Today’s post is really three different posts on three unrelated subjects.  None of them very long (at least by DDLaw Blog standards), but we think that each will be of interest to at least some our readers.  

On Generic Plaintiffs’ Preemption “Win” in New Jersey

This piece is from the non-Dechert side of the blog.

Plaintiffs alleging failure to warn of the risks of a generic drug scored a “win” of sorts in In re Reglan Litigation, 2014 WL 5840281 (N.J. Super. App. Div. Nov. 12, 2014).  The court held, in an unpublished decision, that “failure-to-update” claims survived the otherwise comprehensive impossibility preemption that applies to generic drugs:

[T]he trial court correctly determined that plaintiffs’ claims based on the Generic Defendants' failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.  The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve . . . .  Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law.

Id. at *4.  As the Appellate Division points out, non-preemption of “duty to update” is the majority view.

We may not like it, but we’re not losing much sleep about it.

Why?

We have never seen a plaintiff, permitted to allege anything else, voluntarily bring a claim against a prescription medical product manufacturer for failure to update a label to conform to FDA-mandated changes.  We doubt we ever will.

That’s why we put “win” in parentheses.  Compared to the usual product liability theories, “failure to update” is a really lousy cause of action.  Let us count some of the ways:

  • Failure to update is very manufacturer specific, an especially serious problem in generic drug cases where a plaintiff might have taken bioequivalent products made by more than one manufacturer.  Sorting out the causative effects of chemically identical products differing only in when their labels are updated will not be easy for plaintiffs.
  • The “defect” is defined solely by the period of time that the product was not updated, which will not have anything to do with the dosage or exposures necessary to prove medical causation. Focusing solely on a few months of un-updated warnings will be scientifically dubious and probably not very appealing to a jury.
  • Plaintiffs normally like warning claims to be “moving targets” so they are hard to pin down.  Failure to update claims are the antithesis of a moving target, since every jot and tittle of the necessary warning change is known in advance. Plaintiffs are deprived of many of their “what if” games, both in discovery (prescriber depositions) and at trial.
  • By definition, a failure to update claim involves a product risk sufficiently well established that it has been evaluated by the FDA and a new warning promulgated. Regulatory action necessarily lags the underlying science, so the likelihood is high that a plaintiff’s prescriber will have already learned of the risk through other sources, thereby greatly increasing the likelihood of a successful warning causation defense under the learned intermediary rule.
  • Plaintiffs love to call every warning up to and through the end of their exposure “defective.”  The non-updated period may well not have extended that far, putting plaintiffs in the awkward position of having contended that the FDA’s updated warning is still “defective.”  We know of no state, outside of the failure-to-update context, recognizing a warning theory predicated on an alternative warning that, while “better,” is nonetheless still “defective.”  The theory makes no logical sense and has little jury appeal.  In metoclopramide cases, we’ve seen it rejected as a matter of law on several occasions.
  • We presume that the FDA has some kind of guidelines for how long of an update lag is “reasonable.”  Plaintiffs will have to abide by that FDA judgment to avoid preemption.

So while Reglan and other similar cases count as “wins” for the other side of the “v.,” in that complete dismissal was avoided, such victories are likely to be of the Pyrrhic variety in most cases.  That may set generate some nuisance settlements, but in the long run we think that most of our adversaries will not be chomping at the bit to take failure-to-update cases, even if there were an actual delay in updating the label.  They have more remunerative ways to spend their time.

An Alternative Demise Scenario for the FDA’s Ban on Truthful Off-Label Promotion?

We find the FDA LawBlog, run by our friends at Hyman Phelps particularly informative.  Those readers interested in off-label promotion issues would be well-advised to read their recent post, “How Far Does FDA’s Say-So Travel?”  When we read it, we immediately thought about not only the government’s criminal prosecutions for alleged illegal promotion, but also the plague of tag-along False Claims Act (“FCA”) cases screeching “me too.”

We recently did a post about a Supreme Court certiorari denial statement involving a cy pres case.  Similarly, the FDA Law Blog’s post highlights a statement in last week’s United States Supreme Court denial of certiorari in Whitman v. United States, 135 S. Ct. 352 (2014).  Two justices (Scalia and Thomas) questioned the amount of deference properly afforded administrative interpretations in situations “that contemplate[] both criminal and administrative enforcement.”  Id.

As discussed in more detail in the FDA Law Blog postWhitman was not an FDCA case at all but rather a Rule 10-b-5 criminal prosecution by the Securities & Exchange Commission.  Citing to the “rule of lenity,” the Justices’ statement posits that administrative interpretations of ambiguous statutes are not entitled to deference in criminal prosecutions:

I doubt the Government’s pretensions to deference. They collide with the norm that legislatures, not executive officers, define crimes. . . .  With deference to agency interpretations of statutory provisions to which criminal prohibitions are attached, federal administrators can in effect create (and uncreate) new crimes at will, so long as they do not roam beyond ambiguities that the laws contain. Undoubtedly Congress may make it a crime to violate a regulation, but it is quite a different matter for Congress to give agencies − let alone for us to presume that Congress gave agencies − power to resolve ambiguities in criminal legislation..

The Government’s theory that was accepted here would, in addition, upend ordinary principles of interpretation.  The rule of lenity requires interpreters to resolve ambiguity in criminal laws in favor of defendants.  Deferring to the prosecuting branch’s expansive views . . . would . . . replac[e] the doctrine of lenity with a doctrine of severity.

Id. at 353 (citations omitted).  These justices agreed that Whitmanwas not the proper vehicle (for procedural reasons) to review this question, but, as the FDA Law Blog recognizes, they are “explicitly sending a signal that [they] want[] the Supreme Court to address th[is] issue.”

The FDA Law Blog does not speculate on what type of “enforcement action[s] taken on the basis of an ambiguous provision of the FDCA” might constitute a proper vehicle to explore the deference issue spotlighted by the statement in Whitman, but we have to think that off-label promotion would be high on that list (almost any enforcement action involving social media would be another – the FDA is so far behind the curve here that it risks becoming irrelevant).

First, as we’ve pointed out several times, such as here, the FDA’s off-label promotion ban is not explicit anywhere in either the FDCA or the regulations.  Rather the FDA had to cobble together several separate sections (including a definition of “intended use” that hasn’t been updated in 70 years) in order to create a rationale for an outright ban.  Heck, neither the statute nor any FDA regulation even defines “promotion.”

Second, as any reader of this blog is well aware by now, the FDA’s flat ban on truthful speech “promoting” off-label use has profound free speech implications.  The Supreme Court has dealt with that issue twice (Western States Medical and Sorrell), as have the courts of appeals (CaroniaCaputoPearson).  Courts often are reluctant to reach constitutional issues if they can find an alternative non-constitutional ground.   The “rule of lenity” could be that alternative to get rid of the FDA’s ban.

Third, the government has ruthlessly monetized its questionable ban on truthful off-label promotion for quite a few years now. Indeed, the government has used this ban as the basis for a creeping administrative takeover of pharmaceutical and medical device public relations practices.  Don’t believe us?  Just take a look at the Office of Inspector General’s list of “corporate integrity agreements.”  Increasingly, relators in FCA are following suit.

Thus, the FDA’s off-label promotion ban is:  (1) precisely the sort of “ambiguous” criminal/administrative enforcement situation described in Whitman; (2) an alternative basis to avoid having to decide serious constitutional implications that have interested (and divided) the Court in the past; and (3) the subject of frequent, high-stakes governmental and “private attorney general” enforcement activity.

Gentlemen, start your engines.

Not Even Conte Goes That Far

This last one comes courtesy of Harley Ratliff of Shook Hardy.  It’s a trial court decision from San Diego Superior Court in California. See Hamiltion [sic] v. AstraZeneca, 2014 WL 5817660 (Cal. Super. Sept. 22, 2014) (we handled getting it on Westlaw).

In Hamiltion the plaintiff attempted to convert Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) − bad enough as it is − into a sort of super-market-share-liability theory.  The drug in question, terbutaline sulfate, has two very different indications – bronchodilation (anti-asthma) and neonatal.  These different uses involve different products.  Plaintiff claimed injury from the neonatal use.  Not satisfied with suing the maker of that product (probably because it was a generic drug protected by generic preemption), the plaintiff simply sued everybody he thought ever made the stuff.  Among those named as defendants was Sanofi, which had made the type of terbutaline sulfate product used to treat asthma, but had stopped years before plaintiff was born.

Plaintiff claimed that, under Conte, it was “foreseeable” that any label about any type of this drug (asthmatic or neonatal) could “be relied upon by doctors” prescribing the neonatal version.  This claim was even worse than Conte, which is at least limited to bioequivalent products.  Heck, it was worse than Sindell market share, which at least requires the defendant’s product to have been on the market at the time the plaintiff allegedly used it.

Fortunately the San Diego court was having none of it.  The court held that plaintiff’s compound-liability theory was way beyond even what Conte contemplated, and in so doing limited Conte to its (bad enough) facts:

This Court does not read Conte as broadly as Plaintiffs.  Rather, the Court finds Conte to be limited to holding that the duty owed by a name-brand prescription drug manufacturer providing product warnings extends to not only warnings concerning its own product but also to those whose doctors foreseeably rely on the name-brand manufacturer’s information when prescribing a generic medication. The court there explained its reasoning to include in part, that pharmacists are permitted to substitute a name-brand prescription drug with a generic drug. This case does not concern the ingestion of a Sanofi drug or a generic for Sanofi and the Court, therefore, finds Conte distinguishable.

Hamiltion, 2014 WL 5817660, at *1.

We want Conte reversed altogether because its foreseeability-is-enough rationale misstates California law.  See O’Neil v. Crane Co., 266 P.3d 987 (Cal. 2012).  But it will take an appellate court to do that.  Until then, keeping Conte from expanding liability further is something to be welcomed.