Mensing v. Wyeth, Inc.’s Empirical Analysis

Citation profile

9 federal appellate · 10 district · 4 state decisions

Most-quoted passages

The sentences later courts lift from this opinion, ranked by how many decisions quote each — the parts of the opinion doing the work. These counts are smaller than the citation total above because most of the 46 citing decisions cite the case generally; a passage count includes only decisions quoting that exact language verbatim.

1. “[G]eneric defendants were not compelled to market metoclopramide. If they realized their label was insufficient ... they could have simply stopped selling the product”

   3 later decisions quote this exact passage · from the majority
   e.g. Mut. Pharm. Co. v. Bartlett · Mut. Pharm. Co. v. Bartlett

2. “[t]he FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.”

   1 later decision quote this exact passage · from the majority
   e.g. 696 F. Supp. 2d 599 - VITATOE v. Mylan Pharmaceuticals, Inc.

3. “[When Congress] enlarged the FDA’s powers to protect the public health and assure the safety, effectiveness, and reliability of drugs, [it] took care to preserve state law.... In 2007, ... Congress ... granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. In doing so, however, Congress did not enact a provision in the Senate bill that would have required the FDA to preapprove all changes to drug labels.... [T]hrough many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.”

   1 later decision quote this exact passage · from the majority
   e.g. 776 F. Supp. 2d 907 - SCHEDIN v. ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC.