Generic drugs are supposed to be identical to the brand
names that preceded them. According to the law, they must have identical
warnings and labels. The question is if they also need to carry the same liability
since they cannot change the product or its labeling. The U.S. Supreme Court will
rule on that issue soon. .
It will hear oral arguments in a case where consumers claim to be injured by generic drugs. The generic manufacturers in question argue that they should be shielded from those kinds of lawsuits since they do not have any discretion to change the product or its labeling.
A 2011 decision by the court protected generic manufacturers from the most common kind of lawsuit involving prescription drugs. In that case, PLIVA v.Mensing, the court ruled that a generic drug maker could not be held liable for failing to adequately warn consumers of side effects in its labeling, since US federal law requires generic drugs to carry the same label as the brand name.
The current case is Mutual Pharmaceutical Co. v. Bartlett.
In this case, the question is if makers of a defective drug — even if they
can’t change the label — can stop selling the product without violating federal
law and be held accountable if they don’t.
This is one of two Supreme Court cases involving generic drugs. The second one, going before the court soon, centers on what the Federal Trade Commission exactly has labeled as “pay for delay” patent settlements between brand name and generic drugs.
The FDA argues that “pay for delay” is anti-competitive and is
costing consumers billions. The generics industry argues that its an efficient
way of bringing cheaper products to market before the patents on brand name
drugs expire.
