PRESIDENT BUSH STRESSES NEED FOR RESPIRATORS IN PREPARATION FOR PANDEMIC INFLUENZA, BUT SUPPLY THREATENED BY WAVE OF QUESTIONABLE SILICA LITIGATION

The Coalition for Breathing Safety warned today that availability of respirators — a key aspect of President Bush's National Strategy To Safeguard Against The Danger Of Pandemic Influenza — is threatened by the growing burden of questionable silica litigation, and called for federal legislation to address this problem.

President Bush's plan for pandemic influenza preparation and response includes building stockpiles of important equipment such as respirators. In his speech outlining the U.S. government's plan to respond to pandemic influenza, Bush stated, "we need medical personnel and adequate supplies of equipment. In a pandemic, everything from syringes to hospital beds, respirators, masks and protective equipment would be in short supply. So the federal government is stockpiling critical supplies in locations across America as part of the Strategic National Stockpile."

Respirators have long-played an important role in protecting workers against exposure to hazardous materials, and would be necessary in the event of a pandemic, terrorist incidents and other disasters," said Daniel K. Shipp, President of the International Safety Equipment Association (ISEA), a member of the Coalition for Breathing Safety. However, a wave of unfounded lawsuits claiming defective design or failure to warn may force manufacturers to abandon production of respirators, when, conversely, what we need right now is to preserve U.S. respirator production capacity so that U.S. respirator manufacturers can help build stockpiles that will be available in case of a national emergency."

The Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have recommended the use of disposable respirators (N95) to protect poultry workers and other individuals involved in a response to an outbreak of avian influenza. France has already begun to stockpile respirators, with 200 million masks to be stockpiled by early 2006.

Shipp noted that U.S. manufacturers want to help build stockpiles in the United States. However, he said, The more respirators they supply without some liability protections the more they open themselves to massive numbers of claims. Based on experience, the overwhelming majority of such claims will turn out to be without merit. But the costs of administering thousands of claims and determining that they have no merit totals tens of millions of dollars each year. This is already causing manufacturers to drop out of the commercial market and more will do so unless this litigation burden can be effectively addressed."

U.S. respirator manufacturers are facing a challenge that is very similar to that of U.S. vaccine manufacturers. In his November 1st speech, President Bush asked Congress to remove one of the greatest obstacles to domestic vaccine production: the growing burden of litigation." He continued, "In the past three decades, the number of vaccine manufacturers in America has plummeted, as the industry has been flooded with lawsuits… That leaves our nation vulnerable in the event of a pandemic… Congress must pass liability protection for the makers of life-saving vaccines."

Shipp stated, Like vaccine makers, U.S. respirator manufacturers need federal legislation not only to protect against frivolous lawsuits, but also to provide manufacturers with the financial stability and predictability that will allow them to support the stockpiling of respirators. Such legislation would not prevent legitimate claims from being filed."

Between 2000 and 2004, plaintiff attorneys filed more than 300,000 claims against five respirator manufacturers alone alleging injury because of defective design or inadequate warning. Total costs of defending this litigation are already approaching the total net income from respirator sales, threatening the wide availability, dependable supplies, and high quality of U.Smade respiratory safety products.

In July 2005, a federal judge in Texas labeled as "fraudulent" thousands of silicosis diagnoses that form the basis for lawsuits in eight states, stating that the diagnoses "were about litigation rather than health care" and "were driven by neither health nor justice: they were manufactured for money." House Commerce Committee Chairman Joe Barton (R-TX) and Oversight and Investigations Subcommittee Chairman Ed Whitfield (R-KY) requested information from doctors and medical screeners on conduct suggesting a serious corruption of medical practices and standards" related to silica diagnoses in August 2005.

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.