Bartolini et al v. Abbott Laboratories, Inc

Filing 268

ORDER REGARDING PLAINTIFFS' MOTIONS IN LIMINE NOS. 1-11 AND DEFENDANT'S MOTIONS IN LIMINE NOS. 1-17 195 ; 196 ; 197 ; 198 ; 199 ; 200 ; 201 ; 202 ; 205 ; 206 ; 208 ; 209 ; 210 ; 211 ; 212 ; 213 ; 214 ; 215 ; 216 ; 217 ; 218 ; 219 ; 220 ; 221 ; 230 . See the text of the Order for further detail. Signed by Judge Nancy J. Rosenstengel on 5/16/2017.J. Rosenstengel on 5/16/2017. (jmw)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF ILLINOIS
IN RE DEPAKOTE:
E.R.G., a minor, by CHRISTINA
RAQUEL, individually as parent and
next friend of E.R.G.,
Plaintiffs,
vs.
ABBOTT LABORATORIES, INC.,
Defendant.

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Case No. 15-CV-702-NJR-SCW

MEMORANDUM AND ORDER
ROSENSTENGEL, District Judge:
Pending before the Court are eleven motions in limine filed by Plaintiffs and
seventeen motions in limine filed by Defendant.
A district court’s authority to rule on motions in limine is derived from its inherent
authority to control the course of trials. See Luce v. United States, 469 U.S. 38, 41, n. 4
(1984). “[A] motion in limine should be granted only if the evidence sought to be
excluded is clearly inadmissible for any purpose.” Noble v. Sheahan, 116 F. Supp. 2d 966,
969 (N.D. Ill. 2000). Motions in limine are intended “to avoid the delay and occasional
prejudice caused by objections and offers of proof at trial.” Wilson v. Williams, 182 F.3d
562, 566 (7th Cir. 1999). Such motions permit the district court to eliminate evidence
“that clearly ought not be presented to the jury,” because it is inadmissible for any
purpose. Jonasson v. Lutheran Child and Family Services, 115 F.3d 436, 440 (7th Cir. 1997).

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“[T]he party moving to exclude evidence in limine has the burden of establishing that the
evidence is not admissible for any purpose.” Euroholdings Capital & Inv. Corp. v. Harris
Trust & Sav. Bank, 602 F. Supp. 2d 928, 934 (N.D. Ill. 2009).
Motion in limine rulings “are made before the district court has had a chance to
hear all of the evidence or see the trial develop.” Currie v. Cundiff, No. 09-cv-866-MJR,
2012 WL 2254356, at *1 (S.D. Ill. June 15, 2012). As such, these rulings are preliminary
and may be revisited based on the court’s exposure to the evidence at trial. Id.; United
States v. Connelly, 874 F.2d 412, 416 (7th Cir. 1989).
Some evidentiary submissions cannot be evaluated accurately or sufficiently prior
to trial. Jonasson, 115 F.3d at 440. “In these instances, it is necessary to defer ruling until
during trial, when the trial judge can better estimate its impact on the jury.” Id. Further,
the denial of a motion in limine does not preclude a party from objecting to any evidence
at trial or from requesting a limiting instruction. Team Play, Inc. v. Boyer, No. 03-C-7240,
2005 WL 3320746, at *1 (N.D. Ill. Dec. 5, 2005).
The motions have been thoroughly briefed, and the Court heard from the parties
concerning particular questions on certain motions at the final pretrial conference on
May 5, 2017. For the reasons set forth below, the Court rules as follows.
A. PLAINTIFFS’ MOTIONS IN LIMINE
1. Plaintiffs’ Motion in limine Nos. 1 and 5—To exclude evidence, argument, or
discussions regarding any collateral support Plaintiff E.R.G. received or will
receive from sources wholly independent of the Defendant (Doc. 195).
GRANTED. The collateral source doctrine states that “if an injured party
receives some compensation for his injuries from a source wholly independent of the
tortfeasor, such payment should not be deducted from the damages which the plaintiff
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would otherwise collect from the tortfeasor.” Hrnjak v. Graymar, Inc., 4 Cal. 3d 725, 729,
484 P.2d 599, 602 (1971). Moreover, gratuitous care is not guaranteed or even legally
required after the minor plaintiff turns eighteen.
2. Plaintiffs’ Motion in limine No. 2—To exclude argument that Defendant was
prohibited from changing the Depakote label without prior approval from the
FDA (Doc. 195).
GRANTED in part and DENIED in part. Any evidence or testimony that Abbott
should have implemented a developmental delay warning prior to E.R.G.’s in utero
exposure to Depakote is not admissible at trial. See (Case No. 14-CV-847, Doc. 285, pp.
4-10) (containing a detailed analysis on the preemption of label changes related to
development delay). As to other evidence that Defendant could have changed the
Depakote label via the Change Being Effected process, Defendant will be allowed to
explain that the FDA maintains the authority to accept, reject, or request modification of
those changes.
3. Plaintiffs’ Motion in limine No. 3—To exclude statements or arguments that
mischaracterize evidence or misstate facts central to the present litigation
(Doc. 195).
DENIED. All counsel are bound by the ethical rules of professional conduct, the
local rules, and the Federal Rules of Civil Procedure. This issue cannot be properly
addressed outside the context of the evidence introduced and the specific objection
raised at trial. Accordingly, the Court will take up objections to alleged
mischaracterizations of evidence or misstatements of fact on a case-by-case basis during
the course of trial.

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4. Plaintiffs’ Motion in limine No. 4—To exclude any argument or suggestion that
implies that it is the FDA’s responsibility to conduct post-market studies of
medications or that the Depakote label is what the FDA wanted (Doc. 195).
GRANTED in part and DENIED in part. Statements implying that the FDA had
a legal duty to conduct post-market studies of medication will not be allowed. However,
whether Defendant followed existing labeling regulations to produce a label “the FDA
wanted” will be subject to expert testimony on direct and cross-examination.
6. Plaintiffs’ Motion in limine No. 6—To exclude evidence, argument, and testimony
regarding any alleged negligence or fault of Christina Raquel or of Christina
Raquel’s pre-pregnancy knowledge of risks (Doc. 196).
GRANTED in part and DENIED in part. At the final pretrial conference,
Defendant agreed to not argue or introduce evidence that Christina Raquel was
negligent or at fault for the alleged injuries to E.R.G. (Doc. 262, pp. 27-31). Defendant
does, however, seek to introduce evidence of what Christina Raquel was told regarding
the risk of birth defects and what her response was to that knowledge. Plaintiffs assert
that this is irrelevant evidence because the dispositive question concerns whether or not
her doctors would have prescribed Depakote given the proposed stronger warnings.
(Doc. 262, p. 26). While this may be partially true, the prescription decision is not made
in a vacuum. If evidence in the case indicates that the prescribing decision was based in
part on the conversations, understanding, and preferences of the patient, then the
patient’s knowledge of the risks and responses to that information are directly connected
to the ultimate issue.
For example, in a recent key prescriber status report, Plaintiffs asked the doctor
whether or not he would have shared the alleged increased risk with the patient in
making the prescribing decision. Plaintiffs then asked the doctor, if the patient did not
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want to take Depakote in light of the increased risk, would he have still prescribed it.
The doctor stated he would not have prescribed Depakote under those circumstances.
See (Case No. 12-CV-52, Doc. 947, pp. 2-3). Such patient involvement in the prescription
decision makes the patient’s knowledge and responses to the risks and benefits clearly
probative to the ultimate question. But this ruling should not be read as a campaign carte
blanche to “blame the mother.” Abbott is cautioned that its questioning on this topic will
be limited.
7.

Plaintiffs’ Motion in limine No. 7; 8; 9—To exclude certain details of Christina
Raquel’s personal history (Doc. 201)(unsealed)(Doc. 202)(sealed).
GRANTED in part and DENIED in part. Plaintiffs seek to exclude details of

Christians Raquel’s personal history including evidence of her experience with domestic
abuse or violence, her suicidal ideations or attempts, or her family history of mental
illness. Abbott has indicated that “[a]t present, Abbott does not intend to present
evidence of any alleged neglect or possible abuse that Ms. Raquel experienced as a
minor.” (Doc. 249, p. 3).
At the final pretrial conference, Plaintiffs asserted that beyond this one
concession, there is no need to introduce any of this information as “it is undisputed that
Ms. Raquel suffers from bipolar disorder.” (Doc. 262, at pp. 33-32). Plaintiffs have clearly
indicated, however, that they intend to challenge the appropriateness of the prescription
decisions for Ms. Raquel. (Doc. 262, at p. 35) (“Ms. Raquel was prescribed [Depakote] for
an off-label purpose….”); see also (Doc. 253). It is also clear that Plaintiffs seek to argue
that Ms. Raquel did not need to be on Depakote at all, as evidenced by her
post-conception treatment regime. (Doc. 262, at pp. 63-65). The unfortunate nature of Ms.

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Raquel’s disorder necessarily means that the sensitive details of her symptoms, as they
are manifest (assuming a cognizant expert adequately connects the conduct with her
disorder), will be allowed in at trial. Abbott will only be given a small amount of latitude
on these subjects and therefore should use great caution in developing questions.
10.

Plaintiffs’ Motion in limine No. 10—To exclude evidence, argument, and
testimony regarding any alleged negligence or fault of Christina Raquel’s
prescribing physicians (Doc. 198)(sealed); (Doc. 197)(unsealed).
GRANTED. Plaintiffs seek to exclude any evidence, inference, argument, or

testimony that Ms. Raquel’s prescribing physicians were somehow negligent or at fault
with respect to what they did or knew about birth defects associated with Depakote use.
(Doc. 197, p. 1). At the final pretrial conference, Defendant articulated that it does not
contest the motion. (Doc. 262, at pp. 33-34) (“[O]ur case does not include anything that
suggests that the physicians—the four physicians who saw her at El Hogar during this
time period and had any interaction with her on her Depakote prescription were at fault
in any way.”).
11. Plaintiffs’ Motion in limine No. 11—To admit evidence, testimony, and argument
regarding the May 2012 plea agreement, civil settlement, and corporate integrity
statement in this particular case (Doc. 205).
GRANTED in part and DENIED in part. See the Court’s Order regarding Abbott’s
motion in limine No. 17.

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B. DEFENDANT’S MOTIONS IN LIMINE
1. Defendant’s Motion in limine No. 1—To exclude references to post-conception
labeling and regulatory communications (Doc. 199).
GRANTED. Defendant seeks to exclude evidence of post-conception labeling and
regulatory communications. Every Court to review this issue has excluded the
post-conception labels and communications with the FDA under Rule 407 and/or Rule
403. Plaintiffs do not contest Defendant’s motion, rather they seek a reciprocal
prohibition on “any pre-conception regulatory communications between Abbott and the
FDA regarding these prospective label changes that were not approved and effective at
the time of Plaintiffs’ conception.” During the final pretrial status conference, Defendant
agreed to the exclusion of the above quoted language. (Doc. 262, p. 57-58).
2. Defendant’s Motion in limine No. 2—To exclude references to the December 3,
2009 FDA Alert (Doc. 208).
GRANTED. Defendant seeks to exclude an alert posted by the FDA on its website
“reminding health care professionals about the increased risk of [birth defects] in babies
exposed to [Depakote] during pregnancy.” (Doc. 208-1, p. 1). Two facts are dispositive in
excluding this document under Rule 403. First, Plaintiff E.R.G. was conceived three
years before the alert was published. Second, the two page alert is not a “study” or other
academic paper that provides further clarification as to Depakote’s known teratogenicity
back the in pre-2006 timeframe. Instead, the document simply draws attention to
existing studies—generated outside the FDA—in an effort to “remind” healthcare
providers of the serious risks of birth defects. In short, any probative value to this case is
dramatically outweighed by the risk of prejudice and confusion. Again, however, this
Order should not be read as an exclusion of the underlying studies that existed before
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E.R.G.’s conception.
3. Defendant’s Motion in limine No. 3—To preclude admission of a document titled
“neurology consultant meeting” and other suggestions that Depakote should have
been contraindicated for the treatment of epilepsy in women of childbearing years
(Doc. 215).
GRANTED. Defendant seeks to exclude (1) a specific document produced during
discovery and (2) any suggestion that Depakote should be contraindicated for women of
child bearing years. The first sub-issue concerns a document known as “Carbone 921.”
The document was produced by Abbott during the discovery process when it “hit”
during an electronic search of Abbott’s records based on agreed upon search terms.
Carbone 921 is a typed document concerning a meeting in Chicago, Illinois, in 2001.
Plaintiffs seek to introduce the document due to the following language:
4)

Discuss develop a flowchart for the treatment of adult epilepsies and
co-morbid conditions (eg, behavioral disorders).
Not use Depakote in female of child bearing years due to
teratogenic potential. Many not aware of the actual risk. Dr.
Hughes quoted 1-2% of neural tube defects, just not sure
with new AEDs.

(Doc. 215-1, p. 3). Plaintiffs assert that the document is in essence a smoking gun
showing that Abbott knew back in 2001 that Depakote should not be used in the female
population of childbearing potential. Plaintiffs’ assertion is highly speculative and
requires an untenable number of assumptions to reach such a conclusion. First, no one
has been able to identify the author of the document, nor is there any evidence as to how
the document came to be in the possession of an Abbott custodian. Beyond the
foundational and hearsay problems presented by the untethered document, the
fragmented short-hand sentence is inherently unclear in its true meaning. Showing
Carbone 921 to the jury absent evidence of its author’s identity and intent, or sufficient
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details concerning the June 2001 Chicago meeting, is to invite impermissible speculation.
The second sub-issue in Defendant’s motion in limine ties directly into Carbone
921 and Plaintiffs’ assertion that Abbott knew Depakote “should not be administered to
women of childbearing years.” Defendant argues that no expert has ever disclosed such
a sweeping opinion that Depakote is never appropriate for woman of child bearing
potential. In response, Plaintiffs assert that their labeling and regulatory expert, Dr.
Kessler, clearly states: “Abbott’s Depakote labeling should have stated that valproate
should not be used to treat women of childbearing age with the forms of epilepsy and
phases of bipolar disorder for which it has been approved unless all other available
medications have failed to control their symptoms or are otherwise unacceptable.”
(Doc. 247, pp. 2-3) (emphasis omitted). Dr. Kessler’s use of the word “unless” makes
Defendant’s very point.
Should Plaintiffs seek to introduce expert testimony that Depakote should never
be prescribed to woman of child bearing potential under any circumstance, counsel will
need to bring to the Court’s attention a previously disclosed expert report containing
such a sweeping, blunt assertion.
4. Defendant’s Motion in limine No. 4—To exclude references to post-conception
codes of business conduct, ethical guidelines, or similar documents promulgated
by Abbott, FDA, PhRMA, or any other entity (Doc. 213).
RESERVE RULING. The Court will instruct the jury on the law and what
Abbott’s duty was to Plaintiffs. At the previous Kaleta trial, the parties agreed that they
would bring any issues relating to this motion in limine to the Court’s attention before
evidence of this type is introduced at trial. The parties are instructed to follow the same

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course of action as previously utilized in Kaleta. To the extent evidence of this nature is
contained in the video depositions, the parties shall raise objections with the Special
Master.
5. Defendant’s Motion in limine No. 5—To exclude evidence and testimony about
legal standards, duties, and obligations (Doc. 218).
RESERVE RULING. This motion is closely related to Abbott’s motion in limine
No. 4, discussed above. Again, the Court will instruct the jury on the applicable law
regarding Abbott’s duty. The admissibility of this evidence depends on the context and
nature of the questions posed. Plaintiffs accurately pointed out at the final pretrial
conference that there is an important distinction between commenting on the FDA
regulatory scheme as opposed to commenting on the tort duties Defendant owed to
E.R.G. The Court intends to address these concerns at trial where the nuance of the
questions and potential answers can be assessed by the Court. The Court also intends to
offer a more thorough evaluation of the issue as it relates to Dr. Kessler in the Order
addressing Defendant’s pending Daubert motion.
6. Defendant’s Motion in limine No. 6—To limit references to comparative
teratogenicity data (Doc. 211).
DENIED. The birth defect warning for Depakote is identical regardless of
whether it is prescribed for bipolar or epilepsy; additionally, the 2006 label included a
sentence likening Depakote to other antiepileptic drugs. The combination of these two
facts makes comparative teratogenicity data of other available antiepileptic drugs and
psychiatric drugs relevant to this case. Plaintiffs will be allowed to introduce evidence
concerning the comparative teratogenicity of all antiepileptic drugs or psychiatric drugs

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available before the conception of E.R.G. If Abbott believes alternative drugs were not
appropriate for Ms. Raquel, then they are free to evaluate such assertions on
cross-examination. This Order should not be read as allowing references to other drugs
unrelated to the treatment of bipolar or epilepsy, i.e. reference to Thalidomide or
Accutane.
7. Defendant’s Motion in limine No. 7—To exclude references to promotional,
marketing, or sales activities (Doc. 216).
DENIED in part and RESERVED RULING in part.
Abbott seeks to preclude Plaintiffs from presenting testimony, evidence,
argument, and other references to promotional, marketing, or sales activities and
materials. In the alternative, they seek to exclude three specific categories of marketing
material. (Doc. 216, at pp. 1-2). The Court denied a similar Abbott motion in limine in
Kaleta based on the following rationale:
Even without testimony that these materials affected the decisions of Mrs.
Kaleta’s physicians (and it is not entirely clear at this point that is the case),
this evidence is, on the issue of what Abbott knew and when it knew about
the scope of Depakote’s birth defect risks and its proper use in women of
childbearing years. This evidence may also be relevant to the content of the
1999 label if, as Plaintiffs suggest, they can show that Abbott’s marketing
strategy influenced its label. As Judge Herndon found in the Yaz cases,
“evidence about sales goals is certainly relevant particularly when it may
impact decision making regarding labeling.” In re: Yaz, at *10; see also In re
Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prods. Liab. Litig., 369
F.3d 293, 314 (3d Cir. 2004) (“[E]xcessive concern with the image and
marketing of the diet drugs at the expense of making efforts toward
determining whether they were safe could be probative as to whether [the
manufacturer] breached a duty of care towards the plaintiffs.”).
(Case No. 14-CV-847, Doc. 285, at pp. 17-18). Defendant has not provided any new
information or arguments that counter the probative value of this evidence. Indeed,
unlike in Kaleta where it was unclear whether marketing material reached the
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prescribing physicians in question, here Plaintiffs assert that there are call sheets
indicating sales representatives directly marketed to Raquel’s physicians. (Doc. 262, at
p. 36).
To summarize, marketing materials issued before the birth of E.R.G. are certainly
relevant; a decision about post-2006 marketing materials will have to be made on a
case-by-case basis, but unless they contain pre-2006 facts, it is likely that they are not
relevant. The probative value of marketing materials available before E.R.G.’s birth is
not outweighed by the danger of unfair prejudice, confusion, or waste of time.
Additionally, because the teratogenicity warning section of the Depakote label is
identical regardless of the indication, marketing material for epilepsy and migraine
indications will not be excluded (subject to Plaintiffs’ ability to connect the evidence to
the 2006 label or Abbott’s knowledge).
8. Defendant’s Motion in limine No. 8—To exclude reference to off-label use or
promotion (Doc. 217).
DENIED. Defendant seeks to exclude any reference that Christina Raquel was
prescribed Depakote for an off-label purpose. Plaintiffs have indicated that Depakote
was authorized only for the treatment of the acute manic phase of the bipolar disorder.
At the final pretrial conference they indicated that prescribing the medication for over
three weeks indicates that she was prescribed Depakote as a maintenance medicine,
which they allege is an “off-label” purpose. This issue is directly related to Defendant’s
motion in limine No. 14 and No. 17. As Defendant will almost certainly argue that
Christina Raquel’s use of Depakote was appropriate and necessary, Plaintiffs will be
allowed to ask questions and introduce evidence surrounding the prescribing decisions,

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as well as introduce evidence concerning efforts by Abbott to market Depakote for
off-label bipolar treatment. The evidence of Abbott’s conduct concerning pushing
Depakote for unapproved bipolar treatment is admissible, as Plaintiffs put it in Kaleta, to
demonstrate that Abbott had a corporate climate where marketing and sales trumped
patient safety.
9. Defendant’s Motion in limine No. 9—To exclude references to two draft abstracts
and a draft manuscript reporting North American Antiepileptic Drug Registry
data (Doc. 221).
DENIED. Defendant seeks to exclude references to draft abstracts concerning the
preliminary data from the North American Antiepileptic Drug Registry as well as any
email exchanges between the authors and Abbott. The primary argument from
Defendant is that there is no evidence that Ms. Raquel’s doctors ever saw the material.
Plaintiffs counter by arguing that this is evidence that Abbott was made aware of
negative information concerning the teratogenicity of birth defects but instead of
publishing the information, people at Abbott sought to suppress it. They point directly
to the fact the marketing officials were included in the email exchanges used to influence
the choice of language in the final reports. This information certainly is relevant to
Plaintiffs’ theory that marketing decisions were impacting the label. Additionally, the
probative value of this information is not outweighed by the danger of unfair prejudice,
confusion, or waste of time.
10. Defendant’s Motion in limine No. 10—To exclude duplicative testimony
(Doc. 220).
DENIED. Defendant’s request is overly broad and context dependent.

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11. Defendant’s Motion in limine No. 11—To exclude the recitation of exhibits as
evidence (Doc. 219).
DENIED. Defendant’s request is overly broad and context dependent.
12. Defendant’s Motion in limine No. 12—To preclude prescribing physicians who
may testify live at trial from testifying about the adequacy of Abbott’s warnings
and/or offering testimony beyond that provided during their depositions
(Doc. 214).
GRANTED in part and DENIED in part. All of the treating physicians for Ms.
Raquel were designated during discovery as fact witnesses under Rule 26(a)(1)(A).
(Doc. 243, p. 3). They were not designated as expert witnesses. Accordingly, the treating
physicians will be prohibited from offering expert testimony that falls within the scope
of Rule 702. For example, Plaintiffs will not be able to ask questions regarding what
Abbott knew or should have known about Depakote’s teratogenicity. Nor will they be
allowed to offer opinions as a subtitle for an expert psychiatrist regarding Ms. Raquel’s
future treatment (or speculate as to the appropriate treatment for Ms. Raquel once she
departed their respective practices).
Each physician will be allowed, however, to offer testimony concerning his or her
observations, diagnosis, and treatment of Christina Raquel. The Court will address
objections on a case-by-case basis throughout course of trial. Finally, the Court will not
prophylactically limit the treating physicians to the information provided in their
depositions. Any addition or change from the deposition is appropriately handled
through cross-examination and impeachment.
13. Defendant’s Motion in limine No. 13—To exclude references to foreign product
warnings (Doc. 210).
DENIED. This motion seeks to exclude the label for Epilim, the version of

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Depakote sold in the United Kingdom and elsewhere in Europe. Abbott contends that
foreign product labels and the regulatory actions are irrelevant to any issue in this case
because “Ms. Raquel was prescribed Depakote to treat the severe, recurrent manic
symptoms caused by her bipolar disorder.... [whereas the] foreign regulators [approved
Depakote] to treat epilepsy—a different disease with different alternative medications
and different risk-benefit considerations.” (Doc. 210, at p. 1).
The Court disagrees. This evidence is relevant on the issue of Abbott’s knowledge
during a relevant time period (before E.R.G.’s conception) about the drug it introduced
into the United States market. See In re: Yaz, 2011 WL 6740391, at *2 (“While the
regulatory actions of European Medical regulators are not binding on the FDA—a fact
that should be made clear to the finders of fact in this case to avoid confusion—the full
body of knowledge including the foreign regulatory process that came to bear on the
drugs at issue and which were well within the notice and knowledge of [the
manufacturer] is admissible as part of the fabric of how these drugs came to the United
States market and whether all the information which should have been utilized in doing
so was utilized.”); see also Newman ex rel. Newman v. McNeil Consumer Healthcare, No. 10 C
1541, 2013 WL 4460011, at *13 (N.D. Ill. Mar. 29, 2013) (Denying Defendants’ motion in
limine because “[t]he probative value of . . . foreign labeling, as it relates to Defendants’
knowledge of the risks and willfulness in not sharing certain of those risks on its
American OTC label, is not substantially outweighed by the time, potential for
cumulative evidence, or risk of confusion to the jury.”).
The teratogenicity warning section in the Depakote label is identical regardless of

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the indication. Clearly the teratogenicity of Depakote is independent of the indication for
which it is approved. The fact that there are “alternative medications and different
risk-benefit considerations” is fertile ground for cross-examination, but it is not grounds
to exclude evidence of the original Epilim label.
14. Defendant’s Motion in limine No. 14—To exclude references to Christina Raquel’s
post-conception lawful prescription drug use.
DENIED. Defendant seeks to exclude evidence concerning the prescription
medications taken by Christina Raquel to treat her bipolar disorder following the
conception of E.R.G. The Court understands that Ms. Raquel stopped taking Depakote
following the conception of E.R.G. In each case tried to date where the minor child’s
mother took Depakote following the conception, Abbott has sought to introduce the
evidence of that use at trial. Defendant claims that Plaintiffs cannot lay the proper
foundation to make the post conception drug use relevant because they do not have an
expert psychiatrist to talk about the appropriateness of future prescription decisions.
Plaintiffs respond by first noting “on the issue of foundation, Abbott very
conveniently omits the testimony of two of the prescribers who listed a whole laundry
list of available alternative medications at the time, which include medications that she
has taken since the birth….” (Doc. 262, at pp. 63-64). Plaintiffs also correctly point out
that “Abbott is going…. to tell this jury—through their expert… that Depakote was a
necessary and essential medication for [Christina Raquel].” (Doc. 262, at p. 64).
It is clear from the arguments at the final pretrial conference and through other
briefing that Abbott intends to introduce evidence that Depakote was an appropriate
and necessary treatment for Ms. Raquel prior to the conception of E.R.G. What

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medications she took to treat her bipolar disorder following the conception of E.R.G. is
certainly relevant to the veracity of this assertion. Objections based on foundation will be
addressed at trial based on the nature and circumstances of the question posed.
15. Defendant’s Motion in limine No. 15—To exclude references to the heeding
presumption.
GRANTED. The parties agree that California has not adopted the heading
presumption; thus, there will be no reference to this legal doctrine.
16. Defendant’s Motion in limine No. 16—To exclude references to alleged future
problems of E.R.G. not supported by expert testimony to a reasonable degree of
medical certainty (Doc. 200).
RESERVE RULING. Defendant has presented excerpts from Dr. Lott’s
deposition indicating that for certain future medical conditions of E.R.G. he cannot say
to a reasonable degree of medial certainty whether they will occur. Plaintiffs counter by
pointing to his expert report and sections of his deposition transcript claiming that these
same opinions are to a reasonable degree of medical certainty. With this contradiction,
the Court must reserve its ruling on the issue until after Dr. Lott has testified regarding
the future prognosis of Plaintiff E.R.G.
17. Defendant’s Motion in limine No. 17—To exclude evidence, testimony, argument,
and other references to the May 2012 plea agreement, civil settlement, and
corporate integrity agreement in this case (Doc. 230).
GRANTED in part and DENIED in part. In 2012, Abbott pleaded guilty to a
misdemeanor crime and settled an entirely different suit, all related to illegal off-label
marketing efforts by the company towards individuals with schizophrenia and elderly
dementia. 1 In the Kaleta trial, a case involving an epilepsy disorder, the Court excluded

1

Depakote has never been approved as a safe and effective treatment option for individuals with

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this same evidence commenting as follows:
The fact that Abbott pleaded guilty to a misdemeanor crime and settled an
entirely different suit has no relevance in this case. Even if it had minimal
probative value, any probative value is outweighed by the danger of unfair
prejudice, confusing the issues, misleading the jury, undue delay, and/or
wasting time. The Court doubts that this evidence would even be
admissible for the purpose of impeachment (unless Abbott opens the door)
or punitive damages. Counsel shall alert the Court during trial if it intends
to offer this evidence or elicit testimony relating to it in any way.
(Case No. 14-CV-847, Doc. 289, p. 4). Plaintiffs seek to introduce this evidence in Raquel
because “the cited violative conduct is related and substantively connected to how
Abbott’s comprehensive psychiatric marketing strategy influenced its label and
impacted Abbott’s decision-making regarding labeling.” (Doc. 238, at p. 2).
There is no denying that Abbott engaged in a systematic effort to increase sales by
attempting to expand Depakote prescriptions for other non-approved indications. It
appears, however, that Plaintiffs cannot sufficiently connect these activities with the
2006 Depakote teratogenicity warning. The fatal flaw in their assertion is that the link
between the off-label marketing for elderly dementia and schizophrenia is far too
attenuated to the teratogenicity warnings in the 2006 label. Even if the Court were to
accept that the “violative” marketing concerning these two unapproved indications
influenced the teratogenicity labeling in this case, the risk of confusion and unfair
prejudice outweighs the limited probative value. Every trial attorney would relish an
opportunity to talk about how their opponent was found guilty and paid over a billion
dollar fine in a case. The reasoning is simple; the jury would be galvanized against the
“guilty” party from the onset of trial, regardless of whether or not the underlying action

schizophrenia or elderly dementia.

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was connected to the case at hand. Even attempts to explain the distinction would play
into this prejudice as it would simply keep the topic fresh in the minds of the jury.
On the other hand, however, Plaintiffs will be allowed to introduce evidence
regarding the off-label marketing and sales efforts by Abbott regarding the bipolar
disorder. This evidence is relevant to Plaintiffs theory that the corporate culture at
Abbott valued marketing and sales over patient safety. Also, unlike schizophrenia or
elderly dementia, bipolar disorder will be discussed at length throughout trial, thereby
limiting the risk of undue prejudice and confusion of the jury.
IT IS SO ORDERED.
DATED: May 16, 2017
____________________________
NANCY J. ROSENSTENGEL
United States District Judge

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