United States District Court, D. Massachusetts
IN RE ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION This Document Relates To All Actions
MEMORANDUM AND ORDER ON GSK'S EMERGENCY MOTION TO
STRIKE THE SUPPLEMENTAL REPORTS OF PLAINTIFFS' GENERAL
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 strike
the second supplemental report of one of plaintiffs'
expert witnesses on general causation, Dr. Bengt R.
Danielsson. Dr. Danielsson previously filed an expert report
in this matter in July 2018. In that report, he opined that,
based on his review of the available medical literature, the
use of Zofran by pregnant women can cause a variety of birth
Dr. Danielsson's initial report, three relevant
studies-one by Huybrechts et al., one by Parker
et al., one by Zambelli-Weiner et al.-have
been published. Dr. Danielsson has twice supplemented his
initial report to address the Parker and Zambelli-Weiner
studies: once in a brief report on November 23, 2018, and a
second time in a more detailed submission on February 28,
2019. As for the Huybrechts study, Dr. Danielsson has
supplemented his initial report to address it only once, in
his submission on February 28, 2019.
issue before the Court is whether that February 2019 report
was timely under Fed.R.Civ.P. 26. For the reasons set forth
below, the Court concludes that it was timely as to the
Huybrechts study, but not as to the Parker and
Zambelli-Weiner studies, and that exclusion of the untimely
portion of the report is appropriate. Accordingly, GSK's
motion to strike will be granted as to those portions of the
February 2019 report.
Bengt. R. Danielsson, M.D., Ph.D. is a physician and
teratologist. A focus of his research is how drug-induced
alterations in the heart rhythms of human embryos can cause
various birth defects. Plaintiffs have engaged Dr. Danielsson
to opine on whether Zofran “is capable of causing birth
defects such as congenital heart defects and orofacial
clefts.” (Danielsson Report at 1).
17, 2018, this Court issued MDL Order No. 25. Among other
things, that order set a timetable for “[e]xpert
discovery on general causation and general liability
issues.” (MDL Order No. 25 (Docket No.
1006)). It provided that plaintiffs were to serve
“expert disclosures under Fed.R.Civ.P. 26(a)(2),
including expert reports, ” by July 16, 2018.
(Id.). The order did not set a deadline by which the
parties were required to supplement their expert disclosures.
10, 2018, Dr. Danielsson submitted his initial expert report
in this matter. In that report, he concluded that Zofran
“is capable of causing congenital heart defects and
orofacial defects, both in animals and in humans, through the
hERG-mediated mechanism of teratogenicity.” (Danielsson
Report at 68). He wrote that in forming his opinion, he had
considered “the totality of the available evidence,
” including, among other things, several
epidemiological studies in humans. (Id. at 3-4).
While he relied on at least one abstract from an
epidemiological study, (Id. at 5 (Andersen et al.,
2013a)), he apparently did not consider the abstracts from
three epidemiological studies that were eventually published
later in 2018: Huybrechts, Parker, and Zambelli-Weiner.
(See Id. at References).
August 27, 2018, Dr. Danielsson submitted a
“Supplemental and Rebuttal Expert Report.” That
report also did not address the Parker or Zambelli-Weiner
October 12, 2018, GSK deposed Dr. Danielsson. Dr. Danielsson
confirmed that he had neither reviewed the Parker study nor
discussed it in either his initial or his rebuttal report.
(Danielsson Dep. at 112:17-113:7). Counsel for GSK asked why
he had not reviewed the study in order to prepare his
rebuttal report even after GSK's own experts referred to
it. (Id. at 120:21-122:16). He replied that he had
not had the opportunity to read every study cited by
GSK's experts, and that he was “on holiday”
when the Parker study came out and could not spend
“every day looking at the reference list.”
(Id. at 121:14-17). He also had not reviewed an
abstract for the Huybrechts study, which had not yet been
published at that point. (Id. at 389:17-21).
November 23, 2018, Dr. Danielsson submitted an
“Additional References Considered” list, which
listed the Parker and Zambelli-Weiner studies. (GSK Mem., Ex.
C). At the bottom of the list, Dr. Danielsson wrote that
“[h]aving considered this additional material . . . my
opinions from my expert report are unchanged.”
Danielsson's most recent report is dated February 28,
2019. (GSK Mem., Ex. F (“Danielsson 2019 Report”)
at 3). It is three pages long. (Id.). GSK contends
that it did not receive the report until March 15, 2019. (GSK
Mem. at 3). In that report, Dr. Danielsson describes the
Huybrechts, Parker, and Zambelli-Weiner studies; interprets
their results; and concludes that they do not alter the
opinion he offered in his initial report. (See id.).
Curiously, he does not include the Parker article, which he
discusses, on his list of additional references considered.
(Id. at 3).
moved to strike Dr. Danielsson's February 2019 report.
Fed R. ...