Generic drugs are often as effective as and less expensive than their brand name counterparts. However, an important 2011 U.S. Supreme Court ruling may limit a patient’s recovery if that patient is hurt by a drug and claims that the generic drug manufacturer failed to provide an appropriate warning of the risks.
Several state attorneys general, including Chris Koster, the Missouri Attorney General, are requesting that Congress amend federal law so that the problem is fixed and so that patients who are not warned about the risks of a medication and suffer adverse consequences from a medication, can sue for a fair recovery, even if the medication is generic.
Who Controls Generic Medication Labels?
Absent an FDA directive, only brand name drug manufacturers can change drug labels to include additional warnings. Generic drug manufacturers cannot do so. Instead, they must wait for the brand name manufacturer to change the label and then follow suit. This system was devised to provide uniformity for similar medications.
However, an unintended problem developed. Consider what happens when two patients suffer the same adverse reactions to the same type of medication. One patient took the brand name medication and is able to sue the drug manufacturer for failure to provide adequate warnings about the drug’s risks if the label does not clearly state the risks. The second patient took the generic equivalent of the brand name drug and suffered the same adverse effect. However, the second patient does not have the right to sue because the generic drug manufacturer did not have the legal authority to change the drug label to include the warning.
It is often the pharmacist who makes the decision between providing a patient with a generic or brand name drug (unless the doctor specifically requests one or the other). Thus, a recovery from a prescription medication injury could be contingent on the pharmacist’s decision pursuant to current law.
Have You Or A Loved One Been Injured By Using A Dangerous Drug?
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