Last week appears to have been a bit of a slow week in the drug and device litigation arena. It was after all a short work week. It was back to school week (at least in the North East), which while bringing delight to parents everywhere also brings the chaos of last minute school supply shopping, discovering sneakers no longer fit, and the start of chauffeur season where parents essentially become Uber drivers between school, lessons, practices, and games. And we know our friends in the South had a few other things on their mind as they prepared for Irma.

So, that leads us to look beyond our normal comfort zone to see what else might be going on. Sure, enough we found a discussion of Buckman preemption in an automobile emissions case.

The case comes out of the In re: Volkswagen "Clean Diesel" Marketing, Sales Practices, and Products Liability Litigation, MDL 3354 and specifically the case of Wyoming v. Volkswagen Group of America, Inc., 2017 U.S. Dist. LEXIS 142586 (N.D. Cal. Aug. 31, 2017). Volkswagen's "clean diesel" issues have been widely publicized and were the subject of significant criminal penalties and civil settlements having to do with Volkswagen's installation in its diesel cars of software to defeat emissions testing which allowed the vehicles to acquire the necessary new-vehicle certifications from the EPA. Id. at *805-806. Under EPA regulations, the installation of such a "defeat device" is prohibited and the EPA has authority to bring a civil action for violation of that regulation. 42 U.S.C. §§7522(a)(3)(B); 7524(b). Wyoming, among other states, sued Volkswagen alleging the defendant violated Wyoming's State Implementation Plan ("SIP"). Trying not to delve too deeply into the law, essentially the Clean Air Act requires each state to develop a SIP to enforce the EPA's national air quality standards. The individual states are supposed to focus on stationary sources (factories, plants) and are limited in how they can regulate motor vehicles. Id. at *810. Considering how freely and frequently (daily) motor vehicles cross state lines, we understand why individual state plans regulating car emissions would be almost impossible to enforce.

So, the Clean Air Act allows states to regulate the use of "registered or licensed motor vehicles" as opposed to new vehicles Id. at *823, citing 42 U.S.C §7543(d). For instance, states can require testing after sale to ensure cars continue to meet emissions standards. Along those lines, Wyoming's SIP includes provisions that say you cannot remove or render ineffective any air pollution control device and you cannot use a device that conceals an emission. Id. at *810-811. It is these two provisions which Wyoming argues Volkswagen is liable for violating.

The Clean Air Act, however, also contains an express preemption clause:

No State or any political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part. . . .

42 U.S.C. § 7543(a). "States accordingly may not adopt their own rules prohibiting defeat devices in new vehicles, nor may they attempt to enforce EPA's rule barring defeat devices in new vehicles." Id. at *829. If you interpret Wyoming's SIPs the way Wyoming is asking, they would run afoul of the express preemption clause. The SIPs are fine if you are talking about a mechanic tampering with a device so a car passes emissions inspection. That's something for the state to regulate.

The court found additional support for its preemption analysis in Buckman. Wyoming is essentially bringing a fraud-on-the-EPA claim. Like the authority vested to the FDA for drugs and medical devices, Congress has given the EPA the same authority to both regulate and enforce new-vehicle emissions standards. Id. at *832-834.

If, despite this authority, States could bring actions against vehicle manufacturers based on deceit of EPA during new-vehicle certification, manufacturers would be forced to comply with EPA regulations "in the shadow of 50 State" regimes, which would "dramatically increase the burdens" manufactures would face in bringing new vehicles to market.

Id. at *833-34 (quoting Buckman).

Therefore, the court dismissed Wyoming's claims as preempted and perhaps foreshadowed a similar demise for claims brought by other states. And while that is a great result, there is one glitch in the decision. This court apparently missed our post on the demise of the presumption against preemption in express preemption cases. As it begins its preemption analysis, the court states that part of its "interpretative framework" would include the presumption against preemption. Id. at *819. Fortunately, the presumption plays no further role in the court's analysis and ultimate conclusion – because it shouldn't it. The court even quotes Medtronic v. Lohr, that the presumption applies "unless [preemption] was the clear and manifest purpose of Congress." Id. at *818 (quoting Lohr 518 U.S. 481, 485 (2006)). An express preemption clause like the one quoted above is fairly clear and manifest. And, if that wasn't enough, the Supreme Court has been even more explicit:

[B]ecause the statute "contains an express pre-emption clause," we do not invoke any presumption against pre-emption but instead "focus on the plain wording of the clause, which necessarily contains the best evidence of Congress' pre-emptive intent.

Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016). Done and done. So, while we laud the conclusion, we also use the decision to remind our readers that the presumption against preemption has been definitely knocked out of express preemption cases.

This article is presented for informational purposes only and is not intended to constitute legal advice.