| 23-1016 |
William Facteau and Patrick Fabian v. United States |
First Circuit |
2024-03-15 |
Denied |
Amici (1) |
arbitrary-enforcement fda-regulations fifth-amendment first-amendment interstate-commerce medical-device off-label-use truthful-speech |
1. Whether FDA's "intended use" regulations violate the First Amendment by requiring manufacturers to refrain from truthful, non-misleading speech abo… |
| 20-1069 |
Janssen Pharmaceuticals, Inc., et al. v. A. Y., et al. |
Pennsylvania |
2021-02-05 |
Denied |
Amici (4) |
civil-liability drug-labeling fda-regulation federal-preemption impossibility-preemption off-label-use preemption state-tort-law |
Whether federal law preempts state-law claims that a manufacturer failed to provide adequate warnings relating to the off-label use of their products,… |
| 19-1276 |
Michael B. White, Individually and as Personal Representative of the Estate of Darla K. White, Deceased v. Medtronic, Inc., et al. |
Sixth Circuit |
2020-05-12 |
Denied |
|
21-usc-360 adulteration buckman diversity-of-jurisdiction fda-regulations medical-device-preemption off-label off-label-use pleading pleading-standard private-causes-of-action riegel state-court-jurisdiction summary-disposition |
1. Adulterated products are not a medical device, no preemption for FDA violations.
2. A doctor could not develop well-informed off-label use opinion… |