Tag: health

Fitness App Agrees to Pay $56 Million to Settle Class Action Alleging Dark Pattern Practices

On February 14, 2022, Noom Inc., a popular weight loss and fitness app, agreed to pay $56 million, and provide an additional $6 million in subscription credits to settle a putative class action in New York federal court. The class is seeking conditional certification and has urged the court to preliminarily approve the settlement.

The suit was filed in May 2020 when a group of Noom users alleged that Noom “actively misrepresents and/or fails to accurately disclose the true characteristics of its trial period, its automatic enrollment policy, and the actual steps customer need to follow in attempting to cancel a 14-day trial and avoid automatic enrollment.” More specifically, users alleged that Noom engaged in an unlawful auto-renewal subscription business model by luring customers in with the opportunity to “try” its programs, then imposing significant barriers to the cancellation process (e.g., only allowing customers to cancel their subscriptions through their virtual coach), resulting in the customers paying a nonrefundable advance lump-sum payment for up to eight (8) months at a time. According to the proposed settlement, Noom will have to substantially enhance its auto-renewal disclosures, as well as require customers to take a separate action (e.g., check box or digital signature) to accept auto-renewal, and provide customers a button on the customer’s account page for easier cancellation.

Regulators at the federal and state level have recently made clear their focus on enforcement actions against “dark patterns.” We previously summarized the FTC’s enforcement policy statement from October 2021 warning companies against using dark patterns that trick consumers into subscription services. More recently, several state attorneys general (e.g., in Indiana, Texas, the District of Columbia, and Washington State) made announcements regarding their commitment to ramp up enforcement work on “dark patterns” that are used to ascertain consumers’ location data.

Article By: Privacy and Cybersecurity Practice Group at Hunton Andrews Kurth

For more cybersecurity legal news, click here to visit the National Law Review.
 
Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.

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.

Article By Eric J. Beste, Anthony J. Burba and Heather F. Delgado of Barnes & Thornburg LLP

For more health law legal news, click here to visit the National Law Review.

© 2022 BARNES & THORNBURG LLP

U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate

On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.

The Court based its holding on two main points.  First, the Court held that Congress clearly authorized CMS to put conditions on funding it provides to the Medicare and Medicaid certified facilities.  The Court opined that perhaps CMS’s “most basic” function is to ensure that regulated facilities protect the health and safety of their patients, noting that Medicare and Medicaid patients are often some of the most vulnerable to infection and death from COVID-19.  Because CMS determined that a vaccine mandate is necessary to protect patient health and safety, the Court held the mandate “fits neatly within the language of the [authorizing] statute.”  The Court acknowledged that CMS has never required vaccinations in the past, but attributed this in part to the fact that states typically already require necessary vaccinations like hepatitis B, influenza, and measles for healthcare workers.

Second, the Court held that the mandate is not arbitrary and capricious, and cautioned the district courts that their role is merely to make sure an agency acts within the “zone of reasonableness.”  The Court found the administrative record sufficient to explain CMS’s rationale for the mandate and also accepted that getting the vaccine mandate in place ahead of winter and flu season satisfied the “good cause” standard for skipping the notice and comment period.

Healthcare employers subject to the Rule should immediately start implementing vaccine requirements if they have not already.  It is anticipated that in all states but Texas, CMS will likely begin enforcement of the vaccine mandate in approximately 30 days.  On December 28, 2021, CMS released guidance to state surveyors with enforcement standards to use starting 30 days from the memo, though at the time the memo only applied to the 25 states that were not enjoined.  Healthcare employers should also keep in mind that this is not the end of the road: the Court’s holding only means that the CMS vaccine mandate is in force while the 5th and 8th Circuits complete their review of the underlying state challenges to the mandate.  While the Supreme Court’s opinion sends a strong message that lower courts should uphold the mandate, there is no guarantee they will do so.

The legal landscape continues to evolve quickly and there is a lack of clear-cut authority or bright line rules on implementation.  This article is not intended to be an unequivocal, one-size-fits-all guidance, but instead represents our interpretation of where applicable law currently and generally stands.  This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, including, without limitation, potential liability should an employee become ill, requirements regarding family leave, sick pay and other issues.

Article By Keeley A. McCarty and Ashley T. Hirano of Sheppard, Mullin, Richter & Hampton LLP

For more health law legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

OSHA’s COVID-19 Vaccine, Testing Mandates Back On – Effective Jan. 10, 2022

On December 17, the U.S. Court of Appeals for the Sixth Circuit lifted the stay of OSHA’s Emergency Temporary Standard (ETS) that had been imposed by the Fifth Circuit, putting the ETS’ employer vaccination and testing requirements for COVID-19 back into effect. Following the decision, OSHA announced a Jan. 10, 2022, effective date, but added it will not cite employers for noncompliance with the testing requirements prior to Feb. 9, 2022.

Accordingly, employers can consider these dates as the new compliance deadlines: Jan. 10 for all ETS requirements except testing and Feb. 9 for testing requirements. Notably, OSHA will require employers to demonstrate good faith efforts to come into compliance. So employers covered by the ETS should begin taking steps to demonstrate compliance and documenting all such efforts.

Right now, employers should conduct vaccination inquiries, create a roster of employee vaccination status, and decide whether to require vaccinations for all employees or allow weekly testing as an alternative.

Employers should also consider reviewing options from payroll providers or HRIS software for the confidential storage and retrieval of vaccination and test information. Unionized employers need to consider their bargaining obligations over the discretionary aspects of the ETS, as well as over the effects of its nondiscretionary requirements.

This court decision adds another twist in the winding litigation challenging President Biden’s federal vaccine mandates. Following the Dec. 17 decision, the parties challenging the ETS immediately filed emergency applications with the U.S. Supreme Court to reimpose the stay. Justice Brett Kavanaugh will review and make a decision on the applications, as he is the justice assigned to hear such petitions arising from the Sixth Circuit. Justice Kavanaugh will have the option to grant the applications and stay the ETS pending review by the full Supreme Court, refer them to the full court for a decision, or take no action pending review.

It is possible the Supreme Court will weigh in on the emergency applications quickly, so employers can expect updates in the coming days and weeks.

© 2021 BARNES & THORNBURG LLP
For more about OSHA Mandates, visit the NLR Coronavirus News section.

Study Demonstrates Earlier Physician Retirement Overall and Increased Pay Equity Concerns for Female Doctors During the Pandemic

This month, Doximity issued its Fifth Annual 2021 Physician Compensation Report. With the continued strain of the pandemic spanning 2021, the self-reported physician data reflected widespread burnout and early retirement, especially by female physicians. With respect to physician compensation, Doximity findings demonstrated:

  • While average doctor pay increased 3.8 percent between 2020 and 2021, there was a decline of real income compared to 2020 given the CPI 6.2% rate of inflation in 2021.
  • The top five metro areas with the highest physician pay were Charlotte, NC; St. Louis, MO; Buffalo, NY; Jacksonville, Florida; and, Orlando, Florida.
  • The top five metro areas with the lowest physician pay were Baltimore, MD; Providence, RI; San Antonio, TX; Washington, D.C.; and Boston, MA.
  • A widening gender pay gap of 28.2% this year, with female physicians making $122,000 less than male physicians in 2021.
  • Based on 2014-2019 data, Doximity estimates that over the course of a career, female physicians will earn over $2 million less than male physicians.

Specialties with the largest pay equity gaps between men and women are oral & maxillofacial surgery; allergy and immunology; ENT; pediatric nephrology; and thoracic surgery. Significantly, there is no one medical specialty where women earned the same or more than men in 2021. All specialties had a pay gap over 10%, except Pediatric Rheumatology (which had a gap of 7.9%). To compound matters, a recent Jama Network Open research letter found that physician residents who were mothers – compared to physician residents who were fathers – were more likely to be responsible for childcare or schooling (24.6% v. .8%), household tasks (31.4% v. 7.2%), to work primarily from home (40.9% to 22%), and to reduce their work hours (19.4% to 9.4%). The study reflected the significant concern that these “short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact advancement.”

Doximity’s research also revealed that due to the pandemic, over 1% of physicians retired before expected, which is feared to strain an already tight labor market. The report also highlighted studies suggesting about half of doctors are considering an employment change due to the “COVID-related overwork.” The overwork also had a disproportionate impact on women physicians, with 25% of them reporting they are “considering early retirement” due to increased work during the pandemic.

This research reflects the importance of a physician/employer in any setting reflecting on the impact of the pandemic on its healthcare team. Moreover, the research shows continued pay equity deficits between female and male physicians, which may be exacerbated by the pandemic. Internal reflection on current pay practices to identify the factors contributing to it are critical to maintain top talent, improve morale amidst very difficult times and avoid wage and hour litigation.

Article By Dorothy Parson McDermott of Jackson Lewis P.C.

For more healthcare and health law legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2021

Given Deadlines Set by Sixth Circuit, ETS Likely Stayed Until At Least December 10, 2021

Earlier this month, the Occupational Safety and Health Administration (“OSHA”) issued its “COVID-19 Vaccination and Testing; Emergency Temporary Standard” (the “ETS”) requiring employers of 100 or more employees to implement policies requiring employee vaccination or enhanced safety measures for unvaccinated employees (including wearing face coverings and weekly COVID-19 testing). Our alert on the ETS is here. The ETS was subject to over 30 petitions for review in the federal circuit courts and was quickly stayed by the United States Court of Appeals for the Fifth Circuit.

Although the petitions for review were consolidated before the United States Court of Appeals for the Sixth Circuit, the Fifth Circuit’s stay remains in place. While OSHA has publically stated that it will comply with the stay, its position has been – and continues to be – that employers should prepare to comply with the ETS and that OSHA will succeed in litigation challenging the ETS. Yesterday, OSHA filed an emergency motion to immediately lift the stay.

With the stay in place, covered employers have been in the difficult position of trying to determine how much preparation to do to comply with the ETS’s requirements, many of which are scheduled to be effective on December 6, 2021. The question has been whether the stay will continue beyond the initial deadlines and, if not, whether deadlines will be extended to account for the period during which the ETS was stayed.

The deadlines set out in the Sixth Circuit’s Scheduling Order, which is available here, provide some insight into the timing of the requirements of the ETS.  The Scheduling Order sets the following briefing deadlines:

  • Tuesday, November 30, 2021 – motions to join OSHA’s emergency motion or to modify, revoke, or extend the stay.
  • Tuesday, December 7, 2021 – responses to motions regarding the stay.
  • Friday, December 10, 2021 – replies to responsive motions.

Given these deadlines, it is likely that the ETS will continue to be stayed until at least December 10th (past the December 6, 2021 deadline) while the Sixth Circuit considers briefing.  However, it is possible that, before December 10th, the Sixth Circuit lifts the stay. If the stay is lifted, the ETS requirements could become effective on the date of the court’s order or on a later date set by the Sixth Circuit.

While the briefing schedule does not provide definitive answers to employers on the potential deadlines for ETS compliance, it suggests that the ETS’s December 6, 2021, deadlines may be extended for at least a few days while the Sixth Circuit considers briefing.

© 2021 Bracewell LLP
For more on OSHA COVID-19 updates, visit the NLR Coronavirus News section.

Travelers Take Note: City of Chicago Issues Emergency Travel Order

If you, your colleagues, your employees, or your clients have travel plans to or from a COVID-19 hotspot, the City of Chicago is requiring a two-week quarantine. On July 2, 2020, the City of Chicago issued an Emergency Travel Order directing travelers either coming into Chicago or returning to Chicago from a state experiencing a surge in COVID-19 cases to quarantine for 14 days. The emergency order took effect on July 6, 2020, at 12:01 a.m. To date, this emergency order only applies to individuals arriving in Chicago. The State of Illinois has not taken similar action.

The emergency order applies to states that have had a case rate of COVID-19 greater than 15 new cases per 100,000 residents, per day, on a seven-day rolling average. The emergency order applies only if the traveler has spent 24 hours in the designated states. Therefore, if an individual simply drove through a designated state or had a connecting flight in a designated state, they are not subject to the restriction. In addition, the emergency order does not apply currently to international travel.

As of the date the emergency order was issued, the following states were subject to this quarantine restriction:

  • Alabama
  • Arkansas
  • Arizona
  • California
  • Florida
  • Georgia
  • Idaho
  • Louisiana
  • Mississippi
  • North Carolina
  • Nevada
  • South Carolina
  • Tennessee
  • Texas
  • Utah

This list is subject to change and is scheduled to be amended every Tuesday starting on July 14, 2020, with the changes to take effect three days thereafter, or the next Friday. For the latest information on the states subject to the travel ban, you can visit the City of Chicago’s website.

Importantly, an individual can be fined if found to be in violation of the emergency order. The fines range from $100 to $500 per day, up to a maximum $7,000. There are exemptions for “essential workers,” as designated by the Cybersecurity and Infrastructure Security Agency, such as individuals employed in emergency services, government facilities, and information technology. However, the definition of “essential workers” can be technical and the emergency order adds requirements for these professionals, including that the travel be for a work purpose and that any nonessential activities be avoided until the quarantine period has ended.

© 2020 Much Shelist, P.C.

For more COVID-19 travel restrictions, see the National Law Review Coronavirus News section.

EEOC: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws

The U.S. Equal Employment Opportunity Commission (EEOC), the federal agency responsible for enforcing federal anti-discrimination laws, today updated its Technical Assistance Questions and Answers, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.” This Technical Assistance is intended to help employers address practical issues that may arise in their day-to-day operations and oversight of their employees as they return to work in the context of COVID-19. The EEOC has consistently reminded employers that the federal anti-discrimination laws continue to apply during the pandemic and that these laws do not interfere with the guidance issued by public health authorities, including the CDC.

What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws

The EEOC’s previously issued Technical Assistance discussed critical issues such as disability-related inquiries and medical examinations, confidentiality of medical information, and hiring and onboarding during the COVID-19 pandemic. In addition, the EEOC provided detailed guidance on handling reasonable accommodations during the pandemic. In this newly issued Technical Assistance, the EEOC focuses in even further on these and related issues, and provides an analysis of common topics that many employers have been or will be facing as employees are preparing to return to work.

The updated questions and answers include topics such as: whether an employee is entitled to an accommodation under the ADA to avoid exposing a family member who is at higher risk of severe illness from COVID-19; whether reasonable accommodations are required during the process of screening employees before they enter the worksite; whether employees age 65 or older, who are at higher risk of severe illness from COVID-19, can be involuntarily excluded from the workplace based on their age; whether pregnant employees can be involuntarily excluded from the workplace due to their pregnancy and, relatedly, whether there is a right to accommodation based on pregnancy during the pandemic. In addition, the updated Technical Assistance discusses steps employers can take to prevent and address possible harassment and discrimination that may arise related to the pandemic, particularly as against employees who are or perceived to be Asian.

EEOC Technical Assistance Questions and Answers

Employers should review this newly issued Technical Assistance from the EEOC so that they are prepared to address these issues if they arise as businesses are re-opening and employees are returning to the workplace.

©2020 Norris McLaughlin P.A., All Rights Reserved

For more on EEOC COVID-19 guidance, see the National Law Review Labor & Employment law section.

Beware the COVID-19 Cure: The FTC Issues Warnings to Products Making COVID-19 Treatment Claims

With no approved vaccine, the world waits for the next big breakthrough in 2020’s medical emergency. Some companies already claim to have found it – and subsequently received warning letters from the Federal Trade Commission (FTC) for misbranding. The FTC is targeting companies promoting products with supposed COVID-19 cures, treatment or prevention for making illegal, unsubstantiated claims.

One of the FTC’s objectives is eliminating false and misleading information from the marketplace. The FTC Act defines false advertising as misleading in a “material respect,” which includes both affirmative statements and failure to “reveal facts material in the light of [the product’s] representations[.]” See 15 USC 55(a)(1).

The FTC accomplishes its goal by sending warning letters. Under the FTC Act, a product may be misbranded if it is promoted as a prevention, cure or treatment for COVID-19 – when in fact it has not been approved for such use by the Food and Drug Administration. Since March 2020, the FTC has issued more than 200 warning letters to various businesses that advertise wellness products and other services that allegedly address COVID-19.

In some instances, the claims involved a gross exaggeration of the product’s effectiveness. For example, the website “NothingsIncurable.com” advertised products alleged to “literally make you invulnerable.” The FTC concluded those claims constituted misbranding. But even when promotional statements do not include an explicit falsehood, overpromotion still can cross into misbranding. For example, businesses that claimed, “[this product] will target and increase your immunity to help ward off the COVID-19 virus” or that recommended their products as “scientifically proven to support healthy immune function” also were found to be misbranded.

In another example, a company included “Coronavirus” in the website navigation menu that led consumers to therapy kits intended to provide “specific nutrition” to “balance the terrain of the body to make it conducive to” its particular function. Although the product description did not reference COVID-19, the FTC concluded that the website navigation menu was suggestive enough to warrant a warning for misbranding.

Summary

The FTC warning letters advise businesses that “under the FTC Act, 15 U.S.C. § 41 et seq.,” they are prohibited from advertising “that a product or service can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” In addition, products that claim or imply the ability to mitigate, prevent, treat, diagnose or cure COVID-19 must be approved drugs under section 505(a) of the Federal Food, Drug and Cosmetic Act. In each case, the FTC required a response from the business within 48 hours, detailing the actions taken to address the FTC’s concerns.

During this unprecedented health crisis, companies that sell consumer products should exercise caution when mentioning COVID-19 in advertising or promotional statements. Mentioning COVID-19 in relation to a product, even if the product is intended to address more routine health issues, could be misleading.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.

For more on COVID-19, see the National Law Review Coronavirus News section.

Temperature Checks: Three Things to Know Before Screening Employees and Customers

As businesses begin the calculated process of re-opening their doors to employees and customers, many are considering implementing temperature checks to monitor for at least one known COVID-19 symptom – the fever.

Beyond nailing down the logistics of temperature checks (e.g., who will perform them, has that person been trained, do employees need to be paid while waiting in line, how will social distancing be maintained, etc.) there are several significant legal considerations that should be evaluated before implementation.

The Illinois Biometric Privacy Act

Some temperature screening devices utilize facial-recognition technology to quickly identify those with fever so that they can be promptly tracked down and removed from the facility. While these systems provide logistical advantages, especially to large employers and retailers, they likely implicate provisions of the Illinois Biometric Privacy Act (BIPA) which can lead to costly litigation and result in stiff penalties for anyone who violates the statute, even unwittingly.

According to BIPA, businesses utilizing this type of facial-recognition technology must obtain advance, written consent from the individuals to be scanned, and must also maintain a publicly available policy that specifies information regarding the collection, use, storage, and destruction of individuals’ biometric information. And, again, these policies and consents must be executed and implemented before temperature screenings begin. It is, therefore, critical to determine whether your temperature screening devices perform facial recognition scans or capture other biometric information.

Confidentiality of Employee Information

Employers screening employee temperatures must also remember they are conducting a “medical examination,” as defined by the Equal Employment Opportunity Commission (EEOC) and would be wise to adhere to the EEOC’s guidance on the issue. This means information collected about employees’ temperature, such as the temperature readings themselves, or the fact that an employee had or has a fever, must be treated as confidential medication information and maintained in a confidential file separate from an employee’s personnel file. Employers should also take care to not divulge the identity of any employee sent home with fever, absent consent from the employee to share that information with other personnel, or a strict need-to-know among involved supervisor(s) or members of human resources.

The California Consumer Privacy Act

California’s sweeping new privacy law, the California Consumer Privacy Act (CCPA), contains broad protection of consumers’ “personal information,” and requires businesses subject to the statute to, among other things, notify consumers when their personal information is being collected. Though body temperature is not explicitly mentioned in the statute, the definition of “personal information” is broad, and includes information that “identifies, relates to, describes, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer …” It includes biometric information. Whether an individual’s temperature constitutes personal information is up for some debate, but debates often lead to costly litigation, and it is easy enough to amend CCPA notices to include temperature until that debate is resolved in an effort to avoid litigation altogether.

So, if a business is subject to the CCPA and intends to collect employee or customer temperatures (whether or not with the use of biometric technology), it should consider updating its CCPA notices to include “temperature” (and, if applicable, scans of face geometry) to the list of personal information collected.

© 2020 Much Shelist, P.C.

For more employer COVID-19 guidance, see the National Law Review Coronavirus News section.