Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), is a decision by the Supreme Court of the United States holding that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.

Because submitting an NDA is expensive and lengthy, the U.S. Congress set out to create an easier path for generic drugs to be issued to the public.

In 1978, the Food and Drug Administration (FDA) approved an anti-inflammatory pain reliever called sulindac under the brand name Clinoril.

When the patent expired, the FDA approved several generic versions including one manufactured by Mutual Pharmaceutical.

The District Court dismissed her failure-to-warn claim on her doctor's own testimony that she had not read the box or the label.

The Court centered its opinion on the impossibility of a generic drug manufacturer meeting its obligations under both state and federal laws.