The Principals of Olsson Frank Weeda Terman Matz (OFW Law) are pleased to announce the promotion of Kristen O’Brien, Mason Weeda and John Dillard to Principal Attorneys at the firm. Kristen, Mason and John have all produced excellent work, and have demonstrated deep dedication and commitment to our clients. We welcome them as Principal Attorneys, and look forward to their continued provision of value to our clients in their new roles.
Kristen O’Brien serves as a Principal in OFW’s Health Industry Policy and Regulatory Practice. She is principally responsible for the group’s work with health care delivery system clients, including large physician groups, integrated health systems and other provider organizations. She also represents biopharmaceutical companies relating to government payment issues. In this capacity, she provides both substantive legal and regulatory advice, in addition to direct advocacy before government decision-makers.
Kristen is especially active in providing legal analysis and counsel related to government health payment programs under Medicare and Medicaid. Her areas of substantive focus include the Quality Payment Program (QPP), Alternative Payment Models (APMs), Meaningful Use (MU), and the Center for Medicare and Medicaid Innovation (CMMI). In particular, she has advised clients on aligning reporting requirements, improving quality and reducing costs.
Kristen also has significant experience navigating efforts to reform the health care industry, including providing counsel related to both the passage and reform of the Affordable Care Act. Moreover, Kristen has substantial experience working to implement new laws through the rulemaking process, as well as working with relevant agency officials to develop regulations and other agency guidance. In particular, she has considerable experience working with the Centers for Medicare & Medicaid Services (CMS), the Office of Civil Rights (OCR), the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Program Integrity (CPI).
Mason Weeda is a Principal with OFW Law and devotes his practice to a blend of matters, principally representing FDA regulated medical device, drug, and food manufacturers, distributors, and importers. In addition, Mason provides counsel to trade associations and commodity groups that include FDA or USDA regulated industry. Mason also has an expertise in advising software and application developers, particularly where “protected health information” is used, stored, or disclosed under HIPAA, or where such software or applications include promotion of FDA regulated products.
Mason advises clients principally in the following areas:
- FDA regulated product applications and approvals, ranging from Premarket Clearance (510(k)) applications for medical devices, to Drug Master Files for drug-related products, to Temporary Marketing Permits for foods
- FDA and USDA enforcement and administrative matters including, without limitation, counsel regarding Warning Letters, Complaints for Injunctive Relief and Consent Decrees, Citizen Petitions, and Trade Complaints
- FDA and FTC promotion and advertising compliance, including promotion of medical devices and drugs (e.g., “off-label promotion”), and compliance with Federal Anti-kickback Statute, Sunshine Act, CAN-SPAM, other laws that may apply to advertising and promotion of FDA-regulated products
- Legislative and regulatory policy strategy, including comments on relevant rulemaking and agency guidance
- Import issues involving FDA and USDA regulated products, including import alerts, holds, detentions, and refusals, and Customs and Border Protection petitions regarding liquidated damages
- Compliance with FDA Food regulations, including food labeling, dietary supplement promotion, formulation and ingredients, and FSMA requirements, including preventive controls
- Compliance with the Health Insurance Portability and Accountability Act (HIPAA), including breach reporting, Business Associate Agreements, Privacy and Security Rule compliance, regulatory audits, and HHS enforcement.
- Qui Tam (False Claims Act) defense
- Trade association governance and general counsel
- Regulatory due diligence opinions regarding the purchase or merger of a FDA or USDA regulated entity or product
In addition to the above, Mason teaches Food and Drug Law to new employees at FDA’s Center for Device and Radiological Health, and is a frequent presenter at local and national symposiums and trade events.
John Dillard is a Principal at OFW Law. He provides regulatory counsel, general counsel, and litigation services to clients in the agriculture and food industries.
In his regulatory practice, John provides advice to companies and trade associations on diverse topics affecting clients in the food and agriculture industries. This includes food labeling and food safety matters before USDA’s Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA). John advises meat packers, poultry processors, restaurant chains, and animal food manufacturers on food safety and labeling matters. He also regularly advises clients on compliance with the Packers and Stockyards Act, the National Bioengineered Foods Disclosure Standard, and the National Organic Program. John is also a Preventive Controls Qualified Individual (PCQI) for human and animal foods and has completed the FSPCA PCQI Lead Instructor training for animal food facilities.
John also provides general counsel services to several food and agricultural trade associations, such as the American Feed Industry Association, the National Association of Wheat Growers, and the National Institute of Oilseed Products. In this role, he provides advice on corporate governance, contract drafting and evaluation, antitrust, director fiduciary responsibilities, and employment matters.
John also represents clients in litigation in state and federal civil matters and USDA administrative enforcement proceedings. John has litigated cases involving Clean Water Act disputes, livestock nuisance odor torts, Packers and Stockyards Act enforcement, Animal Welfare Act enforcement, biotech seed patenting, country-of-origin labeling requirements, and Native American agriculture. John has also represented the interests of trade association clients that have participated in several high-profile agricultural law cases.
John’s specific experience includes:
- Successfully representing a dissenting class representative in the post-settlement phase of a major Native American civil rights class action case. The revised settlement resulted in an additional payment of $77 million to class members.
- Representing a feed manufacturer in a civil case initiated by a U.S. Attorney seeking a permanent injunction based on allegations of adulterated and misbranded medicated feed. John coordinated with coordinated efforts with feed manufacturing experts and negotiated a favorable consent decree with FDA and the Office of the U.S. Attorney.
- Assisting in coordinating a major global labeling and advertising compliance project involving numerous foreign markets for a major restaurant chain.
- Representing a large, private zoo in an administrative license revocation proceeding initiated under the Animal Welfare Act by USDA’s Animal and Plant Health Inspection Service’s Animal Care Division. John successfully defeated USDA’s motion for summary judgment and assisted in negotiating a consent decree resulting in no suspension or revocation of the establishment’s license.
- Representing numerous livestock dealers in administrative enforcement proceedings under the Packers and Stockyards Act.
John obtained his undergraduate degrees in Animal and Poultry Sciences and Agricultural and Applied Economics from Virginia Tech. He earned a master’s degree in Agricultural Economics from Purdue University and his law degree cum laude from the University of Richmond. John has an extensive background in agriculture dating back to his family’s beef cattle operation in Virginia. He speaks extensively to producers, manufacturers, and fellow counsel and writes columns on legal and policy issues for Farm Journal and National Provisioner.