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Covid Vaccines’ Emergency Status Doesn’t Bar Mandates: DOJ (1)

July 26, 2021, 7:09 PMUpdated: July 26, 2021, 10:14 PM

The Covid-19 vaccines’ status as an emergency product—which has fueled lawsuits against vaccination mandates—doesn’t prohibit employers, universities, or other entities from requiring inoculations, the U.S. Justice Department said.

The language in federal drug approval law cited by legal challengers only says that certain information should be provided to potential vaccine recipients, the department’s Office of Legal Counsel said in a memo seen by Bloomberg Law Monday.

Although the OLC memo isn’t binding authority and thus doesn’t guarantee court approval of a vaccine mandate, it provides a boost to employers and others that either have imposed such a requirement or are considering it.

The memo, dated July 6, became public as concern is growing that unvaccinated Americans are contributing to the rapid spread of the Delta variant of the coronavirus. It signals that the White House is beginning to embrace vaccine mandates, a sharp departure from the Biden administration’s earlier hesitancy on the subject.

Further demonstrating the Biden administration’s pivot, the Department of Veterans Affairs announced Monday that it will require doctors, nurses, and other health-care personnel at Veterans Health Administration facilities to get vaccinated. The White House views private-sector employer mandates as potentially beneficial, according to spokeswoman Jen Psaki.

“Beyond the president’s goals, it may save lives,” Psaki said during a press briefing Monday. “That’s the most important factor in our view.”

California authorities said Monday that state employees must prove they’re vaccinated or wear masks and get tested weekly for Covid-19. Those rules apply for workers in all health-care facilities in California, except they must be tested twice weekly. New York City officials also announced that city workers must be vaccinated or wear masks and get tested weekly.

So far in the private sector, universities and health-care facilities have led the way on vaccination mandates. Some major hospitals, including New York Presbyterian Hospital and Houston Methodist Hospital, have requirements in place. Hundreds of colleges have mandates for students, with many extending to faculty and other staff.

Emergency Authorization

The legal controversy over mandating vaccines while they’re under emergency authorization stems from language in the Food, Drug and Cosmetic Act saying individuals have an option to refuse them. That section was cited in lawsuits challenging workplace mandates at Houston Methodist, Los Angeles Unified School District, a New Mexico detention facility, and a North Carolina sheriff’s department. It was also included in a lawsuit against Indiana University’s mandate for students.

A federal judge threw out the Houston Methodist lawsuit, saying the language on emergency use products applies to powers and obligations of the head of the U.S. Department of Health and Human Services, not a private employer. The federal judge who rejected an initial bid to block Indiana University’s mandate said the language directs HHS to establish conditions to allow for informed consent.

In the OLC memo, Justice Department lawyers said the plain language of the section on emergency use authorization, known as EUA, concerns only the provision of information to vaccine recipients. The FDA agrees that the section places no restrictions on the ability to require an EUA product, the memo said.

“Indeed, if Congress had intended to restrict entities from imposing EUA vaccination requirements, it chose a strangely oblique way to do so, embedding the restriction in a provision that on its face requires only that individuals be provided with certain information,” government lawyers said in the memo. “Congress could have created such a restriction by simply stating that persons (or certain categories of persons) may not require others to use an EUA product.”

VIDEO: As employers are making plans to return to their workplaces. How quickly they succeed will likely depend on how many of their employees get vaccinated.

‘Nonsense’ Argument

Courts generally don’t defer to OLC memos when interpreting laws, though they sometimes look to and learn from the office’s analyses of complex statutes, said Daphna Renan, a Harvard University law professor and former OLC attorney during the Obama administration.

The memo on EUAs and mandates could provide ammunition to counter a company’s risk-averse general counsel who cites the emergency authorization issue as a reason against imposing a vaccination requirment, said Nicholas Bagley, a University of Michigan law professor who’s written about health law and regulatory policy. The memo further clarifies that the EUA-based argument against mandates is “nonsense,” he said.

But company lawyers are mainly dodging the hard questions about mandates when they point to the debate over requiring vaccines approved as emergency products as a reason not to impose requirements, Bagley said.

“What’s holding back employers is not fear of litigation,” he said, “so much as it is fear of alienating their employees.”

(Updated with additional reporting throughout.)

To contact the reporters on this story: Robert Iafolla in Washington at riafolla@bloomberglaw.com; Courtney Rozen in Washington at crozen@bgov.com

To contact the editors responsible for this story: Jay-Anne B. Casuga at jcasuga@bloomberglaw.com; Andrew Harris at aharris@bloomberglaw.com

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