The six manufacturers who sent the letter Aearo, Bacou-Dalloz, Inovel, Moldex, MSA and North Safety, all of which are members of the Coalition for Breathing Safety assert that the legislation is needed to ensure the supply and availability of disposable respirator masks (N-95 respirators) for health care workers and other first responders. The Coalition for Breathing Safety was formed in 2004 to ensure that millions of emergency responders, workers and citizens across the globe continue to have access to respiratory safety products.
The coalition urged President Bush to support bi-partisan legislation introduced by Sens. John Cornyn, R-Texas, and Ben Nelson, D.-Nev., in the Senate (S. 1406) and Reps. Bud Shuster, R-Pa., and Tim Holden, D-Pa., in the House (H.R. 2357) that would preempt lawsuits claiming defective design or insufficient warning if a respirator is NIOSH-approved.
"Unfettered liability costs will dramatically affect our nation's ability to respond to an avian flu pandemic," wrote the respirator company executives. "Costs of defending litigation, aside from settlements or verdicts, amount to hundreds of millions of dollars. In fact, currently, 90 to 94 percent of profits are being consumed to maintain litigation efforts."
Industry Deluged with Lawsuits
The National Institute for Occupational Safety and Health (NIOSH) tightly regulates the respirator industry by setting strict design standards, conducting tests to ensure they are met and approving each and every respirator model as well as the warning labels that accompany the product.
However, trial lawyers have deluged the industry with lawsuits claiming defective design or failure to warn users despite the fact that manufacturers cannot affect how or when the respirators are used.
The letter stated that due to liability concerns, the respirator manufacturers "are compelled to withhold further investment in production capacity, exit the marketplace or manufacture abroad for foreign buyers where no litigation crisis exists. This is not in the public interest. Respirator manufacturers are not, and have never been, part of the problem underlying end-user illnesses, but we can be part of the solution to minimize the spread of avian flu in the United States if a pandemic occurs."
Without Legislation, Production Will Be "Constrained"
The letter from the industry echoes a letter sent to the administration in May by a bipartisan group of 86 members of Congress calling for the National Strategy for Pandemic Flu Influenza to stockpile N-95 respirator masks instead of surgical masks.
"Without legislation, the ability for American manufacturers to address emergency preparedness or have surge production capacity is and will be severely constrained," wrote the corporate leaders. "Already, one major manufacturer has announced that it will no longer produce N-95 respirators for the industrial market. Another is seriously considering withdrawing from the market, and it has become difficult to convince shareholders to invest in new capacity in the United States."
France has begun stockpiling 685 million N-95 respirator masks just for first responders, while the U.S. government to date has had one request for proposals for 50 million masks. The recent experience with SARS showed that countries will embargo exports of respirator masks in the case of a global pandemic and the United States will need its domestic sources for these masks.