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The federal law's supervision of medical devices is different from that of drugs, and the supervision of brand-name drugs is also different from generic drugs. Whether a particular state law infringement claim is given priority, usually depends on whether the claim involves a medical device, brand-name drug, or generic drug. Often but not always. As shown in today’s case, there is an implicit preemption principle that also applies to medical devices, brand-name drugs, and generic drugs.

Medford v. Eon Labs, 2021 WL 5204035 (DNJ 2021), involving failure to warn and consumer protection claims against manufacturers of generic drugs, especially manufacturers of amiodarone, a generic version of amiodarone, for treatment Irregular heart rhythm.

The plaintiffs claimed that they or their deceased were injured while taking amiodarone to treat atrial fibrillation. According to the plaintiff, the use of amiodarone to treat atrial fibrillation is an off-label use of the drug, and its FDA-approved label is said to indicate that the drug is suitable for the treatment of ventricular fibrillation and ventricular tachycardia.

The plaintiff’s state law claims were based on the arguments of the generic drug manufacturer: 1. Failed to distribute the drug guidelines required by the federal government; 2. Promoted the off-label use of amiodarone; 3. Failed to warn about the risks associated with off-label use of the drug; 4 . No adverse event report was submitted to the FDA.

The court held that federal law implicitly gave priority to the plaintiff’s claim. The court relied on (albeit indirectly) 21 USC § 337(a) as the authoritative interpretation in Buckman Co. v. Plaintiffs' Legal Comm., 531 US 341 (2001). Section 337(a) declares that all actions to implement the Food, Drug, and Cosmetic Act "shall be carried out by and on behalf of the United States." Buckman said that "it is undoubtedly that the federal government, not private litigants, is authorized to bring non-compliance lawsuits to the FDCA." ID. At 349 n.4. "The Medford court in the generic drug case relied on the equipment case Buckman emphasized the fact that section 337(a), that is, no private litigation clause, also applies to all products regulated by the FDCA.

The plaintiff’s claim is implied by § 337(a) because they failed to distribute the drug guide based on the manufacturer’s claim, because the court stated that their complaint "does not identify any state law requiring generic drug manufacturers to provide a drug guide." 2021 WL 5204035, at *4. "[T]Instead," their complaint "repeatedly cited [d] FDA's drug guidelines" as the basis for the manufacturer's claimed liability for infringement. ID. Therefore, even though the plaintiffs “claimed in the traditional state tort law that they failed to warn of the claims,...the main content of these claims” is the defendant’s claim that they violated the “FDA’s Drug Guidelines.” ID. The court correctly concluded that Buckman does not allow this situation, and Buckman believes that Section 337(a) implied to take precedence over all “state legal claims that exist solely under FDCA requirements.” Ibid. (quoted from Frei v. Taro Pharms. USA, Inc., 443 F. Supp. 3d 456, 468 (SDNY 2020), also cited Buckman, 531 US at 352).

The plaintiff’s claim was also implied by Buckman as priority because they were promoting off-label use of amiodarone based on the manufacturer’s claim. The court explained that since there was no “applicable state law parallel to the FDCA’s claim that off-label promotion is prohibited,” the plaintiff’s claim of off-label promotion “is entirely dependent on federal law.” 2021 WL 5204035, at *4.

The court stated that this was also the case. With regard to the plaintiff’s claim, the manufacturer claimed that it failed to submit an adverse event report to the FDA because “'New Jersey is a jurisdiction that refuses to recognize a separate state”. Warn of FDA's legal obligations. ”'” 2021 WL 5204035, at *4.

Please note that if similar claims are made against equipment manufacturers or brand-name drug manufacturers, everything the court holds will be equally true. Nothing can change the fact that generic drugs have problems. Section 337(a) prohibits all private actions taken to enforce any provision of the FDCA, regardless of the product involved.

However, as pointed out at the beginning, preemption usually depends on the product in question. In the Medford case, the plaintiffs claimed that the manufacturer of the generic drug should be held liable because they failed to modify the label to warn of the alleged risks associated with the off-label use of amiodarone. In the case of PLAVA, Inc. v. Mensing, 564 US, it was silent. Show priority 604 (2011), because generic drug manufacturers cannot unilaterally change their warning labels, even for newly acquired information. In Wyeth v. Levine, 555 US 555 (2009), if the drug in question is a brand-name drug, the results may be different because FDA regulations allow brand-name manufacturers to unilaterally change their labels under certain circumstances. If the product in dispute is a pre-market approved medical device, the statement will not be tacitly preempted, because the device manufacturer may unilaterally modify its label in some cases. However, although the priority is not implied in the statement related to medical equipment, it can be clearly prioritized according to 21 USC § 360k(a), because-as stated in the National Meat Association v. Harris, 565 US 452 (2012) State law: When federal law prohibits state requirements that are different from or in addition to federal requirements, federal permission may not be required.

Therefore, please be aware of the differences between medical devices, brand-name drugs, and generic drugs, but also remember that 21 USC § 337(a) applies to each.

This article was written by Andrew Tauber of Winston & Strawn LLP.

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