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392 F. Supp. 3d 179
D.D.C.
2019
Read the full case

Background

  • MDL product-liability case: plaintiffs allege maternal use of Zofran (ondansetron) caused birth defects; a peer-reviewed epidemiological study by April Zambelli‑Weiner, Ph.D. is central to plaintiffs' causation proof.
  • Plaintiffs' counsel funded the study and paid Dr. Zambelli‑Weiner roughly $210,000 through her company TTi; she also served as a paid consulting expert for plaintiffs.
  • Dr. Zambelli‑Weiner and plaintiffs initially resisted discovery about counsel’s communications and payments, asserting protections under Fed. R. Civ. P. 26(b)(3) (work product) and 26(b)(4)(D) (consulting expert).
  • Dr. Zambelli‑Weiner submitted an affidavit to the court containing material falsehoods about her relationship to plaintiffs’ counsel; her counsel later withdrew and corrected the record.
  • The court conducted in camera review of withheld documents (including presentation slides from a public 2015 conference) and ordered production, finding the materials not protected by Rule 26 and that protections were waived by disclosure/misconduct.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether documents about communications/payments between plaintiffs' counsel and Dr. Zambelli‑Weiner are protected as attorney work product under Rule 26(b)(3) Documents prepared for litigation by counsel or their consultant are protected from discovery GSK argued it needed the documents (substantial need) and they were not protected because they were prepared for study publication and because protections were waived Not protected; produced—work‑product protection does not apply or was waived by disclosure and misconduct
Whether consulting‑expert protections under Rule 26(b)(4)(D) shield facts/opinions or documents from discovery Dr. Zambelli‑Weiner was a consulting expert; thus facts/opinions and related communications are ordinarily undiscoverable GSK argued exceptional circumstances, substantial need, and inability to obtain equivalent materials; plus waiver by false affidavit and counsel funding of the study Not protected; court found exceptional circumstances and waiver; documents discoverable
Whether materials presented at a public conference remain confidential/protected Plaintiffs claimed communications/slides were protected GSK argued public presentation waived confidentiality and increased access to adversaries Not protected; public presentation waived protection and materials should be produced
Whether any attorney‑client privilege attached Plaintiffs asserted privilege on some documents GSK disputed existence of attorney‑client relationship with Dr. Zambelli‑Weiner No attorney‑client relationship shown; privilege not established

Key Cases Cited

  • F.T.C. v. Grolier Inc., 462 U.S. 19 (1983) (Rule protects materials prepared for a party by or for that party)
  • United States v. Massachusetts Inst. of Tech., 129 F.3d 681 (1st Cir. 1997) (work‑product waiver turns on whether disclosure increases adversaries' opportunity to obtain information)
  • Bryan Corp. v. Chemwerth, Inc., 296 F.R.D. 31 (D. Mass. 2013) (third‑party disclosure can waive work‑product protection where disclosure substantially increases access by adversaries)
  • In re Raytheon Sec. Litig., 218 F.R.D. 354 (D. Mass. 2003) (analysis of work‑product waiver due to disclosure)
  • Hoffman v. Owens‑Illinois Glass Co., 107 F.R.D. 793 (D. Mass. 1985) (elements for Rule 26(b)(3) protection: prepared in anticipation of litigation and substantial‑need exception analysis)
Read the full case

Case Details

Case Name: In re Zofran (Ondansetron) Prods. Liab. Litig.
Court Name: District Court, District of Columbia
Date Published: Jul 25, 2019
Citations: 392 F. Supp. 3d 179; MDL No. 1:15-md-2657-FDS
Docket Number: MDL No. 1:15-md-2657-FDS
Court Abbreviation: D.D.C.
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