Examples of James’ experience include:

Private practice experience

• Assisting a biotechnology company in successfully challenging FDA’s denial of its request for orphan drug designation.
• Conducting FDA-related due diligence for a client’s acquisition of a company that markets an OTC drug, dietary supplements, and cosmetics.
• Developing federal preemption arguments that persuaded a potential consumer class action plaintiff to not file suit against an OTC drug manufacturer.
• Advising drug manufacturers on responding to FDA Form 483s (Inspectional Observations) regarding cGMP issues.
• Advising a drug manufacturer on issues relating to an FDA Risk Evaluation and Mitigation Strategy (REMS).
• Advising a medical device manufacturer on FDA requirements for investigating possible device malfunctions.
• Writing a post-trial motion that resulted in a 99.6% reduction of a $9 billion punitive damages verdict against the defendants in a pharmaceutical product liability trial (then reported to be the seventh largest punitive damages verdict in U.S. history).
• Having primary responsibility for legal briefing in four federal multidistrict litigation (MDL) proceedings, two statewide coordinated proceedings, and many other federal and state cases throughout the country.
• Serving as a member of on-site motions and/or witness preparation teams for 10 multi-week jury trials (including MDL “bellwether” trials) in Minnesota, Missouri, New York, New Jersey, and Ohio).

FDA experience

• Obtaining summary judgment or dismissal for FDA in three cases in which generic drug manufacturers sought Hatch-Waxman marketing exclusivity for their products.
• Obtaining summary judgment for FDA in a case in which a drug manufacturer challenged the agency’s denial of its request to reclassify its drug as a biological product under the Biologics Price Competition and Innovation Act.
• Serving on a DOJ/FDA trial team that won a six-day trial in the Central District of California in which the government obtained an injunction preventing an OTC drug manufacturer from selling its products.
• Drafting amicus curiae briefs for FDA that resulted in decisions from the U.S. International Trade Commission and U.S. Court of Appeals for the Federal Circuit holding that the FDCA precluded a prescription drug manufacturer’s Lanham Act and Tariff Act claims against dietary supplement manufacturers.
• Drafting FDA’s submission in support of a California administrative agency’s proposed regulation exempting coffee from the state’s Proposition 65 cancer-warning requirement. The submission explained that the FDCA would preempt such a warning; the regulation was subsequently adopted.
• Obtaining dismissals of challenges to FDA labeling decisions regarding foods, cosmetics, and tobacco products.
• Advising FDA officials on responding to Citizen Petitions requesting regulatory actions regarding medical devices and cosmetics.