Howard M. Hoffmann is a commercial and white-collar trial lawyer. Among other practice areas, he represents compounding pharmacies and trade association against the FDA and DEA in federal appellate, criminal and civil trial and administrative courts throughout the United States. He also practices widely in hospital and physician disputes, construction litigation, healthcare fraud and abuse and appellate litigation including the United States Supreme Court. He practices white collar criminal defense in courts throughout the United States.

Mr. Hoffmann is a former Assistant United States Attorney with the U.S. Attorney's Office for the Northern District of Illinois - Chicago, where he served as chief of the Criminal Division, Deputy United States Attorney and chief of the Tax Division. A frequent lecturer on criminal practice and healthcare advocacy at trade association and bar associations, he is a member of the American and Chicago bar associations, the Decalogue Society, the American Health Lawyers Association and the Federal Trial Bar.

He is a 1968 graduate of Chicago-Kent College of Law.

Areas of Practice

• Complex commercial litigation
• Appellate advocacy, including the Supreme Court of the United States
• White collar criminal defense
• Healthcare fraud and abuse and reimbursement litigation
• Hospital/physician litigation
• Legal malpractice
• Contested decedent's estates

Representative Matters

• Represents individuals, businesses, business owners and shareholders, administrators and executors of decedent's estates, physicians, manufacturers, hospitals, nursing homes, and pharmacists in state and federal regulatory, criminal, constitutional, and complex commercial matters.
• Represents plaintiffs and defendants in complex commercial disputes, emergency injunctive relief, class actions, theft of confidential proprietary information, employee raiding, corporate dissolution, complex contract disputes, and breaches of fiduciary duty.
• Represents individuals and organizations, including businessmen, physicians, pharmacists, hospitals, and nursing homes, in criminal political corruption investigations and other criminal investigations and grand jury proceedings through investigation, grand jury, and trial.
• Represents individuals and organizations in federal appellate proceedings around the country, including the Supreme Court of the United States, the Third Circuit Court of Appeals, the Fifth Circuit Court of Appeals, the Seventh Circuit Court of Appeals, and the Ninth Circuit Court of Appeals.
• Has represented individuals and organizations in trial court matters in federal and state jurisdictions, including Connecticut, New York, Ohio, Georgia, Colorado, Wisconsin, Florida, Mississippi, Texas, California, Arizona, Missouri, Iowa, Illinois, Indiana, and others.
• Women's International Pharmacy, College Pharmacy, Wedgewood Village Pharmacy, The Kronos Group, et al: In the representation of seven specialty pharmacies, successfully argued before the Supreme Court of the United States the unconstitutionality of advertising restrictions in an Act of Congress, thereby striking the entire Act.
• In the representation of a hospital, successfully prevented the filing of federal criminal charges for health care billing fraud.
• On behalf of specialty pharmacies, brought an action against the Illinois Department of Public Aid and State Treasurer for cutting pharmacy reimbursement rates below and in violation of legislated federal standards. As a result of the lawsuit, a political settlement was achieved, netting the industry untold millions.
• Successfully represented an individual in a three-week federal criminal jury trial for alleged EPA bid bond fraud.
• A six-week trial in West Palm Beach, Florida, including putting on 72 witnesses, successfully represented the executor and several beneficiaries in a will contest against siblings' claims of lack of testamentary capacity.
• Counsel to a nursing home in a federal §1983 lawsuit against the State of Illinois for a discriminatory survey. Recovered $250,000 and mandatory minority sensitivity training for state surveyors.
• Counsel to an anesthesiology group in a dispute among group members and the hospital at which they rendered anesthesia services.
• Successfully represented 360 Dade County, Florida homeowners against a major developer for defective construction.
• Representation of entity in class action against claims of misleading limitations of liability (ongoing).
• Defense of a nursing home and an individual in a qui tam action (ongoing).
• Defense of a business against the denial of coverage by its insurer (ongoing).
• Representation of purported class (not yet certified) in a Magnuson Moss and related claims arising out of failures of 5,000 airplane engines (ongoing).
• Defense of a major compounding pharmacy and its chief owner/pharmacist in charge in an 18-count federal criminal indictment and forfeiture claims (ongoing).
• Defense of major pharmacies with national practices in DEA de-registration proceedings (one still ongoing).

Admissions

• Illinois
• U.S. Court of Appeals for the Seventh Circuit
• U.S. Court of Appeals for the Third Circuit
• U.S. Court of Claims
• U.S. District Court for the Northern District of Illinois
• U.S. District Court for the Southern District of Illinois
• U.S. District Court for the Central District of Illinois
• U.S. District Court for the District of Arizona
• U.S. District Court for the District of Colorado
• Supreme Court of the United States
• Supreme Court of Illinois

Education

• Chicago-Kent College of Law, J.D., 1968

Other Experience

• Duane Morris LLP
  - Partner, 1999-present
• Holleb & Coff, Chicago, Illinois
  - Partner, 1977-1999
• United States Attorney's Office for the Northern District of Illinois, Chicago, Illinois
  - Deputy United States Attorney, 1976-1977
  - Chief, Tax Division, 1970-1977
  - Chief, Criminal Division, 1971-1976
  - Trial Attorney, 1968-1971
• While a federal prosecutor, successfully prosecuted corrupt politicians and professionals, including securing the conviction and life imprisonment term of a Chicago police sergeant who was a hired assassin.

Professional Activities

• American Bar Association
  -Member, Commercial and Financial Litigation Committee
  -Member, National Committee to Evaluate F.R.C.P. 11
• The Chicago Bar Association
• American Health Lawyers Association
• Federal Trial Bar
• Serves as a frequent author and lecturer on criminal practice; healthcare advocacy; estate litigation; corporate officer and director conflicts of interest issues; duties and responsibilities of in-house counsel, including the attorney-client privilege; and establishment of corporate policies to avoid litigation.
• Adjunct law school lecturer on trial practice and procedure

Honors / Awards

• 1998 Keshet Hall of Heroes Honoree
• 1967 Ford Foundation Fellow Grant Recipient administered by Northwestern Law School
• AV® Preeminent™ Peer Review Rated by Martindale-Hubbell

Civic and Charitable Activities

• Member of Board of Trustees and pro bono counsel to Keshet, an organization that operates schools, residences and camps for severely disabled children
• Board of Directors, Tel Aviv Foundation
• Two-term president to congregation

Publications

• "Government Regulation as a Defense in Criminal and Civil Cases: Chevron to the Defense," New Jersey Lawyer Magazine, June 2010
• Preventing a Personal Indictment Crisis -- Part II, Law360, March 9, 2009
• Preventing a Personal Indictment Crisis -- Part I, Law360, February 27, 2009
• "Elements of Triage", Counsel to Counsel, July 2007
• "Emergency Legal Intervention, Part Three: Surprise Sunrise Searches and Raids", Andrews Litigation Reporter, May 2007
• "Emergency Legal Intervention, Part Two: I Did Not Have Sexual Relations With That Woman, Or Perception Is Everything", Andrews Litigation Reporter, April 2007
• "Emergency Legal Intervention, Part One: Strangulation by Tri-Strangulation", Andrews Litigation Reporter, March 2007
• "History, Decision, and Aftermath of Thompson v. Western States - Drug Advertising and the First Amendment," Food and Drug Law Institute's Update Magazine, 2003
• "Eight Inches Below the Horizon: An Argument in the U.S. Supreme Court," NJ Lawyer Magazine, April 2003

Speaking Engagements

• Co-Presenter, American Hormone Symposium on Treatment of Endocrine Disorders with Compounded Drugs, Washington, D.C., November 3, 2012
• Food and Drug Law Institute's annual confab, addressed whether the First Amendment gives drug and medical device manufacturers the right to advertise off-label uses for their products and, if so, under what circumstances, Washington, D.C., March 27, 2008
• Food Drug Law Institute, 49th Annual Conference, overview of statutory framework of FDA jurisdiction over pharmacies compliant with state law in light of recent decisions, including the 2002 decision by the U.S. Supreme Court in Western States, Washington, D.C., April 2006.
• International Academy of Compounding Pharmacists, Annual Meeting on Capitol Hill, overview of recent federal compounding pharmacy cases regarding lack of FDA jurisdiction, Washington, D.C., June 2005.
• "The Future of All Drug Advertising After the U.S. Supreme Court's Decision in Thompson vs. Western State, et al.," audio conference sponsored by the Food and Drug Law Institute (FDLI). The First Amendment Issues forum addressed the latest court developments and their implications for FDA regulation on speech, marketing and promotion, Washington, D.C., August 1, 2002
• "Ramifications of the Firm's Recent Victory on Behalf of Compounders in the Supreme Court of the United States," and Panel Presentation with Top Officials from the Food and Drug Administration, Annual Convention of the International Association of Compounding Pharmacists, Washington, D.C., June 24, 2002
• "Post 9/11 Laws and Regulations Which Serve As New and Unfamiliar Barriers to International Commerce" and "Intellectual Property Protection in Foreign Courts, Foreign Transactions, Licensing Agreements, Choice of Law and Forum Provisions and International Arbitration Opportunities," Conference of German and U.S. Manufacturers attended by German and U.S Trade Representatives and Manufacturers, as well as Consultants and Manufacturers from England and Japan, Chicago, Illinois, June 13, 2002
• "Practice of Pharmacy as Argued Before the U.S. Supreme Court," seminar titled The Effects of Tommy Thompson et al. v. Western States Medical Center et al., Philadelphia, Pennsylvania, March 16, 2002
• "Estate Contests: What They Are, How to do Them and How to Avoid Them," Chicago Bar Association, Chicago, Illinois, October 5, 1999 and January 17, 2002
• Corporate Compliance Plans," Illinois Council for Long Term Care, Springfield, Lincolnwood, and Oak Forest, Illinois, May 17-18, 2000
• "Knowledge is Safety: Pending State and Federal Criminal Investigations," Illinois Council on Long Term Care, February 1999
• "OIG Corporate Compliance Plans: To Be or Not To Be?" Illinois Council for Long Term Care, Lincolnwood, Illinois, December 2, 1999
• "Health Care Fraud" and "Documentation and Legal Liability", Illinois Health Care Association, Springfield, September, 1998
• "Corporate Criminal Liability," seminar for clients, Chicago, Illinois, February, 1997
• "Medicare/Medicaid Crimes," Illinois Health Care Association, Peoria, Illinois, September, 1997
• "Nursing Home Accounting Methods: Accrual versus Cash," Illinois CPA Society, Chicago, Illinois, January, 1996
• "Life Cycle of a Venture Capital Deal," seminar for clients, Chicago, Illinois, January, 1996
• " The Administrator and the Illinois Department of Professional Regulation," Illinois Health Care Association, Springfield, Illinois, September, 1996
• "The War Between the Governments," National Institute for Health and Human Services, Arlington Heights, Illinois, February, 1995
• "Weatherproofing Against the Gathering OBRA Store," Illinois Council on Long Term Care, Oak Lawn, Illinois, Lincolnwood, Illinois, and Springfield, Illinois, July, 1995
• "Developments in Pharmacy Law," American Society for Pharmacy Law, New Orleans, Louisiana, November, 1995
• "Enforcement and Your Administrator's License," American College of Health Care Administrators, Springfield, Illinois, November, 1995
• "Keys to Effective Decision Making," Illinois Health Care Association, Springfield, Illinois, February, 1994
• "Sunrise Raids: Be Courteous, Be Quiet," Illinois Pharmacists Association, Rosemont, Illinois, February, 1993
• "The State and Federal Survey Process as a Management Device," Illinois Council on Long Term Care, June 1993
• "Riding Out the Storm," co-presentation with a nationally-recognized accounting firm, Lincolnwood, Illinois, November, 1992
• "The Accounting Expert Witness," presentation for accounting firms, Chicago, Illinois, September, 1991