Allergies Lead to Wave of Lawsuits Against
Latex Glove Makers
By Avram Goldstein
Washington Post Staff Writer
Saturday, May 9, 1998; Page A12
Buoyed by a $1 million jury award to a Milwaukee hospital technician who
developed a severe allergy to natural rubber latex gloves, hundreds of U.S.
health care workers are suing glove manufacturers, alleging they knew
prolonged exposure could cause reactions from mild skin irritations to
deadly ailments.
In the last year, a steady stream of new claims against latex glove
manufacturers has been filed in federal court in Philadelphia, where about
150 cases from across the country have been consolidated for pretrial
purposes. About 50 more plaintiffs are suing in other courts, raising the
specter of millions of dollars' worth of judgments against manufacturers.
The Food and Drug Administration is considering a ban on certain latex
gloves that are more apt to cause allergies in users. The agency also will
require manufacturers to place allergy warnings on packages of gloves and
prohibit them from describing gloves as "hypoallergenic."
Industry leaders acknowledge that some natural rubber latex gloves can
cause health problems, but they say that until researchers determine how
much latex exposure is a health problem, they have no plans to change
their processes or products.
"If the FDA says these gloves cause more harm than good, we would be in
agreement with them," said Donna Gaidamak, spokeswoman for
Allegiance Healthcare Corp., the largest distributor of latex and synthetic
gloves.
Scientists and government officials estimate that about 950,000 U.S. health
care workers who wear gloves because they come into contact with
patients or blood have developed an allergic sensitivity to latex. Some have
experienced skin rashes, respiratory ailments or potentially fatal shock.
Colette Riefer, a surgical technician at Holy Cross Hospital in Silver
Spring, used latex gloves at work for years but didn't suffer a significant
reaction until she had a Caesarean section in 1992. When latex particles
came into contact with her body during surgery, she went into anaphylactic
shock and respiratory arrest. She continued working for two more years
with non-latex gloves but had to end her career when she touched a latex
glove and suffered bronchial spasms.
"It leaves you bitter, but you need to move on," she said, although she will
always have to guard against the hazards of latex. "There's not a day that
goes by you don't think about it."
Although health care workers have been reporting latex allergy symptoms
since the late 1980s, the wave of lawsuits is a sign that natural rubber
gloves -- once seen as protection against AIDS and other blood-borne
diseases -- have become a serious occupational hazard.
Plaintiffs say the companies knew the gloves caused them to develop
allergies and failed to warn them or change the products. The makers have
responded that they shouldn't be held liable, saying that hospitals and
health professionals are sophisticated enough to protect themselves and
that researchers have much to learn about the allergy.
Unknown numbers of health care workers have been forced to give up
their careers because their allergic reactions increased with each exposure
to latex. Many workers are asking employers to buy gloves made of
synthetic materials or natural latex that has been more thoroughly cleansed
to eliminate latex particles.
The FDA underscored the problem by gathering medical and industry
experts for a satellite teleconference on the hazards of natural rubber latex
gloves that was broadcast this week to more than 50,000 health
professionals.
"This is a growing public health concern," U.S. Surgeon General David C.
Satcher told viewers.
Researchers say the allergens -- loose, microscopic particles of latex
proteins on the gloves -- bind with the cornstarch powder that is dusted on
the gloves to make it easier to pull them on and off. The proteins become
airborne and can be inhaled, inducing a variety of allergic reactions in some
people.
So far, no U.S. health care worker has died of latex allergy. But with
continued exposure to latex -- commonly found in items such as carpets,
toys, shoes, clothing, paint, pantyhose, housekeeping gloves, diaphragms
and tires -- some people can suffer skin irritations, asthma or even
potentially fatal shock. Condoms can trigger allergic reactions in sensitized
people, and there has been talk of adding warning labels to condom
wrappers. But government officials say the manufacturing process for most
condoms leaves few allergens on them.
Peggy Williams, a nurse, used 50 pairs of gloves a day while she helped
deliver babies at Frederick (Md.) Memorial Hospital. She is suing a
half-dozen glove companies after episodes of asthma, hives and swelling
became life-threatening, forcing her to quit her job. She complained that
the companies should have warned her of the danger and changed their
manufacturing processes.
"I adored my career," she said. "Still now, I could get choked up about
leaving it."
Her attorney, Robert K. Jenner, said surgeons, anesthesiologists and
others who work in operating rooms are most vulnerable. "It's a very
closed environment, where gloves are being snapped on and off with
rapidity," he said.
Now Williams, 44, is a virtual prisoner in her Frederick County home. She
reacts to latex in the more than 40,000 everyday products that contain it.
She fears that if she went into anaphylactic shock, rescue personnel would
use latex products to try to revive her.
A number of hospitals have eliminated high-protein gloves while others,
including Children's National Medical Center in Washington and Johns
Hopkins Hospital in Baltimore, have instituted partial bans. Johns Hopkins
also tries to keep visitors from bringing latex balloons into its buildings.
Last week, North Arundel Hospital in Glen Burnie asked residents to bring
only mylar balloons to patients.
The Johns Hopkins glove restrictions "took a number of years to do," said
Robert G. Hamilton, an associate professor of medicine who is developing
a skin test for latex allergy. He favors eliminating powdered latex gloves
but said many doctors and nurses prefer them because they allow more
feeling in the hands than powder-free or vinyl gloves.
Allegiance Healthcare officials estimate that banning powdered latex gloves
would cost U.S. hospitals $285 million a year, because low-protein gloves
generally cost more. The FDA says powdered latex gloves cost $3.90 per
hundred compared with $5.80 for powder-free.
Ultimately, the mounting number of lawsuits against glove manufacturers,
who produce 20 billion gloves a year, could provide more impetus for
change.
In February, a Milwaukee jury awarded $1 million to a woman who
developed a severe latex allergy while working as a radiology technician,
saying they wanted to send a message to the glove manufacturer that its
products should be safer. The technician argued that the product was
defective and unreasonably dangerous because it was capable of
sensitizing people or causing reactions.
"Production was not defective, and the gloves were not unreasonably
dangerous," said lawyer Donald R. Peterson, who defended the glove
maker Smith & Nephew HHP Inc. and plans to appeal.
Seven years ago, when the Occupational Safety and Health Administration
imposed "universal precautions" requiring health care workers to wear
protective gloves, the increased demand led some firms to produce
cheaper gloves that have more proteins, critics say, but glove companies
say they have seen no evidence of that.
"The vast majority of manufacturers at that time were unaware that proteins
were allergens to some people," Peterson said.
The FDA and OSHA have moved cautiously in hopes the industry would
set voluntary standards that would eliminate high-protein gloves with
cornstarch, but so far that has not happened.
OSHA is circulating a draft hazard bulletin that would encourage
employers to ask new workers if they are latex-sensitive so they can avoid
exposure in the workplace. The Health Industry Manufacturers
Association, which represents at least 20 producers of latex products,
opposes that idea as an invasion of employee privacy.
Jay E. Slater, an allergist and latex researcher at Children's National
Medical Center, said the FDA should require low-protein, powder-free
gloves.
"It would be doing the glove industry a tremendous favor," Slater said. "It
will level the playing field."
c Copyright 1998 The Washington Post Company
How long before all medical devices manufacturers are forced to make the kinds of moves American BioMed has already done to protect people from potentially life threatening allergic reactions to latex?
Regards, Jeff |
