In re Coordinated Latex Glove Litigation

• Citation: 121 Cal.Rptr.2d 301,99 Cal.App.4th 594
• Decision Date: 20 June 2002
• Docket Number: No. D036680.,No. D037435.,D036680.,D037435.
• Parties: In re COORDINATED LATEX GLOVE LITIGATION.
• Court: California Court of Appeals

121 Cal.Rptr.2d 301

99 Cal.App.4th 594

In re COORDINATED LATEX GLOVE LITIGATION.

No. D036680.

No. D037435.

Court of Appeal, Fourth District, Division 1.

June 20, 2002.

As Modified on Denial of Rehearing July 15, 2002.

Review Denied October 2, 2002.^*

Bien & Summers, E. Elizabeth Summers, Novato; Kazan, McClain, Edises, Simon & Abrams, Philip A. Harley, Wes Wagnon and James L. Oberman, Oakland, for Plaintiff and Appellant.

Crosby, Heafey, Roach & May, James C. Martin, Costa Mesa, Thomas M. Freeman, Oakland, Denise M. Howell, Los Angeles; Seyfarth, Shaw, Robert M. Mitchell and Lawrence E. Butler, San Francisco, for Defendants and Respondents.

HUFFMAN, J.

In this opinion we discuss the two-pronged test for a strict liability manufacturing defect as applied to the production of latex gloves. (Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 432, 143 Cal.Rptr. 225, 573 P.2d 443 (Barker).) This products liability action filed by plaintiff Christine McGinnis was the first to go to trial in a group of cases in coordinated proceedings involving allegations against various defendants who manufactured or distributed latex gloves, used by the plaintiffs at their work, that contained natural or artificial substances that were alleged to be causative factors in the development of the plaintiffs' serious latex allergies. McGinnis's individual action against Baxter Healthcare Corporation (Baxter) went to jury trial on her manufacturing defect strict liability theory, as well as negligence and failure to warn. A defense verdict was obtained on failure to warn and negligence, but the jury found a manufacturing defect had been proven and awarded McGinnis compensatory damages.

However, in posttrial proceedings, Baxter moved for judgment notwithstanding the verdict (JNOV) and for new trial on the manufacturing defect issue, and both motions were granted by the trial court. (Code of Civ. Proc., §§ 629, 657.) McGinnis appeals the ensuing judgment, arguing the trial court applied an incorrect legal standard in ruling on the motions, such that under a proper analysis, there was substantial evidence that Baxter's latex gloves were defective, either as a defective product that differed from the manufacturer's intended result or that differed "from other ostensibly identical units of the same product line." (Barker, supra, 20 Cal.3d at p. 429, 143 Cal.Rptr. 225, 573 P.2d 443.)

McGinnis also makes a last ditch claim that the court erred in refusing to instruct the jury on her design defect theory, based on a consumer expectations approach. (See Morson v. Superior Court (2001) 90 Cal.App.4th 775, 784, 109 Cal.Rptr.2d 343 (Morson), a prior mandamus proceeding in these consolidated cases, originating in this McGinnis case, in which this court rejected the application of that same consumer expectations theory to latex gloves in the health care context.)

Our examination of the record and the applicable legal principles persuades us that the trial court correctly granted JNOV under the two-part test for a manufacturing defect and that no new trial on that theory is warranted in light of that determination. Nor was there any reversible instructional error regarding design defect. We need not reach the alternative grounds on which the trial court denied Baxter's new trial motion (lack of causation evidence and inconsistent verdicts). We affirm the judgment in favor of Baxter.

FACTUAL AND PROCEDURAL BACKGROUND

A Pleadings and Background

On review of this order granting JNOV, we state the facts in the light most favorable to the jury's verdict. (Hansen v. Sunnyside Products, Inc. (1997) 55 Cal. App.4th 1497, 1510, 65 Cal.Rptr.2d 266.) As this court outlined the background facts in Morson, supra, 90 Cal.App.4th 775, 109 Cal.Rptr.2d 343, the plaintiffs in these coordinated cases pursue a theory of product liability that the latex gloves supplied to them caused a serious, disabling, and potentially life-threatening allergy to all forms of natural rubber latex (referred to as NRL) to develop, even though they did not have this condition prior to their extensive use of latex gloves. They accordingly claim improperly designed and manufactured NRL gloves caused this allergy by allowing excessive levels of allergenic agents, latex proteins, to remain present on the surface of the gloves during manufacture. It is not disputed that such agents may be greatly reduced or eliminated through washing and chlorinating procedures in the design and manufacture of these gloves. The issue is whether, as plaintiff complains here in the context of her manufacturing defect claim, Baxter "took too long" to make that its standard practice, in light of its knowledge and research.

McGinnis (sometimes referred to as Plaintiff) was employed as a respiratory technician by various hospitals and care facilities for a number of years between 1982 and 1996, and used thousands of pairs of Baxter NRL gloves during her career. The brands she used over 93 percent of the time, Flexam powdered exam gloves and Triflex powdered surgical gloves, were manufactured at Baxter plants in the United States and Malaysia. In addition, Baxter purchased gloves from other manufacturers to sell under its brand names ("buyin gloves"). Baxter began to receive reports around 1988-1989 that some health care workers commonly exposed to NRL products were developing severe latex allergies. It began a research and development effort in its glove production and purchases around that time, as we later describe.

Both through her own use of NRL products and the use by others around her, McGinnis became sensitized to that substance to the point of developing a serious Type I latex allergy, which caused her in 1995 to experience symptoms going beyond mild symptoms of itching and skin irritation, to 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.

McGinnis sued Baxter and other defendants (who were no longer involved in the case by the time of trial and this appeal) 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.

B Jury Trial: Evidence

Extensive testimony and documentary evidence was presented at trial about the manufacturing process of NRL gloves. The critical qualities provided by rubber gloves to the health care profession include barrier protection and tactile sensitivity. The market for gloves grew tenfold from 1983 to 1990 after the FDA recommended and then in 1987 adopted universal precautions for health care workers to prevent the spread of AIDS and hepatitis, requiring expanded use of gloves and other barrier protection equipment. By 1990, Baxter was manufacturing and distributing approximately four billion gloves per year, which represented approximately half of the American medical glove market. Most of these gloves were made of NRL.

The multistep manufacturing process begins with the tapping of rubber trees and centrifuging and mixing of raw rubber, the preparation of glove molds to be positioned on a continuous conveyor line, the dipping of the mold in coagulant and rubber compounds, the leaching in water of the molds, curing, rinsing, powdering, chlorination and sterilization, and packaging of the gloves. (Morson, supra, 90 Cal.App.4th at pp. 780-781, 109 Cal. Rptr.2d 343.) Plaintiff presented evidence that additional washing and chlorination of the gloves would reduce allergenic protein levels, while Baxter presented evidence that these steps might lead to defects in barrier protection such as pinholes, tearing, or a change in texture. (Id. at p. 782, 109 Cal.Rptr.2d 343.) Baxter continued its defense: "Additionally, each of these steps may differ from line to line, glove to glove, and plant to plant depending on line speed, temperature, plant configuration and other conditions." (Id. at p. 781, 109 Cal.Rptr.2d 343.) Accordingly, "[e]ach of the steps must be performed with an acute awareness of barrier protection issues, with an eye toward ensuring that the function of this life-saving medical device will not be compromised." (Id, at p. 782, 109 Cal. Rptr.2d 343.)

Baxter's witnesses testified about the company's efforts to reduce the protein levels in their products, in response to consumer complaints received as part of the process of federal regulatory monitoring of the production of gloves. From 1989 through 1991, Baxter sold over 15 billion gloves, and received a total of 10 user complaints describing Type I severe allergic reactions to NRL gloves. Dr. Wava Truscott, Baxter's manager of laboratories for the applicable division, was assigned to head the investigation of the glove protein allergy problem, beginning in 1988. The task included assessing many different production lines and dealing with many different aspects of production, and it appears that Truscott's efforts were at first an uphill battle. She was concerned that during these years, Baxter was perceived as dragging its corporate feet on the matter. By 1991, her research had proposed a target or threshold level of protein for gloves, and she worked with product engineer Charles Gosnell to test her research. Complaints had been received about both high and low protein level gloves.

In response to the problem, by 1992, Baxter had implemented protein reduction techniques on all its production lines. By 1994, Baxter was requiring all its gloves to undergo a post-cure rinse to reduce surface protein levels. Later, a post-cure protein leach procedure was added. Baxter also made educational efforts about NRL allergies for health care workers, presenting traveling seminars as part of its...