United States District Court, D. Massachusetts
IN RE ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION This Document Relates To: All Actions
MEMORANDUM AND ORDER ON PLAINTIFFS' MOTION TO
STRIKE EVIDENCE FROM GSK'S RENEWED MOTION FOR SUMMARY
JUDGMENT BASED ON PREEMPTION
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.
19, 2018, defendant GlaxoSmithKline LLC (“GSK”)
moved for summary judgment based on federal preemption-in
substance, on the ground that state-law claims of failure to
provide an adequate warning label were preempted by federal
law. Among other things, GSK contends that the federal Food
and Drug Administration has twice rejected label changes
containing warnings similar to those that plaintiffs contend
should have been provided. The Court denied that motion on
February 5, 2019, having concluded that the issue was one of
fact for the jury to decide and that there were disputed
issues of material fact precluding summary judgment.
20, 2019, the Supreme Court held in Merck Sharp &
Dohme Corp. v. Albrecht, 139 S.Ct. 1668, 1679 (2019),
that the issue of federal preemption in a pharmaceutical
product liability case must be treated “not as a matter
of fact for a jury but as a matter of law for the judge to
decide.” This Court then vacated the relevant portions
of its February 5 order.
22, 2019, GSK renewed its motion for summary judgment on
preemption grounds. When it renewed its motion, it submitted
four witness declarations, which had not been submitted with
its original motion, and 139 other exhibits consisting almost
entirely of items such as deposition transcripts, internal
GSK documents, journal articles, and documents from the FDA.
Plaintiffs have moved to strike all evidence submitted with
GSK's motion that was not previously part of the summary
following reasons, plaintiffs' motion to strike will be
granted as to the declarations of Dr. Dena Hixon, Dr. Gary
Shaw, and Dr. Patrick Wier, which are GSK's Exhibits 1,
3, and 4, and will otherwise be denied.
The Preemption Issue Generally
is an anti-emetic-that is, a drug that prevents or treats
nausea or vomiting. It was initially approved by the Food and
Drug Administration in 1991 for the prevention of nausea and
vomiting induced by chemotherapy or radiation therapy and
post-operative nausea and vomiting.
was not approved, and never has been approved, for the
prevention of nausea and vomiting in pregnancy. Nonetheless,
Zofran has been prescribed off-label to pregnant women for
many years. According to plaintiffs, that widespread practice
was due in large part to unlawful marketing practices by GSK
that sought to promote off-label usage.
point, the FDA became aware that Zofran was being prescribed
to pregnant women in significant numbers. In 2010, the FDA
requested that GSK provide supplemental information
concerning the safety of Zofran when used during pregnancy.
In response, GSK provided an analysis of the then-available
safety data. The FDA did not require any labeling changes. In
2013, a citizen petition requested that the FDA revise the
Zofran label to indicate an increased risk to fetal safety if
ingested during pregnancy. The FDA rejected that request. In
2015, the current manufacturer of Zofran, Novartis, submitted
a proposed label change to provide, among other things, a
warning that use in pregnancy could cause harm to the fetus
and is not recommended. That, too, was rejected.
short, whether Zofran poses a risk to fetal safety has been
considered, and rejected, by the FDA on multiple occasions
since the drug's initial approval. Even today, it is not
contraindicated for use during pregnancy, and its label
contains no enhanced form of warning for such use. Indeed,
the current label states that “[a]vailable data do not
reliably inform the association of Zofran and adverse fetal
nonetheless contend that ingestion of Zofran during pregnancy
in fact causes birth defects, that the label should contain
such a warning, and that GSK's failure to provide such a
warning should result in tort liability under state law.
Plaintiffs contend that the FDA's initial approval of
Zofran in 1991, and its subsequent rejection of label
changes, were based on incomplete information-essentially,
because GSK withheld certain data from the FDA and made
material misrepresentations. GSK denies that it withheld
information and contends that any state-law failure-to-warn
claims are preempted by federal law.
present dispute principally concerns the filing of additional
declarations by GSK in support of its renewed motion for
summary judgment, which plaintiffs contend are untimely
expert disclosures. A review of the procedural background is
necessary to address that issue.
17, 2018, this Court issued MDL Order No. 25. Among other
things, that order provided that discovery as to “Phase
3, ” which was defined as “discovery as to
general causation and preemption issues, ” should
conclude by June 29, 2018, and “may proceed”
after that date “only by agreement of the parties or by
leave of court upon good cause shown.” (MDL Order No.
25 (Docket No. 1006)). It further provided that “any
motion for summary judgment based on preemption” should
be filed by June 15, 2018. (Id.).
Order No. 25 also set a timetable for “[e]xpert
discovery on general causation and general liability
issues.” (Id.). It provided that plaintiffs were
to serve “expert disclosures under Fed.R.Civ.P.
26(a)(2), including expert reports, ” by July 16, 2018,
and that GSK was to do so by August 6, 2018. (Id.).
11, 2018, the Court extended the deadlines for GSK to file a
summary judgment motion on preemption to July 2, 2018.
(Docket No. 1030).
27, 2018, the Court extended the deadlines for expert
disclosures concerning general liability issues. (Docket No.
1036). Under the revised deadlines, plaintiffs' expert
disclosures were to be served by July 31, 2018, and GSK's
were to be served by September 21, 2018. (Id.).
2, 2018, GSK timely filed its initial motion for summary
judgment based on federal preemption. GSK submitted a number
of exhibits with that motion, but did not submit any expert
affidavits. (See Hill Decl. (Docket No. 1042)).
August 1, 2018, plaintiffs filed an opposition to GSK's
motion for summary judgment. Plaintiffs submitted a number of
exhibits with that opposition, but did not submit an expert
affidavit on regulatory or preemption issues. (See
Jenner Decl. (Docket No. 1105)).
August 6, 2018, GSK timely disclosed an expert report of Dr.
Gary Shaw, one of its general causation experts. (GSK's
Opp., Ex. J). Dr. Shaw's report did not directly touch on
August 15, 2018, GSK filed a reply memorandum, together with
multiple exhibits, in support of its motion for summary
judgment on preemption. Again, no expert report on regulatory
or preemption issues was submitted. (See Hill Decl.
(Docket No. 1126)).
September 11, 2018, plaintiffs filed a supplemental
memorandum of law in opposition to GSK's motion for
summary judgment, together with additional exhibits. Among
the exhibits was an expert report from Dr. Brian Harvey dated
August 30, 2018, addressing certain regulatory and preemption
issues. (See Jenner Decl. (Docket No. 1155), Ex. 5).
September 13, 2018, the Court heard oral argument on the
motion for summary judgment and took the matter under
September 21, 2018, GSK timely disclosed to plaintiffs an
expert report of Dr. Dena Hixon, a regulatory expert, who
addressed preemption issues. (GSK's Renew. Mot. for Summ.
J., Ex. 17).
October 2, 2018, plaintiffs filed a revised version of Dr.
Harvey's expert report. The revised version included an
affirmation that it was signed under oath, without any change
to the substance of the report.
February 5, 2019, the Court issued its opinion denying
GSK's motion for summary judgment based on preemption.
Among other things, the Court held that the preemption issue
involved disputed issues of material fact that should be
resolved by a jury.
February 26, 2019, the Court issued MDL Order No. 31. (Docket
No. 1355). That order provided, among other things, that
“GSK's case-specific expert disclosures under
Fed.R.Civ.P. 26(a)(2), including expert reports, ”
should be served by April 5, 2019. (Id.). The order
further provided that the opposing party would be entitled to
take the deposition of a “case-specific expert [who]
appear[s] in more than one case for a party.”
April 5, 2019, GSK made a case-specific expert disclosure to
plaintiffs concerning Dr. Patrick Wier, a GSK employee.
(Docket No. 1650, Ex. G). The disclosure was four pages long,
and indicated that Dr. Wier would provide opinion testimony
concerning Zofran animal studies at trial. (Id.).
That disclosure was made as to the eight individual cases
that were being prepared for the first trial group, not in
the MDL proceeding as a whole. GSK had previously identified
Dr. Wier in 2015 and 2016 as a fact witness concerning the
effectiveness and safety of Zofran. (GSK's Opp. (Docket
No. 1650), Exs. B, C). Based on those disclosures, plaintiffs
had deposed Dr. Wier on March 28, 2018. (Wier Dep. at 1).
20, 2019, the Supreme Court issued its decision in
Albrecht. In light of that decision, the Court
permitted GSK to file a renewed motion for summary judgment
based on federal preemption. (Docket No. 1575). In response
to questions by the parties as to what types of materials
they could submit, the Court expressed a desire to decide the
preemption issue on a full factual record. (July 10, 2019
Hr'g Tr. at 44:5-12). However, the Court also noted that
the parties could move to strike any supporting materials
that they believed were improperly submitted. (Id.).
22, 2019, GSK filed its renewed motion for summary judgment
on preemption. Attached were declarations by four witnesses:
Dr. Dena Hixon, Dr. Luise Rogg, Dr. Gary Shaw, and Dr.
Patrick Wier. (GSK's Renew. Mot. for Summ. J., Exs. 1-4).
GSK also attached 139 other exhibits to its motion.
(Id., Exs. 5-143).
August 26, 2019, plaintiffs moved to strike all four
declarations and all 139 exhibits.
Fed R. Civ. P. 26(a)(2)
Civ. P. 26(a)(2) governs the disclosure of expert testimony.
“[A] party must disclose to the other parties the
identity of any [expert] witness it may use at trial to
present evidence . . . .” Fed.R.Civ.P. 26(a)(2)(A). If
the witness “is one retained or specially employed to
provide expert testimony in the case or one whose duties as
the party's employee regularly involve giving expert
testimony, ” the party must also submit a
“written report” with numerous detailed facts,
data, exhibits, and other items. Fed.R.Civ.P.
26(a)(2)(B). If the witness is not such a person, the
party must nonetheless disclose “(i) the subject matter
on which the witness is expected to present [expert] evidence
. . .; and (ii) a summary of the facts and opinions to which
the witness is expected to testify.” Fed.R.Civ.P.
party must make these disclosures at the times and in the
sequence that the court orders.” Fed.R.Civ.P.
26(a)(2)(D). As with all disclosures made under Rule 26(a),
parties must “supplement or correct” their expert
disclosures “in a timely manner” if a party
learns of an omission or error unknown to the other party or
“as ordered by the court.” Fed.R.Civ.P. 26(e)(1).
“For an expert whose report must be disclosed under
Rule 26(a)(2)(B), the party's duty to supplement extends
both to information included in the report and to information
given during the expert's deposition.” Fed.R.Civ.P.
Fed R. Civ. P. 26(a)(3)
Civ. P. 26(a)(3) requires parties to disclose the evidence
that they may present at trial. “[A] party must provide
to the other parties and promptly file . . .: (i) the name,
and if not previously provided, the address and telephone
number of each witness . . .; (ii) the designation of those
witnesses whose testimony the party expects to present by
deposition . . .; and (iii) an identification of each
document or other exhibit, including summaries of other
evidence . . . .” Fed R. Civ. P. 26(a)(3)(A). A party
must make those disclosures at the times ordered by the
court, or if the court sets none, then at least 30 days
before trial. Fed.R.Civ.P. 26(a)(3)(B). As with all
disclosures made under Rule 26(a), parties must
“supplement or correct” those disclosures
“in a timely manner” if a party learns of an
omission or error unknown to the other party or “as
ordered by the court.” Fed.R.Civ.P. 26(e)(1).
Fed R. Civ. P. 37
provides sanctions for violations of Rule 26. “If a
party fails to provide information or identify a witness as
required by Rule 26(a) or (e), the party is not allowed to
use that information or witness to supply evidence on a
motion, at a hearing, or at a trial, unless the failure was
substantially justified or is harmless.” Fed.R.Civ.P.
37(c). “[T]he required sanction in the ordinary case is
mandatory preclusion.” Poulis-Minott v. Smith,
388 F.3d 354, 358 (1st Cir. 2004) (alteration in original)
(internal quotation marks omitted) (quoting Klonoski v.
Mahlab, 156 F.3d 255, 269 (1st Cir. 1998)). But
“preclusion is not a strictly mechanical exercise;
district courts have some discretion in deciding whether or
not to impose that onerous sanction.”
Santiago-Díaz v. Laboratorio Clínicio y de
Referencia del Este, 456 F.3d 272, 276 (1st Cir. 2006).
In determining the proper sanction, the court should consider
“(1) the party's justification for the late
disclosure; (2) the opposing party's ability to overcome
any prejudice; (3) the impact on the court docket; (4) the
party's history of litigation abuse; and (5) the
party's need for the late evidence.” Glass
Dimensions, Inc. ex rel. Glass Dimensions, Inc. Profit
Sharing Plan & Tr. v. State Street Bank & Tr.
Co., 290 F.R.D. 11, 17 (D. Mass. 2013) (citing
Harriman v. Hancock Cty., 627 F.3d 22, 30 (1st Cir.
2010)); see also Gagnon v. Teledyne Princeton, Inc.,
437 F.3d 188, 191 (1st Cir. 2006).
may avoid a Rule 37 sanction if it shows “that its
failure to comply with the Rule was either justified or
harmless and therefore deserving of some lesser
sanction.” Wilson v. Bradlees of New England,
Inc., 250 F.3d 10, 21 (1st Cir. 2001). A substantial
justification, as used in Rule 37, “is one that
‘could satisfy a reasonable person.'” Pan
American Grain Mfg. Co. v. Puerto Rico Ports Auth., 295
F.3d 108, 117 (1st Cir. 2002) (interpreting prior, similar
version of Rule 37). Substantially justified “does not
mean justified to a high degree, but only justified in
substance or in the main-that is, justified to a degree that
could satisfy a reasonable person.” Sheppard v.
River Valley Fitness One, L.P., 428 F.3d 1, 12 (1st Cir.
2005) (internal quotations omitted). In weighing the
justification for and harm caused by a disclosure violation,
“[t]he Court must bear in mind the intent of the
disclosure rules ‘to facilitate a fair contest with the
basic issues and facts disclosed to the fullest practical
extent.'” Jalbert v. Grautski, 2009 WL
3754698, at *4 (D. Mass. Feb. 12, 2009) (quoting
Poulis-Minott, 388 F.3d at 358).