United States District Court, W.D. Virginia, Harrisonburg Division
EMILY C. KELLINGTON, Plaintiff,
BAYER HEALTHCARE PHARMACEUTICALS, INC., et al., Defendants.
Elizabeth K. Dillon United States District Judge.
a personal injury case in which plaintiff, Emily Kellington,
seeks to hold defendants, Bayer Healthcare Pharmaceuticals,
Inc., Bayer Pharma AG, and Bayer OY (collectively defendants
or Bayer), liable for personal injuries she contends she
sustained as a result of using Mirena, a
levonorgestrel-releasing intrauterine system manufactured by
Bayer. Pending before the court and addressed herein is
Bayer's motion to exclude (Dkt. No. 95), which has been
fully briefed and was argued before the court. For the
reasons set forth in this opinion, the motion will be granted
in part and denied in part.
motion to exclude, Bayer seeks an order excluding certain
expert opinions and reliance materials under Federal Rule of
Civil Procedure 37(c)(1) on the grounds that they were not
timely disclosed, and also asks for monetary sanctions.
(Bayer's Mot. to Exclude, Dkt. No. 95.) While all parties
agree that plaintiff timely submitted expert reports pursuant
to Rule 26(a)(2), Bayer takes issue with certain opinions
expressed and documents used at the depositions of four
experts. Specifically, Bayer asserts that two of
plaintiff's experts, Drs. Ross and Maggio, provided
completely new opinions and new bases for existing opinions
at their depositions. A third expert, Dr. Fraunfelder,
purportedly disclosed new reliance materials and testified
that he had not finalized most of his opinions. And a fourth
expert, Dr. Tang, revealed new reliance materials that served
as the primary basis for one of her core opinions without
ever producing those materials.
counters that her experts clarified existing opinions; that
counsel merely defended and rehabilitated, or bolstered, her
experts; and that no disclosure rule was
violated.Alternatively, plaintiff states that the
experts supplemented their reports through their testimony,
and so she filed supplemental “expert reports, ”
following the depositions, which merely incorporate each
expert's deposition testimony. (Dkt. No. 96-13.)
Plaintiff further asserts that even if she failed to disclose
in violation of a rule, the nondisclosure was justified or
harmless. As part of this final contention, plaintiff
contends that Bayer had the opportunity to examine
plaintiff's experts at the depositions and could have
asked to take supplemental depositions of the
Legal Standards Governing Expert Disclosures
26(a) requires an expert witness to submit a written report
that contains “(i) a complete statement of all opinions
the witness will express and the basis and reasons for them;
(ii) the facts or data considered by the witness in forming
them; [and] (iii) any exhibits that will be used to summarize
or support them . . . .” The report “should be a
comprehensive document that, by itself, provides all the
expert's opinions that will be offered at trial, along
with the bases for those opinions.” Samsung Elecs.
Co., v. Nvidia Corp., 314 F.R.D. 190, 198 (E.D. Va.
2016) (citations omitted). The report then “form[s] the
basis for informed deposition-taking.” Id.
There is also a duty to timely supplement expert reports if
they are “incomplete or incorrect” “in some
material respect” and “the additional or
corrective information has not otherwise been made known to
the other parties . . . .” Fed.R.Civ.P. 26(e)(1)(A).
With regard to retained experts, the duty to supplement also
includes information conveyed at the expert's deposition.
Fed.R.Civ.P. 26(e)(2). The supplemental information is due no
later than the deadline for pretrial disclosures under Rule
26(a)(3)-so thirty days before trial. Id.;
have distinguished between supplementation and
“gamesmanship.” Disney Enters., Inc. v.
Kappos, 923 F.Supp.2d 788, 795 (E.D. Va. 2013).
Supplementation is appropriate to “add or correct
information, ” but a party may not use Rule 26(e)
supplementation “whenever [it] wants to bolster or
submit additional expert opinions” or it would
“amount to unlimited expert opinion preparation.”
Campbell v. United States, 470 F. App'x 153, 157
(4th Cir. 2012). Put differently, the duty and ability to
supplement “does not permit a party to make an end-run
around the normal timetable for conducting discovery.”
Colony Apartments v. Abacus Project Mgmt., Inc., 197
F. App'x 217, 231 (4th Cir. 2006); see also East
West, LLC v. Rahman, 2012 WL 4105129, at *6 (E.D. Va.
2012) (quoting Abacus). Rather, supplementation is
“only for the narrow purpose of correcting inaccuracies
or adding information that was not available at the time of
the initial report.” Minebea Co. v. Papst, 231
F.R.D. 3, 6 (D.D.C. 2005); Disney Enters., 923
F.Supp.2d at 795 (describing examples of “true
supplementation” as “correcting inadvertent
errors or omissions”).
there has been a failure to disclose timely all opinions or
information, as required by Rule 26 or a pre-trial order, the
court must determine whether the nondisclosure was
substantially justified or harmless. If so, then no action is
required by the court. Fed.R.Civ.P. 37(c). If not, then the
party may not be allowed to use the witness or the
information, or the court may impose “other appropriate
sanctions” in addition to, or instead of, exclusion.
Id. If the court finds a disclosure violation that
is not substantially justified or harmless, it has
“broad discretion to select an appropriate remedy in
light of the totality of the circumstances.” S.
States Rack & Fixture, Inc., v. Sherwin-Williams
Co., 318 F.3d 592, 593 (4th Cir. 2003).
Challenged Opinions and Materials
the law as stated above in mind, the court considers each of
the experts whose opinions Bayer challenges. In this section,
the court sets forth the eight items (allegedly new opinions
and/or reliance materials) that Bayer seeks to exclude, the
plaintiff's response regarding each of the eight items,
and then provides the court's finding as to whether there
was a nondisclosure. Within this structure, the court also
provides a very brief summary of each expert's opinions.
In a separate section that follows, the court considers
whether-as to those materials or opinions that were not
timely disclosed-the nondisclosure was harmless or
substantially justified, and also determines any appropriate
David Ross - regulatory expert
of very brief summary, it appears from Dr. Ross's report
that he concluded that there is a reasonable association
between the use of Mirena and idiopathic intracranial
hypertension (IIH),  and that there is reasonable evidence of a
causative relationship. He stated that the reasonable
evidence for an association was present at the time of
Mirena's original approval, and the evidence supporting
such a relationship has increased over time. He also
concluded that the FDA-approved labeling for Mirena has never
contained a summary of the relevant, essential scientific
information regarding the relationship between use of Mirena
and IIH. (Ross Report 2, Dkt. No. 96-1.) His report stated
that an adverse reaction must be listed on a label, even if
it has not shown to be caused by the drug, if there is a
“reasonable association, whether causal or not, between
the reaction and the use of the drug.” (Ross Report
challenges four opinions or aspects of Dr. Ross's
testimony as being “new” and/or raised for the
first time at his deposition:
New Opinion on Other Drug Labels.
deposition, Dr. Ross testified as to the labels for a class
of drugs called fluoroquinolones (antibacterial medicines)
that warn of IIH, and analogized them to Mirena. (Ross Dep.
20-21, Dkt. No. 96-2 .) He pointed out that the labels for
fluoroquinolones include information about reports of adverse
events, even though there is not “absolutely proven,
confirmed evidence of an association.” (Id. at
74.) Dr. Ross admitted, though, that he had not reviewed the
full body of data on that class of drugs to see how it
compared to similar data of adverse effect reports for Mirena
(e.g., is there a stronger or weaker correlation).
(Id. at 75-76.)
characterizes Dr. Ross's testimony about fluoroquinolones
not as a new opinion, but as a “good example of the
threshold of evidence needed by the FDA in order to require
PTC warnings.” (Pl.'s Resp. 14, Dkt. No. 104.) She
points out that his report discussed this issue at length,
citing to his report at 44-48. Plaintiff's counsel
confirmed this characterization at the hearing.
finding and ruling:
court agrees that Dr. Ross was simply providing an additional
example of his opinion that warning labels for “adverse
events” can include information about adverse reports,
even absent confirmed evidence of an association between the
drug and the adverse reports. Thus, the court finds no
violation of the disclosure rule.
New Opinion on Clinical Trial Cases.
claims that Dr. Ross's reliance on a chart created by
plaintiff's counsel, which purportedly showed three cases
of “generic intracranial hypertension reported during
clinical trials of levonorgestrel-containing IUDs” was
a new opinion. (See Ross Dep. 386-89.) Dr. Ross
admitted in his deposition that he was not previously aware
of these three cases, and he offered opinions at his
deposition concerning what the three cases meant. In
particular, he said that those three incidences were
“very concerning” and “strengthen[ed] the
opinions in [his] report.” (Ross Dep. 391.) Bayer then
examined him about these three cases, at which point he
testified that he may have missed them initially.
(Id. at 442-43.)
admits that Dr. Ross did not recall reviewing information on
these three cases prior to his deposition, and she also does
not dispute that the three cases were not discussed in his
report. While the data containing the three cases was
disclosed as being among the original materials considered by
Dr. Ross (Pl.'s Resp. 15), he testified he was not aware
of the cases, so he could not have considered them in forming
finding and ruling: The court finds that these cases
were a new basis for Dr. Ross's opinion and were not
New Opinion on ...