Friday, September 14, 2012

Let's Put A Stop To This Right Away

In Whitener v. PLIVA, Inc., 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012), the court recently allowed “a state-law tort claim based on alleged promotion of [a generic drug] for off-label purposes in violation of federal law” to escape preemption on a motion to dismiss.  This claim was presented as a “parallel claim”:

Plaintiffs argue that their complaint involves parallel state law claims − in other words, they claim that Defendants’ violations of federal law also violated Defendants’ state law duties to Plaintiffs.

Id. at *5 (emphasis original).  The only case plaintiff cited in favor of these allegations wasn’t even a generic drug case, but rather a medical device case, Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 378–79 (5th Cir. 2012) (a very good case for defendants, by the way).  2012 WL 3948797, at *5.

The court let the allegation skate, finding it different from Mensing because plaintiffs “allege that Defendants simultaneously violated both state and federal law by actively engaging in off-label promotion despite known risks not listed on the label.”  Id. (emphasis original).  It wasn’t a particularly strong endorsement, however, as the court stated:

The [Mensing] Court simply did not reach the issue of whether federal regulations preempt state tort claims that are not based on failure to change the label in violation of federal regulations.  Furthermore, the parties still have not cited a case on point for this issue.  Accordingly, the Court remains “hesitant to hold as a matter of law that there is not a kernel of a viable claim somewhere in Plaintiffs’ allegations.”

Whitener, 2012 WL 3948797 at *6.

Next thing we know, the very next day in fact, we see a routine order in different litigation, concerning amendment of complaints, suggesting that − once again − plaintiffs suing generic drug manufacturers are “asserting off-label promotion“ as a supposedly unpreempted claim.  In re Prempro Products Liability Litigation, 2012 WL 3985752, at *1 (E.D. Ark. Sept. 11, 2012).

We’d like to see a stop put to such allegations right away, before they gain any real traction.  The simple fact is that the idea of a “parallel claim” is a principle of express − that is, medical device preemption − not implied generic drug preemption under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  The existence of a preemption exception (assuming for purposes of this post that it exists) for “parallel” claims in medical device cases is based entirely on the specific language of the express preemption clause (21 U.S.C. §360k) concerning medical devices, which preempts state law that is “different from or in addition to” an FDA “requirement“ concerning medical devices.  This was made perfectly clear in Lohr itself:

Nothing in §360k denies Florida the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.  Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the state-law cause of action would make the state requirements narrower, not broader, than the federal requirement.  While such a narrower requirement might be “different from” the federal rules in a literal sense, such a difference would surely provide a strange reason for finding pre-emption of a state rule insofar as it duplicates the federal rule.  The presence of a damages remedy does not amount to the additional or different “requirement” that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing “requirements” under federal law.

Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (emphasis added).  The dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), says the same thing, more succinctly:

State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law.  §360k(a)(1).  Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.

Id. at 330.  Essentially, the only reason why a “parallel” claim exception can exist in medical device preemption is the language of the preemption clause − which does not extend to any kind of prescription drug, generic or branded.

Preemption in the generic drug context, by contrast, is implied − arising from the impossibility of maintaining “the same” warning if state tort plaintiffs could demand changes in generic labeling independently from the FDA-approved language.  These are separate concepts.  “[T]he absence of express pre-emption is not a reason to find no conflict pre-emption.”  Mensing, 131 S. Ct. at 2577 n.5 (emphasis original); see Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”).  Under Mensing anything that would “change” the labeling violates this federal “sameness” requirement, and is preempted.

If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.  Taking [plaintiffs’] allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic [drug].  Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels.  Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.

131 S. Ct. at 2578.

What about the allegations of off-label promotion in Whitener?  Without some kind of informationally-based allegation − that is to say that the FDA-approved “same” labeling is inadequate − there is simply no causation.  “Promotion” necessarily involves the transmission of information, which means that it concerns what the FDA considers “labeling,” and all generic labeling is subject to the “sameness” requirement that underlies Mensing.

To the extent any investigation, testing, or marketing surveillance would have revealed the dangers of the drug, that knowledge would have been helpful only to the extent it was communicated through labeling − which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations.  The Generic Defendants could not have unilaterally improved the labeling of the drug any further even if they had wanted to.

Truddle v. Wyeth, LLC, 2012 WL 3338715, at *4 (N.D. Miss. Aug. 14, 2012).  Thus, in order to avoid a “pure” FDCA-based claim (off-label promotion being considered within the FDA’s definition of “labeling”), of the type preempted under Buckman, there must be something inadequate about the label that has to do with the allegedly promoted off-label use.  There’s no other way for a manufacturer violate state common law.  Off-label promotion is not a state common-law concept.  State law theories predicate liability, not on “intended uses,” but only on the inaccuracy or inadequacy of the information itself.

You don’t have to take our word for it.  Although apparently not before the court in Whitener, a number of cases have recognized that express preemption concepts, such as “parallel” claims, have no place in implied preemption analysis involving generic drugs.

Plaintiff’s focus on decisions involving express preemption is misplaced. Mensing involved conflict preemption, which does not depend on the limitations of the language in a preemption provision.  In other words, no parallel state-law claims or alternative theories of liability survive the Supreme Court's ruling in Mensing.

Guarino v. Wyeth LLC, 823 F. Supp.2d 1289, 1292 (M.D. Fla. 2011) (emphasis added), reconsideration denied, 2012 WL 28810 (M.D. Fla. Jan. 5, 2012).  It's hard to get more direct than that.

Express preemption concepts such as “parallel” claims cannot be imported into implied preemption cases solely governed by Mensing.  “[E]xpress preemption is not applicable here because the Supreme Court [in Mensing] clearly identified the conflict between the LPLA and the FDA labeling rules as a case of conflict or impossibility preemption.”  Morris v. Wyeth, Inc., 2011 WL 4973839, at *2 (W.D. La. Oct. 19, 2011), reconsideration denied, 2012 WL 601455 (W.D. La. Feb. 23, 2012).  To argue otherwise is “misguided”:

The Supreme Court very clearly based its decision in Mensing on conflict or impossibility pre-emption, which determines whether the private party could independently do under federal law what state law requires of it.  Thus, [plaintiff’s] attempt to analyze the claim under express pre-emption is misguided.

Del Valle v. PLIVA, Inc., 2011 WL 7168620, at *6 (Mag. S.D. Tex. Dec. 21, 2011), adopted, 2012 WL 2899406 (S.D. Tex. June 22, 2012).

Likewise, in Phelps v. Wyeth, Inc., ___ F. Supp.2d ___, 2012 WL 1499343 (D. Or. April 24, 2012), the plaintiff sought to assert (among other things) “misbranding” claims alleging FDCA violations to get around Mensing preemption.  The court correctly recognized that such claims did not alter the federal “sameness” requirement at the heart of Mensing:

When enacting the FDCA, Congress was explicit that only the federal government may bring an action to enforce its provisions.  Consequently, failure to comply with the FDCA cannot form the basis for a state-law claim.  Plaintiffs cannot sue to enforce the federal statute. . . .  Plaintiffs’ reliance on Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) [a medical device “parallel claim” case] is misplaced.  Hughes involved a medical device and whether the plaintiff’s claims were expressly preempted under §360k of the Medical Device Amendments.  The court’s holding in Hughes does not change the preemption analysis outlined in Mensing.  Here, plaintiffs’ claims are preempted by impossibility; they are not expressly preempted.

Id. at *9.

Thus, there isn’t a “kernel of a viable claim” in a generic drug case alleging off-label promotion.  “Parallel” claim analysis is about as useful in a Mensing implied preemption case as a bicycle is to a fish.  The generic plaintiffs are still asserting that the label is inadequate − which they simply can’t do under Mensing. They’re only offering a different reason (a claimed FDCA violation) for the inadequacy.  Whether or not that creates a “requirement” that’s “different from or in addition to” under Lohr express preemption analysis, such allegations do not change the Mensing requirement of labeling “sameness” one iota .