Generic drugs account for the vast majority of prescriptions filled in the United States, and when a generic drug causes injury through an inadequate warning or a defective formulation, the plaintiff faces a preemption barrier that does not exist for brand-name manufacturers. The Supreme Court's decisions in PLIVA, Inc. v. Mensing (2011) and Mutual Pharmaceutical Co. v. Bartlett (2013) held that federal law preempts failure-to-warn and design defect claims against generic drug manufacturers because those manufacturers are legally required to use the same labeling and formulation as the brand-name drug. State tort claims that would require different labeling or a different formulation are therefore preempted under the Supremacy Clause. The Mensing-Bartlett barrier is real and has barred thousands of plaintiff claims. It is not, however, absolute.
The Preemption Framework
Under the Hatch-Waxman Act, a generic drug manufacturer must obtain FDA approval through the ANDA (Abbreviated New Drug Application) process, which requires the generic to be bioequivalent to its brand-name reference listed drug (RLD) and to use the same labeling. The sameness requirement is the hook: a generic manufacturer cannot unilaterally change its label to add a warning, and it cannot reformulate its product to eliminate a design risk, without FDA approval. Because a state tort verdict that required a different label or a different design would impose a duty the manufacturer cannot perform without violating federal law, the duty is impossible to satisfy, and the state claim is preempted.
Mensing applies to failure-to-warn claims. Bartlett extends the preemption to design defect claims, holding that where the only way to make the generic drug safe is to reformulate it, and reformulation requires FDA approval the generic manufacturer does not have, the design defect claim is also preempted. Together, these decisions eliminate the two most common pharmaceutical product liability theories for generic manufacturers.
Theories That Survive
Despite Mensing and Bartlett, several plaintiff theories remain viable against generic drug defendants.
Manufacturing defect claims are not preempted by Mensing or Bartlett. The preemption analysis addresses labeling and design, not manufacturing quality. A generic drug that was contaminated during production, that was produced out of tolerance from the approved specifications, or that suffered a packaging failure that affected potency or sterility is defective in a way that has nothing to do with the sameness requirement. Manufacturing defect claims against generic manufacturers proceed under state tort law unimpeded by the Mensing-Bartlett framework.
Fraud on the FDA claims are available in theory when the generic manufacturer misrepresented information to the FDA during the ANDA process or during post-approval safety reporting. If a manufacturer concealed adverse event data from FDA, submitted inaccurate bioequivalence data, or failed to fulfill its obligation to submit adverse event reports that would have triggered an FDA-mandated label change, a fraud-on-the-agency theory may survive preemption under the reasoning of Wyeth v. Levine's discussion of the would-have-approved argument, though this path is difficult and requires substantial evidence of the specific misrepresentation.
Claims against the brand-name manufacturer are available even when the plaintiff took the generic version of the drug. In a minority of states, courts have held that the brand-name manufacturer is liable for injuries caused by the generic because the brand-name manufacturer writes the label that the generic must copy. Under this innovator liability theory, the brand-name manufacturer's failure to update its label to reflect known safety risks creates liability for injuries caused by the generic. California, Massachusetts, Illinois, and a handful of other states have recognized some form of innovator liability, though the theory remains the minority rule and has been rejected in the majority of state and federal courts that have considered it.
Plaintiff counsel in states that have not yet ruled on innovator liability should evaluate whether to bring the brand-name manufacturer as a defendant and argue the theory. The legal question is genuinely open in many jurisdictions, and courts in several states have not yet considered whether to adopt or reject the innovator liability rule. Preserving the theory through the pleading and motion practice stages is worth the effort in a case with serious injuries where the brand-name manufacturer's failure to update its label is well-documented.
Failure-to-Update CBE Claims
Post-Mensing litigation has produced an important refinement: generic manufacturers retain a limited ability to update their labeling when FDA initiates a labeling change for the brand-name drug through the CBE (changes being effected) regulation, 21 CFR 314.70(c). If the brand-name manufacturer updated its label through the CBE process to add a safety warning, and the generic manufacturer did not correspondingly update its label in a timely way, the generic manufacturer may have violated its own federal obligation. A state tort claim premised on that delayed or absent updating is not preempted because the generic manufacturer could comply with both state law and federal law by updating its label when the brand-name label changed.
This CBE theory is limited but can be significant where the timing of label changes is central to the injury. It requires proof that the brand-name manufacturer's updated label change predated the plaintiff's injury and that the generic manufacturer failed to update its label correspondingly. Document the label history from FDA's Drugs@FDA database and compare the dates of brand-name label changes against the generic label versions in circulation at the time of the plaintiff's use.
The Brand-Name vs. Generic Dispensing Record
Before building any pharmaceutical product liability case, verify which version of the drug the plaintiff actually received. Pharmacies maintain dispensing records that identify the manufacturer and lot number of the drug dispensed. If the plaintiff received the brand-name drug, Mensing does not apply and the full range of warning and design defect theories are available. If the plaintiff received a generic from a specific manufacturer, the Mensing-Bartlett analysis applies to that manufacturer. Pharmacy dispensing records are discoverable through the plaintiff's own records, through HIPAA-compliant requests, or through subpoena to the pharmacy.
For related coverage on medical device preemption and the parallel claim strategy, see our product liability section. Pharmaceutical warning defect claims against brand-name manufacturers and Wyeth v. Levine's continuing relevance are addressed in our case law and settlements coverage.