Defining the Boundaries for Pre-emption of Drug Labeling Claims

Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the information contained in – or missing from – the labels should be preempted if it would be impossible for a manufacturer to comply with both state law and FDA requirements. Several lower court decisions in Massachusetts state and federal courts over the past year, as well as the United States Supreme Court’s recent decision in Merck Sharp & Dohme Corp. v. Albrecht, provide useful guidance for manufacturers regarding the boundaries of pre-emption in the context of a labeling claim.

The effect of information obtained after a label is approved

When new evidence comes to light that a drug on the market may be associated with a risk of harm, a drug manufacturer may add or strengthen existing warning labels without first obtaining FDA approval, in accordance with so-called “Changes Being Effected” or “CBE” regulations. The federal CBE regulation allows drug manufacturers to take immediate action to address the harm by amending the label before seeking formal approval from the FDA for the change at a later date. Plaintiffs have cited to the CBE regulations to argue that state law labeling claims should not be preempted because the manufacturer could (and should) have made such changes. These arguments, however, may not always overcome a preemption defense, as two 2019 decisions illustrate .

In Goodell v. Bayer Healthcare Pharmaceuticals Inc., the United States District Court for the District of Massachusetts underscored the requirement that in order to avoid preemption, a plaintiff must provide factual allegations detailing why the CBE regulation applies. In Goodell, the plaintiff sought to avoid preemption of its claim that the manufacturer of an MRI contrast agent failed to properly warn him of the product’s health risks. The plaintiff argued that the defendant manufacturer could have changed its label without FDA pre-approval pursuant to the CBE regulation, but failed to allege any newly acquired information that should have prompted the manufacturer to make the labeling change during the relevant time period. The court explained that absent such details, the plaintiff’s claim would be preempted.

In Merck Sharp & Dohme Corp. v. Albrecht, the United States Supreme Court clarified an exception to the general rule that the CBE regulation will prevent a pre-emption defense. The Supreme Court noted that although a manufacturer could make changes to a label without FDA pre-approval under the CBE regulation, the changes ultimately must be reviewed by the FDA, which retains the authority to reject the changes. As a result, a manufacturer could successfully assert a pre-emption defense if it provided “clear evidence” that the FDA ultimately would not have approved the change in question. The Supreme Court held that there was “clear evidence” that the FDA would not have approved of a warning label change where a manufacturer showed that it “fully informed the FDA of the justifications for the warning required by state law,” and that the FDA responded to that information by alerting the manufacturer that it “would not approve changing the drug’s label to include that wording.” Therefore, where a manufacturer can provide “clear evidence” that the FDA would not have approved the changes, a claim that such changes should have been implemented will be preempted.

Claims focused on marketing practices

Nevertheless, manufacturers must be aware that a preemption defense will only extend so far. A pair of Massachusetts Superior Court decisions issued in November 2019 and January 2020, Com. v. Purdue Pharma and City of Boston v. Purdue Pharma, serve as a reminder that while pre-emption may bar state law claims focused on the content of drug warning labels, it does not necessarily bar claims focused on marketing activity that is inconsistent with or unrelated to label information.

In these two cases, the Commonwealth of Massachusetts and municipalities brought suit against opioid manufacturers seeking remedy for the public harms caused by opioid addiction, on the theory that Purdue made unfair and deceptive representations when marketing these drugs. In both cases, the defendant manufacturer unsuccessfully asserted a pre-emption defense. Rejecting this defense, the court noted that neither complaint actually challenged the contents of the drug labels. Instead, the complaints targeted marketing activities that were either allegedly inconsistent with labeling, such as producing publications that minimized risks listed on the labels; or involved assertions that were not actually FDA-approved, such as the claim that other analgesics are more toxic than opioids.

Because the manufacturer could comply with both FDA labeling requirements and state law related to marketing under such circumstances, the court held that pre-emption was not a valid defense. However, the court emphasized the fact that none of the marketing in dispute in these cases actually involved FDA-approved statements. It is therefore not clear whether a manufacturer could successfully raise a pre-emption defense in circumstances where claims focused on marketing rather than label contents, but the challenged marketing activities were consistent with FDA-approved labeling.

Ultimately, these recent cases illustrate the reality that a drug manufacturer’s conduct, including its response to new information regarding risks, and its sales tactics, will have bearing on the availability of the pre-emption defense.


Posts by Johanna


Posts by Julie

Leave A Comment