More preemption inside baseball this post. If you’re not a preemption wonk like us, try again tomorrow. If you are, you’ll get a present today. We got exercised and went out and did some original research.
We started this post out thinking mostly about Executive Order 13132. Why an eight year old executive order, you might ask? Well, back in 1999, President Clinton ordered, among other things, that federal agencies should: (1) “closely examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States,” (2) “carefully assess the necessity for such action,” and (3) “[t]o the extent practicable” “consult” with “State and local officials . . . before any such action is implemented.” E.O. 13132 §3(a).
Plaintiffs opposing preemption in medical device cases prefer to ignore this order – because it specifically authorizes preemption “where the statute contains an express preemption provision” (§4(a)) – which the Medical Device Amendments unquestionably do.
But plaintiffs opposing preemption in prescription drug cases like to beat us about the head with E.O. 13132 §3(a) because, they claim, the FDA didn’t properly consult with the states before releasing the Preemption Preamble to its Final Rule on January 24, 2006. They’ve even convinced a couple of courts to go along with them on that. Jackson v. Pfizer, Inc., 432 F.Supp.2d 964, 968 n. 3 (D. Neb. 2006); McNellis v. Pfizer, Inc., 2006 WL 2819046, at *9 (D.N.J. Sept. 29, 2006). Neither of those court looked at the question more than superficially, though.
On the other hand, in Sykes v. Glaxo-SmithKline, the court carefully examined the FDA’s actual record of consultation with respect to the final rule and determined that the Agency “did consult with a number of organizations representing the interests of state and local governments about the potential interaction between FDA drug labeling requirements and state law.” 484 F.Supp.2d 289, 316 n.27 (E.D. Pa. 2007). See also In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, 2006 WL 2374742, at *7 (C.D. Cal. Aug. 16, 2006) (any administrative failure to consult with the states “does not mean that this Court cannot consider the FDA’s view of how certain state laws stand as an obstacle to the accomplishment of the objectives of Federal law”). We’re not going into what the FDA did or might not have done in terms of consulting with the states, because that would take too much work. We’ve got other work to do.
Suffice it to say that our first reaction to arguments based on E.O. 13132 is along the lines of “who gives a damn,” since that executive order explicitly states:
This order is intended only to improve the internal management of the executive branch, and is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers, or any person.
E.O. 13132 §11 (“judicial review”) (emphasis added). In other words, even if the FDA had ignored E.O. 13132 altogether – which the courts that actually bothered to examine the FDA’s actions before adopting the Preemption Preamble have concluded it did not – it’s not any plaintiff’s business.
Our second reaction to plaintiffs’ arguments about E.O. 13132 is to remind them to quote the darn thing in full. The order expressly recognizes that agencies are justified in applying preemption “where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” §4(a). That’s good old conflict preemption folks.
Our third reaction to claims by state law plaintiffs that a federal agency failed to comply with a federal executive order during the course of federal administrative rulemaking is to think that determination of allegations about the course of federal administrative procedure present precisely the type of “embedded” inherently federal question that would justify removal to federal court under Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005). We’ve discussed the Grable issue here. We’re not going to get into that again.
Our fourth reaction is to note that there doesn’t seem to be much interest by the states themselves in preemption of tort litigation. If states (or others, for that matter) thought that any particular type of product liability litigation should escape preemption and the FDA had gotten it wrong, they could file a citizen’s petition or seek an informal opinion from the FDA seeking an exemption (we don’t claim to be regulatory lawyers, but we don’t think there’s a formal exception process for drugs, since there’s no express preemption, see 62 Fed. Reg. 9826, 9829 (FDA Mar. 4, 1997)). To us, it seems that if the states really felt that their federalism rights were being unduly impacted here, we’d expect at least one state to try at least one of the available administrative processes to save its tort law from preemption.
That is to say we’re unaware of any state bothering to seek administratively some sort of exception for any litigation potentially impacted by the six preempted categories delineated in the Preemption Preamble – either by citizen’s petition or by a request for advisory opinion. We’re not omniscient, and we could be wrong, but this is the kind of thing that we think we’d have heard about, since we keep our ears pretty close to the ground in this area. Moreover, we think there’s a very good reason for this lack of activity – no responsible state government would agree that a private litigant should be able to sue over something that the FDA has expressly required an approved warning either to include or omit.
In sum, the whole E.O. 13132 argument strikes us as a deliberately created tempest in a teapot about specific categories of preemption that, when push comes to shove, the states aren’t really interested in anyway.
But our final reaction, which is what generated this post, was to take a look at what the FDA has actually said over the years about preemption. Has the FDA ever re-consulted with states after a routine notice and comment rulemaking generates preemption issues that the Agency is obligated to address under the Administrative Procedures Act? Did the FDA abruptly and surreptitiously embrace implied preemption after the change of administrations in early 2001? Just what has the FDA said over the years about preemption of tort litigation anyway?
Well, for one thing, we can now say that we’ve looked through over 300 FDA submissions in the Federal Register, including a bunch of final rules. We’ve yet to find a single one of them that did what the plaintiffs argue that the FDA should have done here – redo the outreach functions set out in E.O. 13132 (or its predecessor, E.O. 12612) again because some of the comments raised preemption issues that the Agency was obligated to address.
Ain’t never happened as far as we can tell.
We’ve found one other occasion where the FDA explicitly decided not to engage in such a re-canvass where, in response to comments, it opted to increase the preemptive effect of a final rule. 69 Fed. Reg. 6788, 6848 (FDA Jan. 28, 2004) (banning ephedrine alkaloids from dietary supplements). Giving states a “second bite at the apple” after notice and comment is nowhere mandated by the executive order itself, and it doesn’t seem to be something that at least this particular agency does during its administrative processes.
Here, we could frankly use some help. We’re not administrative lawyers, so we’re really out of our depth. If anybody out there can let us know if any agency in the federal government interprets E.O. 13132 to require a new round of post-comment consultation with the states concerning preemption, where preemption is raised by the comments the agency received, we’d really like to know. Our gut reaction is that nobody does this, which leads us to believe that, if plaintiffs were to succeed in getting E.O. 13132 interpreted in the fashion they argue (and to get courts to ignore §11 of the order), there could be an adverse impact on administrative rulemaking throughout the federal government – way beyond the FDA.
Another thing we’ve noticed is that over the last few years, the FDA has repeatedly stated something that no longer should be subject to serious dispute – but which a lot of plaintiffs simply refuse to accept despite losing the issue repeatedly in the Supreme Court (in Bates, Geier, Lohr, and Cipollone, at least). That issue is: federal preemption, and specifically preemption involving FDA regulations, “displaces both state legislative requirements and state common law duties.” 72 Fed. Reg. 5367, 5373 (FDA Feb. 6, 2007); 72 Fed. Reg. 1455, 1459 (FDA Jan. 12, 2007); 72 Fed. Reg. 497, 516 (FDA Jan. 5, 2007); 71 Fed. Reg. 74785, 74790 (FDA Dec, 13, 2006); 71 Fed. Reg. 29248, 29250 (FDA May 22, 2006); 71 Fed. Reg. 15559, 15563 (FDA Mar. 29, 2006); 68 Fed. Reg. 51738, 51757-48 (FDA Aug. 28, 2003); 68 Fed. Reg. 51693, 51703 (FDA Aug. 28, 2003); 68 Fed. Reg. 44207, 44208 (FDA July 28, 2003); 68 Fed. Reg. 41434, 41498 (FDA May 7, 2003); 68 Fed. Reg. 39831, 39832 (FDA July 3, 2003). Most of these are routine administrative modifications of food or dietary supplement regulations.
We also took a look back at the prior 2000 FDA request for comments that (over five years later) produced a final rule and the Preemption Preamble. Was the possibility that there might be comments on limitations (such as preemption) to product liability litigation somehow hidden? Nah. One of the questions upon which the FDA specifically requested comment was what to do about product liability:
(2) Does the inclusion of a highlights section have a significant effect on manufacturers’ product liability concerns and, if so, is this concern adequately addressed by: (a) Titling this section “highlights” rather than “summary”; and (b) including the following statement, in bold, at the end of the highlights section: “These highlights do not include all the information needed to prescribe (name of drug) safely and effectively. See (name of drug)’ s comprehensive prescribing information provided below.” If these are not sufficient, could the agency take different or additional measures to alleviate product liability concerns without eliminating the highlights section altogether or lengthening it to an extent that it would no longer serve its intended purpose. . . .
65 Fed. Reg. 81082, 81086 (FDA Dec. 22, 2000) (emphasis added). And again:
The agency is seeking comment on whether the inclusion of a highlights section would have a significant effect on manufacturers’ product liability concerns and, if so, whether this concern has been adequately addressed in this proposal. 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. . . .
Id. at 81088 (emphasis added).
While the labeling proposal as written in 2000 did “not preempt State law,” id. at 81103, for anyone not to consider preemption as a possible “different or additional measure to alleviate product liability concerns” that might be raised by the comments that the FDA solicited strikes us as short-sighted, if not willfully blind – especially for those who seek to demonize the FDA as being “politically motivated.” After all, December 22, 2000 was after the election (if not necessarily all the recounts). Perhaps more notably, December 22, 2000 was after the FDA had started filing amicus briefs in favor of preemption. If no state sought to comments on preemption, or even product liability implications generally, well, what we’ve said already about nine paragraphs previous about whether there is really any significant state interest in this area applies here as well.
There had certainly been comments by industry about product liability concerns in response to the previously circulated “Prototype 3” drug labeling proposal. 65 Fed. Reg. at 81087-88.
Going further back, we’ve found some interesting language in a July, 2000 proposal to require premarket approval processes for food contact substances (things that come into contact with food). The Clinton era FDA sure didn’t seem to have as much faith in the tort system as plaintiffs’ would now have courts believe. It stated, about civil tort liability:
If products cause harm, consumers would have to rely on the tort system for redress. Consumers would have to prove that harm was linked to the food contact substance based on a standard that might vary by jurisdiction or at the whim of a jury. . . . [I]n practice, the tort system is rarely used to remedy the harm that comes from unsafe foods or food additives. Therefore, the costs of private monitoring and enforcement of safety using the tort system in an unregulated market are probably substantially greater than the social costs of regulatory enforcement.
65 Fed. Reg. 43269, 43278-79 (FDA July 13, 2000) (emphasis added). The FDA’s “whim of a jury” statement is a plea for uniformity that one of us could have just as easily written. And as for the tort system imposing “greater” “social costs” than FDA regulation – well, that’s preaching to the choir, too.
When the FDA decided to expand its patient package insert program in 1998, there were some comments requesting that the agency impose preemption (sound familiar?) to limit product liability litigation with respect to the products included in that program. The FDA decided not to exercise its discretion to make the regulation preemptive – but nowhere in the discussion did the Agency so much as suggest that it lacked the power to issue a preemptive regulation in the prescription drug area. What the FDA did conclude was:
- “Tort liability cannot be a major consideration for FDA which must be guided by the basic principles and requirements of the act in its regulatory activities.”
- Patient labeling would not “adversely affect civil tort liability” because providing more information “could reduce potential liability by improving patient compliance and patient monitoring of serious adverse events, thus decreasing drug-induced injuries.”
- Existing patient labeling requirements had not “caused a noticeable change in tort rules” since “courts have not recognized an exception to the ‘learned intermediary’ defense in situations where FDA has required patient labeling, and the courts seem increasingly reluctant to recognize new exceptions to this defense.”
- “[T]he information required by FDA will be such that States will have little reason to impose additional labeling requirements.”
- “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. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling.”
63 Fed. Reg. 66378, 66383-84 (FDA Dec. 1, 1998).
Well, this 1998 Final Rule presents a mixed bag. We don’t have any problem with the FDA not letting tort liability become the predominate factor in making its regulatory decisions. The Agency should follow its own administrative standards, not tort law. But as the Agency also acknowledges, tort law isn’t irrelevant either. See, e.g., 62 Fed. Reg. 27183, 27188 (FDA May 19, 1997) (modifying adverse event reporting regulation so it doesn’t appear that the manufacturer is admitting liability); 61 Fed. Reg. 8432, 8437 (FDA Mar. 4, 1996) (“FDA agrees that clearer labeling may in some instances help shield manufacturers from product liability. However, regardless of any effect on product liability, improved labeling, which may help reduce the incidence of injury and death is important.”); 50 Fed. Reg. 7452, 7476 (FDA Feb. 22, 1985) (essentially same as 62 Fed. Reg. 27183, citing “products liability consequences of reporting possible adverse effects”).
As for patient package inserts, with the hindsight advantage of almost a decade’s perspective, we agree with the FDA’s conclusion. We haven’t seen any upsurge in liability based upon anything in such inserts, and as we’ve already discussed, there hasn’t been any significant move (lately) to use these patient package inserts to poke holes in the learned intermediary rule. We also agree that there is “little reason” for states to impose tort standards that differ from FDA labeling requirements.
The last bullet, though, shows that not every FDA prediction comes true. The “evolution of state tort law” unfortunately did not respect the Agency’s caution that states “cannot reduce, alter, or eliminate FDA-required labeling.” 63 Fed. Reg. at 66384. In all too many areas – probably most blatantly in the SSRI/suicide cases – 21st Century product liability litigation purports to demand that manufacturers include information on their labeling that the FDA specifically rejected. In short, too many state plaintiffs these days seek to lead state common law down precisely the path that the FDA said in 1998 was forbidden. That’s what led the FDA in 2006 to limit the “minimal standards” rationale used in 1998 and explicitly to recognize preemption in six areas where state tort suits sought to “reduce, alter, or eliminate FDA-required labeling.” Id.
We also ran across the FDA’s 1998 decision to withdraw its proposal to rewrite its preemption regulations as they concern medical devices. Since this post isn’t really about express preemption, we’ll pass over this one, except to note the following:
Concerns have been raised by industry and congressional representatives that the agency did not share its thinking on its interpretation of section 521 of the act. . ., even though an early draft of the proposed rule was shared during the spring of 1997 with attorneys for Public Citizen Litigation Group, who represented Lohr in the Lohr case. The remedy under FDA’s regulations for disclosure of a draft regulation is ordinarily to issue a notice in the Federal Register making the draft publicly available. Such a contemporaneous notice was not, however, provided in this case.
63 FR 39789, 39789 (FDA July 24, 1998) (emphasis added).
In other words, the tears that plaintiffs – including Public Citizen – purport to shed these days about the FDA supposedly favoring industry are very much of the crocodilian variety. Public Citizen was perfectly willing to accept secret assistance from its friends in the Agency in support of its ultimately successful advocacy in Lohr. When just how far Public Citizen had its hands in the FDA cookie jar was exposed, even the FDA had to admit that it broke its own rules – with the intent (possibly successful) to influence the outcome in a major court case. When they had the chance, plaintiffs demonstrably subverted the Agency’s processes far worse than anything that’s happened since.
The Clinton FDA specifically recognized conflict preemption under the FDCA in 1997. The vehicle was new regulations concerning mammography. In giving the Agency authority to regulate, Congress apparently (we have no independent knowledge here) explicitly gave the states a role to play, so there was no express preemption. 62 Fed. Reg. 55852, 55858 (FDA Oct. 28, 1997). Later on, the FDA addressed the tougher question – what if a state did something that “conflict[ed]” with the regulations the FDA was adopting. That, the Agency stated, would be preempted even in the face of the congressional saving clause:
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.
Id. at 55932.
Other than in the 2006 Preemption Preamble itself – which we’re not planning to address for the 500th time here – perhaps the FDA’s most extensive discussion of preemption of state law tort actions in the absence of express preemption is 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) (lots of citations and internal quotation marks omitted). This is an FDA final rule limiting the obligations of regulated manufacturers to turn over FDA-mandated adverse event reports in state-law civil litigation. The FDA explicitly relied upon implied conflict preemption as the basis of its power to preempt state law, including state tort litigation:
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). See also 59 Fed. Reg. 3944, 3948 (FDA Jan. 27, 1994) (almost identical preemption analysis in initial FDA proposal), id. at 3947 (preemption required by adverse effects of an “increase in product liability and medical malpractice litigation”).
We like it. We could practically plop this description of preemption generally – and conflict preemption in particular – right into our own briefs without any changes. Far from asserting that the obscure 1962 FDCA amendments eliminated “obstacle/interference” preemption, the FDCA relied specifically on obstacle preemption in interposing conflict preemption to protect manufacturers against the depredations of state tort litigation. Id. at 16966 (“this final rule preempts State and local disclosure laws, rules, regulations, and other requirements in order to eliminate obstacles”); id. (“Through preemption of conflicting State and local rules. . ., this rule removes an obstacle”). An E.O. 12612 notice produced no comments from the states. 60 Fed. Reg. at 16967 (sound familiar?).
Isn’t that just like those Bush Administration industry hacks running the FDA…?
Hey! Wait a minute!
Back then Bush was still in Texas trying to reform a state tort system in which the plaintiffs had run wild, and Dan Troy was tilting at FDA windmills at the WLF. What’s going on?
Well, it so happens that we’ve already posted about exactly what was going on. Tort litigants were using discovery to pierce the confidentiality of the adverse experience reports that companies were required to collect and forward to the FDA. Some courts were letting them get away with this, and the doctors who voluntarily reported such events were afraid of being dragged into litigation. The FDA filed amicus briefs (sound familiar?) urging state appellate courts not to allow this, and advocating preemption (sound familiar?). When the state courts declined to go along (sound familiar?) the FDA acted administratively to enforce preemption (sound familiar?). The 1994 discussion, quoted above, was part of the FDA’s response.
In fact, almost (but not quite) everything we’ve discussed in this post about took place during the Clinton administration. During that period, the FDA, while not utilizing preemption as broadly as the current administration, certainly never denied having the power to assert implied conflict preemption against state tort claims. See also 62 Fed. Reg. 9024, 9041-42 (FDA Feb. 27, 1997) (similar discussion of preemption in context of OTC drug regulations; FDA purported to exempt private tort litigation from preemption). There doesn’t appear to be any doctrinal difference between the Clinton and Bush FDAs on preemption at all. Both took/take the position – repeatedly – that conflict preemption can apply against state common-law tort actions. The current FDA has simply been forced, by the assault of 21st Century tort claims upon the Agency’s authority to enforce its labeling decisions, to assert conflict preemption more often and more widely. If there’s any doctrinal difference at all, it’s that the Clinton FDA assumed that it could expressly exempt tort law from conflict preemption, something that the Supreme Court later rejected in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), where it made clear that implied preemption operates independently of express preemption (including savings clauses).
Indeed, the FDA’s preemption position has been consistent for much longer than this. Back in 1986, the FDA gave a succinct description of its view of conflict preemption in responding to a couple of comments seeking preemption rulings. First, with respect to a food additive (back when there was no express preemption in this area):
The agency does not use its authority to preempt State requirements unless there is a genuine need to stop the proliferation of inconsistent requirements between FDA and the States. FDA is not persuaded that such a need now exists with regard to sulfite labeling.
51 Fed. Reg. 25012, 25016 (FDA July 9, 1986) (emphasis added). Second, with respect to food irradiation:
The act contains no specific provision preempting the field of food irradiation. The test of whether a State activity is preempted by Federal law and regulations is whether the State activity conflicts with and stands as an obstacle to the Federal program.
51 Fed. Reg. 13376, 13392 (FDA Apr. 18, 1986) (emphasis added).
We can live with the 1986 FDA, too. There it goes again. The Agency is once again relying upon good old “obstacle” conflict preemption. What’s more, the “proliferation of inconsistent requirements” in 21st Century product liability is precisely why the FDA was forced to act in January, 2006.
There’s another similar statement regarding implied conflict preemption from the FDA in 1982, this time involving OTC labeling (back when there was no express preemption in this area, either). The FDA stated:
These cases and others describe the criteria used to determine whether State and Federal laws are at such odds that the State law must give way. . . . The basic standard that has evolved is whether under the circumstances the State law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress in enacting the Federal law. . . . [T]he doctrine of implied preemption must be applied. As stated in the proposed rule, a single national pregnancy-nursing warning with a specified text is necessary to ensure that OTC drugs are used safely and for their intended purposes. . . . FDA believes that differing State OTC drug pregnancy-nursing warning requirements would prevent accomplishment of the full purpose and objectives of the agency in issuing the regulation and that, under the doctrine of implied preemption, these State requirements are preempted by the regulation as a matter of law.
47 Fed. Reg. 54750, 54756 (FDA Dec. 3, 1982) (emphasis added). Plainly, the FDA’s always thought it could rely upon “obstacle” implied conflict preemption.
Going back still further, in 1979, the FDA received some comments about tort law the last time (before 2006) it engaged in a comprehensive revision of drug labeling. Somebody complained about the Agency not simply imposing labeling upon manufacturers but rather engaging them in give and take. The comment claimed “that such a compromise acts to insulate the manufacturer from liability.” The FDA replied that it couldn’t be concerned with that:
[FDA] acknowledges that the final labeling for a drug is often the result of interactions between FDA and the manufacturer. . . . It is not the intent of FDA to influence the civil tort liability of the manufacturer or the physician. Rather, it is the agency’s intent to ensure that a complete and accurate explanation of the drug is provided to the medical community.
44 Fed. Reg. 37434, 37437 (June 26, 1979). This is another one that plaintiffs love to quote out of context. To us – in context – it’s exactly as it should be. Later in the same final rule, the FDA fielded a comment that suggested that decisions about what risks should be on labeling should be delegated outside the Agency. The FDA shot that one down as well, determining that, although certain “information about a hazard” can be added “without advance approval,” final authority over labeling necessarily remains with the Agency itself:
[T]he act requires warnings about both potential and verified hazards. Accordingly when medical information justifies a warning, the act requires that it be included in drug labeling. Although FDA often refers questions of whether a warning should be included in the labeling of a drug to its standing advisory committees, the decision as to whether a warning is legally required for the labeling of a drug must rest with the agency.
Id. at 37447 (emphasis added). Again, context is everything. We agree on both counts. As we already said above, the Agency has statutory and regulatory standards to follow. Whether the result increases or decreases civil liability is a secondary issue. Also, whatever an advisory committee might say, or whatever a manufacturer might put in a “changes being effected” supplement, at the end of the day it’s the FDA’s call what’s in the label. If necessary, the FDA can call upon preemption to make sure that its authority prevails.
The earliest reference we’ve been able to find to the tort consequences of FDA regulatory actions dates from 1977 (thirty years ago), when the FDA was first deciding to mandate patient package inserts for oral contraceptives. In response to comments that these new inserts would affect product liability litigation, the FDA did what it’s supposed to do and responded to the comments (sound familiar?). The FDA concluded that its actions might well reduce product liability litigation because “giving patients information on the hazards associated with estrogen drug products” could:
likely result in reduced potential manufacturer liability, owing to improved patient compliance and a corresponding decrease in drug-induced injury. In any event, however, whether particular labeling may alter a manufacturer’s liability in a given instance cannot be considered as a dispositive factor by the Commissioner in reaching a decision.
42 Fed. Reg. 37636, 37637 (FDA July 22, 1977). Such labeling was “under no circumstances… intended to supersede the role of the physician.” Id. The FDA did not purport to preempt anything with this regulation and thus, did not discuss preemption at all. To us, it’s pretty much the same point that the FDA made on a number of occasions over the years – that the FDA lets the chips fall where they may in tort litigation, unless and until such litigation starts to conflict with what the FDA says must go on drug labeling.
When we started looking into this, we actually expected to find a lot more divergence in the FDA’s positions over the years. We were rather surprised with how consistent the FDA has been – and how consistently the Agency has applied implied conflict preemption whenever a state, or a state-law plaintiff, took a position that threatened to “reduce, alter, or eliminate FDA-required labeling” (1998) or would cause a “proliferation of inconsistent requirements” (1986).
Maybe even we were a bit (just a tiny bit) brainwashed by the plaintiffs’ propaganda.
What we can truthfully say, now that we’ve looked at the question thoroughly, is that over the past thirty years (which is all we could access by computer) the FDA has been remarkably consistent in what it’s said about preemption. Moreover, there’s very little out there that couldn’t fit comfortably into its 2006 Preemption Preamble. Moreover, we’re not the only ones who think that. In 2004, five former FDA Chief Counsel, from as long ago as 1972, wrote a letter to a congressional committee (that letter appears in the Congressional Record at 150 Cong. Rec. S8657 (July 22, 2004)) shooting down claims that the FDA’s amicus briefs in favor of preemption were some sort of “radical new direction” for the Agency. Instead, the Agency’s preemption position was necessary “to protect FDA’s jurisdiction and the integrity of the federal regulatory process”:
If every state judge and jury could fashion their own labeling requirements
for drugs and medical devices, there would be regulatory chaos for these two
industries that are so vital fo the public health and FDA’s ability to advance
the public health by allocating scarce space in product labeling to the most
important information would be seriously eroded.
150 Cong. Rec. S8657. We’re happy to keep company with five FDA Chief Counsel on this.