Hundreds of lawsuits filed against latex glove makers
Sensitized HCWs sue in federal and state courts
Health care workers have filed more than 300 lawsuits in federal court against at least seven major latex glove manufacturers and a handful of smaller companies, alleging that exposure to natural rubber latex gloves at work has caused the HCWs to suffer from Type 1 latex hypersensitivity.
The latex allergy lawsuits have been combined into multi-district litigation (MDL), a procedure that allows similar cases to be consolidated for pretrial discovery and motions. Lawsuits pending in federal courts in different parts of the country were transferred to a Philadelphia federal court. After the pretrial process, the cases will be transferred back to the courts where they originated for further proceedings, including trials, explains David Shrager, plaintiffs’ lead counsel and senior partner of Shrager, McDaid, Loftus, Flum and Spivey law firm in Philadelphia.
Shrager chairs the plaintiffs’ steering committee, which includes 12 law firms. Hundreds of additional cases pending in state courts are being handled in conjunction with the MDL cases.
Many of the HCWs suing glove manufacturers are disabled by latex allergy, and all have been sensitized to latex from glove use, Shrager says. Plaintiffs contend that the defendants have manufactured gloves that were high in natural rubber latex proteins.
"As a consequence of that, when an explosion in the use of gloves occurred in association with the CDC’s universal precautions relative to AIDS in the 1980s, the [glove manufacturing] industry took shortcuts. There was a concomitant increase and risk of harm to what you would predict would be a high-risk group, namely health care providers who would repeatedly don gloves and would be exposed with frequency to dipped latex-containing products as opposed to vulcanized products such as tires," he says.
While most of the cases will probably be settled out of court, Shrager expects at least some to be heard by a jury. Last year, a radiologist was awarded $1 million in the first major latex product liability case to go to trial. Legal experts said the verdict could set a precedent for similar outcomes in the hundreds of pending lawsuits. (See Hospital Employee Health, September 1998, pp. 107-109.)
At the time, attorneys for defendant Smith & Nephew PLC, a British medical device firm that also is a defendant in the MDL, said the outcome was affected by the court’s failure to instruct the jury properly. They maintain that the latex gloves they manufactured were not unreasonably dangerous or defective, as the plaintiff charged. The case is on appeal.
Statutes of limitations could block action
Shrager says the MDL defendants are using two main defense strategies: waiting for the statute of limitations to run out and claiming that product identification — proving which manufacturer’s gloves were responsible for a HCW’s latex sensitization — is impossible.
Statutes of limitation vary from state to state, but usually are between one and six years. A California case scheduled for trial in state court this month may not get there. The plaintiff, a registered nurse, suspected in 1992 that the allergy symptoms she was experiencing were caused by the latex gloves she wore at work, but she waited until 1996 to file her complaint. The judge agreed with the glove manufacturer — Baxter International, now known as Allegiance Healthcare Corp. in McGaw Park, IL — that the nurse’s claims were barred by California’s one-year statute of limitation.
"Their defense is the clock and which gloves did it," says Shrager. "Instead of facing up to the situation and settling it, they’re toughing it out. I think it will take a few trials to straighten things out."
Hospital Employee Health contacted several defendants in the MDL lawsuits, but all refused to discuss the charges because they are in litigation.
Becton-Dickinson Corp., in Franklin Lakes, NJ, is a defendant in more than 200 federal and state product liability lawsuits relating to latex gloves, but spokeswoman Camilla Jenkins says the company sold its latex gloves division in 1995. Becton-Dickinson is suing insurers for refusing to cover the company in those lawsuits.
When asked if Allegiance, a major manufacturer of powdered and powder-free latex as well as synthetic gloves, might modify its product lines depending on the outcomes of some 400 state and federal latex-related lawsuits against the company, spokesman Geoffrey Fenton replied, "Allegiance offers the broadest line of products and we intend to continue to do so."
Nevertheless, Shrager says the litigation will have a positive effect on the glove manufacturing industry.
"Once they feel comfortable facing up to their responsibility for what happened, they will in retrospect realize that the threat of litigation and the reality of litigation have given them the economic encouragement to produce safer gloves," he states. "This will also improve the quality and safety of medical care, encouraging industry to think of alternative products and to improve latex gloves without sacrificing what they believe to be the qualities of barrier protection offered by latex and the tactile sensation important to a lot of health care providers."
Shortcuts may have increased risk
The plaintiffs maintain that a warm-water wash of the latex would have removed most of the allergenic proteins from its surface, but this step of production was eliminated as one of the shortcuts taken by glove manufacturers to meet increased demand during the late 1980s, they allege.
This explanation also was offered by the Occupational Safety and Health Administration in a technical bulletin issued earlier this year,1 as well as by the National Institute for Occupational Safety and Health in the latex hazard warning the agency published in 1997.2
Glove makers could have changed their manufacturing processes when the Food and Drug Administration (FDA) issued an alert in 1991,3 says Lise Borel, DMD, a dentist disabled by occupational latex allergy who now is national president of the Education on Latex Allergy Support Team and Information Coalition.
"Given the nature of the warnings by the FDA and the notable increase in the number of cases reported right after universal precautions were implemented, there was an opportunity to make an immediate change that may have averted or reduced the amount of litigation that has come to be," says Borel, who became so ill from latex allergy and treatments that, at age 45, she has undergone five cardiac procedures and wears a pacemaker.
Borel is adamant that hospitals accept their share of the responsibility.
"They have to consider their glove and other [latex-containing] product purchases very carefully. Otherwise, they’re just contributing to what their future patient care is going to be like. Hospitals have the responsibility to look at the safety features and risks associated with everything they use. They’re as much responsible as the glove manufacturers are. They have the opportunity to be part of the process to stop the sensitization. It’s the easier road to take when you look at the long-term effects," Borel says.
Some manufacturers have denied a correlation between natural rubber latex proteins and latex allergy in the pretrial process, Shrager notes.
"That’s medical history revisionism of the worst sort," he asserts. "They don’t concede anything. We hope they stay with that attitude because if they insist that the moon is made of green cheese, that will certainly compromise their real defenses. We think when the time comes, they’ll be willing to deal fairly and appropriately with these cases. If their lawyers go sufficiently far and it becomes necessary to try a few cases, the price tag may go up for them."
References
1. Occupational Safety and Health Administration. Technical Information Bulletin: Potential for Allergy to Natural Rubber Latex Gloves and Other Natural Rubber Products. Washington, DC: OSHA; April 12, 1999.
2. National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplace. DHHS (NIOSH) Pub. No. 97-135. Washington, DC: NIOSH; 1997.
3. Food and Drug Administration. Medical Alert: Allergenic Reactions to Latex-Containing Medical Devices. FDA: Rockville, MD; March 29, 1991.
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