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Latex: More than 200 lawsuits filed against latex manufacturers
July 1999, Naples/Collier News
An 11-year-old boy with latex allergy is chased into the bathroom by other boys who attempt to rub latex gloves in his face, just to see what will happen.
A 36-year-old physician goes into muscular paralysis from the steroids she takes to control her allergy, but cannot go to the latex-laden emergency room for treatment.
A nurse in a prison infirmary has a violent reaction associated with gloves, but is separated by locked doors from the shot of Epipen that will halt her anaphylaxis. She dies in the prison.
An ever-growing list of people have seen their lives forever altered or even ended because they developed a sensitivity to natural rubber latex.
"If you have a drug that causes two deaths, it's taken off the market. These are not cases, these are not numbers, these are lives," said Lise Borel, a once-practicing dentist who now is a health activist. Borel lost her ability to practice dentistry after she became disabled by her own latex allergy.
The life-threatening allergic reactions were only half the misery. The treatments that prevent the lethal anaphylaxis are themselves so hard on the body, Borel and others like her endure interrelated maladies and a general deterioration in health. At 45, she just had a pacemaker installed - her fifth cardiac procedure.
Yet latex allergy is an enigma even those whose lives stand to be ruined by it. It's not well understood by even doctors and nurses, let alone lower-level workers who are constantly exposed to the risk of sensitization. And this is to say nothing of latex users outside of medicine, of which there are many.
Since 1988, more than 700 research articles have been published addressing its origins, its prevention and its treatment.
Yet that information isn't being systematically disseminated, Borel said, so too many people who need to know about the risks remain in the dark. Often, by the time people learn, they already have been sensitized and their lives are forever changed.
Some choose to sue latex glove manufacturers. More than 200 cases have been filed in federal court, including a recent $20 million suit by Karen Vivonetto of Naples, who disabled by a latex allergy acquired during a career as an obstetrics nurse at Naples Community Hospital.
Most latex suits have been consolidated into multi-district case to help control the legal costs. One court in Philadelphia is handling all the pretrial work, discovery and motions.
Latex allergy works as any allergy does: The body is exposed to a substance it doesn't like - an allergen - in this case, the proteins of natural rubber latex.
Cells if the immune system make a record of the allergen. Some are programmed to look for that specific allergen in the future, to seek it out and destroy it. That programming is sensitization.
At its essence, allergy is hypersensitivity, an overreaction of the immune system.
This hypersensitivity could be just a minor skin rash caused by latex gloves. But when a sensitized immune system is repeatedly exposed to an offending allergen, the reactions can become more exaggerated until a sort of physiological hysteria sets in. The body pulls out all sorts of defense systems that aren't necessary, and these are themselves potentially dangerous.
When this hypersensitivity is at its worst, the immune system creates a special antibody against the allergen. The antibody makes fluids accumulate in the tissues, muscles contract - including those in the windpipe - the person begins to suffocate. That response is anaphylaxis.
Unless halted immediately, with a shot of epinephrine (Epipens) for instance, the worst level of reaction can be fatal within minutes.
But sensitivity varies greatly from one person to the next. The FDA says there is no way to know which latex-using workers will become sensitized to what degree, the length of time sensitization will take, nor the extent of a worker's reaction once sensitized.
It is also not possible to predict who will go from local skin rashes to dangerous anaphylaxis, because not everybody progresses through the various stages of the allergy.
Glove manufacturers, who now are the target of more than 200 lawsuits, and their critics agree that latex allergy became a problem after the CDC recommended "universal precautions" in 1987 in response to AIDS.
Use of latex gloves quadrupled during 1988 and 1989, as workers used them more often and more workers used them.
'A nurse, who prior to universal precautions might have been exposed to latex two hours a day, was suddenly exposed eight to ten hours a day. They'll literally go through 70 or 80 pairs a day," said Doug Roberts, a litigator representing numerous latex allergic people, including Vivonetto of Naples.
An ancillary result of the increased use was a boom in demand for latex gloves. And to meet the increased demand, shortcuts were taken in the manufacturing processes used for gloves, according to OSHA.
Most significant was the elimination or abbreviating of a rinse that removed most of the allergenic proteins from the surface of the latex, where they settle.
"The reason I can be so unqualified in telling you (these illnesses) could have been prevented is that the gloves simply needed to be washed," said Alan Laufman, a Texas physician and attorney who wants glove manufacturers held responsible.
Laufman cites a 1991 FDA alert to manufacturers and the medical field that addressed the problem of latex allergy, listing steps that could reduce if not eliminate the problem, including rinsing.
"Every manufacturer knows what is going on - the government holds seminars and symposia," Laufman said. "But the imperative for companies to make money caused those without internal checks to maximize their profits at the risk of causing unnecessary harm."
Gaidamak said Allegiance, at least, didn't cut out it's washing process. Even so, she said, while washing reduces the concentration of proteins on the gloves, it doesn't remove all of them.
Researchers say they don't know which of the two dozen or so antigenic latex proteins will create sensitivity, or in whom, so even washed gloves could be allergenic to some people.
"If you can't isolate the protein it is, then it could be those specific ones in that glove," she said, "and you'd still be exposed."
Borel said it's a matter of simple mathematical logic: reduce the number of threats and you reduce the risk of injury.
Though domestic glove manufacturing has improved and the FDA is looking at establishing standards on protein levels, many gloves are imported.
"Today, into this country, we are still getting millions of foreign-made gloves that are dangerous," Laufman said "Imagine all over the country there's hospitals with purchasing departments that are knowledgeable, that are buying by price, not by some characteristic bearing on quality."
It is money that will drive change in the medical field, Laufman said.
"There's a movement to get away from the most dangerous powdered gloves. The increases in workers' compensation premiums will eventually force the hospitals to do the right thing," he said, adding:
"But the real point is what is the cost when a veteran nurse like Karen Vivonetto can no longer work at the hospital where she was employed, counseling expectant parents, teaching other nurses in your community?"
Robert Grossman & Associates, LLP
7 Chesley Road
White Plains, NY 10605
tel (914) 684-0785
fax (914) 448-2698
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