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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.

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.

• 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.

• Expert in intota for consulting on on Experimental Design.
• FDA expert forconsulting on FDA audit inspection.

• Expert for consulting on GCPs and FDA Issues: Arditi vs Mannkind.
• Pharmaceutical regulatory forensic expert for consulting on GCPs, potential fraudulent clinical data.