The Next Wave of ADA Website Accessibility Lawsuits Against Alcohol Suppliers
The increasing popularity of online shopping has made e-commerce businesses – specifically those in the alcohol beverage industry – a frequent target for costly litigation. In lockstep with the continued prevalence of website accessibility cases, plaintiff firms are sending pre-suit demand letters to alcohol suppliers and, in some cases, filing a state or federal court lawsuit. These lawsuits, which are typically filed in California, Florida, or New York, involve claims that a supplier’s website is not accessible to individuals who are blind in violation of Title III of the Americans with Disabilities Act (ADA) and related state laws. In these cases, plaintiffs seek attorneys’ fees, damages (only under state law), and injunctive relief that would require the website to conform with the Web Content Accessibility Guidelines (WCAG) standards, which have been broadly adopted by courts and regulators.
While many e-commerce companies, including alcohol suppliers, have turned to “accessibility widgets” to improve WCAG compliance, these quick-fix solutions are not always what they seem. More than 25% of all website accessibility lawsuits in 2024 (more than 1,000) were brought against businesses that used widgets, with many plaintiffs explicitly citing widget features as alleged obstacles to accessibility. Widget developers have also faced scrutiny. The Federal Trade Commission recently leveled a $1 million fine against one such company for falsely claiming that its widgets “make any website complaint.” Therefore, relying solely on widgets to comply with WCAG standards has proven ineffective and could render e-commerce businesses vulnerable to website accessibility lawsuits.
To prevail on a website accessibility claim, plaintiffs must first show that a defendant is a private entity that owns, leases, or operates a “place of public accommodation.” Courts, however, are split on what it means for a website to be considered a place of public accommodation under Title III of the ADA. While some jurisdictions require a “physical nexus” between the website and a brick-and-mortar store, other jurisdictions have permitted these cases to go forward against a website-only company that does not own or operate any physical retail location. Even so, the “physical nexus” test is applied by a majority of federal courts and was recently adopted by the most active court for ADA website litigation in the country: the US District Court for the Southern District of New York. This development will likely add to an emerging trend of website accessibility plaintiffs resorting to state courts in search of more favorable laws.
In addition to establishing that the supplier’s website is a place of public accommodation, the plaintiff must satisfy certain jurisdictional requirements that will depend on whether products can be purchased directly from the website and whether the supplier ships to the state in which the suit was filed. Leveraging these defenses (among others) will be critical when it comes to either convincing the plaintiff to withdraw the claim, filing a motion to dismiss, or achieving an early resolution on favorable terms.
Due to the rise in these website accessibility lawsuits, we encourage industry members to take a proactive approach by:
Training personnel on accessibility requirements and WCAG standards.
Testing their website against WCAG standards (through independent consultants or user testing) and retaining testing documentation to demonstrate that users with disabilities can fully use the website.
Assessing potential areas of nonconformance with WCAG standards.
Working with internal and external technical teams to implement accessibility features into the website.
Developing an accessibility policy that informs users about the company’s accessibility practices.
Considering including a link to their website accessibility policy on every webpage, including a reporting option that is appropriately routed to address accessibility issues.
Regularly auditing their website to assess its level of accessibility (particularly after website updates).
Prioritizing manual audits over “quick fixes,” like accessibility widgets.
Engaging legal counsel to minimize litigation risk associated with website accessibility issues, including whether the ADA is applicable to the company’s website in light of the current state of the law.
Council of the EU Agrees on Negotiating Mandate on Plants Obtained by New Genomic Techniques
The Council of the European Union (EU) announced on March 14, 2025, that the Committee of the Permanent Representatives of the Governments of the Member States to the EU (Coreper) endorsed the Council’s negotiating mandate on the regulation on plants obtained by new genomic techniques (NGT) and their food and feed. The regulation proposed by the European Commission (EC) would create two ways for NGT plants to be placed on the market:
Category 1 NGT plants: Could occur naturally or through conventional breeding methods; they would be exempted from the rules currently set out in the genetically modified organism (GMO) legislation and would not be labeled; seeds produced through those techniques would have to be labeled, however; or
Category 2 NGT plants: All other NGT plants; rules under GMO legislation would apply (including a risk assessment and authorization before they are placed on the market); they would be labeled as such.
The proposed regulation would exclude the use of NGTs in organic production.
The press release states that the Council suggested the following changes in its negotiating mandate, including:
Cultivation and presence of new genomic techniques plants:
Opt-out from cultivation: Under the Council’s mandate, EU member states can decide to prohibit the cultivation of category 2 NGT plants on their territory;
Optional coexistence measures: EU member states can take measures to avoid the unintended presence of category 2 NGT plants in other products and will need to take measures to prevent cross-border contamination; and
The Council’s position also clarifies that, to avoid the unintended presence of category 1 NGT plants in organic farming on their territories, EU member states can adopt measures, in particular in areas with specific geographical conditions, such as certain Mediterranean island countries and insular regions.
Category 1 new genomic techniques plants and patenting: According to the press release, under the Council’s mandate, when applying to register a category 1 NGT plant or product, companies or breeders must submit information on all existing or pending patents. The patenting information must be included in a publicly available database created by the EC that lists all NGT plants that have obtained a category 1 status. The press release notes that the database would ensure transparency regarding NGT 1 plants and information about patents included in the database would be updated. The press release states that on a voluntary basis, companies or breeders could also report the patent holder’s intention to license the use of a patented NGT 1 plant or product under equitable conditions.
Patenting expert group: The Council’s mandate provides for the creation of an expert group on the effect of patents on NGT plants, with experts from all member states and the European Patent Office.
Study on patenting: The press release states that according to the Council’s mandate, one year after the entry into force of the regulation, the EC would be required to publish a study on the impact of patenting on innovation, on the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. The study would also have a special focus on how breeders can have access to patented NGT plants. To produce the study, the EC would take into account the findings of the patenting expert group and input from the plant breeding sector. According to the press release, if appropriate, the EC would indicate what follow-up measures are needed or publish a legislative proposal to address any issues found in the study. The press release notes that if the first study does not foresee any follow-up measures or a new legislative proposal, the EC would be required to issue a second study four to six years after the publication of the first one.
Labeling: Category 2 NGT plants must contain a label indicating them as such, in line with the EC proposal. The press release states that the Council proposes that, in case information on modified traits appears on the label, it must cover all the relevant traits (e.g., if a plant is both gluten-free and drought-tolerant owing to genomic changes, either both of those features or neither of them should be mentioned on the label). The Council intends this proposal to ensure that consumers have access to accurate and comprehensive information.
Traits: The Council negotiating mandate states that tolerance to herbicides cannot be one of the traits for category 1 NGT plants. According to the press release, the Council proposes this change to ensure that such plants remain subject to the authorization, traceability, and monitoring requirements for category 2 NGT plants.
The agreement on the Council’s negotiating mandate allows its presidency to begin negotiations with the European Parliament (EP) on the final text of the regulation. The final text must be formally adopted by the Council and the EP before the regulation can enter into force.
HHS Secretary Kennedy Directs FDA to Explore Rulemaking to Eliminate Self-Affirmed GRAS Pathway
On March 10, 2025, the Department of Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that he is directing the U.S. Food & Drug Administration (FDA) “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.”
This self-affirmation process is built into the 1958 Food Additive Amendments, which amended the definition of a “food additive” and allows certain substances to be exempt from premarket review if they are GRAS based on scientific procedures or history of use in food as determined by qualified experts. Notably, the announcement also specifically references “substances that come into contact with food.”
The announcement is made to promote oversight and transparency. The announcement expresses a commitment to working with Congress to close the GRAS self-affirmation pathway and acknowledges that legislation will be pursued in tandem with potential future rulemaking.
Importantly, there is no immediate effect on ingredients currently marketed, allowing companies to continue their operations without disruption while FDA explores potential rulemaking. Keller and Heckman will continue to monitor developments related to the GRAS program.
Telehealth Companies and Social Media Influencers May Face New FDA Laws
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes” in social media advertisements by telehealth companies. The Act would require the U.S. Food & Drug Administration (FDA) to target false and misleading prescription drug promotions by social media influencers and telehealth companies.
Background
Whether or not telehealth companies are under FDA jurisdiction when marketing and promoting prescription drugs has been under debate since The New York Times published its 2019 article, Drug Sites Upend Doctor-Patient Relations: ‘It’s Restaurant-Menu Medicine’. The report called into question whether telehealth companies are — or ought to be — subject to FDA oversight when advertising drugs and medical devices. Subsequent investigative reporting alleged how some telehealth companies ran ads on social media describing benefits of prescription drugs but failing to describe the risks of these drugs. Reporters claimed telehealth companies promoted drugs for unapproved uses or featured “testimonials” without disclosing whether or not the testimonials came from actual patients or were from paid actors or company employees.
Under the Federal Food, Drug, and Cosmetic Act (FDCA), advertisements for prescription drugs may not be false, lacking in fair balance, or otherwise misleading. Any advertisements for prescription drugs (with the narrow exception of exempt reminder ads), must present a true statement of information in brief summary relating to side effects, contraindications, and effectiveness. The term “side effects, contraindications” means side effects, warnings, precautions, and contraindications, and also includes any such information under such headings as cautions, special considerations, important notes, etc.
Some have claimed these FDCA legal requirements, although clearly applicable to drug manufacturers, packers, and distributors, do not apply to telehealth companies and associated medical providers because the telehealth company and their associated providers are not addressed in the FDCA and not included in the definition of “firm” under applicable FDA Guidance documents. Under this argument, telehealth companies and their associated providers are not subject to these drug advertising laws in their direct-to-consumer marketing campaigns. Former FDA Commissioner Robert Califf observed how a number of online advertisements by telehealth companies fail to give the complete risk-benefit story (something drug manufacturers must do), as he noted how the FDA lacks the legal authority to regulate the advertising activities of such telehealth companies.
What’s Next?
If signed into law, the Protecting Patients from Deceptive Drug Ads Act would extend FDA’s jurisdiction to specifically include market surveillance of social media influencers and health care providers for whom a financial benefit exists when such communications contain false or inaccurate statements, omits labeling or other key facts regarding a medication, or fails to include traditional risk and side effect disclosures. The Act authorizes FDA to issue warning letters and civil penalties for non-compliance.
The Act is a bipartisan effort and the controversy surrounding telehealth advertising of prescription drugs is not new. We do not anticipate this issue will fade away soon, although similar legislation previously proposed did not pass. Whether this bill can garner sufficient support remains to be seen. What is clear is there is a growing concern among federal policymakers about what they consider unsafe and imbalanced advertisements for prescription drugs by telehealth companies. Given this climate, a best practice is to ensure advertisements and marketing campaigns are reviewed by skilled advisors who can maintain the effective impact of direct-to-consumer promotions while reducing the legal risk of non-compliant advertising campaigns. As the Act moves through Congress, we will provide updates.
Want to Learn More?
Regulation of Digital Health Products by FDA
FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information
DTC Promotional Labeling and Advertisements: Quantitative Efficacy Wins Over FDA in Final Guidance on Presenting Risk Information
Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers
Alert: New Mexico Is a Step Closer to Legalizing the Supervised Use of Psilocybin
We’ve previously highlighted psilocybin as an alternative treatment for various neuropsychiatric disorders, including anxiety, depression, and PTSD, along with legislative efforts at the state and federal levels to legalize and regulate the psychedelic drug. On March 12, 2025, New Mexico advanced its initiative to establish a therapeutic psilocybin program in the state.
By a bipartisan vote of 33-4, the New Mexico Senate passed Senate Bill 219, also known as the Medical Psilocybin Act, which now awaits a vote in the House of Representatives. If enacted, the bill would allow physicians to prescribe psylocybin to patients suffering from specific qualifying conditions such as major treatment-resistant depression, PTSD, substance use disorders, end-of-life care, and other conditions approved by the state’s Department of Health.
The bill defines psilocybin as “the naturally occurring psychedelic compound 4-phosphoryloxy-N,N-dimethyltryptamine, also known as 4-PO-DMT, and its pharmacologically active metabolite psilocin, 4-hydroxy-N,Ndimethyltryptamine, found in certain mushrooms, but does not include synthetic or synthetic analogs of psilocybin”. The bill proposes the establishment of a nine-member medical psilocybin advisory board to, among other things, “review and recommend to the [health] department for approval medical conditions that may benefit from the medical use of psilocybin” and “recommend formulation or preparation rules and dosage standards for psilocybin”. If the bill is enacted, New Mexico would join Oregon and Colorado as the only states to legalize the supervised use of psylocybin.
Essential Employee Handbook Considerations for Florida Employers in 2025
With a new presidential administration and the start of the 2025 Regular Session of the Florida Legislature, Florida employers face a dynamic landscape of evolving workplace policies and legal requirements. From updates in discrimination and harassment prevention to new leave laws and medical marijuana protections, updating handbooks to stay compliant is more crucial than ever.
Quick Hits
Florida employers are facing a complex landscape of evolving workplace policies and legal requirements in 2025, including updates in discrimination prevention, leave laws, and medical marijuana protections.
Employers may want to regularly review and update their workplace policies to ensure compliance with changing laws, particularly in areas like discrimination, harassment, leave policies, and wage disputes.
Key updates for Florida employee handbooks in 2025 include removing references to outdated presidential executive orders, implementing reasonable suspicion drug testing, and ensuring compliance with new paid sick leave and family leave laws.
Employers may want to regularly review and update their workplace policies and procedures to ensure compliance with evolving laws. This can be particularly important in litigation involving discrimination and harassment, leave policies, wage and hour disputes, and at-will employment. This article highlights key employee handbook updates Florida employers might want to consider in 2025.
Discrimination, Harassment, and Retaliation Prevention
Diversity, Equity, and Inclusion (DEI) and Equal Employment Opportunity (EEO). As one of his first acts in office, President Donald Trump issued six executive orders (EO) impacting federal contractors, subcontractors, and grant recipients. One of these revoked EO 11246 (requiring affirmative action in employment for minorities and females, issued in 1965 by President Lyndon Johnson) and established new certification requirements for “unlawful DEI.” Impacted Florida employers may want to remove handbook references to EO 11246 and carefully review DEI and EEO policies to ensure compliance while also being mindful of state and local laws. For instance, multiple Florida counties have ordinances protecting sexual orientation and gender identity or expression.
Employer Work Rules and the National Labor Relations Board (NLRB). On February 14, 2025, NLRB Acting General Counsel William B. Cowen rescinded a series of memoranda issued by his predecessor, including those regarding electronic monitoring of employees, restrictive covenants, and others. The move effectively reshapes federal labor law and signals a new policy direction for the NLRB under the Trump administration. More changes are likely to follow, including potentially relaxing prior scrutiny of other employer work rules.
Medical Marijuana Protections. In a recent lawsuit, Giambrone v. Hillsborough County, a Florida state court granted summary judgment in favor of a former public employee who had been placed on unpaid administrative leave after testing positive for alleged off-duty use of medical marijuana. In light of this decision, Florida employers may want to consider implementing reasonable suspicion drug testing and adding an interactive disability accommodation process to existing drug testing policies for job applicants or employees who are medical marijuana cardholders. However, Florida employers still do not need to allow their employees to show up to work under the influence of medical marijuana or possess marijuana on company property. Public employers in Florida may also want to monitor pending House Bill 83 / Senate Bill 142, which, if passed, would provide specific job protections for medical marijuana cardholders.
Mandatory Leave
Paid Sick Leave (PSL). PSL laws are continually evolving, with eighteen states and Washington, D.C., having PSL requirements. In 2025, Alaska, Missouri, and Nebraska were added to this list. In recent years, states like California, Colorado, Illinois, Michigan, New York, Oregon, and Washington have increased required hours and expanded reasons for taking leave. Florida employers may want to be mindful that existing paid time off policies may not be compliant in other states and localities. A handbook addendum or separate state policy may be required, including for remote workers. Understanding which laws apply is critical for compliance.
Family and Medical Leave (FML). Ten states and Washington, D.C., have mandatory paid FML programs, with additional states like Delaware, Maine, and Minnesota scheduled to implement programs soon, and Maryland, where elements of the program may be delayed until 2027. While Florida does not have mandatory FML leave at the state level, employers doing business in Miami-Dade County should note a local ordinance may expand what the federal Family and Medical Leave Act (FMLA) typically allows when caring for a grandparent with a serious health condition. As of 2023, Florida’s insurance code includes voluntary paid family leave as a new form of insurance.
Jury Duty. Florida law provides general protections for employees when they serve on jury duty or as witnesses in legal proceedings. Local ordinances in Broward and Miami-Dade counties require jury duty pay for certain employees.
Wage and Hour Policies
Timekeeping and Pay. Wage and hour litigation continues to be one of the most frequently filed types of employment litigation in Florida and is one of the most common class or collective actions filed across the country. Employers may want to consider adopting policies requiring employees to thoroughly review their time and pay records to ensure accuracy. Many employee handbooks do not provide specific contact information for employees to report concerns regarding their hours and pay, leaving employers vulnerable to the argument that employees did not have an avenue to resolve complaints. Employers may also want to include a provision prohibiting retaliation against employees who come forward with complaints about their hours or pay.
Child Labor Laws. Recent changes to Florida’s child labor laws enacted in 2024 may impact policy provisions for employers with minors in the workplace. Restrictions on the amount of work hours and days of work have been eased for minors sixteen and seventeen years old. An updated poster is also available.
Legal Disclaimers and Keeping Contracts Separate
At-Will Disclaimers. Employers may want to consider including a disclaimer at the beginning of their handbooks expressly stating that the handbook does not constitute a contract, that the employer can change policies without prior notice, and reiterating the at-will nature of the employment relationship. Moreover, contracts and other legally binding instruments—including noncompete, Non solicitation, and nondisclosure agreements, along with arbitration agreements and releases of liability—should be kept separate from the handbook. This helps employers enforce these obligations post-employment and may protect the entire handbook from being construed as a contract. To avoid conflicts with official plan documents, it may be best to communicate employee benefits details separately from the handbook.
Introductory Periods. Implementing an initial introductory period of up to ninety calendar days can be beneficial to Florida employers when defending unemployment claims. Dismissing an employee for unsatisfactory performance during this period may avoid unemployment benefits being charged against the employer’s reemployment assistance account in accordance with section 443.131, Florida Statutes. Employers must give notice of the introductory period within the employee’s first seven days of work, which can be accomplished through a handbook acknowledgment.
Employee Acknowledgments. Employers may want to make it a standard practice to obtain signed acknowledgments from all employees when they receive the handbook and whenever significant updates are made. Consider including directions for how employees can access or obtain copies of the handbook. This can be critical in legal disputes where an employee claims he or she was unaware of certain policies or procedures.
Language Barriers. If a significant portion of the workforce is not proficient in English, translating the acknowledgement and handbook into the primary languages spoken by employees may be beneficial. This ensures that all employees can understand the content, particularly with the prevalence of native Spanish speakers in Florida.
McDermott+ Check-Up: March 14, 2025
THIS WEEK’S DOSE
Congress Debates Government Funding. A continuing resolution (CR) to fund the government through September passed the House and will very likely pass the Senate today.
Senate HELP Committee Advances NIH, FDA Nominations, Meanwhile White House Pulls CDC Director Nomination. National Institutes of Health (NIH) director nominee Jay Bhattacharya and US Food and Drug Administration (FDA) commissioner nominee Martin Makary are expected to be confirmed by the full Senate. The White House abruptly withdrew Dave Weldon’s nomination for Centers for Disease Control and Prevention (CDC) director just prior to his Senate confirmation hearing and has not yet announced a new nominee.
Senate Finance Committee Holds CMS Administrator Nomination Hearing. The committee held its nomination hearing for Mehmet Oz, MD, to be administrator of the Centers for Medicare and Medicaid Services (CMS) as this Check-Up went to press.
House Oversight Committee Holds Hearing on Preventing Improper Payments and Fraud. The hearing continued previous committee work broadly focused on improper payments and fraud, including in Medicare and Medicaid.
House Ways and Means Committee Examines Access to Medicare Post-Acute Care. Members discussed barriers to accessing quality post-acute care and highlighted potential solutions.
Senate Aging Committee Discusses Solutions to Senior Loneliness. There was bipartisan concern about the burden of senior loneliness.
CMS Issues Marketplace Integrity and Affordability Proposed Rule. The agency’s first proposed rule in the Trump administration aims to reduce improper enrollments in the Marketplace.
CMMI Releases Statement on Strategic Direction. The Center for Medicare and Medicaid Innovation (CMMI) announced actions to cancel certain models and transition participants to other models.
OCR Announces Investigations into Four Medical Schools and Hospitals. The schools and hospitals being investigated were not officially identified.
Federal Judges Rule Agencies Must Reinstate Fired Probationary Employees. One of the rulings applies to the US Department of Health and Human Services (HHS).
CONGRESS
Congress Debates Government Funding. In advance of the March 14, 2025, government funding deadline, House Republicans on March 8 released a 99-page CR to fund the government through September 30, 2025, the end of the fiscal year (FY). The CR includes short-term extensions of healthcare programs and provisions, including Medicare telehealth flexibilities and community health center funding, through September 30. The legislation includes increases in defense spending and cuts to nondefense spending, including a 50% cut to the Congressionally Directed Medical Research Programs (CDMRP) within the US Department of Defense. CDMRP funds biomedical research on conditions such as cancer, Alzheimer’s disease, and autism.
The CR does not include a Medicare physician payment fix or additional bipartisan health provisions, such as pharmacy benefit manager reform, from the December 2024 bipartisan healthcare package, which has been reintroduced by Sens. Wyden (D-OR) and Sanders (I-VT). Rep. Murphy (R-NC), Co-Chair of the GOP Doctors Caucus, originally said he would oppose the CR if it did not include the so-called doc fix. However, the caucus received a commitment from Republican leadership to include a doc fix in the upcoming budget reconciliation bill, so Rep. Murphy supported the CR.
On March 11, 2025, the House passed the CR mostly along party lines in a 217 – 213 vote. Rep. Golden (D-ME) joined Republicans in voting yes, and Rep. Massie (R-KY) joined Democrats in voting no. In the Senate, the bill needs 60 votes to overcome a procedural hurdle, known as cloture, before final passage, necessitating support from Democrats. Senate Minority Leader Schumer (D-NY) initially pushed back and said Democrats would seek a separate vote on a clean, shorter-term CR that would allow appropriators to finish the full slate of FY 2025 bills. Schumer later reversed and stated he and other Senate Democrats would vote yes on the cloture vote to avoid a government shutdown. The final cloture vote was xx – xx. XX Democrats voted with all but one Republican, Sen. Paul (KY), to achieve the 60 votes necessary to clear the procedural hurdle. As of the time of this publication, a vote on final passage is expected today to avert a government shutdown and complete the FY 2025 appropriations process.
Senate HELP Committee Advances NIH, FDA Nominations, Meanwhile White House Pulls CDC Director Nomination. The Senate Health, Education, Labor, and Pensions (HELP) Committee voted on the nominations of Jay Bhattacharya, MD, for NIH director and Martin Makary, MD, for FDA commissioner. The committee held its nomination hearings last week. Bhattacharya advanced with a vote of 12 – 11 along party lines. Makary advanced with a vote of 14 – 9, with Sens. Hassan (D-NH) and Hickenlooper (D-CO) joining Republicans. Both nominations now move to the full Senate floor, where they are expected to be confirmed. Sen. Hawley (R-MO) expressed concern over Makary’s initial support of Hilary Perkins as FDA chief counsel. Perkins previously worked for the US Department of Justice under President Biden and defended that administration’s abortion and vaccine policies. Sen. Hawley noted that Makary withdrew his support for Perkins, who resigned on March 13, 2025, only two days after becoming FDA chief counsel.
On the morning of Dave Weldon’s scheduled Senate HELP Committee nomination hearing for CDC director, the White House suddenly withdrew his nomination. Weldon was previously a US representative from Florida. He has been subject to significant scrutiny for his views on vaccines, and there have been rumors for some time that his nomination could be withdrawn. At the time of publication, President Trump had not yet announced a new CDC director nominee.
Senate Finance Committee Holds CMS Administrator Nomination Hearing. The Senate Finance Committee held its nomination hearing for Mehmet Oz, MD, to be administrator of CMS as this issue went to press.
House Oversight Committee Holds Hearing on Preventing Improper Payments and Fraud. The hearing included three witnesses who discussed the prevalence of fraud broadly across federal spending, including in Social Security and Medicaid. Members of both parties expressed interest in working together to address waste, fraud, and abuse, but Democrats emphasized the importance of Medicaid and ensuring it remains accessible. Republicans highlighted the Department of Government Efficiency’s role in addressing waste, fraud, and abuse.
House Ways and Means Committee Examines Access to Medicare Post-Acute Care. During the hearing, Democrats predominantly focused on the impact that potential cuts to Medicare and Medicaid (under discussion as part of the ongoing budget reconciliation process) would have on long-term care hospitals and skilled nursing facilities. Republicans focused on the burden of prior authorization for beneficiaries and the impact of workforce shortages on access to care. Both members and witnesses discussed the importance of Medicare telehealth flexibilities in home health and hospice care and the proposal to create a single Medicare payment system for all post-acute care providers.
Senate Aging Committee Discusses Solutions to Senior Loneliness. Witnesses for the hearing included individuals from organizations that provide social services to seniors. Members of both parties expressed concern about senior loneliness and its impact on health outcomes. Both members and witnesses expressed support for the Social Engagement and Network Initiatives for Older Relief (SENIOR) Act and the Older Americans Act. There was discussion about the cost burden of senior loneliness on Medicare and Medicaid.
ADMINISTRATION
CMS Issues ACA Marketplace Integrity and Affordability Proposed Rule. CMS issued a proposed rule on March 10, 2025, that would undo Biden-era policies designed to enhance enrollments through the Marketplace. Key proposals include the following:
CMS proposes to shorten the annual open enrollment period by one month, such that it would run from November 1 to December 15, as under the first Trump administration, instead of November 1 to January 15. CMS also proposes to apply this timeframe to state-based Marketplaces, which were previously permitted flexibility on this front.
CMS proposes to add sex-trait modifications to the list of items and services that may not be covered as essential health benefits beginning in plan year 2026.
CMS proposes to amend the definition of “lawfully present” to exclude Deferred Action for Childhood Arrivals recipients for purposes of enrolling in Marketplace coverage.
CMS proposes to end the availability of the monthly special enrollment period for individuals with household incomes below 150% of the federal poverty level. All Marketplaces would also have to reinstitute pre-enrollment verifications of eligibility for special enrollment periods and conduct further verifications of income when no tax data is available for verification.
The policies would have varying effective dates, some as early as immediately upon implementation, but the proposed rule specifically requests input on implementation timelines. There is a 30-day comment window that ends April 11, 2025. Click here for the press release, and here for the fact sheet.
CMMI Releases Statement on Strategic Direction. On March 12, 2025, CMMI stated that it plans to announce a new strategy focused on choice, competition, consumer empowerment, and evidence-based practices. CMMI will also work to streamline payment models, and some models will end early on December 31, 2025, with participants transitioning to other models. CMMI subsequently announced that the Maryland Total Cost of Care, Primary Care First, ESRD Treatment Choices, and Making Care Primary models will end early. CMMI is considering options to reduce the size of the Integrated Care for Kids model, and the Medicare $2 Drug List and Accelerating Clinical Evidence models will not be implemented. CMMI estimates that ending these models will save taxpayers approximately $750 million but doesn’t spell out how those savings will be realized. Read more about what’s next for value-based care under the Trump administration here.
OCR Announces Investigations into Four Medical Schools and Hospitals. The HHS Office for Civil Rights (OCR) stated that four medical schools and hospitals provide medical education and training that discriminates on the basis of race, color, national origin, or sex. OCR alleges that the institutions are in violation of Title VI of the Civil Rights Act and Section 1557 of the Affordable Care Act. The announcement states that the action aligns with President Trump’s executive order “Ending Illegal Discrimination and Restoring Merit-Based Opportunity.” The institutions subject to the investigation are not officially identified. For more details, please see this article by our McDermott Will & Emery colleagues.
COURTS
Federal Judges Rule Agencies Must Reinstate Fired Probationary Employees. On March 13, 2025, two federal judges ruled that certain federal agencies must reinstate fired probationary employees. The first judge’s order applied only to six agencies, while the second judge’s order applied to 18 agencies, including HHS. Both judges ruled that the firings by the Office of Personnel Management were unlawful. The Trump administration is likely to appeal the decisions. Other efforts by the Trump administration to shrink the federal workforce, including a reduction in force, will likely continue.
QUICK HITS
House Democratic Health Leaders Send Letter to CMS on Staff Firings. The ranking members of the full Ways and Means Committee and Energy and Commerce Committee, along with the ranking members of the Health Subcommittees, expressed concern over the impact of the recent firings of Medicare and Medicaid staff. The letter from Reps. Neal (D-MA), Pallone (D-NJ), Doggett (D-TX), and DeGette (D-CO) poses 15 questions to Acting Administrator Stephanie Carlton and asks for responses by March 17, 2025.
OGC Announces Reorganization Effort. The HHS Office of General Counsel (OGC) will consolidate its regional offices from 10 to four. House Ways and Means Committee Ranking Member Neal and Energy & Commerce Committee Ranking Member Pallone released a statement criticizing the action as inhibiting efforts to reduce waste, fraud, and abuse.
Senate HELP Chairman Cassidy Announces CDC Working Group. Chairman Cassidy (R-LA) along with Sens. Johnson (R-WI), Lee (R-UT), Marshall (R-KS), Murkowski (R-AK), Paul (R-KY), and Scott (R-SC) announced the working group to examine potential legislative reforms to the CDC. The press release states that the working group aims to restore the public’s trust in the CDC.
Congressional Democrats File Amicus Brief in Supreme Court Medicaid Case. All Senate Democrats and 191 House Democrats filed the brief in Medina v. Planned Parenthood South Atlantic. At question is whether South Carolina’s exclusion of abortion providers from the Medicaid program violates the “any qualified provider” Medicaid provision.
MACPAC, MedPAC Release March 2025 Reports to Congress. The Medicaid and CHIP Payment and Access Commission (MACPAC) report includes recommendations to improve the managed care external quality review process, home- and community-based services (HCBS) access, and Medicaid Section 1915 authorities for HCBS. The Medicare Payment Advisory Commission (MedPAC) report includes recommendations for updating 2026 payment rates in traditional Medicare.
Sen. Jeanne Shaheen (D-NH) Won’t Run for Reelection. Sen. Shaheen has been in office since 2009 and serves on the Senate Appropriations Committee. She is the third Democratic senator, following Sens. Peters (D-MI) and Smith (D-MN), to announce they won’t run for reelection. Her announcement exacerbates Democrats’ challenge to take back the Senate in 2026, as open seats are often more difficult to win than those with incumbents running for reelection.
CMS Postpones, Renames Annual Conference. CMS postponed its annual Health Equity Conference, originally scheduled for April 23 – 24, 2025 and renamed it the Conference for Building a Healthier America. A new date has not been announced.
BIPARTISAN LEGISLATION SPOTLIGHT
Reps. Matsui (D-CA) and Bilirakis (R-FL) and Sens. Klobuchar (D-MN) and Wicker (R-MS) reintroduced the Scientific External Process for Educated Review of Therapeutics Act of 2025. The legislation would require the FDA to convene quarterly externally-led scientific-focused drug development meetings to discuss the development and review of rare disease treatments.
NEXT WEEK’S DIAGNOSIS
The House and Senate are both scheduled to be in recess next week and return March 24, 2025. After the federal government is funded, Republicans will return their attention to the budget reconciliation process. Votes to confirm President Trump’s nominees are also expected to continue in the Senate when members return.
Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112
Synopsis:
In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera, Inc. (Natera) against its competitor CareDx, Inc. (CareDx).1 In January 2024, a jury found that two of CareDx’s cell-free DNA (cfDNA) blood tests (AlluSure and AlloSeq) infringed two of Natera’s patents and awarded Natera damages of approximately $96 million.2 CareDx filed a motion for judgment as a matter of law, asking Chief Judge Connolly to find the asserted patents invalid for lack of written description under 35 U.S.C. § 112. On February 24, 2025, Judge Connolly granted CareDx’s motion and found the asserted claims of Natera’s patents invalid for lack of written description.3
1. Patent Dispute Between CareDx and Natera: Background and Claims
CareDx sells AlloSure and AlloSeq—blood tests that are used to assess whether a transplanted kidney is being rejected by the recipient’s body. Specifically, AlloSure and AlloSeq are used to detect cfDNA, which “is fragmented DNA in the bloodstream that originates from cells undergoing cell injury and death.”4 When a transplanted kidney is being rejected, “donor-derived cell-free DNA (dd-cfDNA) increases in the blood” of the transplant recipient.5 AlloSure and AlloSeq allow for the detection of dd-cfDNA in a transplant recipient’s blood.
Natera asserted two patents, U.S. Patent Nos. 10,655,180 (the ’180 patent) and 11,111,544 (the ’544 patent) (collectively, the “asserted patents”), related to methods for preparing, amplifying and detecting cfDNA.6 Relying on the insight that dd-cfDNA will be present in different fractions depending on whether the transplanted kidney is being accepted or rejected by the recipient, Natera’s patent claims were directed to extracting and amplifying cfDNA from a patient at given locations on the genome:
A method for preparing a preparation of amplified DNA derived from a biological sample of a second individual useful for determining genetic data for DNA from a first individual in the biological sample, the method comprising:
Extracting cell-free DNA from the biological sample;
Preparing a preparation of amplified DNA by amplifying a plurality of target loci on the cell-free DNA extracted from the biological sample to generate amplified DNA;
Analyzing the preparation of amplified DNA by sequencing the amplified DNA using sequencing-by-synthesis to obtain genetic data of the plurality of target loci, and determining the most likely genetic data for DNA from the first individual based on allele frequencies in the genetic data at the plurality of target loci.
Asserted claim 14 of the ’180 patent recites a similar method, directed to identifying SNPs (Single Nucleotide Polymorphisms), as a way of assessing the relative amount of DNA in each sample:
A method for measuring an amount of DNA in a biological sample, the method comprising:
Performing a targeted PCR amplification for more than 100 SNP loci on one or more chromosomes expected to be disomic in a single reaction mixture using more than 100 PCR primer pairs, wherein the reaction mixture comprises cell-free DNA extracted from a biological sample of a subject comprising DNA of mixed origin, wherein the DNA of mixed origin comprises DNA from the subject and DNA from a genetically distinct individual, wherein neither the subject nor the genetically distinct individual is a fetus, wherein the DNA of mixed origin comprises DNA from a transplant, and wherein the amplified SNP loci comprise SNP loci on at least chromosome 1, 2, or 3;
Measuring a quantity of each allele at a plurality of amplified SNP loci that comprise an allele present in the genetically distinct individual but not the subject, wherein the quantity of each allele at a plurality of amplified SNP loci are measured by high-throughput sequencing;
Measuring an amount of the DNA from the genetically distinct individual in the biological sample using the quantity of each allele at the SNP loci and an expected quantity of each allele at the SNP loci for different DNA fractions,
Wherein the method is performed without prior knowledge of genotypes of the genetically distinct individual.
At trial, CareDx argued, among other things, that the asserted claims were invalid for lack of written description under 35 U.S.C. § 112. The jury disagreed and found that the asserted patents were not invalid.
CareDx filed a motion for judgment as a matter of law under FRCP 50(b), arguing that no reasonable jury could find that the specifications of the asserted patents satisfy the written description requirement in view of the evidence presented at trial.
2. Judge Connolly’s Opinion
Beginning with the ’544 patent, Judge Connolly explained that claim 21 recites “a method by which (1) cell-free DNA is extracted from a biological sample of one individual (i.e., the ‘second individual’); (2) target loci on the extracted cell-free DNA is ‘amplified’ and ‘sequenc[ed by] synthesis to obtain genetic data’; and (3) ‘the most likely genetic data’ for DNA from another individual (i.e., the ‘first individual’) in the obtained genetic data is ‘determin[ed]’ from that data ‘based on allele frequencies.’”7 Thus, to satisfy the written description requirement, the specification must show that the inventors possessed the full scope of this claim, including the individual claim elements and all three claim elements “as an integrated whole.”8
Judge Connolly first focused on whether the specification “adequately describes the combination of the claimed steps as an integrated whole.”9 CareDx’s expert, Dr. Brian Van Ness, testified that the specification does not describe all three of the claimed steps being performed in combination. Dr. Van Ness’s testimony was largely unrebutted—Natera cited only two passages from the specification, admitted that the specification lacked working examples, and otherwise relied on the testimony of its expert, Dr. John Quackenbush.
Judge Connolly found Dr. Quackenbush’s testimony “conclusory” and “‘far too general’” to support the jury’s decision.10 Specifically, Dr. Quackenbush “never pointed to any text in the patent’s written description that would lead an artisan of ordinary skill to know that the inventor had invented a combination of those different pieces.”11 And Judge Connolly explained that the Federal Circuit has held that “pointing to an ‘amalgam of disclosures’ from which an artisan could have created the claimed invention does not satisfy” the written description requirement.12
Judge Connolly also explained that after CareDx introduced evidence that supports its written description position, it was Natera’s burden to produce evidence to rebut that position. But Natera did not produce any evidence beyond Dr. Quackenbush’s conclusory testimony. Because there was “no substantial evidence to support the jury’s finding of adequate written description,” Judge Connolly held that “judgment of invalidity of the asserted claims of the ’544 patent as a matter of law is warranted.”13
Likewise, Judge Connolly held that “[t]he ’180 patent’s written description… is inadequate as a matter of law for the same reason the ’544 patent’s written description is inadequate—i.e., Natera did not adduce at trial substantial evidence that the patent’s text shows that the inventor possessed the combination of the elements of the claimed methods.”14
3. Conclusion and Takeaways
In the competitive and litigious field of molecular genomics, where new applications (e.g., new computational approaches) for the underlying technology of high-throughput screening are being developed and patented, Judge Connolly’s decision suggests that placing all elements into a specification in piecing them together later may be insufficient. Instead, Judge Connolly’s decision underscores the importance of tying the individual components of an invention together in a patent specification, and that providing working examples of the inventions may be critical.
For patent litigators, Judge Connolly’s decision highlights several important points to be mindful of at trial. Judge Connolly held, consistent with Federal Circuit precedent, that if a patent broadly claims several components of an invention, the specification must disclose those elements “as an integrated whole” to satisfy the written description requirement. Pointing to disparate portions of the specification will not suffice if nothing is tying those elements together.
Judge Connolly’s opinion also underscores the importance of lawyers minding their burdens and ensuring that they have supported their arguments (including their expert’s testimony) with reliable evidence. This is especially true, and can be easy to overlook, where burdens shift from one party to the other, as was the case here.
Finally, this case shows that even after an adverse jury decision, it is still possible to prevail—but understanding how to proceed, and what issues to focus on, are critical. Here, CareDx chose to focus on a select number of issues in its motion rather than attempting to relitigate the full spectrum of issues the jury considered. In doing so, CareDx successfully invalidated the patents and avoided the $96 million in damages for which it was otherwise liable.
[1] Natera, Inc. v. CareDx, Inc., No. 20-38-CFC-CJB (D. Del.).
[2] Id., D.I. 460.
[3] Id., D.I. 558.
[4] https://labproducts.caredx.com/products/alloseq-cfdna
[5] Id.
[6] Natera asserted three claims of the ’544 patent (claims 21, 26, and 27) and two claims of the ’180 patent (claims 14 and 15) against CareDx.
[7] D.I. 558 at 8-9.
[8] Id. at 9.
[9] Id. at 10.
[10] Id. at 11 (quoting Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1336-37 (Fed. Cir. 2021)).
[11] Id.
[12] Id. (quoting Flash-Control, 2021 WL 2944592, at *3).
[13] Id. at 13.
[14] Id. at 14.
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase out the agency’s historical approach of enforcement discretion towards such tests (see here, here, here, and here). However, one infrequently considered regulatory compliance issue for LDTs is their reliance on separate specimen collection devices or convenience kits. All LDTs require the use of some form of biological specimen, such as blood or saliva, which may be collected by health care professionals in a clinical setting or by consumers in their homes before being submitted to a laboratory for testing.
As we detail below, specimen collection devices and kits are independently regulated as medical devices by FDA, and any clinical laboratory developing or performing LDTs must have a sound strategy for either manufacturing and distributing them in compliance with device regulations or sourcing them from FDA-compliant third-party suppliers. Although the LDT final rule is currently under attack in the courts and may not survive those challenges, stakeholders should keep in mind that FDA has an alternative method to bring enforcement actions against clinical laboratories: targeting noncompliant specimen collection devices and kits being distributed in interstate commerce.
How Are Specimen Collection Devices and Kits Regulated?
Under long-standing FDA regulations, any product that is “intended for use in the collection, preparation, and examination of specimens taken from the human body” for the ultimate purpose of diagnosing diseases or other conditions is an “in vitro diagnostic product” (see 21 C.F.R. 809.3(a)). This means that any device that collects patients’ biological specimens for use in clinical assays is an in vitro diagnostic (IVD) product. Furthermore, all IVD products are regulated as medical devices under the federal Food, Drug, and Cosmetic Act (FD&C Act) because they are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” (see 21 U.S.C. 321(h)).
In addition, FDA considers individual devices packaged together in a branded and marketed kit (i.e., not just co-packaged in the same shipping container) to be a “convenience kit” because they are assembled and sold together as a unit for the convenience of the end user. The agency has clearly stated that “[c]onvenience kits are…medical devices in their own right, apart from their constituent devices” (see the Unique Device Identification (UDI) System Rule at 78 FR 58792) and are subject to the device general controls, such as establishment registration, product listing, labeling (including UDI requirements), and quality system requirements. Therefore, specimen collection kits, which typically include multiple devices whose purpose is to aid in the collection of a biological sample for subsequent diagnostic testing, qualify as convenience kits and must comply with FDA device regulations separate and apart from the individual device components contained within the kit.FDA’s “interim” guidance on convenience kits (published almost 30 years ago, in May 1997) includes a list of convenience kit types that are subject to enforcement discretion with respect to pre-market notification (510(k)) requirements only, which by definition means that all other device general controls apply to such kits.
If a specimen collection device or convenient kit must be cleared by FDA through the 510(k) pathway prior to marketing, the 510(k) submission must include an intended use describing the environment in which the device may be used, such as point-of-care by a medical professional or at home by a consumer. In particular, 510(k) submissions for specimen collection devices and kits that are intended for at-home use by laypersons without the assistance or supervision of a health care professional must specify the user’s home as the intended use environment and must include substantial evidence, such as data from human factors studies, demonstrating that the design and labeling are sufficient to allow a consumer to use the device or kit safely and effectively with minimal risk (see FDA’s guidance for industry on Design Considerations for Devices Intended for Home Use).
Enforcement Hooks for Specimen Collection Devices and Kits Used for LDTs
A clinical laboratory must have some method to distribute (either itself or through a third-party vendor) specimen collection devices or kits to health care professionals or consumers so that the laboratory can receive the necessary biological specimens to test with its LDT. There are many specimen collection devices that are already authorized and marketed in the United States (e.g., blood vials, urine containers, safety lancets, saliva collection systems), so in many cases, laboratories do not need to design and develop a brand-new collection device or engage a contract manufacturer to do so for their specific LDTs. Specimen collection kits are also common in the marketplace, but as described above, each custom kit with specific components is subject to general controls and the manufacturer of such devices, also called a kit assembler, must be registered as a medical device establishment and must list the kit with FDA.
Despite FDA’s requirements relating to specimen collection devices and kits, some laboratories and even kit assemblers developing and providing such products are not aware that convenience kits are separately regulated devices and may not be complying with applicable general controls. There also are specimen collection devices or kits being marketed for intended uses that are not consistent with their FDA-authorized uses (e.g., dried blood spot cards to collect blood specimens for testing other than newborn screening), as well as kits containing class II devices being distributed directly to consumers even though they are not specifically cleared for at-home use. All of these situations lead to the manufacture and distribution of noncompliant commercial device products and could lead to FDA enforcement action.
It is also important to remember that the specimen collection device or kit is not a “component” of an LDT being offered by a licensed clinical laboratory – it is a separate medical device that is independently subject to FDA regulations when placed in interstate commerce. This means that even if FDA exercises enforcement discretion with respect to a given LDT, the specimen collection device or kit used in conjunction with that LDT is not necessarily under enforcement discretion as well. In contrast, IVD manufacturers may submit information relating to a specimen collection device or kit with a pre-market submission for an IVD assay because FDA will review all information about the assay and collection method (including validation testing data showing that the collection method reliably and safely collects biological specimens that lead to accurate results) together. The option to couple the assay and collection method into one submission is not available to a clinical laboratory, unless its entire LDT assay is submitted for pre-market review.
If a clinical laboratory decides to use a class II or III specimen collection device or kit in conjunction with an LDT, it can create a Catch 22 for some clinical laboratories because FDA will require adequate data demonstrating that the specimen collection device or kit (especially those intended for at-home use) is safe and effective for use with the LDT in order to clear or approve the kit for that specific intended use. But obtaining such data can be difficult without conducting a formal clinical trial—the laboratory cannot collect real world data because the specimen collection device or kit cannot be distributed to consumers prior to obtaining marketing authorization. Moreover, submitting a novel specimen collection device or kit for pre-market review means providing assay-specific information to FDA, which could result in the agency scrutinizing and commenting on the LDT assay itself. Distributing and promoting a class II or III specimen collection device or kit for an unauthorized intended use is at high risk of enforcement action, especially in the context of LDTs that FDA considers inherently to pose greater risks for patients, such as tests for serious communicable diseases or cancer.
Although FDA has not frequently targeted specimen collection devices and kits in enforcement actions in the past (especially in the context of LDTs), there has been a recent uptick in agency warnings and safety notices relating to collection kits, indicating that the agency is monitoring compliance in this area. State agencies with authority over clinical laboratories and LDTs, such as the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP), have also stated to clinical laboratories that any device or kit intended to collect biological specimens for an LDT must comply with FDA’s device regulations.
Impact of the LDT Final Rule
The LDT final rule is currently in effect and year one of the enforcement discretion phase-out process is almost complete. In May 2025, clinical laboratories are expected to be complying with medical device reporting, correction and removal reporting, and compliant handling requirements. As the phase-out process continues (if it is not invalidated by a court or otherwise rescinded) and FDA begins to review LDTs for device marketing authorization, it is possible that enforcement of specimen collection devices and kits will increase because the agency will have better information about the intended uses and distribution of such products to obtain patient specimens for those LDTs.
However, even if the final rule is invalidated or rescinded, FDA may resort to increasing compliance monitoring and enforcement for specimen collection devices and kits as a method of maintaining an oversight foothold in clinical laboratories that design, offer, and perform LDTs. As described above, certain intended uses of specimen collection devices and kits may require pre-market clearance or approval, irrespective of what happens to the LDT final rule, such that FDA could demand detailed data demonstrating safety and effectiveness, which could even include clinical trials that involve the LDT itself.
Conclusion
Throughout the LDT design, development, and validation process, clinical laboratories and those who assist laboratories with bringing an LDT to market should remember that the design or selection of the device or kit that will be used by health care professionals or consumers to collect the biological specimens needed for the assay is a critical decision with many regulatory implications. FDA has been clear that specimen collection devices and kits are medical devices separate and apart from the assay used to test the specimen, even if the assay is an LDT, and the agency is beginning to step up enforcement against noncompliant devices and kits. Moreover, in the preamble to the final rule, FDA highlighted the desire to use its existing device authority to ensure the safety and effectiveness of LDTs, and full implementation of the final rule’s framework will likely lead to increased oversight of and enforcement actions against clinical laboratories. However, even if the final rule is invalidated or rescinded, it is possible that FDA will still increase oversight and enforcement activities against clinical laboratories by focusing on the specimen collection devices and kits they choose to pair with their LDTs.
Skin360 App Can’t Escape Scrutiny under Illinois Biometric Law
A federal district court has denied a motion by Johnson & Johnson Consumer Inc. (JJCI) to dismiss a second amended complaint alleging it violated the Illinois Biometric Information Privacy Act (BIPA) by collecting and storing biometric information through its Neutrogena Skin 360 beauty app without consumers’ informed consent or knowledge. The plaintiffs also allege that the biometric information collected through the app is then linked to their names, birthdates, and other personal information.
Plaintiffs alleged that the Skin360 app is depicted as “breakthrough technology” that provides personalized at-home skin assessments by scanning faces and analyzing skin to diagnose enigmas like wrinkles, fine lines, and dark spots. The app then uses that data to recommend certain Neutrogena products for the consumer to eliminate those concerns. JJCI argued that the Skin360 app recommends products designed to improve skin health, which means that the consumers should be considered patients in a healthcare setting, making BIPA inapplicable.
However, the court disagreed and cited Marino v. Gunnar Optiks LLC, 2024 Ill. App. (1st) 231826 (Aug. 30, 2024), which held that a customer trying on non-prescription sunglasses using an online “try-on” tool is not considered a patient in a healthcare setting. In Marino, the court defined a patient as an individual currently waiting for or receiving treatment or care from a medical professional. Alternatively, Skin360 uses artificial intelligence software to compare a consumer’s skin to a database of images and provides an assessment based on a comparison of these images. Of course, JCCI did not dispute that no medical professionals are involved in providing the service through the Skin360 app.
The court stated that “[e]ven assuming Skin360 provides users with this AI assistant and ‘science-backed information’ the court finds it a reach to consider these services ‘medical care’ under BIPA’s health care exemption; [i]ndeed, Skin360 only recommends Neutrogena products to users of the technology, which suggests it is closer to a marketing and sales strategy rather than to the provision of informed medical care or treatment.”
Inventor’s Motivation to Combine Does Not Control Obviousness
The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the motivation to use the claimed dosing was not the same as the inventor’s motivation. ImmunoGen, Inc. v. Coke Morgan Stewart, Case No. 23-1763 (Fed. Cir. Mar. 6, 2025) (Lourie, Dyk, Prost, JJ)
The claims at issue involved a dosing regimen for administering IMGN853, an already-patented antibody drug conjugate used for treating certain cancers, at a claimed dose of six milligrams (mg) per kilogram (kg) of adjusted ideal body weight (AIBW) of the patient.
ImmunoGen argued that it was undisputed that, at the time of the invention, a person of ordinary skill in the art would not have known that IMGN853 caused ocular toxicity in humans and that without a motivation to address the problem of ocular toxicity, the claimed dosing limitation could not have been obvious. Therefore, according to ImmunoGen, the district court erred in its motivation-to-combine analysis. The Federal Circuit disagreed, stating, “that the specific problem the inventors . . . purported to solve via the claimed dosing regimen was unknown does not necessarily mean that the dosing regimen itself was not obvious.” The Court also noted that because ocular toxicity was a well-known adverse event in the administration of drugs containing a payload included in IMGN853, “a person of ordinary skill in the art, despite not knowing of IMGN853’s ocular toxicity, would have nonetheless been motivated to monitor for those side effects when administering the drug to a human.”
ImmunoGen also argued that the district court erred in finding that a person of ordinary skill in the art would have been motivated to use AIBW dosing to eliminate ocular toxicity. The Federal Circuit again disagreed, reasoning that although AIBW dosing has not been used for drugs such as IMGN853, it would still have been within the range of knowledge of a person of ordinary skill in the art when addressing dosing-induced ocular toxicity. The Court explained that AIBW was well known, had been used for drugs both smaller and larger than IMGN853, and had proven effective in reducing ocular toxicity.
The Federal Circuit concluded that the district court did not clearly err in determining that a person of ordinary skill in the art would have been motivated to select the claimed dose of six mg/kg AIBW with a reasonable expectation of success. The claimed dose had already been described in the literature for patients at their ideal body weight, regardless of whether a doctor was aware of AIBW dosing specifically. The Court also noted that the district court was not required to find that a person of ordinary skill in the art would have had a reasonable expectation of eliminating ocular toxicity using the claimed dose, as “the obviousness inquiry is generally agnostic to the particular motivation of the inventor” and the claims made no reference to ocular toxicity.
Practice Note: The motivation to combine analysis is not limited by the problem or need recognized by the inventors. Instead, any problem known at the time of the invention can provide a reason for combining elements as claimed.
This Week in 340B: March 4 – 10, 2025
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation.
Issues at Stake: Contract Pharmacy; HRSA Audit Process; Medicare Payment; Rebate Model
In a case appealing a decision on a state contract pharmacy law, two amicus briefs were filed in support of the defendant-appellant state.
In one Health Resources and Services Administration (HRSA) audit process case, the court granted motion to withdraw the plaintiff’s motion for preliminary injunction.
In a case challenging a Medicare Advantage plan’s response to 340B payment cuts, defendants’ motion to compel the production of a damages spreadsheet was granted in part and denied in part.
In six cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
In five such cases, the court granted intervenor’s motion to intervene and a group of amici filed an amicus brief in support of the defendant.
In one such case, intervenors filed a notice of supplemental authority to which the plaintiff filed a response and a group of amici filed an amicus brief in support of the defendant.
Nadine Tejadilla also contributed to this article.