United States District Court, D. Massachusetts
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
Dennis Saylor IV, United States District Judge.
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.
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.
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
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.
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.
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
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). 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.
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).
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).
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).
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).
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.
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).
January 18, 2019, the Court denied the motion for a
protective order. (Docket No. 1292).
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
11. Undersigned Counsel can no longer represent to this Court
that all of the factual assertions in Dr.
Zambelli-Weiner's Motion for Protective ...