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Ebola Drug Makers Could Be Immune From Liability Under 2005 Law

If the Department of Health and Human Services declares a public health emergency, manufacturers could benefit from a liability waiver, even if potential risks were known before the drugs were used.

Posted on October 14, 2014, at 9:33 a.m. ET

Jaime R. Carrero / Reuters

WASHINGTON — Vaccine manufacturers scrambling to get Ebola-related products to market could enjoy nearly unlimited immunity from lawsuits, thanks to language inserted into a defense spending bill under questionable circumstances days before Congress headed home for Christmas in 2005.

The language allows the secretary of the Department of Health and Human Services (HHS) to provide blanket liability immunity to manufacturers of vaccines and other "countermeasures" after declaring a public health emergency in response to a pandemic.

Specifically, the language reads:

if the Secretary makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency, the Secretary may make a declaration, through publication in the Federal Register, recommending, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, and stating that subsection (a) is in effect with respect to the activities so recommended.

The law also bars any judicial review of claims against companies that manufacture the vaccines covered by the liability waiver. Only in the case of narrowly defined "willful misconduct" could someone injured by a vaccine — or the family of people who lost their lives as a result of a covered drug — file suit in federal court.

Shortly after midnight on Sunday, Dec. 18, 2005, former Senate Majority Leader Bill Frist and former Speaker Denny Hastert inserted the liability provisions into the fiscal year 2005 Defense Department appropriations bill.

The move was highly unusual. Not only did it come during a then-rare weekend session in which Congress was rushing to wrap up work before Christmas, but it appears to have been included after House and Senate negotiators had agreed to a deal on the bill that did not include the provision.

At the time, outbreaks of avian bird flu had raised fears of a massive pandemic that could catch governments off guard. Frist and other supporters argued the language was critical to ensuring vaccines could be quickly provided in case of an outbreak.

Still, the exemption was not without its critics. Rep. John Conyers argued that if HHS declares a public health emergency and designates a vaccine as a countermeasure, even if it is later demonstrated that the company knew of potential risks, "families who are trying to gain compensation for their losses are left without recourse."

Similarly, former Rep. Dennis Kucinich, for instance, harshly criticized the proposal before it was included, argued it constituted a "massive holiday gift to the pharmaceutical industry. … Liability is not the reason for vaccine shortages, especially in the case of avian flu."

Indeed, vaccines have become an increasing part of the pharmaceutical industry's business over the last decade.

According to the World Health Organization, vaccines, while still a small part of overall global drug sales, have shown 10–15% growth per year, and have gone from a $5 billion market in 2005 to nearly $24 billion in 2013.

The pharmaceutical industry is a significant player in U.S. politics, as well. According to Open Secrets, since the 2006 cycle, political contributions by individuals in the industry and associated political action campaigns tops more than $150 million.

Congress appears to have approved the language since 2005, including in a 2013 public health bill. While the Senate passed the measure by "unanimous consent" — meaning no lawmaker raised an objection — in February of 2013, the House passed the bill in March on a 370 to 28 vote. President Obama signed the bill into law March 13, 2013.

A BuzzFeed News investigation, in partnership with the International Consortium of Investigative Journalists, based on thousands of documents the government didn't want you to see.