The U.S. Supreme Court is preparing to issue a ruling on the highly contested issue of when federal law should preempt state laws in a case that experts say could help bolster states' defense of their rules regulating vehicle greenhouse gas emissions as well as other stringent state environmental requirements.
While the high court case, Riegel v. Medtronic Inc., is focused on the narrow issue of whether federal laws preempt state tort laws in the case of medical devices that have won Food and Drug Administration (FDA) approval, the case has also attracted interest from environmentalists who are urging the court to grant state environmental rules broad deference from federal preemption.
Chemical industry officials, however, are urging the court to narrow states' rights.
The court heard oral arguments in the case Dec. 4, and a ruling is expected in April or May 2008. Relevant documents are available on InsideEPA.com.
Public interest groups and other experts say the court's decision on the issue of federal preemption may set a broad precedent that could also be applied in environmental cases -- including those currently being litigated on automobile emissions -- in addition to suits over pesticides and toxic substances.
"Anything the court says on preemption is going to have an impact" on vehicle emissions suits, one legal expert says of the case. The ruling could clarify the standard federal courts will use in determining whether EPCA and the air act preempt state greenhouse gas laws for motor vehicles, and possibly undermine the automotive industry's claims, the expert adds.
Federal preemption of state vehicle emissions laws has emerged as a highly contentious debate since the high court's ruling in Massachusetts et al . v. EPA, which said the agency has the power to regulated carbon dioxide (CO2). A dozen states have sought to impose new CO2 rules for automobiles.
The automotive industry has challenged the state rules in federal courts, with suits filed in California and Vermont that argue federal statutes like the Clean Air Act and the Energy Policy & Conservation Act (EPCA) -- which governs fuel economy standards -- preempt the state regulations.
However, a federal district court in Vermont recently rejected industry preemption arguments and upheld the legality of the state's vehicle rules.
An attorney close to the high court suit says justices in Riegel could issue a much narrower ruling, however, that would apply only to the regulation of medical devices under the Federal Food Drug and Cosmetics Act (FFDCA) section 360(k)(a), the provisions which give the FDA power over approving medical devices and which parties are debating in the lawsuit.
Nevertheless, the attorney acknowledges that if the court takes a broad view of the preemption issue, the case could influence the ongoing vehicle emissions suits. The ruling could also influence litigation involving federal approvals of products and questions pertaining to how the approval shields the companies that create the the products, the attorney says. For example, the attorney notes that pesticides require approval from EPA, as do certain toxic substances created by industry, factors that have attracted broad chemical industry participation in the case.
However, the attorney close to the case expects the court will take a narrower view of the preemption question. The attorney notes that a similar high court case heard in 1996 -- Medtronic v. Lohr -- resulted in a 5-4 split decision. Seven of the nine justices that took part in that ruling remain on the court. The prospect of a narrower ruling could diminish the precedential value of the case for the vehicle emissions litigation, the attorney adds.
The Riegel case centers on the question of whether federal law preempts state law when the federal statute is ambiguous regarding what types of claims it preempts. The suit stems from a case in the U.S. Court of Appeals for the Second Circuit, which ruled the FFDCA shields medical technology manufacturer Medtronic from liability under state tort laws for the injuries suffered by Charles Riegel due to a catheter that burst during heart surgery.
In a brief earlier this year, the U.S. Solicitor General urged the high court to uphold the appellate court's ruling that federal law preempts state tort claims, arguing that for medical devices section 360(k) generally preempts any requirement that is different from federal laws.
Several states and two congressmen, Rep. Edward Kennedy (D-MA) and Rep. Henry Waxman (D-CA), have also submitted amicus briefs to the high court urging the justices to uphold Riegel's claims. In addition, public interest groups like the Community Rights Counsel, the Public Health Advocacy Institute and Prescription Access Litigation LLC have also submitted briefs supporting Riegel.
While the briefs put forth by the congressmen and the states focus on medical device laws, the public interest groups' brief addresses the broader question of how and when state laws should be preempted by federal statutes. The Aug. 27 brief argues that unless a statute contains a plain and unambiguous statement of preemption, states should be able create laws and regulations without federal authority superseding them.
"[W]here there is ambiguity, there is no preemption," the brief argues, noting several high court precedents which suggest that justices should presume no preemption exists in statutes that are silent or equivocate on the issue.
The legal expert says that should the court adopt the standard the public interest groups present for determining preemption, the automobile industry would have to find clear and undeniable preemption statements in EPCRA and the air act to prevail in its challenges of the states' emissions rules. This standard could place a significant burden on the industry's attorneys to demonstrate preemption, and may bolster the states' claims that the state emissions rules are lawful.
In contrast, Medtronic contends federal preemption bars claims against the company based on state tort laws, a claim also supported in an October brief to the court by several industry amici, including Croplife America, the American Chemistry Council and the Consumer Specialty Products Association. In their brief, the industry groups argue that any ruling which imposes state law requirements on companies separate from federal statutes that should preempt them "can seriously disrupt federal regulatory programs" like those for medical devices and pesticides.
The industry amici further argue that federal preemption of state laws "enhances" consumer protection by placing the duty to safeguard the public from harmful products in the hands of federal agencies.
Industry also takes issue with Riegel's claim that state tort law claims are not preempted based on a 2005 high court precedent in Bates v. Dow Agrosciences, which centered on the regulation of pesticides. In Bates, the high court held that federal preemption would not apply to state tort law claims without a "nonambiguous command" in federal statute, a point raised both by the Riegel's and the public interest groups to support their claims. The case also set standards under federal pesticide laws for which claims are preempted, limiting preemption only to states' pesticide packaging and labeling rules if they are different from federal regulations. But the industry petitioners in their brief note that, since the Bates decision, courts have been "acting reflexively" by failing to investigate whether product claims are based on the criteria the case establishes for preemption. The industry groups urge the court to clarify in its pending decision that "form does not trump substance when determining whether a state-law product liability claim, no matter how denominated, is expressly preempted by a federal regulatory statute."