Before a new brand-name drug enters the market in the United States, it must go through a rigorous safety review process culminating in U.S. Food and Drug Administration approval. This is called the new drug application process. If approved, the manufacturer of the brand-name drug will, for a time, have exclusive control of the market before other pharmaceutical manufacturers can start producing and selling generic versions the drug. The generic versions are bioequivalent to the brand-name version, meaning that they affect the body in the exact same ways.

Because of this, and for other reasons, generic versions must be accompanied by the same warnings and precautions as the brand-name labels. Generally speaking, however, it is the brand-name manufacturer who retains the sole ability to update the label.

The U.S. Supreme Court relied on this regulatory framework in PLIVA Inc. v. Mensing, when it held that failure-to-warn claims brought against manufacturers of generic medications under state law are preempted by federal law. The result was a surge in the number of cases holding that generic drug manufacturers could not be held liable for state law failure-to-warn claims. Notably, these cases further entrench a central tenet of product liability law — that a manufacturer should not be held liable for the alleged defects of products it did not manufacture.

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