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).
- 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.
- “FDA 101 for Product Liability Defense Attorneys,” ABA Mass Torts Newsletter, January 2023
- “What a Product Liability Defense Lawyer Learned While Working for FDA,” Drug & Device Law Blog, November 2022
- “Opportunities to Convert Adverse Administrative Determinations into Successful Outcomes,” Q1 Medical Device Coverage & Reimbursement Conference, Chicago, July 2022
- “Trends and Risks in Medical Device Enforcement Litigation,” Food and Drug Law Institute’s Annual Conference, Washington, D.C., June 2022
- “Updates in Litigation Risks for FDA-Regulated Companies: Product Liability, Private Litigation, Consumer Class Actions, and More,” Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference, Washington, D.C., December 2021
- Food and Drug Law Institute’s Medical Products Committee
- University of Maryland Francis King Carey School of Law, adjunct professor, Written and Oral Advocacy, 2019 and 2020 spring semesters
- The University of Iowa College of Law, J.D., 1995, with distinction,
Iowa Law Review, associate editor; American Jurisprudence Award in Constitutional Law
- Michigan State University, B.A., 1992
- District of Columbia
- U.S. District Court for the District of Columbia
- U.S. District Court for the District of Maryland
- U.S. Court of Appeals for the Third Circuit
- U.S. Court of Appeals for the Fourth Circuit
- U.S. Court of Appeals for the Sixth Circuit
- U.S. Supreme Court