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We’ve got a copy of the Reply Brief filed by defendant Wyeth in the Wyeth v. Levine case. Here are the highlights as we see them (we’re trying to stay away from the Phenergan or Wyeth specific stuff):

  • Conflict preemption operates by the direct force of the constitution. Express congressional intent to preempt thus is not an issue. It’s enough that Congress intended to have drug labeling decisions made by the FDA. Contrary state-law claims interfere with the accomplishment of that objective, and are preempted by the Supremacy Clause. Neither the presence, nor absence, of expressly preemptive language makes a difference to a finding of actual conflict.
  • This is a failure to contraindicate case. It’s a lot different from the 40+ year old drug product liability cases plaintiffs assert as “history.” With respect to labeled uses, the FDA is required by law to balance the risks against the benefits of all labeled indications. As a matter of law, state law cannot obstruct federal regulation of drugs by imposing a different outcome to this balancing decision from the one reached by the FDA.
  • As a matter of fact, the FDA did address the risks and benefits of the particular method of drug delivery at issue in this case. It was required to do so by law. The agency told the defendant to use “identical” labeling to that which the jury held was inadequate under state law (our one foray into Phenergan-specific stuff).
  • Because plaintiffs and their amici cannot win on the facts of the case, they try to make it into something it is not. There are no allegations of concealment from the agency or of failure to make a label change in response to newly emerging risk information. Here the FDA had all the necessary information before it, and made a decision. Plaintiffs told the jury explicitly that they could, and should, ignore the FDA’s determination. The court need not reach scenarios that are not before it.
  • The FDCA has always broadly prohibited unilateral changes to agency approved labeling, especially where methods of use are involved. This was not, and could not have been, a CBE case.
  • The FDA’s interpretation of the CBE, supported by contemporaneous administrative history, as an administrative construction of the agency’s own regulation, is entitled to considerable (Auer) deference. Thus the CBE regulation was always intended to apply solely to new, emergent information. There is not factual basis for the CBE regulation, as properly interpreted, to apply to this case.
  • The FDA regularly consults with manufacturers about possible CBE submissions. It’s quite effective in making its wishes know. Therefore, it’s hardly surprising that there aren’t many enforcement actions based upon improper CBE submissions.
  • The FDA’s “association with a serious hazard” standard (§ 201.80(e)) does not address when CBE submissions are to be filed, only the nature of the information that can be included. To interpret it in the broad fashion plaintiff does would render the CBE regulation itself a nullity.
  • The argument that defendants can simply pay judgments and continue doing what they are doing is meritless. That’s another form of special pleading for tort claims that the Supreme Court has repeatedly rejected, most recently in Riegel, every time it has held that tort law is premised on legal duties and is therefore preempted.
  • The argument that the defendant must prove that a CBE submission would be unsuccessful to qualify for preemption would involve courts and juries in adjudicating hypothetical, contrafactual situations, which the Court has disapproved in analogous situations (including Buckman).
  • There are excellent discussions of Sprietsma, Bates, and Lohr as involving situations where the responsible agency was excused from making specific judgments that balanced safety and risk. The NDA process is federal safety review. This will be quite useful in other cases.
  • That devices, but not drugs, do not have express preemption language is an accident of history, as Congress didn’t get into the habit of including express preemption clauses in statutes until after the original FDCA was enacted.
  • There’s also an excellent discussion of why the legislative history of the 1933 version of the FDCA isn’t relevant to the version that finally passed five years later, since the 1933 bill did not provide for FDA pre-approval of drugs and their labeling. This will also is useful in any case where the plaintiff makes the argument.
  • It’s irrelevant what precise authority the FDA had before 2007 to order post-approval labeling changes, since that isn’t what this case is about. The FDA told the defendant exactly how to address this particular risk at the time, and did so on full information.
  • Our pick for best quote: “No matter its purposes or benefits, tort law cannot be said to complement federal regulation when it imposes a state-law duty that contradicts manufacturers’ federal obligations and FDA’s labeling approval judgments.” Reply brief at 27.

In short, there’s a lot of good stuff here for those of us laboring in the preemption vineyards.