In Re Coordinated Latex Glove Litigation
99 Cal. App. 4th 594, 121 Cal. Rptr. 2d 301 (2002)
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Rule of Law:
Variations in a product line that result from a manufacturer's ongoing research, development, and evolving production techniques do not constitute a manufacturing defect under a strict liability theory, so long as the products conformed to the manufacturer's intended design specifications at their respective times of manufacture.
Facts:
- Christine McGinnis worked as a respiratory technician from 1982 to 1996, during which time she used thousands of pairs of natural rubber latex (NRL) gloves manufactured by Baxter Healthcare Corporation (Baxter).
- Beginning around 1988-1989, Baxter became aware that some healthcare workers were developing severe latex allergies and initiated a research and development program to reduce allergenic protein levels in its gloves.
- As Baxter's research progressed, its manufacturing processes and the resulting protein levels varied over time and across different production plants, including gloves it produced and 'buy-in' gloves purchased from other manufacturers but sold under the Baxter brand.
- By 1992, Baxter had implemented protein reduction techniques on all its production lines, and by 1994, it required all its gloves to undergo a post-cure rinse to further reduce surface proteins.
- McGinnis developed a severe, life-threatening type I latex allergy, which culminated in an anaphylactic reaction in 1995.
- As a result of her severe allergy, McGinnis was forced to leave her career in healthcare.
- During the time McGinnis used the gloves, there were no FDA-mandated standards for protein levels in most latex gloves.
Procedural Posture:
- Christine McGinnis sued Baxter Healthcare Corporation in a California trial court on theories of strict liability (manufacturing defect and failure to warn) and negligence.
- The case proceeded to a jury trial, where the jury returned a verdict in favor of McGinnis on her manufacturing defect claim, awarding her compensatory damages.
- The jury found for Baxter on the failure to warn claim and found that while Baxter was negligent, its negligence was not a cause of McGinnis's injuries.
- Following the verdict, Baxter filed a motion for judgment notwithstanding the verdict (JNOV) and a motion for a new trial, arguing the manufacturing defect verdict was not supported by substantial evidence.
- The trial court granted both of Baxter's motions, setting aside the jury's verdict and entering judgment for Baxter.
- McGinnis, as the appellant, appealed the trial court's grant of the JNOV and new trial to the California Court of Appeal. Baxter is the appellee.
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Issue:
Does a variation in the allergenic protein levels of latex gloves, resulting from a manufacturer's evolving research and different production techniques over time, constitute a manufacturing defect under strict liability when all gloves met the manufacturer's design specifications at the time of their production?
Opinions:
Majority - Huffman, J.
No, a variation in protein levels resulting from a manufacturer's evolving production techniques does not constitute a manufacturing defect. A manufacturing defect exists only when a product deviates from the manufacturer's intended result or from other ostensibly identical units. McGinnis’s claim was functionally a design defect claim disguised as a manufacturing defect claim, as her evidence focused on the argument that Baxter's overall design and processes were flawed until they were improved. The gloves McGinnis used were manufactured exactly as Baxter intended at that time, in light of the state of scientific knowledge and its ongoing research. The court reasoned that finding a manufacturing defect based on a company's subsequent improvements would penalize research and innovation, which is contrary to public policy, especially for life-saving medical devices. The fact that different product lines or 'buy-in' gloves had different protein levels does not establish a manufacturing defect because Baxter intended to produce gloves with a range of protein levels while its research was still evolving, and there was no single, uniform design standard from which any particular glove deviated.
Analysis:
This decision reinforces the critical distinction between manufacturing defect and design defect theories in products liability law. It prevents plaintiffs from re-characterizing a design defect claim (that the product's blueprint was inherently unsafe) as a manufacturing defect claim (that a specific item was flawed in its construction) simply by pointing to variations within a product line. The ruling provides significant protection to manufacturers, especially in scientifically complex fields like medical devices, by ensuring that their own internal research and product improvements cannot be used retroactively to prove that older products had a manufacturing defect. This precedent encourages continuous innovation without creating strict liability for earlier, less-advanced versions of a product.
