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A.J. Carvalho

A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance matters across the full product lifecycle. He partners with clients to navigate complex product quality requirements, respond to enforcement risks, and resolve challenges that arise during product development and commercialization, with a focus on achieving practical, business-oriented outcomes.

A.J. brings investigations and white collar experience that allows him to counsel companies through government inquiries, internal reviews, and high-stakes compliance matters, especially in cross-practice contexts. He regularly advises on inspection readiness, FDA Form 483 responses, data integrity reviews, and other significant compliance events arising from agency inspections and enforcement activity both domestically and around the globe. A.J. frequently works closely with Covington’s investigations, litigation, and transactional teams to ensure regulatory strategies are integrated with clients’ other legal concerns and overarching business goals.

Prior to joining the Food, Drug, and Device Practice Group, A.J. was a member of the firm’s Patent Litigation and White Collar Defense and Investigations Practice Groups. He has represented innovative pharmaceutical and biotechnology companies in Hatch-Waxman patent litigation and advised life sciences clients in connection with civil and criminal investigations by the Department of Justice and FDA, helping clients manage risk and advance strategic objectives. He leverages this experience to inform his regulatory advising and better understand his client’s business goals.

Before entering private practice, A.J. served as a clinical research coordinator at Walter Reed National Military Medical Center, where he conducted exploratory research on blast injuries, advanced prosthetics, and related conditions. His work has been published in numerous peer-reviewed scientific journals.

A.J. maintains an active pro bono litigation practice alongside his client work. He was named a Young Lawyer of the Year by the Bar Association of the District of Columbia in recognition of his leadership in fundraising for DC Legal Aid’s 2025 Making Justice Real Campaign.

Contact:Read more about A.J. CarvalhoEmail

As discussed in our previous post, multiple federal courts have issued preliminary injunctions blocking the Biden Administration’s COVID-19 vaccine mandate for employees of federal contractors.  On January 27, 2022, the United States District Court of Arizona issued a new and additional injunction barring enforcement of the mandate within the State of Arizona.  In so doing, the Arizona court added to the injunctions previously issued by the U.S. District Courts for the Eastern District of Kentucky, Western District of Louisiana, Eastern District of Missouri, Middle District of Florida, and Southern District of Georgia.

The Georgia injunction is the only one of the rulings that applies nationwide.  Like the Arizona injunction, the Missouri, Florida, and Kentucky injunctions are limited to specific states (collectively, Kentucky, Ohio, Tennessee, Missouri, Nebraska, Alaska, Arkansas, Iowa, Montana, North Dakota, South Dakota, Wyoming, and Florida).  The Louisiana injunction is also limited, but its limitations are based on entities rather than geography; it applies to contracts and other agreements between the federal government and the governments of Louisiana, Mississippi, and Indiana.  The Biden Administration has appealed these earlier decisions; we expect that an appeal of the Arizona decision to the Ninth Circuit will likewise be forthcoming.

At the same time, the Biden Administration’s other primary COVID-19 initiative for large employers — the vaccination and testing emergency temporary standard issued by the Occupational Safety and Health Administration (the so-called “OSHA Mandate”) — was stayed by the United States Supreme Court on January 13, 2022.  In the wake of that decision, OSHA announced on January 25, 2022 that it is withdrawing the enforceable emergency temporary standard.

While the Supreme Court’s decision halted immediate application of the OSHA Mandate, the emergency temporary standard qualifies as a proposed rule for purposes of OSHA’s notice-and-comment rulemaking process under 29 U.S.C. § 655, and OSHA has announced that it will continue to consider the emergency temporary standard pursuant to that process.  Accordingly, OSHA could attempt to promulgate a final rule (as opposed to an emergency temporary standard) that addresses vaccines or testing requirements.

The rest of this post consists of (1) an overview of the Arizona decision regarding the federal contractor vaccine mandate; and (2) an update on the status of the other challenges to the federal contractor vaccine mandate, including the Kentucky, Louisiana, Missouri, Florida, and Georgia litigations.Continue Reading COVID-19 Vaccine Mandate Update: Arizona District Court Issues Additional Injunction; Mandate Remains Enjoined Nationwide; OSHA Mandate Withdrawn

Several federal courts have issued preliminary injunctions blocking the Biden Administration from enforcing its federal contractor COVID-19 vaccine mandate.  As discussed in our previous posts, President Biden issued Executive Order 14042 mandating that employees of federal contractors and subcontractors be vaccinated against COVID-19 and take various other workplace safety measures.  Executive Order 14042 relies on the president’s authority under the U.S. Constitution and the Federal Property and Administrative Services Act (“FPASA”) to effectuate this policy.  Prior to issuance of the injunctions, contractors were required to have covered employees fully vaccinated by January 18, 2022.
Continue Reading Contractor COVID-19 Vaccine Mandate Blocked Nationwide – UPDATE

On September 24, the Safer Federal Workforce Task Force released guidance on workplace safety protocols for federal contractors and subcontractors related to COVID-19 (“the Guidance”).  The Guidance was issued pursuant to President Biden’s Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

As expected, the Guidance covers a broad range of contract types and contractors, and mandates COVID-19 vaccinations for covered contractor employees along with masking and social distancing measures to prevent the spread of the disease.  But it also includes some unanticipated exceptions.  The Guidance sets baseline requirements under the Executive Order that are expected to be updated over time and implemented through a contract clause that will be issued by the Federal Acquisition Regulatory (“FAR”) Council.  Federal contractors should carefully examine the Guidance and ensure that they are prepared to timely comply as well as monitor for and adapt to any updates from the Task Force.

Our prior post on the Executive Order can be found here.Continue Reading Task Force Releases Guidance on New COVID-19 Vaccine Mandate for Federal Contractors

On September 9, the Biden Administration released a number of new details for its Path out of the Pandemic that will impact U.S. Government contractors and a number of other individuals and entities.  In addition to requiring most executive agency employees to receive COVID-19 vaccines, the Administration plans to mandate that executive agency contractors and subcontractors, with some exceptions, impose similar requirements on their employees pursuant to an executive order that will fully go into effect on October 15, 2021.  The overall impact of the executive order will not be clear until additional details are released in the coming weeks, but government contractors should begin considering the implications of the new requirements and take steps to ensure timely compliance.
Continue Reading COVID-19 Vaccine Requirements for U.S. Government Contractors