Relating to MDLs that concern a bunch of circumstances a couple of drug or system, they usually have a reputation like “In re [name of product(s)] Product Legal responsibility 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 as a result of advisory committees solely give recommendation to FDA.) FDA has not modified the regulatory standing of those medicine and all however one of many OP defendants nonetheless promote them. The OP plaintiffs contend that they might haven’t purchased the OTC medicine with phenylephrine or would have paid much less for them if that they had been labeled with a disclosure that phenylephrine didn’t work. We have now heard many plaintiffs argue that an FDA-regulated medical product ought to have been labeled to say one thing like “this doesn’t work” for its authorised indication or “don’t use this” for its authorised indication, however we’ve by no means seen any merchandise with such labeling out in the true world. One motive is that such labeling could be tantamount to a rejection of FDA’s resolution to permit the product for use legally for a selected function. That might run into a variety of preemption theories, however OTC medicine have specific preemption of state regulation necessities which are “totally different from or as well as, to, or that’s in any other case not similar with” the federal necessities below the FDCA. Id. at *3 (quoting 21 U.S.C. § 379r). That specific preemption provision has an enormous exception for product legal responsibility claims, however, like we mentioned above, this litigation with none threat or bodily accidents had no product legal responsibility claims, at the least within the take a look at class grievance.
Plaintiffs’ New York state regulation claims, no matter how titled, associated to the content material of the labeling for the OTC medicine, which complied with the monograph governing labeling for OTC decongestants as a substitute of claiming what plaintiffs needed them to say. The monograph permitted the indication for these medicine to choose from a variety of specified language associated to efficacy for momentary aid of congestion. Id. at *4. The overall regulation on indications for monograph medicine required using language from the monograph or “various truthful and nonmisleading statements describing solely these indications to be used which were established in an relevant monograph.” 21 C.F.R. § 330.1(c)(1). “Nothing within the PE monograph or the final monograph suggests producers have a freestanding responsibility to replace their indications in response to new scientific info.” 2024 WL 4606818, *4. You actually can not honestly describe the authorised indications by having labeling that claims the “actual reverse” of the monograph language—i.e., that the drug will not be efficient for the indication. Id. Imposing an obligation to contradict the monograph would clearly be expressly preempted, because the Second Circuit beforehand held in a cosmetics case mentioned right here. Plaintiffs tried to muddy the water by referring to FDA necessities about updating a label by way of CBE or ceasing sale of a misbranded drug that’s “harmful to well being when used within the dosage or method, or with the frequency or length prescribed, beneficial, or advised within the labeling thereof.” 21 U.S.C. § 352(j). These provisions set off no duties primarily based on doubts concerning the drug’s efficacy for an authorised indication, although.
Calling the labeling claims “false promoting,” “false concealment,” and “specific guarantee” didn’t change that they activate having labeling according to the monograph language on the authorised indication. “As a result of every responsibility would have required defendants to replace the labels of their [phenylephrine] merchandise or cease promoting the merchandise altogether, the claims are preempted.” 2024 WL 4606818, *7. The rejection of a cease promoting argument primarily based on specific preemption is noteworthy, provided that Bartlett arose within the battle preemption content material.
By way of the preemption of state regulation claims, there isn’t a explicit motive why the ruling on New York regulation wouldn’t apply to different states’ legal guidelines. Plaintiffs’ specific guarantee declare was rejected partially as a result of New York treats financial specific guarantee claims as contract claims. Id. Some states might deal with specific guarantee claims that contain private damage as product legal responsibility claims, which might be topic to the financial savings clause within the specific preemption provision for OTC medicine. Nonetheless, these plaintiffs seem to not have any accidents to shoehorn their claims right into a product legal responsibility bucket. Even when they escaped specific preemption, product legal responsibility claims as instantly opposite to an authorised monograph as these would seemingly be impliedly preempted.
The final a part of OP was to deal with standing for the civil RICO claims. Plaintiffs have been all oblique purchasers of the medicine, so, following the rule long-established in antitrust circumstances, that they had no standing. Findings that oblique purchasers lack standing to convey civil RICO claims is outwardly the bulk place. Id. at *8 n.6. Thus, we want not dwell on it, besides to say that the standing argument ought to apply to different circumstances in opposition to producers within the OP MDL. If state regulation claims are preempted and there’s no standing to say a federal declare that might not be topic to preemption, then there shouldn’t be a lot if something left within the OP MDL. Not that we anticipate the plaintiff attorneys to surrender in pursuing this MDL that entails no threat and no bodily damage. Have we already talked about that?
