DeRobertis, L R

Galiher, G O

eVols at University of Hawaii at Manoa

The Legal Aspects of the Latex ProteinAllergy EpidemicGary 0. Galiher JD and L. Richard DeRobertis JDThe epidemic of Type I allergies to latex proteins appears to belimited to healthcare workers and others who have used or beenexposed to powdered latex gloves.’ This phenomenon apparentlybegan with the advent of universal precautions in the late 1 980s andthe consequent ten-fold increase in the demand for latex gloves.2Lawsuits against the manufacturers of powdered latex glovescommenced in the 1990s. They are filed in both state courts andfederal courts. Cases tiled in Hawaii State Circuit Court have beendesignated “complex litigation” and assigned to the Hon. Gail C.Nakatani. Cases filed in federal courts have all been temporarilytransferred by the Multi-District Litigation panel to Philadelphiaand assigned to the Hon. Edmund Ludwig. One recent jury trial inWisconsin resulted in a verdict of $l,000,OO0. Documents produced by the manufacturers have been subjected to court protectiveorders which prohibit even alluding to their contents. Yet, publishedarticles on this topic contend that the manufacturers shortened oreliminated the post-oven leaching time of their latex gloves and thusproduced gloves with high extractable protein content.4 Somemembers of the industry appear to concede that changes in themanufacturing process, such as the shift from alcohol coagulants towater and decreasing the use of zinc-bearing components may beone of the factors in the increase in Type I reactions to latex.5Leaching has long been described in the manufacture of “rubbergloves” as “probably reduc[ingj the risk ofdermatitis to the wearer.”6Persons with Type I allergies have at least two parallel legalrecourses: (1) filing worker’s compensation claims for occupationaldisease (which provided limited benefits) and (2) filing productliability actions against latex glove manufacturers (which providefull compensation for losses). Occupational diseases, includingdisabling allergies, have long been compensable under state workers’ compensation laws.7 A causal connection between work and thedisease is sufficient. Product liability is more complex. UnderHawaii law, a manufacturer is liable to end-users for personal injuryand disease caused by its defective products. A product is defectiveif rendered dangerous by a flaw in the manufacturing process, or itis defectively designed, or if the manufacturer fails to warn ofdangers in the expected uses of the product by the public.6 A productis deemed defectively designed if (I) it is not as safe as an ordinaryconsumer or user would expect when used in a reasonably foresee-Correspondence to:Gary 0. Galiher JD andL. Richard DeRobertis JO610 Ward Aye, #200Honolulu, HI 9681 43308able manner; or (ii) the benefits of the product as designed areoutweighed by the dangers imposed by the product.9To the extent that latex glove manufacturers decreased the totalleach time to below the industry standard and this resulted in a higherlevel of latex proteins in the finished product, this would establishliability under both the manufacturing defect (i.e., flaw in themanufacturing process) and the balancing test for defectively designed products. That is, a product designed to have more latexproteins in the finished product than is otherwise necessary producesno added benefit to the end-user compared to the protective benefitsalready present in a properly leached latex glove.A parallel theory of liability of the latex glove manufacturers istheir failure to warn. Under well-established Hawaii law, a manufacturer is negligent if it fails to warn of the reasonably foreseeabledangers in its products.”> It is established in the published literaturethat the latex glove industry knew since the 1930’s that certainindividuals can become sensitized to the naturally occurring proteins in latex gloves.” Therefore, the manufacturers had both a dutyto eliminate the dangerous levels of latex proteins from the finishedproduct and to warn end-users of the risks inherent in high proteinpowdered latex gloves. Failure to warn liability can also beestablished if the warnings were inadequate or rnisieading.2Thus,latex glove manufacturers which promoted their products as“hypoallergenic” when in fact they had high levels of proteinallergens could be found negligent and consequently liable forsensitizing healthcare workers who develop Type I systemic allergies. Numerous documents in the public domain indicate that thelatex manufacturers, through the trade association, Health IndustryManufacturers Association, actively resisted discontinuing the claimsof “hypoallergenic” for latex gloves. On June 24, 1996, the FDAproposed that the term “hypoallergenic” be eliminated because it isfalse and misleading in that it incorrectly implies that the productlabelled as “hypoallergenic” may be used safely by latex sensitivepersons.’3It is vital for anyone with a Type I allergy to understand thattheir claims against the manufacturers and for worker’s compensation benefits are subject to statutes of limitations. That is, a claim forbeing exposed and sensitized to latex proteins through powderedgloves will be barred if a legal action is not promptly filed. The exactknowledge which triggers the running of the statute of limitations isa technical legal issue and depends upon the particular facts of eachindividual case. Indeed, the elements triggering the running of thestatute of limitations have been the subject of numerous appellatecourt opinions.’4No healthcare worker should assume his/her claimis already barred; nor should he/she assume that it is safe to delayseeking legal advice.continued on page 167HAWAII MEDICAL JOURNAL, VOL 58, JUNE 1999160Scientists report that half of all cases of dog andcat bites carry pasteurella which can cause septicemia, bursitis and even meningitis. (JAMA &NEJM)A recent study says calcium supplements(I ,200mg/d) reduce the growth of colon adenomas. Researchers theorize that calcium bindswith compounds that irritate the colon lining.(Time 1/25/99)Mayo Clinic reports that 639 women with moderate to high risk of developing breast cancerunderwent prophylactic mastectomies form 1960to 1993, thus reducing their risk of dying frombreast cancer by 90% (a figure which is debatable). Researchers have identified two majorgenes BRAC 1 and BRAC 2 whose mutationsincrease breast and ovarian cancers. Tests forthese genetic mutations cost $2,400 for the firsttest per family and $400 for subsequent tests...(Time 1/25/99)Medical Tid Bits Ill...FDA has approved a hand-held imaging devicecalled T Scan 2000 which sends tiny jolts ofelectricity into mammogram detected breast tumors. Malignant cells apparently conductelectricity differently from normal cells. Thescan may prevent 200,000 unnecessary biopsiesper year.Root Canal specialists say that when a toothgets knocked out, put it in a glass of milk. Milkkeeps the tooth alive by nourishing the root cellsfor at least an hour.The Wall Street Journal reports 10 deaths and11 cases of GI hemorrhage attributed to Celebrax.Monsanto says there is no proof that the drugcaused the deaths. Since January, 2.5 millionprescriptions have been written for the drug.(Time 5/3/99)Eating an egg a day won’t keep the doctor away,but probably won’t hurt your heart either or causea stroke per JAMA. Researchers from Harvardand Brigham and Woman’s Hospital in Bostonstudied egg consumption by 120,000 nurses andother healthy professionals with normal cholesterol levels and found no link between eggs andheart disease or stroke (except in diabetics)Dietary fat may be unhealthy for the heart, butwill not cause breast cancer according to a studyinvolving 90,000 women.Viagra may not work for women according topreliminary data. Thirty post menopausal womentook the drug and only 21% reported improvedsexual function viz enhanced desire and easilyachieved orgasms... (Time 3/22/99)Continuedfrom page 158References:1. Yuniger, J.W., Jones RT., FranswayA.F., Kelso,J.M., Warner, MA., and Hunt, LW., “Extractable Latex Allergens and Proteins in DisposableMedical Gloves and Other Rubber Products”. J. Allergy Ctin Immunot 1994, 93:836-42.2. Hunt, el al,”An Epidemic of Occupational Allergy to Latex, JOEM, Vol.77, No. 10 (Oct. 1995).3. Linda M. Green v. Smith & Nephew AHP, Inc., No. 94-C V-4t99, Wisc.Cir., Milwaukee Co., verdict returned February 25, 1998, Reported inMealey’s Litigation Report: Latex, Vol. 1, tssue #10 (Feb. 1998).4. A. Subramaniam, “The Chemistry of Natural Rubber Latex” printed in Immunology and Allergy Clinics ot North Amedca, Vol. 5; No. 1 (Feb.1995(.5. W. Truscott, Ph.D., “The tndustry Perspective on Latex” printed in Immunology and Allergy Clinics ot North Amedcan, Vol.5; No. 1 (Feb.1995).6. Wilson, Rubber-glove dermatitis, British Med.J., July 2, 1960.7. lB Larson’s Workmen’s Compensation Law § 41.62, p. 7-446 (1987).8. Masaki v. General Motors Corp., 71 Haw. 1,833 P.2d 899 (1989).9. Ontai v. Straub Clinic & Hospital, Inc., 66 Haw. 237,659 P.2d 734 (1983).10. Masaki v. General Motors Corp., 71 Haw. 1,833 P.2d 899 (1989).11. Downing, J.G.: Dermatitis From Rubber Gloves. N. EngI. J. Med, 208:196, 1933.12. Ontai v. Straub Clinic & Hospital, 66 Haw. 237, 659 P.2d 734 (1983).13. Guidance For Medical Gloves: A Workshop Manual, HHS Publication DA 96-4257 (Sept. 1996), p.6-5.14. Carvalho v. Raybestos-Manhattan, Inc., 794 F.2d 454 (9th Cir. 1986); Change. Johns.Manville Sales Corp., 847 F.2d 523 (9th Cir. 1988);In re Hawaii Federal Asbestos Cases, 871 F.2d 891 (9th Cii. 1989): Larsen v. Pacesetter Systems, Inc., 74 Haw. 1,837 P.2d 1273(1992)(touryears period br claims under UCC(; Miyakev. Welders, Inc., 71 Haw. 269,788 P.2d 170(1990) (rules torworkes compensation claimsfor occupational disease).

The legal aspects of the latex protein allergy epidemic.

http://evols.library.manoa.hawaii.edu/bitstream/10524/53899/1/1999-06p160-167.pdf

The legal aspects of the latex protein allergy epidemic.

Abstract

Similar works

Full text

Available Versions

eVols at University of Hawaii at Manoa