What’s Past is Prologue | Drug & Device Law

A little over two years ago, we wrote a post called What’s In a Name? discussing an attempt by two plaintiffs to hold Pfizer liable for fraud and misrepresentation based on an allegation that it was misleading to call the drug Chantix by its name if it was contaminated.  That case, as we noted in our post, was dismissed.  But, in the meantime, additional lawsuits were being filed around the country and eventually became an MDL in the Southern District of New York – In re: Chantix (Varenicline) Marketing, Sales Practices and Products Liability Litigation.  So today we turn from star-crossed lovers to the sorcery and revenge of The Tempest.  While Shakespeare’s characters were attempting to justify murder, here “what’s past is prologue” means another preemption victory (except for some manufacturing defect claims). 

The MDL decision, available at 2024 WL 2784234 (S.D.N.Y. May 28, 2024), is lengthy and thorough.  And notes from the outset that the Harris decision (our What’s in a Name case), “looms in the background” because the key allegations in the MDL are virtually identical to those in Harris.  Leading the court to a seemingly inevitable conclusion that plaintiffs are not permitted to “relitigate Harris’s rejection of Plaintiff’s alleged misstatements in connection with Defendant’s use of the Chantix brand name.”  Id. at *6.  Leaving plaintiffs with only “a narrow set” of manufacturing defect claims based on Current Good Manufacturing Practices (“CGMP”) violations that were not dealt with in Harris.

A couple of facts we want to set out to help fill in the picture.  The contaminants at issue are nitrosamines.  In 2021, Pfizer voluntarily recalled Chantix because it may contain nitrosamine levels above the FDA’s acceptable intake limit.  The FDA also advised patients and doctors that “there is no immediate risk to patients taking this medication” and that patients should continue taking the Chantix they had.    

Plaintiffs allege three categories of misstatements.  The first of which the court calls the Sameness Misstatement – our rose-by-any-other-name misstatement.  To get around Harris, however, the MDL plaintiffs make a “sweeping” argument that the presence of contaminants in Chantix “rendered Chantix so different that it should be considered to be a new and unapproved drug with additional active ingredients” making it not the therapeutic equivalent of Chantix.  Id.  In attempting to dodge Harris, plaintiffs ran headfirst into preemption.  Plaintiff’s entire argument relies exclusively on the FDA’s standard for therapeutic equivalence.  Decisions about therapeutic equivalence are made by the FDA, not the courts.  Nowhere does plaintiff allege any independent state law duty that defendant is in violation of.   Making this nothing more than “an impermissible attempt to privately enforce provisions of the FDCA.”  Id. at *15.

Further bolstering the court’s decision to dismiss claims based on the Sameness Misstatement is that plaintiffs are essentially asking the court to apply the FDA’s own regulations to reach a conclusion that “the FDA itself has declined to make . . . and even advised patients to continue taking the medication notwithstanding the issue.”  Id.at *16.  That would go against Buckman.  The court also distinguishes the decision reached in the Valsartan MDL (which we scathingly review here) as one involving generic drugs.  Since we think Valsartan got it wrong, we won’t pick apart the analysis other than to say we think it may be a distinction without a difference.  Id. at *17.   

Finally, even if a claim based on bioequivalence was not preempted, plaintiff’s argument is that the bioequivalence requires the drugs to be absolutely identical.  Not so.  The FDA standard only requires “the absence of a significant difference” regarding the active ingredient.  All Chantix on the market had the same dose of active ingredient and plaintiffs do not allege otherwise.

Plaintiff’s second misrepresentation is what the court calls the Active Ingredient Misstatement.  Plaintiffs allege that nitrosamines were an active ingredient in Chantix that should have been disclosed on the drug’s labeling.  Id. at *7.  However, manufacturers have limited ability to unilaterally change a drug’s label.  So, a labeling claim is preempted unless plaintiffs plead a “labeling deficiency that [Defendant] could have corrected using the [Changes Being Effected (“BE”)] regulation.  Id. at *18.   The CBE regulation only allows a manufacturer to add or strengthen a warning where there is “sufficient evidence of a causal association” based on “newly acquired information.”  But the Chantix plaintiffs “do not identify any studies, data, or other information evidencing the specific causal association between the nitrosamine contaminants in Chantix and a clinically significant adverse reaction from taking Chantix.”  Id. at *19.  In fact, the FDA reached the opposite conclusion, finding no immediate or significant health risk.   

Even if the contamination could be such a risk, it was not known prior to the recall.  In response to FDA guidance on nitrosamines, defendant opted to recall Chantix rather than pursue a labeling change. And the court was unwilling to allow issues with other drugs to serve as newly acquired information on which a CBE could be based.  Because plaintiffs did not sufficiently plead facts that support that defendant would have been able unilaterally to change its label to add nitrosamines, all claims based on the Active Ingredient Misstatement were preempted.     

That leaves only plaintiffs’ cGMP Misstatement—that defendant, by selling Chantix as FDA-approved, represented and warranted that the drug had been manufactured in accordance with CGMPs.  Id. at *7.  Defendant’s motion to dismiss claims based on the cGMP Misstatement was denied based on the court’s conclusion that manufacturing defect claims are non-preempted parallel claims.  And if you are now wondering when this case turned into a PMA medical device case, so are we.  Plaintiff alleges defendant failed to adhere to two cGMPs requiring a “quality control unit” and “written procedures.”  Id. at *21.  Neither regulation specifies particular actions, but the court lets that slide.  Stressing that the case is at the pleadings stage, the court found plaintiffs plausibly alleged cGMP violations staving off dismissal but commenting that discovery might shed light that would lead to a different conclusion down the road.  Id.   

The decision deals with some other issues as well, such as:  plaintiffs have standing except as to injunctive relief (id. at *11-12); fraud was dismissed for failure to plead scienter (id. at *22-23); issues related to privity and notice requirements for plaintiffs’ remaining warranty claim (limited to manufacturing defects) are premature and require additional briefing (id. at *24-27); Magnuson Moss claims dismissed as inapplicable (id. at *28); consumer fraud survives for now (id. at *29-31); and unjust enrichment claims under certain states’ laws are dismissed as duplicative (id. at *31-34). 

But the core of plaintiffs’ claims has been struck as preempted.  And to that we say O just but severe law!