In a recent posting, here, MassTortDefense examined the less than happy reaction of some members of the Arkansas Supreme Court to medical device preemption as defined by the U.S. Supreme Court. In Despain v. Bradburn, No. 07-714 2008 WL 1067202, (Ark., April 10, 2008), notions of “federalism,” the asserted importance of the common law, and the desire to compensate injured plaintiffs, compelled members of the court to decry (even as they applied) the guidance of the Supreme Court, and to call for the legislative reversal of the Riegel v. Medtronic,128 S. Ct. 999 (2008), decision.

A week later, the Texas Supreme Court decided an interesting preemption case, and relied on the rationale of Riegel to apply preemption outside the medical device area. Obviously, the government regulates the design and hazard communications of numerous other non-medical products for important safety reasons. And one of the things we love to do at MassTortDefense is point out how successful ideas in one mass tort may help in another significant product litigation as well. In Bic Pen Corp. v. Carter, 2008 WL 1765550 (Tex. Apr. 18, 2008), the Texas Supreme Court considered a case involving a disposable lighter and federal standards for child-proofing them promulgated by the CPSC.

Background

A six-year-old was severely burned when her five-year-old brother allegedly set fire to her dress with a J-26 model BIC lighter. Plaintiff claimed the injuries resulted from manufacturing and design defects in the J-26 lighter. The jury found for Carter, awarding three million dollars in actual damages and two million dollars in exemplary damages. A variety of issues were raised on appeal including spoliation and causation. But we focus here on preemption. The Court concluded that plaintiff’s manufacturing defect claim was not preempted, which simply asserted that the particular lighter involved in the case deviated “in its construction or quality” from the manufacturer’s design specifications. 2008 WL 1765550 at *6. It did not depend on standards different from what the CPSC had promulgated for child-proof lighters, and thus did not require a state court jury to set a state-law design standard that differed from the federal standard.

Design Defect

More interesting, however, is the Court’s conclusion that plaintiff’s design defect claim was preempted by federal law. The CPSC is charged with protecting the public against unreasonable risks of injuries from consumer products in the 1972 Consumer Product Safety Act. Specifically, the J-26 lighter is subject to the federal standards for child-proof lighters and must be certified as compliant by the Consumer Product Safety Commission. CPSC evaluated data regarding disposable lighters and promulgated regulations for child-proofing them. The Commission adopted regulations requiring disposable lighters to be child-resistant and setting a protocol for testing a lighter’s child resistance. The regulations set forth specific requirements for compliance, and required the manufacturer to submit a description of all child-resistant features. The J-26 lighter underwent qualification testing in 1994. Bic completed the other requirements for the disposable lighter at issue in the case, and received a certificate of compliance from the CPSC.

In the Consumer Product Safety Act, Congress included both a preemption clause and a savings clause. The preemption clause states that no State “shall have any authority either to establish or to continue in effect any provision of a safety standard or regulation which prescribes any requirements as to the … design” if it is “designed to deal with the same risk of injury” that the CPSC addressed through its regulations. 2008 WL 1765550 at *3. The savings clause, however, specifically allowed some common law tort lawsuits. The Texas Supreme Court considered the interplay between saving clauses and express preemption provisions based on the guidance of Geier v. American Honda Motor Co., 529 U.S. 861, 869-73 (2000). The combination of express preemption and savings clauses do not bar the ordinary working of conflict preemption principles. If the state law claim conflicts with federal regulations, it is still preempted. Because Carter maintained that the J-26 lighter was unreasonably dangerous under common law because more effective child-resistant lighter designs were available, the issue for preemption purposes was whether Carter’s claim of a need for a higher standard of child resistance under the common law is compatible with federal regulation under the CPSA.

The opinion noted that one other trial court had rejected implied preemption in a child-proof lighter case, Colon v. BIC USA, Inc., 136 F. Supp. 2d 196 (S.D.N.Y. 2000), with the reasoning that the goal of reducing injuries to children was best served by supplementing the federal minimum standard on a case-by-case basis, according to the stricter requirements, if any, imposed by state common law. See id. at 209.

Analysis of the Regulatory Scheme

However, the Texas Court found preemption. Analyzing the CPSC scheme, the Court noted that the Commission weighed several factors, including child resistance, overall safety, the realities of manufacturing, the variability and randomness of child testing, the product’s utility, and the importance of consumer acceptance. Indeed, one of the CPSC’s primary objectives was to create a standard that encouraged the manufacture of child-resistant lighters and yet did not discourage adults from using them. The Commission was concerned that if adults were unable or unwilling to use child-resistant lighters, they might switch to non-child-resistant lighters or matches, which could expose children to an even greater risk. 2008 WL 1765550 at *4. The Commission, moreover, was aware that greater child resistance might be achieved but specifically rejected imposing higher standards, finding that a higher standard would reduce the utility and convenience of the product and increase costs disproportionate to the benefits.

Thus, interpreting federal regulation in this area merely as a liability floor that may be enhanced by state law, as plaintiff argued, undercut the federal regulations and the Commission’s conclusion that the chosen standard “strikes a reasonable balance between improved safety for a substantial majority of young children and other potential fire victims and the potential for adverse competitive effects and manufacturing disruption.” Id. at *4. As the Commission judged, a stricter design requirement might “on its face, appear to increase safety,”  but the practical effect would be otherwise. Id.

Riegel Analysis Relevant

Although Riegel addressed an express preemption provision, the Texas court found its policy analysis applicable here, id. at *6, in part because both cases involved a balancing of factors by the regulators that ensure the product meets carefully prescribed safety standards. Significantly, the Texas Court quoted the Supreme Court’s admonition that that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation that state regulation, because it does not include the cost-benefit analysis similar to that applied by the experts at the FDA. Instead, a jury sees only the cost of a more dangerous design, and is not concerned with its benefits. Id. at *5.

Particularly where a federal agency has balanced the relevant factors and rejected the idea of more stringent standards, this case is more support for the notion that under Riegel a common-law tort claim could impose duties that conflict with the federal regulatory scheme and therefore would stand as an obstacle to the accomplishment and execution of the full purpose and objections of Congress, even outside the medical device area.