RESPIRATOR MANUFACTURERS CRITICAL OF AVIAN FLU PLAN;
BOGUS SILICA LAWSUITS THREATEN U.S. STOCKPILE

The Coalition for Breathing Safety warned today that a government plan to stockpile N95 respirator masks contained in the National Strategy for Pandemic Flu Influenza released by the White House today may not be possible because of an ongoing deluge of frivolous silicosis and asbestos lawsuits against U.S. respirator manufacturers. The Coalition urged Congress to quickly pass legislation that would help ensure an adequate supply of masks from U.S. manufacturers.

The National Strategy document states that "all health care systems…should consider stockpiling consumable critical medical materials," including N95 respirators, surgical and or procedural masks. The plan also calls on "State, local and tribal governments and private sector partners" to develop and test plans within six months to allocate and distribute "critical medical material" such as face masks in a health emergency.

Yet respirator manufacturers in the U.S. are confronted by a constant stream of baseless litigation, which affects their ability to meet the increased demand in the event of a flu pandemic. U.S. manufacturers of disposable respirators are facing tens of thousands of silicosis claims, even as Centers for Disease Control figures show that silicosis deaths nationwide have declined 93% from 1968 to 2002.

"The Coalition is disappointed that the National Strategy document calls for addressing regulatory and legal obstacles to expansion of domestic vaccine production capacity, but says nothing about addressing similar issues confronting U.S. respirator manufacturers," said Dan Shipp, President of the International Safety Equipment Association (ISEA), a member of the Coalition for Breathing Safety.

"We are extremely concerned about the repeated government calls to stockpile and distribute respirator masks without any actions to ensure that U.S. manufacturers maintain their ability to produce these masks. Manufacturers may be unable to respond to the demand for N-95 respirator masks due to the ongoing litigation."

"During the SARS epidemic, countries around the world embargoed all exports of respirator masks and worldwide demand quickly overwhelmed supply. The U.S. must maintain its own manufacturing capability. Manufacturers are doing everything they can to meet demand, but they are not investing in additional capacity because every new mask that comes on line simply offers one more target for trial lawyers," said Shipp.

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, relying on asbestos-style litigation tactics, 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.

"Respirator manufacturers’ litigation costs in 2004 equaled 90% of the net income earned from selling the products that same year." continued Shipp. "To meet the government’s call to stockpile masks, the industry desperately needs protection from baseless mass tort claims to allow companies to focus on the business of making respirators to meet the avian flu challenge."

The Coalition supports bi-partisan legislation introduced by Senators John Cornyn (RTX) and Ben Nelson (D-NE) in the Senate (S. 1406) and Representatives Bill 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.

"Respirator manufacturers have no need for blanket indemnity from the government," reiterated Shipp. "The legislative solution we seek would protect manufacturers from having state judges and juries overrule federal standards that they have to meet, and allow these companies to keep making respirators to protect workers and the public."

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.

For additional information, please contact Paul Nathanson at 202-466-6210 or paul.nathanson@pbnco.com or George Felcyn at 202-466-6210 or george.felcyn@pbnco.com.