As almost everyone knows, the manufacturers of COVID-19 vaccines are immune from lawsuits until later this year.
In February of 2020, then-Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act, or PREP, which allows HHS to provide protection to vaccine manufacturers unless there’s “willful misconduct,” according to CNBC. That protection, invoked as the vaccines were undergoing emergency use authorization, sunsets in October of this year, according to BioSpace — but even then, lawsuits against vaccine manufacturers will be difficult.
“Even when this immunity goes away, the vaccine manufacturers are largely immune anyway, in the sense that there’s this very complicated administrative proceeding and process that somebody has to go through first before they can ever sue a vaccine manufacturer,” said legal expert Omar Ochoa, who talked to BioSpace about the possibility that lawsuits might go forward after the PREP Act protections sunset Oct. 1.
In a completely unrelated note, Pfizer just settled over 10,000 cases in a class-action suit that alleged it hid the cancer risks of a major drug for up to $250 million, according to a report in the Financial Times earlier this month.
The suit has to do with the drug Zantac, an antacid with the active ingredient ranitidine.
Multiple drugmakers, including GSK and Sanofi, have held the U.S. patent since it became a prescription drug in 1983 and an over-the-counter treatment in 1996, according to Bloomberg.
Pfizer sold the drug between 1998 and 2006. Sanofi eventually recalled the drug in 2019 after a lab showed it released a likely carcinogen called NDMA if it was subjected to higher temperatures or left untaken over longer periods of time.
The announcement was found in what Bloomberg said was a “telltale filing” on April 29 as GSK defends itself in the first jury trial over what they knew about the drug and its potential for carcinogenic activity.
The filing said that a Chicago judge had cleared the suit to go to trial, but noted that the order only applied to GSK and one other company because “Pfizer had already settled.”
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The company said that it was a canny business move in a decision. Analysts would agree; the companies who made the drug shed $40 billion in combined value after an analyst noted that exposure to liability to the companies who manufactured the drug could total $45 billion.
“Pfizer has explored and will continue to explore opportunistic settlements of certain cases if appropriate, and has settled certain cases,” Pfizer said in a statement after the announcement on Thursday.
“The company has not sold a Zantac product in more than 15 years and did so only for a limited period of time.”
Analysts would agree, given that Pfizer shares were up 1.5 percent after the news broke on May 8. The stock has gone from 27.18 on May 1 to 28.69 as of closing on May 23.
This comes after Sanofi settled for $100 million in about 4,000 Zantac cases and GSK, which has the most liability exposure to the drug, has settled a handful of cases in California.
Of course, this is merely a reminder that pharmaceutical companies are merely human and run by fallible beings. It’s also a reminder that flaws in a drug can come long after it’s introduced; Zantac hit the market in 1983 and we’re just seeing court cases reach juries now.
This, of course, means that any side effects — temporary or permanent — caused by Comirnaty, the brand name for Pfizer’s COVID-19 vaccine, won’t ever go to the judge no matter when they’re found.
“It is very rare for a blanket immunity law to be passed,” Rogge Dunn, a Dallas labor and employment attorney, told CNBC at the time that PREP was invoked to provide Pfizer and Moderna with blanket immunity for their COVID vaccines.
“Pharmaceutical companies typically aren’t offered much liability protection under the law.”
Meanwhile, as we also now know, the vaccines were rushed to market in a race to beat or treat COVID, meaning that issues — including what BioSpace noted were “cardiovascular and respiratory outcomes” — were likely overlooked. And just because the PREP Act sunsets in October of this year, that doesn’t mean that it won’t be re-invoked if Congress or the White House is in the wrong hands.
But, of course, none of that has anything to do with Zantac. Nothing to see here, folks. Move along!
