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Rita McDaniel, Individually and as Personal Representative of the Estate of Johnny F. McDaniel, Deceased v. Upsher-Smith Laboratories, Inc.

Paid petition · United States Court of Appeals for the Sixth Circuit, No. 17-5741 · judgment June 29, 2018

Certiorari denied · October 5, 2020
Pre-decision estimate: 3% cert probability

Before the decision, well below the 4.1% base rate, with no standout signals pointing toward a grant.

Question presented

Rita McDaniel sued because Defendant failed to ensure the distribution of an FDA-mandated warning to her husband. Tennessee recognizes a tort claim based on failure to warn. Parallel federal regulations, 21 C.F.R. §§ 208.24(a), (b), require Defendant to ensure that sufficient medication guides are made available pharmacies or distributers for distribution to patients. Defendant also misled Mr. McDaniel’s doctor. The question presented is: Whether a state-law, failure-to-warn claim that parallels a defendant’s failure to follow FDA labeling regulations is impliedly preempted?

Counsel of record

For petitioner
Edward Kirksey Wood Jr.
Wood Law Firm, LLC

For respondent
Cary Silverman
Shook, Hardy and Bacon LLP

Case

Conference history
Distributed for 1 conference

Proceedings

  1. Oct 05 2020
    Petition DENIED.
  2. Jul 08 2020
    DISTRIBUTED for Conference of 9/29/2020.
  3. Jul 06 2020
    Reply of petitioner Rita McDaniel filed. (Distributed)
  4. Jun 22 2020
    Brief of respondent Upsher-Smith Laboratories, Inc. in opposition filed.
  5. Apr 30 2020
    Motion to extend the time to file a response is granted and the time is extended to and including June 25, 2020.
  6. Apr 29 2020
    Motion to extend the time to file a response from May 26, 2020 to June 25, 2020, submitted to The Clerk.
  7. Oct 31 2018
    Petition for a writ of certiorari filed. (Response due May 26, 2020)