So why did we just sit there and take it from the FDA Law Blog?
Well, we thought they were on our side, for one.
Which necessarily means that we, in fact, have a side.
Darn right we do. As we’ve said over and over again, we publish this blog from the perspective of defense lawyers in product liability litigation. We’re in litigation – not regulatory. That means (among other things) that we’re biased in favor of our clients’ litigation positions. We are. We always will be. And we’ve always been very up front about that.
Stop being oblique, guys, what does any of this have to do with Tucker II?
Specifically, Tucker II is a slip opinion from a court (in this case, a federal district court) that is not automatically published or obtained by online services, such as Westlaw or Lexis . When we encounter an adverse case of this sort, it’s not our policy to discuss it until it’s got a reported citation. Until that happens, there’s a possibility that the adverse case might drop from sight without a trace.
We're not in the business of helping the other side make bad law (not intentionally, anyway).
And that possibility does happen, we know of at least two-and-a-half (don’t ask, because we aren't telling) instances just in the preemption area. Conversely, we know of at least seven instances where we took affirmative steps to ensure that favorable drug preemption decisions did make it on to the services (and, in two cases, got officially reported). We're a full-service blog.
No such luck here. Tucker II got a Westlaw (and presumably a Lexis) citation the other day.
That means we can now have at it.
So where do we think Tucker II went wrong?
Where didn’t it? That would be a shorter post.
But not as interesting for our readers or as satisfying to write for us.
Well, just looking at the FDA Law Blog’s discussion of Tucker II (even though they’re poachers, they’re very competent poachers), we see two glaring problems with the rationale of the decision.
The first problem is that Tucker II is completely inconsistent when it comes to retroactivity.
Here’s what we mean. First, as FDA Law Blog describes, Tucker II bought the argument that:
even if there is a conflict as a result of class-wide antidepressant labeling changes implemented in 2007 concerning suicide, “no conflict existed in 2002 when [defendant] could have warned [plaintiff] or his physician about [the drug’s] alleged association with suicidality.”They’re describing what Tucker II held at *9 of the Westlaw opinion:
[T]o preempt [plaintiff’] claims based on actions by the FDA in 2007 would have the effect of retroactively absolving [defendant] of a duty it might have owed to [plaintiff] in the fall of 2002. Regardless of what the FDA ordered in 2007, if [defendant] had evidence of a reasonable association between [the drug] and adult suicidality in 2002, it had the duty then under the FDA’s regulations to strengthen the warnings on [the drug’s] label. [Defendant] had no way of knowing in 2002 what the FDA would order in 2007.Thus, Tucker II refused to give effect to anything the FDA did (such as the 2006 Preemption Preamble) retroactively – even though the preamble states (which is why it’s an informal opinion in this respect) that it’s reiterating a “longstanding” position.
But when retroactivity favors the plaintiff, Tucker II takes the opposite tack. That’s the case (so the opinion holds) with new scientific knowledge under the CBE (“changes being effected”) regulation, 21 C.F.R. §314.70(c)(6)(iii). In that instance, Tucker II holds that, for some reason, a subsequent scientific advance would be retroactively relevant to defeat preemption even though the plaintiff was injured in 2002:
[I]n spite of the FDA’s direction regarding [the drug’s] label in May 2007, [defendant] still had (and has) the obligation to revise its label to strengthen a warning upon reasonable evidence of an association of a serious hazard, particularly with respect to this individual drug. If [defendant] were to receive such evidence, it would be obligated to revise its label in spite of the FDA’s directive in May 2007. . . . In other words, the FDA’s revisions were not necessarily the final word on [the drug’s] label and did not put [defendant] into a position where it was impossible for [defendant] to comply with both state and federal law.
FDA Law Blog, quoting Tucker II, 2008 WL 2788505, at *8.
Even putting aside preemption, this is profoundly unsettling reasoning, because Tucker II is ignoring the scientific state of the art. That’s because, in an SSRI (“selective seratonin reuptake inhibitor”) case such as Tucker II, there’s no way to argue credibly that information actually known at the time of a 2002 (or 2003 or 2004 or 2005 or 2006 or 2007) adult suicide could form the basis of a CBE revision. During this period, the FDA did in fact look (over and over again) at all available information, and the Agency positively rejected proposals to add suicide warnings.
So, to avoid the result that, under existing science, plaintiffs can’t use the CBE loophole to evade preemption, Tucker II invokes speculative (“if defendant were to receive”) changes in existing scientific knowledge that haven’t even been discovered yet (let alone back in 2002) to hold that there can’t be preemption because something might require/support/allow a CBE label change in the future.
Not only does the anti-preemption ruling in Tucker II require a rather dramatic resort to speculation – it’s also in direct conflict with the substantive state-of-the-art rules of almost every state in the country, including plaintiff Tucker’s home state of Indiana (Tucker I, 2007 WL 2726259, at *1). Indiana’s state-of-the-art rule in drug cases does not permit liability to turn on scientific information not known at the time of injury:
But, in the view of this court, that is where the reason for the rule ceases and the rule of “strict” liability itself should stop. To exact an obligation to warn the user of unknown and unknowable allergies, sensitivities and idiosyncrasies would be for the courts to recast the manufacturer in the role of an insurer beyond any reasonable application of the rationale expressed above. We are persuaded that the duty to warn under Comment K does not arise until the manufacturer knows or should know of the risk. . . . [D]ates are vitally important with respect to the duty to warn. Because a manufacturer cannot be required to warn of a risk unknown to science, the knowledge chargeable to him must be limited to that of the period during which the plaintiff was using the product in question.
Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979) (citations and quotation marks omitted) (emphasis added). Accord Phelps v. Sherwood Medical Industries, 836 F.2d 296, 305 (7th Cir. 1987) (“[defendant] only had a duty to warn of those dangers which it knew or should have known at the time it distributed its [medical device]”) (applying Indiana law). See generally Bexis’ book §2.04 at footnote 17 (collecting state-of-the-art citations from drug and device cases in 35 states, the District of Columbia, and Puerto Rico).
So that’s one thing – one pretty big thing – that we think is wrong with the anti-preemption rationale in Tucker II. Not only does the decision apply, or refuse to apply, retroactively in a result-oriented fashion, but it does so in a way that’s inconsistent with supposedly controlling substantive tort law.
A second major issue that we have with Tucker II is it’s treatment of the FDA’s Preemption Preamble itself. Again the FDA Law blog usefully describes the relevant holding:
Citing a recent essay authored by former FDA Commissioner Dr. David Kessler and Georgetown University Law Professor David Vladeck, Judge Hamilton states that “FDA’s current position on preemption is not ‘long standing’ but is in fact a ‘180-degree reversal’ from its earlier stance.” Thus, “[t]he court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations.”See Tucker II, 2008 WL 2788505, at *5.
We object to this aspect of the decision because, first, it’s simply not correct, and second because, as we’ve blogged about before, we like our advocacy straight here at Druganddevicelaw – not masquerading as something academic. We’ve found that a lot of what passes for scholarship in the tort/preemption area is really thinly disguised advocacy for one side or the other. And just as the law review article we dissected in the prior post misrepresented the legislative history of the FDCA, the law review article cited in Tucker II – David A. Kessler & David C. Vladeck, “A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims,” 96 Geo. L.J. 461 (2008) – has taken very biased look at the FDA’s previous statement about preemption.
Allow us to deconstruct (like you had any choice).
What do Kessler and Vladek cite for the proposition that the FDA has done a 180º turn on implied preemption in the drug area? Tucker II helpfully points us to to footnote 59 of their article, so that’s where we look. That footnote precedes the proposition, “Among other things, the agency asserts that its pro-preemption position reflects the agency’s’ ‘longstanding view,’ even though the available evidence suggests otherwise.” That certainly looks like the right place.
So what do we find in footnote 59? That footnote cites five things:
- In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. M: 05-1699 CRB, 2006 WL 2374742, at *8 (N.D. Cal. Aug. 16, 2006) (observing that “the FDAs current view of the preemptive effect of its labeling regulations is a 180-degree reversal of its prior position”)
- Brief for Public Citizen as Amicus Curiae Supporting Cross-Appellee at *12, Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004) (Nos. 02-55372, 02-55498), 2003 WL 22716063
- Davis, supra note 10, at 25 n.140 and accompanying text.
- Additionally, the proposal for the rule change stated that the new rules would not have a preemptive effect. See Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66,378, 66,384 (Dec. 1, 1998) (to be codified at 21 C.F.R. pts. 201, 208, 314, 601, & 610) (“[T]he written patient medication information provided does not alter the duty, or set the standard of care for manufacturers .... FDA does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency's regulations.”).
- The FDA itself has acknowledged in amicus briefs that this pro-preemption stance is a change from past views held by the agency. See Brief for the United States as Amicus Curiae Supporting Appellee at *3, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) (No. 02-4597), 2004 WL 1143720 (“We acknowledge that ... this [preemption] position represents a change for the United States.”).
Scratch one citation.
We’re also going to throw out the second citation. Amazingly, that’s to an amicus brief filed by Public Citizen, a pro-plaintiff group without any pretense of being an unbiased or evenhanded. That would be like a law review article citing us as authority for a pro-preemption proposition. Finding a citation to something like that in this article only reinforces our suspicions about exactly what is being passed off as scholarship.
Another one bites the dust.
Back to the top, then. Bextra/Celebrex, 2006 WL 2374742, at *8 (N.D. Cal. Aug. 16, 2006), certainly says that the FDA’s current drug preemption view is a “180-degree reversal.” What Kessler/Vladek doesn’t mention is that the Bextra/Celebrex court (like Horn) deferred to the FDA anyway.
Drilling down further, we see that Bextra/Celebrex cites three FDA actions (which is two more than Kessler/Vladek do): 44 Fed. Reg. 3735 (FDA 1979); 63 Fed. Reg. 66384 (FDA 1998); and 65 Fed. Reg. 81082 (FDA 2000). Fortunately, we discussed all three of those before.
The 1979 citation (a typo, by the way – the proper page citation is 37437) doesn’t involve preemption at all. It’s a general statement about the FDA’s “intent” “not” “to influence civil tort liability.” The FDA made that statement while fielding a complaint about manufacturers adding things to labeling that helped them make adequacy as a matter of law arguments, not preemption. Later in the same release, FDA said (also, not in a preemption context): “the decision as to whether a warning is legally required for the labeling of a drug must rest with the agency.” 44 Fed. Reg. at 37447.
Obviously, a statement, such as the 1979 quote, that’s not about preemption cannot fairly be counted as a change in the FDA's preemption position. But we’re talking advocacy here, not scholarship.
The 1998 citation, like the one in 1979, had nothing to do with preemption and, indeed, nothing to do with drug labeling generally. The FDA was expanding a regulation that required the package inserts of certain drugs to include material that doctors could give directly to patients. That raised tort concerns, and back in 1998 the Agency expressed a rather benign view of tort liability:
FDA does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency’s regulations. FDA’s regulations establish the minimal standards necessary, but were not intended to preclude the states from imposing additional labeling requirements.Once again, the 1998 submission doesn’t address preemption. Nor did it deal with allegations that FDA-approved drug labeling is defective. At most, on the basis of its 1998 statements, the FDA could be accused of changing its mind about “minimum standards” – not about preemption.
Finally, the 2000 statement stated the FDA’s belief about the preemptive effect of a particular proposal before it received public comments about what ultimately became the 2006 Final Rule. The FDA modified a lot of other things about that same rule. If divergence between a proposed and a final version of the same rule is all it takes to create a “contradiction” that eliminates administrative deference, than a lot of final rules are in jeopardy. This aspect of the anti-deference argument proves too much, and would turn administrative law on its head if applied outside beyond this one instance (which is why it probably hasn’t been – we’re not administrative lawyers, so we can’t say for sure).
In 2000, the FDA specifically requested, “If it is believed that product liability concerns have not been adequately addressed, the agency seeks comment on whether it could take different or additional measures to alleviate product liability concerns.” 65 Fed. Reg. at 81088. The requested product-liability-related comments to the 2000 proposal raised preemption concerns that the Agency hadn’t anticipated, so in that sense, yes, the Agency changed its mind about preemption with respect to that pending proposal.
But why are administrative agencies required to obtain comments in the first place? Isn’t it sort of the idea that an agency is supposed to be willing to alter a proposed position in response to public comment. Denying administrative deference because an agency reconsidered some aspect of a proposal in light of public comments doesn’t make much practical sense. We don’t think that can possibly be the law generally. It’s a litigation-inspired argument, that’s all.
So, we’re still looking for that 180º change of FDA position as to drug preemption generally.
The next Kessler/Vladek citation is a little harder to follow. The full cite is for “Davis” is Mary J. Davis, “The Final Battle for Preemption: The FDA and Prescription Drug Labeling Product Liability Actions” (Berkeley Elec. Press, Working Paper No. 1591, 2006). The "working paper" is available here.
First of all, the Davis paper is “electronic.” That means it’s an unpublished paper. It’s also a "working paper," which means it’s not even a final draft. In litigation, something like that would draw a Daubert challenge, as unworthy of even being cited.
Second, Kessler/Vladek cite to note 140 “and accompanying test” of the Davis paper. Well, that particular note of the Davis paper states, in its entirety, “See supra note 131 and accompanying text.” That’s it. Still looking for anything substantive.
Third, the “accompanying text” to note 140 states: “that description appears at odds with prior statements of the FDA.” While that restates the conclusion Kessler/Vladek (and, thus, Tucker II) is trying to justify, it does not independently support it.
Fourth, our next step in this academic version of a snipe hunt takes us to footnote 131 of the Davis article. Here, we finally find four citations: (1) the aforementioned “Motus Amicus Brief of Public Citizen”; (2) certain “Hearings Before Subcomm. of Comm. on Commerce on S. 1944, 73d Cong., 2d Sess. 400, 403 (1933)” (but only as “cited” in the Public Citizen brief) – these 70-year old hearings aren’t even from the same Congressional session that passed the 1938 FDCA, and they’re certainly not a position taken by the FDA; (3) Borden Co. v. Liddy, 200 F. Supp. 221, 225 (S.D. Iowa 1961), a case about food, not drugs, decided before the 1962 FDA amendments; and (4) “Porter, supra note 7 at _,” which is not even a complete cite (a peril of relying on unpublished papers), so we’re not going to bother with it.
Thus, while purporting to address the “prior statements of the FDA,” the Davis paper doesn’t cite a single such statement. It amounts to “we think it’s so because Public Citizen says so.”
Some scholarship this is turning out to be. But, frankly, we’re not surprised. Kessler/Vladek is all about advocacy, not academics.
One more to go.
The last thing Kessler/Vladek relies on for its attack upon the consistency of the FDA’s position is – drum roll please…. Wait a minute! We’ve already gone over 63 Fed. Reg. at 66384. That’s the FDA’s patient package insert rule that didn’t have anything to do with preemption.
There’s essentially nothing there.
So adding up everything Kessler/Vladek footnote 59, all we find is, (1) a pro-plaintiff litigation brief (cited more than once, it turns out), (2) three Federal Register citations – two not about preemption at all, and one about a proposal that was changed before it became final, (3) a drug preemption case that deferred to the FDA and found in favor of preemption, (4) an unpublished draft article citing nothing from the FDA at all, and (5) the express preemption Horn case where preemption also prevailed.
That’s a very thin reed, indeed.
Not only that, but Kessler/Vladek – and by extension Tucker II – don’t bother mentioning what the FDA actually did say about preemption. How about this?
Were a State to enact a law that conflicts with this regulation or if, contrary to FDA’s understanding, such laws currently do exist, those State laws would be preempted. The agency disagrees with comments that have inferred such laws would be permissible under the provision. . .that allows States to establish more stringent requirements.62 Fed. Reg. 55852, 55932 (FDA Oct. 28, 1997).
There’s also this:
Under the Supremacy Clause of the Constitution, State laws that interfere with or are contrary to Federal law are invalid. Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. Preemption may be found where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress left no room for supplementary state regulation, or where the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.
Federal preemption may also be found where Federal law conflicts with State law. Such conflict may be demonstrated either when compliance with both federal and state law is a physical impossibility, or when State law stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress. State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals.
Additionally, a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law. Federal regulations have no less preemptive effect than federal statutes.
When an agency’s intent to preempt is clearly and unambiguously stated, the Court’s inquiry will be whether the preemptive action is within the scope of that agency’s delegated authority. If the agency’s choice to preempt represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by statute the regulation will stand unless it appears from statute or its legislative history that the accommodation is not one that Congress would have sanctioned. . . FDA possesse[s] the authority to promulgate regulations preempting . . . local
[litigation] rules that compromise adverse reporting systems that are essential to postmarketing surveillance and protection of the public health.
Conflicts between State and local disclosure laws and Federal law on adverse event reporting justify FDA’s preemption of these laws. Although Congress did not expressly preempt State law in this area, the agency’s action is appropriate because State and local laws significantly interfere with the methods by which the Federal law is designed to achieve its goals.
60 Fed. Reg. 16962, 16965-66 (FDA Apr. 3, 1995) (citations and internal quotation marks omitted).
And the third time’s the charm:
Although Congress did not expressly preempt State law in this area, the agency finds Federal preemption to be appropriate because such State or local laws, rules, regulations, or other requirements would impede FDA’s ability to monitor product safety after approval to ensure that human drug products, biologics, and medical devices are safe and effective for their intended uses. Thus, under principles of preemption law, congressional intent to preempt State law can be inferred.60 Fed. Reg. 16962, 16963 (FDA Apr. 3, 1995).
All three of these FDA positions specifically concerning preemption (and a number of others that we won’t bore you with here) were taken while Mr. Kessler was Commissioner of the FDA.
Strike three, Vladek/Kessler are outta there.
It’s inconvenient, but quite true, that what passes for scholarship in the area of tort preemption needs to be regarded with a much more jaundiced eye than occurred in Tucker II.
Moreover, those three quotes hardly scratch the surface of what the FDA has actually said about preemption and product liability law. For a more complete review, readers should click on this link to our prior post, “Ruminations on Executive Orders and the Federal Register.”
In short, the FDA could not, as Tucker II states, have made “a 180-degree reversal from its earlier stance.” 2008 WL 2788505, at *5. That’s because the Agency didn’t have an “earlier stance” to reverse. The only inconsistency in the FDA’s preemption positions occurred back before 2000, that is, before the Buckman case brought the FDA to a consistently pro-preemption stance. Before then, the FDA’s position was quite variable, with the FDA sometimes favoring preemption and on other occasions opposing it.
So on that point, Tucker II is – plain and simple – wrong. And on that point Kessler/Vladek either have amazingly selective memories or amazingly poor research help.
Those are our two main beefs with the reasoning in Tucker II. We could go on at length, but we won’t. Briefly, some other low points of the opinion:
Item: Tucker II refuses to recognize a conflict unless there’s actually been a government prosecution. “If the FDA exercises its power to disapprove the revised label, the FDA's disapproval is not retroactively illegal; the manufacturer simply stops distributing the new label.” 2008 WL 2788505, at *3; id. at *3 n.2 (FDA “must proceed to court for a judicial determination in an enforcement action”). But actual prosecution has never been the test for implied preemption – not in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), where auto manufacturers were not forced to defy air-bag mandates, and not in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), where the Court did not require either a successful, or an unsuccessful, prosecution for fraud on the FDA before preemption would attach. This preemption “requirement” is made up from whole cloth.
Item: Tucker II appears to hold (even we’re not sure exactly what’s going on at this particular point) that preemption requires “a specific example of a runaway jury verdict in which a jury found for a plaintiff in a failure-to-warn case.” 2008 WL 2788505, at *6. That can’t be right, either, as the same two Supreme Court cases (Geier and Buckman) demonstrate. Neither involved any verdict at all. That’s not to say that a runaway verdict can’t help a preemption argument. See Wyeth v. Levine. But, again, such a preemption “requirement” (if that’s what it is) seems to be something conjured in Tucker II simply for the purposes of this particular case. There’s certainly no precedent for it.
Item: There’s the statement, “[i]t is worth recalling here that under the defendant’s preemption theory here, a plaintiff could not recover for an injury or death even if the plaintiff could prove beyond reasonable dispute: . . . (c) that the FDA regulatory process had failed to identify a significant danger.” Tucker II, 2008 WL 2788505, at *7. While we’d love to have preemption where the risk in question wasn’t even “identified” during the drug’s approval process, that’s not what SSRI cases are all about. The suicide risk in Tucker II had been “identified” to a farethewell. Suicide and SSRIs were reviewed by the FDA over and over again – both before and after the 2002 suicide at issue in the case. That’s why, as we’ve already discussed, Tucker II had to ignore the state of the art in the first place. Moreover, in the 2006 Preemption Preamble, none of the six preemptive circumstances the FDA recognized involves a situation where the FDA had not reviewed the risk.
Have you ever sat down and stared really hard at a printed word? Almost any word more than two syllables long will do. Look at a word long enough, and you can almost always convince yourself that the word is somehow misspelled, even though it isn’t. We think something similar happened in Tucker II after the court had gotten preemption right the first time around.