U.S. RESPIRATOR MANUFACTURERS CONCERNED ABOUT MEETING SKYROCKETING
DEMAND FOR MASKS NEEDED FOR AVIAN FLU PREPARATION DUE TO BOGUS SILICOSIS LAWSUITS

The Coalition for Breathing Safety warned today that respirator manufacturers' ability to meet growing demand for respirator masks driven by the avian flu threat is jeopardized by an ongoing avalanche of spurious silicosis lawsuits. The Coalition urged quick passage of federal legislation to protect respirator manufacturers and sellers against baseless and frivolous lawsuits and litigation fraud in order to help to address the potential shortage of N95 respirators, a key component of the "social distancing" strategy U.S. government officials are counting on enacting in the event of an avian flu pandemic.

Despite the fact that the U.S. government sets strict design standards for respirators, conducts tests to ensure those standards are met, and approves respirators and the warning labels placed on them, respirator manufacturers are engulfed in a wave of bogus silica lawsuits filed by trial lawyers claiming defective design or failure to warn users. The lawsuits also ignore the fact that manufacturers cannot affect how or when the respirators are used.

Between 2000 and 2004, more than 300,000 claims were filed against five respirator manufacturers alone. Although these claims are routinely dropped, dismissed, or settled for very small amounts, respirator manufacturers' litigation costs in 2004 consumed 90% of the gross revenues earned from selling the products.

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have recommended the use of government-approved, respirators (N95 or better) to protect poultry workers and other individuals involved in responding to an outbreak of avian influenza. Public and private sector health experts have concluded that the first line of defense if avian flu begins infecting humans will be "social distancing," and that NIOSHapproved respirators will be essential to fighting the flu pandemic. The Department of Health and Human Services recently announced a request for proposals for 50 million N95 masks.

"Respirators are taken for granted as an essential component in protecting the public and health care workers in the event of an avian flu pandemic," said Daniel K. Shipp, President of the International Safety Equipment Association (ISEA), a member of the Coalition for Breathing Safety. "During the SARS scare, which never reached our shores, demand for respirators stretched available supply. Preparations for an avian flu pandemic have already caused demand for respirator masks to skyrocket. If there's an outbreak, demand will be exponentially higher. Companies will have to ramp up production to meet this demand."

Shipp continued, "Yet, without some protection from the flood of bogus lawsuits, many manufacturers will face a hard choice. Do they make the capital investment necessary to expand capacity when they are risking more groundless lawsuits every time they market their product? Faced with this situation, some manufacturers have already withdrawn from key industrial markets."

Last week, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held a hearing probing into allegations of misconduct by doctors and plaintiffs' lawyers in silicosis lawsuits. The allegations stem from Texas Federal Judge Janice Jack's 2005 findings that diagnoses forming the basis for thousands of individual claims in eight states were "fraudulent." Judge Jack found that these diagnoses "were about litigation rather than health care" and "were driven by neither health nor justice: they were manufactured for money."

The Coalition for Breathing Safety supports legislation introduced in the House of Representatives and the Senate to protect respirator manufacturers and sellers against baseless and frivolous lawsuits and litigation fraud. Respirators are 100% regulated by the U.S. government in that all significant aspects of respirator design, manufacturing, and labeling are regulated by the National Institute for Occupational Safety and Health (NIOSH), a U.S. government agency. The legislation would protect manufacturers only if their products are certified as complying with U.S. government design standards and warning label requirements imposed by NIOSH.

"The members of our coalition are working around the clock to produce respirators, but the costs of administering thousands of claims — even if it's only to determine that they have no merit — total tens of millions of dollars each year," continued Shipp. "The industry desperately needs protection from baseless, mass tort claims to allow companies to focus on the business of making respirators, and meeting the avian flu challenge."

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 is seeking a federal solution to protect companies that make these products from the hundreds of thousands of lawsuits now threatening their availability.

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.