Prins, Andrew D.

Andrew D. Prins

Partner

andrew.prins@lw.com
    Prins, Andrew D.

    Andrew D. Prins

    Partner

    andrew.prins@lw.com

    Profile

    Andrew Prins represents clients in their most important and complex disputes involving federal administrative agencies and state government regulators.

    Andrew focuses on challenges to the legality of government regulatory action that raise novel questions of:

    • Administrative law and procedure under the Administrative Procedure Act (APA)
    • Constitutional law
    • Statutory interpretation and authority
    • Federal preemption
    • Jurisdiction

    He represents clients as plaintiffs in litigation against the government to invalidate regulatory action, and clients as intervenor-defendants alongside the government to defend the legality of regulatory action that benefits his clients.

    Andrew regularly appears before the federal courts in D.C., as well as before trial and appellate courts across the country. Many of his matters involve requests for emergency relief, such as temporary restraining orders, preliminary injunctions, and stays of agency action.

    In addition to litigating in trial court and on appeal, Andrew provides pre-dispute counseling in regulatory matters pending before agencies that may result in litigation.

    He works with clients in a number of highly regulated industries, including pharmaceuticals and life sciences, healthcare, biotechnology, telecommunications, and technology.

    He has handled litigation involving many different federal departments and agencies, with particular experience in matters involving the US Department of Health and Human Services (HHS), against which Andrew has won many precedent-setting victories involving:

    • Food and Drug Administration (FDA) drug approvals and statutory drug exclusivities, including those arising under the Orphan Drug Act and Hatch-Waxman Act
    • FDA regulation of tobacco products under the Tobacco Control Act, including e-cigarettes
    • Centers for Medicare & Medicaid Services’ (CMS) various programs, including the Star Ratings program for Medicare Advantage plans
    • The Health Resources and Services Administration’s (HRSA) administration of the 340B Drug Pricing Program.

    Complementing his government-facing practice, Andrew also represents clients in other forms of litigation involving a complex regulatory overlay, including consumer class actions and arbitrations.

    A recognized leader at the firm, Andrew served on the Finance Committee and the Technology Committee.

    Before joining Latham, Andrew served as a judicial law clerk to Judge J.L. Edmondson of the US Court of Appeals for the 11th Circuit.

    For 10 years prior to practicing law, he served in various senior-level engineering and management roles at a large multinational internet and telecommunications company, where he oversaw network architecture and data security.

    Experience

    Andrew’s experience includes:

    Government-Facing Litigation

    • Clover Insurance Co. v. CMS, 2026 WL 1483515 (S.D. Ga. 2026): Invalidating CMS’s erroneous calculation of Clover’s Medicare Advantage Star Rating as substantively inconsistent with the statute and procedurally invalid
    • Pharmaceutical Research Manufacturers of America v. McCuskey, – F.4th –, No. 25-1054 (4th Cir. 2026): Affirming lower court victory granting preliminary injunction against enforcement of state law attempting to regulate the federal 340B program, because the state law is likely preempted
    • Corr-Williams Co. v. FDA, 25-60443 (5th Cir. 2025): Obtaining stay of FDA marketing denial order concerning e-cigarette products issued in violation of the Tobacco Control Act
    • PharmaEssentia USA Corp. v. CMS, 805 F. Supp. 3d 261 (D.D.C. 2025): Rejecting CMS’s interpretation of Specified Small Manufacturer Status provision of the Inflation Reduction Act and setting aside agency’s status determination as arbitrary and capricious
    • Jazz Pharmaceuticals Inc. v. FDA, 141 F.4th 254 (D.C. Cir. 2025): Affirming a lower court victory permitting client to market its innovative narcolepsy drug, notwithstanding a competitor’s alleged orphan drug exclusivity
    • Pharmaceutical Research Manufacturers of America v. Morrissey, 760 F. Supp. 3d 439 (S.D.W. Va. 2024): Obtaining a preliminary injunction against enforcement of state law attempting to regulate the federal 340B drug pricing program on preemption grounds
    • R.J. Reynolds and ITG Brands v. FDA, 762 F. Supp. 3d 529 (E.D. Tex. 2025): Obtaining a preliminary injunction against enforcement of FDA’s “graphic warnings” requirements for likely statutory violations by agency
    • Zenwork v. SSA, No. 25-0036 (N.D. Tex. 2025): Successfully resolving a case in which the government agreed to reinstate access to a tax document filing system following a challenge to the agency’s statutory authority
    • SCAN Health Plan v. CMS, 2024 WL 2815789 (D.D.C. 2024): Invalidating CMS’s erroneous calculation of SCAN Health Plan’s Medicare Advantage Star Rating as inconsistent with the governing regulations
    • United Therapeutics v. HRSA, 102 F.4th 452 (D.C. Cir. 2024): Affirming a lower court victory invalidating violation determination issued by HHS/ Health Resources and Services Administration (HRSA) concerning the federal 340B drug pricing program
    • Endo Par Innovation Co. v. FDA, 2024 WL 2988904 (D.D.C. 2024): Obtaining preliminary injunction staying FDA approval of Endo’s competitor’s drug product, due to the agency’s likely arbitrary policy change
    • Insight Global v. DHS, No. 24-2192 (N.D. Ga. 2024): Successfully resolving a case in which the government agreed to reopen and grant over 80 denied H-1B visas for nurses following a challenge to the agency’s statutory authority
    • Jazz Pharmaceuticals v. FDA, 2024 WL 4625731 (D.D.C. 2024): Defeating, as intervenor-defendant, the plaintiff’s attempt to remove the client’s drug from the market due to alleged orphan drug exclusivity
    • Nat’l Ass’n of Wheat Growers v. Bonta, 85 F.4th 1263 (9th Cir. 2023): Affirming a lower court victory enjoining enforcement of California’s Proposition 65 on First Amendment grounds
    • Fontem USA v. FDA, 82 F.4th 1207 (D.C. Cir. 2023): Vacating a marketing denial order that the FDA issued concerning the client’s e-cigarette applications as unlawful under the Tobacco Control Act and arbitrary and capricious
    • Jacobus Pharmaceutical Co. v. Catalyst Pharmaceuticals, No. 21A328, 2022 WL 20619490 (U.S. 2022): Defeating attempt by the client’s competitor to obtain a Supreme Court stay of lower-court judgment invalidating the competitor’s drug approval
    • United Therapeutics v. HRSA, 2021 WL 5161783 (D.D.C. 2021): Invalidating violation determination that HHS/HRSA issued concerning the federal 340B drug pricing program because the determination rested on an invalid statutory interpretation
    • Catalyst Pharmaceuticals v. FDA, 14 F.4th 1299 (11th Cir. 2021): Reversing district court and directing that judgment be entered in client’s favor in a case challenging FDA’s approval of a competitor’s drug due to the client’s orphan drug exclusivity
    • Eagle Pharmaceuticals v. FDA, 952 F.3d 323 (D.C. Cir. 2020): Affirming a lower court victory that concluded the FDA’s interpretation of the Orphan Drug Act’s exclusivity provision was inconsistent with the statute
    • Genus Lifesciences v. FDA, 486 F. Supp. 3d 450 (D.D.C. 2020): Granting partial summary judgment to Genus Lifesciences and concluding that the FDA erred in approving a competitor’s drug product
    • Institute for Justice v. IRS, 941 F.3d 567 (D.C. Cir. 2019): Obtaining a rare reversal of a grant of summary judgment to the government under the Freedom of Information Act
    • Charter Communications v. US, 722 Fed. Appx. 604 (9th Cir. 2019): Invalidating part of the Telephone Consumer Protection Act as a content-based regulation of speech inconsistent with the First Amendment
    • Nat’l Family Farm Coalition v. EPA, 747 F. App’x 646 (9th Cir. 2019): Dismissing a challenge to the client’s pesticide approval on jurisdictional grounds
    • Athenex v. FDA, 397 F. Supp. 3d 56 (D.D.C. 2019): Defeating a challenge by the client’s competitor to FDA’s regulatory determination in the client’s favor regarding bulk drug compounding
    • Nat’l Ass’n of Wheat Growers v. Zeise, 468 F. Supp. 3d 1247 (E.D. Cal. 2018): Granting a permanent injunction against enforcing California’s Proposition 65 warning requirement on First Amendment grounds
    • Eagle Pharmaceuticals v. FDA, 2018 WL 3838265 (D.D.C. 2018): Ordering FDA to recognize orphan drug exclusivity for Eagle’s drug and setting aside its prior refusal to do so as inconsistent with the statute
    • Par Sterile Products v. FDA, 1:17-cv-02221 (D.D.C. 2017): Challenging an FDA “guidance” document purporting to exercise “enforcement discretion” over certain drug compounding activities
    • Atay v. County of Maui, 842 F.3d 688 (9th Cir. 2016): Affirming a lower court victory invalidating a county ban on biotechnology crops as preempted by federal and state law
    • Residents for The Beverly Hills Garden and Open Space Initiative v. City of Beverly Hills, 2:16-cv-05532 (C.D. Cal. 2016): Obtaining on First Amendment grounds a preliminary injunction against enforcing a city ordinance placing restrictions and burdens on political speech
    • Robert Ito Farm v. County of Maui, 111 F. Supp. 3d 1088 (D. Haw. 2015): Invalidating a county ban on biotechnology crops as preempted by federal and state law
    • New York Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep’t of Health & Mental Hygiene, 23 N.Y.3d 681 (2014): Affirming a lower court victory invalidating New York City’s “soda ban”
    • Teva Pharmaceutical Industries v. FDA, No. 1:14-cv-00786 (D.D.C. 2014): Defeating a competitor’s challenge to the client’s pending FDA generic drug application
    • Ctr. for Food Safety v. USDA, 718 F.3d 829 (9th Cir. 2013): Affirming a lower court victory defeating a challenge to biotechnology crop approval
    • New York Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep’t of Health & Mental Hygiene, 2013 WL 1343607 (N.Y. Sup. Ct. 2013): Invalidating New York City’s “soda ban” on constitutional grounds
    • Walgreen Co. v. DEA, No. 12-1397 (D.C. Cir. filed Oct. 10, 2012): Challenging a Drug Enforcement Administration (DEA) enforcement action and regulatory interpretation of the Controlled Substances Act
    • Community Coalition Against Beverage Taxes v. City of Richmond, 3:12-cv-04545 (N.D. Cal. 2012): Obtaining on First Amendment grounds a temporary restraining order and preliminary injunction against enforcing a city ordinance placing restrictions and burdens on political speech
    • Ctr. for Food Safety v. USDA, 844 F. Supp. 2d 1006 (N.D. Cal. 2012): Defeating a challenge to the client’s biotechnology crop approval

    Other Complex Litigation

    • Hart v. Charter Communications Inc., 2023 WL 3914285 (C.D. Cal. 2023): Dismissing claims of lead putative class representative asserting nationwide false advertising claims based on allegedly deficient internet speeds
    • Hale v. Teladoc Health Inc., 2021 WL 1163925 (S.D.N.Y 2021): Dismissing with prejudice TCPA class action for failure to state a claim for vicarious liability
    • Suttles v. Facebook Inc., 461 F. Supp. 3d 479 (W.D. Tex. 2020): Dismissing with prejudice TCPA case for failure to adequately pled existence of a “telephone solicitation” and use of an “ATDS”
    • Hart v. Charter Communications Inc., 814 Fed. Appx. 211 (9th Cir. 2020): Affirming lower court victory compelling arbitration based on contract formed through inquiry notice
    • Hunter v. Time Warner Cable Inc., 2019 WL 3812063 (S.D.N.Y. 2019): Defeating class certification in case alleging about 150 million phone calls placed in violation of the TCPA
    • Olsen v. Charter Communications Inc., 2019 WL 3779190 (S.D.N.Y. 2019): Compelling plaintiffs in putative class action into arbitration concerning claims asserting misrepresentation of internet broadband speeds
    • Hart v. Charter Communications Inc., 2017 WL 6942425 (C.D. Cal. 2017): Compelling plaintiffs into arbitration concerning claims asserting misrepresentation of Internet broadband speeds
    • Robert Ito Farm Inc. v. County of Maui, 842 F.3d 681 (9th Cir. 2016): Defeating challenge by proposed intervener to denial of intervention in the lower court
    • Miller v. Time Warner Cable Inc., 2016 WL 7471302 (C.D. Cal. 2016): Dismissing injunctive TCPA claim for lack of Article III standing and compelling remaining damages claim to arbitration
    • In re: Time Warner Cable Inc., Telephone Consumer Protection Act (TCPA) Litigation, 247 F. Supp. 3d 1388 (J.P.M.L. 2016): Denying centralization of TCPA class actions

    Qualifications

    Bar Qualification

    • District of Columbia
    • Maryland

    Education

    • BS, Florida Atlantic University
      magna cum laude
    • JD, Duke University School of Law
      with Honors

    Practices

    Recognition

    Read More

    News & Insights

    Washington D.C., USA
    August 31, 2023 In the News

    DC Circ. Says FDA Botched Part of E-Cig Review

    A D.C. Circuit panel chastised the US Food and Drug Administration Tuesday for moving the "regulatory goalpost" when the agency denied premarket authorization to Fontem US LLC's unflavored e-cigarettes products.
    Read More