Back in December 2020, CNBC reported that Americans who suffer severe side effects after vaccination and intend to sue may find themselves in a losing endeavor. According to the report, former Department of Health and Human Services (HHS) Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness (PREP) Act in early 2020. The 2005 legislation empowers the health secretary to provide legal protection to companies making or distributing critical medical supplies – including vaccines.
This protection will last until 2024, which means that vaccine manufacturers such as Pfizer and Moderna "cannot be sued for money damages in court" for the next three years. Furthermore, they cannot be sued over injuries related to the administration or use of vaccines and other products to treat or protect against COVID-19. However, this legal protection will not apply if there is evidence of "willful misconduct" by the company.
Dallas labor and employment attorney Rogge Dunn put forward two possible reasons why companies such as Pfizer have demanded overarching legal immunity. First, the immunity is a response to authorities' requests to expedite vaccine development. "When the government said, 'We want you to develop this [vaccine] four or five times faster than you normally do,' most likely the manufacturers said to the government, 'We want you … to protect us from multimillion-dollar lawsuits,'" he said.
Another reason Dunn cited is that legal immunity helps lower the cost of immunizations per person. "The government doesn't want people suing the companies making the [COVID-19] vaccine. Because then, the manufacturers would probably charge the government a higher price per person per dose," he explained.
The lawyer ultimately remarked: "It is very rare for a blanket immunity law to be passed. Pharmaceutical companies typically aren't offered much liability protection under the law."
Pfizer has been given legal immunity in the U.S., courtesy of the PREP Act. The company now seeks legal immunity in other countries in case something goes wrong with its BNT162b2 vaccine for COVID-19. It managed to obtain this immunity in a number of Central and South American nations, but failed to do so in Argentina and Brazil. The two countries claimed the drug giant "bullied" them in vaccine negotiations.
Talks between Argentina and Pfizer began in June 2020, with Argentinian President Alberto Fernandez meeting with the drug manufacturer's top official for the country. In October 2020, the Argentinian parliament passed a law making Pfizer liable for negligence at the minimum – which did not sit well with the drugmaker. The company demanded that the law be amended through a new decree despite the country offering to make the law's definition of negligence clearer. (Related: Pfizer is threatening governments around the world and demanding RANSOM to protect against future vaccine injury lawsuits.)
Aside from this, Pfizer asked Argentina to buy international insurance to pay for potential future cases against the pharmaceutical firm. The company returned with more demands in December 2020. It asked Argentina to put up its bank reserves, military bases and embassy buildings as collateral, but the South American country did not agree with this. The deal did not prosper, which left Argentina's citizens with one less choice for a COVID-19 vaccine. Former Argentinian Minister of Health Ginés González Garcia commented: "Pfizer misbehaved with Argentina. Its intolerance with us was tremendous."
Pfizer later applied the same strong-arming tactics during its vaccine negotiations with Brazil. It asked the largest South American country to create a guarantee fund and deposit money in a foreign bank account. However, Brazil did not cave into the pharmaceutical firm's demands.
The Brazilian Ministry of Health released a statement on Jan. 23. It cited a number of excerpts from Pfizer's pre-contract clauses, which the Brazilian government slammed as "abusive." The clauses mentioned in the statement demanded that Brazil waive the sovereignty of its overseas assets in favor of Pfizer. It also asked that Brazilian law be not applied on Pfizer -- essentially exempting it from civil liability in case Brazilians experience post-vaccination side effects. Furthermore, the clauses also demanded Brazil take possible delivery delays into consideration and not penalize Pfizer for these delays.
Because of this, Pfizer's potential vaccine deal with Brazil fell through. Legal experts have remarked that the firm's demands on Argentina and Brazil amount to an "abuse of power."
According to public health law expert Lawrence Gostin, drug manufacturers such as Pfizer "shouldn't be using their power to limit life-saving vaccines in low- and middle-income countries." Gostin is the director of the World Health Organization's Collaborating Center on National and Global Health Law. He added that companies such as Pfizer should not use protection against liability as a “sword of Damocles hanging over the heads of desperate countries with a desperate population."
Check out BigPharmaNews.com for more news about drug manufacturers' bullying and abusive demands.