Millions of workers, responders, and citizens in the United States and around the world depend on the availability of respirators (masks) for protection against exposure to hazardous materials, bioterrorism threats, airborne disease epidemics, and other disasters.

A rising tide of silica-related lawsuits naming respirator manufacturers as defendants threatens the availability of respirators as a safety protection product.

Preparations for a defense and response against the pending avian flu pandemic rely heavily on the use of respirators as a part of the first line of defense against this virus.

The National Institute for Occupational Safety and Health independently establishes standards for, regulates and approves respirators. Manufacturers must submit each model of respirator (and a quality assurance plan) to NIOSH for independent testing by its laboratory, and evaluation to assure that the design meets all NIOSH criteria. The entire label, including user information, for each respirator must be submitted to NIOSH.

NIOSH oversees respirator manufacturers to assure consistency with its standards.

Only the employer can properly select and use respirators. Respirator manufacturers cannot be and are not at each individual worksite site to evaluate specific conditions. The Occupational Safety and Health Administration ("OSHA") requirements obligate employers to be sure employers buy, distribute and use appropriate respiratory protection.

Unfounded lawsuits claiming defective design or inadequate warnings are overwhelming respirator manufacturers, despite NIOSH regulation of design and labeling and manufacturers' inability to affect how or when the respirators are used. The vast majority of the claimants in silicosis litigation are not sick.

Before 2002, one respirator manufacturer had about 200 silicosis claims filed against it each year. Between 2002 and 2004, 29,000 silicosis claims were filed. This is a 5000% increase in claims filed. In contrast, according the CDC, from 1968 to 2002, silicosis deaths decreased from 1,157 to 148, a 93% decline in the overall mortality rate.

The litigation system is fraught with fraud. Numerous plaintiffs have filed or have been paid settlements for tobacco, asbestos, AND silica claims, and there are paid "experts" available to testify to anything that supports litigation by plaintiffs.

Potential costs of defending litigation, aside from settlements or verdicts, is hundreds of millions of dollars, and total costs could actually exceed annual industry revenue.

This level of risk seriously strains limited industry resources and threatens the wide availability of respirators. This is not in the public interest, and could dramatically affect the United States' ability to respond to an avian flu pandemic.

Federal legislation is needed to protect respirator manufacturers and sellers against frivolous lawsuits and litigation fraud.

A respirator manufacturer who designs and labels a respirator in compliance with NIOSH approval, and manufactures that respirator in compliance with the NIOSH-approved design and labeling, should not be liable for any claim based on that design or warning.