This article originally appeared in the August 2012 Drug, Device and Biotechnology Committee Newsletter.
Since the United States Supreme Court's holding in PLIVA v. Mensing (1) that federal regulations governing generic pharmaceuticals pre-empt state law failure-to-warn tort claims, the law governing pre-emption in regard to generic pharmaceuticals has been in flux within United States courts. This article addresses Mensing itself, lower court decisions interpreting Mensing, and recent legislation proposed as a response to Mensing, which would change the framework of the U.S. Food and Drug Administration's (FDA) regulation of generic pharmaceutical manufacturers.
Mensing was the consolidation of two cases in which plaintiffs alleged state law failure to warn claims against generic pharmaceutical manufacturers. (2) Each plaintiff claimed that her longterm use of metoclopramide "caused her tardive dyskinesia and that the [generic manufacturers of the metoclopramide] were liable under state law (specifically that of Minnesota and Louisiana) for failing to provide adequate warning labels." (3) They argued that the generic drug manufacturers should have and failed to change their labels in light of "mounting evidence" showing that tardive dyskinesia was a larger risk than was stated on the metoclopramide label. (4) The generic manufacturer defendants argued that plaintiffs' state law tort claims were pre-empted by federal statutes and FDA regulations that "required them to use the same safety and efficacy labeling as their brand-name counterparts and that it was impossible to simultaneously comply with both federal law and any state tortlaw duty that required them to use a different label." (5)
In an opinion delivered by Justice Thomas, the Supreme Court held that "federal drug regulations applicable to generic pharmaceutical manufacturers directly conflict with, and thus preempt," state law failure to warn claims. (6) Pre-emption occurs where "it is 'impossible for a private party to comply with both state and federal requirements.'" (7) As discussed below, there remains uncertainty as to the breadth of the holding in Mensing, namely whether it is limited to failure to warn claims or if it causes state law design defect product liability claims to be pre-empted as well.
The pre-emption question in Mensing was framed as applying to generic pharmaceutical manufacturers only, because regulations governing labeling for brand-name and generic manufacturers differ. (8) "A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label." (9) "A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's." (10) Thus, federal regulations prevent generic pharmaceutical manufacturers "from independently changing their generic drugs' safety labels." (11)
The conflict in Mensing arose because, despite the federal regulations, the state tort law at issue (which has corollaries throughout the country) "place[d] a duty directly on all drug manufactures to adequately and safely label their products." (12) As a result, it was impossible for the generic pharmaceutical manufacturer defendant to comply with both federal and state law:
If the [generic pharmaceutical
m]anufacturers had independently
changed their labels to satisfy their
state law duty, they would have
violated federal law.... [S]tate law
imposed on the [generic
pharmaceutical m]anufacturers a
duty to attach a safer label to their
generic [pharmaceutical at issue].
Federal law, however, demanded
that generic drug labels be the same
at all times as the corresponding
brand-name drug labels. See, e.g.,
21 C.F.R. [section] 314.510(b)(10). Thus,
it was impossible for the generic
pharmaceutical manufacturers to
comply with both their state-law
duty to change the label and their
federal law duty to keep the label
the same. …