Ryan Dowell, MJLST Staffer
Most people have had to take prescription medication at some point. Acquiring these medications is an experience often characterized by another stuffy waiting room and forking over a fair amount of money (enough that 8% of adults forgo or delay filling prescriptions). Finally the pharmacist hands over the goods and it’s time to get out ASAP. Who takes the time to stop and look if it’s name-brand or generic?
Generics, which are required by the FDA to have the same active ingredient and performance as the brand-name drug, account for almost 80% of prescriptions filled in the US. For most customers, the only impact of generic medications is a smaller dent in the wallet (to the tune of $1.68 trillion from 2005-2014). Anecdotally, the tug-of-war between name and generic medications has driven down my out-of-pocket expenses … somewhat surprisingly for the name-brand drug, which is currently cheaper than its new-to-market generic competitor.
Last year, in Generic Pharmaceuticals and the “Unfortunate Hand” Dealt to Harmed Consumers: The Emerging State Court Resistance, Arlen W. Langvardt discussed the impact of a trilogy of SCOTUS rulings that preempt tort claims by people harmed by generic drugs First, Wyeth v. Levine determined that Congress has not given express preemption to FDA approval of prescription drugs and FDA may regard common-law tort actions as a piece of drug regulation. In other words, FDA approval does not preempt tort actions by harmed customers against drug manufacturers.
After Wyeth, SCOTUS found that such tort claims were preempted in PLIVA, Inc. v. Mesning. This difference hinged on the fact that the subject drug was generic. Generics must essentially mirror the brand-name drug, limited for the most part to the characteristics previously approved by the FDA. Conflicting state & federal requirements resulted in preemption via impossibility; that is the FDA requirements prevented compliance with state requirements. The phrase “unfortunate hand” was coined here to refer to customers’ inability to seek redress when the harm came from generics, yet those who received brand-name medications were not barred by preemption. Mutual Pharmaceutical Co. v. Bartlett followed Mensing, again preempting tort claims stemming from generics; this time preempting both failure-to-warn (as in Mensing) and design-defect claims due to impossibility. The sum of these cases is that generic manufacturers are functionally unable to alter the product under FDA regulation, thus cannot adapt it to meet other standards, which result in impossibility preemption.
Langvardt’s article discusses this as part of the “war over whether tort claims against drug makers should be permitted at all.” With most prescriptions filled with generics, consumers have little viable recourse through tort claims. Langvardt examines potential means of opening claims for those who suffer such harms from generic drugs; including [unlikely] Congressional action, changes in FDA regulations, and certain actions in state courts.
The issue of generic drug tort liability will likely see new developments with the rise of biologics, where the ‘tied-hands’ reasoning may be less persuasive. Since biologics are complex and often not 1:1 replicable, generic biologics take the form of FDA-approved biosimilars and “interchangeable biological products”.Biosimilars are “highly similar to an already FDA-approved biological product … and have been shown to have no clinically meaningful differences.” “Interchangeable biological products” are biosimilars that are additionally expected to produce the same clinical result. Approval for these products is similar to that for generics, relying heavily on the reference product.
Many harms from prescription drugs are not realized until many years down the road. Here the products are merely similar, not identical–what may seem benign could have a later impact. Generic manufacturers might not be as insulated by an impossibility defense. Perhaps more clearly, the FDA has stated that biosimilars are not generics. For these medications, this might be a key opportunity to distinguish from the trilogy described by Langvardt and allow consumers to recover when harmed.