Kellington v. Bayer Healthcare Pharmaceuticals, Inc.
Filing
117
MEMORANDUM OPINION. Signed by District Judge Elizabeth K. Dillon on 8/30/16. (kld)
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF VIRGINIA
HARRISONBURG DIVISION
EMILY C. KELLINGTON,
Plaintiff,
v.
BAYER HEALTHCARE
PHARMACEUTICALS, INC., et al.,
Defendants.
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Civil Action No.: 5:14-cv-2
By: Elizabeth K. Dillon
United States District Judge
MEMORANDUM OPINION
This is 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.
I.
BACKGROUND
In its 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
1
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.
Plaintiff counters that her experts clarified existing opinions; that counsel merely
defended and rehabilitated, or bolstered, her experts; and that no disclosure rule was violated.1
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 experts.2
II.
DISCUSSION
A. Legal Standards Governing Expert Disclosures
Rule 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)
1
Plaintiff also accuses defendants of providing new, extensive information on its reliance lists
immediately prior to depositions of their experts. This matter, however, is not before the court because plaintiff has
not filed any motion challenging Bayer’s experts.
2
At the hearing, plaintiff’s counsel candidly admitted that he was unlikely to have granted such a request.
2
(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.; Fed. R. Civ. P. 26(a)(3).
Courts 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”).
If 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.
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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).
B. Challenged Opinions and Materials
With 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 remedy.
Dr. David Ross - regulatory expert
By way 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),3 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
3
The experts and parties use several different acronyms for the same basic condition or syndrome,
although there are subtle differences between them. Bayer has generally used “idiopathic intracranial hypertension,”
or IIH, to refer to the syndrome. Some other drug labels or adverse event reports use either the terms pseudotumor
cerebri (PTC), pseudotumor cerebri syndrome (PTCS), or the allegedly “obsolete” term, “benign intracranial
hypertension.” (See Ross Report 50–51, Dkt. No. 96-1; see also Pl.’s Resp. 3, Dkt. No. 104 (also referencing IH,
BIH, SIH, and MIH).) For purposes of this opinion, the court will use IIH or PTC to refer to these conditions.
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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 30.)
Bayer challenges four opinions or aspects of Dr. Ross’s testimony as being “new” and/or
raised for the first time at his deposition:
1. New Opinion on Other Drug Labels. At his 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. 962 .) 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.)
Plaintiff’s Response: Plaintiff 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.
Court’s finding and ruling: The court agrees that Dr. Ross was simply providing an
additional example of his opinion that warning labels for “adverse events” can include
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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.
2. New Opinion on Clinical Trial Cases. Bayer 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 levonorgestrelcontaining 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.)
Plaintiff’s Response: Plaintiff 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 his opinions.4
Court’s finding and ruling: The court finds that these cases were a new basis for Dr.
Ross’s opinion and were not properly disclosed.
4
The three cases were referenced in three rows of data from an Excel spreadsheet produced by Bayer
having 12,000 data points.
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3. New Opinion on Rechallenge Case.5 Bayer next argues that the questions from
plaintiff’s counsel and Ross’s testimony regarding a specific rechallenge case
involving Mirena should be excluded. Dr. Ross testified generally about
rechallenges under questioning from Bayer’s counsel. (Ross Dep. 233–37.)
Then, he answered plaintiff’s counsel’s questions about the specific rechallenge
case. (Id. at 392–400.) Defense counsel later questioned him about it, as well.
(Id. at 460–63.)
Plaintiff’s Response: Much like the first opinion (concerning the fluoroquinolones),
plaintiff argues that this is simply another example that supports Dr. Ross’s general opinion
about the seriousness of a rechallenge event. (Pl.’s Resp. 17.) Also, like the three clinical cases
discussed previously, the data about the rechallenge case was included in the spreadsheet listed
as part of the materials Dr. Ross had reviewed. (Id.)
Court’s finding and ruling: This is different than the fluoroquinolones issue. Here, Dr.
Ross relied on data specifically concerning Mirena. And while that new data appears to support
his general opinion that Mirena’s label should warn of the risks of IIH and that there is an
association, and even a causal relationship, between Mirena and IIH, this specific rechallenge
case was certainly not discussed in his report, and bears on a critical issue in the case. Thus, it
cannot be characterized as an example of the general statements in his report about rechallenge
cases. The report simply said that “even a single well-documented case report can be viewed as
a [safety] signal if the report describes a positive rechallenge or if the event is extremely rare in
the absence of drug use.” (Ross Report 37, 75 (quoting The 2005 Guidance on
5
A “rechallenge” case is one in which a patient’s symptoms stop upon stopping use of a particular drug,
and then the symptoms restart when the drug is restarted. Dr. Ross said that generally such events are afforded
particularly heavy weight in determining an association or causation between a drug and an illness. (Ross Report
37.)
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Pharmacovigilance Practices and Pharmacoepidemiologic Assessment).) It did not identify any
rechallenge case involving Mirena in support of that proposition. Accordingly, this is a
completely new basis for his opinions and should have been disclosed in his report.
4. New Disproportionality Analysis. Bayer’s last complaint as to Dr. Ross is that he
“relied on the results of a new disproportionality analysis—the centerpiece of his
opinions—that Plaintiff’s counsel showed him for the first time during his
deposition.” (Bayer’s Mem. 16, Dkt. No. 96.) Bayer calls this the “most
egregious new material.” (Id. at 5.) In his report, Dr. Ross discussed his
disproportionality analysis at pages 68 and 69. (Ross Report 68–69.)
Plaintiff’s Response: Plaintiff argues that her counsel was simply rehabilitating Dr. Ross
after the “ordeal” of his questioning by Bayer’s counsel. She contends that the analysis she
presented during the deposition was offered to show that Dr. Ross’s original results were
reproducible, depending on the search terms used for a search. She presented this information
after defendant’s counsel had repeatedly tried to undermine the analysis performed by Dr. Ross.
Court’s finding and ruling: Based on the totality of this testimony, it is undisputed that
this specific search was not disclosed, but the court concludes that it is not a new opinion or a
new basis for his opinion, because he never offered a conclusive opinion as to the new search. It
appears that counsel ran the search the night before the deposition when trying to reproduce Dr.
Ross’s results, after they were challenged in the report of one of defendant’s experts, Dr. Feigal.
(Ross Dep. 27–29.) Then, after Dr. Ross was questioned about it, plaintiff’s counsel tried to
show him the report she had made to get him to explain any error in his report. This appears to
be an attempt at classic “correction” to a report, albeit one made during the deposition, and by
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counsel who is offering the expert. So, it may have been a proper ground for supplementation,
had proper supplementation ever occurred.
Ultimately, however, Dr. Ross was not sure whether his initial analysis was correct or
not, or exactly what search terms he had used or had not used. He repeatedly said he believed
that plaintiff’s counsel had identified any error in his report, but he would need to re-run the
analysis and the search to confirm that. At the conclusion of his deposition, he did not know
which analysis was right, and the defendant did not have the benefit of knowing what the bases
for his opinion were. So, as it stands now, Dr. Ross has not actually offered any opinion based
on the second analysis prepared by counsel, and it is not new reliance material. Thus, no
disclosure violation occurred. The initial analysis was disclosed and may later present a Daubert
issue, but that is not before the court now.
Dr. Rick Fraunfelder - ophthalmologist
Dr. Fraunfelder’s report included five opinions, which he offered based on his experience
and expertise as a medical doctor and as an expert in drug safety monitoring. First, he claimed
that there are a number of adverse reports of “PTC and/or papilledema” associated with the use
of levonorgestrel, or LNG. Second, he claimed that the number of reports suggests a relationship
between LNG-containing hormonal contraceptives, such as Mirena, and PTC and/or
papilledema. Third, he stated that epidemiological evidence suggests a likelihood that Mirena is
associated with the development of PTC and/or papilledema, making it more likely than not that
Mirena causes or contributes to the development of these conditions. His fourth and fifth
opinions concerned labeling, although those opinions are not directly challenged here.
(Fraunfelder Report 1, Dkt. No. 96-4.)
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5. Reliance on Three New Analyses. Bayer complains that Dr. Fraunfelder brought
to his deposition an entirely new VigiBase search (a 232-page document)
performed the prior evening by his assistant, as well as two additional VigiBase
searches not disclosed in his expert report. He clearly admitted as much.
(Fraunfelder Dep. 150, Dkt. No. 96-3 (agreeing with the statement that “the
output of those [three] searches [is] not contained in [his] report.”).) Bayer also
points out that Dr. Fraunfelder admitted he had not thoroughly reviewed the most
recent search, but nonetheless stated that it was a “supplement to the spontaneous
report aspect of [his] basis of [his] opinion.” (Id. at 49.)
Plaintiff’s Response: Plaintiff responds that Dr. Fraunfelder has a duty to supplement his
report and argues that these additional reports were simply proper supplementation. (Pl.’s Resp.
9–10.) She also contends that his expert report notes that there are adverse event case reports of
PTC associated with use of LNG. She claims that his testimony that he may continue to draw on
new reports “is not inconsistent with his report or with accepted scientific principles.” (Id. at
10.)
Court’s finding and ruling: At the hearing, plaintiff’s counsel agreed that the 232-page
VigiBase search report can be excluded as a basis for Dr. Fraunfelder’s opinion. By agreement,
then, the court excludes that search report. The other two VigiBase search reports6 were
produced in advance of the deposition, but Dr. Fraunfelder, while relying on them to supplement
his opinion, had not thoroughly reviewed the searches and could not be questioned adequately on
them for that reason. An expert cannot merely state that he is relying upon information that he
has not reviewed adequately and avoid being questioned about the same. Either these two
6
It appears that the VigiBase is updated quarterly, so an expert could rely upon new information that was
not previously available to supplement a report. It is not clear, however, that this is what Dr. Fraunfelder was doing.
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reports are not reliance materials at all and will not be considered as such, or the materials were
not timely disclosed.
6. Refusal to Commit to Final Opinions and Analyses. Bayer also notes that Dr.
Fraunfelder repeatedly “reserved the right” to later supplement his opinions or to
add to them, which Bayer states is simply illustrative of the problem with all four
of these experts. Bayer complains that they have not “finalized” their opinions,
making it impossible for Bayer to finish deposing them, and thus prejudicing
Bayer.
Plaintiff’s Response: Plaintiff’s response is essentially the same as her response to Issue
5 above: it is appropriate for an expert to supplement and update his report with new
information.
Court’s finding and ruling: Dr. Fraunfelder has missed the point of his deposition and
fails to understand that his testimony was supposed to be finalized before his deposition, so it
could be tested or examined there by Bayer’s counsel. There is certainly no provision that
allows unlimited “supplementation” in the sense of adding opinions or bases for them or support
for them up until he testifies at trial. That would defeat the entire purpose of depositions and
would create an endless cycle of supplementation without any consequences. As to any issue on
which Dr. Fraunfelder “reserved” his right to supplement, then, the court will not allow this
supposed reservation to be used to introduce at trial previously undisclosed opinions or bases for
them. That being said, there are simply no new opinions or reliance materials challenged in Item
6, so there is nothing to exclude as untimely disclosed, and the court makes no ruling with regard
to Item 6.
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Dr. John Maggio - pharmacologist
Dr. Maggio is not a medical doctor, but is a research scientist. Dr. Maggio’s report
focused on the background of hormonal contraception, and included a discussion of the
chemistry behind it. It also explains in detail how LNG is believed to work. (See Maggio Report
19, Dkt. No. 96-5.) His opinions are listed on pages 1–2 of his report (id. at 1–2), and the court
will not repeat them completely here. But he concluded that studies and case reports strongly
suggest a significant association between LNG and IIH and, in particular, between Mirena and
IIH. He also opined that a “significant fraction of Mirena users show higher systemic LNG
exposure than the average user of certain former devices (like Norplant), but the Mirena label
does not contain a warning about IIH.” He stated it is “more likely than not that the high
systemic levels of [LNG] in some users of the Mirena [IUD] can cause or substantially
contribute to the development of [IIH]. The Mirena label should bear a warning for [IIH].” (Id.
at 2.)
7. New Opinions on Thirteen Documents. According to Bayer, during Dr. Maggio’s
deposition, he provided new opinions on thirteen documents that plaintiff’s
counsel had left the deposition to gather. (Maggio Dep. 348, Dkt. No. 96-6.)7 The
documents included clinical study reports, internal copy documents, and
published articles containing data on serum blood concentrations for Mirena.
More than half of these documents were not on Dr. Maggio’s reliance list, and
thus he had not considered these documents prior to submitting his report. Bayer
7
These were exhibits 40–49 and 51–53 to his deposition, although neither party has given the court copies
of them.
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also explains, in a footnote, that Dr. Maggio admitted at his deposition that the
causation opinion was based on a single pharmacokinetic study. (Id. at 157.)8
Plaintiff’s Response: Plaintiff claims—falsely, according to Bayer—that “no new
material was proffered at the deposition.” (Pl.’s Resp. 19.) She explains that the documents
(which were all documents Bayer produced) were tendered in order to demonstrate the
correctness of Dr. Maggio’s alleged “assumption,” which was that the patients in the one study
he relied upon (and assumed was reasonable because it was published by Bayer and for other
reasons), were representative of Mirena users. She further claims that the additional documents
merely showed that he was correct and that the serum levels of the patients in the one study were
representative, or at least consistent with, the serum levels in other studies.
Court’s finding and ruling: A review of Dr. Maggio’s deposition transcript did not reveal
to the court thirteen new opinions based upon thirteen documents, and the thirteen documents
were not provided to the court. It appears, however, that some of the thirteen documents may not
have been identified to Bayer in advance of the deposition as reliance materials. (Maggio Dep.
at 349 (defense counsel objecting on this ground).) It appears, from at least some of the
testimony, that Dr. Maggio may have been asked to merely state what was in a document shown
to him. It is hard for the court to determine whether this is the case, and the court will not finely
sift through the testimony, without even the benefit of the documents, to try to determine what
might be a new opinion, what might be new reliance materials, and what might be merely a
document shown to Dr. Maggio for some comment. Bayer, in bringing this motion, must show
that there has been a violation of a disclosure rule, and it has not done so with regard to Dr.
Maggio.
8
Bayer challenges the reliability of his opinions and the data on which they are based, but asserts it is not
bringing a Daubert motion at this time. Thus, the court does not consider these arguments, which are more
appropriately addressed in a Daubert motion.
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Dr. Rosa Tang - neuro-ophthalmologist
Dr. Tang will be offered to testify generally about IIH (or its other used terms), how it is
diagnosed and treated, and its impacts on a patient’s life. She will also testify about “other
causes of intracranial hypertension” and known associations. Her report also discussed labeling
to some degree, although she initially testified at her deposition that she is not an expert in
labeling or regulatory matters and later clarified that, although she is not a scientific “expert” on
the labeling issue, she could offer helpful information to a jury. Her report offered two
“conclusions to a reasonable degree of medical certainty and based on her background and
experience.” (Tang Report 9, Dkt. No. 96-8.) First, she concluded that Mirena is likely
associated with (but not necessarily causally related to) the development of intracranial
hypertension. (Id.) She also says Mirena’s “labeling may be inadequate . . . to alert physicians”
about the association. (Id.) With regard specifically to Ms. Kellington, she opines that
Kellington developed “Mirena Induced Intracranial Hypertension.” (Id. at 10.)
8. New Database of reliance materials. Bayer contends that Dr. Tang testified that
her opinion that Mirena is associated with IIH comes “mainly” from her
experience in the 1990s with patients using Norplant. It claims that she “formed
her core Mirena opinion based on her decades-old Norplant research.” (Bayer’s
Mem. 13.) It relies on the following pages from her May 10, 2016 deposition:
416–417, 234–235, 284–86. Relatedly, Bayer complains that plaintiff has
“promised” to provide those documents, but is now refusing to do so unless Bayer
pays for Dr. Tang’s time in searching for them.
Plaintiff’s Response: Plaintiff contends that Bayer is taking Dr. Tang’s statements out of
context and that she was not in fact relying on those studies for her association opinion. Instead,
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Dr. Tang testified that her history with the drug Norplant was in relation to her experience in
treating patients with IIH, and that her earlier study did not serve as the basis for opinions, nor
did she rely on it. Based on the emails exchanged by counsel on the subject, it appears plaintiff’s
position is that Dr. Tang could not have relied on documents she has not looked at in more than
20 years, that she was just relying on her experience, and that her “experience” and whatever the
documents may be are two different things. (See, e.g., Bayer’s Mem. Ex. 12, at 3, 5, Dkt. No. 9612.) As to the issue of producing the Norplant files or research, plaintiff further argues that she
should not have to pay for Dr. Tang to find studies that she is not relying on to form her
opinions.
Court’s finding and ruling: It is patently clear that Dr. Tang is, in fact, relying on her
experience with Norplant and treating women who used Norplant and developed IIH. When she
was asked what information she was relying on for her opinion that Mirena is likely associated
with the development of intracranial hypertension, she responded that she was “[m]ostly relying
on what levonorgestrel can do from when I had my experience with Norplant . . . .” (Tang May
10, 2016 Dep. 234–35, Dkt. No. 96-7.) She was then asked: “So you’re relying on your clinical
experience from treating patients with Norplant?” She answered, “Yes.” (Id.) She then also
referred to several other bases for her opinion, including textbooks related to Norplant, and the
Rai report. (Id. at 236–37.) Also, her report itself identified her experience with Norplant and
IIH (which she describes as “reviewing multiple cases of young women who developed a
syndrome of intracranial hypertension while on Norplant.”) (Tang Report 5.) And she claims
that these cases were “Norplant induced.” (Id.)
She testified that she thought she had documents in storage that related to a poster that
she presented at a conference. The poster concerned the association of Norplant and intracranial
15
hypertension. Although the poster never developed into a controlled study, due to funding
problems, she nonetheless had gathered information about 100 patients, who she recruited by
reaching out to ophthalmologists in Texas to see if they had any Norplant patients. (Tang May
10, 2016 Dep. 285.) She then examined “most, if not all, of these patients” prior to presenting
her poster at the conference. (Id.) The research related to these 100 patients, which she did not
consult in writing her expert report, is what she thought she had in storage.
Even if Dr. Tang meant she was relying on her “experience with Norplant” in a more
general sense (that she evaluated women who received levonorgestrel and developed IIH), Bayer
is entitled to the information that she relied on to reach that conclusion, i.e., her treatment notes
reflecting, for example, the weight of the women, their actual histories and use of the drugs, etc.
Bayer is entitled to probe the bases for her opinion and the strength of the Norplant-IIH
connection vis-à-vis the Mirena-IIH connection. It is difficult to do so without those notes.
C. Remedy
The court finds disclosure violations with regard to Drs. Ross (Items 2 and 3) and
Fraunfelder (Item 5) and an inadvertent nondisclosure with regard to Dr. Tang. Bayer has failed
to show a violation of the disclosure rule with regard to Dr. Maggio, so no remedy is necessary
with regard to his report or deposition testimony.
Because the court finds nondisclosure violations, the court turns to whether the
nondisclosures were harmless or substantially justified. The party failing to disclose bears the
burden of proof as to justification and harmlessness. Quesenberry v. Volvo Grp. N. Am., Inc.,
267 F.R.D. 475, 478 (W.D. Va. 2010) (citing S. States Rack & Fixture, 318 F.3d at 596). To
determine whether the nondisclosure was harmless, the court looks to “surprise to the opposing
party, ability to cure that surprise, disruption of the trial, and importance of the evidence.” S.
16
States Rack & Fixture, Inc., 318 F.3d at 597. To determine whether the nondisclosure was
substantially justified, the court looks to the “explanation for the nondisclosure.” Id.
The court easily finds that the nondisclosures were not substantially justified. Indeed,
plaintiff provided no explanation or justification for any nondisclosures, instead arguing only
that there were no disclosure violations. There is certainly no justification evident from the
record, either.
As to whether the nondisclosures were harmless, plaintiff argues that even if there was a
disclosure violation, there was no surprise, and that Bayer had the ability to cure any surprise
because it was able to examine all four experts at their depositions. She also points out that the
depositions were completed six weeks before the expert discovery deadline, and Bayer could
have asked for supplemental depositions, but did not. As recently stated in Samsung, however,
“notice in deposition testimony does not render a failure to disclose in the expert report
unsurprising or curable, even when that deposition testimony completely covers the material that
should have been disclosed.” Samsung, 314 F.R.D. at 198 (citations omitted). This is because
“disclosure in the right form (complete) and at the right time (with the expert report, before the
expert’s deposition) is critical to an opposing party’s ability to engage in meaningful expert
discovery (critical analysis of the expert’s report, and taking of a targeted deposition).” Id.
That reasoning is on display here. Bayer was surprised at the depositions of Dr. Ross and
Dr. Fraunfelder by new opinions and/or reliance materials. Bayer’s ability to examine Dr. Ross
and Dr. Fraunfelder about the new opinions/materials at their respective depositions was not an
adequate cure for the surprise. Especially when expert witnesses are deposed, the opposing party
often plans carefully for examination in advance of the deposition, relying upon the expert’s
report and consultation with that party’s own experts. An immediate examination, without
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consultation and careful planning and review, regarding new opinions or materials, is not an
adequate or fair substitute. Plaintiff’s suggested cure—to permit supplemental depositions—is
disingenuous given her admission that such a request was not likely to have been voluntarily
granted.
In any event, to allow additional depositions for new disclosures would be disruptive to
the trial. The trial is scheduled to begin November 29, 2016, and is scheduled for four weeks,
making it difficult to reschedule easily or within a few months. Further, the scheduling order has
important deadlines designed to ensure that the case will be ready for trial as scheduled, and
those deadlines are upon the parties now.
Plaintiff provided little, if any, information about the importance of the evidence, and the
court finds that plaintiff has not demonstrated the importance of the new opinions and materials.
For all of these reasons, the new opinions and reliance materials are not substantially justified or
harmless and will be excluded.
Dr. Tang’s underlying Norplant research and records were supplemental information that
was inadvertently omitted as reliance materials, but was referenced in her report. The parties
represent that they have been paying for their own experts’ time and expenses; thus, the court
orders that Dr. Tang search for the documents in storage at plaintiff’s cost and either produce
what she finds or report the search efforts that resulted in the inability to locate the documents in
storage no later than September 14, 2016, or another date upon agreement by the parties.
Plaintiff is then to make Dr. Tang available for a supplemental deposition if requested by Bayer
no later than September 28, 2016, or another date upon agreement by the parties. Bayer will bear
its own costs of the supplemental deposition. If Dr. Tang is re-deposed, the court will allow a
separate Daubert motion to be filed regarding Dr. Tang no later than October 5, 2016.
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The court finds the above remedies to be sufficient to remedy the violations and will not
grant any additional sanctions requested by Bayer.
III.
CONCLUSION
For the reasons set forth above, Bayer’s motion to exclude will be granted in part and
denied in part. A separate order will be entered.
Entered: August 30, 2016
/s/ Elizabeth K. Dillon
United States District Judge
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