Generic vs. 505(b)(2) Failure-to-Warn Liability
- Posted by: Ken Phelps
- Published on: April 2, 2012
A recent editorial (may need subscription) in the New York Times opined that a recent Supreme Court decision – a “bizarre outcome” – “makes it virtually impossible to sue generic manufacturers for failing to provide adequate warning of a prescription drug’s dangers.” The court case the Times is referring to is Pliva Inc. v. Mensing . In this case, the Court overturned previous lower-court rulings that were even more bizarre – see my previous posting https://camargopharma.com/2010/02/11/can-and-should-anda-labeling-differ-from-the-rld/. The Court ruled, in effect, that generic companies cannot be sued under state liability laws for inadequate labels (failure-to-warn) since federal law provides no mechanism for the labels to be different than the brand labels. Previously, the Court had ruled that Wyeth was responsible for adequate warning on its labels because federal law allowed such changes by the innovator.
What the Times was labeling as bizarre is the fact that an injury to a patient who takes the generic or takes the brand can have two different outcomes in court. As noted in the majority opinion, “[w]e recognize that from the perspective of Mensing and Demahy, finding pre-emption here but not in Wyeth makes little sense. Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits. We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated.
…. It is beyond dispute that the federal statutes and regulations that apply to brandname drug manufacturers are meaningfully different than those that apply to generic drug manufacturers. Indeed, it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public. But different federal statutes and regulations may, as here, lead to different pre-emption results.” (internal citations omitted)
What does this mean for a producer of 505(b)(2) drug products? Since a 505(b)(2) is an NDA, the manufacturer has the obligation to update their label to reflect safety concerns for their drug product. This means that a survelliance system needs to be in place to capture adverse events and to monitor the labeling of the reference product(s).