The Risks of Using Generic Drugs

by Sarah Hoffman, SpringerLyle •••

In June of 2011, the United States Supreme Court decided an important issue regarding the warning labels on prescription drugs in Pliva, Inc. et al v. Mensing.  Mensing was a prescription drug failure-to-warn-case.  It dealt with prescription drug companies’ failure to put accurate warnings on their drug labels, leading to patients taking dangerous drugs that they otherwise would not have taken.

In Mensing, the Court held that name-brand manufacturers of prescription drugs have an obligation, both under the federal regulations and under state common law, to keep up with current research on the risks posed by the drugs they manufacturer and to notify the Federal Drug Administration of any necessary changes to the label so the label can be kept accurate and up to date.  On the other hand, the Court held that federal law does not require any “generic” drug manufacturer to keep up with current research regarding the risks posed by their drugs and that any state law claim alleging that a generic drug’s label was inaccurate is therefore preempted.

What does that mean for prescription drug consumers?  Basically, if you take a drug and end up getting hurt because the manufacturer did not keep the label up to date with the current research regarding that drug’s risks, you can only be compensated for your injuries if you took the name-brand manufacturer’s drug.  If you took the generic manufacturer’s drug, you have no recourse.

If you or someone you know has taken a prescription drug and been injured, please contact our firm.  We may be able to help.