Assume a doctor prescribes two people the same medication. The two people go to different pharmacists. The first pharmacist fills the prescription with the brand-name medication. The second pharmacist fills the prescription with a generic version of the medication. The chemical compositions of the medications are identical. The warning labels on both medications are identical. For all intents and purposes, the medications are identical.
Both patients use the medication as directed. Both patients develop severe adverse reactions. Neither manufacturer disclosed these side effects in their medications’ warning labels. The patients learn that both manufacturers knew about the risk of these side effects, but failed to disclose them to the FDA and failed to update their products’ warning labels. Can both patients bring a claim against the manufacturer of their respective medications? Common sense would tell you yes, but common sense would be wrong, at least under current federal law.
Under the current law, the patient who took the brand-name drug has a right to sue the manufacturer of that drug for failing to warn the patient of the undisclosed side effect. In contrast, the patient whose pharmacist tried to save him or her a few dollars by supplementing the generic version of the drug for the brand name is barred from suing the generic-drug manufacturer.
This bewildering outcome is the result of three recent United States Supreme Court decisions interpreting Food and Drug Administration (FDA) regulations. In Wyeth v. Levine, 555 U.S. 555 (2009), the Court allowed a failure to warn claim against the brand-name manufacturer because the court found that FDA regulations permitted the manufacturers of brand-name medications to update their warning labels in response to new safety concerns. In contrast, the Supreme Court held in Pliva Inc. v. Mensing, 131 S. Ct. 2567 (2011), that the manufacturers of generic drugs were not permitted to unilaterally alter their warning labels because under FDA regulations the generic-drug manufacturers’ product labels must be identical to the brand-name manufacturers’ labels. Under Mensing, if the generic drug’s label was consistent with the brand-name drug’s label, federal law preempted a patient’s failure to warn claim. The 2013 decision in Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466, reaffirmed Mensing’s holding. The pivot point in these decisions was the court’s interpretation of what flexibility FDA regulations gave to generic-drug manufacturers to alter their labels in response to safety concerns.
In response to the Supreme Court’s decisions, the FDA is considering the adoption of a new regulation to allow generic-drug manufacturers to alter their warning labels without prior FDA approval to reflect ongoing safety information they receive about the risks their drugs pose to patients. This proposed regulation will restore the duty on generic drug manufacturers to communicate the adverse effects of their products so the patient and their physician can properly consider the benefits and risks of a given medication.
By some estimates, generic drugs constitute 80% of all prescriptions filled in the United States. The vast majority of persons taking a medication are taking generic versions of the medication because the medications are bioequivalent and generic drugs are vastly cheaper than brand-name drugs. Yet, current federal law bars 4/5’s of the population from bringing a failure to warn claim against a generic-drug manufacturer if the generic-drug manufacturer fails to adequately communicate the risks of using a medication. The proposed FDA regulation will remedy this imbalance by restoring parity between brand-name and generic-drug manufacturers’ duty to warn patients about the adverse side effects and other risks of their medications.
The FDA’s comment period for this new regulation is now closed. The FDA is reviewing whether to adopt the proposed regulation and a decision is expected within the next few months. More information about the proposed FDA regulation.