{"data":{"filter_options":{"titles":[{"name":"Managing Partner Atlanta Office","value":"Managing Partner Atlanta Office"},{"name":"Partner","value":"Partner"},{"name":"Partner / Head of Pro Bono","value":"Partner / Head of Pro Bono"},{"name":"Partner / Chief Operating Officer","value":"Partner / Chief Operating Officer"},{"name":"Partner / General Counsel","value":"Partner / General Counsel"},{"name":"Partner / Dir. E-Discovery Ops","value":"Partner / Dir. E-Discovery Ops"},{"name":"Partner / Chairman, Saudi Arabia Practice","value":"Partner / Chairman, Saudi Arabia Practice"},{"name":"K\u0026S Talent Partner","value":"K\u0026S Talent Partner"},{"name":"Partner / Chief Human Resources Officer","value":"Partner / Chief Human Resources Officer"},{"name":"Chairman","value":"Chairman"},{"name":"Senior Counsel","value":"Senior Counsel"},{"name":"Associate Director, E-Discovery Operations","value":"Associate Director, E-Discovery Operations"},{"name":"Counsel","value":"Counsel"},{"name":"Senior Associate","value":"Senior Associate"},{"name":"Associate","value":"Associate"},{"name":"Senior Attorney","value":"Senior Attorney"},{"name":"Senior Lawyer","value":"Senior Lawyer"},{"name":"Attorney","value":"Attorney"},{"name":"Senior Counsel and Policy Advisor","value":"Senior Counsel and Policy Advisor"},{"name":"Managing Director - Capital Solutions","value":"Managing Director - Capital Solutions"},{"name":"Senior Government Relations Advisor","value":"Senior Government Relations Advisor"},{"name":"Associate General Counsel","value":"Associate General Counsel"},{"name":"Senior Advisor","value":"Senior Advisor"},{"name":"Patent Agent","value":"Patent Agent"},{"name":"Consultant","value":"Consultant"},{"name":"Government Relations Advisor","value":"Government Relations Advisor"},{"name":"Chief of Lateral Partner Recruiting \u0026 Integration","value":"Chief of Lateral Partner Recruiting \u0026 Integration"},{"name":"Chief Financial Officer","value":"Chief Financial Officer"},{"name":"Chief Information Officer","value":"Chief Information Officer"},{"name":"Chief Revenue Officer","value":"Chief Revenue Officer"},{"name":"Chief Recruiting Officer","value":"Chief Recruiting Officer"},{"name":"Chief Lawyer Talent Development Officer","value":"Chief Lawyer Talent Development Officer"},{"name":"Chief Marketing Officer","value":"Chief Marketing Officer"},{"name":"Tax Consultant","value":"Tax Consultant"},{"name":"Director of Community Affairs","value":"Director of Community Affairs"},{"name":"Director of Facilities \u0026 Admin Operations","value":"Director of Facilities \u0026 Admin Operations"},{"name":"Senior Office Manager","value":"Senior Office Manager"},{"name":"Director of Operations","value":"Director of Operations"},{"name":"Pro Bono Deputy","value":"Pro Bono Deputy"},{"name":"Director of Office Operations","value":"Director of Office Operations"},{"name":"Director of Operations Europe","value":"Director of Operations Europe"},{"name":"Law Clerk","value":"Law Clerk"},{"name":"Deputy General Counsel","value":"Deputy General Counsel"}],"schools":[{"name":"(Commercial Law), in front of Monash University, Australia","value":3045},{"name":"Aberystwyth University","value":3004},{"name":"Albany Law School","value":2118},{"name":"American University Washington College of Law","value":3042},{"name":"American University, Washington College of Law","value":3024},{"name":"Appalachian School of Law","value":2891},{"name":"Ateneo de Manila University","value":2914},{"name":"Ave Maria School of Law","value":2892},{"name":"Baylor University School of Law","value":181},{"name":"Benjamin N. Cardozo School of Law","value":2619},{"name":"Binghamton University","value":3002},{"name":"Boston College Law School","value":245},{"name":"Boston University School of Law","value":247},{"name":"BPP Law School Leeds","value":2642},{"name":"BPP Law School London","value":2782},{"name":"BPP University","value":2984},{"name":"Brooklyn Law School","value":2705},{"name":"Cairo University, Law School","value":2962},{"name":"California Western School of Law","value":315},{"name":"Capital University Law School","value":327},{"name":"Case Western Reserve University School of Law","value":345},{"name":"Cecil C. Humphreys School of Law","value":2235},{"name":"Chapman University School of Law","value":377},{"name":"Charleston School of Law","value":2910},{"name":"City Law School, London","value":2998},{"name":"City Law School","value":2857},{"name":"Clark University","value":3006},{"name":"Cleveland-Marshall College of Law","value":426},{"name":"Columbia University School of International and Public Affairs","value":3008},{"name":"Columbia University School of Law","value":485},{"name":"Columbia University","value":3126},{"name":"Columbus School of Law, Catholic University of America","value":3010},{"name":"Columbus School of Law","value":350},{"name":"Concord Law School of Kaplan University","value":1026},{"name":"Cornell Law School","value":512},{"name":"Creighton University School of Law","value":518},{"name":"Creighton University","value":3025},{"name":"Cumberland School of Law","value":1759},{"name":"CUNY School of Law","value":2893},{"name":"David A. Clarke School of Law","value":2399},{"name":"Deakin University School of Law","value":2907},{"name":"DePaul University College of Law","value":565},{"name":"DePaul University College of Law","value":3060},{"name":"Dickinson School of Law","value":2719},{"name":"Drake University Law School","value":609},{"name":"Duke University School of Law","value":613},{"name":"Duquesne University School of Law","value":614},{"name":"Dwayne O. Andreas School of Law","value":173},{"name":"Edinburgh Law School","value":3160},{"name":"Emory University School of Law","value":659},{"name":"ESADE Business and Law School – Universidad Ramon Llull","value":3215},{"name":"Fachseminare von Fürstenberg","value":2918},{"name":"Faculté Libre de Droit, Université Catholique de Lille","value":3055},{"name":"Faculty of Law, University of Zagreb","value":2983},{"name":"Faculty of Law","value":2944},{"name":"Faculty of Law","value":3039},{"name":"Federal University of Rio de Janeiro","value":3022},{"name":"Federal University of Rio Grande do Sul School of Law (Brazil)","value":3062},{"name":"Florida A\u0026M University College of Law","value":699},{"name":"Florida Coastal School of Law","value":2894},{"name":"Florida International College of Law","value":707},{"name":"Florida State University College of Law","value":720},{"name":"Fordham University School of Law","value":722},{"name":"Franklin Pierce Law Center","value":734},{"name":"Friedrich-Schiller-Universität Jena","value":3015},{"name":"George Mason University School of Law","value":752},{"name":"George Washington University Law School","value":753},{"name":"Georgetown University Law Center","value":755},{"name":"Georgia State University College of Law","value":761},{"name":"Ghent Law School","value":2793},{"name":"Golden Gate University School of Law","value":770},{"name":"Gonzaga University School of Law","value":772},{"name":"Graduate Institute of International and Development Studies, Geneva","value":2997},{"name":"Hamline University School of Law","value":811},{"name":"Harvard Law School","value":824},{"name":"Hebrew University of Jerusalem Faculty of Law","value":2994},{"name":"Hofstra University School of Law","value":858},{"name":"Howard University School of Law","value":872},{"name":"Huazhong University of Science and Technology","value":3016},{"name":"Humboldt University of Berlin","value":3012},{"name":"Indiana University School of Law","value":2711},{"name":"Indiana University School of Law","value":890},{"name":"International Association of Privacy Professionals","value":3009},{"name":"J. Reuben Clark Law School","value":262},{"name":"Jacob D. Fuchsberg Law Center","value":2084},{"name":"James Cook University of North Queensland","value":3034},{"name":"Jean Moulin University Lyon 3, France","value":2938},{"name":"Johns Hopkins Bloomberg School of Public Health","value":2992},{"name":"Justus-Liebig-Universität Gießen Rechtswissenschaft (Germany)","value":3063},{"name":"Kansas City School of Law","value":2247},{"name":"Keio University","value":2968},{"name":"Kent College of Law","value":883},{"name":"Kline School of Law","value":611},{"name":"KU Leuven","value":3007},{"name":"Levin College of Law","value":2189},{"name":"Lewis and Clark Law School","value":1089},{"name":"Liberty University School of Law","value":1094},{"name":"Lincoln College of Law","value":2253},{"name":"LL.M. in International Crime and Justice UNICRI","value":2937},{"name":"Loyola Law School","value":2895},{"name":"Loyola University Chicago School of Law","value":1135},{"name":"Loyola University New Orleans College of Law","value":1136},{"name":"Marquette University Law School","value":1176},{"name":"McGeorge School of Law","value":2402},{"name":"McGill University","value":2659},{"name":"Melbourne Law School","value":2899},{"name":"Mercer University Walter F. George School of Law","value":1221},{"name":"Mexico Autonomous Institute of Technology","value":2996},{"name":"Michael E. Moritz College of Law","value":2728},{"name":"Michigan State University College of Law","value":1245},{"name":"Mississippi College School of Law","value":1285},{"name":"Moscow State University","value":2815},{"name":"National and Kapodistrian University of Athens","value":3032},{"name":"National Law University Jodhpur","value":3020},{"name":"National University of Singapore, Faculty of Law","value":2662},{"name":"New England School of Law","value":2886},{"name":"New York Law School","value":1403},{"name":"New York University School of Law","value":1406},{"name":"Norman Adrian Wiggins School of Law","value":323},{"name":"North Carolina Central University School of Law","value":1417},{"name":"Northeastern University School of Law","value":1430},{"name":"Northern Illinois University College of Law","value":1432},{"name":"Northwestern Pritzker School of Law","value":1451},{"name":"Notre Dame Law School","value":2278},{"name":"Ohio Northern University Law School","value":3036},{"name":"Oklahoma City University School of Law","value":1487},{"name":"Osgoode Hall Law School","value":3124},{"name":"Pace University School of Law","value":1516},{"name":"Panteion University","value":3033},{"name":"Paul M. Hebert Law Center","value":2713},{"name":"Pennsylvania State University, Dickinson School of Law","value":1562},{"name":"Pepperdine University School of Law","value":1570},{"name":"Pettit College of Law","value":1473},{"name":"Pontificia Universidad Catolica de Chile","value":3203},{"name":"Pontificia Universidad Catolica del Peru","value":3011},{"name":"Pontificia Universidad Javeriana","value":3013},{"name":"Pontificia Universidade Catolica de Sao Paulo","value":3095},{"name":"Prince Sultan University College of Law","value":3167},{"name":"Queens College, Cambridge","value":3003},{"name":"Quinnipiac University School of Law","value":1626},{"name":"Ralph R. Papitto School of Law","value":1686},{"name":"Regent University School of Law","value":1649},{"name":"Rice University","value":3043},{"name":"Ruprecht-Karls-Universität Heidelberg","value":3049},{"name":"Rutgers University School of Law-Newark","value":1699},{"name":"Rutgers University School of Law","value":1697},{"name":"S.J. Quinney College of Law","value":2408},{"name":"Saint Louis University School of Law","value":1732},{"name":"Salmon P. Chase College of Law","value":1433},{"name":"Sandra Day O'Connor College of Law","value":103},{"name":"Santa Clara University School of Law","value":1771},{"name":"Seattle University School of Law","value":1787},{"name":"Seton Hall University School of Law","value":1790},{"name":"Shepard Broad Law Center","value":1460},{"name":"South Texas College of Law","value":2721},{"name":"Southern Illinois University School of Law","value":1849},{"name":"Southern Methodist University Dedman School of Law","value":1852},{"name":"Southern University Law Center","value":1857},{"name":"Southwestern Law School","value":1876},{"name":"St. John's University School of Law","value":2724},{"name":"St. Mary's University School of Law","value":1896},{"name":"St. Thomas University School of Law","value":1746},{"name":"Stanford Law School","value":1904},{"name":"Stetson University College of Law","value":1910},{"name":"Sturm College of Law","value":2184},{"name":"Suffolk University Law School","value":1921},{"name":"Syracuse University College of Law","value":1956},{"name":"Temple University Beasley School of Law","value":1974},{"name":"Texas A\u0026M School of Law","value":1980},{"name":"Texas Tech University School of Law","value":1994},{"name":"Texas Wesleyan University School of Law","value":1996},{"name":"The College of Law Australia","value":3091},{"name":"The College of Law, London","value":2935},{"name":"The John Marshall Law School","value":2034},{"name":"The Judge Advocate General's Legal Center and School","value":2896},{"name":"The Ohio State University Moritz College of Law","value":2990},{"name":"The University of Akron School of Law","value":2143},{"name":"The University of Alabama School of Law","value":2045},{"name":"The University of Birmingham, U.K.","value":2796},{"name":"The University of Iowa College of Law","value":2206},{"name":"The University of Texas School of Law","value":2055},{"name":"The University of Tulsa College of Law","value":2407},{"name":"Thomas Jefferson School of Law","value":685},{"name":"Thomas M. Cooley Law School","value":2729},{"name":"Thurgood Marshall School of Law","value":1992},{"name":"Tianjin University of Commerce","value":2995},{"name":"Tulane University Law School","value":2113},{"name":"UC Davis School of Law","value":2160},{"name":"UCLA School of Law","value":2162},{"name":"Universidad Católica de Honduras","value":2916},{"name":"Universidad Francisco Marroquin","value":3090},{"name":"Universidad Panamericana","value":2904},{"name":"Universidad Torcuato di Tella","value":3035},{"name":"Universidade de São Paulo, Faculdade de Direito","value":3028},{"name":"Universidade Presbiteriana Mackenzie","value":2977},{"name":"Università Commerciale Luigi Bocconi","value":3135},{"name":"University at Buffalo Law School","value":1928},{"name":"University College Dublin Law School","value":2900},{"name":"University of Alberta Faculty of Law","value":3088},{"name":"University of Amsterdam","value":2980},{"name":"University of Arizona, James E. Rogers College of Law","value":2149},{"name":"University of Arkansas School of Law","value":2154},{"name":"University of Baltimore School of Law","value":2156},{"name":"University of California College of the Law","value":3196},{"name":"University of California Hastings College of Law","value":2158},{"name":"University of California Irvine School of Law","value":2161},{"name":"University of California, Berkeley, School of Law","value":2159},{"name":"University of California, Davis","value":3019},{"name":"University of Cambridge, U.K","value":2991},{"name":"University of Canterbury","value":2981},{"name":"University of Central Florida","value":3027},{"name":"University of Chester Law School","value":3005},{"name":"University of Chicago Law School","value":2174},{"name":"University of Chicago","value":3038},{"name":"University of Cincinnati College of Law","value":2175},{"name":"University of Colorado School of Law","value":2177},{"name":"University of Connecticut School of Law","value":2180},{"name":"University of Dayton School of Law","value":2182},{"name":"University of Detroit Mercy School of Law","value":2185},{"name":"University of East Anglia","value":3000},{"name":"University of Florida, Levin College of Law","value":3188},{"name":"University of Georgia School of Law","value":2190},{"name":"University of Houston Law Center","value":2197},{"name":"University of Hull","value":3040},{"name":"University of Idaho College of Law","value":2201},{"name":"University of Illinois College of Law","value":2204},{"name":"University of Kansas School of Law","value":2208},{"name":"University of Kentucky College of Law","value":2210},{"name":"University of La Verne College of Law","value":2211},{"name":"University of Law, London","value":2999},{"name":"University of Lethbridge","value":3030},{"name":"University of Louisville Brandeis School of Law","value":2214},{"name":"University of Maine School of Law","value":2391},{"name":"University of Maryland School of Law","value":2224},{"name":"University of Miami School of Law","value":2236},{"name":"University of Michigan Law School","value":2237},{"name":"University of Minnesota Law School","value":2243},{"name":"University of Mississippi School of Law","value":2244},{"name":"University of Missouri School of Law","value":2246},{"name":"University of Montana School of Law","value":2048},{"name":"University of Nebraska College of Law","value":2744},{"name":"University of New Mexico School of Law","value":2262},{"name":"University of North Carolina School of Law","value":2266},{"name":"University of North Dakota School of Law","value":2271},{"name":"University of Oklahoma Law Center","value":2747},{"name":"University of Oregon School of Law","value":2281},{"name":"University of Pennsylvania Law School","value":2282},{"name":"University of Pittsburgh School of Law","value":2354},{"name":"University of Richmond School of Law","value":2370},{"name":"University of San Diego School of Law","value":2377},{"name":"University of San Francisco School of Law","value":2378},{"name":"University of South Carolina School of Law","value":2750},{"name":"University of South Dakota School of Law","value":2387},{"name":"University of Southern California Gould School of Law","value":3051},{"name":"University of St. Thomas School of Law","value":2751},{"name":"University of Sydney Law School","value":3031},{"name":"University of Tennessee College of Law","value":2051},{"name":"University of the West of England, Bristol","value":3001},{"name":"University of Toledo College of Law","value":2406},{"name":"University of Toronto","value":2912},{"name":"University of Utah","value":3026},{"name":"University of Virginia School of Law","value":2410},{"name":"University of Washington School of Law","value":2412},{"name":"University of Wisconsin Law School","value":2419},{"name":"University of Wyoming College of Law","value":2429},{"name":"University of Zürich","value":3037},{"name":"University Paris Dauphine","value":2976},{"name":"University Paris II Assas","value":2975},{"name":"University Paris II Assas","value":3052},{"name":"USC Gould School of Law","value":2389},{"name":"Utrecht University","value":3085},{"name":"Valparaiso University School of Law","value":2441},{"name":"Vanderbilt University School of Law","value":2442},{"name":"Vermont Law School","value":2451},{"name":"Villanova University School of Law","value":2454},{"name":"Wake Forest University School of Law","value":2471},{"name":"Washburn University School of Law","value":2482},{"name":"Washington and Lee University School of Law","value":2484},{"name":"Washington College of Law","value":61},{"name":"Washington University in St. Louis School of Law","value":2489},{"name":"Wayne State University Law School","value":2493},{"name":"West Virginia University College of Law","value":2517},{"name":"Western New England College School of Law","value":2528},{"name":"Western State College of Law","value":2897},{"name":"Wharton School of Business","value":3044},{"name":"Whittier Law School","value":2564},{"name":"Widener University Delaware Law School","value":2569},{"name":"Willamette University College of Law","value":2573},{"name":"William \u0026 Mary Law School","value":462},{"name":"William H. Bowen School of Law","value":2150},{"name":"William Mitchell College of Law","value":2758},{"name":"William S. Boyd School of Law","value":2256},{"name":"William S. Richardson School of Law","value":2195},{"name":"Wilmington University","value":2993},{"name":"Yale Law School","value":2605}],"offices":[{"name":"Abu Dhabi","value":13},{"name":"Atlanta","value":1},{"name":"Austin","value":12},{"name":"Brussels","value":23},{"name":"Charlotte","value":8},{"name":"Chicago","value":21},{"name":"Dallas","value":28},{"name":"Denver","value":22},{"name":"Dubai","value":6},{"name":"Frankfurt","value":9},{"name":"Geneva","value":15},{"name":"Houston","value":4},{"name":"London","value":5},{"name":"Los Angeles","value":19},{"name":"Miami","value":25},{"name":"New York","value":3},{"name":"Northern Virginia","value":24},{"name":"Paris","value":14},{"name":"Riyadh","value":27},{"name":"Sacramento","value":20},{"name":"San Francisco","value":10},{"name":"Silicon Valley","value":11},{"name":"Singapore","value":16},{"name":"Sydney","value":26},{"name":"Tokyo","value":18},{"name":"Washington, D.C.","value":2}],"capabilities":[{"name":"Corporate, Finance and Investments","value":"cg-1"},{"name":null,"value":72},{"name":null,"value":26},{"name":null,"value":40},{"name":null,"value":27},{"name":null,"value":80},{"name":null,"value":28},{"name":null,"value":35},{"name":null,"value":10},{"name":null,"value":134},{"name":null,"value":121},{"name":null,"value":78},{"name":null,"value":29},{"name":null,"value":32},{"name":null,"value":31},{"name":null,"value":33},{"name":null,"value":126},{"name":"Real Estate","value":36},{"name":null,"value":82},{"name":null,"value":37},{"name":null,"value":115},{"name":"Government Matters","value":"cg-2"},{"name":null,"value":1},{"name":null,"value":6},{"name":null,"value":71},{"name":null,"value":21},{"name":null,"value":23},{"name":null,"value":116},{"name":null,"value":24},{"name":null,"value":135},{"name":null,"value":25},{"name":null,"value":110},{"name":null,"value":20},{"name":null,"value":11},{"name":"Trial and Global Disputes","value":"cg-3"},{"name":null,"value":129},{"name":null,"value":2},{"name":null,"value":38},{"name":null,"value":3},{"name":null,"value":5},{"name":null,"value":19},{"name":null,"value":7},{"name":null,"value":4},{"name":null,"value":136},{"name":null,"value":13},{"name":null,"value":14},{"name":null,"value":15},{"name":null,"value":17},{"name":null,"value":18},{"name":null,"value":16},{"name":"Industries / Issues","value":"cg-4"},{"name":null,"value":133},{"name":null,"value":106},{"name":null,"value":124},{"name":null,"value":111},{"name":null,"value":132},{"name":null,"value":131},{"name":null,"value":102},{"name":null,"value":125},{"name":null,"value":127},{"name":null,"value":107},{"name":null,"value":112},{"name":null,"value":105},{"name":null,"value":109},{"name":null,"value":103},{"name":null,"value":128},{"name":null,"value":123},{"name":null,"value":118}]},"title_id":null,"school_id":null,"office_id":null,"capability_id":"21","extra_filter_id":null,"extra_filter_type":null,"q":null,"starts_with":"R","per_page":12,"people":[{"id":432953,"version":1,"owner_type":"Person","owner_id":986,"payload":{"bio":"\u003cp\u003eNikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25\u0026nbsp;years of experience.\u0026nbsp; Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.\u0026nbsp; Nikki previously co-chaired\u0026nbsp;the firm\u0026rsquo;s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450\u0026nbsp;lawyers across seventeen practice areas in the firm.\u0026nbsp; In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.\u0026nbsp; Nikki is ranked nationally by \u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a\u0026nbsp;\u003cem\u003eLMG Life Sciences Star\u003c/em\u003e in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a\u0026nbsp;\u003cem\u003eLaw360 Compliance MVP\u003c/em\u003e\u0026nbsp;in 2020.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.\u0026nbsp; Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.\u0026nbsp; She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.\u0026nbsp; She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.\u0026nbsp; She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.\u0026nbsp; She routinely advises company executives and board members and represents her clients before federal agencies.\u0026nbsp; She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\u003c/p\u003e\n\u003cp\u003eNikki leads two pharma and device industry coalitions on transparency and disclosure laws.\u0026nbsp; The\u0026nbsp;\u003cem\u003eAd Hoc Sunshine and State Law Compliance Group\u003c/em\u003e is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.\u0026nbsp; The \u003cem\u003eInternational Marketing and Disclosure Compliance Group\u003c/em\u003e is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\u003c/p\u003e\n\u003cp\u003eKing \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice has been named \u003cem\u003eLaw360\u003c/em\u003e Practice Group of the Year from 2017-2020.\u0026nbsp; King \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.\u0026nbsp; According to\u0026nbsp;\u003cem\u003eChambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA\u003c/em\u003e\u0026nbsp;(2022)\u003c/p\u003e\n\u003cp\u003eNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.\u0026nbsp; Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board\u0026nbsp;and has served\u0026nbsp;on the\u0026nbsp;Advisory Board for FDAnews and the PCF Pharma Congress planning committee.\u0026nbsp; She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the \u003cem\u003eFDLI Food \u0026amp; Drug Law Journal\u003c/em\u003e and a member of the FDLI Medical Device Committee.\u0026nbsp; Nikki has also served on the Leadership Advisory Board for the National Women\u0026rsquo;s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten\u0026nbsp;years.\u003c/p\u003e\n\u003cp\u003eNikki was elected by her partners in 2017 to serve for three years\u0026nbsp;on the firm\u0026rsquo;s Policy Committee, which is the firm's executive management committee.\u0026nbsp; Nikki served for many years on the firm\u0026rsquo;s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.\u003c/p\u003e","slug":"nikki-reeves","email":"nreeves@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.\u003c/p\u003e","\u003cp\u003eAdvised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.\u003c/p\u003e","\u003cp\u003eAdvised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.\u003c/p\u003e","\u003cp\u003eConducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.\u003c/p\u003e","\u003cp\u003eStand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.\u003c/p\u003e","\u003cp\u003eLed risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":245}]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":1,"source":"smartTags"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":3,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":4,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":5,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":6,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":7,"source":"capabilities"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":109,"guid":"109.capabilities","index":9,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":10,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":11,"source":"capabilities"},{"id":120,"guid":"120.capabilities","index":12,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":14,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":15,"source":"smartTags"},{"id":135,"guid":"135.capabilities","index":16,"source":"capabilities"}],"is_active":true,"last_name":"Reeves","nick_name":"Nikki","clerkships":[],"first_name":"Nikki","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Women, Influence \u0026 Power in Law Award for Thought Leadership","detail":"Corporate Counsel 2024"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eNikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25\u0026nbsp;years of experience.\u0026nbsp; Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.\u0026nbsp; Nikki previously co-chaired\u0026nbsp;the firm\u0026rsquo;s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450\u0026nbsp;lawyers across seventeen practice areas in the firm.\u0026nbsp; In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.\u0026nbsp; Nikki is ranked nationally by \u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a\u0026nbsp;\u003cem\u003eLMG Life Sciences Star\u003c/em\u003e in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a\u0026nbsp;\u003cem\u003eLaw360 Compliance MVP\u003c/em\u003e\u0026nbsp;in 2020.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.\u0026nbsp; Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.\u0026nbsp; She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.\u0026nbsp; She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.\u0026nbsp; She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.\u0026nbsp; She routinely advises company executives and board members and represents her clients before federal agencies.\u0026nbsp; She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\u003c/p\u003e\n\u003cp\u003eNikki leads two pharma and device industry coalitions on transparency and disclosure laws.\u0026nbsp; The\u0026nbsp;\u003cem\u003eAd Hoc Sunshine and State Law Compliance Group\u003c/em\u003e is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.\u0026nbsp; The \u003cem\u003eInternational Marketing and Disclosure Compliance Group\u003c/em\u003e is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\u003c/p\u003e\n\u003cp\u003eKing \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice has been named \u003cem\u003eLaw360\u003c/em\u003e Practice Group of the Year from 2017-2020.\u0026nbsp; King \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.\u0026nbsp; According to\u0026nbsp;\u003cem\u003eChambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA\u003c/em\u003e\u0026nbsp;(2022)\u003c/p\u003e\n\u003cp\u003eNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.\u0026nbsp; Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board\u0026nbsp;and has served\u0026nbsp;on the\u0026nbsp;Advisory Board for FDAnews and the PCF Pharma Congress planning committee.\u0026nbsp; She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the \u003cem\u003eFDLI Food \u0026amp; Drug Law Journal\u003c/em\u003e and a member of the FDLI Medical Device Committee.\u0026nbsp; Nikki has also served on the Leadership Advisory Board for the National Women\u0026rsquo;s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten\u0026nbsp;years.\u003c/p\u003e\n\u003cp\u003eNikki was elected by her partners in 2017 to serve for three years\u0026nbsp;on the firm\u0026rsquo;s Policy Committee, which is the firm's executive management committee.\u0026nbsp; Nikki served for many years on the firm\u0026rsquo;s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.\u003c/p\u003e","matters":["\u003cp\u003eAdvised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.\u003c/p\u003e","\u003cp\u003eAdvised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.\u003c/p\u003e","\u003cp\u003eAdvised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.\u003c/p\u003e","\u003cp\u003eConducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.\u003c/p\u003e","\u003cp\u003eStand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.\u003c/p\u003e","\u003cp\u003eLed risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.\u003c/p\u003e"],"recognitions":[{"title":"Women, Influence \u0026 Power in Law Award for Thought Leadership","detail":"Corporate Counsel 2024"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1139}]},"capability_group_id":2},"created_at":"2025-07-29T16:08:40.000Z","updated_at":"2025-07-29T16:08:40.000Z","searchable_text":"Reeves{{ FIELD }}{:title=\u0026gt;\"Women, Influence \u0026amp; Power in Law Award for Thought Leadership\", :detail=\u0026gt;\"Corporate Counsel 2024\"}{{ FIELD }}Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.{{ FIELD }}Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.{{ FIELD }}Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.{{ FIELD }}Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.{{ FIELD }}Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.{{ FIELD }}Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.{{ FIELD }}Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.{{ FIELD }}Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25 years of experience.  Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.  Nikki previously co-chaired the firm’s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450 lawyers across seventeen practice areas in the firm.  In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.  Nikki is ranked nationally by Chambers USA for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a Law360 Compliance MVP in 2020. \nAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.  Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.  She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.  She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions. \nNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.  She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.  She routinely advises company executives and board members and represents her clients before federal agencies.  She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\nNikki leads two pharma and device industry coalitions on transparency and disclosure laws.  The Ad Hoc Sunshine and State Law Compliance Group is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.  The International Marketing and Disclosure Compliance Group is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\nKing \u0026amp; Spalding’s FDA \u0026amp; Life Sciences Practice has been named Law360 Practice Group of the Year from 2017-2020.  King \u0026amp; Spalding’s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.  According to Chambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA (2022)\nNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.  Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board and has served on the Advisory Board for FDAnews and the PCF Pharma Congress planning committee.  She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the FDLI Food \u0026amp; Drug Law Journal and a member of the FDLI Medical Device Committee.  Nikki has also served on the Leadership Advisory Board for the National Women’s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten years.\nNikki was elected by her partners in 2017 to serve for three years on the firm’s Policy Committee, which is the firm's executive management committee.  Nikki served for many years on the firm’s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office. Kelly Reeves Partner Women, Influence \u0026amp; Power in Law Award for Thought Leadership Corporate Counsel 2024 North Carolina State University  University of Maryland  North Carolina State University  District of Columbia Maryland Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications. Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct. Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations. Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies. Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program. Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations. Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.","searchable_name":"Nikki Reeves","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":445446,"version":1,"owner_type":"Person","owner_id":6346,"payload":{"bio":"\u003cp\u003eMike\u0026rsquo;s practice focuses on complex civil litigation, with a concentration representing\u0026nbsp;food and beverage, dietary supplement and consumer packaged good clients as well as matters involving accounting and financial issues. He has experience in a wide range of litigation, including jury trials, appeals, matters with governmental agencies and internal investigations. Having served as general counsel for a global food company, Mike has a unique perspective that leads to a practical and creative approach to optimize results for clients.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMike began his career trying cases for the U.S. Attorney's Office in the Western District of Virginia, and has focused on representing clients in litigation, regulatory and white-collar matters, and investigations. Mike has regularly practiced in state and federal trial and appellate courts in false advertising and employment class actions, professional liability cases, trade secret misappropriation and other complex litigation, including in actions relating to alleged contaminants in products (heavy metals, glyphosate, PFAS, mycotoxins, phthalates). Mike has also represented clients before FDA and USDA in connection with ingredient labeling, recall-related issues and the National Organic Program.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter more than 15 years representing clients in high stakes litigation, Mike transitioned to general counsel of a globally branded food manufacturing company.\u0026nbsp; The company also opened several quick serve restaurant locations during his time there. As part of his role, Mike had responsibility for food safety and regulatory affairs and worked with in-house and outside experts to conduct root cause analyses and develop corrective and preventative actions. This experience provides valuable insight into the daily challenges faced by clients, including developing and executing a strategic approach to litigation and other dispute resolution, as well as developing creative approaches and proactive measures that can be taken to avoid disputes in the first place.\u003c/p\u003e","slug":"michael-resch","email":"mresch@kslaw.com","phone":null,"matters":["\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eKind LLC\u0026nbsp;\u003c/strong\u003ein multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name.\u003c/p\u003e","\u003cp\u003eSecured victory for\u0026nbsp;\u003cstrong\u003eCampbell Soup\u003c/strong\u003e\u0026nbsp;in a false advertising class action in the Northern District of Florida.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eBolthouse Farms\u0026nbsp;\u003c/strong\u003eutilizing preemption defense against organic labeling allegations.\u003c/p\u003e","\u003cp\u003eSuccessfully obtained dismissal for\u0026nbsp;\u003cstrong\u003eChobani\u0026nbsp;\u003c/strong\u003ein the Northern District of California in class action with respect to the labeling of Greek yogurt products.\u003c/p\u003e","\u003cp\u003eDefended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit.\u003c/p\u003e","\u003cp\u003eSecured victories for\u0026nbsp;\u003cstrong\u003eAmy\u0026rsquo;s Kitchen\u003c/strong\u003e\u0026nbsp;against numerous class actions alleging false advertising based on an ingredient name.\u003c/p\u003e","\u003cp\u003eDefended food manufacturers\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003ein donning/doffing class actions in California state court.\u003c/p\u003e","\u003cp\u003eRepresented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments.\u003c/p\u003e","\u003cp\u003eUSDA meetings and related written submissions in connection with organic ingredient labeling.\u003c/p\u003e","\u003cp\u003eDeveloped a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":1,"source":"capabilities"},{"id":11,"guid":"11.capabilities","index":2,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":3,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":4,"source":"capabilities"},{"id":111,"guid":"111.capabilities","index":5,"source":"capabilities"},{"id":766,"guid":"766.smart_tags","index":6,"source":"smartTags"},{"id":1409,"guid":"1409.smart_tags","index":7,"source":"smartTags"}],"is_active":true,"last_name":"Resch","nick_name":"Michael","clerkships":[],"first_name":"Michael","title_rank":9999,"updated_by":32,"law_schools":[{"id":2484,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"1999-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"L.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eMike\u0026rsquo;s practice focuses on complex civil litigation, with a concentration representing\u0026nbsp;food and beverage, dietary supplement and consumer packaged good clients as well as matters involving accounting and financial issues. He has experience in a wide range of litigation, including jury trials, appeals, matters with governmental agencies and internal investigations. Having served as general counsel for a global food company, Mike has a unique perspective that leads to a practical and creative approach to optimize results for clients.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eMike began his career trying cases for the U.S. Attorney's Office in the Western District of Virginia, and has focused on representing clients in litigation, regulatory and white-collar matters, and investigations. Mike has regularly practiced in state and federal trial and appellate courts in false advertising and employment class actions, professional liability cases, trade secret misappropriation and other complex litigation, including in actions relating to alleged contaminants in products (heavy metals, glyphosate, PFAS, mycotoxins, phthalates). Mike has also represented clients before FDA and USDA in connection with ingredient labeling, recall-related issues and the National Organic Program.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter more than 15 years representing clients in high stakes litigation, Mike transitioned to general counsel of a globally branded food manufacturing company.\u0026nbsp; The company also opened several quick serve restaurant locations during his time there. As part of his role, Mike had responsibility for food safety and regulatory affairs and worked with in-house and outside experts to conduct root cause analyses and develop corrective and preventative actions. This experience provides valuable insight into the daily challenges faced by clients, including developing and executing a strategic approach to litigation and other dispute resolution, as well as developing creative approaches and proactive measures that can be taken to avoid disputes in the first place.\u003c/p\u003e","matters":["\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eKind LLC\u0026nbsp;\u003c/strong\u003ein multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name.\u003c/p\u003e","\u003cp\u003eSecured victory for\u0026nbsp;\u003cstrong\u003eCampbell Soup\u003c/strong\u003e\u0026nbsp;in a false advertising class action in the Northern District of Florida.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eBolthouse Farms\u0026nbsp;\u003c/strong\u003eutilizing preemption defense against organic labeling allegations.\u003c/p\u003e","\u003cp\u003eSuccessfully obtained dismissal for\u0026nbsp;\u003cstrong\u003eChobani\u0026nbsp;\u003c/strong\u003ein the Northern District of California in class action with respect to the labeling of Greek yogurt products.\u003c/p\u003e","\u003cp\u003eDefended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit.\u003c/p\u003e","\u003cp\u003eSecured victories for\u0026nbsp;\u003cstrong\u003eAmy\u0026rsquo;s Kitchen\u003c/strong\u003e\u0026nbsp;against numerous class actions alleging false advertising based on an ingredient name.\u003c/p\u003e","\u003cp\u003eDefended food manufacturers\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003ein donning/doffing class actions in California state court.\u003c/p\u003e","\u003cp\u003eRepresented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments.\u003c/p\u003e","\u003cp\u003eUSDA meetings and related written submissions in connection with organic ingredient labeling.\u003c/p\u003e","\u003cp\u003eDeveloped a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9733}]},"capability_group_id":2},"created_at":"2026-01-31T22:03:15.000Z","updated_at":"2026-01-31T22:03:15.000Z","searchable_text":"Resch{{ FIELD }}Defended Kind LLC in multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name.{{ FIELD }}Secured victory for Campbell Soup in a false advertising class action in the Northern District of Florida.{{ FIELD }}Defended Bolthouse Farms utilizing preemption defense against organic labeling allegations.{{ FIELD }}Successfully obtained dismissal for Chobani in the Northern District of California in class action with respect to the labeling of Greek yogurt products.{{ FIELD }}Defended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit.{{ FIELD }}Secured victories for Amy’s Kitchen against numerous class actions alleging false advertising based on an ingredient name.{{ FIELD }}Defended food manufacturers in donning/doffing class actions in California state court.{{ FIELD }}Represented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments.{{ FIELD }}USDA meetings and related written submissions in connection with organic ingredient labeling.{{ FIELD }}Developed a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic{{ FIELD }}Mike’s practice focuses on complex civil litigation, with a concentration representing food and beverage, dietary supplement and consumer packaged good clients as well as matters involving accounting and financial issues. He has experience in a wide range of litigation, including jury trials, appeals, matters with governmental agencies and internal investigations. Having served as general counsel for a global food company, Mike has a unique perspective that leads to a practical and creative approach to optimize results for clients.\nMike began his career trying cases for the U.S. Attorney's Office in the Western District of Virginia, and has focused on representing clients in litigation, regulatory and white-collar matters, and investigations. Mike has regularly practiced in state and federal trial and appellate courts in false advertising and employment class actions, professional liability cases, trade secret misappropriation and other complex litigation, including in actions relating to alleged contaminants in products (heavy metals, glyphosate, PFAS, mycotoxins, phthalates). Mike has also represented clients before FDA and USDA in connection with ingredient labeling, recall-related issues and the National Organic Program.  \nAfter more than 15 years representing clients in high stakes litigation, Mike transitioned to general counsel of a globally branded food manufacturing company.  The company also opened several quick serve restaurant locations during his time there. As part of his role, Mike had responsibility for food safety and regulatory affairs and worked with in-house and outside experts to conduct root cause analyses and develop corrective and preventative actions. This experience provides valuable insight into the daily challenges faced by clients, including developing and executing a strategic approach to litigation and other dispute resolution, as well as developing creative approaches and proactive measures that can be taken to avoid disputes in the first place. Partner Pepperdine University Pepperdine University School of Law Washington and Lee University Washington and Lee University School of Law U.S. Court of Appeals for the Federal Circuit U.S. Court of Appeals for the Ninth Circuit U.S. District Court for the Northern District of Illinois U.S. District Court for the Central District of California U.S. District Court for the Eastern District of California U.S. District Court for the Northern District of California U.S. District Court for the Southern District of California U.S. District Court for the District of Columbia California District of Columbia Defended Kind LLC in multiple class actions in New York and Illinois District Courts challenging a product name and ingredient name. Secured victory for Campbell Soup in a false advertising class action in the Northern District of Florida. Defended Bolthouse Farms utilizing preemption defense against organic labeling allegations. Successfully obtained dismissal for Chobani in the Northern District of California in class action with respect to the labeling of Greek yogurt products. Defended a Big 4 accounting firm in arbitration arising out of claims scrutinizing firm's audit. Secured victories for Amy’s Kitchen against numerous class actions alleging false advertising based on an ingredient name. Defended food manufacturers in donning/doffing class actions in California state court. Represented more than 10 clients in the food and beverage industry in connection with FDA draft guidance and related written comments. USDA meetings and related written submissions in connection with organic ingredient labeling. Developed a food manufacturing company's comprehensive Covid-19 response plan, including planning safety, regulatory and litigation strategy and opening a Covid-19 vaccine clinic","searchable_name":"Michael L. Resch","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":32,"capability_group_featured":null,"home_page_featured":null},{"id":442370,"version":1,"owner_type":"Person","owner_id":880,"payload":{"bio":"\u003cp\u003eJohn Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by\u0026nbsp;President George W. Bush\u0026nbsp;and confirmed by unanimous consent of the U.S. Senate.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLaw360\u003c/em\u003e\u0026nbsp;has named\u0026nbsp;John \"White-Collar MVP of the Year\".\u0026nbsp; He also has been\u0026nbsp;recognized as one of the top 100 trial lawyers in America by\u0026nbsp;\u003cem\u003eBenchmark Litigation\u003c/em\u003e\u0026nbsp;and as a Life Sciences Star for litigation by\u0026nbsp;\u003cem\u003eLMG Life Sciences\u003c/em\u003e.\u0026nbsp; Most recently, he was elected President of the National Association of Former United States Attorneys.\u003c/p\u003e\n\u003cp\u003eDuring his tenure at the Criminal Division, he led investigations, prosecutions, and policy development in many areas of federal criminal law, including healthcare fraud, securities fraud, Foreign Corrupt Practices Act and export violations, bank secrecy and money laundering offenses, public corruption, and organized crime. He served as a member of the President\u0026rsquo;s Corporate Fraud Task Force and oversaw the Enron Task Force. He also served as the Commissioner Ex-Officio to the U.S. Sentencing Commission and represented the Department in matters before the Committee on Foreign Investment in the U.S.\u003c/p\u003e\n\u003cp\u003eAs U.S. Attorney, John served as the chief federal law enforcement officer for the district, tried cases, argued appeals, and oversaw the prosecution and defense of a wide-range of criminal and civil matters on behalf of the U.S., including bank fraud, healthcare fraud, money laundering and other economic and regulatory cases. In 2009, he was awarded the U.S. Department of Health and Human Services\u0026rsquo; Inspector General\u0026rsquo;s Award for Combating Medicare and Medicaid Fraud. He also served as Chairman of the Attorney General\u0026rsquo;s Advisory Committee on Sentencing, and as a member of the Attorney General\u0026rsquo;s Advisory Committee on White Collar Crime.\u003c/p\u003e\n\u003cp\u003eJohn began his career as a federal prosecutor as an Assistant U.S. Attorney in Atlanta and Oklahoma City, during which time he investigated and prosecuted a wide-range of federal cases, including health care, bank, and securities fraud. He began his career as a prosecutor as an Assistant District Attorney in Cobb County, Georgia.\u003c/p\u003e\n\u003cp\u003eIn private practice, John has represented and defended clients in trials and investigations involving U.S. Attorneys\u0026rsquo; Offices in over fifteen different districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general\u0026rsquo;s offices for all 50 states and the District of Columbia. These matters often have also involved parallel proceedings by regulatory agencies and parallel class action or\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;whistleblower litigation.\u003c/p\u003e\n\u003cp\u003eIn addition to tenures as prosecutor and in private practice, John also served as Vice President and Deputy General Counsel at WellCare Health Plans, Inc.,\u0026nbsp;where he led the successful resolution of enterprise-threatening criminal and civil investigations by the U.S. Department of Justice, as well as parallel investigations by other federal and state regulatory agencies, private securities class actions, derivative class actions, and\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;cases.\u003c/p\u003e","slug":"john-richter","email":"jrichter@kslaw.com","phone":null,"matters":["\u003cp\u003eSuccessful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges.\u003c/p\u003e","\u003cp\u003eSuccessful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ civil investigation and dismissal of a whistleblower\u0026rsquo;s complaint of publicly traded health insurer based on false claims allegations.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eSuccessful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities.\u003c/p\u003e","\u003cp\u003eInvestigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company\u0026rsquo;s computer system and theft of trade secret and proprietary information.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":3134}]},"expertise":[{"id":6,"guid":"6.capabilities","index":0,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":1,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":4,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":5,"source":"capabilities"},{"id":20,"guid":"20.capabilities","index":6,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":7,"source":"smartTags"},{"id":1303,"guid":"1303.smart_tags","index":8,"source":"smartTags"},{"id":766,"guid":"766.smart_tags","index":9,"source":"smartTags"},{"id":780,"guid":"780.smart_tags","index":10,"source":"smartTags"},{"id":11,"guid":"11.capabilities","index":11,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":12,"source":"smartTags"},{"id":984,"guid":"984.smart_tags","index":13,"source":"smartTags"},{"id":1188,"guid":"1188.smart_tags","index":14,"source":"smartTags"},{"id":1199,"guid":"1199.smart_tags","index":15,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":16,"source":"smartTags"}],"is_active":true,"last_name":"Richter","nick_name":"John","clerkships":[{"name":"Law Clerk, J. Owen Forrester, U.S. District Court for the Northern District of Georgia","years_held":"1992-1994"}],"first_name":"John","title_rank":9999,"updated_by":202,"law_schools":[{"id":2410,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"1992-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"C.","name_suffix":"","recognitions":[{"title":"“Richter stands out for his significant capabilities as a trial lawyer”","detail":"Legal 500 - 2024"},{"title":"Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024)","detail":"NAFUSA 2023"},{"title":"Selected,Top 100 Trial Lawyers","detail":"Benchmark Litigation, 2017"},{"title":"Selected, Life Sciences Star","detail":"LMG Life Sciences, 2017"},{"title":"Selected, White Collar Defense MVP","detail":"Law360, 2016"},{"title":"Elected to the Board of Directors, 2017","detail":"National Association of Former United States Attorneys"}],"linked_in_url":null,"seodescription":"John Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group. Find out more about him.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJohn Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by\u0026nbsp;President George W. Bush\u0026nbsp;and confirmed by unanimous consent of the U.S. Senate.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLaw360\u003c/em\u003e\u0026nbsp;has named\u0026nbsp;John \"White-Collar MVP of the Year\".\u0026nbsp; He also has been\u0026nbsp;recognized as one of the top 100 trial lawyers in America by\u0026nbsp;\u003cem\u003eBenchmark Litigation\u003c/em\u003e\u0026nbsp;and as a Life Sciences Star for litigation by\u0026nbsp;\u003cem\u003eLMG Life Sciences\u003c/em\u003e.\u0026nbsp; Most recently, he was elected President of the National Association of Former United States Attorneys.\u003c/p\u003e\n\u003cp\u003eDuring his tenure at the Criminal Division, he led investigations, prosecutions, and policy development in many areas of federal criminal law, including healthcare fraud, securities fraud, Foreign Corrupt Practices Act and export violations, bank secrecy and money laundering offenses, public corruption, and organized crime. He served as a member of the President\u0026rsquo;s Corporate Fraud Task Force and oversaw the Enron Task Force. He also served as the Commissioner Ex-Officio to the U.S. Sentencing Commission and represented the Department in matters before the Committee on Foreign Investment in the U.S.\u003c/p\u003e\n\u003cp\u003eAs U.S. Attorney, John served as the chief federal law enforcement officer for the district, tried cases, argued appeals, and oversaw the prosecution and defense of a wide-range of criminal and civil matters on behalf of the U.S., including bank fraud, healthcare fraud, money laundering and other economic and regulatory cases. In 2009, he was awarded the U.S. Department of Health and Human Services\u0026rsquo; Inspector General\u0026rsquo;s Award for Combating Medicare and Medicaid Fraud. He also served as Chairman of the Attorney General\u0026rsquo;s Advisory Committee on Sentencing, and as a member of the Attorney General\u0026rsquo;s Advisory Committee on White Collar Crime.\u003c/p\u003e\n\u003cp\u003eJohn began his career as a federal prosecutor as an Assistant U.S. Attorney in Atlanta and Oklahoma City, during which time he investigated and prosecuted a wide-range of federal cases, including health care, bank, and securities fraud. He began his career as a prosecutor as an Assistant District Attorney in Cobb County, Georgia.\u003c/p\u003e\n\u003cp\u003eIn private practice, John has represented and defended clients in trials and investigations involving U.S. Attorneys\u0026rsquo; Offices in over fifteen different districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general\u0026rsquo;s offices for all 50 states and the District of Columbia. These matters often have also involved parallel proceedings by regulatory agencies and parallel class action or\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;whistleblower litigation.\u003c/p\u003e\n\u003cp\u003eIn addition to tenures as prosecutor and in private practice, John also served as Vice President and Deputy General Counsel at WellCare Health Plans, Inc.,\u0026nbsp;where he led the successful resolution of enterprise-threatening criminal and civil investigations by the U.S. Department of Justice, as well as parallel investigations by other federal and state regulatory agencies, private securities class actions, derivative class actions, and\u0026nbsp;\u003cem\u003equi tam\u003c/em\u003e\u0026nbsp;cases.\u003c/p\u003e","matters":["\u003cp\u003eSuccessful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges.\u003c/p\u003e","\u003cp\u003eSuccessful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company.\u003c/p\u003e","\u003cp\u003eRepresentation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eSuccessful declination of DOJ civil investigation and dismissal of a whistleblower\u0026rsquo;s complaint of publicly traded health insurer based on false claims allegations.\u003c/p\u003e","\u003cp\u003eSuccessful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts.\u003c/p\u003e","\u003cp\u003eSuccessful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act.\u003c/p\u003e","\u003cp\u003eIndependent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities.\u003c/p\u003e","\u003cp\u003eInvestigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company\u0026rsquo;s computer system and theft of trade secret and proprietary information.\u003c/p\u003e"],"recognitions":[{"title":"“Richter stands out for his significant capabilities as a trial lawyer”","detail":"Legal 500 - 2024"},{"title":"Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024)","detail":"NAFUSA 2023"},{"title":"Selected,Top 100 Trial Lawyers","detail":"Benchmark Litigation, 2017"},{"title":"Selected, Life Sciences Star","detail":"LMG Life Sciences, 2017"},{"title":"Selected, White Collar Defense MVP","detail":"Law360, 2016"},{"title":"Elected to the Board of Directors, 2017","detail":"National Association of Former United States Attorneys"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4491}]},"capability_group_id":2},"created_at":"2025-11-05T05:03:40.000Z","updated_at":"2025-11-05T05:03:40.000Z","searchable_text":"Richter{{ FIELD }}{:title=\u0026gt;\"“Richter stands out for his significant capabilities as a trial lawyer”\", :detail=\u0026gt;\"Legal 500 - 2024\"}{{ FIELD }}{:title=\u0026gt;\"Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024)\", :detail=\u0026gt;\"NAFUSA 2023\"}{{ FIELD }}{:title=\u0026gt;\"Selected,Top 100 Trial Lawyers\", :detail=\u0026gt;\"Benchmark Litigation, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Selected, Life Sciences Star\", :detail=\u0026gt;\"LMG Life Sciences, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Selected, White Collar Defense MVP\", :detail=\u0026gt;\"Law360, 2016\"}{{ FIELD }}{:title=\u0026gt;\"Elected to the Board of Directors, 2017\", :detail=\u0026gt;\"National Association of Former United States Attorneys\"}{{ FIELD }}Successful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges.{{ FIELD }}Successful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government.{{ FIELD }}Independent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management.{{ FIELD }}Successful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts.{{ FIELD }}Representation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company.{{ FIELD }}Representation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation.{{ FIELD }}Successful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act.{{ FIELD }}Successful declination of DOJ civil investigation and dismissal of a whistleblower’s complaint of publicly traded health insurer based on false claims allegations.{{ FIELD }}Successful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts.{{ FIELD }}Successful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act.{{ FIELD }}Independent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities.{{ FIELD }}Investigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company’s computer system and theft of trade secret and proprietary information.{{ FIELD }}John Richter is a trial and investigations partner in the Special Matters and Investigations Practice Group, and represents and defends companies, Boards of Directors, Board committees, and individuals facing a variety of white-collar criminal and regulatory enforcement matters, parallel civil litigation, and internal corporate investigations. John previously served as the Acting Assistant Attorney General in charge of the Criminal Division at the U.S. Department of Justice and as the U.S. Attorney for the Western District of Oklahoma, having been nominated by President George W. Bush and confirmed by unanimous consent of the U.S. Senate. \nLaw360 has named John \"White-Collar MVP of the Year\".  He also has been recognized as one of the top 100 trial lawyers in America by Benchmark Litigation and as a Life Sciences Star for litigation by LMG Life Sciences.  Most recently, he was elected President of the National Association of Former United States Attorneys.\nDuring his tenure at the Criminal Division, he led investigations, prosecutions, and policy development in many areas of federal criminal law, including healthcare fraud, securities fraud, Foreign Corrupt Practices Act and export violations, bank secrecy and money laundering offenses, public corruption, and organized crime. He served as a member of the President’s Corporate Fraud Task Force and oversaw the Enron Task Force. He also served as the Commissioner Ex-Officio to the U.S. Sentencing Commission and represented the Department in matters before the Committee on Foreign Investment in the U.S.\nAs U.S. Attorney, John served as the chief federal law enforcement officer for the district, tried cases, argued appeals, and oversaw the prosecution and defense of a wide-range of criminal and civil matters on behalf of the U.S., including bank fraud, healthcare fraud, money laundering and other economic and regulatory cases. In 2009, he was awarded the U.S. Department of Health and Human Services’ Inspector General’s Award for Combating Medicare and Medicaid Fraud. He also served as Chairman of the Attorney General’s Advisory Committee on Sentencing, and as a member of the Attorney General’s Advisory Committee on White Collar Crime.\nJohn began his career as a federal prosecutor as an Assistant U.S. Attorney in Atlanta and Oklahoma City, during which time he investigated and prosecuted a wide-range of federal cases, including health care, bank, and securities fraud. He began his career as a prosecutor as an Assistant District Attorney in Cobb County, Georgia.\nIn private practice, John has represented and defended clients in trials and investigations involving U.S. Attorneys’ Offices in over fifteen different districts around the country, the Criminal and Civil Divisions at the Justice Department, and state attorney general’s offices for all 50 states and the District of Columbia. These matters often have also involved parallel proceedings by regulatory agencies and parallel class action or qui tam whistleblower litigation.\nIn addition to tenures as prosecutor and in private practice, John also served as Vice President and Deputy General Counsel at WellCare Health Plans, Inc., where he led the successful resolution of enterprise-threatening criminal and civil investigations by the U.S. Department of Justice, as well as parallel investigations by other federal and state regulatory agencies, private securities class actions, derivative class actions, and qui tam cases. john richter Partner “Richter stands out for his significant capabilities as a trial lawyer” Legal 500 - 2024 Elected, President – National Association of Former United States Attorneys (NAFUSA) (2023-2024) NAFUSA 2023 Selected,Top 100 Trial Lawyers Benchmark Litigation, 2017 Selected, Life Sciences Star LMG Life Sciences, 2017 Selected, White Collar Defense MVP Law360, 2016 Elected to the Board of Directors, 2017 National Association of Former United States Attorneys Emory University Emory University School of Law University of Virginia University of Virginia School of Law Supreme Court of the United States U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Tenth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. District Court for the Western District of Oklahoma U.S. District Court for the Northern District of Georgia District of Columbia Georgia Oklahoma President, National Association of Former United States Attorneys Law Clerk, J. Owen Forrester, U.S. District Court for the Northern District of Georgia Successful defense and full jury acquittal on all charges of Vascular Solutions, Inc., a publicly traded medical device company, in a high-stakes criminal trial in the W.D. Tex., stemming from alleged conspiracy and off-label marketing charges. Successful dismissal of multi-billion dollar whistleblower lawsuit in the N.D. Cal.,against global telecommunications provider on claims of fraud in connections with wireless services provided to departments and agencies of the federal government. Independent internal investigation on behalf of independent members of the Board of a publicly traded real estate investment trust company into certain financial transactions and activities by management. Successful negotiation and resolution of enterprise-threatening investigations by DOJ and attorneys general for all 50 states and the District of Columbia against a global medical device manufacturer based on allegations of kickbacks and violations of federal and state false claims acts. Representation of and successful declination against senior executives of a global pharmaceutical company in DOJ FCPA investigation of the company. Representation of and successful declination against former Prime Minister of European country in DOJ FCPA investigation. Successful declination of DOJ criminal and civil investigation of a publicly traded global medical device company based on allegations of off-label marketing and violations of the federal false claims act. Successful declination of DOJ civil investigation and dismissal of a whistleblower’s complaint of publicly traded health insurer based on false claims allegations. Successful negotiation and resolution of civil investigations by DOJ and 47 state attorneys general against a publicly traded pharmacy service provider based on allegations of violations of federal and state false claims acts. Successful declinations of numerous DOJ civil investigations against a drug monitoring and testing company based on various allegations of violations of the federal false claims act. Independent internal investigation on behalf of the Board of a publicly traded healthcare intermediary service provider into alleged financial and accounting irregularities. Investigation of and referral to law enforcement for the successful criminal prosecution of a former employee of a global oil and gas services company based on the unlawful intrusion into the company’s computer system and theft of trade secret and proprietary information.","searchable_name":"John C. Richter","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":426281,"version":1,"owner_type":"Person","owner_id":2105,"payload":{"bio":"\u003cp\u003eJessica Ringel advises\u0026nbsp;medical device, pharmaceutical, HCT/P, and cosmetics manufacturers\u0026nbsp;and distributors\u0026nbsp;on matters involving FDA regulation. Jessica\u0026rsquo;s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica\u0026rsquo;s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s device regulatory practice spans the entire FDA regulatory lifecycle.\u0026nbsp; She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.\u0026nbsp; After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.\u0026nbsp; She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.\u0026nbsp; Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.\u0026nbsp; She further assists life sciences clients with the review and development of compliant marketing strategies and materials.\u0026nbsp; She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.\u0026nbsp; Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA\u0026rsquo;s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.\u0026nbsp; She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.\u003c/p\u003e","slug":"jessica-ringel","email":"jringel@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":3,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":4,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Ringel","nick_name":"Jessica","clerkships":[],"first_name":"Jessica","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJessica Ringel advises\u0026nbsp;medical device, pharmaceutical, HCT/P, and cosmetics manufacturers\u0026nbsp;and distributors\u0026nbsp;on matters involving FDA regulation. Jessica\u0026rsquo;s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica\u0026rsquo;s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s device regulatory practice spans the entire FDA regulatory lifecycle.\u0026nbsp; She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.\u0026nbsp; After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.\u0026nbsp; She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.\u0026nbsp; Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.\u0026nbsp; She further assists life sciences clients with the review and development of compliant marketing strategies and materials.\u0026nbsp; She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.\u0026nbsp; Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA\u0026rsquo;s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.\u0026nbsp; She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1146}]},"capability_group_id":2},"created_at":"2025-05-26T04:50:06.000Z","updated_at":"2025-05-26T04:50:06.000Z","searchable_text":"Ringel{{ FIELD }}Jessica Ringel advises medical device, pharmaceutical, HCT/P, and cosmetics manufacturers and distributors on matters involving FDA regulation. Jessica’s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica’s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.\nJessica’s device regulatory practice spans the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.  Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  She further assists life sciences clients with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.   \nJessica’s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.  She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance. Partner Cornell University Cornell Law School Georgetown University Georgetown University Law Center District of Columbia Maryland","searchable_name":"Jessica Ringel","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":445647,"version":1,"owner_type":"Person","owner_id":3646,"payload":{"bio":"\u003cp\u003eKristin Roshelli is a partner in King \u0026amp; Spalding\u0026rsquo;s Houston Healthcare practice. Kristin\u0026rsquo;s practice focuses on corporate and regulatory matters in the healthcare and life sciences industries.\u0026nbsp; She represents a broad range of prominent healthcare and life science\u0026nbsp;clients\u0026nbsp;on mergers and acquisitions, affiliations, general health law questions, and complex corporate governance and contracting matters. She has extensive experience structuring transactions, particularly as to complex arrangements involving health systems, physician practices, and academic medical centers.\u0026nbsp; Kristin has helped establish the legal and operational framework in connection with the startup of three new medical schools and multiple new health systems.\u0026nbsp; She is also a go-to lawyer for\u0026nbsp;leading pharmaceutical,\u0026nbsp;biotech, organ procurement and other large companies for assistance with complex collaboration arrangements with third parties and in establishing and negotiating\u0026nbsp;their supply chain and other key contracts.\u0026nbsp;\u0026nbsp;Her life sciences work often involves advising on product supply and manufacturing agreements, licensing arrangements, commercialization and distribution agreements, specialty pharmacy agreements,\u0026nbsp;research agreements and other complex collaboration arrangements and\u0026nbsp;key service and supply contracts.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eShe is Chambers-ranked for healthcare in Texas\u0026nbsp;and has been\u0026nbsp;recognized by \u003cem\u003eLegal 500\u003c/em\u003e as a \u0026ldquo;Recommended Key Lawyer,\u0026rdquo; by \u003cem\u003eTexas\u0026nbsp;Super Lawyers\u003c/em\u003e as a healthcare rising star,\u0026nbsp;and by\u0026nbsp;\u003cem\u003eTexas Lawyers\u003c/em\u003e with an \u0026ldquo;On the Rise Award,\u0026rdquo; which recognizes lawyers under the age of 40 who have wielded influence in their practice areas in Texas and beyond.\u0026nbsp; Prior to entering the legal field, Kristin served as a nurse in the United States Air Force, worked in the general counsel\u0026rsquo;s office of a large academic medical center, and practiced as a registered nurse in a medical intensive care unit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e2016 Health Care Fraud and Abuse Top Ten List Reimbursement Advisor, Vol 32, No. 6, February 2017\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;The Plot Thickens for the Medicare Narrative Requirement,\u0026rdquo; Law360, February 2015\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;When is a Hospital a \u0026lsquo;New Hospital?,\u0026rsquo;\u0026rdquo; Reimbursement Advisor, Vol. 30, No. 4, December 2014\u003c/li\u003e\n\u003c/ul\u003e","slug":"kristin-roshelli","email":"kroshelli@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[{"id":3777}]},"expertise":[{"id":24,"guid":"24.capabilities","index":0,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":3,"source":"capabilities"},{"id":826,"guid":"826.smart_tags","index":4,"source":"smartTags"},{"id":32,"guid":"32.capabilities","index":5,"source":"capabilities"}],"is_active":true,"last_name":"Roshelli","nick_name":"Kristin","clerkships":[{"name":"Law Clerk, P. Kevin Castel, U.S. District Court for the Southern District of New York","years_held":"2010-2011"}],"first_name":"Kristin","title_rank":9999,"updated_by":202,"law_schools":[{"id":2724,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"2010-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"\"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\"","detail":"Chambers USA"},{"title":"\"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\"","detail":"Chambers USA"},{"title":"\"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\"","detail":"Chambers USA"},{"title":"On the Rise Award","detail":"Texas Lawyer, 2020"},{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas (2021-2025)"},{"title":"\"She's very wise with her advice, as well as being detail-oriented and organized.\"","detail":"Chambers USA"}],"linked_in_url":null,"seodescription":"Kristin M. Roshelli is a lawyer of our Government Matters \u0026 Regulation Practice Group. Read more.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKristin Roshelli is a partner in King \u0026amp; Spalding\u0026rsquo;s Houston Healthcare practice. Kristin\u0026rsquo;s practice focuses on corporate and regulatory matters in the healthcare and life sciences industries.\u0026nbsp; She represents a broad range of prominent healthcare and life science\u0026nbsp;clients\u0026nbsp;on mergers and acquisitions, affiliations, general health law questions, and complex corporate governance and contracting matters. She has extensive experience structuring transactions, particularly as to complex arrangements involving health systems, physician practices, and academic medical centers.\u0026nbsp; Kristin has helped establish the legal and operational framework in connection with the startup of three new medical schools and multiple new health systems.\u0026nbsp; She is also a go-to lawyer for\u0026nbsp;leading pharmaceutical,\u0026nbsp;biotech, organ procurement and other large companies for assistance with complex collaboration arrangements with third parties and in establishing and negotiating\u0026nbsp;their supply chain and other key contracts.\u0026nbsp;\u0026nbsp;Her life sciences work often involves advising on product supply and manufacturing agreements, licensing arrangements, commercialization and distribution agreements, specialty pharmacy agreements,\u0026nbsp;research agreements and other complex collaboration arrangements and\u0026nbsp;key service and supply contracts.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eShe is Chambers-ranked for healthcare in Texas\u0026nbsp;and has been\u0026nbsp;recognized by \u003cem\u003eLegal 500\u003c/em\u003e as a \u0026ldquo;Recommended Key Lawyer,\u0026rdquo; by \u003cem\u003eTexas\u0026nbsp;Super Lawyers\u003c/em\u003e as a healthcare rising star,\u0026nbsp;and by\u0026nbsp;\u003cem\u003eTexas Lawyers\u003c/em\u003e with an \u0026ldquo;On the Rise Award,\u0026rdquo; which recognizes lawyers under the age of 40 who have wielded influence in their practice areas in Texas and beyond.\u0026nbsp; Prior to entering the legal field, Kristin served as a nurse in the United States Air Force, worked in the general counsel\u0026rsquo;s office of a large academic medical center, and practiced as a registered nurse in a medical intensive care unit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e2016 Health Care Fraud and Abuse Top Ten List Reimbursement Advisor, Vol 32, No. 6, February 2017\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;The Plot Thickens for the Medicare Narrative Requirement,\u0026rdquo; Law360, February 2015\u003c/li\u003e\n\u003cli\u003e\u0026ldquo;When is a Hospital a \u0026lsquo;New Hospital?,\u0026rsquo;\u0026rdquo; Reimbursement Advisor, Vol. 30, No. 4, December 2014\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"\"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\"","detail":"Chambers USA"},{"title":"\"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\"","detail":"Chambers USA"},{"title":"\"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\"","detail":"Chambers USA"},{"title":"On the Rise Award","detail":"Texas Lawyer, 2020"},{"title":"Top Ranked Lawyer, Healthcare","detail":"Chambers USA, Texas (2021-2025)"},{"title":"\"She's very wise with her advice, as well as being detail-oriented and organized.\"","detail":"Chambers USA"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11456}]},"capability_group_id":2},"created_at":"2026-02-06T21:25:46.000Z","updated_at":"2026-02-06T21:25:46.000Z","searchable_text":"Roshelli{{ FIELD }}{:title=\u0026gt;\"\\\"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"\\\"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"On the Rise Award\", :detail=\u0026gt;\"Texas Lawyer, 2020\"}{{ FIELD }}{:title=\u0026gt;\"Top Ranked Lawyer, Healthcare\", :detail=\u0026gt;\"Chambers USA, Texas (2021-2025)\"}{{ FIELD }}{:title=\u0026gt;\"\\\"She's very wise with her advice, as well as being detail-oriented and organized.\\\"\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}Kristin Roshelli is a partner in King \u0026amp; Spalding’s Houston Healthcare practice. Kristin’s practice focuses on corporate and regulatory matters in the healthcare and life sciences industries.  She represents a broad range of prominent healthcare and life science clients on mergers and acquisitions, affiliations, general health law questions, and complex corporate governance and contracting matters. She has extensive experience structuring transactions, particularly as to complex arrangements involving health systems, physician practices, and academic medical centers.  Kristin has helped establish the legal and operational framework in connection with the startup of three new medical schools and multiple new health systems.  She is also a go-to lawyer for leading pharmaceutical, biotech, organ procurement and other large companies for assistance with complex collaboration arrangements with third parties and in establishing and negotiating their supply chain and other key contracts.  Her life sciences work often involves advising on product supply and manufacturing agreements, licensing arrangements, commercialization and distribution agreements, specialty pharmacy agreements, research agreements and other complex collaboration arrangements and key service and supply contracts. \nShe is Chambers-ranked for healthcare in Texas and has been recognized by Legal 500 as a “Recommended Key Lawyer,” by Texas Super Lawyers as a healthcare rising star, and by Texas Lawyers with an “On the Rise Award,” which recognizes lawyers under the age of 40 who have wielded influence in their practice areas in Texas and beyond.  Prior to entering the legal field, Kristin served as a nurse in the United States Air Force, worked in the general counsel’s office of a large academic medical center, and practiced as a registered nurse in a medical intensive care unit. \nPublications\n\n2016 Health Care Fraud and Abuse Top Ten List Reimbursement Advisor, Vol 32, No. 6, February 2017\n“The Plot Thickens for the Medicare Narrative Requirement,” Law360, February 2015\n“When is a Hospital a ‘New Hospital?,’” Reimbursement Advisor, Vol. 30, No. 4, December 2014\n Kristin Roshelli lawyer Partner \"Kristin is very calm and intelligent, and extremely responsive. I always enjoy working with her.\" Chambers USA \"She is extremely knowledgeable, responsive and always able to navigate the most complex matters\" Chambers USA \"Kristin really understands our business well. She doesn't miss anything and is highly responsive.\" Chambers USA On the Rise Award Texas Lawyer, 2020 Top Ranked Lawyer, Healthcare Chambers USA, Texas (2021-2025) \"She's very wise with her advice, as well as being detail-oriented and organized.\" Chambers USA University of Pennsylvania University of Pennsylvania Law School St. John's University St. John's University School of Law U.S. District Court for the Eastern District of New York U.S. District Court for the Southern District of New York New Jersey New York Texas American Bar Association (2014) American Health Lawyers Association (2011) New York State Bar Association (2011) Houston Young Lawyers Association (2014) Law Clerk, P. Kevin Castel, U.S. District Court for the Southern District of New York","searchable_name":"Kristin M. Roshelli","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":443985,"version":1,"owner_type":"Person","owner_id":6913,"payload":{"bio":"\u003cp\u003eAs a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA\u0026rsquo;s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eLauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner\u0026rsquo;s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA\u0026rsquo;s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.\u003c/p\u003e\n\u003cp\u003ePreviously, Lauren was a Senior Advisor to FDA\u0026rsquo;s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.\u003c/p\u003e\n\u003cp\u003eBefore joining FDA, Lauren served as Assistant General Counsel to an association of the United States\u0026rsquo;s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.\u003c/p\u003e\n\u003cp\u003eIn private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.\u003c/p\u003e\n\u003cp\u003eLauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the\u003cem\u003e Virginia Law Review.\u003c/em\u003e\u003c/p\u003e","slug":"lauren-roth","email":"lroth@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":118,"guid":"118.capabilities","index":2,"source":"capabilities"},{"id":133,"guid":"133.capabilities","index":3,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":4,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Roth","nick_name":"Lauren","clerkships":[],"first_name":"Lauren","title_rank":9999,"updated_by":35,"law_schools":[{"id":2410,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"2007-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"K.","name_suffix":"","recognitions":[{"title":"FDA Award of Merit","detail":"2023"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eAs a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA\u0026rsquo;s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eLauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner\u0026rsquo;s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA\u0026rsquo;s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.\u003c/p\u003e\n\u003cp\u003ePreviously, Lauren was a Senior Advisor to FDA\u0026rsquo;s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.\u003c/p\u003e\n\u003cp\u003eBefore joining FDA, Lauren served as Assistant General Counsel to an association of the United States\u0026rsquo;s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.\u003c/p\u003e\n\u003cp\u003eIn private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.\u003c/p\u003e\n\u003cp\u003eLauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the\u003cem\u003e Virginia Law Review.\u003c/em\u003e\u003c/p\u003e","recognitions":[{"title":"FDA Award of Merit","detail":"2023"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12437}]},"capability_group_id":2},"created_at":"2025-12-05T05:02:19.000Z","updated_at":"2025-12-05T05:02:19.000Z","searchable_text":"Roth{{ FIELD }}{:title=\u0026gt;\"FDA Award of Merit\", :detail=\u0026gt;\"2023\"}{{ FIELD }}As a partner in our FDA and Life Sciences practice, Lauren leverages nearly two decades of experience in legal practice and senior roles at the FDA to advise clients on legal, regulatory, and compliance matters across FDA-regulated industries. Most recently, as FDA’s Associate Commissioner for Policy, Lauren played a key role in all major policy initiatives. Lauren translates her experience to help clients navigate the complex issues facing their businesses at the intersections of law, science, and policy.\nLauren brings a breadth of experience advising senior public officials and life sciences companies on legal, regulatory, and policy matters. As the Associate Commissioner for Policy from 2019-2024, Lauren led the Commissioner’s Office of Policy (OP), supervising issuance of all FDA regulations and guidance documents. She advised agency, HHS, and Administration officials on high priority and novel matters, including implementation of new authorities for drugs, devices, food, and cosmetics. She also served as FDA’s lead negotiator for the fifth medical device user fee agreement, playing a pivotal role in shaping current policies and practices related to premarket review, digital health, patient engagement, and use of real-world evidence.\nPreviously, Lauren was a Senior Advisor to FDA’s Chief of Staff (2017-2019) and the Associate Director for Strategy and Regulatory Operations within the Center for Devices and Radiological Health (2016-2017). In those roles, she advised on regulatory, legislative, and compliance matters, including strategic initiatives on device safety and tobacco product regulation.\nBefore joining FDA, Lauren served as Assistant General Counsel to an association of the United States’s leading manufacturers of innovative pharmaceutical products, Pharmaceutical Research and Manufacturers of America (PhRMA). She advised the association on issues related to government enforcement of healthcare fraud and abuse laws, corporate compliance programs, patient adherence and access programs, and drug distribution channels.\nIn private practice, Lauren advised companies on compliance with healthcare regulations, including the Federal Food, Drug, and Cosmetic Act; the False Claims Act; the anti-kickback statute; and exclusion and debarment laws. She also guided healthcare companies in government investigations (criminal and civil) and conducted internal investigations to analyze legal risk and compliance issues.\nLauren earned her J.D. from the University of Virginia, where she served as an Articles Editor for the Virginia Law Review. Partner FDA Award of Merit 2023 University of Virginia  University of Virginia University of Virginia School of Law District of Columbia Food \u0026amp; Drug Law Institute","searchable_name":"Lauren K. Roth","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":35,"capability_group_featured":null,"home_page_featured":null},{"id":427667,"version":1,"owner_type":"Person","owner_id":1348,"payload":{"bio":"\u003cp\u003eGillian Russell has over 15 years of experience counseling pharmaceutical, medical device, and cosmetic clients on a wide range of regulatory, compliance, and enforcement issues, with a focus on regulatory strategies and initiatives for the labeling, promotion and advertising of FDA-regulated products. Gillian frequently serves as legal counsel on Medical/Legal/Regulatory (MLR) committees and medical/scientific review committees and is known for providing practical and actionable advice and solutions. Gillian routinely advises on the full spectrum of promotional and non-promotional communications, including new product launches, direct-to-consumer promotion, social media, influencer marketing, and payer communications.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGillian graduated from the University of Virginia School of Law, where she served as Executive Editor for the\u0026nbsp;\u003cem\u003eVirginia Environmental Law Journal\u003c/em\u003e\u0026nbsp;and as a Hardy Cross Dillard fellow for legal research and writing. Gillian earned her B.A. magna cum laude from Princeton University, where she was a four-year member of the swimming team.\u0026nbsp;\u003c/p\u003e","slug":"gillian-russell","email":"grussell@kslaw.com","phone":null,"matters":["\u003cp\u003e\u0026ldquo;Industry Update \u0026ndash; New FDA Guidance on Social Media,\u0026rdquo; FX Conferences (September 2014).\u003c/p\u003e","\u003cp\u003e\u0026ldquo;The New Drug Approval Process: New Drug Research and Development,\u0026rdquo; FDLI Introduction to Drug Law and Regulation, Washington, D.C. (April 2, 2014).\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":1,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":2,"source":"capabilities"}],"is_active":true,"last_name":"Russell","nick_name":"Gillian","clerkships":[],"first_name":"Gillian","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"M.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":14,"translated_fields":{"en":{"bio":"\u003cp\u003eGillian Russell has over 15 years of experience counseling pharmaceutical, medical device, and cosmetic clients on a wide range of regulatory, compliance, and enforcement issues, with a focus on regulatory strategies and initiatives for the labeling, promotion and advertising of FDA-regulated products. Gillian frequently serves as legal counsel on Medical/Legal/Regulatory (MLR) committees and medical/scientific review committees and is known for providing practical and actionable advice and solutions. Gillian routinely advises on the full spectrum of promotional and non-promotional communications, including new product launches, direct-to-consumer promotion, social media, influencer marketing, and payer communications.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGillian graduated from the University of Virginia School of Law, where she served as Executive Editor for the\u0026nbsp;\u003cem\u003eVirginia Environmental Law Journal\u003c/em\u003e\u0026nbsp;and as a Hardy Cross Dillard fellow for legal research and writing. Gillian earned her B.A. magna cum laude from Princeton University, where she was a four-year member of the swimming team.\u0026nbsp;\u003c/p\u003e","matters":["\u003cp\u003e\u0026ldquo;Industry Update \u0026ndash; New FDA Guidance on Social Media,\u0026rdquo; FX Conferences (September 2014).\u003c/p\u003e","\u003cp\u003e\u0026ldquo;The New Drug Approval Process: New Drug Research and Development,\u0026rdquo; FDLI Introduction to Drug Law and Regulation, Washington, D.C. (April 2, 2014).\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":6074}]},"capability_group_id":2},"created_at":"2025-05-26T05:03:27.000Z","updated_at":"2025-05-26T05:03:27.000Z","searchable_text":"Russell{{ FIELD }}“Industry Update – New FDA Guidance on Social Media,” FX Conferences (September 2014).{{ FIELD }}“The New Drug Approval Process: New Drug Research and Development,” FDLI Introduction to Drug Law and Regulation, Washington, D.C. (April 2, 2014).{{ FIELD }}Gillian Russell has over 15 years of experience counseling pharmaceutical, medical device, and cosmetic clients on a wide range of regulatory, compliance, and enforcement issues, with a focus on regulatory strategies and initiatives for the labeling, promotion and advertising of FDA-regulated products. Gillian frequently serves as legal counsel on Medical/Legal/Regulatory (MLR) committees and medical/scientific review committees and is known for providing practical and actionable advice and solutions. Gillian routinely advises on the full spectrum of promotional and non-promotional communications, including new product launches, direct-to-consumer promotion, social media, influencer marketing, and payer communications.\nGillian graduated from the University of Virginia School of Law, where she served as Executive Editor for the Virginia Environmental Law Journal and as a Hardy Cross Dillard fellow for legal research and writing. Gillian earned her B.A. magna cum laude from Princeton University, where she was a four-year member of the swimming team.  Counsel Princeton University  University of Virginia University of Virginia School of Law District of Columbia New Jersey Pennsylvania “Industry Update – New FDA Guidance on Social Media,” FX Conferences (September 2014). “The New Drug Approval Process: New Drug Research and Development,” FDLI Introduction to Drug Law and Regulation, Washington, D.C. (April 2, 2014).","searchable_name":"Gillian M. Russell","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null}]}}