United States: Redistribute This!

As a distributor of [branded] Fosamax, [defendant] has no power to change [the] labeling. That power lies with the applicant who filed the New Drug Application (NDA). . . . Additionally, if FDA had become aware of new safety information in connection with [the drug] that "it believe[d] should be included in the labeling," FDA must notify the holder of the NDA to initiate the changes. Neither of these procedures involves a distributor.

As a result of the scheme set forth by the FDCA, [the branded distributor] has no authority to initiate a labeling change of Fosamax. That authority lies with the FDA and/or with [the NDA holder]. Even taking the allegation . . . as true, a contractual relationship between [the defendant and the NDA holder] cannot change the fact that [defendant] is not the NDA holder. Consequently, [defendant] has no power to unilaterally change [drug] labeling. Because [defendant] could not "independently do under federal law what state law requires of it," the state law claims brought against it are preempted.

Although Mensing addressed the liability of generic drug manufacturers, [distributor] contends that the same rationale may be extended to state law claims asserted against drug distributors who, like generic manufacturers, are not at liberty to change, modify, or extend the labeling. The court agrees.

[This] is an FDA approved product. Federal law requires FDA approval of a New Drug Application ("NDA") prior to marketing the drug in the United States. The company that owns and controls the NDA is referred to as the "applicant." Following FDA approval of the new drug "only the applicant" may propose a change or supplement to the NDA. [Co-defendant] was the NDA applicant. . . . Accordingly, [the distributor] has no authority to unilaterally change or add to the [drug's] labeling.

Because federal law will not permit [the distributor] to do what state law purports to require of it, plaintiff's incompatible state law claims are preempted. . . .

When a company does not have the NDA, it has no more power to change the label of a drug than a generic manufacturer. A distributor, even of a brand name drug, has no power to change labeling. That power lies with the applicant who filed the New Drug Application (NDA). Because [the distributor] could not independently do under federal law what state law requires of it, the state law claims brought against it are preempted.

[P]laintiff's claims against [the distributor] are preempted because [it] is not the holder of the approved application for [the drug] in the United States. A distributor, even of a brand name drug, has no power to change labeling. That power lies with the applicant who filed the New Drug Application (NDA). In Mensing, the Supreme Court held that claims against a manufacturer of generic drugs were preempted because such a manufacturer has no authority under federal regulations to modify labeling. The same reasoning compels the Court to find preemption here. Federal regulations do not permit [defendant], as a distributor, to change labeling. Any claim that state law compelled it to do so is therefore preempted.

Multiple courts have done the same. As [defendant] is alleged to be a distributor rather than a manufacturer of [the drugs], I cannot draw a reasonable inference that [it] had the ability to modify the warning labels of those drugs. Plaintiffs' claims against [defendant] are preempted to the extent they seek to hold it liable for failing to warn plaintiffs of the risks or defects of [the drugs].

The Court notes that both Mensing and Bartlett involved generic manufacturers and not generic distributors. Thus, as an initial matter, the Court must consider whether Mensing and Bartlett are applicable to [defendant] − the distributor of a generic drug. . . . [T]he rationale for excusing generic manufacturers from liability is that generic manufacturers do not have the ability to unilaterally effectuate a label change. Only brand manufacturers have the ability to take unilateral action to strengthen a drug's warning label. This rationale is equally applicable to generic distributors. Under applicable federal regulations, generic distributors have no more authority than generic manufacturers to alter a drug's composition, label, or design. Accordingly, the principles announced in Mensing and Bartlett are equally applicable to generic distributors.

Outside of the context of fraudulent joinder and removal/remand, courts have extended Mensing to entities that merely distribute prescription drugs, be they generic prescription or brand-name prescription drugs. These cases recognize that mere distributors lack the ability to make any changes to an FDA approved label, rather only the holder of a New Drug Application (NDA) or the FDA itself can make any change to an FDA approved prescription drug label. In this respect, a mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label. . . . [B]ecause the Court is unaware of a federally lawful way for a mere prescription drug distributor to include its own warnings or otherwise alter an FDA approved label, the Court agrees with those courts that hold Mensing applies to distributors of prescription drugs, be they brand-name or generic.

[P]laintiff . . . alleged . . . that she ingested a product manufactured by [the contract manufacturer] for [the generic manufacturer] beginning in 2003, after [the contract manufacturer] had divested its NDAs. Therefore, her claims against [the contract manufacturer] are preempted, failing for the same reasons that the Plaintiffs' other claims against the Generic Manufacturers do. After the divestiture, [the contract manufacturer] had no more power to change the label than did [the generic manufacturer]. Because [the contract manufacturer] was no different than the other Generic Manufacturers at the point . . . plaintiff allegedly may have taken their product, the district court did not err in dismissing their claim.

Even if it were possible to state a claim under state law against [a pharmacy] for labeling of a drug, any such claim would preempted by federal law. The U.S. Supreme Court has held that a generic drug manufacturer cannot change its label without FDA approval and, thus, any state law claims alleging that the manufacturer should have changed its label are preempted by federal law. As a result of the scheme set forth by the Federal Drug and Cosmetic Act (FDCA), a pharmacy also has no authority to unilaterally change a drug's label. . . . Thus, any claims against [the pharmacy defendant] based on [the drug's] label are preempted under Mensing.