And Now For The Good News: US FDA Poised To Restore Drug Injury Victims’ Right to Sue Generic Drug Manufacturers

And Now For The Good News: US FDA Poised To Restore Drug Injury Victims’ Right to Sue Generic Drug Manufacturers

By Leslie Brueckner, Senior Attorney

UPDATE: Public Justice joined these comments filed today in support of the FDA’s proposed rule change.  The comments, which were principally authored by Joanne Doroshow at the Center for Justice & Democracy, explain that the proposed rule change is essential to protect patients. The current system allows generic drug makers to use warning labels even if the makers know the labels are inadequate and out-of-date—a direct risk to patient safety that will be addressed by the new proposed rule.  

usually blog when I’m angry. This is partly because I like to vent when I’m pissed off, and partly because outrage makes relatively juicy copy. So last week, for example, I criticized the U.S. Food and Drug Administration for failing to impose any meaningful restrictions on the use of antibiotics in industrialized animal agriculture. 

pillsBut this week (drum roll) I actually have some good news to share for a change. The very same agency that I griped about last week – the FDA – has issued a proposed rule that, if enacted into law, will restore the rights of victims of dangerous generic prescription drugs to sue drug manufacturers for money damages.

If the agency goes forward with its proposal (described in more detail below), we can happily kiss goodbye to the U.S. Supreme Court’s spine-tingley awful decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which held that federal law preempts all failure-to-warn claims involving generic drugs.

What made Mensing so bad is that, for various reasons, the vast majority of drug prescriptions are filled with generic drugs. As a result, Mensing effectively wiped out the vast majority of failure-to-warn claims against drug manufacturers, regardless of the dangers of the drug and the inadequacy of its warning label. (Two years later, the U.S. Supreme Court added insult to injury by blocking injury victims from pursuing most design defect claims against generic drug manufacturers).

Not only is this horribly unfair to the victims of inadequately labeled drugs, but it is also terrible public policy. Without the threat of litigation to keep them honest, generic drug manufacturers have far less incentive to ensure that their labels accurately reflect the true risks of the drug. This makes the world a scarier place for everyone.

But there’s light at the end of this depressing tunnel because the FDA’s proposal is expressly designed to fix the problems created by Mensing. In the intro to its proposed new rule, the FDA criticized Mensing and proposed to allow generic drug manufacturers to deviate from the labeling of the brand name manufacturers under certain circumstances. If adopted, this new rule will undercut Mensing in a big way by limiting generic drug companies’ ability to argue that, because the FDA prevents them from changing their labels without prior federal approval, all failure-to-warn claims are impliedly preempted by federal law.

Predictably, the defense bar is mobilizing to stop this rule change from going forward. A recent blog by a major corporate law firm announced that the FDA’s proposal would “eliminate product liability protection” for generic drug companies. There is no doubt that the FDA will be inundated with industry comments on why this proposed rule change is a bad idea.

We intend to weigh in on the other side. If this is an issue you care about – and you should, because it is literally a matter of life and death – please let your voice be heard as well! Comments are due March 13, 2014. For details, please go here.

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