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Despite the fact that Federal agencies have not yet been able to reach a consensus on the regulation of latex gloves, exposure to which has resulted in a growing epidemic of allergic reactions, on April 12, 1999 The Occupational Safety & Health Administration (OSHA) issued a Technical Information Bulletin (TIB) to all its field offices to alert its personnel to the potential for allergic reactions in some individuals using natural rubber latex (NRL) products, particularly gloves, in the workplace setting.

OSHA has indicated that a "safe zone" may need to be established to protect workers who are already sensitized to NRL. OSHA had other recommendations including the following: that latex gloves be used only for health care workers and NOT for food service staff, that suitable nonlatex gloves be provided for workers with latex allergies, and that a catalog of all latex products used in the workplace be made. It has indicated that health care facilities may be required to develop policies and procedures for reducing the risk of NRL allergies in the workplace. It has also recommended that there be mechanisms for reporting and managing cases of allergic reactions. Since the allergic reactions may be systemic and immediate, OSHA has recommended that the fundamentals of an emergency response (i.e., assuring airway, breathing and circulation) remain of primary importance if a worker develops symptoms requiring resuscitation, that these situations should be anticipated in the workplace, and that provision of immediate access to non-natural rubber containing equipment be considered. 

Once NRL sensitivity occurs, allergic individuals continue to experience symptoms, which have included life-threatening reactions, not only on exposure to NRL in the workplace but also upon receiving or accompanying a family member receiving healthcare services at inpatient as well as office-based settings.

In September of 1997, the Food and Drug Administration (FDA) issued a final rule FN1 requiring cautionary statements in the labeling of all medical devices that contain natural rubber likely to come in contact with humans. The rule provides that such products must contain the following cautionary statement in bold print: "Caution: This product contains natural rubber latex which may cause allergic reactions." Additionally, the FDA issued a final ruling that the labeling of medical devices that contain natural rubber, likely to come in contact with humans, shall not contain the term "hypoallergenic".

Over the last few years, there has been a significant increase in the number of workers' compensation claims filed against employers on behalf of individuals who have suffered latex allergic reactions. Scientists and government officials estimate that about 950,000 U.S. health care workers have developed an allergic sensitivity to latex. Additionally, a significant number of claims have been filed against the manufacturers, suppliers and distributors of latex gloves and products. The claims filed in the Federal District court throughout the United States have been joined in one action for pretrial management and discovery in accordance with a Multi-District Litigation Order issued by the court.

The regulation of NLR products has been a concern both for the federal government and for individual states. The Federal government has initiated agency evaluations and Congress is conducting oversight investigatory hearings on latex allergies in the healthcare industry. Some state governments are now considering enacting legislation in order to protect the health of those exposed to NLR products.

History of Latex Litigation

Latex gloves used by health care workers and others have allegedly caused respiratory, cardiovascular and skin disorders. We are currently investigating claims for this type of litigation.

The FDA (US Food and Drug Administration) issued the following alert concerning these products on September 30, 1997: In response to reports of allergic reactions to some medical devices, the Food and Drug Administration is requiring all medical devices containing latex to be labeled as such and to carry a caution that latex can cause allergic reactions. Devices that contain natural rubber latex will be required to carry a statement on the label which says, "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." Medical device packaging that contains latex will be required to carry a similar statement on the label. Products and packaging that contain dry natural rubber will have to be identified as containing dry natural rubber.

The new requirements, published today in the Federal Register as a final regulation, will help protect people who are allergic to latex by enabling them to easily identify medical devices that contain latex and avoid contact with them.

Over the past decade, the FDA has received more than 1,700 reports of severe allergic reactions, including 16 deaths, related to medical devices containing latex. The deaths all occurred in 1989 among children with spina bifida. They were caused by a reaction to latex cuffs used on the tip of barium enema catheters. The manufacturer voluntarily recalled all the enema tips on the market and started using tips with silicone cuffs instead.

Allergic reactions to a wide range of medical devices that contain latex have been reported, including latex surgical gloves, adhesive bandages, intravenous catheters, and anesthesia equipment. The FDA sponsored an international conference on latex sensitivity in 1992 to determine the cause and extent of the problem and explore ways to address it.

For the general public, the risk of an allergic reaction to latex is estimated to be less than 1 percent. But because of constant exposure to latex, two groups are at greater risk -- health-care workers and children with spina bifida and other conditions involving multiple surgical procedures.

The FDA is also requiring that all "hypoallergenic" claims on medical devices be removed because they incorrectly imply that the devices may be safely used by people sensitive to latex. Such claims are currently found on many medical devices that contain reduced levels of latex protein. However, these products may still cause allergic reactions in people who are latex sensitive.

Protective gloves may seem like an unlikely occupational hazard. But latex allergies — in which individuals exposed to latex gloves and other latex products become sensitized and develop allergic reactions — are becoming more common among workers’ compensation claims throughout the United States.

• Q: What are some symptoms of latex allergy?
• A: There are three major types of reactions to latex:
  
  1. Irritant contact dermatitis involves non-allergic reactions, which amounts to about 80 percent of the cases. Between 25 percent and 40 percent of those who wear latex gloves develop a mild reaction.
  2. Type IV hypersensitivity is a delayed reaction involving contact dermatitis. Inflammation occurs several hours — and possibly up to four days — after exposure to latex.
  3. The third type is the most serious. Type I hypersensitivity occurs when an antigen interacts with an antibody. The immune system responds within two hours after exposure and sometimes the reaction is immediate. Type I hypersensitivity can trigger hives (either on the hands or all over), swelling in the face and throat, asthma or even a life-threatening reaction called “anaphylaxis.” Type I hypersensitivity is the one that most latex claims for workers’ compensation and products liability are based upon.
• Q: What’s the success rate in bringing a workers’ compensation claim for latex allergy sensitivity?
• A: About 70 percent of the reported workers’ compensation cases for Type I latex allergy sensitivity have resulted in awards to the worker. And the rate is increasing.
• Q: What has the Occupational Safety and Health Administration (OSHA) done to protect the worker?
• A: OSHA has indicated that a “safe zone” may be needed to protect workers who are already sensitized to latex. OSHA recommends that latex gloves be used only by health care workers and not by food service staff, that suitable non-latex gloves be provided for workers with latex allergies and that employers catalog all latex products used in the workplace. OSHA has said that health care facilities may be required to develop policies and procedures for reducing the risk of natural-rubber latex allergies in the workplace. It has also recommended that there be procedures for reporting and managing cases of allergic reactions.
• Q: What has the Food and Drug Administration (FDA) done to protect workers exposed to latex products?
• A: In September 1997, the FDA issued a final rule requiring cautionary statements in the labeling of all medical devices containing natural rubber that people are likely to come into contact with. The rule provides that such products must contain the following warning in bold print: “Caution: This product contains natural rubber latex which may cause allergic reactions.” The FDA also ruled that the labeling of medical devices that contain natural rubber shall not contain the term “hypoallergenic.”
• Q: Is the reaction to latex products considered an occupational exposure or a specific event?
• A: The courts appear divided on this. In a landmark case, the Iowa Supreme Court decided that latex allergy/sensitivity claims are to be considered work related accidents rather than occupational diseases. It also ruled that sensitized workers are entitled to receive workers’ compensation benefits, including those for loss of functional ability. The court’s decision to pinpoint the reaction as a specific event rather than to characterize it as a long period of occupational exposure will make it easier, less complicated and less costly for injured workers to claim benefits.
• Q: Who pays for continued medical treatment after workers’ compensation is awarded for latex sensitivity?
• A: Most workers’ compensation agencies have the authority to order the employer to pay for medical treatment and medications required to relieve and cure the medical conditions connected to latex products.
• Q: May dependents of a latex allergic worker be awarded workers’ compensation benefits?
• A: Yes. In most jurisdictions, if a latex sensitive worker dies as a result of a compensable latex reaction, his or her dependents would be entitled to benefits. Benefit periods and amounts vary from jurisdiction to jurisdiction.
• Q: Can a homebound latex sensitive individual be entitled to a computer?
• A: A Nebraska Workers' Compensation Court has ordered that a personal computer must be furnished to a homebound former health care worker suffering from latex sensitivity. This ruling is consistent with a national trend by the courts recognizing the catastrophic impact of latex allergy. The injured worker was so sensitized to latex that she couldn’t even leave her home to attend computer training. She was unable to handle ordinary textbooks and physical training aids because of her sensitivity to the ink and binding materials. The court reasoned that the allergic reaction potentially triggered by further exposure could be so severe as to be life threatening.
• Q: Can a skilled health care professional be “totally disabled” under workers’ compensation laws because of latex sensitivity?
• A: Yes. A surgical registered nurse was declared to be totally and permanently disabled because of her latex allergy. The court declared that the nurse could not work outside of her house. The court also said the nurse should be considered unable to work at all and entitled to benefits until “products containing latex are eliminated from hospitals and public settings.” The court cited prior Nebraska law that an injured worker should be declared totally and permanently disabled, even though not altogether incapacitated, “if the worker is so handicapped that he will not be employed regularly in any well-known branch of the labor market.” The court reasoned that, while the nurse could probably sell her services in the competitive labor market, she could not depend on regular employment without factors such as business booms, sympathy of others, good luck or superhuman efforts to rise above her medical disability.
• Q: In addition to a workers’ compensation claim, may a latex sensitized worker bring a claim against the manufacturers and suppliers of latex products?
• A: A jury awarded a radiologist $1 million for doctors’ bills and damages in her lawsuit against glove manufacturer Smith & Nephew of England. In most jurisdictions, workers’ compensation laws don’t prohibit an additional claim against the manufacturers of latex gloves. Workers’ compensation may not be the only avenue employees can pursue if they believe a health care facility’s latex policies are inadequate. Health care providers may soon see lawsuits claiming violation of the Americans with Disabilities Act, in addition to third-party claims.
• Q: Must a sensitized worker report the allergic reaction to the employer in a timely manner to receive compensation benefits?
• A: Many jurisdictions require that an employee properly notify his employer in a timely fashion. The statute of limitations varies by jurisdiction and the injured worker must comply with these rules in a timely fashion or else lose the right to seek benefits.

Individuals exposed to latex gloves and other latex products become sensitized and develop an allergic reaction. Latex allergy sensitivity claims are becoming a more common phenomenon in workers’ compensation systems throughout the United States.

• Health care workers (Physicians, dentists, nurses, technicians and nurses aides)
• Food Handlers
• Patients
• Visitors at medical facilities
• Laboratory workers
• Tire workers