Viropharma Incorporated v. Department of Health and Human Services
2012 U.S. Dist. LEXIS 35215
| D.D.C. | 2012Background
- ViroPharma owns NDA for Vancocin (vancomycin capsules) used to treat C. difficile infections; no FDA-approved generic vancomycin exists.
- FDA previously required in vivo (human) bioequivalence tests; in February 2006 FDA allegedly shifted to in vitro tests without a public notice.
- ViroPharma alleges the 2006 policy shift harmed it financially by lowering stock value after private disclosures.
- ViroPharma filed FOIA requests seeking the administrative record and communications related to vancomycin bioequivalence policies; requests were processed with ongoing document releases.
- FDA created a Vaughn index and repeatedly withheld documents under FOIA Exemptions 4 and 5, and some under Exemption 6; ViroPharma sought in camera review and broader disclosure.
- The court granted summary judgment for most documents, ordered supplementation for specific Vaughn index entries, and denied in camera review and plaintiff’s summary judgment in part.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Exemption 4 applies to information referencing pending ANDAs | ViroPharma argues FDA over-redacted and improperly withheld non-core content. | FDA claims redactions concern pending ANDAs and related contents. | Exemption 4 applies to pending-ANDAs content; some segregation required for non-exempt portions. |
| Whether incoming correspondence related to bioequivalence can be segregated and released | FDA should release nonresponsive and segregable portions. | Inquiries are intertwined with confidential information; some nonresponsive content may be non-disclosable. | Court requires supplementation to assess segregability of bioequivalence discussions in incoming correspondence. |
| Whether Exemption 5 (deliberative process) justifies withholding internal drafts and review documents | Drafts and internal documents should be released to reveal factual content. | Deliberative process and evolving drafts warrant withholding, including factual content when intertwined. | Most drafts/internal reviews properly withheld; some internal factual material may require further segregation; supplementation ordered. |
| Whether laboratory data must be disclosed or segregated from deliberations | Laboratory data are purely factual and should be disclosed. | Laboratory data are part of deliberative process and may be withheld. | Laboratory data may be withheld as part of deliberative process; requires clarification and supplementation. |
| Whether the court should conduct in camera review due to alleged bad faith | Rolling document releases show bad faith. | Rolling releases are not evidence of bad faith; not required to review in camera. | In camera review declined; no basis found for bad-faith finding. |
Key Cases Cited
- Judicial Watch v. FDA, 449 F.3d 141 (D.C. Cir. 2006) (exemption 4/5 application and Vaughn indexing standards)
- Appleton v. FDA, 451 F. Supp. 2d 129 (D.D.C. 2006) (exemption 4, contents of pending ANDAs and related information)
- Public Citizen Health Research Group v. FDA, 185 F.3d 898 (D.C. Cir. 1999) (non-conclusory risk of substantial harm; segregability limits)
- Brinton v. Department of State, 636 F.2d 600 (D.C. Cir. 1980) (Exemption 5 final statements vs. deliberative material)
- Ancient Coin Collectors Guild v. Department of State, 641 F.3d 504 (D.C. Cir. 2011) (deliberative process scope; intermingled factual content)
- Mead Data Cent., Inc. v. Department of the Air Force, 566 F.2d 242 (D.C. Cir. 1977) (disclosure of factual material in deliberative context)
- Wilderness Soc. v. Department of Interior, 344 F. Supp. 2d 1 (D.D.C. 2004) (segregability and non-exempt material)
- Reliant Energy Power Generation, Inc. v. FERC, 520 F. Supp. 2d 194 (D.D.C. 2007) (line-by-line search and segregability considerations)