And one of the most common questions we get asked – well, not exactly, but it’s what the questions turn into – is about the practical difference between express and implied preemption. The question usually starts out as either, “Is Wyeth v. Levine really as important as both you guys and the other side say?” or “What’s the big deal with Levine after you guys won Riegel?”
It all gets back to the differences between express and implied preemption.
Express preemption (Riegel) is all about what Congress said – in the express preemption clause (that’s why it’s called “express”), and about what it meant. It’s just about entirely statute specific. You look at the words of the statute. If the words are ambiguous (something one side or the other inevitably argues), you look at whatever Congress said when the statute was being passed. Since it’s statutory, one side or the other – or both – will resort to “canons” of statutory construction.
You gotta love “canons” of statutory construction, because for each canon (such as “remedial statutes are to be construed broadly”), there’s an equal and opposite one (such as “statutes in derogation of the common law are to be construed narrowly”). Lawyers make sure the law is like that. It keeps us employed.
Because it’s sort of a canon of construction, express preemption land is where our pet peeve, the presumption against preemption, lives.
Express preemption can be broader than implied preemption. That’s because Congress, if it wants to, can tell states that they can’t do anything in a certain field. That’s why there’s no state regulation of airlines, to take one example, or of the astounding interest rates charged by a lot of credit card companies.
But the fundamental limitation of express preemption is that it depends on what a particular statute says – its dependent on the language (if any) that Congress used in determining the preemptive reach of that individual piece of legislation. That’s why our side winning Riegel is no guarantee that it will win Levine.
Congress has always addressed preemption – if at all – on a statute-by-statute basis. While, theoretically, it could pass some general preemption statute and provide that that statute supersedes (preempts?) all statute-specific preemption language, it’s never done that or, as far as we know, even seriously considered such a thing. There’s no express preemption in the air. It’s all statute specific.
Implied preemption is just the opposite – it’s “implied” in the absence of anything Congress said or even thought about. It operates because the Supremacy Clause in the Constitution has for some 200 years been construed to place independent limits on state power whenever the states interact with the federal government.
Among other things, we fought a civil war over that.
Implied preemption is a way of looking at federal-state conflicts. Is it “impossible” to do what both the state and the feds are telling you to do? Or is what the state tells you to do going to “obstruct” either the goals of the feds or the means Congress has given the feds to reach those goals? If the answer to either of these questions is “yes,” then there’s preemption – whether Congress said so or not. Whether Congress thought about it or not.
Why? Because the Constitution itself says so, and neither Congress nor the states can overrule the Supremacy Clause short of a constitutional amendment.
So we’re sort of stuck with implied preemption. It’s a gift, or a curse (depending on whose ox is being gored), left to us by the Founding Fathers.
Congress can take away express preemption by changing a statute’s express preemption language. There are already rumblings in Congress from the other side, threatening to do that with the Medical Device Amendments in order to wipe out our win in Riegel.
Congress can’t take away implied preemption – at least not without taking away the FDA’s authority over drug labeling – so that’s another reason why Levine’s a big deal. If we win Levine, then even if Congress takes away Riegel, there would still be implied preemption for medical devices under whatever principles the Court sets out in Levine.
Why? Because implied preemption is not statute specific. This means that whatever implied preemption principles the Court adopts for the FDCA in Levine would be equally applicable to the Medical Device Amendments. Now, as long as the preemption clause interpreted in Riegel stands unamended, that’s probably an academic issue – because the express preemption provided under the statute is broader than what implied preemption would provide. At the risk of gross oversimplification, under Riegel there’s preemption of anything “different from or in addition to” (because that’s what the statute says) what the FDA requires, while implied preemption would preempt only the “different from” prong.
But if we win Levine, and Congress … say, deleted the MDA's express preemption provision altogether, then medical device manufacturers would still have available whatever implied preemption Levine recognized, even if express preemption goes away altogether.
And express preemption can’t touch that. The Court has ruled several times that implied preemption operates independently of express preemption. It first did that in tort preemption cases involving cars. Freightliner Corp. v. Myrick, 514 U.S. 280, 288 (1995) (well, a truck, if you want to get picky); Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000), and applied that principle in our neck of the woods in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 352 (2001).
Repeat after us: Because implied preemption is not statute specific.
And this non-statute specific nature of implied preemption effectively puts our clients at the point of the preemption spear. We (pharma defense lawyers, that is) are out there making the law every day, good or bad. And in Levine, the principles we establish, or fail to establish, will be applicable to all claimed conflicts between state common law and other federal regulatory schemes.
Here’s a recent example:
Apparently some lawyers on the other side have convinced themselves (if nobody else) that the ubiquitous cell phone gives off radiation that causes brain cancer. So they sue the manufacturers, claiming that every cell phone that can be used without a headset – that’s every cell phone we’ve ever seen – is defective. But the government, which regulates cell phones through the Federal Communications Commission, has looked at this issue and concluded that the cancer claims are bogus. The government hasn’t required all of us to use headsets with our cell phones. So the cell phone defendants asserted that the claims are preempted.
It certainly should to regular readers of this blog, since we're like broken records on preemption.
And guess what? The cell phone defendants won. Earlier this month a court in the Eastern District of Pennsylvania held that the claims were preempted. See Farina v. Nokia, 2008 WL 4058686 (E.D. Pa. Sept. 2, 2008). Not only that, but the court’s preemption holding was contrary to an appellate decision in identical litigation (just how identical was something else the court also had to address) from only a couple of years ago. Compare, Pinney v. Nokia, Inc., 402 F.3d 430 (4th Cir. 2005).
The EDPA is in the Third Circuit, and that circuit issued its prescription drug preemption decisions in Colacicco and Pennsylvania Employees Benefit Trust Fund, that’s what. After denying express preemption (the presumption against preemption and all that rot) the court held, in accordance with the rationales adopted by the Third Circuit in the drug preemption cases, that the FCC’s actions concerning cell phones preempted the plaintiffs' attempt to make us all wear headsets. 2008 WL 4058686, at *20-23. From the precedent Farina cites (Lohr and Fellner, in addition to big block quotes from two of our favorites), you’d think it was an FDCA case.
It wasn’t. It was just the rest of the spear, following the point and piercing the heart of those plaintiffs' claims.
Farina illustrates that what happens to our clients in the FDCA theater of action will profoundly affect everybody else in the implied preemption war. At one time it was the auto guys. Now it's us. We’re on point.
To take another example with a little more history to it, consider our favorite case, Buckman. It’s been around for seven years. Its rationale for implied preemption of fraud on the FDA (again, grossly oversimplified) is that it would interfere with federal authority for states to adjudicate whether a regulated entity defrauded its federal regulator.
If, as we’ve been saying, implied preemption is not statute specific, then agency fraud claims involving any federal agency should be preempted under the same rationale.
Has that happened?
Fraud on the Environmental Protection Agency? Preempted. Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-1206 (9th Cir. 2002); Beck v. Koppers, Inc., 2006 WL 2228910, at *1 (N.D. Miss. April 7, 2006); Hill v. Brush Engineered Materials, Inc., 383 F. Supp.2d 814, 822 (D. Md. 2005); Williams v. Dow Chemical Co., 255 F. Supp.2d 219, 232 (S.D.N.Y. 2003); Redelmann v. Alexander Chemical Corp., 2002 WL 34423377 (Ill. Cir. July 26, 2002). Evidently, this was the plaintiffs’ favorite, other than the FDA.
Fraud on the National Highway Traffic Safety Administration? Preempted. Zavala v. TK Holdings Inc., 2004 WL 2903981, at *8 (Cal. App. Dec. 16, 2004); Zwiercan v. General Motors Corp., 58 Pa. D. & C.4th 251, 266 (Pa. C.P. Philadelphia Co. 2002).
Fraud on the Occupational Safety & Health Administration? Preempted. Hill, 383 F. Supp.2d at 822.
Fraud on the Federal Energy Regulatory Commission? Preempted. Transmission Agency of Northern California v. Sierra Pacific Power Co., 295 F.3d 918, 932 n.10 (9th Cir. 2002).
Fraud on the Department of Energy? Preempted. Morgan v. Brush Wellman, Inc., 165 F. Supp.2d 704, 722 (E.D. Tenn. 2001).
Fraud on the Health Care Financing Administration? Preempted. McCall v. Pacificare, Inc., 21 P.3d 1189, 1199 n.9 (Cal. 2001) (dictum).
We’ve looked. All these cases cite Buckman as the basis for their decisions. In fact, that’s how we know about them. We read every case that cites Buckman – because they tend to be very interesting cases.
So it’s not just us defense lawyers theorizing. Implied preemption of tort cases is a big deal because how the Supreme Court addresses implied preemption in Levine – the legal principles it recognizes as controlling – will be applicable to analogous regulatory conflict situations involving any other product and any other agency.
It’s as simple as that. That's what being non-statute specific is all about.
So, with that out of the way, what potentially broadly applicable implied preemption issues are before the Court in Levine? We’ve gone through those, in our best legalese, several times before now.
Don’t worry, we’re not doing that again.
This time, like one cave man said to the other about why their last meal wasn't so good, "Let's not eat the bones."
For now, not only are we canning the legalese, we’re also sticking just to the questions. We're not going to say what we think the answers should be. You can probably guess our position, anyway.
So here are some preemption issues – phrased generally – that the Supreme Court could decide in Levine. That’s not to say the Court will decide them all, or even most, of them. Courts are like that. It helps them stay employed. But all of the following issues are lurking in the Levine case:
- Because the plaintiff in Levine sued about the defendant’s failure to contraindicate (that’s medicalese, not legalese – it's how doctors say “prohibit”) a use that the FDA had looked at and said was okay, Levine presents the question, once the government says “you can do X,” can tort plaintiffs sue you on a theory that you shouldn’t have done X? How the Court answers that question will affect a lot of FDA-related situations (comparative claims, off-label risks, class warnings, summarized warnings, and more), but beyond that, the same preemption question comes up in every situation – from cars to chemicals – from cigarettes to securities – where the government is in the business of specifically telling people what they can or can't do with things they sell to the public.
- Levine also presents the question whether there is a presumption against preemption in an implied preemption case. Obviously, a decision on this question, whichever direction it goes, will change the slope of the playing field in every future implied preemption case.
- Another question in Levine is whether there are any differences in scope between the two flavors of implied preemption – “impossibility” and “obstacle” – and specifically whether “obstacle” preemption should get its wings clipped. An answer necessarily affects the future scope of any claim of “obstacle” preemption, and that's most implied preemption claims these days.
- Plaintiff in Levine argues that there’s no conflict where a manufacturer can choose to keep doing what the government tells it to do, but at the cost of paying tort judgments. This is a longstanding argument against tort preemption generally, and probably the last of that genre that the Court hasn’t explicitly shot down. If the Court adopted this view, there wouldn’t be much implied preemption left in tort cases.
- The defendant (and the FDA) assert(s) a government policy against “overwarning” in Levine. Is preventing overwarning a valid basis for implied preemption? Since every labeling decision about what should go into a warning is also a decision about what should be left out, Supreme Court acceptance of the preemptive effect of such a policy would have ramifications for just about all other government-approved warnings.
- There’s a dispute in Levine about whether FDA requirements are “minimum” or “optimum” standards – a dispute that also masquerades as the “floor” versus “ceiling” argument. There are a lot of government requirements out there, and how the Court goes about drawing the line between what's “minimum” and what's “optimum” could create a template against which the preemptive effect of these other requirements are judged.
- The plaintiff side in Levine criticizes the FDA a lot. Our side responds by saying that, even if the criticisms were true, it’s not a proper function of state law to force Congress to fix flawed administrative agencies. If the Court were to say anything about this, it could affect the validity and weight of complaints by tort plaintiffs about the conduct of other federal agencies.
- Plaintiff argues in Levine that government acceptance or rejection of a warning on a particular subject doesn't preclude common law liability for not using a slightly differently phrased warning on the same subject. How the Court analyzes that question could affect the size of the preemptive shadow cast by a lot of decisions by agencies other than the FDA.
- How broadly will “emergency situation” exceptions to agency pre-clearance requirements be interpreted? The Court could construe the FDCA’s emergency provision (the so called “changes being effected” exception) in accordance with either it’s supposed “plain meaning” or in accordance with the FDA’s narrower interpretation. Which option the Levine court selects would affect the preemptive scope of other regulatory schemes having such exceptions.
- Because the two sides disagree about how to interpret the CBE regulation, and the FDA has weighed in on the point, the question of how much, if any, deference is owed to an agency’s construction of its own preemptive power is before the Court in Levine. A ruling on this question would affect the amount of legal force behind everything administrative agencies say about preemption.
- Another CBE-related dispute in Levine is about whether preemption turns on there being an actual CBE filing that the agency rejects. The outcome could have significant practical effects on the number of petitions of this sort that are filed, and thus the workload facing federal agencies.
And because implied preemption is not statute specific (we can’t say that enough; it’s the key takeaway from this post), these questions put Levine squarely at the point of the preemption spear for all tort litigation, and more. What the Court decides will go a long way in deciding how sharp and how broad the point of that spear will be.
And also who gets to throw it at whom.