Frederick R. Ball
Partner

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

Phone: +1 857 488 4229
Fax: +1 312 277 1945
Email: FRBall@duanemorris.com

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Frederick R. Ball

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Frederick (Rick) R. Ball is vice-chair of the White-Collar Criminal Defense division of Duane Morris' Trial Practice Group. Mr. 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. Mr. Ball helps generic pharmaceutical companies, biologics manufacturers, 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 also assists generic manufacturers bring product to market through patent analysis and Hatch-Waxman 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 Illinois State Bar, the Trial Bar of the U.S. District Court for the Northern District of Illinois, the Seventh Circuit and the U.S. Supreme Court. A member of the American and Illinois State bar associations, he is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.

Mr. Ball is an Adjunct Professor of Law at DePaul University College of Law, where he helps train the next generation of lawyers.

Representative Matters

  • 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

Admissions

  • 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
  • Trial Bar of the U.S. District Court for the Northern District of Illinois
  • Supreme Court of Illinois

Education

  • Cornell Law School, J.D., 1996

Experience

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

Professional Activities

  • Illinois State Bar Association
  • Food and Drug Law Institute
    - Board of Directors
    - Editorial Advisory Board, Update Magazine

Honors and Awards

  • Listed in Illinois Leading Lawyers, 2009

Selected Publications

Selected Speaking Engagements

  • 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