In the next episode of the "Legal Bites Podcast" series, Food and Beverage Litigation Team leader Nathan Adams and Practice Development Manager Kristina Merritt speak with Public Policy & Regulation attorney Sara Klock, who...more
A trio of recent cases challenging disparate food and beverage labels offers a few common substantive and procedural lessons for companies. First, the back panels – when considered in light of U.S. Food and Drug...more
3/16/2023
/ Advertising ,
Article III ,
Beverage Manufacturers ,
Class Action ,
Consumers Legal Remedies Act ,
Defense Strategies ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Marketing ,
FRCP Rule 23(b)(2) ,
Injunctive Relief ,
Judicial Notice ,
Residency Requirements ,
Slack-Fill Suits ,
Standing ,
Unfair Competition ,
Whole Foods
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
10/18/2021
/ Abuse of Discretion ,
Anti-Kickback Statute ,
Appeals ,
Attorney-Client Privilege ,
Comment Period ,
Criminal Investigations ,
Discovery ,
Draft Guidance ,
Evidence ,
Failure To State A Claim ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter
"The overwhelming majority of courts have concluded that neither COVID-19 nor the governmental orders associated with it cause or constitute property loss or damage for purposes of insurance coverage." So concluded the...more
7/20/2021
/ Biden Administration ,
Business Losses ,
Collective Bargaining Agreements (CBA) ,
Constitutional Challenges ,
Contracts Clause ,
Coronavirus/COVID-19 ,
Data Breach ,
Department of Labor (DOL) ,
Due Process ,
Equal Protection ,
Farm Workers ,
Farms ,
First Amendment ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Grocery Store Workers ,
Grocery Stores ,
Insurance Claims ,
Insurance Industry ,
Insurance Litigation ,
Malware ,
Misrepresentation ,
NLRA ,
NPRM ,
Policy Terms ,
Preemption ,
Property Damage ,
Putative Class Actions ,
Tip Credit ,
Tipped Employees ,
Unfair or Deceptive Trade Practices ,
Wage and Hour
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
4/28/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Jury Verdicts ,
Medicaid ,
Medical Devices ,
Medicare ,
Medtronic ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Stark Law ,
TRICARE
Insurers have prevailed in several lawsuits filed by restaurants in connection with losses related to COVID-19. For example, in Emerald Coast Restaurants, Inc. v. Aspen Specialty Ins. Co., No. 3:20cv5898-TKW-HTC, 2020 WL...more
3/18/2021
/ Article III ,
Business Interruption ,
Coronavirus/COVID-19 ,
Data Breach ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Insurance Claims ,
Insurance Industry ,
Insurance Litigation ,
NLRA ,
NLRB ,
Putative Class Actions ,
Restaurant Industry ,
Standing ,
Unfair Competition ,
Wage and Hour
More than six months into the pandemic, there is still no easy or definitive answer to the question many retailers are asking about whether there is coverage for their business interruption losses related to COVID-19....more
10/14/2020
/ Agricultural Sector ,
Antitrust Violations ,
Business Interruption ,
Class Action ,
Commercial Insurance Policies ,
Coronavirus/COVID-19 ,
Dismissals ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
FSMA ,
Health Claims ,
NLRA ,
NLRB ,
Notice Requirements ,
OSHA ,
Putative Class Actions ,
Reversal ,
Tip Credit ,
Unfair Competition ,
Wage and Hour
Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims -
In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more
2/25/2020
/ Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Assisted Living Facilities (ALFs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Diagnostic Tests ,
DMEPOS ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Objective Falsity ,
Ownership Interest ,
Physicians ,
Protected Activity ,
Stark Law
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
10/15/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
Anti-Kickback Statute ,
Article III ,
Attorney-Client Privilege ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Dismissals ,
Disproportionate Share Adjustments ,
Draft Guidance ,
Enforcement Actions ,
European Medicines Agency (EMA) ,
False Advertising ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Medical Devices ,
Medicare ,
Patient Engagement Advisory Committee (PEAC) ,
Patient Referrals ,
Physicians ,
Prescription Drugs ,
Standing ,
Stark Law
Wage and Hour -
80/20 Rule Still Followed in Some Parts -
The U.S. Department of Labor (DOL) issued guidance doing away with the so-called "80/20 rule" in November 2018. District courts have greeted the new guidance...more
7/11/2019
/ Americans with Disabilities Act (ADA) ,
Auer Deference ,
Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Class Action ,
Department of Labor (DOL) ,
Dietary Supplements ,
Duty to Defend ,
Employer Liability Issues ,
Fair Labor Standards Act (FLSA) ,
FBI ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GrubHub ,
Hiring & Firing ,
Liquor Control Acts ,
New Guidance ,
Price-Fixing ,
Putative Class Actions ,
Securities Litigation ,
Wage and Hour ,
Wine & Alcohol
CMS Regulation -
District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements -
The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more
7/10/2019
/ Advertising ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Commercial Speech ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Social Security Act ,
Unduly Burdensome
CMS Regulation -
CMS and ONC Unveil Proposals Transforming Interoperability and Patient Access to Data -
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health...more
3/1/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Electronic Health Record Incentives ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
ONC ,
Opioid ,
Proposed Rules
Regulation -
FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat -
On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more
12/24/2018
/ Americans with Disabilities Act (ADA) ,
Appeals ,
Beverage Manufacturers ,
Biotechnology ,
Brand ,
Breweries ,
Class Action ,
Comment Period ,
Consent Agreements ,
Constitutional Challenges ,
Copyright ,
Dismissals ,
Dormant Commerce Clause ,
Due Process ,
Equal Protection ,
EU ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Intellectual Property Litigation ,
Interstate Commerce ,
Joint Statements ,
Local Ordinance ,
Misrepresentation ,
New Legislation ,
NLEA ,
Preemption ,
Public Comment ,
Putative Class Actions ,
Regulatory Oversight ,
Remand ,
Restaurant Industry ,
Reversal ,
Summary Judgment ,
Trademark Registration ,
Trademarks ,
USDA ,
Vacated ,
Website Accessibility
Regulation -
OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor -
On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more
12/20/2018
/ Advisory Opinions ,
Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
EPSDT ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Medicare Advantage ,
Notice of Proposed Rulemaking (NOPR) ,
OIG ,
Protected Class ,
Remuneration ,
Safe Harbors ,
Screening Procedures ,
Telemedicine ,
Unfair or Deceptive Trade Practices
Labor and Employment -
Jimmy John's Avoids Joint-Employer Finding in Worker Overtime Litigation -
In In re: Jimmy John's Overtime Litigation, 2018 WL 3231273 (N.D. Ill. June 14, 2018), a federal district court ruled that...more
9/14/2018
/ Americans with Disabilities Act (ADA) ,
Beer ,
Beverage Manufacturers ,
Brand ,
Breach of Warranty ,
Comment Period ,
Department of Labor (DOL) ,
Dietary Guidelines ,
Employer Liability Issues ,
Fair Labor Standards Act (FLSA) ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Franchisee ,
Hospitality Industry ,
Injunctive Relief ,
Joint Employers ,
Legislative Agendas ,
Mayor de Blasio ,
Minimum Wage ,
Misrepresentation ,
Motion to Dismiss ,
New Rules ,
Organic ,
Over-Time ,
Product Labels ,
Proposed Rules ,
Public Comment ,
Restaurant Industry ,
Standing ,
State Taxes ,
Subpoenas ,
Summary Judgment ,
Terms and Conditions ,
Tip-Pooling ,
Tipped Employees ,
Wage and Hour
Enforcement -
OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor -
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
5/30/2018
/ Adverse Action ,
Advisory Opinions ,
Affordable Care Act ,
Anti-Kickback Statute ,
Antitrust Litigation ,
Beneficiaries ,
Biosimilars ,
CMMI ,
Competition ,
Constructive Discharge ,
Department of Health and Human Services (HHS) ,
Distributors ,
Drug Pricing ,
Employer Liability Issues ,
Enforcement ,
Failure To State A Claim ,
False Claims Act (FCA) ,
FDCPA ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Request For Information ,
Section 340B ,
Sherman Act ,
Statute of Limitations
Antitrust -
FTC Announces Revised Hart-Scott-Rodino Thresholds for Acquisitions and Exclusive Licenses -
The Federal Trade Commission (FTC) has announced this year's revisions to the thresholds under the...more
2/28/2018
/ Antitrust Violations ,
Biosimilars ,
BPCIA ,
CAFA ,
Cartwright Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Eleventh Amendment ,
Enforcement Actions ,
Ex Parte ,
Exclusive Licenses ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FRCP 8 ,
FRCP 9(b) ,
Frivolous Lawsuits ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Insurer Liability ,
Interviews ,
Medicare ,
Physicians ,
Retaliation ,
Reverse Payment Settlement Agreements ,
Unfair Competition
Deceptive Trade Practices -
Meat Exporter Had No Duty Under FCA to Pay for Beef Inspection -
In United States ex rel. Barrick v. Parker-Migliorini Int'l, LLC, 878 F. 3d 1224 (10th Cir. 2017), the court affirmed...more
2/20/2018
/ Agricultural Workers ,
All Natural ,
Arbitration ,
Arbitration Agreements ,
Beverage Manufacturers ,
Breach of Warranty ,
Class Certification ,
Class Members ,
Conditional Certification ,
Court Appearances ,
Credit Card Surcharges ,
Double Damages ,
Economic Loss Doctrine ,
Email ,
Equal Protection ,
Exporters ,
Fair Labor Standards Act (FLSA) ,
False Claims Act (FCA) ,
False Statements ,
Farms ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Former Employee ,
FSMA ,
GMO ,
Hiring & Firing ,
Hospitality Industry ,
Independent Contractors ,
Inspections ,
Liquidated Damages ,
Minimum Wage ,
Misleading Statements ,
Misrepresentation ,
Motion to Dismiss ,
Negligent Misrepresentation ,
Non-Solicitation Agreements ,
Notice Requirements ,
Opt-In ,
Over-Time ,
Qui Tam ,
Restaurant Industry ,
Retailers ,
Rule 9(b) ,
Sherman Act ,
State Labor Laws ,
State Law Claims ,
Summary Judgment ,
Tip Credit ,
Tip-Pooling ,
Unfair or Deceptive Trade Practices ,
Unlawful Trade Practices Acts ,
USDA ,
Wage and Hour ,
Wage Statements
OIG Advisory Opinions -
Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized -
On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
9/6/2017
/ Anti-Kickback Statute ,
Anti-Steering Rules ,
Appeals ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EMTs ,
Expert Testimony ,
False Claims Act (FCA) ,
False Statements ,
Food and Drug Administration (FDA) ,
FRCP 9(b) ,
Health Care Providers ,
Health Insurance ,
Hip Replacement ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
Misrepresentation ,
OIG ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Defects ,
Qui Tam ,
Retaliation ,
Reversal ,
Witness Preparation
Wage and Hour -
Tenth Circuit Aligns with Cumbie on Tip Credits -
In Marlow v. New Food Guy, Inc., No. 16-1134, 861 F. 3d 1157 (10th Cir. June 30, 2017), the court affirmed the district court's ruling, consistent with...more
8/11/2017
/ Alcohol Beverage Control ,
Americans with Disabilities Act (ADA) ,
Arbitration ,
Beverage Manufacturers ,
Department of Labor (DOL) ,
Disability Discrimination ,
Disparagement ,
Equal Employment Opportunity Commission (EEOC) ,
Evaporated Cane Juice ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Joint Employers ,
Likelihood of Confusion ,
Medical Marijuana ,
NLRA ,
NLRB ,
Pattern or Practice ,
Reasonable Accommodation ,
Restaurant Industry ,
Staffing Agencies ,
Standing ,
Tip Credit ,
Trademarks ,
Unfair or Deceptive Trade Practices ,
Unions ,
Wage and Hour
Medicaid -
Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law -
By Eddie Williams -
In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
6/7/2017
/ Anti-Kickback Statute ,
Antitrust Violations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DSM ,
Enforcement Actions ,
Failure To Warn ,
False Claims Act (FCA) ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicaid Act ,
Misrepresentation ,
Noerr-Pennington Doctrine ,
OCR ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Prescription Drugs ,
Sherman Act ,
Stark Law ,
Third-Party Liability ,
Unfair or Deceptive Trade Practices ,
Warning Labels
Legalized Drug Use Impacts the Food and Beverage Industry -
In the November 2016 general election, voters in Arkansas, Florida and North Dakota amended their state constitutions to authorize the use of marijuana for...more
3/15/2017
/ Affordable Care Act ,
Age Discrimination ,
Americans with Disabilities Act (ADA) ,
Ban the Box ,
Breach of Contract ,
City of Los Angeles ,
Colombia ,
Comment Period ,
Criminal Background Checks ,
Dunkin' Donuts ,
Employer Liability Issues ,
Employment Discrimination ,
Equal Employment Opportunity Commission (EEOC) ,
Fair Chance Initiative for Hiring Ordinance (FCIHO) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Form 1095 ,
Franchise Agreements ,
Hiring & Firing ,
Intellectual Property Protection ,
Interference Claims ,
IRS ,
Logos ,
Marijuana ,
Medical Marijuana ,
Misleading Statements ,
New Legislation ,
Reporting Requirements ,
Restaurant Industry ,
Summary Judgment ,
Trade Dress ,
Trademark Infringement ,
Unfair Competition
Overtime Rules Enjoined Nationwide -
In State of Nev. v. U.S. Dep't of Labor Case No. 4:16-cv-00731-ALM, 2016 WL 6879615 (E.D. Tex. Nov. 22, 2016), a Texas district court enjoined nationwide the Department of Labor's...more
12/6/2016
/ American Express ,
Americans with Disabilities Act (ADA) ,
Anti-Steering Rules ,
Antitrust Provisions ,
Beverage Manufacturers ,
Credit Cards ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Exempt-Employees ,
Fair Labor Standards Act (FLSA) ,
Farms ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Forum Selection ,
Franchisors ,
Local Ordinance ,
Minimum Salary ,
Non-Exempt Employees ,
Nutrition Facts Labels ,
Over-Time ,
Preliminary Injunctions ,
Regulatory Oversight ,
Tax Rates ,
Tip-Pooling ,
Trump Administration ,
Wage and Hour ,
Web Content Accessibility Guidelines (WCAG) ,
Website Accessibility ,
White-Collar Exemptions
When food and beverage companies think of their largest risks, data breaches have not historically come to mind, but this is changing because of reports in the past few months of major breaches by companies such as Noodles &...more
8/2/2016
/ COPPA ,
Cyber Insurance ,
Cybersecurity ,
Data Breach ,
Defined Contribution Plans ,
Employee Benefits ,
ESOP ,
Fair Labor Standards Act (FLSA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
IRS ,
Minimum Salary ,
Over-Time ,
Personally Identifiable Information ,
Popular ,
Registration Requirement ,
Restaurant Industry ,
Retailers ,
Selling a Business ,
Tipped Employees ,
Tips ,
Wage and Hour ,
White-Collar Exemptions
Finance -
PACA Liens Could Impact Financing Terms -
The Perishable Agricultural Commodities Act (PACA) is a federal law enacted in 1930 with the goal of protecting suppliers and sellers of agricultural goods from...more
4/27/2016
/ Beverage Manufacturers ,
Class Action ,
Deceptively Misdescriptive ,
Disparagement ,
Distributors ,
Food and Drug Administration (FDA) ,
Food Commodities ,
Food Labeling ,
Franchise Laws ,
Lenders ,
Liens ,
Loans ,
NLRA ,
NLRB ,
Section 7 ,
SNAP Program ,
Statutory Trusts ,
Suppliers ,
USDA