Latex Protein Toxic Syndrome
The Newest Toxic Exposure
This article first appeared in the Legal Intelligencer.
Latex has long been the material of choice for protective gloves in health care settings, providing the wearer with flexibility, a barrier against exposure to infectious agents, and durability.
Unfortunately, for a substantial number of health care workers and other regular wearers of latex gloves, latex glove wearing also leads to a permanent, allergic sensitivity to latex which can be life threatening. So life threatening, in fact, that once the allergic sensitivity to latex has fully developed its most intense form through repeated exposure to latex, the victim may no longer be able to be present in a room with a single birthday balloon — let alone in a latex-rich hospital setting — without risking his or her very life. As a result, many productive careers — primarily of doctors, dentists, and nurses — have been brought to a grinding halt due to allergic sensitivity to latex.
Plaintiffs believe that manufacturers of latex gloves have known for quite some time about the dangers of allergic sensitivity to latex glove wearers but, despite this knowledge, failed to take appropriate action. For example, plaintiffs believe that manufacturers have known about — but failed to take — certain precautions to minimize the amount of protein allergens in latex, which would prevent the devastating consequences of latex allergy to glove wearers. Plaintiffs also believe that manufacturers have had many opportunities to fully warn the potential wearers of latex gloves about those consequences, but failed to do so for self-interested reasons.
In this article, we will review the medical process that leads an unsuspecting wearer of latex gloves to develop the toxic syndrome and we will describe some of the highlights of and issues surrounding the growing legal response against manufacturers and sellers of latex gloves.
Who Is At Risk?
Latex protein toxic syndrome is an intense, usually-progressive allergy to one or more of the proteins which naturally occur in natural rubber latex. Like many serious allergies, the syndrome results from a Type 1 immunoglobulin E (IgE) reaction to the protein allergens in the latex. Type 1 reactions involving immediate hypersensitivity to latex were first reported in Germany in 1927. In 1983, researchers specifically attributed to latex glove use allergic sensitivity in a cohort of health care workers. Other medical and scientific literature has been around for many years. Between 1989 and 1993 the FDA received hundreds of reports of injury and 15 reports of death associated with latex allergy.
The incidence of IgE-mediated latex allergy in health care providers has been reported as being as high as 10%. With over 5.5 million health workers in the United States, an estimated 150,000 to 1 million health care workers may currently be sensitized to latex and thus at risk for serious adverse reactions. Health care workers at highest risk for the most serious reactions of latex allergy are those in latex-rich environments, such as operating rooms. Other highly latex protein-exposed occupations include paramedics, firemen, and police. People who have had multiple surgeries or other medical procedures are at risk of becoming latex sensitive because they have had repeated and directly internal exposures to latex protein. Others at high risk include children with conditions requiring frequent operations (especially spina bifida), workers in the rubber industry, and persons with history of other IgE-dependent allergies.
How The Syndrome Develops
The main routes of exposure (and therefore of allergic sensitization) to the proteins in latex are (1) direct skin contact with the protein allergens in latex during glove wearing and (2) inhalation into the respiratory tract of airborne protein allergens from latex gloves. Health care workers’ exposure to the protein allergens in latex gloves is aided by four basic facts: (1) the protein allergens in latex are water-soluble; (2) protein-absorbing glove powder intended to assist the wearer in donning and removing the gloves — and the protein allergens themselves — become aerosolized when the latex gloves are donned and removed, and float along the air currents for some time before settling; (3) some health care workers (especially nurses) tend to don and remove 30-40 pairs of latex gloves each day, creating a great deal of aerosolized latex protein; and (4) many health care workers spend the greater part of their long shifts continually wearing latex gloves.
During frequent and regular use, the protein allergens in latex gloves enter the body through the skin, respiratory tract, and mucosae. In response, the human immunological system creates latex-specific IgE antibodies. Repeated exposure to the latex allergen causes and progressively amplifies the production of antibodies, resulting in the body’s growing sensitivity to the latex protein allergens. After creation, the antibodies attach to types of cells which produce histamine and, with continued latex exposure, those cells begin to release their histamine. As exposure continues and allergic sensitivity increases, the body creates more and more histamine, which accounts for the increasing range of severity in allergic reactions, from the sniffles to death. Prevention of this progression of events can be achieved only prior to acute sensitization, by removing the protein allergens from the latex during glove manufacture, avoiding the use of powder in latex gloves (only a partial and, many believe, unsatisfactory solution), or a health care facility’s ceasing the use of latex gloves altogether and turning to one of many alternative synthetic glove materials. Because latex proteins easily aerosolize and are thereby inhaled, a single sensitive user’s refraining from using latex gloves in an environment where others are using such gloves is fruitless in preventing continued exposure and increasing sensitivity.
The typical sufferer of latex protein toxic syndrome has worked in the medical field for a period of years. In the beginning, the symptoms mimic benign allergies such as hayfever (runny nose, watery eyes), food allergies (hives), or the well-known irritation caused by glove wearing due to hand dryness or the chemicals used in glove processing (contact dermatitis), thus confounding accurate diagnosis of the syndrome and delaying necessary early intervention. These symptoms may progress to asthma, concomitant with growing sensitivity, exposure to smaller and smaller amounts of latex protein triggering increasingly severe reactions. Some highly latex-sensitized individuals then progress, suddenly and without warning, to a terrifying and life-threatening anaphylactic shock reaction following exposure to even minimal amounts latex protein, with associated unconsciousness and airway obstruction and, without emergency treatment, cyanosis and resulting death. It is typically only at this point in the syndrome’s severity that a treating doctor’s differential diagnostic curiosity is sufficiently piqued and the necessary latex-specific allergy test administered. By this time, however, it is too late: intense sensitivity to even minute amounts of latex protein has developed and is permanent. The only effective steps that can be taken at this point are removing the latex protein from the victim’s environment or, more likely, removing the victim from his or her career. The victim’s allergic sensitivity has left him or her living under the constant threat of anaphylactic shock reactions, which prevents him or her from encountering any latex whatsoever. For example, one of our clients can’t go to her own doctor’s office any longer and must find a “latex-free” doctor. Another can’t take his little daughter to the local “Chuck E. Cheese”, because the latex in the children’s balloons will send him to the emergency room. Both wear “medic alert” bracelets and carry epinephrine with them wherever they go. Other clients battle frequent, debilitating asthma.
In the 1980s, with the growing HIV scare, latex gloves became the barrier of choice, although alternatives such as vinyl and technology for various synthetics existed. As demand for latex gloves increased in the middle 1980s, there arose an acute latex shortage. Plaintiffs believe that production of latex gloves increased furiously at this time as competing manufacturers sought to gain market share. Protein allergen reduction processes, designed to remove from latex the very proteins that cause allergic sensitivity, are time-consuming and cost-additive, and thus conflict with a latex glove manufacturer’s profit motive. Plaintiffs believe that these processes were scaled down or skipped altogether. Without adequate deproteinization, the risk of producing latex that will cause allergic sensitivity increases. Thus, reports of severe allergic reactions in the early 1990s caught the attention of the FDA.
In March of 1991, the FDA issued a Medical Alert concerning the hazards of latex protein allergy. This was followed two months later by an FDA letter to manufacturers of latex gloves, in which the FDA recommended steps to reduce the amount of latex protein in gloves. Later, the FDA recommended that the latex glove industry voluntarily label gloves with a warning concerning the possibility of allergic reactions. Documents obtained from an industry trade group, the Health Industry Manufacturers’ Association, suggest that upon considering the FDA’s recommendation, various glove manufacturers decided instead merely to state on the glove box that the gloves contained natural rubber latex, omitting any reference to allergy. Some latex glove manufacturers even went so far as to label their gloves misleadingly as “hypoallergenic”, when only the powder content (and not the protein allergen content) of the gloves had been reduced.
It is against this background that litigation concerning latex protein toxic syndrome was born. Primarily because of what plaintiffs see as the industry’s failure to warn latex glove wearers adequately or to take the necessary precautions to minimize the protein allergen content of latex gloves through proper processing, many productive people who had regularly worn latex gloves developed a permanent, debilitating and intense allergy, with life-altering consequences.
In this, the second and final article concerning latex protein toxic syndrome litigation, we focus on the characteristics of lawsuits brought on behalf of victims of latex allergy. In our prior article, we reviewed the pertinent medical background of latex protein toxic syndrome.
Litigation In Various Forums
Lawsuits brought on behalf of victims of latex protein toxic syndrome are becoming increasingly numerous nationally. Because the suits generally join as defendants latex glove manufacturers and distributors with a national presence, most feature diversity of citizenship and are brought in or removed to federal courts, although there are many in state court, as well, primarily due to diversity-destroying local manufacturers and distributors of latex gloves.
Significantly for those suits brought in federal court, a petition under the procedures of the Judicial Panel on Multidistrict Litigation was filed by, and granted to, a plaintiff in the Eastern District of Pennsylvania, seeking to have all federal cases coordinated in a single federal district for pre-trial proceedings. Defendant manufacturers such as Baxter and Johnson & Johnson vigorously opposed coordination, some believe because such treatment would lead to document depository creation and facilitate communication and cooperation among victims, who, up until now, have had to suffer the imposition of strict confidentiality orders with regard to the contents of discovery documents.
Currently there is no pending petition in Pennsylvania pursuant to Pa. R. Civ. P. 213.1 for coordinated treatment of statewide litigation, although this is a possibility as well. In Philadelphia County, latex cases are a new addition to the several toxic tort litigation programs supervised in the Complex Litigation Center.
Causes Of Action And Statutes Of Limitation
Complaints in latex cases are fairly uniform. Latex cases are essentially products liability cases, featuring the familiar negligence-402A-implied warranty triad and averments that the latex gloves the victim used were defective in manufacture, design, or for want of adequate warnings, thereby causing Type I latex allergy, consequent injuries and a full range of economic and hedonic damages. Owing to misleading “hypoallergenic” claims and other claims and omissions of manufacturers of the gloves, misrepresentation and concealment claims are joined (featuring all state of mind gradations from strict liability through purposeful and pecuniary gain- driven fraud). Several complaints also join a count based on the consumer protection laws of the jurisdiction.
The product defects alleged vary somewhat, but center on the alleged failure of the manufacturers to subject the gloves to adequate measures to reduce the amount of protein allergen in the latex or to warn users of the possibility and consequences of developing latex allergy.
The choice of causes of action may become important from a statute of limitations standpoint. In Pennsylvania the limitations period for actions complaining of personal injury is, in view of one formulation of the discovery rule, two years from the date the victim should have known (1) that he or she was injured, (2) the operative cause of the injury, and (3) that the injury was due to the conduct of another. The cause of action for breach of implied warranty, however, has a four year limitations period, and that for violation of the Pennsylvania consumer protection statute is six years. These variations are important because plaintiffs can reasonably expect that defendants will devote enormous energy to attempts to portray a plaintiff’s limitations period as having commenced not when a diagnosis of latex allergy was made, but rather when the plaintiff experienced allergy-related symptoms in the workplace. Although discovery rule brawling has not yet taken place in a Pennsylvania latex case concerning the question of what quantum of knowledge a plaintiff must have to commence the running of the statute of limitations; and even though the recent asbestos-limited and defendant-favorable opinions of Cochran and Baumgart have been put into question by lower courts recently; and although various states have recently fixed the commencement of the running of the statute of limitations in latex cases as the point when a reliable diagnosis of latex allergy is made (recognizing the difficulty even competent allergists have in diagnosing latex allergy), plaintiffs are likely joining causes of action that fix the running of the limitations period at more than two years as a hedge against possible defense-oriented statute of limitations rulings.
In a related vein, experienced practitioners who invite latex allergy cases into their offices for evaluation and investigation are wary of the possibility that, if the potential client does not come through the door with a complete set of medical records, the applicable limitations period could conceivably run before the medical copy service gets around to xeroxing that two-year-old report by the client’s allergist diagnosing latex sensitivity. This is not an easily solved problem and requires thoughtful treatment.
Two Disease Rule Applicability?
As a progressive disease, latex protein toxic syndrome features a wide array of symptom manifestations of varying severity, from itchy eyes, through asthma, and finally anaphylaxis and death. Should a plaintiff with watery eyes and a diagnosis of latex allergy be forced to file a complaint (or should a defendant be forced to be exposed to a verdict) when it is not at all certain that the plaintiff will develop more serious symptoms? Should a plaintiff who chooses not to file an action complaining of a runny nose be precluded from later filing an action should an anaphylactic-type reaction emerge later on? In the asbestos context, with the Marinari case, these questions have been answered. They have yet to be answered in the latex context and probably will not arise for several years.
Product (And Defendant) Identification
With the sole DES exception and a decision by the Supreme Court in the lead paint poisoning context pending, it appears that for now Pennsylvania is a product identification state, and alternative liability theories (market share, enterprise, etc.) are not yet recognized. Whether latex glove cases may lend themselves to cognizable market share liability remains to be seen. Each plaintiff, therefore, must assume that the product identification rule of Eckenrod applies, and that contact with a specific manufacturer’s gloves on a regular and frequent basis will be required as an evidentiary sufficiency threshold. Thorough client interview and pre-complaint investigation of the plaintiff’s employer’s purchasing records will in most instances reveal all of the information necessary for purposes of drafting an accurate complaint and obtaining sufficient evidence for trial. (For noncooperative employers, a stern threat regarding the worker’s compensation lien may be necessary, although there is decisional law in Pennsylvania that suggests that such a threat may be empty, an employer’s noncooperation with a third-party suit possibly having no bearing on the plaintiff (and counsel’s) duty to protect the lien.) As with asbestos litigation, the plaintiff will likely be questioned closely in deposition as the defendants try to establish that their products have been misidentified (for example, the plaintiff testifies that the gloves she used came in boxes with a blue stripe, but the defendant’s boxes had orange polka dots), and the employer’s purchasing agents will be similarly questioned (for example, the employer testifies that it only purchased gloves that were powdered, but the defendant never made powdered gloves).
Once a reliable, closed set of glove brands is obtained, the question turns to the identity of the defendants. Here, the relationships of parent/subsidiary and predecessor/successor are important. Although there is a potential laundry list of nationally-recognized surgical and examination glove manufacturers (including Aladan, American Health Products, Ansell Perry, Baxter Healthcare, General Medical, Jason Marketing, Johnson & Johnson, Kendall Healthcare, Safeskin, Tillotson, and many others), it is of no use to a plaintiff (and great use to a defendant) to name parties that turn out to be wrong, since a verified pleading is a non-hearsay party admission and the plaintiff’s credibility can be impeached if the defendant can establish that the plaintiff just sued everybody his or her attorney could think of. But failing to include a responsible defendant before the statute of limitations runs — either because a parent was named instead of the actually-responsible subsidiary, or because it was not discovered until it was too late that a merger or acquisition occurred during the plaintiff’s exposure period and the predecessor or successor was not named — risks an empty chair onto which the remaining defendants can safely heap liability. In this regard, practitioners must bear in mind that large multi-national healthcare corporations may have multiple subsidiaries (Johnson & Johnson has over 100), and the parent may not have any involvement in (and, unless an alter ego situation exists, no vicarious responsibility for) the manufacture or distribution of the relevant latex gloves, which may merely involve one or more subsidiaries. Another fact is that many of the manufacturing facilities for latex gloves are located in the Pacific Rim area, so in identifying the potentially-responsible subsidiaries one should not overlook those based in Thailand, Malaysia, China, etc., even though headaches of foreign service of process attend naming such defendants. Also, there has been a moderate amount of merger and acquisition activity in the latex glove business recently (for example, Smith & Nephew’s “Perry” glove business was sold to Ansell in 1/95, and is now called Ansell Perry. No product lines were discontinued subsequent to the acquisition).
Another question involves naming various non-manufacturing defendants, such as the plaintiff’s employer (a hospital in many cases), the distributors or retail sellers of the gloves to the plaintiff’s employer, and group purchasing organizations which administer purchasing contracts between the plaintiff’s employer and various manufacturers. Regarding the employer, given the immunity granted by the Worker’s Compensation Act such a strategy will most likely be fruitless, unless your client happens to be an independent contractor or falls into another exception to the general rule of immunity for employers. Regarding distributors and other non-manufacturing sellers, there are various considerations. The first is that under ß402A of the Restatement (Second) of Torts and the implied warranty theories, all sellers in the chain of distribution are jointly and severally liable for damages caused by defective products. The second is that under the implied warranty of fitness for a particular purpose, a non- manufacturing seller who selects a product for the purchaser can be held liable. A third consideration is that there exist in the latex glove industry some “private label” arrangements, whereby a seller puts its own label on gloves manufactured by another company (for instance, a hospital services company known as VHA, Inc. arranges to have its own label on gloves manufactured by Ansell and American Health Products). Under Restatement (Second) of Torts ß400, a seller who holds itself out as the manufacturer of the gloves can be liable as the “apparent manufacturer” of the gloves to the same extent as the actual manufacturer.
The affirmative defenses in latex cases are those traditional defenses in all product liability cases, with some special twists. The statute of limitations defense is discussed above. Another twist is borne of the fact that most plaintiffs (and their employers who purchased the gloves) are health care providers whom defendants contend are “sophisticated users” or “sophisticated purchasers” of products for whom no warning is required. A third notable defense is termed the “idiosyncratic reaction” defense: the defendant is not liable for the plaintiff’s injuries because the risk of developing such injuries is particular to the plaintiff. This appears to be some form of an “unforeseeability” argument or a “risk/utility” defense. Other defenses include pre-emption (owing to the classification of latex gloves as medical devices), the viability of which is questionable after the recent Lohr case from the U.S. Supreme Court. It is also expected that defendants will claim that there were no feasible alternatives to latex as the material from which to construct medical gloves. Finally, we expect that defendants will argue that, given the prevalence of latex in the environment (hospitals, especially), latex-containing items other than gloves caused the development of latex sensitivity.
If you would like more information about latex allergy claims, or if you are interested in seeing if you have been dangerously exposed to latex protein, contact the Law Offices of Silverman & Fodera, at 1-800-220-5291 or Do I Have A Case?.
Please visit our Resource Page for a list of world-wide web links, internet, and non-internet resources discussing latex related injuries.
This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the “Do I Have A Case?” link on this web site.