Clot Warnings Urged as J&J Vaccine Liability Shield Stays Strong

Health providers administering Johnson & Johnson’s Covid-19 shot still have robust protection from liability for adverse effects after the nationwide pause, even if they don’t pass out updated fact sheets detailing the risk of rare blood clots.

It’s a high bar to sidestep the immunity shields granted under a 2005 public readiness law, which safeguards vaccine makers, administrators, and other entities from lawsuits unless there’s willful misconduct, attorneys say.

Still, giving a verbal warning along with a written one is likely a best practice for providers as the U.S. vaccination effort continues.

“The combination of public information and the fact sheet is adequate, but I would love to see vaccinators saying a couple things to the people getting vaccinated,” Nancy E. Kass, a bioethicist and vice provost at Johns Hopkins University, said.

The immunity law showcases the interplay between the need to quell fear of liability and the duty to inform—highlighting how striking the right balance is critical in an inoculation campaign as large as the one for Covid-19. Some vaccine advisory panelists said in April, in discussions after the panel voted to lift the freeze, that they feared patients might not be properly warned about the risk of clots.

New Fact Sheets

U.S. health agencies paused use of J&J’s vaccine for 10 days last month while they investigated reports of the shot causing blood clots in a handful of women. Officials identified 28 cases out of 8.7 million doses of J&J’s vaccine administered in the U.S., the Centers for Disease Control and Prevention said in a presentation posted May 12.

Federal officials April 23 voted to resume the vaccine’s use after doctors decided the chance of clots were low enough that the benefits of the shot outweighed potential risks. The agencies, in tandem with J&J, updated the product’s fact sheet for providers and recipients with a warning and the symptoms to watch for.

Patients should receive those sheets when they get their shots. But lifting the pause didn’t add new legal requirements to discuss the risk and benefits with each patient, “just that the fact sheets are handed out,” Bethany Hills, a partner at Morrison & Foerster LLP, said.

And even if administrators forget to hand out the fact sheet to a recipient and that person developed a clot, the liability shield likely still applies, Peter Meyers, professor emeritus at George Washington University Law School and former head of the school’s vaccine injury litigation clinic, said.

It’s “very, very likely that forgetting to do something would not rise to the level of doing something intentionally to achieve a wrongful purpose,” he said.

‘Pretty High Bar’

The pause in administration rattled some Americans’ confidence in the vaccine, and since then demand for Covid-19 shots of all kinds have diminished. Decreased demand means most of the people eager for a shot have already gotten one, and health officials will have to work harder to reach hesitant communities.

Liability shields are important because they encourage more administrators and businesses to get involved in distributing vaccines. The quicker shots are administered, the sooner regular life can resume, health officials say.

The Public Readiness and Emergency Preparedness (PREP) Act of 2005 protects vaccine administrators from liability if a recipient dies or is injured from the inoculation. The Department of Health and Human Services has updated the PREP Act several times to broaden the scope of people and entities it protects, which now ranges from vaccine administrators to distributors to coordination planners.

The law doesn’t protect covered entities from liability “for death or serious physical injury caused by willful misconduct,” which has strict criteria to prove in court. The criteria include showing “an act or failure to act that is taken intentionally to achieve a wrongful purpose,” among other things.

That’s a “pretty high bar,” John Lavelle, a partner at Morgan Lewis, said recently at a Covid-19 liability webinar held by the firm.

Addressing Side Effects

People administering vaccines typically warn patients about side effects they could experience post shot—like fever, soreness, or fatigue.

Briefly going over the risks in the fact sheet along with common side effects will benefit people who wake up the next day with normal side effects as well as those who need to seek medical treatment immediately, Kass said.

She suggested doctors administering the J&J vaccine give a brief verbal warning about symptoms to look out for up to three weeks after inoculation that require immediate attention, such as severe or persistent headaches, chest pain, or leg swelling.

Highlighting with a marker sections of the fact sheet about problematic symptoms that require immediate attention is also a good practice, Kass said.