[Congressional Record (Bound Edition), Volume 151 (2005), Part 17]
[House]
[Pages 23110-23111]
[From the U.S. Government Publishing Office, www.gpo.gov]




             LITIGATION REFORM FOR RESPIRATOR MANUFACTURERS

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Pennsylvania (Mr. Shuster) is recognized for 5 minutes.
  Mr. SHUSTER. Mr. Speaker, I want to talk about a special aspect of a 
subject that has been in our news a great deal lately, emergency 
preparedness.
  As a member of the Select Katrina Committee and as chairman of the 
subcommittee overseeing FEMA, I know that it is absolutely critical to 
prepare our Nation for natural disasters, terrorist attacks, or any 
other catastrophe and the spread of disease that could come with it.
  When disasters strike, the most effective method of prevention 
depends, in part, on effective respiratory protection for millions who 
may be exposed. This protection is available through careful use of 
respirators, the masks, mostly disposable, that we see in pictures of 
first responders, emergency personnel and health care workers who are 
treating the sick.
  The World Health Organization, for example, specifies certain 
respirators for use in avian flu treatments. The United States has a 
number of companies that manufacture respirators that are in a number 
of States around this country. One, Mine Safety Appliances, is 
headquartered in Pennsylvania and manufactures respirators in the 
State.
  These are high quality products, recognized by industry, health care 
authorities and other experts as efficient, cost effective. More 
importantly, these products are 100 percent regulated by an agency of 
the U.S. Government, the National Institute for Occupational Safety and 
health, or NIOSH, which is part of the Centers for Disease Control in 
the Department of Health and Human Services.
  NIOSH prescribes design standards for respirators, tests respirators 
in its own labs by its own professionals and monitors respirator 
manufacturers to ensure their products consistently meet the standards 
for which they are approved.
  It also approves the warning labels that go on respirators to 
indicate what uses are and are not appropriate to emphasize the need 
for users to be sure that these respirators fit well.
  It regulates the respirator manufacturers, but the Occupational 
Safety and Health Administration, or OSHA, regulates employers and 
prescribes what level of approved respirators should be used to protect 
against a particular workplace hazard.
  Respirator manufacturers do not interact with respirator users. They 
make their products according to government standards for their uses 
approved by NIOSH and described on the label, but employers make the 
decision about whether to provide a respirator and which one to provide 
based on OSHA rules.
  Unfortunately, in our litigation-obsessed society that separation of 
responsibility has not protected our respirator manufacturers from 
being sued in literally thousands of cases. Workers allege that a 
respirator was defectively designed or contained an inadequate warning 
label, and they got sick, and that somehow it is partly the fault of 
the manufacturer.
  As absurd as this may sound, it is the premise for up to 30,000 
individual claims brought against each major respirator manufacturer in 
the United States. There has been much controversy over many of these 
claims, since they involve workers who claim to be sick with asbestosis 
or silicosis.
  In one situation, a Federal judge in Texas, a former nurse, found 
that thousands of claims were essentially without any legal or medical 
merit. They were produced by collusion between plaintiffs lawyers, 
doctors paid by the claim, and the x-ray mills that produced the 
diagnosis that could not survive medical review.
  This corrupts the legal system and hurts most those few who are truly 
ill. It also threatens otherwise strong American industries like 
respirator manufacturing.
  Our American respirator manufacturers are faced with the cost of 
administering and processing tens of thousands of claims. Some of these 
will be thrown out and some will be settled for a few hundred dollars, 
but each one requires thousands of dollars of research and process.
  None of these cases has resulted in a trial and a judgment against a 
respirator manufacturer. It is the administrative cost of millions of 
dollars each year that are now about to exceed the net income of many 
companies from making respirators.
  In short, we are in danger of losing a vital American industry that 
we are going to need desperately if disaster strikes. Whether the 
spread of a virus or biological terrorist attack, we already need 
respirators for countless industrial applications and routine medical 
and other health-related needs. Respirators are already providing 
protection from the airborne hazards that are everywhere in the 
recovery efforts from Hurricanes Katrina and Rita.
  They also served thousands in the aftermath of September 11th. We 
cannot afford to have this vital industry torn down by inadequate 
claims with dollar signs at their hubs. That is why I am pleased to be 
the author, along with my original cosponsors, the gentlewoman from 
Pennsylvania (Ms. Hart) and the gentleman from Pennsylvania (Mr. Doyle) 
as well as the gentleman from Texas (Mr. Smith), of H.R. 2357, the 
Respirator Access Assurance Act of 2005.
  This is a very simple bill. It says that if a manufacturer has the 
NIOSH approval for the design and labeling of a

[[Page 23111]]

respirator, a manufacturer cannot be sued on the basis of the detective 
design or failure to warn.
  It would apply to any case that has not gone to trial as of the 
enactment and to future cases. We need this legislation, and I am 
working with my colleagues and the House leadership to find an 
appropriate opportunity to bring it to the House floor for a vote soon.
  I hope my colleagues will share my concern over the need to ensure 
that this American industry continues to produce these vital products 
for emergency preparedness, and will approve this and make it the law 
of the land.

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