered into an information field or text box), URLs of web pages visited, and/or other electronic communications in real[ ]time.” The providers of the code then create a video replay of the user’s visit and make it available to Zillow for analysis.

Zillow’s request for this video, the complaint alleges, “results in the electronic equivalent of ‘looking over the shoulder’ of each visitor to the Zillow website for the entire duration of their website interaction”—that is, eavesdropping on the user’s electronic communications.

The complaint alleges that Zillow is aware that many users are physically present in Illinois when they use the Zillow website or app, through its location-determining tools or the user’s IP address.

Data has become the “world’s most valuable resource,” the complaint alleges, so that businesses now collect personal data, engagement data, behavioral data, and attitudinal data. The complaint alleges, “This information is valuable to companies because they can use this data to improve customer experiences, refine their marketing strategies, capture data to sell it, and even to secure more sensitive consumer data.”

However, consumers are not necessarily comfortable with, or even aware of, their data being used by or shared with anyone other than the website in use. The complaint cites a Consumer Reports study showing that “92% of Americans believe that internet companies and website should be required to obtain consent before selling or sharing consumers’ data,” among other things.

But the complaint alleges that the Session Replay data is received by, and controlled by, the party that wrote the code. That data may include sensitive information, the complaint alleges, like “medical conditions, credit card details, and other personal information displayed or entered on webpages.” It may record data even if the user entered it but did not decide to click Submit or Enter.

The complaint adds, “Session Replay Code does not necessarily anonymize user sessions, either” but offers ways of linking the Replay with specific persons.

Mrs. Smith Frozen Apple Pie Contains Little “Real Butter” Class Action

The complaint for this class action spends a great deal of time explaining why pie crusts made with butter are superior to those made with vegetable oils. This is because the point of the class action is to bring suit about a Schwan’s Consumer Brands, Inc. product, Mrs. Smith’s frozen apple pie, which is marketed as having a “Flaky Crust Made With Real Butter.” The complaint alleges that the crust is actually made with more oil than butter.

Two classes have been defined for this action:

  • The Illinois Class is all persons in Illinois who bought the product during the applicable statutes of limitations.
  • The Consumer Fraud Multi-State Class is all persons in Utah, Virginia, Wyoming, Arkansas, Ohio, Nevada, North Carolina, and Alabama who bought the product during the applicable statues of limitations.

Consumers prefer butter as the shortening in pies, the complaint alleges, because it creates superior flavor and texture in the crust: “When butter is cut into dough, it creates tiny beads or flakes, preventing excess water from absorbing into the flour.” Also, “[w]hen a pie is heated, the butter melts, creating air pockets and releasing its water content.”

Butter has healthier fats, the complaint alleges, and nutrients such as calcium, protein, and vitamins A and D, while vegetable oils have harmful trans fats and “no comparable nutritional value because of the intense processing needed to render them palatable.” Also, the complaint claims, butter has a creamy taste, while vegetable oils are “heavily refined to provide a neutral taste, [but] they are highly susceptible to oxidation and reversion back to their original ‘beany’ and waxy taste.”

Page 1 of the complaint shows an image of the box for a Mrs. Smith’s frozen apple pie, showing a blue ribbon, reminiscent of prizes at state fairs, with images of one and a half apples and two pats of butter, and the words “Made With Real Butter.”

However, page 4 of the complaint shows an image of the ingredient panel for the pie. The first ingredient is “Wheat Flour,” but the second is “Shortening Butter Blend (Palm Oil, Butter [Cream, Salt])” followed by “Palm Oil, Water, Soybean Oil.”

“Contrary to what consumers read,” the complaint says, “the second most predominant shortening ingredient is not ‘Butter,’ even though this is listed after ‘Palm Oil.’” Butter only is listed this early, the complaint implies, as an ingredient in the predominating “Shortening Butter Blend” with an amount that does not actually exceed the amount of palm or soybean oil.

The complaint thus claims, “The amount of butter is de minimis or negligible, in absolute and relative amounts to the shortening ingredients used.” It also claims the ingredient panel does not properly list the ingredients, by their common or usual name in order of predominance by weight.

Michigan Farmer Magazine Subscriber Information Shared PPPA Class Action

Informa Media, Inc., which was formerly known as Penton Media, Inc., publishes Michigan Farmer magazine, to which some people subscribe. The complaint for this class action alleges that Informa makes money from sharing the identities of those subscribers, in violation of Michigan’s Preservation of Personal Privacy Act (PPPA) which attempts to keep confidential the Private Reading Information of Michiganders.

The class for this action is all Michigan residents who, at any point during the applicable pre-July 31, 2016 time period, had their Private Reading Information disclosed to third parties by Informa without their consent. (Although the statutory period for this action is six years, the deadlines for civil actions have been suspended, from the March 10, 2020 beginning of the Covid-19 pandemic period to the end of the states of disaster and emergency.)

The complaint quotes the PPPA as saying, “[A] person, or an employee or agent of the person, engaged in the business of selling at retail, renting, or lending books or other written materials … shall not disclose to any person, other than the customer, a record or information concerning the purchase … of those materials by a customer that indicates the identity of the customer.”

In addition to Michigan Farmer, Informa publishes many agricultural magazines, newsletters, and other publications, such as American Agriculturalist, Beef, Corn & Soybean Digest, Feedstuffs, and Farm Industry News.

How do we know that Informa is sharing this kind of information? Page 3 of the complaint shows a screenshot of a webpage from list broker NextMark, Inc., offering a “US Agriculture MasterFile (formerly Agbase) from Informa Mailing List” of more than 2 million subscribers at a base price of $150 per thousand.

Informa’s data may include other categories of individualized information, such as job title, number of employees, livestock type, sales volume, and annual farm income, the complaint alleges, which is then sold to data aggregators, data cooperatives, and list brokers.

The information, the complaint alleges, can be supplemented with data from other files, and passed it on to “aggressive advertisers, political organizations, and [nonprofit] companies” without the consent of the individuals involved.

The sharing of this information can be dangerous, the complaint alleges, because it can allow dishonest parties to target vulnerable members of society.

“In addition to causing waste and inconvenience,” the complaint alleges, “direct-mail advertisers often use consumer information to lure unsuspecting consumers into various scams, including fraudulent sweepstakes, charities, and buying clubs.” They often target the elderly, the complaint claims, because they are generally at home, may be lonely, and may have cash reserves or assets that they can access if offers seem attractive.

Consumers sign up for Informa’s subscriptions through different avenues, but the complaint claims that they are never asked to consent to any terms of service, privacy policy, or other information-sharing agreement. Informa, the complaint says, therefore has not obtained its customers’ consent to the sharing of their information.

Progressive Universal “Projected Sold Adjustments” Nebraska Class Action

When a vehicle is totaled in an accident, the insurance company must calculate the vehicle’s actual cash value (ACV) in order to determine the payout. The complaint for this class action alleges that Progressive Universal Insurance Company “systematically thumbs the scale” in its own favor by applying something called a Projected Sold Adjustment that the complaint alleges is arbitrary, unfair, and unrealistic as to current practices in the used car market.

The class for this action is all persons who made a first-party claim on an insurance policy issued by Progressive Universal Insurance Company to a Nebraska resident who, between the earliest allowable time and the date the class is certified in this case, received compensation for the total loss of a covered vehicle, where the compensation was based on a vehicle valuation report prepared by Mitchell and the ACV was decreased based on Projected Sold Adjustments to the comparable vehicles used to determine the ACV.

When Progressive Universal attempts to establish a totaled vehicle’s ACV, the complaint alleges, it uses a valuation report prepared by Mitchell International, Inc. in a certain way. That is, the complaint alleges that Progressive Universal has Mitchell find comparable vehicles in the relevant market, make price adjustments according to their mileage, options, and equipment, and then apply something called a Projected Sold Adjustment to reduce most of the prices further.

The only explanation of this Projected Sold Adjustment, the complaint claims, is on the last page of the valuation report, saying that it is meant to “reflect consumer purchasing behavior (negotiating a different price than the listed price).”

The complaint alleges, “This reduction is contrary to appraisal standards and methodologies and is not based in fact, as it is contrary to the used car industry’s market pricing and inventory management practices.”

For example, the plaintiff in this case, Karen Stromquist, was had an accident in November 2016 that totaled her vehicle. Progressive Universal declared it a total loss, and Mitchell came up with a valuation report showing seven comparable vehicles. Projected Sold Adjustments of $818, $497, $611, $614, $701, $573, and $857 were applied to the seven vehicles, respectively.

The complaint alleges that neither Mitchell nor Progressive Universal have done any research to support these adjustments, with all the considerations in the present-day market for used cars. Nowadays, the complaint alleges, “the used auto market is such that, given the ubiquity of Internet advertising and shopping and developments in sophisticated pricing software, car dealerships simply do not negotiate off of Internet-advertised prices.”

The complaint calls the adjustments “capricious and unjustified” and says they “do not reflect market realities … and run contrary to customary automobile dealer practices and inventory management, where list prices are priced to market to reflect the intense competition in the context of Internet pricing and comparison shopping.”

Orchard Apple Nantucket Nectar PFAS in Packaging Class Action

This class action, like a number of others recently, has taken up the topic of per- and polyfluoralkyl substances (PFAS) in packaging. Specifically, it brings suit against Keurig Dr Pepper, Inc. for its Orchard Apple Nantucket Nectars drink, claiming that the drink’s packaging, which “is essential and integral to delivering the Product to the consuming public” is unsafe because it contains PFAS.

The National Class for this action is all persons who, during the fullest period allowed by law, bought the product in the US, for personal use and not for resale. A New York Subclass has also been defined, for those in the above class who bought the product in New York.

PFAS are human-made chemicals that the complaint alleges are termed “forever” chemicals because they break down only very slowly, accumulating over time in humans and the environment.

The complaint claims a 2019 study from the Department of Health and Human Services National Toxicology Program found “that PFAS have adverse effects on human organ systems, with the greatest impact seen in the liver and thyroid hormone.” And, according to the complaint, the Centers for Disease Control’s Agency for Toxic Substances and Disease Registry “has also recognized that exposure to high levels of PFAS may impact the immune system and reduce antibody responses to vaccines.”

Further negative effects alleged by the complaint include decreased fertility, developmental delays, increased risks of some kinds of cancers, reduced immune system ability, interference with hormones, and increased cholesterol levels or risks of obesity.

Page 6 of the complaint shows an image of the Nantucket Nectars product, with the words “All Natural Ingredients” written prominently across the front of the product label. But the complaint alleges that the drink’s packaging contains 123 ng/L of 1H,1H, 2H, 2H-Perfluorooctane sulfonic acid, which it says is a kind of PFOA which is a kind of PFAS.

The complaint claims, “Until June 2022, the EPA health advisor limit for safe consumption … was just 70 nanograms per liter—almost half the levels found in the Product. Since then, the limit has been drastically lowered.” The complaint alleges that the product is therefore not safe and does not contain “all natural ingredients” and presents a health risk to consumers.

Why would a company use this kind of material for packaging? The complaint alleges that the coating acts as a barrier to grease between the product and the consumers’ hands. But the complaint alleges that PFAS is not necessary to this function.

What the complaint is not entirely clear on is the difference between packaging containing PFAS and a product (the juice) containing PFAS. It alleges, “Indeed, numerous food and beverage products on the market contain no detectable levels of PFAS. Accordingly, Defendant would have had knowledge that it could product the Product packaging without the heightened levels of PFAS inherent in its current composition.”

Samsung Electronics America Failure to Safeguard PII Class Action

Samsung Electronics America, Inc. announced that it had suffered a data breach on September 2, 2022. The complaint for this class action alleges that this data breach was a result of Samsung’s failure to properly secure its systems and safeguard the personally identifiable information (PII) it had acquired and stored on its customers. It also claims that Samsung delayed in telling customers that their information had been accessed.

The class for this action is all persons who bought or used Samsung products in the US, and whose PII was compromised as a result of the July 2022 data breach. A Texas Subclass has also been defined, for those in the above class in Texas.

The data breach took place in late July, and Samsung has confirmed that the information stolen included name, contact and demographic information, date of birth, and product registration information. In a footnote, the complaint says that the meaning of “demographic information” is unclear, and alleges, “One tech publication believes it may include GPS location data.”

In any case, the complaint alleges that Samsung did not reveal the exact dates of the intrusion, how long the hackers had access to the information, or how many people were affected.

The complaint alleges, “The Data Breach was a result of Samsung’s failure to properly secure and safeguard … sensitive personal information stored within its network and servers.” It says Samsung only began notifying the individual victims on September 2, 2022. But the complaint also says, “As of the date of this filing, it is unclear if Samsung has provided notice to all impacted individuals.”

The complaint claims that Samsung “maintained the PII in a reckless and negligent manner” and that it exposed people to harm by intentionally, willfully, recklessly, or negligently failing to take adequate and reasonable measures to ensure its data systems were protected against unauthorized intrusions[,]” among other things.

According to its US Privacy Policy, Samsung collects information on its customers for a number of reasons, including providing product support, offering both targeted and generic ads, and collecting user data for its own market research purposes, among other things.

The complaint alleges, “By obtaining, collecting, using, and deriving a benefit from Plaintiff’s and Class members’ PII, [Samsung] assumed legal and equitable duties and knew or should have known that it was responsible for protecting Plaintiff’s and Class Members’ PII from unauthorized disclosure.”

The same data that the company announced the data breach, the complaint alleges that it also updated its privacy policy, adding that Samsung may track users’ physical locations by their devices, for security or advertising purposes, with separate consent, and that it may retain user content shared with the Quick Share feature for up to three days.

Hilcorp Interest on Late Oil and Gas Royalty Payments New Mexico Class Action

This class action against Hilcorp San Juan, LP alleges that the company does not pay its oil and gas royalties on time, and that it violates New Mexico’s Oil and Gas Proceeds Act by not then paying interest on the untimely royalties.

The class for this action is all non-excluded persons or entities who own royalty interests in New Mexico wells who (1) have received untimely payments from Hilcorp at any time since May 26, 2018 on oil, gas, and related hydrocarbons produced and sold by Hilcorp from New Mexico wells in which such non-excluded persons have a royalty interest and (2) on which payment Hilcorp has not paid such persons interest at the statutory rate of eighteen percent per annum.

The New Mexico Oil and Gas Proceeds Act has rules on payments to those who own royalty interests in oil, gas, and other hydrocarbons. The complaint claims that these royalties must be paid “within six months after the first day of the month following the date of the first sale from any well which produces oil, gas, or related hydrocarbons within the State of New Mexico.” This applies to the first sale from the well.

After this six-month period, payments must be made, the complaint says, “within 45 days of the end of the calendar month in which payment is received by the operator on its sale of oil, gas, and other hydrocarbons produced from wells in the State of New Mexico.” Operators like Hilcorp, who do not meet these deadlines and make late payments, the complaint alleges, must pay the royalty owners “statutory interest at a rate of eighteen percent per annum.”

The plaintiff in this case, White River Royalties, Inc., owns royalty interests in some Hilcorp oil or gas wells. The complaint alleges that Hilcorp has failed to make its payments to White River on time, and that it has also failed to pay the eighteen percent interest on the late royalties.

For example, the complaint alleges that Hilcorp produced and sold natural gas from the Carle 002 (Blance MV) San Juan, New Mexico well in September 2017, in which White River has a royalty interest. The complaint claims that this was not a first sale and that Hilcorp received payment for that natural gas before December 2017. But White River did not receive Hilcorp’s payment from this sale until December 2019, the complaint alleges. When Hilcorp finally did pay, the complaint claims, it did not add the eighteen percent interest that it was by then required to pay to White River.

KLM Airlines Misrepresentation of Carbon Offsets Class Action

The flag carrier airline for the Netherlands is known as Koninklijke Luchtvaart Maatschappij, NV, or KLM Royal Dutch Airlines. This class action takes issue with KLM’s advertising campaign encouraging consumers to “Fly Responsibly” to reduce the effects of climate change by using carbon offsets.

Two classes have been defined for this action:

  • The Texas and New York Class is all persons in Texas and New York who bought flights on KLM during the applicable statutes of limitations.
  • The Consumer Fraud Multi-State Class is all persons in Utah, West Virginia, Wyoming, Arkansas, Ohio, Nevada, South Carolina, and Mississippi who bought flights on KLM during the applicable statutes of limitations.

In 2015, 196 countries agreed to the Paris Climate Accords, designed “to limit climate change to an increase of 1.5°C and reach net zero emissions by 2050.” The complaint alleges, “Air travel is one of the most significant contributors to climate change.”

Page 1 of the complaint shows a KLM ad that says, in part, “We recognise the urgent need to limit global warming, and thus have committed to the targets defined in the Paris Climate Agreement.”

KLM has a CO2Zero program that purportedly “offsets” and “reduces” the effects of air travel by allowing travelers to buy carbon credits. The program involves planting trees, the complaint alleges, “which function as carbon dioxide sinks, that in theory absorb a defined amount of CO2 from the atmosphere equivalent to what is expended per flier in a typical flight.”

But portraying these offsets as enough to make up for the bad effects of flying, the complaint alleges, is “false, deceptive and misleading.” The complaint alleges reasons for this:

  • First, it says, there is no credible evidence that offsets actually make up for the effects of flying to the point that a flight could be called “CO2 neutral,”
  • Second, the complaint alleges that the European Aviation Safety Agency has deemed the non-CO2 effects of flying to be three times worse than those of CO2. The complaint says that the carbon program has no effect on other greenhouse gases involved with flying, such as methane, nitrogen, and condensation trails.
  • Third, according to the complaint, “carbon offsets can only be used to reach emission targets in a way that does not impeded reduction in emissions overall consistent with the 1.5°C target of the Paris Agreement.”
  • Fourth, the complaint contends that trees are a “short-lived and unstable form of storage” for carbon, whereas fossil fuels that are not used at all can remain stable for an indefinite period of time.
  • Fifth, the complaint claims that flying, even “responsibly,” does not help limit the effects of climate change.

While KLM has a more complete plan on climate change, the complaint alleges that the airline’s commitment to the reduction of greenhouse gas emissions is far below the aims of the Paris Agreement.

The complaint alleges that KLM’s advertising obstructs the targets of the Paris Agreement by not promoting a reduction in the demand for air travel.