Justin M. L. Stern is a member of the firm's Trial Practice Group as well as the Cannabis industry group and focuses primarily on commercial litigation and regulatory compliance.
Mr. Stern is a 2018 summa cum laude graduate of the University of Miami School of Law, where he was online editor of the University of Miami Law Review and elected to the Order of the Coif, and a magna cum laude graduate of Columbia University, where he was elected to Phi Beta Kappa.
Representative Matters
- Currently represent the developer of mixed-use condominium complexes in related actions against the general contractor, alleging construction defect and various tort claims.
- Obtained a preliminary injunction on behalf of publicly traded transportation and logistics conglomerate in civil litigation involving trade secret misappropriation claims.
- Obtained full dismissal of breach of contract and civil trespass claims brought against a publicly traded telecommunications service provider arising from the alleged misplacement of certain underground fiber optic cables. Live Work Play Developers, LLC v. AT&T Corp. (Fla. Cir. Ct. 2019).
Represented The Benchmark Company LLC, acting as underwriter in a $12.5 million offering of preferred stock for Fortress Biotech, Inc. (Nasdaq: FBIOP), a developer of pharmaceutical and biotechnology products and product candidates.
- Represented B. Riley FBR, Inc., acting as sales agent in a $150 million at the market equity offering of common stock for Novavax, Inc. (NASDAQ: NVAX), a late stage biotechnology company focused on the discovery, development and commercialization of vaccines to prevent serious infectious diseases, including a potential COVID-related vaccine.
Represented JMP Securities LLC and Oppenheimer & Co., acting as underwriters in a $25 million public offering of common stock and related warrants for Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company primarily focused on developing and commercializing innovative products for acute care settings.
Represented JMP Securities LLC, acting as sales agent in a $25 million at the market equity offering of common stock for iCAD, Inc. (Nasdaq: ICAD), a global medical technology company that provides innovative cancer detection and therapy solutions.
- Represent pharmacy operator in connection with civil administrative enforcement action brought by the DEA.
- Cannabis regulatory counsel to a venture capital firm focused on acquiring and developing businesses specializing in cannabis-related consumer goods.
- Regulatory counsel to an aromatherapy and essential oils products manufacturer in connection with the company’s entry into the hemp-derived CBD market.
- Cannabis regulatory counsel to multi-state medical marijuana operator.
- Provided state-specific regulatory advice on the cultivation, manufacture, and sale of CBD products to publicly traded international cannabinoid company.
- Advised a private credit asset management firm on cannabis-related regulatory matters in connection with its provision of a revolving credit facility to support the capital needs of a publicly traded supplier to businesses in the cannabis industry.
Commercial and Real Estate Litigation
Regulatory/Administrative
Cannabis
Admissions
- Florida
- U.S. District Court for the Southern District of Florida
- U.S. District Court for the Middle District of Florida
- U.S. District Court for the Northern District of Florida
Education
- University of Miami School of Law, J.D., summa cum laude, 2018
- Order of the Coif
- Online Editor, University of Miami Law Review - Columbia University, B.A., magna cum laude, 2014
- Phi Beta Kappa
Experience
Duane Morris LLP
- Associate, 2018-present
Civic and Charitable Activities
- Big Brothers Big Sisters of Palm Beach and Martin Counties
Professional Activities
Federal Bar Association, 2019-present
- Food and Drug Law Institute (FDLI), 2019-present
- Cannabis-Derived Products Committee
Selected Publications
- Co-author, "Consumer Class Actions Against CBD Companies Are Hitting a Snag," Cannabis Industry Journal, August 25, 2020
- Co-author, "Okla. High Court Marijuana Ruling Provides Preemption Guide," Law360, July 1, 2020
- Co-author, "Preparing for Resource-Draining Lawsuits," mg Magazine, April 2020
- Co-author, "A Cannabidiol Catalyst? Recent Events Increase Pressure on FDA to Regulate CBD," FDLI Update, Spring 2020
- Co-author, "Why Reformers Want Disclosure Of 3rd-Party MDL Funding," Law360, January 13, 2020
- Co-author, "THC Vaping Health Issues Warrant Safety Standards," Law360, September 25, 2019
Co-author, "Florida’s Budding Cannabis Industry Expands With New Hemp Law," Daily Business Review, July 1, 2019
Co-author, “International E-Discovery: How The 11th Circuit’s Interpretation of ‘Possession, Custody, or Control’ May Impact Multinational Corporations,” The Florida Bar Journal, January/February 2019
Duane Morris Alerts
- Co-author, "Florida Legislators Introduce Bills That Would Impose Strict Prerequisites to Bringing COVID-19 Personal Injury Claims," Duane Morris Alert, January 11, 2021
- Co-author, "Florida Industry Group Urges State to Limit Legal Liability for Florida Businesses," Duane Morris Alert, December 4, 2020
- Co-author, "FDA Clarifies Types of Evidence It Will Consider When Determining a Medical Product's 'Intended Use'," Duane Morris Alert, October 6, 2020
- Co-author, "New MAPP Explains Process for Changing Ownership of Generic Drug Applications," Duane Morris Alert, September 8, 2020
- Co-author, "New Guidance Reveals FDA's Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements," Duane Morris Alert, August 27, 2020
- Co-author, "DEA Issues Interim Final Rule Concerning Marijuana and Hemp," Duane Morris Alert, August 24, 2020
- Co-author, "FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products," Duane Morris Alert, August 6, 2020
- Co-author, "New FDA Draft Guidance on Cannabis-Related Clinical Research Omits Discussion of Nondrug CBD Products," Duane Morris Alert, July 23, 2020
- Co-author, "FDA Issues Guidance on Procedures for Device Establishment Inspections," Duane Morris Alert, July 8, 2020
- Co-author, "As COVID-19 Cases Mount, South Florida Counties Reimpose Restrictions Before Holiday Weekend," Duane Morris Alert, July 1, 2020
- Co-author, "Amid National Outcry for Police Accountability, Supreme Court Declines to Review Qualified Immunity," Duane Morris Alert, June 15, 2020
- Co-author, "New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers," Duane Morris Alert, June 12, 2020
- Co-author, "Judicial Decisions Reflect Need for CBD Regulations and Legal Counsel," Duane Morris Alert, June 9, 2020
- Co-author, "Florida Initiates Phase 1 of Reopening, with South Florida Counties Following a Different Track," Duane Morris Alert, May 4, 2020
- Co-author, "FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks," Duane Morris Alert, April 22, 2020
- Co-author, "CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers," Duane Morris Alert, April 13, 2020
- Co-author, "CARES Act Package Ushers in Changes to OTC Drug Review Process," Duane Morris Alert, April 13, 2020
- Co-author, "Florida Governor Clarifies Terms of First Statewide Safer-at-Home Order," Duane Morris Alert, April 6, 2020
- Co-author, "Florida Governor Issues Statewide Order Restricting Activities Outside the Home," Duane Morris Alert, April 2, 2020
- Co-author, "FDA Unveils Program to Expedite Coronavirus Treatments," Duane Morris Alert, April 1, 2020
- Co-author, "Florida Governor Issues Stay-at-Home Order—But Only for Southeast Florida," Duane Morris Alert, March 31, 2020
- Co-author, "Mix of Statewide Emergency Rules and Local Advisories Dominate Florida's Reaction to COVID-19," Duane Morris Alert, March 24, 2020
- Co-author, "Declaration Provides Immunity for Certain COVID-19 Pandemic Medical Countermeasure Activities," Duane Morris Alert, March 18, 2020
- Co-author, "FDA Guidance Aims to Accelerate Availability of COVID-19 Tests," Duane Morris Alerts, March 18, 2020
- Co-author, "FDA's Report on CBD Reaffirms Status Quo," Duane Morris Alert, March 13, 2020
- Co-author, "FDA Postpones Foreign Inspections Through April in Response to COVID-19," Duane Morris Alert, March 12, 2020
- Co-author, "FDA Revises Policies and Procedures for Prioritization of ANDAs," Duane Morris Alert, February 6, 2020
- Co-author, "FDA Provides Insight on Research and Drug Approval for Cannabis Products," Duane Morris Alert, January 24, 2020
- Co-author, "Federal Minimum Age for Purchase of Tobacco Products Including E-Cigarettes Raised from 18 to 21," Duane Morris Alert, December 24, 2019
- Co-author, "With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy," Duane Morris Alert, December 2, 2019
- Co-author, "FDA's Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances," Duane Morris Alert, November 25, 2019
- Co-author, "U.S. Senators Urge Changes to Testing Requirements Under USDA Interim Final Rule for Hemp Program," Duane Morris Alert, November 22, 2019
- Co-author, "In a Regulatory 'One-Two,' FDA Modifies Terms of Oversight Concerning Homeopathic Drugs," Duane Morris Alert, October 31, 2019
- Co-author, "USDA Releases Long-Awaited Federal Rules on Hemp Production, but State-by-State Regulatory Differences Remain," Duane Morris Alert, October 30, 2019
- Co-author, "In Cannabis Case, Tax Court Dissent Concludes Section 280E Is Unconstitutional," Duane Morris Alert, October 24, 2019
- Co-author, "Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years," Duane Morris Alert, October 22, 2019
- Co-author, "Discovery Ruling in District of Minnesota May Have Far-Reaching Implications for FCA Defendants," Duane Morris Alert, October 8, 2019
Co-author, "FTC Warning Letters and Reports of Vaping-Related Illnesses Hit Cannabis Industry," Duane Morris Alert, September 11, 2019
Co-author, "Much of Oklahoma's $572 Million Opioid Case Likely to Be Replicated Elsewhere, But Unique Cause of Action May Not," Duane Morris Alert, August 28, 2019
Co-author, "OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations," Duane Morris Alert, August 27, 2019
Co-author, "New Texas Law Advances Hemp Production and Regulation," Duane Morris Alert, June 12, 2019
Co-author, "USDA Provides Memo Clarifying Key Provisions of 2018 Farm Bill Regarding Hemp," Duane Morris Alert, May 30, 2019
Co-author, "A Green Light for the Sunshine State - Florida Legislature Approves Sweeping Changes to Hemp, CBD Regulation," Duane Morris Alert, May 7, 2019
Selected Speaking Engagements
- Presenter, "Virtual Happy Hour with Update Magazine Authors Rick Ball and Justin Stern," Food and Drug Law Institute, April 30, 2020
- Presenter, "Cannabis 303: Civil Litigation and COVID-19 Implications for the Cannabis Industry: An Unavoidable Consequence of a Maturing U.S. Cannabis Market," Duane Morris Cannabis Webinar Series, April 21, 2020
- Speaker, "Risks Associated With Cannabis Banking," South Florida Compliance Association, February 11, 2020
- Speaker, "Cannabis Issues in Commercial Real Estate," 6th Annual NAI Florida & Caribbean Conference, Intercontinental Miami, Miami, Florida, November 14-15, 2019
- Speaker, "Overview of New Federal Rules on Hemp Production and Q&A," Duane Morris and American Trade Association for Cannabis and Hemp, Webinar, November 6, 2019
Presenter, "Cannabis 204: The Roundup of State Cannabis Legislation," Duane Morris Cannabis Webinar Series, August 20, 2019
Presenter, "Possession, Custody, or Control Under Fed. R. Civ. P. 34: Implications of Interpretation," Miami, FL, April 12, 2019