Helms v. Sporicidin International

Citations: 871 F. Supp. 837; 1994 U.S. Dist. LEXIS 18433; 1994 WL 713957Docket: 92-10-CIV-4-H

Court: District Court, E.D. North Carolina; December 2, 1994; Federal District Court

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In the case of Dorothy Helms and William C. Helms, III v. Sporicidin International, the United States District Court for the Eastern District of North Carolina addressed a motion for summary judgment filed by Sporicidin. The plaintiffs alleged personal injuries due to exposure to Sporicidin Cold Sterilizing Solution (SCSS) and initially filed a complaint in January 1992, which was later amended to include additional claims and parties.

The plaintiffs' second amended complaint included allegations of negligent design, testing, and manufacture; negligent failure to warn; violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); loss of consortium; and fraudulent concealment/misrepresentation. The defendant's supplemental motion for summary judgment contended that the plaintiffs' claims should be dismissed for failure to state a valid cause of action.

The court's Memorandum and Recommendation indicated that claims based on failure to warn were preempted by FIFRA, while those concerning defective design, testing, and manufacture were not preempted and could proceed. The plaintiffs objected to the dismissal of the failure to warn claims, arguing that the Magistrate Judge misinterpreted case law regarding the relevance of Material Safety Data Sheets (MSDS) under FIFRA. They asserted that Sporicidin had a duty to provide accurate information in the MSDS as mandated by OSHA regulations, which they argued were not preempted by FIFRA. The plaintiffs claimed that Sporicidin failed to adequately disclose the hazards associated with the product's use without proper ventilation, leading to injuries that could have been avoided had their employer been informed of the risks.

FIFRA is established as the supreme law governing pesticide labeling standards, preempting any conflicting state laws. Under 7 U.S.C. § 136v, federal regulations set the standards for pesticide labels, and any state cause of action challenging label adequacy is preempted. The plaintiffs argue a failure to warn claim based on OSHA's requirement for manufacturers to develop Material Safety Data Sheets (MSDS) under 29 C.F.R. § 1910.1200(g)(1). However, private citizens lack a right to sue for OSHA violations, meaning the plaintiffs cannot establish a cause of action based on this federal regulation. 

While both FIFRA and OSHA are federal regulations that coexist, a state law negligence claim cannot be based on alleged violations of OSHA that contradict EPA-approved labels under FIFRA. An MSDS is considered part of the label definition under FIFRA, and claims that challenge the sufficiency of labels are preempted. Although OSHA allows for enforcement actions by the Department of Labor, it does not provide a private right of action. As a result, the court grants summary judgment for the defendant on the failure to warn claim. The defendant also contests the denial of summary judgment on the plaintiffs' negligence claims regarding design, manufacture, and testing, arguing insufficient evidence from the plaintiffs to oppose summary judgment.

The court acknowledges that while the defendant is correct regarding the nonmoving party's burden to present evidence against summary judgment, it finds sufficient evidence backing the plaintiffs' claims of negligent design, manufacturing, and testing. This indicates a genuine issue of fact, making summary judgment inappropriate. The court also identifies adequate evidence for claims of fraudulent misrepresentation, allowing them to survive summary judgment. However, claims based on failure to warn are deemed preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), resulting in summary judgment being granted to the defendant for those specific claims. The defendant's motion for summary judgment is denied concerning negligent design, manufacture, and testing claims. The court adopts the Magistrate Judge’s Memorandum and Recommendation, which supports this decision. The remaining claims for trial include negligent design, testing, and manufacture; failure to comply with FIFRA notification provisions; fraudulent concealment or misrepresentation; and the derivative claim for loss of consortium from William C. Helms. The plaintiffs, Dorothy and William C. Helms, filed the original complaint in January 1992, alleging injuries from exposure to Sporicidin Cold Sterilizing Solution (SCSS), manufactured by Sporicidin International, which contends that all claims are preempted by FIFRA. The court considers both the initial and supplemental motions for summary judgment filed by Sporicidin.

Dorothy Helms worked as a respiratory technician at Craven Regional Medical Center from 1976 to June 1989, during which her responsibilities included cleaning and maintaining medical equipment. In 1988, she started using SCSS, a product that sterilizes and disinfects equipment, and began experiencing health issues in March 1989, attributed to SCSS use. SCSS contained glutaraldehyde, a toxic chemical registered under the Federal Insecticide, Fungicide, and Rodenticide Act and sold by Sporicidin International with EPA-approved labeling. Union Carbide Corporation, the manufacturer of glutaraldehyde, noted its toxicity through various exposure routes and established a Threshold Limit Value (TLV) of 0.2 ppm for safe exposure levels. SCSS, which required mixing a 25% glutaraldehyde solution with a buffer, lacked adequate warnings on its Material Safety Data Sheets (MSDS) regarding glutaraldehyde exposure risks. Testing indicated that exposure could exceed the TLV based on several factors, including room size and ventilation. Had SCSS been shipped in a pre-diluted form, Helms' exposure levels could have been substantially lower.

Sporicidin seeks summary judgment, arguing that Helms' claims are preempted by FIFRA. For summary judgment to be granted, the court must find no genuine issues of material fact after reviewing the entire record favorably towards the non-moving party, who must provide specific facts to demonstrate a genuine trial issue rather than relying solely on allegations.

A scintilla of evidence supporting the non-moving party's position is insufficient; there must be substantial evidence enabling a jury to reasonably rule in their favor, as established in *Anderson v. Liberty Lobby, Inc.*. Summary judgment is warranted when the overall record does not provide a rational basis for the non-moving party's claims, per *Matsushita Electric Industrial Co. v. Zenith Radio Corp.*. Federal law, under the Supremacy Clause, preempts conflicting state law, rendering it ineffective, as affirmed in *Cipollone v. Liggett Group, Inc.*, with preemption occurring when congressional intent is clear or implied. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates pesticide labeling and explicitly preempts state law claims related to labeling, including failure to warn claims, as illustrated in *Worm v. American Cyanamid*. Although FIFRA allows some supplementation, it strictly controls labeling regulations. Claims of negligent testing, manufacturing, and formulation are not subject to preemption. Helms' claim against Sporicidin for inadequate Material Safety Data Sheet (MSDS) falls within the preemption framework since it effectively challenges the sufficiency of the label approved by the EPA, thus warranting summary judgment. Conversely, claims based on product defects are not preempted, although the distinction between mislabeling and defective product claims can be ambiguous.

The court highlighted a test for determining whether a manufacturer might foreseeably alter a product to avoid liability, referencing Sporicidin's claims, which it categorized as failure to warn. In a similar case, the ruling indicated that claims of negligent testing, design, and manufacture were also failure to warn claims, as they relied solely on evidence that was synonymous with that theory. Dr. Robert I. Schattner, president of Sporicidin, acknowledged that he followed EPA testing requirements for SCSS registration but failed to conduct tests assessing glutaraldehyde off-gassing. McLellan's affidavit indicated that exposure to glutaraldehyde could exceed permissible levels under certain conditions, and he determined that an individual, Helms, was exposed to unsafe levels. Schattner maintained that SCSS was safe according to OSHA guidelines, but the dilution process required by users did not guarantee compliance. McLellan asserted that providing SCSS in a pre-diluted form would have mitigated exposure risks. Helms argued that Sporicidin's negligent testing and design led to her injuries, differentiating her claims from the precedent case where only failure to warn was at issue. The court concluded that Helms' claims of defective product testing, design, and manufacturing were not preempted, unlike her failure to warn claims, and allowed these claims to proceed while not ruling out further discussions on their merits. The memorandum was officially entered on September 7, 1994.