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In re Zofran (Ondansetron) Products Liability Litigation

United States District Court, D. Massachusetts

July 25, 2019

IN RE ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION This Document Relates To All Actions

          MEMORANDUM AND ORDER ON IN CAMERA PRODUCTION OF DOCUMENTS CONCERNING DR. APRIL ZAMBELLI-WEINER

          F. Dennis Saylor IV, United States District Judge.

         This is a multi-district litigation (“MDL”) proceeding arising out of product-liability claims that the use of the drug Zofran (ondansetron) by pregnant women caused certain types of birth defects in their children.

         Defendant GlaxoSmithKline LLC (“GSK”) has moved to compel the production of certain documents by plaintiffs and a third-party witness, April Zambelli-Weiner, Ph.D. Plaintiffs and Dr. Zambelli-Weiner have withheld the documents from production, contending that they are protected from discovery as attorney work product under Fed.R.Civ.P. 26(b)(3) and as consulting expert information under Fed.R.Civ.P. 26(b)(4)(D).[1]

         Dr. Zambelli-Weiner is the co-author of an epidemiological study on which plaintiffs rely as evidence that Zofran causes birth defects. At the time she conducted the study, she was a paid consultant to plaintiffs' counsel. The study itself was funded by plaintiffs' counsel in the amount of $210, 000. Dr. Zambelli-Weiner also participated, with plaintiffs' counsel, on a panel at a conference in Las Vegas concerning this litigation.

         When counsel for GSK sought to depose her in this case, she sought a protective order, and submitted an affidavit that included a number of falsehoods. She claimed in that affidavit, among other things, that plaintiffs' counsel had paid her for other work, not for the study at issue. Her counsel, upon discovering the falsehoods, filed a corrective notice with the Court and withdrew his appearance.

         The issue before the court is whether certain documents concerning the relationship between Dr. Zambelli-Weiner and plaintiffs' counsel, which have been provided to the Court for in camera review, should be produced to GSK. For the reasons set forth below, the Court concludes that the documents are not protected from discovery and should be produced.

         I. Background

         April Zambelli-Weiner, Ph.D., is a researcher and the founder, president, and principal epidemiologist of Translational Technologies International Health Research & Economics (“TTi”). (Docket No. 1271-1, Curriculum Vitae).

         Dr. Zambelli-Weiner is the co-author of a study published in the journal of Reproductive Toxicology, titled “First Trimester Ondansetron Exposure and Risk of Structural Birth Defects.” (Docket No. 1271-2).[2] That study, which has become a central piece of plaintiffs' experts' causation opinions in this litigation, found a statistically significant association between early pregnancy ondansetron (Zofran) exposure and specific structural birth defects. (Id.).

         On August 10, 2018, in anticipation of Dr. Zambelli-Weiner's forthcoming study, GSK served a set of request for production of documents and interrogatories on plaintiffs. Plaintiffs were asked to produce, among other things, all communications between plaintiffs' attorneys and Dr. Zambelli-Weiner or her company (TTi) concerning the then-unpublished study. (Docket No. 1406-1).

         On September 10, 2018, plaintiffs' counsel objected to those requests, contending that the request called for information not discoverable under Fed.R.Civ.P. 26(b)(3) and 26(b)(4)(D), and provided no responsive information. (Docket No. 1406-2).

         Meanwhile, on October 29, 2018, the journal Reproductive Toxicology published an abstract of the study, titled “First Trimester Ondansetron Exposure and Risk of Structural Birth Defects.” (Docket No. 1271-2).

         GSK then issued subpoenas seeking to depose Dr. Zambelli-Weiner and a co-author, Dr. Russell Kirby. On November 26, 2018, plaintiffs moved on her behalf for a protective order seeking to prevent the depositions. (Docket No. 1224). In their motion, plaintiffs characterized Dr. Zambelli-Weiner as a research scientist. They did not reveal that she was a paid consulting expert for plaintiffs, and did not cite or rely on the protections of Rule 26(b)(3) or 26(b)(4)(D).

         The Court denied the motion for a protective order on December 7, 2018. The Court stated that it would permit a deposition focused principally on the financial aspects of her relationship with plaintiffs' counsel-that is, what money was paid and how; what communications with counsel, direct or indirect, were made; and how those payments and communications may have affected the study. (Docket No. 1243).

         GSK then served a subpoena duces tecum on Dr. Zambelli-Weiner. That prompted her to move for a protective order on January 9, 2019. (Docket No. 1271). In support of that motion, she submitted an affidavit to the Court setting forth the factual basis of her claims. (Docket No. 1272).

         On January 18, 2019, the Court denied the motion for a protective order. (Docket No. 1292).

         That same day, counsel for Dr. Zambelli-Weiner filed an emergency motion to withdraw his appearance, notifying the Court that he had learned that “factual representations” made in her affidavit were “inaccurate.” (Docket No. 1293). Counsel also filed a “Notice Advising the Court of Factual Inaccuracies” in the affidavit and motion for protective order. (Docket No. 1294). That notice included the following statements:

9. At the time the Motion for Protective Order and Affidavit were filed, all counsel for Dr. Zambelli-Weiner believed that the factual assertions contained in those documents were accurate. Thereafter, Attorney Marder received information indicating that certain of the factual assertions in Dr. Zambelli-Weiner's Motion for Protective Order and Affidavit were inaccurate.
10. As required by Massachusetts Rule of Professional Conduct 3.3 and Maryland Rule of Professional Conduct 19-303.3, Attorney Marder remonstrated with Dr. Zambelli-Weiner about the inaccuracies in the Motion for Protective Order and her Affidavit.
11. Undersigned Counsel can no longer represent to this Court that all of the factual assertions in Dr. Zambelli-Weiner's Motion for Protective ...

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