United States: Redistribute This!

Last Updated: November 5 2019
Article by James Beck

Back in 2012, we published our " Distribute This!" post about In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012), lauding its ruling that, under the "independence principle" of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), implied preemption protects distributors of prescription drugs – all prescription drugs, not just generics – because they can't change drug labeling since only the drug's NDA ("new drug application") holder can do that:

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.

Fosamax, 2012 WL 181411, at *3-4 (quoting Mensing independence principle language; other citations and quotation marks omitted).

It's been a while and there have been more good decisions (see our generic scorecard and branded preemption cheat sheet), so we thought we'd compile them. The triggering event is Smith v. GE Healthcare, Inc., 2019 WL 4565246 (Mag. W.D. La. Sept. 4, 2019), which followed Fosamax and dismissed warning-related claims against a branded drug (we checked; gadolinium contrast agents are drugs, according to the FDA) distributor under the independence principle:

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. . . .

2019 WL 4565246, at *8 (citations and footnote omitted). This magistrate's recommendation was adopted, but in the interim the plaintiff filed a new complaint dropping all claims against the distributor, so that aspect was held to be moot. Smith v. GE Healthcare, Inc., 2019 WL 4551622 (W.D. La. Sept. 19, 2019).

Besides Fosamax, Smith cited four other cases, Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1365 (N.D. Ga. 2016); Amos v. Biogen Idec Inc., 249 F. Supp.3d 690, 700 (W.D.N.Y. 2017); Stevens v. Community Health Care, Inc., 2011 WL 6379298, at *1 (Mass. Super. Oct. 5, 2011); and Pierik v. GE Healthcare, Inc., No. 18-07733, 2019 WL 4686551, at *1-2 (N.D. Ill. June 18, 2019). Of these, three (all but Stevens) likewise applied the independence principle to hold claims against distributors of branded drugs 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.

Brazil, 196 F. Supp.3d at 1364-65 (citations and quotation marks omitted).

[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.

Amos, 249 F. Supp.3d at 700-01 (citations and quotation marks omitted).

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].

Pierik, 2019 WL 4686551, at *1-2 (citations omitted).

Those aren't the only branded distributor cases finding preemption under the independence principle. See also Nelson v. Biogen Idec, Inc., 2018 WL 1960441, at *14 (D.N.J. April 26, 2018) ("Because [the distributor] was not the United States license holder, it could not effect change to the label. . . . Thus, summary judgment is also appropriate for [it] on this ground."); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7644792, at *2 (D.S.C. Nov. 28, 2016) ("the claims against [the distributor] based on [the drug's] label are clearly preempted by federal law. As a result of the scheme set forth by the FDCA, [a distributor] has no authority to unilaterally change [a drug's] label. That authority lies with the FDA and/or with [the manufacturer]") (citations omitted); In re Lipitor (Atorvastatin Calcium) Marketing Sales Practices & Products Liability Litigation, 2016 WL 7335738, at *2 (D.S.C. Nov. 7, 2016) (same); Cleary v. Biogen, Inc., 2017 WL 4126240, at *7 (Mass. Super. Sept. 13, 2017) ("Federal law, however, only allows the holder of the original, approved application for a drug to modify, or seek approval to modify, its label. . . . [T]he distributor[] did not have the ability to modify the warnings present on the label, or to add new warnings. The failure to warn claims against [it] are preempted by federal law.") (citations omitted)

Several cases have also recognized preemption of claims involving distributors of generic drugs. Plaintiffs unsuccessfully attempted to distinguish between manufacturers and distributors in In re Yasmin & Yaz Drospirenone Marketing, Sales Practices & Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. April 24, 2014):

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.

Id. at (citation omitted).

Earlier this year, in Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152 (E.D. Cal. Feb. 14, 2019) ( discussed here), the same purported distinction was rejected:

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.

Id. at 1170 (citations omitted). See In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 2457825, at *1 (E.D. Ky. June 22, 2012) (granting summary judgment on preemption for generic distributors), aff'd, 756 F.3d 917 (6th Cir. 2014); Gentile v. Biogen Idec, Inc., 2016 WL 4128159, at *9 (Mass. Super. July 25, 2016) ("[The manufacturer] is the holder of the original, approved application for [the drug]. Consequently, [the distributor] could not have sought modifications of the label. Plaintiff's failure to warn claim against [the distributor] is therefore preempted.") (citation omitted).

Preemption has likewise been found in a couple of analogous situations. In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 940 (6th Cir. 2014) (which we discussed here), preemption barring claims against the contract manufacturer of a generic drug (that happened to be the former branded manufacturer) was affirmed.

[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.

Id. at 940.

Similarly, claims against a pharmacy were held preempted in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016):

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.

Id. at *2 (citations omitted).

Preemption and drug distributors is one of those situations where the logic supporting dismissal is ineluctable. No NDA = no independent ability to change label = preemption. Most of the contrary precedent is from fraudulent joinder cases where the standard a defendant has to meet is significantly tougher, and even there the tide seems to be turning on the Mensing independence principle rationale.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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