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 Expert  729566

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals


Available for your Consulting and Expert Witness Needs

Illinois (IL)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and devices including clinical investigators, sponsor/monitors, institutional review boards, Good Laboratory Practices, and pre-approval inspections. He served as a supervisory investigator supervising medical device and drug experts and specialists. Expert served as a compliance officer reviewing and evaluating evidence, recommending legal action, drafting complaints and assisting the United States Attorney in prosecution of legal actions. Other responsibilities included service as a criminal investigator assigned to the Department of Justice, and training of FDA investigators and foreign officials.

Expert taught food and drug law as an adjunct professor of law. He also served as the chair for the Chicago Bar Association FDA Law Committee. He has authored a chapter in an expert treatise, and has been requested and provided training to industry and academia.

For more than ten years he has provided litigation support services as a consultant and expert for plaintiff and defense clients. Cases have revolved around compliance with FDA requirements in pre-market development, testing, approval, manufacturing, use, and and post-approval reporting for medical devices and pharmaceuticals. Cases have included fraud and misrepresentation, personal injury, breach of contract, product liability, medical malpractice, libel, and Qui tam actions. Expert has also provided regulatory compliance consulting to industry including corrective action plan design and implementation.

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510(k) document

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abbreviated new drug application

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clinical laboratory regulation

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compliance

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Current Good Manufacturing Practice

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drug

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drug development

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drug labeling requirement

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drug product approval

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drug regulation

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Federal Food, Drug, and Cosmetic Act

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Food and Drug Administration

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Food and Drug Administration compliance

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FDA medical device regulation

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Food and Drug Administration regulation

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Good Laboratory Practice

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Good Manufacturing Practice

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investigational drug

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investigational drug procedures

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medical device auditing

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medical device clinical research

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medical device premarket approval

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new drug application

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pharmaceutical manufacturing facility auditing

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pre-approval inspection

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Safe Medical Devices Act of 1990

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statute


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois;  Rockford, Illinois;  Aurora, Illinois;  Naperville, Illinois;  Joliet, Illinois;  Elgin, Illinois;  South Bend, Indiana;  Gary, Indiana;  Milwaukee, Wisconsin;  and Kenosha, Wisconsin.

Education:
Year   Degree   Subject   Institution  
1992   J.D.   Law   The John Marshall Law School, Chicago, Illinois  
1983   M.S.   Biology   The Universityh of Texas at El Paso, El Paso, Texas  

Work History:
Years   Employer   Department   Title   Responsibilities

1999 to

 

(Undisclosed)

 


 

Consultant/Expert

 

Expert performed inspections, reviewed and evaluated evidence, wrote expert opinions, and provided deposition. Using his extensive experience in on line research of FDA data bases he located and evaluated FDA documents as relevant to litigation support projects.

1997 to 2010

 

Expert's Firm, Attorney at Law

 


 

Attorney

 

He counseled clients in FDA requirements for marketing drugs and devices regulated by the Food and Drug Administration. Expert represented clients to FDA officials and the United States Attorney in civil and criminal actions. And he negotiated consent decrees with the government, and negotiated immunity and non-target letters for grand jury witnesses.

1999 to 2003

 

The John Marshall Law School

 


 

Adjunct Professor of Law

 

Expert taught food and drug law to law students.

1983 to 1997

 

U.S. Food & Drug Administration

 

Investigations/Management/Compliance

 

Investigator/Supervisory Investigator/Compliance Officer

 

Conducted inspections and special investigations of regulated parties. Supervised investigators. Evaluated evidence, drafted complaints, made referrals to the United States Attorney, and assisted United States Attorney in prosecution of civil and criminal actions.

1981 to 1983

 

The University of Texas at El Paso

 

Biology

 

Teaching Assistant

 

Expert taught freshman biology labs and senior level classes in statistical analysis of biological phenomena.

1979 to 1981

 

The University of Texas at El Paso

 

Biology

 

Research Assistant

 

Expert collected field specimens, designed and carried out laboratory experiments, analyzed data, and wrote scientific reports. Results were included in an environmental impact statement relevant to planned developments at White Sands National Monument, New Mexico.


Career Accomplishments:
Licenses/Certifications

Expert earned a Certificate of Professional Achievement in Mediation Training. He was appointed to Illinois State Bar and the Federal Bar for the Northern district of Illinois.

Professional Appointments

Expert was Chair for the Chicago Bar Association Food, Drug, and Consumer Product Regulatory Law committee in 2004 and 2003. He was Adjunct Professor of Law at The John Marshall Law School, Chicago from 1999 through 2003.

Awards/Recognition

Expert was awarded the Regional Directors Citation for excellence, U.S. Department of Health and Human Services in 1993.


Publications:
Publications and Patents Summary

Expert is the author of a chapter in an expert treatise on dug injury, and an article in the peer review journal for the Association of Clinical Research Professionals.

Selected Publications and Publishers  
 - The Monitor  
 - in Drug Injury: Liability, Analysis and Prevention, 2nd Ed. Lawyers & Judges Publishing Company, Inc.  

Government Experience:
Years   Agency   Role   Description
1983 to 1997   U.S. Food & Drug Administration   Investigator, Supervisory Investigator, Compliance Officer, and Federal Grand Jury Investigatory   Expert performed inspections and special investigations of regulated industry, gathered evidence and provided fact testimony in Federal District Court. He also supervised an investigative staff consisting of drug and medical device specialist and national experts. He also served as a compliance officer, reviewing and evaluating documentary and laboratory evidence, drafting complaints, making referrals to the United States Attorney and assisting the United States Attorney in prosecuting cases. He also served a special term as a Federal Grand Jury Agent performing criminal investigations. That included subject identification, location, surveillance, search and seizure, and criminal trial support.

Consulting Services:
Selected Consulting Examples:
  • Expert is currently serving as a compliance expert for the plaintiff in a libel suit. The defendants (corporate and individuals) published a series of newspaper articles of manufacturing and distributing unsafe pharmaceutical products. To date he has reviewed and evaluated production request (discovery) documents as well as FDA records he located on the FDA web site to evaluate the plaintiff's compliance with FDA law and regulations.
  • Expert is currently serving as a compliance expert for the plaintiff in a fraud misrepresentation suit. He located, reviewed and evaluated FDA records relevant to defendant medical device manufacturer's compliance with FDA law and regulations relevant to the manufacturer's financial interest disclosure of clinical investigators. He wrote an expert opinion and was deposed.
  • Expert served as a compliance expert for the relators in a Qui tam action. He reviewed and evaluated production request records as well as records he located on the FDA web site. He wrote an opinion letter on the state of compliance for the defendant medical device manufacturer, which was published to the United States Attorney.
  • Expert was the litigation consultant for the plaintiff/defendant (cross complaints) in a breach of contract case. He inspected a pharmaceutical manufacturing and testing facility, conducted a GLP (Good Laboratory Practices) inspection, reviewed and evaluated bioavailability and bioequivalence testing programs, and reviewed and evaluated numerous ANDA (Abbreviated New Drug Application) approvals.
  • Expert was the litigation consultant for the relator in a Qui tam action. He reviewed and evaluated clinical trial documents for evidence of violations of FDA law and regulations. He advised the attorney significance of violations as well as probable FDA response.
Recent Client Requests:
  • Expert in intota for consulting on on Experimental Design.
  • FDA expert forconsulting on FDA audit inspection.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
Expert has performed on-site inspections of manufacturing and testing facilities, reviewed and evaluated documentary evidence, provided written reports, and provided a deposition. A few cases have been in state courts (Illinois and Ohio). Cases have included product liability, personal injury, libel, breach of contract, medical malpractice, and Qui tam actions in federal and state courts.
Recent Litigation Client Requests:
  • Expert in Clinical Trial Management company's required FDA/CFR compliance.
  • Expert for consulting on GCPs and FDA Issues: Arditi vs Mannkind.
  • Pharmaceutical regulatory forensic expert for consulting on GCPs, potential fraudulent clinical data.
  • Expert for consulting on FDA product recall and marketing strategy.
  • Expert in FDA compliance on medical devices for defendant case.
  • Expert for consulting on Rx warning labels.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1999 to 1999   Maylaysia   Expert performed an on-site visit of a medical device manufacturer in Taiping. He was there as the compliance expert for the defendant medical device distributor in a breach of contract case. His duties included supervision of a medical device manufacturing expert, and identification and procurement of production request documents. Upon returning stateside, he evaluated the documents (8,000 pages), formed and wrote an opinion on the manufacturer's state of compliance with FDA law and regulations as well as the validity of the plaintiff's medical device product approvals.

Additional Skills and Services:
Training/Seminars

Expert has provided training to physicians, nurses, and post-graduated medical students. Venues have included The University of Chicago, Rush Medical University, and the University of Illinois Peoria. He taught food & drug law at the John Marshall Law School, Chicago. He has been a frequent invited guest speaker to professional and trade associations including the Regulatory Affairs Professional Society, The Association of Clinical Research Associates, The Chicago Bar Association, and The Drug Information Association. He is the author of a chapter in the expert treatise on drug injury.


 

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