California Readies for Statewide Extended Producer Responsibility for Pharma Waste
By Charles A. White, Senior Advisor, Environment
The sale of needles (sharps) and pharmaceutical drugs in California is estimated to be on the order of $50 billion per year. Significant concerns have been raised about adverse impacts of wastes generated from the use of these otherwise beneficial products, including impacts on human health, public safety and the environment. However, other than a variety of different drug and sharps take-back programs established by local governments, there is no uniform coordinated program for the take back and appropriate management of these wastes in California. Although the disposal of needles in solid waste was banned in California in 2008, needles are still discovered in the handling of solid waste—posing a serious threat to workers. This is about to change—with significant penalties for noncompliance.
California Senate Bill 212 was enacted in 2018. This legislation requires all businesses involved in the marketing of drugs or home-use medical sharps in California to develop and implement a statewide drug and/or home-generated sharps waste stewardship plan for the collection and disposal of home-generated drug and sharps waste—starting on or after January 1, 2022—less than 3 years from now.
- For drug stewardship plans, there must be five collection sites per county or one per 50,000 people, whichever is greater.
- For home-generated sharps stewardship plans, collection is done through prepaid mail-back containers, for which distribution is made or initiated at the point of sale with no cost to the consumer.
Why Extended Producer Responsibility? Organizations like the California Product Stewardship Council (CPSC), which sponsored SB 212, argue that Extended Producer Responsibility (EPR), also known as Product Stewardship, places a shared responsibility for end-of-life product management on the producers—and all other entities involved in the product chain—instead of just local government and the end user. CPSC maintains that EPR encourages product design changes that minimize negative impacts on human health, public safety and the environment at every stage of the product’s life cycle by:
- Allowing the costs of waste treatment and disposal to be incorporated into the total cost of a product
- Placing the primary responsibility on the producer, or brand owner, that makes design and marketing decisions
- Creating a setting for the emergence of markets that reflect the environmental impacts of a product . . . to which producers and consumers will respond
Because many California cities and counties have already been adopting drug and/or sharps take-back programs, SB 212 preempts a local stewardship ordinance for drug- or sharps-covered products with an effective date on or after April 18, 2018. However, SB 212 also provides that the bill does not preempt a local drug or sharp stewardship program that took effect before April 18, 2018—but such pre-April 2018 local programs may not receive funding from the statewide program unless the local program is repealed. If a pre-April 2018 ordinance is repealed, SB 212 requires compliance with the statewide program within 270 days after the date of the local repeal. It is anticipated that most local governments will repeal their pre-April 2018 ordinances to be consistent with the statewide program.
SB 212 represents a compromise among numerous stakeholders, including the governor’s office, CalRecycle, industry trade associations, CPSC, the California Retailers Association, the California Hospital Association, the Healthcare Distribution Alliance and others. No stakeholder got everything it wanted, but the bill was acceptable to nearly all of those parties involved so as to minimize active opposition. Pharmaceutical companies were largely persuaded because of the preemption provisions to control the burgeoning variety of different local government programs that were being developed.
CalRecycle, a department within CalEPA, has lead responsibility for implementing the statutory and regulatory framework, as well as overseeing each stewardship plan and enforcing the requirements on plans. The California State Board of Pharmacy is also involved. CalRecycle and the Board of Pharmacy are currently seeking public input on the regulations, which must be adopted and effective by January 1, 2021—less than 2 years from now. Compliance by covered entities is not required until at least one year after those regulations are adopted. Although it’s not feasible to list all aspects of the program in this article, some of the issues being discussed as part of the CalRecycle rule-making include:
- Regulatory definitions
- Criteria for determining the entities covered by SB 212 and the regulations
- Submittal of pharmaceutical lists by covered entities
- Consumer educational duties of covered entities including signage and outreach
- Requirements and submittal of the product stewardship plans
- Requirements for reports, budgeting and record-keeping
- Enforcement provisions for administrative penalties of up to $10,000 per day for violations and up to $50,000 per day for violations that are intentional, knowing or reckless
Although CalRecycle is currently in the informal discussion stage of developing the proposed regulations, the formal rule-making process is likely to begin in earnest in the fall of 2019 so that the rules can be adopted and finalized by January 1, 2021.
Bottom Line
If you or someone you know is in the business of manufacturing, packaging, distributing, transporting, selling, accepting, taking back, treating, recycling or disposing of pharmaceutical drugs or sharps in California, you need to be engaged in the CalRecycle process—now!
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Song-Beverly Credit Card Act: Litigation Developments and Guidance for Retailers Collecting Customer Information
By John W. McGuinness, Partner, Manatt Financial Services | Allison C. Nelson, Associate, Litigation
A customer walks into a store and starts browsing through racks of clothing. A salesperson with a tablet or mobile phone approaches the customer and asks her for her name and address, which the customer gives. The salesperson then enters that information on the mobile device. The customer continues to shop, selects her item, proceeds to the cash register, pays with a credit card, and completes the transaction. Is this an unlawful collection of a consumer's personally identifiable information ("PII") under California's Song-Beverly Credit Card Act (the "Act")?
Alternatively, a customer approaches the point of sale, pays with a credit card, the receipt and merchandise are handed to the customer, and then the retail associate asks the customer for her telephone number and enters this information into the point of sale terminal. Does this subject the retailer to a lawsuit under California law?
Retailers who regularly engage in credit card transactions in California should be aware of collection practices that may increase the risk of litigation under the Song-Beverly Credit Card Act. Recent caselaw provides valuable guidance for retailers seeking to collect customer PII while minimizing the risk of litigation.
The Song-Beverly Credit Card Act
Retailers in California are likely already well aware of the Song-Beverly Credit Card Act, codified as Cal. Civ. Code §1747.08, which generally prohibits businesses from requesting or requiring a card holder to provide PII at the time of the transaction as a condition to accepting the credit card as payment in full or in part for goods or services, and then recording that information.
More than a decade ago, retailers experienced a wave of litigation brought by plaintiffs' attorneys construing the Act to prohibit any request for PII (including, address, telephone number and e-mail address) at the point of sale from customers paying by credit card in California. Plaintiffs' attorneys' positions were bolstered in 2011, when the California Supreme Court held that ZIP codes constitute PII, which resulted in a further round of lawsuits involving retailer requests for customers' ZIP codes at the point of sale before purchases were consummated. See Pineda v. Williams-Sonoma Stores, Inc., 51 Cal. 4th 524, 530 (2011). While plaintiffs' lawyers have focused less on these sorts of cases in recent years, litigation risk remains, subjecting retailers to up to $1,000 in civil penalties per violation of the Act.
In the following scenarios, we address various potential ways for retailers to collect PII from credit card paying customers, highlight where courts have weighed in on whether these practices violate the Act, and the likely degree of litigation risk associated with these practices.
Continue reading the full article here. This article was originally published by Bloomberg Law.
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Ninth Circuit Has No Room for Anything but FCRA
Why it matters
Taking a hard line on the standalone document requirement of the Fair Credit Reporting Act (FCRA), the U.S. Court of Appeals, Ninth Circuit, held that the inclusion of any extraneous information relating to various state disclosure requirements violates the federal statute. Desiree Gilberg filed a putative class action against California Check Cashing Stores, alleging that the “Disclosure Regarding Background Investigation” form the company had her sign violated the federal law because it contained not only the mandated FCRA disclosure but additional disclosures from seven other states as well. A district court granted the employer’s motion for summary judgment, finding that it complied with both state and federal statutes. But the Ninth Circuit reversed. The FCRA means what is says, the panel wrote, holding that a prospective employer violates the federal statute’s standalone document requirement by including extraneous information relating to various state disclosure requirements in that disclosure. Not only did California Check Cashing violate the FCRA requirement, but the form of its disclosure also ran afoul of California’s Investigative Consumer Reporting Agencies Act (ICRAA) standalone document requirement, the court added. In light of the Ninth Circuit’s opinion, employers should reread their disclosure forms to ensure compliance with both the FCRA and state law to avoid a similar action.
Detailed discussion
Pursuant to 15 U.S.C. § 1681b(b)(2)(A), the Fair Credit Reporting Act (FCRA) requires employers who obtain a consumer report on a job applicant to provide the applicant with a “clear and conspicuous disclosure” that they may obtain such a report “in a document that consists solely of the disclosure” before procuring the report.
In the process of applying for employment with CheckSmart Financial, Desiree Gilberg completed a three-page form containing an employment application, a math screening and an employment history verification. She later signed a separate form, titled “Disclosure Regarding Background Investigation,” which included the FCRA disclosure as well as mandated state disclosures for California, Maine, Minnesota, New York, Oklahoma, Oregon and Washington.
CheckSmart hired Gilberg, who worked for the company five months before voluntarily leaving her employment. She then filed a putative class action against the company alleging that it failed to make proper disclosures as required by both the FCRA and California’s Investigative Consumer Reporting Agencies Act (ICRAA).
The district court granted the employer’s motion for summary judgment on both claims, ruling that CheckSmart’s disclosure form complied with the FCRA and ICRAA. Gilberg appealed to the U.S. Court of Appeals, Ninth Circuit.
Relying on its 2017 decision in Syed v. M-I, LLC, the federal appellate panel reversed. In Syed, the Ninth Circuit analyzed the FCRA’s standalone document requirement and held that a prospective employer violated the statute when it included a liability waiver in the same document as the mandated disclosure. The statute means what it says, the court held: that the required disclosure must be in a document that “consist[s] ‘solely’ of the disclosure.”
CheckSmart attempted to distinguish its disclosure because the additional information consisted of other, state-mandated disclosure information, which it argued furthered, rather than undermined, the FCRA’s purpose.
“We disagree,” the panel wrote. “Syed’s holding and statutory analysis were not limited to liability waivers; Syed considered the standalone requirement with regard to any surplusage. Syed grounded its analysis of the liability waiver in its statutory analysis of the word ‘solely,’ noting that FCRA should not be read to have implied exceptions, especially when the exception—in that case, a liability waiver—was contrary to FCRA’s purpose. Syed also cautioned ‘against finding additional, implied exceptions’ simply because Congress had created one exception. Consistent with Syed, we decline CheckSmart’s invitation to create an implied exception here.”
Purpose does not override plain meaning, the court said, rejecting CheckSmart’s argument that its disclosure form was consistent with the intent of the FCRA. Further, the employer failed to explain how the surplus language comported with FCRA’s purpose, as the disclosure referred not only to rights under the FCRA and ICRAA applicable to Gilberg, but also to rights under various other state laws inapplicable to her.
“Because the presence of this extraneous information is as likely to confuse as it is to inform, it does not further FCRA’s purpose,” the court said.
“Syed holds that the standalone requirement forecloses implicit exceptions,” the Ninth Circuit wrote. “The statute’s one express exception does not apply here, and CheckSmart’s disclosure contains extraneous and irrelevant information beyond what FCRA itself requires. The disclosure therefore violates FCRA’s standalone document requirement. Even if congressional purpose were relevant, much of the surplusage in CheckSmart’s disclosure form does not effectuate the purposes of FCRA. The district court therefore erred in concluding that CheckSmart’s disclosure form satisfies FCRA’s standalone document requirement.”
The panel also held that CheckSmart’s disclosure form was not “clear and conspicuous” under either the FCRA or the ICRAA. Although the court determined the form was “conspicuous” (despite frowning on the size of the font used), it was not “clear” because it contained language a reasonable person would not understand and would confuse a reasonable reader because it combined federal and state disclosures.
For example, the disclosure stated: “The scope of this notice and authorization is all-encompassing; however, allowing CheckSmart Financial, LLC to obtain from any outside organization all manner of consumer reports and investigative consumer reports now and, if you are hired, throughout the course of your employment to the extent permitted by law.”
The beginning of the sentence did not explain how the authorization was all-encompassing or how that would affect an applicant’s rights, the court said, while the second half of the sentence lacked a subject and was incomplete.
As “CheckSmart’s disclosure form was not both clear and conspicuous, the district erred in granting CheckSmart’s motion for summary judgment with regard to the FCRA and ICRAA ‘clear and conspicuous’ requirements,” the panel wrote.
To read the opinion in Gilberg v. California Check Cashing Stores, LLC, click here.
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Medical Exam Comes Back Negative for Employer in Fourth Circuit
Why it matters
Reversing summary judgment in favor of an employer, the U.S. Court of Appeals, Fourth Circuit, held that the requirement to complete a medical exam may have violated the Americans with Disabilities Act (ADA) as the employer lacked a reasonable belief based on objective evidence that the employee’s medical condition left her unable to perform her job. The Equal Employment Opportunity Commission (EEOC) filed suit on behalf of Cecilia Whitten, a 28-year employee of McLeod Health who was responsible for the company’s internal newsletter. Whitten was born with a physical disability that caused her to struggle with mobility. In 2012, the employer required her to undergo a medical fitness-for-duty exam, which resulted in a discussion of possible accommodations. After placing her on unpaid medical leave, the employer terminated Whitten. She filed a charge of discrimination with the EEOC. A district court judge granted summary judgment in favor of McLeod, but the federal appellate panel reversed. A reasonable jury could find that the employer lacked a reasonable belief based on objective evidence that Whitten’s medical condition left her unable to navigate the employer’s various campuses, particularly as she had been doing so for almost three decades, the Fourth Circuit said.
Detailed discussion
For 28 years, Cecilia Whitten worked for McLeod Health, a company that operates various hospitals and healthcare facilities in South Carolina. As the editor of McLeod’s internal employee newsletter, she was responsible for developing content by interviewing other employees and writing about company events. Whitten typically traveled among McLeod’s various campuses, spread throughout an area of roughly 100 miles.
Whitten was born with a physical disability known as “postaxial hypoplasia of the lower extremity.” Lacking certain bones in her legs, feet and right hand, she has always struggled with mobility, and falling was “a constant” part of her life.
Although Whitten fell multiple times during her almost three decades of employment, she satisfactorily performed her duties for McLeod. However, in 2012, she fell three times in a four-month span (although only one of the falls occurred at work, and it resulted in no harm). Whitten’s supervisor also expressed concern that she looked “sluggish” and appeared flushed and winded after moving short distances.
The supervisor attempted to reduce Whitten’s workload but did not raise any concerns about her health. After her third fall, the supervisor reported the incidents to human resources (HR), and the occupational health department determined Whitten needed to undergo a fitness-for-duty medical exam.
Although “confused about the necessity” of the exam, Whitten underwent the exam. The nurse practitioner concluded Whitten needed a functional-capacity exam, and Whitten was placed on paid administrative leave pending the results. Based on that exam, the occupational therapist recommended that Whitten be restricted to traveling no more than 10 miles from her main office, use an assistive device and be provided with a parking space in an area without a curb.
Whitten, who did not believe she needed any accommodations but thought she was required to submit an accommodation form, responded with a request for a parking space in an area without a curb, help with selecting an appropriate assistive device, a new desk chair with adjustable-height arms, and limitations on walking and standing.
McLeod then informed Whitten that she could not return to her job because her proposed accommodations would prevent her from traveling to the company’s various campuses to collect stories and take photographs, nullifying the purpose of her position. The employer placed Whitten on unpaid medical leave and terminated her six months later.
Whitten filed a charge of discrimination with the EEOC, and the agency filed suit against McLeod for violating the ADA. Specifically, the EEOC alleged that the employer violated the statute by requiring Whitten to undergo a medical exam despite a lack of objective evidence that such an exam was necessary and by discharging Whitten on the basis of her disability.
The district court granted summary judgment to the employer on both claims, and the EEOC appealed. The U.S. Court of Appeals, Fourth Circuit, began with the medical exam.
Pursuant to the ADA, employers may require an employee to undergo a medical exam only where it “is shown to be job-related and consistent with business necessity.” The threshold question for the court: whether navigating to and within McLeod’s campuses was an essential function of Whitten’s job.
The court found evidence supporting McLeod’s position in testimony from Whitten’s supervisor that her job required her to navigate to and from company events and conduct in-person interviews; Whitten agreed in her deposition that her job required her to navigate various locations such as parking lots and grassy areas.
On the other hand, the record contained evidence supporting the EEOC’s position, the court said. McLeod’s own written description of Whitten’s position contained no mention of navigating to and from company events or conducting in-person interviews; Whitten herself did not think that either was a requirement of her job, and the EEOC produced evidence that she was able to conduct interviews and collect other forms of content over the phone.
Given this mixed evidence, “the question is one for the jury, and McLeod is not entitled to summary judgment on the EEOC’s illegal exam claim,” the panel wrote.
“We note that even if it were beyond dispute that navigating to and within McLeod’s campuses was an essential function of Whitten’s job, we would still hold that McLeod is not entitled to summary judgment,” the court added. “A reasonable jury could conclude that when McLeod required Whitten to take a medical exam, the company lacked a reasonable belief—based on objective evidence—that Whitten’s medical condition had left her unable to navigate to and within the company’s campuses without posing a direct threat to her own safety. This, too, makes summary judgment inappropriate.”
Before the employer required Whitten to undergo a medical exam, McLeod knew that Whitten had been able to perform the essential functions of her job—including navigating the campuses—for 28 years, that she had had falls recently and had struggled to handle her workload, and that her manager thought she looked winded, sluggish and groggy.
“[A] reasonable jury, viewing the evidence in the light most favorable to Whitten, could conclude that in the context of Whitten’s employment history, it was not reasonable for McLeod to believe that she had become a direct threat to herself on the job simply because (a) she had fallen multiple times recently and (b) her manager thought she looked groggy and out of breath,” the panel wrote. “This is especially so given that the only one of Whitten’s recent falls to occur at work resulted in virtually no injury.”
The Fourth Circuit reached a similar conclusion on the EEOC’s second claim, that McLeod violated the ADA by discharging Whitten on the basis of her disability. The district court’s reasoning was premised on its analysis of the EEOC’s illegal exam claim, holding that the EEOC could not prove that Whitten was qualified for her job at the time she was fired and that the medical exam indicated that no reasonable accommodation would permit her to navigate the campuses without posing a direct threat to her own safety.
“[I]t is not certain that navigating to and within McLeod’s campuses was essential to Whitten’s job,” the panel said. “By the same token, it is not certain that Whitten’s medical exam was lawful. Since the district court’s grant of summary judgment assumed that those points were not in dispute, we cannot affirm on the basis of the district court’s reasoning.”
The court reversed summary judgment in favor of the employer on both claims and remanded the case to the district court for further proceedings.
To read the opinion in Equal Employment Opportunity Commission v. McLeod Health, Inc., click here.
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Washington State Appears Next in Line for Comprehensive Privacy Legislation
By Donna L. Wilson, Managing Partner-Elect, Leader, Privacy and Data Security | Brandon P. Reilly, Counsel, Privacy and Data Security
The Washington Privacy Act would follow California’s CCPA as the second-in-the-nation law of its kind.
Since the passage of the California Consumer Privacy Act (CCPA) in June 2018, over a dozen other states have moved to enact similar comprehensive privacy legislation. Due to developments this month in both houses of the Washington state legislature, it appears that the Washington Privacy Act (WPA) is likely to become the second major privacy legislation in the United States, and it includes provisions that both reflect the CCPA and go further.
Earlier this month, the Washington Senate passed the WPA in a near-unanimous bipartisan vote, and the Washington House now appears likely to pass the companion bill just as easily. Though the two bills differ somewhat, the WPA’s general architecture appears resolved. Here are the features of the Senate bill:
- Applies to any entity that does business in Washington and either (1) controls or processes the personal data of 100,000 or more consumers; or (2) derives more than 50% of gross revenue from personal data sales and processes or controls the personal data of 25,000 or more consumers.
- Defines “personal data” as any information “that is linked or reasonably linkable to an identified or identifiable natural person.” This definition is substantially similar to the CCPA, but notably lacks the CCPA’s problematic inclusion of “households.”
- Introduces wide-ranging consumer rights pursuant to verified requests, including rights to access, correct and delete data; restrict or object to data processing; and data portability. The WPA also includes a novel protection against “final decisions” based solely on automated data processing (or “profiling”) if the decision would have a legal effect on consumers.
- Requires privacy notices that disclose the categories of personal data collected, the purpose of the personal data’s use and disclosure to third parties, the categories of personal data shared with third parties, and the categories of those third parties. A notice must also disclose sales to data brokers, direct marketing, and any profiling and its envisaged consequences, including facial recognition technology.
- Borrows the European Union’s General Data Protection Regulation’s (GDPR’s) distinction between controllers (i.e., entities deciding how data is used) and processors (i.e., entities handling data on behalf of controllers). Controllers are responsible for responding to consumer requests relating to processors, communicating those requests to processors, and conducting risk assessments both annually and prior to material changes in processing activities.
- Exclusions for data regulated by HIPAA and GLBA. Unlike the CCPA, employment records are expressly excluded.
The only remaining challenges appear to be certain differences between the House and Senate versions that must be resolved. Two major differences await:
- First, the House version includes a private right of action for violations of the WPA, though the provision would allow a 30-day right to cure and forbid attorneys’ fees and costs. The Senate version, like the CCPA, places sole enforcement authority in the hands of the state attorney general, which includes injunctive relief and penalties of $2,500 to $7,500 per violation.
- Second, the applicability thresholds differ, with the House version applying to any entity doing business in Washington or intentionally targeting Washington residents.
Why it matters
Now that a second comprehensive privacy law on the West Coast appears likely, the core privacy rights undergirding the CCPA and WPA appear to be here to stay. Businesses of nearly any size should immediately begin modifying their information governance plans accordingly, if they have not started that process already. For businesses that have been reluctant to greenlight reviews of their data ecosystem and information governance programs, the compliance risk presented by comprehensive privacy laws such as the GDPR, CCPA and the WPA is only going to increase from here.
The Washington Senate Bill, SB-5376, is available here.
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Retailer Not Liable Under Lanham Act—This Time
By Jeffrey S. Edelstein, Partner, Advertising, Marketing and Media
A new decision from a Texas federal court sounds a cautionary note for retailers about the potential for liability based on claims made on items sold in their stores.
In November 2018, the Food and Drug Administration issued a string of announcements notifying the public that certain male dietary products contained hidden drug ingredients that could be dangerous. The products, including supplements known as Rhino Products, were tested and found to contain undisclosed chemicals, the FDA said.
Outlaw Laboratory, a manufacturer of male dietary supplements, filed suit against 14 gas stations and convenience stores in response, asserting violations of the Lanham Act. Outlaw alleged that the defendants sold the Rhino Products—which contained labels touting them as “all natural” and featuring “no harmful synthetic chemicals”—and were therefore liable for false advertising because they displayed and sold the supplements in their stores, even though they were falsely labeled by a third party.
The defendants moved to dismiss the suit, arguing that no cause of action exists under the Lanham Act for merely selling products that contain false labels. While U.S. District Court Judge Jane J. Boyle granted the motion, she did not rule out the possibility of holding a retailer liable for the claims made on products sold at its store.
“To make out a claim for false advertising, a plaintiff must first show that a party made a false or misleading statement of fact about his own or another’s product in the context of ‘commercial advertising or promotion,’” the court wrote. “To qualify as a statement made in the context of commercial advertising or promotion, the representations should be made for ‘the purpose of influencing consumers to buy defendant’s goods or services’ and ‘disseminated sufficiently to the relevant purchasing public.’”
But Outlaw failed to sufficiently make such allegations against the defendants, the court found. The complaint “do[es] no more than allege that the [defendants] ‘own[] and operate[]’ a store at a certain address and ‘promote[], advertise[], disseminate[] and offer[] for sale’ the Rhino Products at its store,” the court said.
Further, the only false statements pointed to by the plaintiff were the labels on the products, but the defendants denied any involvement in making the labels and told the court that, as independent retailers, they had no influence on the product labeling.
Outlaw attempted to persuade the court that its claim should survive because simply putting a product that is falsely labeled into commerce is sufficient to make out a false advertising claim. But Judge Boyle held that a plaintiff must show that the defendants actually made some false statement in commercial advertising or promotion to trigger liability under the Lanham Act—a requirement Outlaw failed to achieve.
“[T]here is nothing in the complaint that alleges the [defendants] here did anything more than passively offer the Rhino Products for sale,” the court wrote.
The court also expressed concern about the policy implications of adopting Outlaw’s position. “Here, Defendants undoubtedly sell many products—should they be responsible for scrutinizing and determining the veracity of every claim on every product label in their stores simply because they sell the product?”
“To be sure, the Court is not holding that retailers or sellers can never be held liable for false advertising,” Judge Boyle wrote. “The Court instead holds that in this case the [defendants] cannot be held liable for false advertising based solely on allegations that they displayed and sold the Rhino Products in their stores.”
To read the memorandum opinion and order in Outlaw Laboratory, LP v. Shenoor Enterprise, Inc., click here.
Why it matters
Although the Texas federal court granted the defendants’ motion to dismiss the Lanham Act suit based on allegations that the retailers displayed and sold the products at issue, it declined to conclude that such an outcome could never be possible, leaving the door open to hold a retailer liable under the Lanham Act where a plaintiff sufficiently alleged that the defendant made false statements in the context of advertising and promotion.
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