Frederick R. Ball


  • Frederick R. Ball
  • Phone: +1 857 488 4229
    Fax: +1 312 277 1945

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  • Duane Morris LLP
    100 High Street, Suite 2400
    Boston, MA 02110-1724

Frederick (Rick) R. Ball  focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences and Medical Technologies industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, food companies (including supplement manufacturers), pharmacies, long term care providers, and other health care providers navigate the complex challenges faced by state and federal regulation of their industries including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation.   Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Finally, Mr. Ball helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.

He is admitted to the Massachusetts State Bar, Illinois State Bar, the Seventh Circuit and the U.S. Supreme Court. He is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.

Representative Matters

  • Represented Windlas Healthcare PVT. Ltd. against Astellas Pharma Inc. in Hatch-Waxman litigation related to Astellas’ overactive bladder treatment Myrbetriq. The matter settled with an license agreement between Astellas and Windlas.
  • Represented iAnthus Capital Holdings, Inc. (CSE: IAN; OTCQX: ITHUF) in its acquisition of CBD For Life, a top-ranked producer of innovative CBD-infused wellness, self-care, and beauty products.
  • Conducted a twelve state analysis of federal and state regulatory framework pertaining to the distributing, marketing, and selling of hemp and hemp-derived CBD, including CA, VA, MD, NC, PA, OH, KY, IN, WV, OR, WA and NY.
  • Represented SVB Leerink LLC, acting as sales agent in a $100 million at the market equity offering of common stock for Cassava Sciences, Inc. (NASDAQ: SAVA), a clinical-stage biotechnology company which works to develop novel solutions for Alzheimer’s disease and other neurodegenerative diseases.
  • Represented Roth Capital Partners, LLC, acting as sales agent in a $50 million at the market equity offering of common stock for Ampio Pharmaceuticals, Inc. (NYSEAMERICAN: AMPE), a development stage pharmaceutical company attempting to develop a treatment for prevalent inflammatory conditions for which there are limited treatment options.
  • Represented JonesTrading Institutional Services LLC, acting as sales agent in a $30 million capital on demand offering of common stock for Curis, Inc. (Nasdaq: CRIS), a clinical-stage biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers.

  • Represented The Benchmark Company LLC, acting as underwriter in a $12.5 million offering of preferred stock for Fortress Biotech, Inc. (Nasdaq: FBIOP), a developer of pharmaceutical and biotechnology products and product candidates.

  • Represented B. Riley FBR, Inc., acting as sales agent in a $150 million at the market equity offering of common stock for Novavax, Inc. (NASDAQ: NVAX), a late stage biotechnology company focused on the discovery, development and commercialization of vaccines to prevent serious infectious diseases, including a potential COVID-related vaccine.
  • Represented B. Riley FBR, Inc., acting as sales agent in a $4.6 million at the market equity offering of common stock for Hepion Pharmaceuticals, Inc. (NYSE American: HEPA), a developer of targeted therapies for liver disease arising from chronic hepatitis, non-alcoholic steatohepatitis, fibrosis, and liver cancer.
  • Represented JMP Securities LLC, acting as sales agent in an $18.9 million at the market equity offering of common stock for Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company which develops treatments for liver disease and immune modulating therapies.

  • Represented JMP Securities LLC, acting as sales agent in a $25 million at the market equity offering of common stock for iCAD, Inc. (Nasdaq: ICAD), a global medical technology company that provides innovative cancer detection and therapy solutions.

  • Represented JMP Securities LLC and Oppenheimer & Co., acting as underwriters in a $25 million public offering of common stock and related warrants for Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company primarily focused on developing and commercializing innovative products for acute care settings.

  • Advised publically traded company related to banking covenants and offering of CBD products.
  • Represented Flexpoint Ford, a Chicago-based private equity firm focused on the healthcare and financial services industries, in its investment in YPrime, a global leader of cloud-based eClinical solutions.
  • Represent a vertically-integrated operator with licenses in MA, MD, and NH in various aspects of its business, including general corporate, capital raising, and intellectual property.
  • Represented underwriter related to At the Market (ATM) offering by a publically traded company considering offering CBD infused cosmetics and beverages.
  • Advised a client in the tobacco industry on labeling of CBD products to comply with federal and state law.
  • Reviewed advertising and promotional material for multiple companies offering CBD products to assure compliance with federal law (FDA and FTC).
  • Drafted a compliance program covering the anti-kickback statute, FCPA, UK Bribery Act, and employee screening for debarment and exclusion for a CSO that provides services to clinical studies sponsors.
  • Represented firm client Wockhardt in New Jersey related to Janssen Biotech Inc.’s oncology medication Zytiga. The District Court found the Janssen patent invalid.
  • Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.
  • Provided regulatory and intellectual property support to the in-house regulatory team of Wockhardt, a pharmaceutical and biotechnology company, for the development of a Risk Evaluation and Mitigation Strategy (“REMS”) for a generic sodium oxybate product that was recently approved by the U.S. Food and Drug Administration (“FDA”).
  • Obtained voluntary no-pay dismissals for a pharmaceutical distributor after filing summary judgment motions establishing that our client’s over-the-counter talcum powder was not contaminated with asbestos and that the plaintiffs’ personal injury claims were preempted by the Federal Food, Drug and Cosmetics Act.
  • Jazz Pharmaceuticals, Inc. et al. v. Wockhardt Bio AG et al., 2:15-cv-5619 (D.N.J. 2015). Obtained settlement for defendant Wockhardt Bio AG in a patent litigation matter relating to Jazz Pharmaceutical's treatment for narcolepsy, Xyrem.
  • Obtained on behalf of Novel Laboratories Inc. a settlement of a patent litigation matter, which will allow Novel to begin marketing its generic form of a medication well prior to the expiration of the patents.
  • Represented Wockhardt in Paragraph IV litigation involving Otsuka's oral Abilify. Negotiated a settlement and license agreement permitting entry into the market prior to the expiration of the Orange Book Patents.
  • Pfizer Inc., et al. v. Wockhardt, Ltd., et al., 12-CV-817 (SLR) (Consolidated) (D. Del.) Patent infringement action regarding Wockhardt's ANDA to make a generic version of Pfizer's antidepressant product Pristiq®, the active ingredient of which is desvenlafaxine succinate.
  • Avanir Pharmaceuticals, Inc., et al. v. Wockhardt, Ltd., et al., 11-CV-704 (Consolidated) (LPS) (D. Del.) Obtained a settlement in a patent infringement action allowing Wockhardt to market a generic version of Avanir’s PBA product Nuedexta®, the active ingredients of which are dextromethorphan hydrobromide and quinidine hydrobromide.
  • Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, with Abbott and Alkermes regarding the drug Tricor.
  • Obtained a settlement for Wockhardt, a global pharmaceutical and biotechnology company, that resolved Hatch-Waxman litigation initiated by Sepracor Inc. seeking to bar Wockhardt from offering a generic version of the blockbuster insomnia medicine Lunesta. Sepracor agreed to allow Wockhardt entry into the market before the expiration of its Lunesta patents.
  • Represented generic pharmaceutical manufacturer Wockhardt in Paragraph IV and Hatch-Waxman litigation, obtaining settlement allowing entry into the market prior to patent expiration.
  • Obtained return of $1.6 million worth of alleged contraband seized by the U.S. Drug Enforcement Administration.
  • Advised private equity firm in acquisition of dietary supplement manufacturer regarding U.S. and China regulatory issues.
  • Represented dietary supplement manufacturer in negotiation of consent decree with FDA following alleged repeated violations of good manufacturing practices.
  • Obtained temporary restraining order against state of Washington halting a 6 percent reduction in Medicaid reimbursement to pharmacies.
  • Negotiated voluntary surrender of DEA registration on behalf of pharmacy and owner allegedly engaged in significant diversion of controlled substances in violation of federal and state law. In return, DEA agreed not to pursue criminal or civil actions and permitted transfer of controlled substances to another pharmacy.
  • Obtained no further action letter from state authorities on behalf of corporation and new management following voluntarily self-reporting of violations of state controlled substances act and statutes and regulations governing out of state wholesalers after internal investigation.
  • Represented dietary supplement manufacturer in criminal proceedings related to violations of Food Drug and Cosmetic Act.
  • Represented dietary supplement manufacturer before the National Advertising Division of the Better Business Bureau regarding advertising claims.
  • Obtained preliminary injunction on behalf of National Association of Chain Drug Stores and National Community Pharmacists Association in litigation against federal Department of Health and Human Services and Centers for Medicare and Medicaid enjoining implementation of reimbursement rule that would have cost pharmacies $8 billion.
  • Ikon v. Reeves: obtained temporary restraining order and preliminary injunction enforcing restrictive covenants
  • Innotek v. Wright Medical: successful defense of trade secrets arbitration
  • Gustafson v. Gonzales: obtained temporary restraining order and permanent injunction enforcing restrictive covenants
  • Represented drug wholesaler in criminal and civil investigation regarding importation of unapproved new drugs.
  • Represented several mail order pharmacies in DEA, FDA, and DOJ investigations regarding dispensing of controlled substances.
  • Prepared and negotiated "voluntary" recalls on behalf of several manufacturers of dietary supplements and generic pharmaceuticals for alleged violations of cGMP.
  • Advised numerous wholesalers and manufacturers on registration and pedigree requirements.
  • Advised numerous entities on import requirements for registration and APIs.
  • Represented compounding pharmacy during criminal, civil, and administrative investigation into dispensing HGH.
  • Represented a generic pharmaceutical company in all regulatory matters related to acquisition.

Areas of Practice

  • Regulatory Enforcement
  • ANDA Litigation
  • Commercial Litigation
  • White-Collar Defense


  • Illinois
  • Massachusetts
  • Supreme Court of the United States
  • U.S. Court of Appeals for the Seventh Circuit
  • U.S. Court of Appeals for the Eighth Circuit


  • Cornell Law School, J.D., 1996


  • Duane Morris LLP
    - Partner, 2005-present
    - Associate, 1999-2004
  • DePaul University School of Law
    - Adjunct Professor of Law, 2009-2013
  • Holleb & Coff, Chicago, Illinois
    - Associate, 1996-1999
  • United States Army, 1985-1987

Professional Activities

  • High Mowing School
    - Board of Trustees, 2016
  • Illinois State Bar Association
  • Food and Drug Law Institute
    - Executive Committee, 2016
    - Treasurer, 2016
    - Board of Directors
    - Editorial Advisory Board, Update Magazine

Honors and Awards

  • Recipient of Lexology/International Law Office Client Choice Award for Healthcare & Life Sciences (Massachusetts), 2016
  • Listed in Illinois Leading Lawyers, 2009

Selected Publications

Selected Speaking Engagements

  • Presenter, "COVID-19: From Sea to Shining Sea: A Quick Update of U.S. and International COVID-Related Restrictions," Duane Morris LLP, Webinar, December 11, 2020
  • Speaker, "Entering the U.S. Market for European Pharma: Essential IP and Regulatory Considerations," Duane Morris Webinar, June 23, 2020
  • Speaker, "Virtual Happy Hour with Update Magazine Authors Rick Ball and Justin Stern," Food and Drug Law Institute, April 30, 2020
  • Speaker, "How COVID-19 Is Affecting Life Sciences and Medical Technologies," Duane Morris Webinar, April 16, 2020
  • Speaker, "Food Enforcement and Compliance Conference," Food and Drug Law Institute, Washington D.C., March 26, 2020
  • Moderator, "The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps," Food and Drug Law Institute, Webinar, January 21, 2020
  • Speaker, "Developments in Enforcement of CBD and Cannabis Products," FDLI's Enforcement, Litigation, and Compliance Conference, Renaissance Downtown Hotel, Washington D.C., December 11-12, 2019
  • Speaker, "Legal and Practical Issues in the Evolving World of Cannabis Regulation," Food and Drug Law Institute, Washington D.C., November 18, 2019
  • Speaker, "How to Free CBD from the FDA Grasp: Call It GRAS," The Cannabis Reporter Radio Show Podcast, May 20, 2019

  • Speaker, "Introduction to Drug, Biologics and Biosimilars Law and Regulation," FDLI's Introduction to Drug, Biologics and Biosimilars Law and Regulation, Boston, July 24, 2019

  • Presenter, "Single, Shared System Risk Evaluation and Mitigation Strategies: Opportunities and Challenges," Food and Drug Law Institute, Webinar, May 14, 2019

  • Panelist, "Entering the U.S. Market: Considerations for Strategic Transactions and Collaborations," Innovation Across Borders: Strategies for Chinese Life Sciences Companies Doing Business in the U.S., Shanghai, March 7, 2019

  • Moderator, "Innovation Across Borders: Strategies for U.S. and Chinese Companies in the Health Sciences Industry," Duane Morris LLP and Chinese Biopharmaceutical Association (USA), January 8, 2019 

  • Speaker, "Emerging Legal Issues in IP and Paragraph IV Litigation," GRx+Biosims Conference, Hilton Baltimore, Baltimore, Maryland, September 6, 2018

  • Speaker, "Recent FDA Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products," CBI Abuse-Deterrent Formulations Summit, Silver Spring, Maryland, March 13, 2018

  • Speaker, "Enforcement Throughout the Supply Chain," Food and Drug Law Institute, December 6, 2017

  • Speaker, "The FDA Reauthorization Act and GDUFA II: What You Need to Know," Food and Drug Law Institute, Live Webinar, November 14, 2017
  • Panelist, "Medical Products: FDA and Opioid Use," Food and Drug Law Journal Symposium, Washington D.C., October 20, 2017
  • Speaker, "Violations and Enforcement," FDLI Introduction to U.S. Drug Law and Regulation, Boston, June 15, 2017
  • Speaker, "Interpretation of the FDA Data Integrity Draft Guidance and Preparing for Compliance," Food and Drug Law Institute's Enforcement Conference, December 7, 2016
  • Speaker, "The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues," Food and Drug Law Institute's Introduction to Drug Law and Regulation Course: The Legal Framework for Drug Regulation, Washington, D.C., April 12-13, 2016
  • Speaker, "Recent Updates and Stories from the Trenches Pathways to Bringing Your Generic Drug to the U.S. Market: Paragraph IV Certifications, Hatch–Waxman Litigation, Section 505(b)(2), and the Biosimiliars Patent Dance," IP Life Sciences Exchange, Frankfurt, Germany, November 10, 2015
  • Speaker, "GDUFA Inspections, and Labeling, Oh My: A Look at the Regulatory Challenges and Opportunities for the Generic Industry Operating in the U.S. in 2015," World Generic Medicines Congress Europe 2015 Conference, Madrid, March 4-5, 2015
  • Moderator, "The Present Part 2: Generic Industry Challenges and Current Issues," Food and Drug Law Institute's Conference on Celebrating the 30th Anniversary of the Hatch-Waxman Amendments: The Past, Present and Future of Generic Drugs, Washington D.C., September 18, 2014
  • Moderator, "Doing Business With India: Latest Developments in Pharmaceutical Regulation," FDLI Webinar, June 27, 2014
  • Presenter, "Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation," The Food and Drug Law Institute, November 7, 2013
  • Moderator, "Practical Impact of Caronia and First Amendment Implications," Food and Drug Law Annual Conference, Washington, D.C., April 23, 2013
  • Presenter, "Violations and Enforcement," Food and Drug Law Institute's Conference on Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, Washington, D.C., April 4, 2013
  • Speaker, "Hot Topics in Food, Medical Devices and Pharmaceuticals," Food and Drug Law Institute's U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation Conference, Sao Paolo, Brazil, September 10, 2012
  • Speaker, American Health Lawyers Association and Food and Drug Law Institute's Conference on The Intersecting Worlds of Drug, Device, Biologics and Health Law, Washington, D.C., May 22, 2012
  • Speaker, "An Exploration of Current Professional Conduct Rules and Ethical Issues Raised by Lauren Stevens and Similar Cases," Food and Drug Law Institute's 55th Annual Conference, Washington D.C., April 25, 2012
  • Speaker, "Biosimilars: Viewing the New Guidances Through an International Lens," Food and Drug Law Institute Webinar, March 28, 2012
  • Presenter, Introduction to Medical Device Law and Regulation: How the Government Regulates the Medical Device Industry, Washington D.C.. March 12, 2012
  • Speaker, Food and Drug Law Institute's U.S.-China Food and Drug Law Conference, Beijing, June 2011
  • Speaker, American Conference Institute Summit on Drug and Device Product Recalls, Philadelphia, March 2011
  • Visiting Lecturer, University of Florida School of Pharmacy, Masters in Pharmacy, March 2011
  • Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., November 2010
  • Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., October 2009
  • Speaker, Food and Drug Law Annual Conference, Washington, D.C., April 22-23, 2009
  • Speaker, Food and Drug Law Institute's Introduction to Drug Law and Regulation, Washington, D.C., June 26-27, 2008
  • Speaker, "E-Discovery Ramifications of the Qualcomm Case," Webinar, March 18, 2008
  • Speaker, Food and Drug Law Institute's Introduction to Drug Law, Import and Export Issues, January 19, 2007
  • Speaker, Food and Drug Law Institute's Introduction to Drug Law, Enforcement, January 19, 2007