Generic Drug Warning Labels Shielded by S. Ct.
A divided Supreme Court on Thursday put an end to the vast majority of generic drug lawsuits, finding that consumers cannot sue generic drug manufacturers for the use of inadequate warning labels.
The case, which does not impact the Court's 2009 ruling regarding liability for non-generic drug labeling, was decided on the basis of preemption.
Five Justices found that it is virtually impossible for generic manufacturers to comply with both federal and state law at the same time.
Ordinarily, under state tort law, a customer can sue a drug manufacturer for improper safety labeling.
However, the FDA requires generic drugs to use the exact label that can be found on their brand name counterparts.
In other words, brand name drug manufacturers are responsible for the content of drug labels, and generic manufacturers have little choice but to use the same warning label.
Because generic drug companies cannot change those labels, they cannot provide more adequate labels as required by state tort law.
Therefore, as always in these situations, federal law wins out.
Though the result, essentially destroying generic drug lawsuits that focus on inadequate labeling, is a bit odd and flies in the face of consumer protection laws everywhere, there's little the Court can do.
Any change to the FDA regulations will need to come from within or be mandated by Congress.
Until then, those of you worried about your inability to file generic drug lawsuits should always request brand name prescriptions. That way you can sue the real culprits--brand name manufacturers.
- Supreme Court Protects Generic Drugs, Drug Marketers (Forbes)
- Dangerous Drugs (FindLaw)
- Analyzing the Supreme Court's Recent Ruling that FDA Approval of Label Warnings Does Not Preempt State Tort Law (FindLaw's Writ)
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