When it comes to MDLs that concern a bunch of cases about a drug or device, they typically have a name like “In re [name of product(s)] Product Liability Litigation” or “In re [name of product(s) Marketing and Sales Practices Litigation.”  In theory, the first group of MDLs involves, shockingly, product liability claims because the plaintiffs allege a physical injury, and the second group of MDLs involves non-product liability claims because the plaintiffs allege only economic injuries.  In reality, the lines are not so clean.  Many non-product liability claims, such as consumer protection and express warranty, are thrown into complaints by plaintiffs claiming injury.  In addition, some plaintiffs assert product liability claims without present injury, including in the context of medical monitoring and fear of future injury theories.  However, in almost every jurisdiction, you need some past or present physical injury to support a product liability claim.  Less universal, but no less logical, is the requirement that warnings claims be based on an inadequate disclosure of the risk of harm that the plaintiff claims to have suffered.

A number of recent litigations have been predicated on purported issues with drugs that do not always translate to an actual physical injury to the plaintiff.  Litigation based on alleged contamination–ranitidine comes to mind–where most plaintiffs allege that they would not have used the drug and been exposed to a hypothetical health risk (that did not manifest in an injury in them) if the defendants had done something different along the way.  There is a less common variant that we see in In re Oral Phenylephrine Marketing and Sales Practice Litigation, MDL No. 3089, — F. Supp. 3d –, 2024 WL 4606818 (E.D.N.Y. Oct. 29, 2024) (“OP”).  That MDL is predicated on the idea that phenylephrine is not effective as a decongestant when included in a bunch of OTC medications made by a bunch of companies.  There is, as far as we can tell, no allegation of a risk of injury from the use of the medications, realized in particular plaintiffs or otherwise.  In OP, the court considered the non-product liability claims asserted in a class complaint under New York law and federal civil RICO as a “test case.”  Without any physical injuries or risks, not asserting product liability claims makes sense.  It also meant that the state law claims were expressly preempted.

Phenylephrine has been approved as a safe and effective OTC decongestant since 1985, and has had a monograph specifying its labeling since 1994.  In 2023, an FDA advisory committee “found that scientific data did not support the use of [phenylephrine] as a decongestant.”  Id. at *1.  (We quote this language because advisory committees only give advice to FDA.)  FDA has not changed the regulatory status of these drugs and all but one of the OP defendants still sell them.  The OP plaintiffs contend that they would have not bought the OTC drugs with phenylephrine or would have paid less for them if they had been labeled with a disclosure that phenylephrine did not work.  We have heard many plaintiffs argue that an FDA-regulated medical product should have been labeled to say something like “this does not work” for its approved indication or “do not use this” for its approved indication, but we have never seen any products with such labeling out in the real world.  One reason is that such labeling would be tantamount to a rejection of FDA’s decision to allow the product to be used legally for a particular purpose.  That could run into a number of preemption theories, but OTC drugs have express preemption of state law requirements that are “different from or in addition, to, or that is otherwise not identical with” the federal requirements under the FDCA.  Id. at *3 (quoting 21 U.S.C. § 379r).  That express preemption provision has a giant exception for product liability claims, but, like we said above, this litigation without any risk or physical injuries had no product liability claims, at least in the test class complaint.  

Plaintiffs’ New York state law claims, regardless of how titled, related to the content of the labeling for the OTC drugs, which complied with the monograph governing labeling for OTC decongestants instead of saying what plaintiffs wanted them to say.  The monograph permitted the indication for these drugs to pick from a range of specified language related to efficacy for temporary relief of congestion.  Id. at *4.  The general regulation on indications for monograph drugs required the use of language from the monograph or “alternative truthful and nonmisleading statements describing only those indications for use that have been established in an applicable monograph.”  21 C.F.R. § 330.1(c)(1).  “Nothing in the PE monograph or the general monograph suggests manufacturers have a freestanding duty to update their indications in response to new scientific information.”  2024 WL 4606818, *4.  You certainly cannot truthfully describe the approved indications by having labeling that says the “exact opposite” of the monograph language—i.e., that the drug is not effective for the indication.  Id.  Imposing a duty to contradict the monograph would clearly be expressly preempted, as the Second Circuit previously held in a cosmetics case discussed here. Plaintiffs tried to muddy the water by referring to FDA requirements about updating a label via CBE or ceasing sale of a misbranded drug that is “dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.”  21 U.S.C. § 352(j).  These provisions trigger no duties based on doubts about the drug’s efficacy for an approved indication, though.

Calling the labeling claims “false advertising,” “false concealment,” and “express warranty” did not change that they turn on having labeling consistent with the monograph language on the approved indication.  “Because each duty would have required defendants to update the labels of their [phenylephrine] products or stop selling the products altogether, the claims are preempted.”  2024 WL 4606818, *7.  The rejection of a stop selling argument based on express preemption is noteworthy, given that Bartlett arose in the conflict preemption content.

In terms of the preemption of state law claims, there is no particular reason why the ruling on New York law would not apply to other states’ laws.  Plaintiffs’ express warranty claim was rejected in part because New York treats economic express warranty claims as contract claims.  Id.  Some states may treat express warranty claims that involve personal injury as product liability claims, which would be subject to the savings clause in the express preemption provision for OTC drugs.  However, these plaintiffs appear not to have any injuries to shoehorn their claims into a product liability bucket.  Even if they escaped express preemption, product liability claims as directly contrary to an approved monograph as these would likely be impliedly preempted.

The last part of OP was to address standing for the civil RICO claims.  Plaintiffs were all indirect purchasers of the drugs, so, following the rule long-established in antitrust cases, they had no standing.  Findings that indirect purchasers lack standing to bring civil RICO claims is apparently the majority position.  Id. at *8 n.6.  Thus, we need not dwell on it, except to say that the standing argument should apply to other cases against manufacturers in the OP MDL.  If state law claims are preempted and there is no standing to assert a federal claim that would not be subject to preemption, then there should not be much if anything left in the OP MDL.  Not that we expect the plaintiff lawyers to give up in pursuing this MDL that involves no risk and no physical injury.  Have we already mentioned that?