Starting, as is proper with defendant/petitioner Warner Lambert’s brief, it’s probably appropriate to remind readers what the precise question is that the Supreme Court has agreed to decide:
Whether, under the implied preemption principles of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), federal law preempts state law to the extent it permits or requires a fact-finder to speculate as to whether a defendant improperly disclosed information to the federal agency that materially affected the agency’s decision to approve or not withdraw the drug.
W-L br. at i. Our first impression of this case is that, from a defense perspective, the statute at issue is our friend. In some ways, that’s ironic, because we also want to have it nullified through preemption. But the express terms of statute make it clear that this is really fraud on the FDA that the Michigan legislature was concerned with. That’s because, the statute’s exception involves not just a misrepresentation to an agency – but intent, materiality and reliance as well. The exception is limited to a manufacturer that:
Intentionally withholds from or misrepresents to [FDA] information concerning the drug that is required to be submitted under the federal Food, Drug, and Cosmetic Act, and the drug would not have been approved, or [FDA] would have withdrawn approval for the drug if the information were accurately submitted.
Mich. Comp. Laws §600.2946(5)(a) (emphasis added). Plaintiffs trying to avoid preemption love to try to recharacterize claims as somehow more benign than they are. That’s going to be rather hard to pull off in Kent since, if this statute isn’t describing fraud on the FDA, it’s hard to see what would.
The first part of Warner-Lambert’s argument isn’t even described as “argument.” Rather, what’s called the “statutory background” in the initial “Statement of the Case” (W-L br. at 3-11) amounts to a carefully sculpted non-argumentative argument that goes to one of the linchpins of the Supreme Court’s earlier analysis of fraud on the FDA preemption in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) – that’s (1) all of the many ways in which the FDA receives information from regulated manufacturers, and (2) all of the many ways the FDA can send fraudsters to jail or do other unpleasant things to them.
Item (1) goes to the many ways that fraud on the FDA claims could gum up the regulatory scheme by inducing manufacturers to give the Agency more than it wants or needs. Item (2) goes to the authority that the FDA has to back up the congressional decision that the Agency – and only the Agency – is authorized to enforce alleged violations of the FDCA.
From our lawyerly perspectives, what’s neat about this “argument” is that it’s not really argument at all, but simply a straightforward recitation of the ins and outs of the regulatory scheme. Yet it makes two of the most critical points necessary to bring this case within the area controlled by Buckman – all without any real “argument” at all. In short, it’s legal ju jitsu at its best. It’s always a pleasure to read good advocacy. And of course, for all you lawyers out there looking to save a research step or two, plagiarism is the sincerest form of legal flattery.
There’s one other practical thing that this section of the W-L brief should make clear to anyone litigating the defense side of this type of litigation. That’s the wealth of regulatory information and statistics available on the FDA’s website. A word to the wise should be sufficient, so if you don’t already, learn how to navigate and use the FDA’s site. The W-L brief contains a half dozen different citations to FDA materials in this section alone. That’s as many URLs as we’ve ever seen in a Supreme Court brief not involving patent litigation.
We’re also particularly gratified to reacquaint ourselves with a couple of our old Bone Screw regulatory favorites. There’s a nice discussion (W-L br. at 9-10) of 21 U.S.C. §337(a), which explicitly provides that all enforcement of the FDCA “shall be by and in the name of the United States.” There’s also a paragraph about §336, which authorizes the FDA to use warning letters for anything it considers to be a “minor violation,” that cleanly segways into a discussion of the Agency’s prosecutorial discretion. The parallelism isn’t at all surprising, since Buckman was a Bone Screw case, and we bone screwers pioneered use of these sections in preemption litigation.
Footnote 7 on page 12 of the W-L brief contains the definitive list of other similar state statutes that will be affected by the Court’s ruling, whatever that ruling might be. Thankfully, that list agrees with ours (wiping sweat from our brows).
After a rather lengthy review of how this particular case came to be what it was (sure, it’s rather boring, but it’s just a fact of life that MDL mass tort proceedings are just plain complicated), we finally get to the real defense argument – what this post is all about. First, there’s the mandatory discussion of the various forms and flavors of preemption (W-L br. at 20-22).
After that, there’s the introduction of Warner-Lambert’s major theme, which is that there’s preemption here because the statutorily-mandated fraud on the FDA investigation necessarily puts the state-law jury in the position of making “what if” determinations about what the FDA might have done had the defendant given it some other, different information. W-L br. at 22. That’s absolutely necessary here because the assault on federal authority inherent in statutes of this sort is a little less frontal and blatant than the self-described fraud on the FDA claim in Buckman. In that earlier case, state-law juries were being invited simply to ignore in-force FDA regulations if they found fraud. Here should a jury find fraud that would have caused the Agency to remove the product, then the jury forgets (theoretically) the whole FDA business and instead is presented with a pre-statute common law tort case under Michigan common law as it predated the tort reform statute that included the offending provision.
That difference, however, is not enough to escape Buckman. Not hardly. The statute still puts state-law juries smack dab in the middle of an area that Buckman held was none of the states’ business – overseeing the interactions between a federal regulatory body and the persons that it regulates. And right there is where our old friends §337(a) and §336 come in.
[T]he duty of the manufacturer to the agency is strictly federal in character. Thus, it is only appropriate that the regime should be administered solely by federal officials, in accordance with federal standards. Put another way, because the FDCA “touch[es] a field in which the federal interest is so dominant” – i.e., policing fraud against the federal agency – involving duties created by federal law and owed to a federal agency, “the federal system will be assumed to preclude enforcement of state laws on the same subject.”
W-L br. at 23 (citations omitted). That’s a broad preemption argument, indeed, but where §337(a) mandates exclusive prosecutorial authority, and §336 mandates broad prosecutorial discretion, conflict and field preemption tend to merge. Precisely because it’s a broad argument, we’d like it to be the rationale that prevails. Almost since Buckman has been decided, courts have tried to chip away at it, something we’ve discussed before. This argument is precisely what’s needed to make Buckman as bulletproof as any precedent can possibly be.
That the statute is a known quantity, not an amorphous common-law claim, helps matters. It’s elements – an intentional, material misrepresentation to the FDA that induced an agency action that otherwise would not have happened – seek to extend state law into the heart of the FDA’s exclusive, discretionary authority. That’s why, after laying out the maximal argument, W-L turns directly to the nature of the statutory exception. W-L br. at 24-25 (“[e]ach one of these [statutory] findings involves the state fact-finder in the interpretation and application of federal statutes and regulations that are, by congressional directive, subject exclusively to federal oversight”). The statutory terms leave the plaintiff only limited room to bob and weave.
After making its affirmative preemption argument, Warner-Lambert turns to the adverse effect of allowing the Second Circuit’s ruling to stand. These are:
- Regulatory matters requiring “application of specialized scientific and public health knowledge” would instead be decided by innumerable non-expert juries. (W-L br. at 26-27, 33-34).
- The FDA’s interpretation of its own rules would not control in private, civil litigation, both creating uncertainty and lessening the Agency’s authority (W-L br. at 27).
- As a defense mechanism against this uncertainty, manufacturers would likely provide more information than the FDA wants or can easily handle (W-L br. at 27).
- Even if there were fraud, lay juries would impose more severe penalties than the FDA thought advisable (W-L br. at 27-28, 34-35).
- The “FDA would be forced to monitor, assess, and possibly engage in a multitude of lawsuits across the country,” including Agency personnel being diverted from their jobs to have to testify (W-L br. at 28).
Instead of being the FDA, the Agency would become the “Food, Drug & Litigation Administration.” Id. Nice touch, guys.
Having made its “A” argument, Warner-Lambert turns to the uniformity implications of statutes like Michigan’s. This is more of a conflict-by-obstruction argument than the previous exclusive authority point, which emphasized inherent incompatibility. In this particular instance, the FDA neither found fraud nor even ordered the drug off the market. W-L br. at 30. But the statute necessarily requires plaintiffs to prove precisely the opposite in order to maintain their suits. Id. In effect the statute usurps the role of the FDA and hands regulatory enforcement determinations to state-law courts and juries. Id. at 30-31. Buckman, however, said “no” to precisely this:
[T]he Buckman Court concluded that policing fraud on federal agencies is a function reserved to the Federal Government, and was delegated to FDA in the FDCA context. Recognizing that the agency itself bears the responsibility to police fraud consistently with its judgment and objectives, the opinion made clear that any attempted showing by a third-party that FDA had been defrauded would upset the delicate balance of statutory objectives implicated in FDA decisionmaking under the FDCA.
W-L br. at 31 (Buckman cites and quotation marks omitted). Were it otherwise, FDA would no longer have the final say, burdens upon both the Agency and those it regulates would skyrocket, and FDA would find its mission distorted by litigation. Id.
Warner-Lambert then begins to take on the Second Circuit’s rationale by pointing out the various ways in which the elements of the statutory exception in no way resemble the proof in “traditional’ product liability litigation. Br. at 32-33. In particular, there’s none of the traditional proximate cause that’s ordinarily required under the learned intermediary rule. Instead, “The fact-finder essentially would be required to determine either that FDA (i) never should have approved the drug, or (ii) should have removed it from the market earlier, because of allegedly fraudulent disclosures to the agency.” Id. at 33.
Because, as previously mentioned, there is no adverse FDA fraud finding in this case, Warner-Lambert was in the enviable position of offering the two concurring Justices in Buckman (Stevens and Thomas) their possible exception to preemption for instances where the FDA has concluded it was defrauded. W-L br. at 36-37. We don’t particularly agree with that exception as a legal matter (since it contradicts the point about prosecutorial discretion and excessive jury remedies), but we understand it. A lawyer’s first obligation is to win the client’s case. We’d take the same position under the same circumstances.
Having made its affirmative arguments, Warner-Lambert then levels its broadside at the Second Circuit’s rationale. As we discussed probably too much in a prior post on Desiano (what Kent was named in the Second Circuit) it’s a target rich environment. There’s a lot there to take issue with the Second Circuit’s reasoning and result.
Most blatantly, the Second Circuit resorted to the old saw – the presumption against preemption – despite the unanimous Supreme Court holding in Buckman that there could be no such presumption because states did not “traditionally” interfere with the relationship between a federal regulatory agency and those it regulated. That’s pretty much what Warner-Lambert says in its brief:
This Court in Buckman already conclusively held that there is no presumption against preemption because policing fraud against federal agencies is hardly a field which the States have traditionally occupied. Buckman, 531 U.S. at 347. Nonetheless, the Second Circuit opinion places an impermissible “thumb on the scale” by framing respondents’ claims as simply invoking the traditional province of the states to safeguard the health and safety of their citizens, rather than a federal issue.
W-L br. at 38. There is no need to “look beyond the clear holding of Buckman to determine that no presumption against preemption applies.” Id. at 40.
What Michigan did was to adopt a federally-set standard as a boundary for state tort law. There’s nothing that says a state can’t do that, in the abstract (indeed, the Michigan Supreme Court already said so as a matter of state law), but whatever its merit, such an adoption isn’t “traditional” by any stretch of the imagination. Id. at 39. Since preemption is not seeking to displace any “traditional” state function, there’s no basis for an adverse presumption.
Very politely, Warner-Lambert informs the court that the Second Circuit’s view of the rationale for Michigan’s law (which betrayed the Second Circuit’s real wish to strike down on the whole statute on state-law severability grounds that, inconveniently, the Michigan Supreme Court had already rejected) just didn’t accord with reality or common sense. Rather the “very premise” of the Michigan statute was to restructure state law along federal lines. Id. To construe the presumption against preemption as the Second Circuit had was simply unprecedented – and contrary to well-established authority:
In any event, the court below cited no authority holding that a presumption against preemption is assessed by the supposed purposes rather than by the operation and effect of the state-law provision at issue. In fact, the actual function of the provision is what matters.
Id. (citations omitted).
Having deflated the presumption already, Warner-Lambert ends with a broader argument that we’d really like to see adopted. That’s the rather undeniable fact that health and safety issues involving prescription drugs aren’t a “traditional” state law area of regulation to begin with. To the contrary, the federal government and the FDA have dominated this realm “[f]or more than a century.” Id. at 40-41. It’s a dandy little argument, and if it won it would oust the presumption from all prescription drug product liability litigation – whether or not concerning fraud on the FDA. And if the Second Circuit’s disregard of the unanimous Buckman decision ticks off enough justices…. Well, who knows?
Warner-Lambert hits the home stretch strongly with what was our biggest gripe against what the Second Circuit had done in Desiano, which is to neuter Buckman by making it into a mere pleading bump in the road – in other words, a plaintiff could allege fraud on the FDA as much as s/he wanted as long as it wasn’t called “fraud on the FDA.” As Warner-Lambert forthrightly points out, that “improperly elevates form over function.” W-L br. at 42.
It does not matter to the analysis that the cause of action in Buckman was denominated fraud-on-the-FDA, while the cause of action in this case incorporates agency fraud as a prerequisite to traditional tort liability. . . . Rather, the focus in Buckman was on the practical effect of the adjudication of the claim: whether it would involve the fact-finder in an area committed to federal regulation, thereby creating an inevitable conflict with the federal scheme.
W-L br. at 43. That’s it in a nutshell. Buckman came out the way it did because of the adverse effect such claims had on FDA authority, FDA functioning, and FDA decisionmaking. It doesn’t matter how state law gets to this point, but once it purports to authorize juries to re-examine FDA decisions for purported taints of fraud, all of these adverse consequences inevitably flow.
Since it’s Christmastime – an apt analogy is that the wrapping isn’t more important than what’s inside the box.
Warner-Lambert’s brief ends with a lot of argument that’s pretty well tailored to the particular circumstances of the case, but it makes one additional point of general interest. It analogizes preemption of fraud on the FDA claims to the considerations underlying the “complete preemption” doctrine. That’s a little much to explain in a couple of sentences, but basically, it’s been the case for decades, that a plaintiff who mixes a federal issue of sufficient magnitude into a state-law claim, can wind up in federal court because federal law “completely preempts” the ability of state law to decide that question. It’s not really “preemption” in the usual sense of the word, but more a means of creating jurisdiction in a federal court over a case that wouldn’t otherwise qualify. If you’re a glutton for punishment, we discuss complete preemption more here.
The analogy is that the relationship between a federal agency and those it regulates presents the same sort of inherently federal issue that the Supreme Court’s complete preemption cases try to delineate:
Extrapolating from. . .complete preemption principles, irrespective of whether the fraud-on-the-FDA inquiry is taken as an element of a state claim or a showing required of a plaintiff to overcome an affirmative defense, the federal issues here are so closely interwoven with the state claims that the resolution of the latter necessarily depends on determination of the former. No matter how postured, [proving fraud on the FDA involves] subjects within the purview of the constitution akin to those which trigger the importance, and even necessity of uniformity of decisions throughout the whole United States.
W-L br. at 49 (citations and quotation marks omitted).
As far as the defense amici (that’s how “amicus” is pluralized – “one amici cannot get on a bus, because one amici is two amicus” (sorry, Tom L.)), the most important, is (of course) the United States Department of Justice’s brief. In fact, that one’s so important we’ve already given the DoJ brief the honor of its own post. That post pretty much covers the DoJ brief. Go read it there, if you haven’t already – every click improves our stats, if nothing else.
Now on to the usual suspects. A familiar face in the Kent case is amicus the Chamber of Commerce. It’s brief makes a number of unique arguments. First – and one that’s near and dear to our hearts – the Chamber addresses whether there should even be a presumption against preemption in a conflict preemption case. CoC br. at 2 n.2, 8-20. The Chamber asks the Court “to clarify once and for all that the presumption against preemption simply does not apply to the analysis of whether state law conflicts with federal law.” Id. at 5.
The applicability of any presumption against preemption to conflict preemption is an incredibly important issue, since it impacts not only implied preemption of fraud on the FDA claims, but implied preemption of tort claims involving prescription drugs generally. As we pointed out in our own post, this presumption is notable by its absence in all of the Supreme Court’s recent conflict preemption rulings. The Chamber’s argument against any presumption in conflict preemption is as well-developed as any we’ve read, and we highly recommend it. The main points:
- For most of the Court’s history, there was no presumption against preemption, and (if anything) a there was a presumption in favor of preemption in conflict cases. CoC br. at 8-9.
- The presumption against preemption arose in field preemption cases, and from there spread – as a maxim of statutory construction – to express preemption cases. CoC br. at 9-10.
- “[A]lmost without exception” no presumption against preemption has been employed in the Court’s implied preemption cases. The few exceptions have been “prefatory” and the presumption did not actually factor into those decisions. CoC br. at 10-11.
- The Court’s rationale in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), United States v. Locke, 529 U.S. 89 (2000), and Sprietsma v. Mercury Marine, 537 U.S. 51 (2002), strongly indicate that application of a presumption against preemption to implied preemption cases is inappropriate. Coc br. at 12-14.
- There’s no basis for any presumption against preemption in the text of the Supremacy Clause – that is what part of “Supreme Law of the Land” don’t the plaintiffs understand? CoC br. at 14-15.
- The “federalism concerns” offered in support of the presumption against preemption were not voiced by the Framers themselves, and in any event were resolved by the adoption of the Supremacy Clause. CoC br. at 15-17.
- A presumption might be justified where it is necessary to infer congressional intent to preempt in the absence of a conflict that brings the Supremacy Clause directly into play. CoC br. at 17-18.
- “Conflict preemption is different,” and does not depend upon any inference of intent, but rather upon the existence and extent of a substantive conflict between supreme federal law and state law. CoC br. at 18-19.
- Because it arises only from conflicts, implied preemption is not dependent upon expressions of congressional intent. CoC br. at 19.
- Once an actual conflict is identified, the Supremacy Clause dictates that state law is nullified to the extent of the conflict. CoC br. at 20.
Straightforward application of the Supremacy Clause. . .facilitates the realization of Congress’s objectives and affords private actors – particularly in regulated fields – an important measure of legal certainty and predictability. The “day” has come for the Court to “consider” the presumption in the conflict preemption context, and to hold that the presumption has no applicability there.
CoC br. at 20 (citation omitted).
We hope that the Court will take up the Chamber’s request. Unless and until that happens though, anybody who’s serious about using implied preemption in the prescription drug arena – actually, in any tort case – needs to understand the argument made in the CoC brief and be prepared to make it themselves. It’s that important, trust us.
The remainder of the Chamber’s argument is, while typically excellent, not of the same level of importance – simply because it’s more closely limited to the specific statute and facts of the Kent case. Primarily the Chamber debunks the rationale by which the Second Circuit, in the teeth of the unanimous Buckman decision to the contrary, concluded that the presumption against preemption applied to a case involving fraud on the FDA. Fraud on the FDA involves neither traditional “state police power” nor an “area” in which states typically regulate. CoC br. at 21-22. The same thing, the relationship between a federal regulator and the regulated, is at issue in Kent as in Buckman. CoC br. at 23-24.
Secondarily, the Chamber makes the points: (1) All Buckman preemption does here is preempt the predicate that allows a state-law cause of action to be brought. It isn’t preemption – but rather Michigan Supreme Court’s state-law ruling on severability – that results in the plaintiff not being able to pursue the tort claim itself. Thus, the plaintiffs’ complaints about “immunity” are misplaced, since it is state, rather than federal, law that created immunity. Coc br. at 27-28. (2) The Second Circuit erred in judging preemption in light of its estimation of the motivation, as opposed to the effect, of the state law. Id. at 29-30. (3) State law that bears upon inherently federal matters, such as fraud on a federal agency, is inherently incapable of threatening police powers as to which states have “historical primacy.” Id. at 30-31.
Fortunately amicus briefs are shorter than those the parties are entitled to file, or else we’d be here all day.
Like the Chamber, the Product Liability Advisory Council (“PLAC”) has appeared in Kent just like it did in Riegel. The first thing we notice is PLAC’s listing, in its statement of interest (PLAC br. at 2), some other “significant preemption cases” it’s briefed. Number one on that list is Wyeth v. Levine, which remains pending. That’s a nifty little nudge that the Court should take Levine. We agree. Nice touch there.
PLAC’s job (we can talk about that since one of us belongs) is to bring a broader perspective to the courts than do the parties. Thus we’d expect PLAC to broaden the impact of Kent – which is precisely what it does:
Adoption of the court of appeals’ approach could unleash plaintiffs in tens of thousands of pending cases – not to mention future ones – to seek damages against drug and Medical device manufacturers based on their dealings with FDA, even where FDA itself is entirely satisfied with the manufacturers’ candor. Inevitably, the proliferation of cases linking liability to the adequacy of companies’ disclosures to FDA will upset the somewhat delicate balance of statutory objectives FDA has struck in deterring and punishing fraud against the agency.
PLAC br. at 5 (citation and quotation marks omitted). That’s good, but for once we think even PLAC may have understated things. The Kent case isn’t just about the FDA – it’s about state-law claims of fraud on NHTSA (cars), on EPA (chemicals), on CPSC (toys, other consumer products), on DOA (veterinary medicine, meat contamination), and on just about any other federal agency that might find it’s decisions open to question in a tort suit.
PLAC goes through its own exegesis (br. at 6-10) describing the FDA’s information requirements and enforcement powers. Doing that is sort of the price of admission in this type of case. If you’re writing a fraud on the FDA brief, you’ll want to look at it (especially where it discusses the 2007 FDAAA), but otherwise it’s frequently plowed ground by now.
We’ll mention one practice pointer that we notice on page 7. There’s a raft of Westlaw citations to various relevant FDA Guidance documents. If you brief FDA issues, you should be aware of and use the new Westlaw library that makes a wide range of FDA regulatory materials a lot more accessible to those of us who aren’t regulatory specialists. Between the Westlaw library and the FDA’s Google-powered website, it’s incomparably easier to research FDA-specific issues than it was when we first tried to do that back in the Dark Ages of Bone Screw (all of 13 years ago).
PLAC then cuts to the chase. The Second Circuit’s distinction between fraud on the FDA as a cause of action and “mere” fraud on the FDA allegations is “illogical” – “even on its own terms.” State intent (or lack of it) has never been what preemption was all about:
There is no hint. . .that preemption – through application of a presumption or otherwise – turns on a state’s intent to regulate. Nor does the question whether state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” depend on whether the state intended it to do so. To hold otherwise would mean that states can override and obstruct federal law so long as they are merely negligent in doing so. In other words, while insisting that Congress would not “cavalierly” override state law, the court of appeals would encourage states to be cavalier in obstructing federal law. If intent were the litmus test for preemption, Buckman would have been a dead letter from the day it was written. This Court instead adopted a functional approach.
PLAC br. at 12-13 (various citations omitted). It simply can’t be less preemptive for a state to interfere with federal function accidentally as opposed to on purpose. The Second Circuit’s attempt to graft a mens rea requirement onto conflict preemption doesn’t make any sense.
Allowing “anything goes short of an actual cause of action for fraud on the FDA,” id. at 15, doesn’t make any more sense. Imposing a fraud on the FDA element in the context of an exception to an immunity statute has the same practical effects, since the “Michigan statute requires such proof in every case.” Id. The Desiano court has reasoned “circularly” because it had assumed at the outset, what it endeavored to prove – “That virtually any litigation of fraud on the FDA short of a stand-alone cause of action. . . could contribute only marginally to any regulatory overload.” PLAC br. at 16. Like Warner-Lambert, PLAC dips into complete preemption case-law for an apt description of the inherently federal nature of fraud on the FDA:
A federal enactment can be a “critical element” in the plaintiffs’ case without being the exclusive tenant in its own cause of action. This Court has recognized as much in cases finding federal jurisdiction where an issue of federal law is lodged within a state claim. . . . The Court applie[s] a practical, functional test for determining if such a claim arises under federal law – whether the state-law claim necessarily raises a stated federal issue, actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities. Here, plaintiffs’ claim clearly raises [such] a federal
Id. at 16-17 (citation and quotation marks omitted).
PLAC is even more dismissive of the Second Circuit’s distinction between a fraud on the FDA cause of action labeled as such (preempted under Buckman) and mere fraud on the FDA allegations (not preempted). That identical allegations – one labeled “fraud on the FDA” and the other embedded in some other claim – would have diametrically opposed fates was “form” being given “more importan[ce] than substance.” “To state the proposition is to refute it.” PLAC br. at 18.
Perhaps because it was also involved in Riegel, PLAC closes with an interesting comparison between the two pending cases. The Second Circuit’s reasoning in Desiano, PLAC argues, could render any decision in Riegel “essentially moot.” PLAC br. at 19.
Under the Second Circuit’s reasoning, Plaintiffs could simply claim that, in securing approval of the PMA or a PMA Supplement, the manufacturer concealed the truth from FDA. That would allow a case to go forward and would render the express preemption provision in the Medical Device Amendments virtually inoperative.
Id. That means, in short, that “the Second Circuit’s logic allows virtually any collateral attack under state law on FDA determinations.” Id. at 21. That’s an interesting – and chilling – thought.
Another repeat amicus customer in the Washington Legal Foundation (“WLF”). It’s brief takes a different track in arguing that federal involvement in the regulation of prescription drugs is greater than it is in medical devices and thus the case for preemption is even greater in Kent than in Buckman. WLF supports this argument by relying upon Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Lohr’s rather dismissive characterization of the §510k “substantial equivalence” approval system for medical devices. Since Buckman also involved a §510k device, FDA involvement was necessarily at a lower level of intensity than either the PMA process for medical devices (that’s the Riegel case) or the NDA process for drugs (that (we hope) is the pending certiorari petition in Levine). WLF br. at 3-8.
In that way WLF rather nicely constructs an a fortiori argument. It also lets WLF spend some time on (WLF br. at 9) the FDA’s January 24, 2006 Final Rule preemption preamble for drugs. Since the Second Circuit went out of its way to denigrate the preemption preamble in Desiano, turnabout’s fair play, we suppose.
WLF also takes a different approach to the presumption against preemption, which )as anybody who’s read this far can tell), looms large in Kent. WLF’s tack is that there can be no such preemption where the state-law claim infringes upon a federal agency’s “primary jurisdiction.” WLF br. at 10-14. Fraud on the FDA allegations infringe in two ways: (1) they take away the Agency’s non-reviewable prosecutorial discretion; and (2) they invade the Agency’s authority over the approval, and withdrawal of approval, of new drugs.
WLF also bolsters the Chamber’s argument that there is no presumption against preemption in conflict preemption cases. WLF br. at 14-21.
Since Kent is a drug case, the pharmaceutical industry’s trade association, PhRMA, also weighs in. Much of the first half of PhRMA’s brief is spent hammering home the practical and legal similarities between fraud on the FDA as asserted in Buckman and as asserted in Kent and, conversely, refuting the Second Circuit’s attempted distinctions. PhRMA br. at 6-11. In the end, it is impossible go obscure that both involve a “state’s assertion of power to review the regularity of FDA approvals under state law,” id. at 3 – a quite pithy way of putting things. In doing so, PhRMA probably conducts the most thorough examination of Buckman of all the defense amici.
Because it serves as the pharmaceutical industry’s trade association, PhRMA also spent more time than any other amicus in addressing purported “industry” statements in the Buckman oral argument that – rather incredibly – the Desiano opinion chose to rely upon instead of the Buckman decision itself. PhRMA br. at 12-15. PhRMA also makes many of the arguments involving the presumption against preemption (not applicable to conflict preemption, actua. conflict obviates need to consider congressional or state intent, agency fraud not a traditional area of state regulation). Id. at 15-22. We won’t go into these arguments at any length, not because they’re not worth it, but because we’ve already discussed them, we’re getting tired, and our readers would rightly criticize us for being repetitive.
PhRMA also provides its own “obstruction” argument, which contains another comprehensive discussion of FDA information requirements imposed upon regulated manufacturers and FDA remedies for suspected fraud. PhRMA br. at 22-24. It points out that a literal reading of Desiano would allow fraud on the FDA claims even where the Agency had affirmatively determined that it had not been defrauded. PhRMA br. at 24-25. It closes with an argument that the “materiality” requirement for fraud on the FDA works to eliminate the FDA’s expert judgment by permitting “limitless second-guessing under state law based on ostensibly unconsidered information.” Id. at 28.
A new player (at least to us) is the Generic Pharmaceutical Ass’n (“GPhA”). GPhA’s brief is probably a portent, because generic drugs are making up a larger and larger proportion of prescriptions, and thus potential product liability exposure. See GPhA br. at 12-13. GPhA concludes that the Michigan statute, with its express reliance upon federal disclosure requirements, is even further from a “traditional” state tort claim than the fraud on the FDA claim in Buckman – as the common-law claims there at least purported to track traditional elements of fraud. GPhA br. at 8. The association also punctures the facile excuse in Desiano that the fraud on the FDA exception is not really in conflict because a defendant can simply waive what the Second Circuit described as a “defense.” GPhA quite correctly exposes that argument as unrealistic, as if any “sophisticated litigant” would be “in the business of leaving dispositive statutory defenses on the cutting-room floor.” GPhA br. at 10.
Finally, GPhA also provides a generic-perspective defense – that the drain on FDA resources, both directly from diversion of Agency personnel to deal with fraud on the FDA litigation, and indirectly from sorting through the extra, unwanted information the Agency would receive, would exacerbate the backlog of generic drug applications (called “ANDAs” for you acronym aficionados). This result, GPhA argues, would run contra to the Hatch-Waxman Act’s intent “to speed the entry of generic drugs to the market. Id. at 11. It’s a bit of a stretch, but there is cause and effect.
That’s it – a complete guided tour of the defense “top side” briefs in Kent. If you practice in this area, read them carefully and use them well. A lot of the best minds in the business spent a lot of time putting together the best legal arguments in favor of preemption.
Remember, plagiarism is the highest form of legal flattery.