Volunteer Professor of Law, University of Cincinnati - CC
Member of the Law Council
James O'Reilly is a Volunteer Professor of Law at University of Cincinnati. He counsels large and small drug, biotech, device and food firms. Prof. O'Reilly's 41 books and 175 articles have been widely cited, and as an FDA expert over many years, he has led trade association and NGO projects dealing with complex FDA approval, recall and enforcement issues. His book on crisis management and his work on product warnings in text and articles have been widely followed. Prof. O'Reilly's federal consulting assignments for the FTC Chairman's office, EPA, Congressional Office of Compliance and Administrative Conference and numerous expert witness and consulting roles have given broad experience on FDA and tort liability issues. He previously worked at The Procter & Gamble Company as Associate General Counsel for 24 years. As the Company's principal regulatory counsel, he worked closely with internal clients and with industry coalitions on EPA, FDA, regulatory agency and Congressional matters. (This is me - Update Profile)
Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
No Company is Bullet-Proof Against Federal Contractor Risks
June 10, 2008
U.S. sues Honeywell over bullet-proof vests | www.latimes.com
Product liability exposure of new materials makers can be severe, especially with fatal consequences of failures Internal memos re product problems can shoot company in the foot; prudent firms have a plan for controlling open-ended speculative memos in an instant-message environment Major PR and govt. contract risk of "getting it wrong" with new materials under expected stressful conditions makes this a good warning to upstream materials suppliers.
Controversy Bred By Under-Regulation: Are Genes Too Casual?
February 4, 2008
Growth of Genetic Tests Concerns Federal Panel | www.nytimes.com
Recent reports by a federal study panel, addressed in stories in the NY Times and other sources, highlight one more gap between expectations and reality in the resource-starved federal safety net for consumers. Much less is being done to oversee Gene Test kits than consumers may expect; eventually there will be a public outcry when some real harm is documented. This Administration has prided itself on responsiveness to industry's preferences, yet choices to not regulate leave open the federal agencies as well as the industry to a backlash when future harms occur.
Paint Industry Needs Global Lead Settlement Quickly
May 9, 2007
Lead paint industry on the defensive | www.lawyersweeklyusa.com
"Son of Asbestos" claims may sound extreme; but the lead paint makers would be prudent to collectively negotiate and fund a 50-state settlement that follow the tobacco companies' model and avoids the bankruptcy model of the asbestos-using firms. Lead injury awareness has increased and demands for public protection will escalate. Paint and related product industries knew of risks long before the warnings and bans, so their parallels to asbestos defendants are likely to bring juries to similar sized awards. Lobbyists can buy time but not buy peaceful continued business operations. As author of studies on building safety, toxic torts and on product warnings liabilities, I see only a matter of a few years before asbestos-like liabilities will inevitably crush those who don't choose a global settlement of the lead legacy.
| Study Group Name | No. Members |
|---|---|
| Medical Device Experts | 319 |
| Pharmaceutical Regulation and FDA Experts: Lawyers | 48 |
August 25, 2005 | Los Angeles
GLGi: FDA RecallsAugust 25, 2005 | San Francisco
GLGi: FDA RecallsAugust 17, 2005 |
GLGi: FDA RecallsAugust 5, 2005 |
GLGi: FDA Recalls