Pair of Lawsuits Target Mint Flavored Products

  • Spencer Sheehan, a well-known class-action attorney, has filed a pair of class-action lawsuits in the U.S. District Court for the Northern District of Illinois, alleging that mint flavored products which do not contain mint are deceptively labeled.
  • The first lawsuit alleged that a “mint chocolate chip ice cream” statement of identity is misleading to consumers where the product’s flavor is derived from “natural flavor” and not any mint or mint-containing ingredient. The product also contains images of mint leaves on the front panel. As support for the allegation that the lack of mint is deceptive, the complaint cites to the ice cream flavoring regulation (21 CFR 135.110(f)(2)), which requires that the term “flavored” (e.g., mint flavored) be used where a product contains a natural flavor which predominates.
  • The second lawsuit alleged that consumers are misled by a gum product which is labeled as “original flavor” with a backdrop of what appears to be a blue mint leaf, but which only contains “natural and artificial flavor,” and no mint-based ingredients. Plaintiff, citing to the general flavoring regulation (21 CFR 101.22), alleged that the product should have been labeled as “naturally and artificially flavored mint” and that the failure to disclose the flavor or include the other qualifiers is misleading.
  • Although Plaintiffs have alleged technical violations of FDA’s labeling regulations, courts have consistently held that a reasonable consumer may not be aware of the intricacies of FDA’s labeling regulations and that therefore a technical labeling violation is not in itself sufficient to show that a reasonable consumer would be misled.
© 2022 Keller and Heckman LLP

California PFAS Legislation Will Dramatically Impact Businesses

We previously reported on three significant pieces of California PFAS legislation that were before California’s Governor Newsom for ratification. Two of the bills were passed, which means that several categories of products will have applicable PFAS bans. The third bill was not signed by the Governor, which would have required companies to report certain data to the state for goods  sold in or otherwise brought into California that contain PFAS.

With increasing attention being given to PFAS in consumer goods in the media, scientific community, and in state legislatures, the California PFAS bills underscore the importance of companies anywhere in the manufacturing or supply chain for consumer goods to immediately assess the impact of the proposed PFAS legislation on corporate practices, and make decisions regarding continued use of PFAS in products, as opposed to substituting for other substances.  At the same time, companies impacted by the PFAS legislation must be aware that the new laws pose risks to the companies involvement in PFAS litigation in both the short and long term.

California PFAS Bills

One of our prior reports was on the first significant PFAS bill that Governor Newsom was expected to sign into law – AB 2771 – and which was indeed passed into law. The bill prohibits the manufacture, sale, delivery, hold, or offer for sale any cosmetics product that contains any intentionally added PFAS. The law would go into effect on January 1, 2025. The bill defines a cosmetics products as “an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

The second bill signed into law by the Governor is AB 1817, which bans the use of PFAS in textiles manufactured and sold in California. More specifically, the bill prohibits, beginning January 1, 2025, any person from “manufacturing, distributing, selling, or offering for sale in the state any new, not previously owned, textile articles that contain regulated PFAS” and requires a manufacturer to use the least toxic alternative when removing PFAS in textile articles to comply with these provisions. The bill requires a manufacturer of a textile article to provide persons that offer the product for sale or distribution in the state with a certificate of compliance stating that the textile article is in compliance with these provisions and does not contain any regulated PFAS. The bill specifically regulates three categories of textiles:

(1) “Textile articles” means textile goods of a type customarily and ordinarily used in households and businesses, and include, but are not limited to, apparel, accessories, handbags, backpacks, draperies, shower curtains, furnishings, upholstery, beddings, towels, napkins, and tablecloths;

(2) “Outdoor apparel” means clothing items intended primarily for outdoor activities, including, but not limited to, hiking, camping, skiing, climbing, bicycling, and fishing; and

(3) “Apparel”, defined as “clothing items intended for regular wear or formal occasions, including, but not limited to, undergarments, shirts, pants, skirts, dresses, overalls, bodysuits, costumes, vests, dancewear, suits, saris, scarves, tops, leggings, school uniforms, leisurewear, athletic wear, sports uniforms, everyday swimwear, formal wear, onesies, bibs, diapers, footwear, and everyday uniforms for workwear…outdoor apparel and outdoor apparel for severe wet conditions.

The bill that California’s Governor vetoed was AB 2247, which would have established reporting requirements for companies that utilize products or substances that contain PFAS and which are used in California in the stream of commerce. “The bill would [have] require[d], on or before July 1, 2026, and annually thereafter, a manufacturer, as defined, of PFAS or a product or a product component containing intentionally added PFAS that, during the prior calendar year, is sold, offered for sale, distributed, or offered for promotional purposes in, or imported into, the state to register the PFAS or the product or product component containing intentionally added PFAS, and specified other information, on the publicly accessible data collection interface.”

Impact of California PFAS Legislation On Businesses

California PFAS legislation places some of the most significant and widely used consumer products in the crosshairs with respect to PFAS. While other states have banned or otherwise regulated PFAS in certain specific consumer goods, California’s bills are noteworthy given the economic impact that it will have, considering that California is the fifth largest economy in the world.

It is of the utmost importance for businesses along the whole cosmetics supply chain to evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate these compounds. One major point of contention among members of various industries is whether to regulate PFAS as a class or as individual compounds.  While each PFAS compound has a unique chemical makeup and impacts the environment and the human body in different ways, some groups argue PFAS should be regulated together as a class because they interact with each other in the body, thereby resulting in a collective impact. Other groups argue that the individual compounds are too diverse and that regulating them as a class would be over restrictive for some chemicals and not restrictive enough for others.

Companies should remain informed so they do not get caught off guard. States are increasingly passing PFAS product bills that differ in scope. For any manufacturers, especially those who sell goods interstate, it is important to understand how those various standards will impact them, whether PFAS is regulated as individual compounds or as a class. Conducting regular self-audits for possible exposure to PFAS risk and potential regulatory violations can result in long term savings for companies and should be commonplace in their own risk assessment.

©2022 CMBG3 Law, LLC. All rights reserved.

THE OLD 9999 SCAM?: Plaintiff Alleges Defendant Made 5000 Illegal Phone Calls to his Number–But is it a Set Up?

So ostensiby the case of Mongeon v. KPH Healthcare, 2022 WL 1978674 Case No. 2:21-cv-00195 (D. Vt. 06/06/2022) is simply a case about the definition of “consumer” under the Vermont Consumer Protection Act (“VCPA”), 9 V.S.A. § 2453.

The plaintiff alleges his receipt of 4000 calls from the Defendant after the Defendant promised to stop calling was an act of “fraud” and “deceit” under the VCPA. But since the Plaintiff has not alleged facts establishing he is a “consumer” within the meaning of the Act the Court dismissed the case, without prejudice.

Pretty blasé.

But let’s back up. Why would Defendant–seemingly a local pharmacy–blast the Plaintiff’s number so many times?

Well the Plaintiff’s full number is not set forth in the decision–but the last four digits are “9999.”

Many years ago before I became a TCPA class action defense lawyer I–like many out there–had a very low impression of the TCPA. I remember a guy in law school who made tuition bring junk fax cases. And I had a colleague who was locked in mortal battle with some clown who was bringing a series of small claims TCPA suits in Southern California arising out of calls to a “designer phone number”: 999-999-9999.

Hmmmmm.

Much like the old case of Stoops in which the Plaintiff had over 80 cell phones–or the recent case of Barton in which the Plaintiff had a cell phone purchased specifically to set up TCPA suits–a 9999 scammer will pick up a “designer number” like 999-999-9999 and wear it is for a legitimate purpose. “I run a real estate agency, etc.” Looking deeper there is rarely any utility behind the number–although other designer numbers like (800) 444-4444 are very helpful–and the numbers are often just used to net TCPA lawsuits.

The reason it works is rather obvious.

When I walk into my local Sports Clips for my monthly trim there is no way I’m going to give them my private cell phone number. So I give them 999-999-9999. (Of course, I also give them my email of no@no.com.) It works perfectly well for check in, and I never receive any texts or calls from them reminding me to come back to style my luscious used-to-be-black locks.

Apart from folks providing the number 999-999-9999 to a business, many companies will knowingly have their agents enter the number as a default when the customer does not otherwise provide their number. This was the case in the old “small claims bandit” run of suits I mentioned earlier–apparently a local hospital group was engaging in this practice, which lead to an endless number of TCPA suits being filed against them by an enterprising Plaintiff.

Well Mongeon appears to be the same issue. Per the ruling: , Defendant’s representatives advised Plaintiff “that his phone number was attached to multiple other customers who had prescriptions at the pharmacy” because Plaintiff’s phone number, XXX-XXX-9999, is “the ‘default’ number for all new or current customers in [Defendant’s] system without a phone number.” 

Pro tip: the 9999 play is arguably the oldest manufactured lawsuit trick in TCPAWorld. Don’t fall for it. Never use 999-999-9999 (or any other series of numbers) as a “default” setting for customer phone numbers. And if you do, you definitely want to suppress dialing to those numbers.

Stay safe out there TCPAWorld.

© 2022 Troutman Firm

Thailand’s Personal Data Protection Act Enters into Force

On June 1, 2022, Thailand’s Personal Data Protection Act (“PDPA”) entered into force after three years of delays. The PDPA, originally enacted in May 2019, provides for a one-year grace period, with the main operative provisions of the law originally set to come into force in 2020. Due to the COVID-19 pandemic, however, the Thai government issued royal decrees to extend the compliance deadline to June 1, 2022. 

The PDPA mirrors the EU General Data Protection Regulation (“GDPR”) in many respects. Specifically, it requires data controllers and processors to have a valid legal basis for processing personal data (i.e., data that can identify living natural persons directly or indirectly). If such personal data is sensitive personal data (such as health data, biometric data, race, religion, sexual preference and criminal record), data controllers and processors must ensure that data subjects give explicit consent for any collection, use or disclosure of such data. Exemptions are granted for public interest, contractual obligations, vital interest or compliance with the law.

The PDPA applies both to entities in Thailand and abroad that process personal data for the provision of products or services in Thailand. Like the GDPR, data subjects are guaranteed rights, including the right to be informed, access, rectify and update data; restrict and object to processing; and the right to data erasure and portability. Breaches may result in fines between THB500,000 (U.S.$14,432) and THB5 million, plus punitive compensation. Certain breaches involving sensitive personal data and unlawful disclosure also carry criminal penalties including imprisonment of up to one year.

Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.

Senate Bill to Revise and Reassess GRAS Program

  • On May 27, Senator Edward J. Markey (D-Mass.), alongside Senators Richard Blumenthal (D-Conn.) and Elizabeth Warren (D-Mass)., introduced the Ensuring Safe and Toxic-Free Foods Act, which is described as “comprehensive legislation that ensures the Department of Health and Human Services (HHS) fulfills its responsibility to promote the health and well-being of American families by directing the Food and Drug Administration (FDA) to strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which exempts companies from seeking pre-market approval for food chemicals.” A summary of the legislation is available here.
  • The legislation would prohibit manufacturers from independently designating substances as GRAS (or manufacturing or selling food containing those substances) without supplying notice and supporting information to the Secretary of HHS. Substances that are carcinogenic or that have evidence of reproductive or developmental toxicity would be prohibited from receiving a GRAS designation. Further, the legislation would require that a GRAS Notice and all supporting information be publicly available online and subject to a 90-day review period.
  • The legislation would also direct the Secretary to create an Office of Food Chemical Safety Reassessment within FDA’s CFSAN. The new office would be responsible for reassessing the safety of existing food additives, food contact substances, color additives, and substances that had already received GRAS status. The office would be required to reassess at least 10 substances (or class of substances) once every three years. As included in the bill, the first 10 substances to be reviewed would be:
    • Perfluoroalkyl substances and polyfluoroalkyl substances
    • Ortho-phthalates
    • The class of bisphenols
    • Titanium dioxide
    • Potassium bromate
    • Perchlorate
    • Butylated hydroxyanisole (BHA)
    • Butylated hydroxytoluene (BHT)
    • Brominated vegetable oil (BVO)
    • Propyl paraben
  • With regard to the legislation, Senator Markey has said “The FDA too often falls short on their responsibility to promote food safety, highlighted recently by the baby formula crisis where FDA’s deputy commissioner for food policy did not learn about the whistleblower complaint for four months. It is long past time we revise existing food safety measures and close the loophole allowing manufacturers to self-regulate what new substances can enter our food supply.”
© 2022 Keller and Heckman LLP

Community Banks and Overdrafts — Time for Reconsideration?

Bank consumer overdraft fees (together with nonsufficient funds (NSF) fees and returned check fees) have long been a target of attacks by consumer advocacy groups and progressive politicians who claim that such fees are disproportionately levied on the most vulnerable consumers. The Obama-era Consumer Financial Protection Bureau (CFPB) initiated efforts to regulate overdraft programs, which were shelved during the Trump administration, and legislation to restrict overdraft fees has regularly been proposed and considered by Congress, but not enacted.

2022, however, may be the year that the US financial regulatory agencies finally move to impose formal restrictions on banks’ overdraft fee programs. In particular, the CFPB, increasingly assertive in President Biden’s second year in office, has clearly signaled its intent to take action in this area:

  • Rohit Chopra, the director of the CFPB, has spoken out on numerous occasions — in public appearances, opinion pieces, and blog posts — regarding the imperative of reining in so-called junk fees charged by banks and other financial companies.
  • On January 26, 2022, the CFPB published a request for public comment targeting “exploitative junk fees,” including overdraft and NSF fees. The CFPB stated that the goal of its information request was to assist the agency’s plan to “craft rules, issue industry guidance, and focus supervision and enforcement resources,” with the goals of reducing excessive fees and eliminating illegal practices.

The attack on overdraft fee programs has been echoed by other administration officials as well as by allied politicians. Acting Comptroller of the Currency Michael Hsu has called traditional bank overdraft programs “a significant part” of a “regressive system” that penalizes the poor and has stated that “banks that hesitate to adopt pro-consumer overdraft programs will soon be negative outliers.” On March 31, 2022, the House Financial Services Subcommittee held a hearing on possible government intervention to restrict overdraft programs, clearly showing coordination by the committee majority with the Biden administration’s initiatives. In March 2022, a group of US Senate Democrats (including Banking Committee Chairman Sherrod Brown) sent letters to seven large banks urging them to abolish or significantly reduce overdraft and other fees, and in early April, New York Attorney General Letitia James, in recent letters signed by numerous other state attorneys general, asked the country’s four largest banks to eliminate consumer overdraft fees altogether by summer 2022.

Adding to the chorus of Biden administration and other political voices critical of overdraft fees has been a steady stream of announcements over the past year by many large banks regarding plans to eliminate or greatly restrict their overdraft and related fees. In January 2022 alone, five of the country’s largest banks announced the planned elimination of NSF fees and certain overdraft charges. These announcements add weight to the CFPB’s attacks on overdraft fee programs and will inevitably result in additional pressure on other large banks to follow suit.

The bottom line is that federal regulation of this area may finally be on the horizon, if not imminent, although it is anyone’s guess what form regulatory action will take. The initial targets of any action taken by the CFPB — whether formal rulemaking, statements of policy, or increased enforcement activity — are likely to be banking companies that have total assets in excess of $10 billion and that are thus subject to direct supervision by the CFPB. However, whatever new policy is implemented by the CFPB in this area will inevitably be applied by the three principal federal banking agencies to financial institutions of all sizes, and community banks should prepare themselves for increased examination scrutiny of their overdraft fee programs and the potential for enforcement actions.

Accordingly, community banks — especially those heavily reliant on overdraft fee income — should review their overdraft programs, ensure that they are compliant with existing regulations and best practices, and consider changes to respond to possible regulatory concerns. While it is impossible to react effectively to a regulatory regime that has not been proposed, much less implemented, reports and statements by the CFPB and other banking agencies provide some guidance. First, the CFPB has indicated that it will demand transparent and fully disclosed pricing of overdraft solutions that allow consumers to make an informed choice. In addition, Acting Comptroller Hsu stated in a December 2021 speech — in which he notably did not call for banks to eliminate overdraft fees — that the OCC had identified several features of bank overdraft programs that could be modified or recalibrated to help achieve the goal of improving the financial health of vulnerable consumers. He stated that these changes included:

  • Requiring consumer opt-in to the overdraft program.
  • Providing a grace period before charging an overdraft fee.
  • Allowing negative balances without triggering an overdraft fee.
  • Offering consumers balance-related alerts.
  • Providing consumers with access to real-time balance information.
  • Linking a consumer’s checking account to another account for overdraft protection.
  • Collecting overdraft or NSF fees from a consumer’s next deposit only after other items have been posted or cleared.
  • Not charging separate and multiple overdraft fees for multiple items in a single day and not charging additional fees when an item is re-presented.

Finally, community banks should closely monitor CFPB and other bank regulators’ overdraft fee initiatives, through state and national bankers associations and otherwise, and continue to explore potential methods of managing their overdraft programs in line with stated and possible future regulatory concerns.

© 2022 Jones Walker LLP
For more about banking institutions, visit the NLR Financial, Securities & Banking section.

L’Oreal PFAS Lawsuit Again Shows ESG Risks of Marketing

In less than six months, L’Oreal has now found itself to be the target of PFAS lawsuits related to its mascara products. The latest L’Oreal PFAS lawsuit was filed in the New Jersey federal court on April 8, 2022. Cosmetics and PFAS is a topic that saw increased scrutiny from the scientific community, legislature, and the media in 2021. As we predicted in early 2021, the increased attention on the industry presented significant risks to the cosmetics industry, and our prediction was that the developments made the cosmetics industry the number two target for future PFAS lawsuits. In less than three months, four industry giants – Shiseido, CoverGirlL’Oreal and Burt’s Bees – were hit with lawsuits related to their cosmetics and PFAS content in some of the companies’ products.  The industry, insurers, and investment companies interested in the consumer goods vertical with niche interest in cosmetics companies must pay careful attention to the cosmetics lawsuits and the increasing trend of lawsuits targeting the industry.

PFAS and Cosmetics: the 2021 Foundation

On June 15, 2021, a scientific study in the Journal of Environmental Science and Technology Letters published conclusions regarding testing of a variety of cosmetics products from the United States and Canada for PFAS content, and found PFAS present in over half of the products. On the same day that the study was published, the No PFAS In Cosmetics Act 2021 was introduced in the Senate by U.S. Senators Susan Collins (R-ME), Richard Blumenthal (D-CT), Dianne Feinstein (D-CA), Maggie Hassan (D-NH), Jeanne Shaheen (D-NH), Kirsten Gillibrand (D-NY), and Angus King (I-ME). The bill sought to ban PFAS in cosmetics.

These two developments led us to conclude “with these developments, our prediction that cosmetics is the number two target for PFAS litigation issues behind water rings true.”

Why PFAS In Cosmetics Is A Concern

PFAS content in cosmetics raises concerns for human health in scientific communities due to the fact that PFAS are capable of entering the bloodstream in ways other than direct oral ingestion, and one of these ways includes dermal absorption. Concerns have also been raised regarding absorption of PFAS into the bloodstream by way of tear ducts. The absorption issue is one that is being studied fairly extensively through various pending scientific studies. At the end of 2021, the federal Agency for Toxic Substances and Disease Registry (ATSDR) went so far as to recommend that citizens in Southern New Hampshire reduce their risk of further PFAS exposure by avoiding the use of certain consumer goods, including cosmetics.

L’Oreal PFAS Lawsuit

On April 8, 2022, plaintiff Rebecca Vega filed a lawsuit in the New Jersey federal court seeking a proposed class action lawsuit against LOreal. The L’Oreal PFAS lawsuit alleges that the company does not disclose to consumers that its mascara and other products contain PFAS. Instead, the lawsuit states, the products were fraudulently and misleadingly marketed as safe for consumers and environmentally friendly, in violation of federal and state consumer laws. The Complaint details several examples of L’Oreal marketing indicating the safe nature of the products.

The plaintiff seeks certification of the class action lawsuit, injunctive relief, damages, fees, costs and a jury trial. The proposed class is any consumer in the United States, or in the subclass of New Jersey, who purchased the relevant L’Oreal products.

Just the Beginning For Cosmetics Industry

With studies underway, legislation pending that targets cosmetics, and increasing media reporting on cosmetics concerns to human health, the cosmetics industry has a target on its back with respect to PFAS that will have impacts on the industry’s involvement in litigation. Twelve months ago, we made this prediction: “Personal injury / products liability cases, false advertising, and failure to disclose theories of liability are some of the more prominent allegations that cosmetics companies are likely to face. Further, the cosmetics industry is concerned about federal and state level regulatory enforcement action for environmental pollution remediation costs stemming from placing PFAS waste into the environment as a by-product of the manufacturing process.”

The first part of our prediction is becoming reality, as four significant cosmetics industry players now find themselves embroiled in litigation focused on false advertising, consumer protection violations, and deceptive statements made in marketing and ESG reports. The lawsuits may well serve as a test case for plaintiffs’ bar to determine whether similar lawsuits will be successful in any (or all) of the fifty states in this country. Each cosmetics company faces the stark possibility of needing to defend lawsuits involving plaintiffs in all fifty states for products that contain PFAS.

It should be noted that these lawsuits would only touch on the marketing, advertising, ESG reporting, and consumer protection type of issues. Separate products lawsuits could follow that take direct aim at obtaining damages for personal injury for plaintiffs from cosmetics products. In addition, environmental pollution lawsuits could seek damage for diminution of property value, cleanup costs, and PFAS filtration systems if drinking water cleanup is required.

Conclusion

It is of the utmost importance that businesses along the whole supply chain in the cosmetics industry evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate PFAS at an ever-increasing pace. Similarly, state level EPA enforcement action is increasing at a several-fold rate every year. Now, the first wave of lawsuits take direct aim at the cosmetics industry. Companies that did not manufacture PFAS, but merely utilized PFAS in their manufacturing processes, are therefore becoming targets of costly enforcement actions at rates that continue to multiply year over year. Lawsuits are also filed monthly by citizens or municipalities against companies that are increasingly not PFAS chemical manufacturers.

©2022 CMBG3 Law, LLC. All rights reserved.
Article By John Gardella with CMBG3 Law.
For more articles on ESG lawsuits, visit the NLR Environmental, Energy & Resources section.

Regulation by Definition: CFPB Broadens Definition of “Unfairness” to Rein in Discrimination

In a significant move, the CFPB announced on March 16revision to its supervisory operations to address discrimination outside of the traditional fair lending context, with future plans to scrutinize discriminatory conduct that violates the federal prohibition against “unfair” practices in such areas as advertising, pricing, and other areas to ensure that companies are appropriately testing for and eliminating illegal discrimination.  Specifically, the CFPB updated its Exam Manual for Unfair, Deceptive, or Abusive Acts or Practices (UDAAPs) noting that discrimination may meet the criteria for “unfairness” by causing substantial harm to consumers that they cannot reasonably avoid.

With this update, the CFPB intends to target discriminatory practices beyond its use of the Equal Credit Opportunity Act (ECOA) – a fair lending law which covers extensions of credit – and plans to also enforce the Consumer Financial Protection Act (CFPA), which prohibits UDAAPs in connection with any transaction for, or offer of, a consumer financial product or service.  To that end, future examinations will focus on policies or practices that, for example, exclude individuals from products and services, such as “not allowing African-American consumers to open deposit accounts, or subjecting African-American consumers to different requirements to open deposit accounts” that may be an unfair practice where the ECOA may not apply to this particular situation.

The CFPB notes that, among other things, examinations will (i) focus on discrimination in all consumer finance markets; (ii) require supervised companies to include documentation of customer demographics and the impact of products and fees on different demographic groups; and (iii) look at how companies test and monitor their decision-making processes for unfair discrimination, as well as discrimination under ECOA.

In a statement accompanying this announcement, CFPB Director Chopra stated that “[w]hen a person is denied access to a bank account because of their religion or race, this is unambiguously unfair . . . [w]e will be expanding our anti-discrimination efforts to combat discriminatory practices across the board in consumer finance.”

Putting it Into Practice:  This announcement expands the CFPB’s examination footprint beyond discrimination in the fair lending context and makes it likely that examiners will assess a company’s anti-discrimination programs as applied to all aspects of all consumer financial products or services, regardless of whether that company extends any credit.  By framing discrimination also as an UDAAP issue, the CFPB appears ready to address bias in connection with other kinds of financial products and services.  In particular, the CFPB intends to closely examine advertising and marketing activities targeted to consumers based on machine learning models and any potential discriminatory outcomes.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

New Tools in the Fight Against Counterfeit Pharmaceuticals

The explosive growth of internet pharmacies and direct-to-consumer shipment of pharmaceuticals has provided increased access to, and reduced the cost of, important medications. Unfortunately, these same forces have increased the risks that counterfeit medicines will make their way to consumers, endangering patient safety and affecting manufacturers’ reputation in the public eye.

While the Food and Drug Administration attempts to police such misconduct through enforcement of the Food, Drug, and Cosmetics Act (FDCA), the resources devoted to enforcement are simply no match for the size and scope of the counterfeiting threat. Fortunately, pharmaceutical manufacturers are not without recourse, as several well-established tools may be used in the right circumstances to stop counterfeiters from profiting from the sale of knock-offs.

Experienced litigators can use the Lanham Act and the Racketeer Influenced Corrupt Organizations (RICO) Act to stop unscrupulous individuals and organizations from deceiving customers with counterfeit versions of trademarked drugs. Until recently, these legal weapons – including search warrants, seizures, forfeitures, and significant penalties – were typically wielded only by the government and only in criminal prosecutions.

As one recent case demonstrates, however, many of the tools that law enforcement has used for years to combat counterfeiters are also available to pharmaceutical manufacturers. In Gilead Sciences, Inc. v. Safe Chain Solutions, LLC, et al., the manufacturer of several trademarked HIV medications filed a civil complaint, under seal, alleging violations of the Lanham Act and RICO against scores of individuals and companies that were allegedly selling counterfeit versions of these drugs to patients across the country.

By deploying private investigators and techniques typically used by law enforcement, Gilead was able to gather a substantial amount of evidence before even filing the case. The company then used this evidence to secure ex parte seizure warrants and asset freezes, allowing it to locate and seize thousands of counterfeit pills and packaging before they could be shipped to unsuspecting consumers. Through the seizure of the financial proceeds of the alleged counterfeiting, Gilead prevented the dissipation of assets. If the company can successfully prove its RICO case, it stands to recover treble damages and attorneys’ fees as well.

Manufacturers of trademarked pharmaceuticals may consider using these and other tools to tackle the threat posed by counterfeiters. By drawing upon the experience and skills of trained litigators – particularly counsel who previously deployed these tools on behalf of the government while serving as federal prosecutors – companies can proactively protect their intellectual property and the consumers who depend on their products.

© 2022 BARNES & THORNBURG LLP

Lawsuits Allege Fudged Fudge

 

hot fudge sundae misleadingly described as fudge dairy fat, are falsely and misleadingly described as “fudge.” (See Reinitz v. Kellogg Sales Company, Bartosiake v. Bimbo Bakeries

Three class-action lawsuits filed in district courts in Illinois allege that products containing vegetable oils, and not dairy fat, are falsely and misleadingly described as “fudge.” (See Reinitz v. Kellogg Sales CompanyBartosiake v. Bimbo Bakeries USA, Inc., and Lederman v. The Hershey Company).  The lawsuits, which are all filed by Sheehan & Associates, P.C. and are substantively identical, have targeted Kellogg Sales Company’s “Frosted Chocolate Fudge,” Bimbo Bakeries USA, Inc.’s “Chocolate Fudge Iced Cake,” and the Hershey Company’s “Hot Fudge” respectively.

The lawsuits allege that fudge is a candy made from the mixing of sugar, butter, and milk, and that the replacement of dairy fats (butter and/or milk) with vegetable oils in each of the three products at issue constitutes deceptive advertising.  In support of these claims, Plaintiff cites a hodgepodge of sources including three recipes from around the turn of the 20th century, a Wikipedia entry, Molly Mills, who is apparently “one of today’s leading authorities on fudge,” and a 1982 Bulletin from the International Dairy Federation.

Plaintiffs have not, however, provided any extrinsic evidence of consumer deception (e.g., market studies), and such information will almost certainly have to be produced for such a case to ultimately succeed. We have previously reported on several other class actions which allege that the replacement of dairy fat with vegetable oil is misleading to consumers (see here and here), and we will continue to monitor and report on the outcomes of these cases.

© 2021 Keller and Heckman LLP

Article by the Food and Drug Law at Keller and Heckman

See links for more articles on Biotech, Food, Drug law, and Consumer Protection law