A recent court case in Massachusetts raised the question of whether drug manufacturers should be held liable for harm that results from a generic counterpart not produced by their company. The concept of “innovator liability” was explored in a recent viewpoint article published in JAMA.
In the case in question, (Rafferty v Merck & Co Inc, 2018) a patient who took finasteride, the generic version of Merck’s Proscar®, asserted that the brand-name drug carried warnings outside of the United States that were not included in either the brand version marketed in the United States or in the generic version; therefore, Merck should be liable for failing to pass the warnings on to the generic label.
By law, generic drug manufacturers are required to maintain a label that is identical to the brand label of the drug. The manufacturers must also ensure that their labeling is up to date and accurate, and must monitor US Food and Drug Administration (FDA) information to update the label as necessary.
In a 2011 case (PLIVA Inc v Mensing), the US Supreme Court held that a consumer of a generic bioequivalent may not bring a claim against a generic drug manufacturer because the FDA controls labeling and the generic manufacturer has no authority to modify the labels of its drugs. Later, in 2013, the Supreme Court held that state law claims against a generic manufacturer are also preempted by FDA regulations (Mutual Pharmaceutical Co v Bartlett). Both of these cases left patients harmed by the generics in question with no legal recourse based on the failure of the labeling to report the adverse effects. This trend has been repeated in a number of cases in various states that have all ruled in favor of the brand drug manufacturers involved.
However, a limited number of cases in Massachusetts and California have seen the ruling in favor of the plaintiff. In these states, drug innovation is a vital part of the state economy, and states may be concerned about public policy. In the case of the recent claim in Massachusetts (Rafferty), it fell to the state to determine the liability of the innovator. Although the FDA proposed a rule in 2013 that would have allowed generic manufactures to update their product labels in light of new safety developments, the rule was never published. Despite this, generic and brand manufacturers are protected from legal liability from failure-to-warn claims in most jurisdictions, creating a situation in which the patient harmed by a generic drug may have no legal recourse.
Boumil MM, Curfman G. Legal liability of generic vs brand drug manufacturers for inadequate product labels. JAMA. 2018;320:547-548.