Today’s case is a straight warnings case.  So, there should be little surprise that if it involves a generic drug preemption shuts it down.  But that does not mean that plaintiffs did not try several avenues of attack to try to find a warning claim that would stick.  None did.

The case is Roncal v. Aurobindo Pharma USA, Inc., 2022 WL 1237888 (D.N.J. Apr. 27, 2022).  Multiple plaintiffs and their spouses brought suit against the manufacturer of generic amiodarone, a drug used to treat atrial fibrillation.  Id. at *1.  While the decision does not specify where all plaintiffs are from, we know they are not all from New Jersey and appear to hail from various states around the country.  That’s important because the court had to figure out what law to apply to defendant’s motion to dismiss.  The complaint only mentioned New Jersey and federal law, but plaintiffs apparently argued that the law of their respective states of residence should apply.  Id. at *2-3.  What plaintiffs failed to argue is how the law of their home states conflicted with New Jersey law.  Absent evidence of a conflict, “the law of the forum governs.”  Id. at *3.  Further, plaintiffs only identified their states of residence, not the states where their injuries occurred – which is the presumed applicable law for personal injury claims.  Therefore, on the additional ground of failing to provide the facts necessary to make a proper choice of law analysis, the court chose to apply New Jersey law to all plaintiffs’ claims.  Id. at *9n.4.

Having decided to apply New Jersey law, the court’s next decision was whether all of plaintiffs’ claims were subsumed by the New Jersey Products Liability Act (“NJPLA”).  There was no dispute that the two strict liability claims – failure to warn and manufacturing defect – were subsumed.  But plaintiffs also alleged negligence and fraud claims which if arising “from the independent conduct of a defendant, which is unrelated to the inherent defect in the product itself,” may exist outside the NJPLA.  Id. at *4.  Here they did not.  All of plaintiffs’ claims were premised on three warnings-based sets of allegations:  failure to provide a warning in the form of a Medication Guide; the failure to report adverse events; and the deficiency of the warnings themselves.  Id.  Because the negligence and fraud claims were based on the same products liability allegations, they could not stand separate from plaintiffs’ NJPLA claims and therefore were dismissed.  Id.

That leaves the court’s final analysis on those two NJPLA claims.  First, plaintiffs really did not have a manufacturing defect claim.  The allegations in that count only talked about warnings, labeling and the Medication Guide.  Without any allegation about the product being in a “substandard condition,” plaintiffs simply recast their warnings claims into a count titled manufacturing defect.  The court treated it like another warnings claim.  Id. at n.8.

Now we are back where we started – a straight warnings case.  The court looked at each of plaintiffs’ warnings theories separately.  First was failure to provide Medication Guides.  Medication Guides are the FDA-approved warnings that are directed to the patient.  The FDCA requires manufacturers to provide “distributors, packers, and dispensers” either enough Medication Guides to distribute to all prescribed patients or the means by which to generate sufficient Medication Guides.  And the important part of that is “the FDCA requires.”  Therefore, the violation of the FDCA is a “crucial element” of the claim and

Plaintiffs’ attempt to use a state products liability law to seek relief for a violation of this FDCA requirement is preempted under Buckman. 531 U.S. at 353.

Id. at *6.  Preemption is the end of the story, but the court did address plaintiffs’ argument that under New Jersey law plaintiffs had a duty to provide the Medication Guide directly to patients.  Plaintiffs cite to no case or other authority creating such a duty and none exists.  Id. at *7.  Plaintiffs tried to rely on Perez v. Wyeth Labs, Inc., 734 A.2d 1245 (N.J. 1999).  But what that case said was if a manufacturer undertakes direct-to-consumer marketing, there is a corresponding duty to warn the patient.  Roncal, at *7.  Plaintiffs are not alleging direct-to-consumer advertising and therefore Perez is inapplicable.  Here we have to point out the court dropped a nice footnote on Erie conservatism.  Id. at n.12 (diversity courts should be reluctant to create new rights).  Plaintiffs also failed to plead facts sufficient to support their Medication Guide claim and so even if it not preempted it would not have survived.  Id. at *8.

Next plaintiffs argued that defendant failed to report adverse events to the FDA.  First and foremost:

Plaintiffs have failed to identify any state law that requires [defendant] to report adverse events to the FDA, and courts in this District have concluded no such duty exists.

Id.  So, this claim is likewise preempted by Buckman.  Even if not preempted, plaintiffs only support for the claim is that based on the number of prescriptions there appears to be a “dearth of adverse events.”  Id.  Plaintiffs do not point to any adverse event that was not reported.

Then there is the warning label itself.  Plaintiffs argued that by providing the labeling to doctors, via things like the Physician Desk Reference (“PDR”), defendant “failed to correct certain information on which physicians relied.”  Id. *9.  This is Mensing preemption.    A generic manufacturer cannot change the label; it is required to use the same label as the brand. Presumably plaintiffs were trying to argue that the PDR material was not labeling and was a means by which generic manufacturer could have skirted the duty of sameness.  If you have ever seen a PDR, it is quite simply just a collection of the labels.  So, plaintiffs’ argument falls seriously flat.  Once again, the actual pleadings are sorely deficient because not only did plaintiffs not explain how a generic manufacturer would have control over or authority to change PDR materials, they failed to make any allegation about what was misleading in the labeling.  Id.

Finally, while not addressed in the body of the opinion the court dismissed both plaintiffs’ off-label promotion and negligence per se claims as preempted as well.  Off-label promotion claims are preempted because only the government can enforce FDCA which is the sole source of the duties on which such a claim relies.  The negligence per se claim was based either on the same Medication Guide allegations or failure to provide an adequate warning.  One is preempted by Buckman and the other by Mensing.  Id. at n.6.

Many avenues were pursued but they all ended at preemption.