Medical Center Pharmacy v. Eric Holder, Jr.
2011 U.S. App. LEXIS 3784
| 5th Cir. | 2011Background
- The case involves FDA authority to inspect records of pharmacy compounding under the FDCA after a prior ruling that compounded drugs are new but exempt if §§353a and 360b(a) complied with.
- On remand, FDA argued the earlier ruling expanded inspection power; the district court allowed limited inspections to determine exemption compliance.
- Ten pharmacies challenged the new district court judgment, contending the FDA forfeited the inspection issue by not appealing the original ruling.
- The district court had previously held that compliant pharmacies under §374(a)(2)(A) were exempt from inspections, and the FDA had not appealed that ruling.
- The court’s first opinion acknowledged the waiver of the inspection issue since neither party appealed the records-inspection holding; on remand the district court reversed that stance, prompting this appeal.
- The Fifth Circuit vacates and remands, holding the FDA forfeited the inspection issue and the district court violated the waiver doctrine by reopening it on remand.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether law-of-the-case/waiver bars remand reconsideration | FDA argues law-of-the-case/waiver should not bar reconsideration | Pharmacies argue FDA forfeited issue by not appealing | Yes; the issue is barred by waiver and law-of-the-case. |
| Whether FDA forfeited the inspection issue by not appealing the original ruling | FDA failed to appeal the inspection ruling in the first appeal | Pharmacies contend waiver applies because issue could have been raised earlier | Yes; FDA forfeited the inspection issue. |
| Whether the district court properly reopened the inspection issue on remand | Reopening was consistent with updated statutory interpretation | Reopening violated waiver because issue already decided | No; reopening violated waiver doctrine. |
| What is the controlling result on remand | Inspection authority should be limited by waiver rules | Inspection authority should be preserved under §374 and §353a | Vacate and remand to enforce waiver rule. |
Key Cases Cited
- United States v. Castillo, 179 F.3d 321 (5th Cir. 1999) (law-of-the-case governs subsequent stages; issues decided cannot be reexamined on remand)
- United States v. Lee, 358 F.3d 315 (5th Cir. 2004) (waiver doctrine bars issues not raised on appeal)
- Alpha/Omega Ins. Servs., Inc. v. Prudential Ins. Co. of Am., 272 F.3d 276 (5th Cir. 2001) (law-of-the-case applies only to issues actually decided)
- General Universal Sys., Inc. v. HAL, Inc., 500 F.3d 444 (5th Cir. 2007) (waiver as consequence of inaction; issues not appealed are forfeited)
- United States v. Griffith, 522 F.3d 607 (5th Cir. 2008) (illustrates waiver where objections not raised on appeal)