Lowe v. Sporicidin Intern.

• Decision Date: 15 February 1995
• Docket Number: No. 94-1821,94-1821
• Citation: 47 F.3d 124
• Parties: 25 Envtl. L. Rep. 20,947, 26 UCC Rep.Serv.2d 87, Prod.Liab.Rep. (CCH) P 14,256 Gina LOWE, Plaintiff-Appellant, v. SPORICIDIN INTERNATIONAL, Defendant-Appellee.
• Court: U.S. Court of Appeals — Fourth Circuit

Page 124

47 F.3d 124

25 Envtl. L. Rep. 20,947, 26 UCC Rep.Serv.2d 87,

Prod.Liab.Rep. (CCH) P 14,256

Gina LOWE, Plaintiff-Appellant, v. SPORICIDIN INTERNATIONAL, Defendant-Appellee.

No. 94-1821.

United States Court of Appeals Fourth Circuit.

Argued Nov. 2, 1994.

Decided Feb. 15, 1995.

ARGUED: Paul Steven Blumenthal, Paul S. Blumenthal & Associates, Davidsonville, MD, for appellant. Lawrence Steven Ebner, McKenna & Cuneo, Washington, DC, for appellee.

Before MURNAGHAN, NIEMEYER, and MOTZ, Circuit Judges.

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

OPINION

MOTZ, Circuit Judge:

In this diversity case 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 plaintiff's 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 a Maryland corporation with its principal place of business in Rockville, Maryland. Lowe inhaled fumes from CSS, a glutaraldehyde based cold sterilizing solution, which assertedly 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 FIFRA, 7 U.S.C. Secs. 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. Sec. 136a(c)(1)(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. Sec. 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. Sec. 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, Sporicidin'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 membranes." Another advertisement stated, under the heading "Human Safety," "Sporicidin has been used in our facility for more than two years ... our staff prefers Sporicidin 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[s] 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.

Worm I, 970 F.2d at 1305. In Worm II, we described FIFRA's "involved process of review by the EPA, culminating in approval of the label under which a product may be marketed." Worm II, 5 F.3d at 747. As part of this review process, FIFRA requires an applicant to furnish "a statement of all claims to be made" for the pesticide, 7 U.S.C. Sec. 136a(c)(1)(C), and then expressly prohibits anyone, when selling the pesticide, from making any claims for it that "substantially differ" from the claims made for the product at the time of registration. 7 U.S.C. Sec. 136j(a)(1)(B). Neither of these statutory sections was at issue in the Worm decisions. There was no argument in those cases that the company had issued any advertisements or other "claims" that "substantially differ[ed]" from its labeling.

Rather, the argument in the Worm cases was that the company should have issued warnings in addition to those contained in its labeling. We held that such claims were preempted by FIFRA, specifically by 7 U.S.C. Sec. 136v(b). Section 136v explains the authority the states retain under FIFRA to regulate pesticides and the authority preempted by federal law. It provides that "(a) ... [a] state may regulate the sale or use of any federally registered pesticide or device in the State," but "(b) ... such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter."

In Worm I, we held, "to the extent that Maryland law imposes a duty to provide a warning 'in addition to or different from' federal pesticide labeling standards, it is preempted by conflicting with federal law." Worm I, 970 F.2d at 1303. However, we also noted, "[a]pplying traditional principles of preemption we conclude that Congress did not expressly, or by implication, preempt the field of pesticide regulation or a more narrowly defined field," id., and that although the definition of labeling "is quite broad, it would not appear to include general advertising statements not made in connection with a particular sale." Id. at 1307 n. 2. We explained:

[A]t oral argument counsel for the Worms observed correctly that if the Maryland common law recognizes a tort based on breach of a federally imposed standard, the Worms would be able to pursue that claim without conflicting with federal law.

We find support for our strict standard in determining whether a conflict exists in the recognition that FIFRA does not explicitly create a federal right of action to compensate persons who may be injured by misleadingly labeled pesticides. For "[i]t is difficult to believe that Congress would without comment, remove all means of judicial recourse for those injured by illegal conduct."

Id. at 1308. (emphasis added). Because the district court appeared to have taken too broad a view of FIFRA's preemptive effect, in Worm I we vacated its judgment and remanded for reconsideration. Id. at 1309...