By Robert K. Jenner
Originally published in American Association for Justice, July 1997

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Contact dermatitis arising from chemicals used in the manufacture of latex gloves has been well documented since the 1930s. In the past few years, however, debilitating and even life-threatening allergies have been linked to repeated latex glove exposure.

The magnitude of this problem cannot be overstated. In July 1995, the American College of Allergy and Immunology issued its second position paper on latex allergy, recognizing latex protein toxic syndrome as "an epidemic."¹ In December 1995, the federal Occupational Safety and Health Administration (OSHA) declared occupational asthma--including latex allergies--to be one of the top 18 preventable, yet little publicized, workplace problems.²

This article provides general information about the most severe form of latex protein allergy and discusses litigation by injured health care providers against latex glove manufacturers.

Scientific literature has shown that repeated physical contact with latex gloves and exposure to airborne latex proteins have caused potentially fatal allergies in many exposed people.³

These workers may put on and take off dozens of pairs of gloves daily. When snapped off, the gloves release donning powder and tiny latex proteins that attach to the powder, giving health care workers a double dose of exposure: percutaneous from the gloves when they wear them and airborne from the gloves when they release latex proteins into the environment.

A person's immunologic sensitivity, the route of toxin entry, and the extent of exposure all influence the degree to which people react to latex protein. Once sensitization occurs, a person may become highly reactive to any product made with latex or rubber. Those who react intensely often have a history of other allergies.

From 1988 through early 1995, the FDA received more than 1,100 reports from patients or health care workers who described allergic reactions associated with use of latex-containing medical devices.

Of those people, 16 died from anaphylactic shock. The estimated number of health care workers actually afflicted with the most devastating latex allergies is up to 10 percent.⁴

History and diagnosis

Latex is collected from the Hevea brasiliensis tree found primarily in Malaysia and is brought to a factory or processing center. The processing of this "field latex" involves either preparing molded dry rubber for goods, such as tires, or concentrating the latex for dipped products, such as gloves, condoms, and balloons.

The processed latex concentrate is mixed with chemicals, leached, and heated. Each of these steps is important to decreasing the amount of extractable proteins in the final latex product. It is repeated exposure to these proteins that causes latex allergies.

Reactions people may experience generally fall into three categories.⁵ The most common is an "irritant" reaction, with no immune system response. Symptoms usually include abnormal redness of the skin, chapped or cracked skin, and blisters.

A second--a Type IV allergy--stems from "delayed contact." The onset of symptoms, which include redness, itching, and blistering, usually occurs within 6 to 48 hours after contact.

A third reaction, known as Type I, occurs within minutes of exposure. Clinical symptoms include swelling; itching; hives; inflammation of nasal passages; asthma; a drop in blood pressure; or, most significantly, anaphylaxis, which is characterized in severe cases by airway obstruction, convulsions, oxygen deprivation, and death.

Latex proteins enter the body through the skin, respiratory tract, and muscosa. In Type I reactions, the body responds by creating latex-specific Immunoglobin E (IgE) antibodies that attack the foreign antigens--the latex proteins. As part of the immune system response, these antibodies attach themselves to mast cells that contain histamine.

Once someone has been sufficiently exposed, antibody production rises and that person becomes increasingly sensitive to latex protein allergens. At this point, any exposure to latex proteins can cause the mast cells to release histamine, launching the allergic response. These Type I reactions have led to civil litigation against glove manufacturers.

The first report of Type I responses to natural rubber latex was published in 1979 in the British Journal of Dermatology.⁶ Reports increased in the late 1980s when more health care workers began using latex gloves as a precaution against AIDS.

Meanwhile, manufacturers hastened the production process, presumably to meet the greater demand for gloves. They used chemicals to extract more rubber from trees; shortened the manufacturing and storage process of latex; failed to respond to recognized manufacturing processes that were known to decrease allergen content; and established new production plants with decreased quality control. These changes likely resulted in increased protein and allergen content in latex products.⁷

Perhaps acting under the folk wisdom of "better late than never," the FDA last year intervened in the latex quagmire. The agency promulgated proposed rules for labeling latex-containing devices.⁸ One of the proposed warnings states, "This product contains natural rubber latex, which may cause allergic reactions in some individuals."⁹

This is hardly the affirmative guidance needed, but it may alert health care workers to the problem. Even today, many manufacturers either fail to place any warnings on latex gloves or simply include the label, "contains natural rubber latex."

The FDA said that it initiated the regulations because medical devices made of natural latex pose a "significant health risk to some health care consumers and providers. A statement on the label of medical devices identifying the presence of natural latex, and its risks, is considered to be necessary for the safe and effective use of such devices."¹⁰

The FDA, which has received reports of sensitivity to gloves marketed as "hypoallergenic," has taken a further step in label regulation.¹¹ The agency recognized that this term erroneously implies that product users are assured that the risk of an allergic reaction would be minimal.

Current manufacturing processes, however, cannot remove all natural proteins from latex gloves. Consequently, the risk of allergic reaction remains to those already sensitized. The FDA, therefore, found that use of the word "hypoallergenic" in connection with the gloves is false and misleading, a statement that is to be included in the regulation.

Litigation

About 150 plaintiffs throughout the country have filed lawsuits against glove manufacturers. Most of the suits name several defendants since health care workers are generally exposed to many brands of gloves.¹² In most jurisdictions, hospitals are immune from suit by health care providers because of workers' compensation laws restricting tort suits by employees against their employers.

About 35 cases involving latex gloves have been filed in federal court. These cases--and the certainty of more to come--prompted plaintiff lawyers to file for multidistrict litigation (MDL) status on October 7, 1996.

In February, the Judicial Panel on Multi-district Litigation said the cases involve common questions of fact and ordered them to be heard by the U.S. District Court in Eastern Pennsylvania.¹³

In a California state court case, plaintiffs unsuccessfully sought class action certification in Kennedy v. Baxter Healthcare Corp.¹⁴ The court ruled that too many variables existed to support a class action, saying,

Latex is a common material found in countless products, not simply gloves used in a health care setting. Health care workers, like others in society, may have come into contact with latex dishwashing or gardening gloves, balloons, paint, condoms, clothing, or any of numerous other latex items, thus raising the possibility that allergies were caused by, or exacerbated by, products other than latex gloves. Moreover, according to defendants, allergic reactions may be caused by the interaction of latex and certain foods, bringing into question the diets of each plaintiff. Furthermore, because there is no allegation that the gloves were manufactured according to a common formula, questions arise as to whether the protein alleged to cause the allergic reactions is present in the same amount and causes the same ill effect in each brand of gloves.¹⁵

Notably, the court's analysis succinctly outlines glove manufacturers' defenses. Defendants have attempted to point to latex products found in virtually every room of every household and office as potential causes and confounding factors of allergic reactions.

Plaintiffs have brought suit under several theories, including negligence, strict products liability, breach of warranty, and fraud.

The common issues in these cases include whether or not the defendants

• designed defective gloves and failed to warn users;
• performed requisite research concerning safety and Type I allergic reactions;
• conducted postmarket surveillance that was adequate;
• accurately reported the fact or results of testing or surveillance;
• acted together in connection with their wrongful conduct; and
• continued to market and sell the gloves after they knew or should have known of the adverse reactions and injuries and risks associated with their use.

In a nutshell, the principal issues are, not surprisingly, what did the manufacturers know, and when did they know it.

Unfortunately, protective orders secured by glove manufacturers have precluded open discussion of more specific issues in this litigation. It is common for defendants to argue, however, that health care providers are "sophisticated users" who should have known the risks. Manufacturers claim hospitals were "learned intermediaries" that insulated them from liability.

The statute of limitations defense is a significant obstacle in these cases. Plaintiffs must rely on a discovery rule that permits plaintiffs to file a lawsuit within a certain period of time following the date that they either knew or should have known they were wrongfully injured.

However, those with Type I allergies often suffer initially from contact dermatitis, hives, and low-level respiratory symptoms and later develop serious respiratory symptoms while they continue working. They do not associate their problems with their gloves or, if they do, they often correlate their symptoms to the powder.

After an anaphylactic episode, sufferers usually consult physicians, but physicians are frequently unaware of latex allergy. Most significantly, health care workers usually have no idea that wrongdoing may be associated with the manufacture of latex gloves.

In latent disease cases, such as latex allergy, the general requirements are that the plaintiff knew or should have had reason to know that (1) he or she has suffered an injury and (2) the injury was caused by the defendant.¹⁶

As the Maryland Court of Appeals wrote in Pennwalt Corp. v. Nasios, "Application of the discovery rule in a product liability action requires that the statute of limitations should not begin to run until the plaintiff knows or through the exercise of due diligence should know of injury, its probable cause, and either manufacturer wrongdoing or product defect."¹⁷ Discovery rule requirements, however, vary from state to state.

Ruling in Bishop v. Farhat, a Georgia trial court squarely refuted the defendants' statute of limitations claims.¹⁸ The trial judge said it was not established, as a matter of law, that the plaintiff appreciated the nature of her injury or whether she linked her allergy to the latex in the gloves or to the cornstarch donning powder. On interlocutory appeal, the court left it to jurors to determine the reasonableness of her actions.¹⁹

Determining damages

Latex allergies can devastate a person's career and life. Those who develop severe Type I reactions to latex not only may be forced to leave their jobs, but they also must be alert to further exposure. Because the protein permeates hospitals, severely allergic people cannot even enter them without risking anaphylaxis and death.

Many people with severe allergies cannot walk into stores that sell toys, shoes, or groceries. They cannot attend birthday parties where latex balloons are present, nor can they use condoms or diaphragms, eat in restaurants where cooks wear rubber gloves, swim in pools containing rubber liners, wear undergarments with elastic . . . . The list is endless.

The tragedy is that these lifelong allergies could have been prevented with the appropriate elimination of latex proteins during the manufacturing process.

To date, no latex protein case has gone to trial. As plaintiff attorneys seek to protect the rights of injured health care workers, the preliminary battles involving protective orders, product identification, and statute of limitations issues make true progress slow-going.

In the interim, manufacturers have the responsibility to place appropriate warnings on their products and to manufacture gloves that contain the smallest possible amount of latex protein. Whether or not the manufacturers will rise to the occasion is yet to be seen.

Notes

1. B. Lauren Chasous et al., Latex Allergy--An Emerging Healthcare Problem, 75 ANNALS ALLERGY, ASTHMA & IMMUNOLOGY 19 (July 1995).
2. U.S. Department of Labor, Office of Public Affairs, Washington, D.C., Occupational Safety and Health Administration press release, "OSHA Lists 18 Priority Safety and Health Hazards of Priority Planning Process" (Dec. 13, 1995).
3. S.M. Tarlo et al., Occupational Asthma Caused by Latex in a Surgical Glove Manufacturing Plant, 85 J. ALLERGY & CLINICAL IMMUNOLOGY 626 (1990).
4. Russell L. Thompson, Educational Challenges of Latex Protein Allergy, IMMUNOLOGY & ALLERGY CLINICS N. AM. 159, 162-63 (Feb. 1995).
5. Dennis R. Ownby, Manifestations of Latex Allergy, IMMUNOLOGY & ALLERGY CLINICS N. AM. 31, 34 (Feb. 1995).
6. A.F. Nutter, Contact Urticaria to Rubber, 101 BRIT. J. DERMATOLOGY 597 (1979).
7. Lynelle C. Granady & Jay E. Slater, The History and Diagnosis of Latex Allergy, IMMUNOLOGY & ALLERGY CLINICS N. AM. 21, 24-25 (Feb. 1995).
8. 21 C.F.R. §801 (1995) (to be codified at 21 C.F.R. §801.437 (1997) in September).
9. 61 Fed. Reg. 32,618 (June 24, 1996).
10. Id. at 32,619.
11. Id. at 32,620.
12. The principal defendants include, but are not limited to, Baxter Healthcare Corp.; Ansell, Inc.; Safeskin; Smith & Nephew Perry; Becton, Dickinson & Co.; Tillotson; and Aladan.
13. In re Latex Gloves Prod. Liab. Litig., MDL No. 1148, Transfer Order (Feb. 26, 1997).
14. 50 Cal. Rptr. 2d 736 (Ct. App. 1996).
15. Id. at 743.
16. Pierce v. Johns-Manville Sales Corp., 464 A.2d 1020, 1026 (Md. 1983); see also Pennwalt Corp. v. Nasios, 550 A.2d 1155, 1162 (Md. 1986); General Motors Corp. v. Superior Court of Los Angeles County, 55 Cal. Rptr. 2d 871, 876 (Ct. App. 1996) (the ultimate issue in a products liability case is whether the plaintiff has actual knowledge of the basic facts giving him or her a claim against the defendant).
17. 550 A.2d 1155, 1165 (emphasis added).
18. No. 95VS95697, slip op. at 5 (Ga., Fulton County State Ct. June 14, 1996).
19. Baxter Healthcare Corp. v. Bishop, No. A97A1114 (Ga. Ct. App. Mar. 28, 1997).

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