At Least, This November 2012 Article In The New England Journal Of Medicine Makes The Point That Something Needs To Be Done Soon, Rather Than Later
The June 2011 ruling by our United States Supreme Court in Pliva v. Mensing essentially held that patients who suffered serious side effects could not file drug injury lawsuits to hold generic drug manufacturers liable in state court for failing to update their drug labels to integrate new safety warning information. Fundamentally, the Court's rationale for this ruling was that any such legal "duty" was preempted by statutory requirements that generic drug manufacturers must keep their drug labels identical to those of the brand-name drug manufacturers.
In a relatively recent article "Risk, Responsibility, and Generic Drugs", by Aaron S. Kesselheim, M.D., J.D., M.P.H., Jerry Avorn, M.D., and Jeremy A. Greene, M.D., Ph.D., and published in the November 1, 2012 edition of The New England Journal of Medicine (NEJM), the authors reach this conclusion as to the practical effect of the Pliva decision (which others, like me, refer to as the Mensing ruling):
It is unfair to patients injured by unanticipated adverse drug effects for their right to reparations to depend on whether they received a brand-name or generic version of the same medication, a choice that may have been entirely out of their control. The existing Pliva decision also removes incentives for generic-drug companies to perform pharmacovigilance and monitor late-emerging safety risks related to the products they make.
In this November 2012 NEJM Perspective piece the authors propose some solutions to the legal compensation and the drug safety problems created by the Supreme Court's decision in the Pliva v. Mensing generic drugs case.
Starting with the legal compensation side, the authors propose:
... to create a fund for compensating patients injured by adverse events that are recognized only after a brand-name drug has lost its market exclusivity. Such a system could be structured like the one for vaccine-related injuries.... In the case of generic drugs, patients could qualify for similar compensation by demonstrating that they had been harmed by a generic-drug side effect that was not properly addressed in the label. Generics manufacturers that joined the program would bear additional liability only if their labels did not match the consensus version.
And that reference to a "consensus" label takes us to the drug safety side:
A central repository of information on adverse drug events could be used to study late-arising side effects and to assess the need for changes to drug labels. This repository could be based at the FDA and managed by its Sentinel program, the Patient-Centered Outcomes Research Institute, or another organization with pharmacoepidemiology expertise. Such a database would make it possible to conduct more active oversight of the safety of generic drugs by assessing pooled adverse-event reports, which would lead to additional primary research as needed. The FDA would be responsible for overseeing the integration of new findings into a centrally written consensus label.
At the outset of their article the authors acknowledge that a bipartisan group of lawmakers has introduced legislation seeking to "fix" the Mensing ruling, i.e., to make generic drug companies legally responsible for updating their labels just as brand-name drug companies are by means of drug injury lawsuits in the court system. Here is how the authors view this proposed legislation, which remains under consideration in both the House and the Senate:
Current legislative proposals to impose liability directly on generics manufacturers for discovering and reporting new adverse effects are unlikely to solve the problem, and such an approach disregards the special position that generics hold in the pharmaceutical marketplace.
Ultimately, I disagree with the authors on their outcome as regards whether generic drug companies should be held legally liable for serious side effects that they failed to warn about in their drug labels, for reasons that are apparent in some of my earlier articles about the Mensing ruling:
- March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling
- Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling
I do, however, applaud the authors for pointing out the drug safety and legal compensation problems for generic drugs that patients live with after the Pliva v. Mensing ruling in 2011, and then going on to offer some possible solutions to those problems.
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