For this one, we go to the wisdom of Homer:
(Lisa) “I’m going to become a vegetarian”
(Homer) “Are you saying you're never going to eat any animal again? What about bacon?”
(Homer) “Pork Chops?”
(Lisa) “Dad, those all come from the same animal.”
(Homer) “Heh, heh, heh. Ooh, yeah, right, Lisa. A wonderful, magical animal.”
("The Simpsons" Lisa the Vegetarian (1995).) That wonderful, magical animal yesterday helped forge a unanimous preemption decision from the Supreme Court that is, in our view, helpful and comforting with regard to medical device preemption.
The Supreme Court ruled that a California statute that outlawed certain treatment and uses of non-ambulatory (basically, they can’t move) animals by slaughterhouses was preempted. National Meat Assoc. v. Harris, No. 10-224, slip op. (U.S. Jan. 23, 2012). After some nasty undercover video, California enacted the statute, which made it a crime for slaughterhouses to accept non-ambulatory animals. They couldn’t buy them, sell them, handle them, or sell meat or other products made from such animals. Slaughterhouses were required to euthanize in a humane manner any non-ambulatory animals in their possession. This regulation, of course, seems well intentioned.
The problem is that someone else was already doing it – the federal government. Similar journalism, a century ago, inspired the 1906 Federal Meat Inspection Act (FMIA). Read Upton Sinclair’s novel, The Jungle, if you don’t believe us. Congress later expanded FMIA to include humane standards for the treatment and slaughter of animals (while humane slaughter seems like a prickly, almost oxymoronic, concept, that’s an issue for some other blog).
FMIA’s regulation is extensive. The Dep’t of Agriculture’s inspection arm examines animals before they are slaughtered and, for diseases or afflictions – including inability to move – says what can be done with them. Most important, for our purposes, FMIA has an express preemption provision that is almost spot-on to the one contained in the Medical Device Amendments of 1976. Here it is:
Requirements within the scope of this [Act] with respect to premises, facilities and operations of any establishment at which inspection is provided under . . . this [Act] which are in addition to or different than those made under this [Act] may not be imposed by any State.
That’s the same preemption language (“different from or in addition to”) in the Medical Device Amendments. Only the order’s been reversed and “from” changed to “than.”
Seems pretty straightforward, doesn’t it? But like inventive plaintiffs’ lawyers, California and other advocates crafted a number of arguments to try to get around preemption. California’s main argument, which actually won in the Ninth Circuit, was to redefine the reality of what the federal scheme actually regulates, something we’ve seen from plaintiffs’ lawyers in medical device cases. California argued for instance that the FMIA scheme applies only to the group of “animals that are going to be turned into meat,” while the California statute on the other hand simply excludes certain animals from that group. The Ninth Circuit may have bought this one, but it was roadkill in the Supreme Court:
According to the Court of Appeals, “states are free to decide which animals may be turned into meat.” . . . We think not. The FMIA’s scope includes not only “animals that are going to be turned into meat,” but animals on a slaughterhouse’s premises that will never suffer that fate.
That kind of argument by redefinition recalls the plaintiffs’ arguments in cases like Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), over whether tort claims could be “requirements” within the meaning of the statute.
Some of California’s other arguments are also similar to those we’ve seen from medical device plaintiffs’ lawyers, who often lower a microscope to a regulatory scheme and stare only at certain granules of it, hoping to blur any focus on the regulatory scheme as a whole, leaving it unrecognizable and applicable to almost nothing. For instance, California argued that the portion of its statute that prohibits the sale of meat taken from non-ambulatory animals is not preempted because FMIA doesn’t apply to the sale of meat, only its processing. More roadkill for the Court, which rejected California’s offer to look at a single tree and lose focus on the forest of the FMIA’s regulatory scheme. The Court instead determined that the California statute’s sales ban is aimed at prohibitions within the slaughterhouse: “The idea—and the inevitable effect—of the provision is to make sure that slaughterhouses remove non-ambulatory pigs from the production process . . . by criminalizing the sale of their meat.” Accordingly, “the sales ban regulates how slaughterhouses must deal with non-ambulatory pigs on their premises.”
Importantly, the Court rejected California’s argument that its statute is not preempted because it neither prohibits something required by FMIA nor requires something prohibited by FMIA. The Court said that this doesn’t matter. That sounds like impossibility, which as much as we liked it in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has nothing to do with express preemption. Direct conflict is not the issue: “FMIA’s preemption clause covers not just conflicting, but also different and additional state requirements.” As those of us in the business of defending medical device companies know, that is essentially the same language in the preemption clause of the Medical Device Amendments of 1976 (“no State . . . may establish . . . with respect to a device intended for human use any requirement which is different from, or in addition to, any requirement applicable under this chapter to the device and which relates to the safety or effectiveness of the device”)Homer may or may not be right that a pig is a wonderful, magical animal. But either way the Supreme Court’s decision in Harris is pretty good too. It underscores once again that broad preemptive language like that contained in the Medical Device Amendments of 1976 is not something to be explained away or rendered meaningless by redefinition and strained parsing. It means what it says, and Harris provides further rock-solid Supreme Court precedent that it should be applied that way.