Even though many Americans assume that there is no difference between a brand-name drug and its generic equivalent, the legal remedies for victims of a drug’s side-effects of medication may depend in large part on the distinction. The Supreme Court, in deciding Pliva v. Mensing last summer, established protections for generic pharmaceutical companies for claims alleging failure to warn; such protections do not exist for brand-name manufacturers. The difference is with regard to who controls what is said on the drug’s label.
Under federal law, drug manufacturers may establish that the drug they produce is equivalent to a brand-name drug already on the market. In doing so, the a drug manufacturer establishes that its medication is a “generic” drug, and sidesteps a lengthy FDA approval process. One consequence of this process is that the generic drug manufacturer must adopt the label of the brand-name equivalent.
Since generic drug manufacturers do not have control over the label that is placed on the drugs they produce, the Supreme Court reasoned that those manufacturers do not have liability for inadequate labels. This means that when a patient is harmed by a side-effect of a drug, that patient can sue the drug manufacturer alleging a failure to warn of those side-effects only if the manufacturer has control over the label – this requirement exempts generic drug manufacturers from liability.
However, both the FDA and Congress have the power to restore a patient’s right to sue a generic drug manufacturer for failure to warn, by providing the generic drug manufacturer the responsibility to warn about side-effects without regard to the warning label provided on the brand-name equivalent. Until such a change, however, patients who take brand-name drugs have access to a broader range of legal remedies than do patients who take generics.