The Drug and Device Law Rock Climber celebrated her birthday this week by acquiring a companion for the Irascible Rescue Pomeranian (you can read about him here). The new family member is a four-month-old Australian Shepherd mix, pure white with blue eyes.  We sense figurative ears perking up at this description, as dog- (and cat-) savvy readers are no doubt aware that this lack of pigmentation is genetically linked to deafness.  And, indeed, the puppy is totally deaf, “thrown in” as an extra when a previous owner purchased another puppy (not deaf) from his litter, then dumped because he was “too much trouble.”  Puppies born deaf have no idea that anything is “missing.”  Taught to understand sign language early, they lead full lives (this is a wonderful book about a deaf Great Dane) and they are exceptionally loving and rewarding for the right owners.  We can’t wait to meet our new “grand-dog” and to watch him blossom.

Deafness does not figure in today’s case (shocking, we know, that there is no logical transition), except to the extent that the plaintiffs turned a deaf ear to well-established preemption jurisprudence.  In Jankowski v. Zydus Pharmaceuticals USA, Inc., 2021 WL 2190913 (D.N.J. May 28, 2021), the defendants manufactured Amiodarone, the generic form of a last-resort drug used to treat ventricular fibrillation and ventricular tachycardia in individuals who were facing probable death and whose conditions did not respond to other available treatments.  The plaintiffs alleged that the manufacturer of the branded version of the drug had “aggressively and successfully” marketed its product for inappropriate off-label use as a first-line therapy,   Jankowski, 2021 WL 2190913 at *1, and that the defendants took advantage of this marketing plan and “directly benefited from the directing marketing of the [branded] drug for off-label uses” through increased sales of their products.

There is nothing we haven’t seen before, and we have already drawn lessons from this litigation.

The plaintiffs alleged that the defendants failed to provide, or make available for distribution, an FDA-required Medication Guide, thereby failing to inform doctors, distributors, and patients of the dangers associated with the drug and of the fact that it was not intended for use as a first-line treatment.  With this “hook,” the plaintiffs asserted a litany of product liability claims:  failure to warn, negligent off-label marketing and sale, negligence per se, manufacturing defect, and fraud.  The defendants moved to dismiss the complaint, arguing federal preemption and failure to state a claim.

The court began by providing background about “impossibility preemption,” which, as many of you are aware, preempts state law claims when it is “impossible for a private party to comply with both state and federal requirements.”  Id. at *2 (citation to Bartlett omitted). The court went on to explain Mensing’s holding that traditional failure-to-warn claims against manufacturers of generic drugs are preempted because only branded manufacturers can unilaterally change drugs’ labels – generic manufacturers’ labels are required to be identical to the labeling of the branded versions of their drugs.  Finally the court set the stage by citing Frei v. Taro Pharm. U.S.A., Inc., 443 F. Supp. 3d 456 (S.D.N.Y. 2020), which followed Buckman to hold that “when a plaintiff’s claims exist solely by virtue of the FDCA’s requirements, state law claims are impliedly preempted.”  Id. at *3 (internal punctuation and citations omitted).  (We have discussed Frei in these pages – here, for example, in our fifty state survey on “failure to report to the FDA” decisions – more about that in a minute – here and here).

Failure to Warn Claims

The plaintiffs asserted failure-to-warn claims sounding in both strict liability and negligence, relying on the defendants’ alleged failure to provide “Medication Guides” to circumvent the preemption of traditional failure-to-warn claims.  As in Frei, as the court explained, the plaintiffs “conflate[d] a failure to provide the Medication guide in sufficient numbers with misbranding of the drug, in an attempt to couch their failure to warn claims in traditional state tort law.”  Id. at *4 (internal punctuation and citation omitted).  And, as in Frei, the court held that the claim was preempted because the plaintiffs did not identify a parallel state law that required distribution of the Medication Guide.

Manufacturing Defect Claim

As we’ve learned already, “all claims that seek to change warnings concerning generic drugs, however, they’re pleaded – read, disguised – by plaintiffs are preempted.”

It was “clear that the existence of the FDA’s Medication Guide regulation [was] the gravamen of” the manufacturing defect claim.  Id.  The plaintiffs alleged that the failure to provide a Medication Guide violated the FDA’s “Good Manufacturing Practice for Finished Pharmaceuticals” regulation, and that failure, along with the failure “to implement a safer alternative design for the delivery of the Medication Guide” (anyone else’s eyes rolling at this nonsense?) rendered the drug “adulterated.”   Underscoring the obvious, the court stated, “First, Plaintiffs’ allegations here do not sound in defective manufacturing and may be dismissed on that basis.”  Id. at *5.

In addition, the court again found that the plaintiffs did not assert a state law claim that paralleled the FDA requirement, because New Jersey’s law addressing adulterated drugs deems a drug “adulterated” when it is used as the labeling suggests, and the Jankowski plaintiffs did not and could not seek to change the label on their drug.   The court concluded, “To the extent Plaintiffs plausibly allege a claim for manufacturing defect, Plaintiffs’ claim is preempted.”

Failure to Report Adverse Events to the FDA

The court explained, that “a manufacturer’s failure to report adverse events to the FDA can form the basis of a parallel claim that survives preemption,” in states that recognize such claims.” (Again, see our 50-state survey for much more on this.)  But New Jersey “is a jurisdiction that declines to recognize a separate state law duty to warn the FDA,” so there was no parallel state-law claim and, again, this claim was preempted.  Id. (citations omitted).   Even the claim were not preempted, as the court explained, the plaintiffs only “speculatively alleged that [the defendant] failed to report adverse events to the FDA” and did not “allege actual adverse events that [the defendant did not report to the FDA,” so the allegations failed to satisfy Twiqbal and the claim failed on that basis as well.

Negligent Marketing and Sale for Off-label Purpose

The plaintiffs claimed that the defendants took advantage of the branded manufacturer’s off-label marketing by “marketing, selling, and distributing [the generic drug] as a first-line therapy . . . without the Medication Guide” and that they failed to correct information appearing in in third-party prescribing reference sources.   Once again, the court held that Mensing “impossibility preemption” doomed the claims, because the plaintiffs alleged that the Medication Guide and third-party reference materials constituted labeling and defendants, as generic manufacturers, were not permitted to make changes to their drugs’ labeling.

Finally, the court dismissed the negligence per se claim, again premised on issues related to the Medication Guide, and the fraud claim, based on the defendants’ alleged failure to report adverse events and to correct misleading information in third-party reference materials, on the same airtight reasoning it had applied throughout the decision.   And so, with eyebrow firmly raised, the court thwarted the plaintiffs’ attempted end-run around federal preemption and dismissed the complaint, albeit without prejudice.  The court provided the plaintiffs “one final opportunity” to amend the complaint, and we’ll keep you posted on that.  In the meantime, stay safe out there.