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Housley v. Wave Energy Systems

August 14, 2001

BOBBIE K. HOUSLEY, PLAINTIFF-APPELLANT
v.
WAVE ENERGY SYSTEMS, INC., JOHNSON & JOHNSON MEDICAL, INC., PHYSICIANS SALES AND SERVICES (IMPROPERLY NAMED AS LEE SURGICAL), GENERAL MEDICAL, AND METREX RESEARCH CORP., DEFENDANTS-RESPONDENTS, AND HIP, HEALTH PLAN OF NEW JERSEY, DEFENDANT
KATHLEEN SCHIRMER, INDIVIDUALLY; CAROL DAYTON IEVA AND RONALD IEVA, HER HUSBAND; MARIA SAWLER AND PATRICK SAWLER, HER HUSBAND; CAROL YOUNG, INDIVIDUALLY; AND PATRICIA LEWIS AND NEIL LEWIS, HER HUSBAND, PLAINTIFFS-APPELLANTS
v.
WAVE ENERGY SYSTEMS, INC., JOHNSON & JOHNSON MEDICAL, INC., PHYSICIANS SALES AND SERVICES (IMPROPERLY NAMED AS LEE SURGICAL), GENERAL MEDICAL, AND METREX RESEARCH CORP., DEFENDANTS-RESPONDENTS, AND COTTRELL, LTD., CENTRAL NEW JERSEY MEDICAL GROUP (RCHP, NEW BRUNSWICK), AND HIP, HEALTH PLAN OF NEW JERSEY, DEFENDANTS



On appeal from the Superior Court of New Jersey, Law Division, Civil Part, Middlesex County, L-1854-95 and L-3771-95.

The opinion of the court was delivered by: Kestin, J.A.D.

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

Argued May 1, 2001

Before Judges Kestin and Ciancia.

In these consolidated products liability cases, six nurses sued the manufacturers and suppliers of chemical substances used to sterilize medical devices and instruments, among other defendants. The husbands of three of the nurses sued per quod. Plaintiffs claimed damages on account of occupational respiratory illnesses suffered by the nurses from exposure to defendants' chemicals. The complaints were filed in February and March, 1995. The products liability defendants moved for summary judgment in the fall of 1997. After allowing a period for additional discovery, the trial court heard argument on those motions on September 18, 1998, as well as on plaintiffs' motion to dismiss the products liability defendants' preemption defenses.

For the reasons stated in a well-considered, comprehensive oral opinion rendered on October 21, 1998, Judge Chambers granted those defendants' motions on the ground that plaintiffs' claims were preempted under federal law, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C.A. §§ 136-136y. We affirm substantially for the reasons articulated by Judge Chambers, and set out in full the portion of her bench opinion resolving this issue:

This is a lawsuit that has been brought by the plaintiffs who are nurses employed by the Garden State Medical Group and Central Jersey Medical Group of HIP facilities. The plaintiffs claim that they were exposed to the defendants' product[s] in the work place for a period from 1990 to 1994. The product[s] in question are glutaraldehyde based products that are used to sterilize medical devices such as surgical instruments, and the plaintiffs maintain that they were exposed to these products in the work place and that as a result of that exposure they sustained respiratory problems.

The plaintiffs allege that the defendants failed to provide adequate warnings of a risk attendant to using the products. Specifically, the plaintiffs' expert . . . alleges that the material safety data sheets for the products are deficient and that they do not describe the possible chronic effects from exposure to glutaraldehyde nor do they indicate that respiratory protection is needed when using the products. The specific products in question [are] Wavicide . . ., manufactured by Wave Energy [Systems, Inc. (Wave Energy);] Metricide . . ., manufactured by Metrex [Research Corp. (Metrex);] and [Cidex], manufactured by [Johnson & Johnson Medical, Inc. (J & J Medical)].

Up until 1996 and during the entire time that the plaintiffs were exposed to these products, the products were regulated by the Federal Insecticide, Fungicide & Rodenticide Act known as FIFRA, in accordance with EPA [Environmental Protection Agency] regulations. Each of these products had a label approved under the FIFRA Act. The federal statute similarly provides that a FIFRA label would preempt state law, and I'm referring to 7 [U.S.C.A. §] 136[v(b):] A state may not impose or effect any requirement for labeling or packaging in addition to or different from those required under this section.

A failure to warn claim such as the plaintiffs assert here constitutes a labeling requirement. In other words, the plaintiffs are invoking state law to say that the defendants should have inserted additional warnings on the label. To permit this claim to proceed, New Jersey would be, in effect, imposing additional labeling requirements on these products, something that the federal statute says a state may not do. This issue has been recently and specifically addressed by New Jersey's highest Court in the case of Lewis v. American Cyanamid Co., 155 N.J. 544 (1998). The New Jersey Supreme Court held that FIFRA preempted a claim that the warning label on an insecticide was inadequate.

Interestingly, in two federal cases claims by medical workers for failure to warn brought against these same defendants, the defendants involved in this case, also found that the claims were preempted by FIFRA. In the case of Kenepp v. American Edwards Laboratories, 859 F. Supp. 809 (E.D. Pa. 1994), it's probably as close a case on all fours as one can get. The case involved a nurse who claimed that she had developed respiratory problems from using the defendants' products, and the defendants in that case were the same defendants in this case, Johnson & Johnson, Wave Energy and Metrex. The Court granted the defendants' motion for a summary judgment finding that the plaintiff's failure to warn theory could not proceed due to the preemption of FIFRA.

Similarly, in Sowers v. Johnson & Johnson Medical, Inc., 867 F. Supp. 306 (E.D. Pa. 1994), a nurse working in the hospital claimed personal injury from using . . . cold sterilant disinfectant products containing glutaraldehyde to sterilize medical equipment. The products were manufactured by the same defendants involved in this case, J & J, Metrex and Wave Energy. The products had their labels approved by the EPA under FIFRA. The Court found that the plaintiffs' claim for inadequate warnings and instructions was preempted by FIFRA and granted summary judgment in favor of the defendants. See also Helms v. Sporicidin International, 871 F. Supp. 837 (E.D.N.C. 1994).

There it was held that the FIFRA preempted a failure to warn claim brought against the manufacturer of a cold sterilizing solution. Also, Lowe v. Sporicidin, 47 F.3d 124 (4th Cir. 1995), FIFRA preempted a failure to warn claim brought by a hospital worker suing for respiratory problems due to inhaling cold sterilant solutions.

Thus, the law is resoundingly clear that if a product label is approved by the EPA pursuant to FIFRA, a state law claim for failure to warn must fail due to the preemption provisions under FIFRA. Here, the plaintiffs, in their argument before this Court, have attempted to circumvent this clear law by turning to the FDA [Food and Drug Administration] law. Unlike products with labels regulated by FIFRA, products such as these, which are regulated by the FDA, may still be subject to suits under state law. That is, the general clearance ...


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