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J&J Vaccine Liability Shield a Boon Despite Rare Blood Clots (1)

April 14, 2021, 7:59 PM; Updated: April 14, 2021, 9:47 PM

Johnson & Johnson, AstraZeneca plc, and other Covid-19 vaccine makers are shielded from liability for adverse effects on recipients, and attorneys say the protections are a boon for medical innovation that’s critical to combating the pandemic.

A vaccine advisory panel for the Centers for Disease Control and Prevention met on Wednesday to discuss how to move forward with the J&J vaccine after seven women developed rare and dangerous blood clots following their shots. The CDC’s Advisory Committee on Immunization Practices didn’t make a recommendation and said it will find a time to reconvene—leaving the vaccine on pause.

U.S. officials on Tuesday called for the nationwide pause, but they only expected it to last a few days. Removing the J&J from the vaccination rotation, even for a few weeks, could hamper efforts to give the shot to hard-to-reach communities.

Roughly 7 million Americans have gotten the J&J vaccine, which makes these adverse cases extremely rare. But the incidents highlight how drugmaker protections are essential for enabling fast-paced clinical trials and output when speed is key to a national response to an emerging health threat.

Health lawyers say fear of liability could dissuade manufacturers from jumping into the vaccine space during a public crisis, given the risk of complications—even rare ones—from any new treatment.

Shielding companies from being sued is “one of the ways we’re substantially encouraging manufacturers to get involved in producing the Covid-19 vaccine,” Peter Meyers, professor emeritus at George Washington University Law School and former head of the school’s vaccine injury litigation clinic, said.

“We have to accept for vaccines—or any medications—there is a very, very small number of people who will have serious adverse reactions,” he said.

The women who reported the rare blood clots—and others injured from vaccines—would be unlikely to prevail in litigation unless they could prove willful misconduct on behalf of the company under a federal emergency preparedness law and a congressional injury compensation program.

There’s no evidence to suggest J&J hid data about blood clots from federal regulators, and it’s still unclear if the vaccine directly caused them. One woman has died, and several are still in the hospital. One has been discharged.

Even if blood clotting or other injuries are found to be caused by the vaccine, health officials say the benefits of vaccine production still far outweigh the limited risks. Nora Freeman Engstrom, a Stanford Law professor and vaccine injury researcher, is among those who argue getting vaccinated is still the right choice.

“Knowing all I know about vaccines and vaccine injury, I did not hesitate to get vaccinated—and I got my shots with confidence that I was making the right choice for my own health and the welfare of our communities,” she said.

Reputation Is Essential

The threat of being sued is usually the main deterrent for shady behavior, but Meyers said that companies like J&J have enough on the line without lawsuit fear to encourage them to be as cautious as possible with their vaccines.

“It could destroy the corporation” if regulators found J&J was hiding information, Meyers said. “Their reputation is so important, and in this instance I do not think you need the possibility of legal liability here” to pressure them to be cautious with adverse events.

The Countermeasures Injury Compensation Program, launched by Congress in 2005, shields vaccine manufacturers from liability unless there’s willful misconduct, such as not disclosing unfavorable clinical trial findings.

Federal officials have extended similar liability shields through the Public Readiness and Emergency Preparedness (PREP) Act of 2005 to other companies making Covid-19 products, including tests, drugs, and vaccines.

That law authorizes the Secretary of the Department of Health and Human Services to issue a declaration that provides immunity from liability for claims of loss relating to the administration or use of “medical countermeasures” in responding to a public health emergency.

Those injured from Covid-19 vaccinations can turn to the CICP for compensation. The program isn’t without its critics, however, many of whom characterize its operations as opaque and slow moving.

“CICP is outside the legal system with no court, judge, or right to appeal to a higher court and very little compensation awarded,” said Altom Maglio, managing partner at Maglio Christopher & Toale PA. “It is entirely unclear how a right to compensation would be determined as that is done in secret.”

Warranted Risk

So far the evidence for Covid-19 vaccines show they’re overall “extraordinarily” safe and effective, Meyers said. And Covid-19 vaccine injury reports are exceedingly rare—for J&J and other companies.

“There are risks in any medical treatment including taking an aspirin or receiving a vaccination. Determining how to balance those risks is what public health officials are doing right now,” Maglio said.

For J&J, it remains to be seen whether the vaccine itself caused the blood clots.

“People are getting blood clots all the time,” Meyers said. “How do you determine the vaccine was a substantial factor in causing the injury?”

“We have to accept this is the kind of risk benefit analysis,” he added. “Nothing is ever 100% safe for everybody every time.”

(Updates with result of CDC advisory committee meeting in the second and third paragraphs.)

To contact the reporters on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com; Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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