In Re Coordinated Latex Glove Litigation

Facts

P was the first in a series of plaintiffs to pursue a theory of product liability that the latex gloves manufactured by D caused a serious, disabling, and potentially life-threatening allergy to all forms of natural rubber latex. P claims D improperly designed and manufactured gloves which caused this allergy by allowing excessive levels of allergenic agents, latex proteins, to remain present on the surface of the gloves during manufacture. Such agents may be greatly reduced or eliminated through washing and chlorinating procedures in the design and manufacture of these gloves. D began to receive reports around 1988-1989 that some health care workers commonly exposed to NRL products were developing severe latex allergies. P was one of the victims. P experienced a life-threatening anaphylactic reaction (respiratory distress, hives, and other symptoms). She was forced to leave health care work, has undergone emergency medical treatment for such reactions, and must carry medication to treat them at all times, as her allergy is a lifelong condition. P sued D on various products liability and negligence theories. The matter went to jury trial on strict liability theories of manufacturing defect and failure to warn of a defective product, and well as negligence through manufacture and failure to warn. P presented evidence that additional washing and chlorination of the gloves would reduce allergenic protein levels, while D presented evidence that these steps might lead to defects in barrier protection such as pinholes, tearing or a change in texture. From 1989 through 1991, D sold over 15 billion gloves and received a total of 10 user complaints describing type I severe allergic reactions to NRL gloves. In response to the problem, by 1992, D had implemented protein reduction techniques on all its production lines. By 1994, D was requiring all its gloves to undergo a postcure rinse to reduce surface protein levels. Later, a postcure protein leach procedure was added. D also made educational efforts about NRL allergies for healthcare workers, presenting traveling seminars as part of its marketing efforts. Around 1992-1994, it was advertising its gloves as 'The Right Choice,' due to D's research and improvements in its manufacturing processes regarding allergens. In March 1993, the FDA announced its plans to issue regulations requiring manufacturers to state the latex content of medical devices such as gloves. Although the FDA was conducting research in the area of latex allergies, it did not require warning labels on that subject until 1996. Until 1998, due to concerns about the success of the AIDS, etc., universal precautions requirement of glove usage, the FDA prohibited glove manufacturers from making comparisons about protein levels of their product. P's claims did not include a strict liability design defect cause of action as new case law prohibited her from presenting a design defect theory based on consumer expectations. P did not present any alternative design defect theory under a risk-benefit analysis. P went to the jury on her manufacturing defect claim, failure to warn of a defect and/or through negligence, and negligent manufacture and/or design. D argued that the protein level evidence offered by P had not been placed in context with any applicable government requirements. The jury found that a manufacturing defect had been proven and awarded P net compensatory damages of $ 886,921.20. It found that D had been negligent, but there had been no causation of her injuries through negligence. D filed its motions for JNOV and new trial. It argued that with respect to the manufacturing defect finding, no substantial evidence supported the verdict. It also argued the causation findings were inconsistent and lacked support in the evidence, and excessive damages had been awarded. D got the JNOV, and P appealed. 

Issues

Rule of Law

Holding and Decision

Legal Analysis

© 2007-2024 ABN Study Partner.