Gina Lowe v. Sporicidin International

47 F.3d 124, 25 Envtl. L. Rep. (Envtl. Law Inst.) 20947, 26 U.C.C. Rep. Serv. 2d (West) 87, 1995 U.S. App. LEXIS 2884, 1995 WL 59962
CourtCourt of Appeals for the Fourth Circuit
DecidedFebruary 15, 1995
Docket94-1821
StatusPublished
Cited by63 cases

This text of 47 F.3d 124 (Gina Lowe v. Sporicidin International) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Gina Lowe v. Sporicidin International, 47 F.3d 124, 25 Envtl. L. Rep. (Envtl. Law Inst.) 20947, 26 U.C.C. Rep. Serv. 2d (West) 87, 1995 U.S. App. LEXIS 2884, 1995 WL 59962 (4th Cir. 1995).

Opinion

Affirmed by published opinion. Judge MOTZ wrote the opinion, in which Judge MURNAGHAN and Judge NIEMEYER joined.

OPINION

MOTZ, Circuit Judge:

In this diversity ease a plaintiff, who has alleged she was injured after using defendant’s disinfectant, appeals from the district court’s order granting defendant’s motion for summary judgment. The district court held plaintiffs claims were preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or were supported by “insufficient evidence” to create a genuine issue of material fact precluding summary judgment. We affirm, although for reasons somewhat different than those of the district court.

I.

Gina Lowe alleged that she was injured through the use of Sporicidin Cold Sterilizing Solution (CSS), a product manufactured by Sporicidin International. 1 Lowe is a citizen of the District of Columbia; Sporicidin is á Maryland corporation with its principal place of business in Rockville, Maryland. Lowe inhaled fumes from CSS, a glutaraldehyde based cold sterilizing solution, which assert-edly caused Lowe to develop asthma and other respiratory disorders. Lowe used CSS to sterilize hospital instruments as part of her duties as a hospital technician. At the time that Lowe used CSS, it was a pesticide registered with the EPA as required by FI-FRA, 7 U.S.C. §§ 136-136y, and so bore an EPA-approved label.

When registering a pesticide with the EPA, an applicant must submit, inter alia, “a complete copy of the labeling of the pesticide, a statement of all claims made for it and any directions for its use.” 7 U.S.C. § 136a(c)(l)(C). The Administrator of the EPA will register the pesticide if he determines, inter alia, “its labeling and other material require[d] to be submitted comply with” FIFRA’s requirements. 7 U.S.C. § 136a(c)(5)(B). The record reveals that, when Sporicidin applied for registration of CSS, the EPA informed the company that Sporicidin was “required” to “delete[ ] from the label” the claim that “ ‘when diluted for disinfection (1:16), Sporicidin is hypoallergenic (non-sensitizing).’ ” The EPA stated, “[w]ith respect to the issue of hypoallergenic claims, EPA has no data or approval from FDA regarding such a claim. Moreover, EPA would not allow the claim anyway because it is considered a safety claim that is violative of the regulations set forth at 40 C.F.R. § 162.10(a)(5)(ix).” In addition, the EPA stated that the phrase “ ‘no gloves required’ ... should be deleted” from the label. The EPA also stated, “Your new proposed statement: ‘Solutions more concentrated than 1:16 may sensitize and may cause skin irritation’ is acceptable so long as you do not use it in conjunction with statements such as ‘nonirritating’, ‘nonsensitizing’, ‘non-hypoallergenic’, etc. at 1:16.”

Consistent with these directives, Sporici-din’s 1989 EPA-approved label for CSS contained the following “PRECAUTIONARY STATEMENTS”:

Avoid skin contact. Solution more concentrated than 1:16 may sensitize and may cause skin irritation. Flush thoroughly with water after contact.
Avoid eye contact. Causes eye irritation. In case of contact flush with water immediately, and get medical attention....
Use in ventilated areas....

This label and the CSS 1987 label, which contained similar warnings, 2 were the only documents in the record for which Sporicidin received EPA approval.

The record reveals, however, that some 1987 to 1989' advertisements for CSS stated, “Sporicidin is a ‘tamed’ glutaraldehyde that does not yellow or irritate skin or mucous *127 membranes.” Another advertisement stated, under the heading “Human Safety,” “Sporici-din has been used in our facility for more than two years ... our staff prefers Sporici-din because it does not irritate the eyes or nasal passages.” Yet another advertisement stated, “ ‘There was no indication of skin irritation or toxicity.’ ” Still other advertisements stated, “[n]o gloves are necessary for safety.”

Lowe filed a skeletal complaint alleging claims for negligent design, manufacture, marketing, distribution, and sale of CSS, negligent failure to warn, breach of implied warranties, breach of express warranties, and strict liability. Lowe’s subsequent pleadings and argument before the district court establish that the principal basis for her claims — except for that based on an implied warranty of merchantability — was not that the EPA-approved label for CSS was misleading, inadequate, or otherwise unlawful, but that Sporicidin’s advertisements, which were assertedly contrary to the EPA-approved label, were. As her counsel stated at oral argument before the district court, “we don’t have any allegations that Ms. Lowe was put off by the label, but by the promotional material [advertisements] and express representations by the defendants. ...” Thus the district court correctly recognized that Lowe’s chief claim was “not failure to warn per se.” Rather, what she asserted was that Sporicidin in its advertisements made “statement^] that [are] allegedly inconsistent with ... the warning that has been approved.” The district court found that all claims based on such a theory were preempted by FIFRA and that any remaining claims were supported by “insufficient evidence” to create a genuine dispute of material fact precluding summary judgment.

II.

In considering whether Lowe’s claims are preempted by FIFRA, we “express no opinion on whether [they] are viable claims as a matter of state law; we assume arguendo that they are.” Cipollone v. Liggett Group, Inc., - U.S. -, -, 112 S.Ct. 2608, 2621, 120 L.Ed.2d 407 (1992). The parties focus their preemption arguments solely on the question of whether Worm v. American Cyanamid Co., 970 F.2d 1301 (4th Cir.1992) (Worm I), and Worm v. American Cyanamid Co., 5 F.3d 744 (4th Cir.1993) (Worm II), require preemption here. These precedents, to be sure, are important to our consideration of preemption in this case. But of equal importance are portions of FIFRA that were not involved in, or pertinent to, the Worm decisions.

As we explained in Worm I,

FIFRA, enacted originally in 1947 as a pesticide licensing and labeling statute .... was amended in 1972 .... [t]he amendments, which were prompted by safety and environmental concerns, as well as a “growing perception that the existing legislation was not equal to [its] task” transformed FIFRA into “a comprehensive regulatory statute,” regulating the labeling, sale, and use of pesticides both in intrastate and interstate commerce.

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47 F.3d 124, 25 Envtl. L. Rep. (Envtl. Law Inst.) 20947, 26 U.C.C. Rep. Serv. 2d (West) 87, 1995 U.S. App. LEXIS 2884, 1995 WL 59962, Counsel Stack Legal Research, https://law.counselstack.com/opinion/gina-lowe-v-sporicidin-international-ca4-1995.