Willis et al v. Abbott Laboratories et al

Filing 172

MEMORANDUM OPINION AND ORDER by Chief Judge Joseph H. McKinley, Jr. on 12/1/2017. Plaintiffs' motion for partial summary judgment (DN 80 ) is DENIED. Defendants' motion for summary judgment (DN 95 ) is GRANTED IN PART and DENIED IN PART. Plaintiff K.R.W. is DISMISSED as a plaintiff from this action. Defendants' motion to exclude the expert testimony of Dr. Robert Lerer on causation (DN 89 ) is DENIED. Defendants' motion to exclude the expert testimony of Dr. Michael Cecil on causation (DN 87 ) is GRANTED. Defendants' motion to exclude the expert testimony of Dr. Michael Privitera on causation (DN 92 ) is DENIED. cc: Counsel (CDR)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF KENTUCKY
BOWLING GREEN DIVISION
CIVIL ACTION NO. 1:15-CV-00057-JHM
PLAINTIFFS

SUSAN KAY WILLIS and WILLIE
R. WILLIS, both individually and
as parents and natural guardians of
K.R.W. and K.W.W., minors
v.
ABBOTT LABORATORIES and
ABBVIE, INC.

DEFENDANTS

MEMORANDUM OPINION AND ORDER
This matter is before the Court on a motion for summary judgment by defendants Abbott
Laboratories and Abbvie, Inc. (collectively “Abbott”) (DN 95), as well as a motion for partial
summary judgment by plaintiffs Susan and Willie Willis, individually and as parents and natural
guardians of their children K.R.W. and K.W.W. (DN 80.) Also before the Court are three
motions by Abbott to exclude the testimony of expert witnesses for the plaintiffs: Dr. Michael
Cecil (DN 87), Dr. Robert J. Lerer (DN 89), and Dr. Michael Privitera. (DN 92.) Fully briefed,
these matters are ripe for decision.
I. BACKGROUND
A. SUSAN WILLIS
Susan Willis was diagnosed with juvenile myoclonic epilepsy at the age of fifteen in
1995.

(Dep. David Blake [DN 62-1] at 36:13–20.)

She was prescribed Depakote, an

antiepileptic drug (“AED”), to help control her condition. (Id. at 43:3–21.) Susan continued to
take Depakote and was taking it when she became pregnant with K.R.W. around August 2001.
(Dep. Susan Willis [DN 72-1] at 94:23–95:7.) However, she was switched from Depakote to

Dilantin, a different AED, at some point in September 2001 after discovering she was pregnant.
(Id. at 95:9–96:10.) K.R.W. was born on April 22, 2002. (Lerer Report [DN 81-1] at 5.)
Susan remained on Dilantin until May 2003, when she began taking Depakote again.
(Dep. Susan Willis [DN 72-1] at 124:3–11.)

She became pregnant with K.W.W. around

December 2005 and continued to take Depakote throughout her pregnancy. (Id. at 129:14–23;
Lerer Report [DN 81-1] at 6.) K.W.W. was born on September 12, 2006. (Id.) K.R.W. and
K.W.W. suffer from various physical deformities and cognitive disabilities, which the plaintiffs
attribute to Susan’s use of Depakote during her pregnancies. (Pl.’s Compl. [DN 1] ¶¶ 57, 62.)
B. DEPAKOTE
Depakote is an AED that is manufactured and sold by Abbott.1 It was approved by the
Food and Drug Administration (“FDA”) in 1983 for the treatment of absence seizures. (Dep.
James Lavery [DN 50-1] at 196:9–16.) During both of Susan’s pregnancies, the label for
Depakote contained identical warnings about the risk of birth defects. (See 2001 Physicians’
Desk Reference [DN 95-3] at 5–6, 8; 2006 Physicians’ Desk Reference [DN 95-4] at 3, 5–6.)
Each label had a “black box warning” regarding the drug’s teratogenic effects:
TERATOGENICITY:
VALPROATE2 CAN PRODUCE TERATOGENIC EFFECTS
SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA).
ACCORDINGLY, THE USE OF DEPAKOTE TABLETS IN
WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT
THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE
RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY
IMPORTANT
WHEN
THE
TREATMENT
OF
A
SPONTANEOUSLY
REVERSIBLE
CONDITION
NOT
ORDINARILY ASSOCIATED WITH PERMANENT INJURY
OR
RISK
OF
DEATH
(E.G.,
MIGRAINE)
IS
In 2013, Abbott Laboratories transferred ownership of the “New Drug Application” for Depakote to Abbvie. (Pl.’s
Compl. [DN 1] ¶ 14.) For the purposes of this motion, there is no meaningful distinction between Abbott
Laboratories and Abbvie, Inc.
2
Valproate is the active ingredient in Depakote.
1

2

CONTEMPLATED. SEE WARNINGS, INFORMATION FOR
PATIENTS.
AN
INFORMATION
SHEET
DESCRIBING
THE
TERATOGENIC
POTENTIAL
OF
VALPROATE
IS
AVAILABLE FOR PATIENTS.
(Id.) (emphasis in original). Following the black box warning, in the ordinary “Warnings”
section, the label also states the following:
Usage in Pregnancy
ACCORDING TO PUBLISHED AND UNPUBLISHED
REPORTS,
VALPROIC
ACID
MAY
PRODUCE
TERATOGENIC EFFECTS IN THE OFFSPRING OF HUMAN
FEMALES RECEIVING THE DRUG DURING PREGNANCY.
THERE ARE MULTIPLE REPORTS IN THE CLINICAL
LITERATURE WHICH INDICATE THAT THE USE OF
ANTIEPILEPTIC DRUGS DURING PREGNANCY RESULTS
IN AN INCREASED INCIDENCE OF BIRTH DEFECTS IN
THE OFFSPRING. ALTHOUGH DATA ARE MORE
EXTENSIVE WITH RESPECT TO TRIMETHADIONE,
PARAMETHADIONE,
PHENYTOIN,
AND
PHENOBARBITAL, REPORTS INDICATE A POSSIBLE
SIMILAR ASSOCIATION WITH THE USE OF OTHER
ANTIEPILEPTIC DRUGS. THEREFORE, ANTIEPILEPSY
DRUGS SHOULD BE ADMINISTERED TO WOMEN OF
CHILDBEARING POTENTIAL ONLY IF THEY ARE
CLEARLY SHOWN TO BE ESSENTIAL IN THE
MANAGEMENT OF THEIR SEIZURES.
THE INCIDENCE OF NEURAL TUBE DEFECTS IN THE
FETUS MAY BE INCREASED IN MOTHERS RECEIVING
VALPROATE DURING THE FIRST TRIMESTER OF
PREGNANCY. THE CENTERS FOR DISEASE CONTROL
(CDC) HAS ESTIMATED THE RISK OF VALPROIC ACID
EXPOSED WOMEN HAVING CHILDREN WITH SPINA
BIFIDA TO BE APPROXIMATELY 1 TO 2%. OTHER
CONGENITAL
ANOMALIES
(E.G.,
CRANIOFACIAL
DEFECTS, CARDIOVASCULAR MALFORMATIONS AND
ANOMALIES INVOLVING VARIOUS BODY SYSTEMS),
COMPATIBLE AND INCOMPATIBLE WITH LIFE, HAVE
BEEN REPORTED. SUFFICIENT DATA TO DETERMINE
THE INCIDENCE OF THESE CONGENITAL ANOMALIES IS
NOT AVAILABLE. THE HIGHER INCIDENCE OF

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CONGENITAL ANOMALIES IN ANTIEPILEPTIC DRUGTREATED WOMEN WITH SEIZURE DISORDERS CANNOT
BE REGARDED AS A CAUSE AND EFFECT RELATIONSHIP.
THERE ARE INTRINSIC METHODOLOGIC PROBLEMS IN
OBTAINING
ADEQUATE
DATA
ON
DRUG
TERATOGENICITY IN HUMANS; GENETIC FACTORS OR
THE EPILEPTIC CONDITION ITSELF, MAY BE MORE
IMPORTANT THAN DRUG THERAPY IN CONTRIBUTING
TO CONGENITAL ANOMALIES.
(Id.) (emphasis in original).
During Susan’s pregnancies, the Depakote label contained no warnings regarding the risk
of cognitive developmental delay from in utero exposure to Depakote. However, in 2005 and
2007, Abbott sent correspondence to Dr. Russell Katz of the FDA suggesting revisions to the
Depakote label. (See 2005 FDA Correspondence [DN 95-10]; 2007 FDA Correspondence [DN
95-12].) In both letters, Abbott noted that it had monitored and reviewed the available safety
data on Depakote use during pregnancy and suggested the following update to the “WARNINGS
– Usage in Pregnancy” section of the label: “There have been reports of developmental delay in
the offspring of women who have received valproate3 during pregnancy.” (2007 FDA
Correspondence [DN 95-12] at 4.) In both instances, the FDA indicated that the data relied upon
was insufficient to justify a label change at that time and that “the proposed sentence should not
be incorporated into labeling.” (2006 FDA Correspondence [DN 95-11] at 3.) (See also 2008
FDA Contact Report [DN 95-13] at 3) (“Dr. Katz stated they can not approve this labeling
change at this time.”) Further, in 2009 Abbott sent another letter to the FDA seeking “advice on
the acceptability of [recent] data for use to support an amendment to the current label regarding
the risk of developmental delay and/or autism/autism spectrum disorder with intrauterine
exposure to valproate.” (2009 FDA Correspondence [DN 95-14] at 4.) The FDA told Abbott

The 2005 proposed warning uses the term “valproic acid” as opposed to “valproate.” (2005 FDA Correspondence
[DN 95-10] at 7.)

3

4

later in 2009 that “they were not ready to ‘sign off on the labeling language.’” (2009 FDA
Contact Report [DN 95-16] at 4.)

The FDA finally approved a label change for Depakote in

October 2011 that included a warning “pertaining to valproate and neurodevelopmental delay.”
(2011 FDA Correspondence [DN 95-20] at 2.)
C. PROCEDURAL HISTORY
Susan and her husband, Willie Willis, brought the present action against Abbott both
individually and on behalf of their children. (Pl.’s Compl. [DN 1].) They assert seven state-law
claims against Abbott related to the manufacturing, labeling, and sale of Depakote: strict
products liability – design defect (Count I); strict products liability – failure to warn (Count II);
negligence (Count III); negligent misrepresentation and fraud (Count IV); breach of express
warranty (Count V); breach of implied warranty of merchantability (Count VI); and breach of
implied warranty of fitness (Count VII). (Id. ¶¶ 82–168.) Abbott has moved for summary
judgment as to all claims against it. (DN 95.) The plaintiffs have also moved for partial
summary judgment on Abbott’s defense of preemption. (DN 80.)
Both parties have also submitted motions to exclude or limit the testimony of a variety of
experts. (See DN 83–94, 163.) Based upon the grounds asserted in the parties’ motions for
summary judgment, the Court need only decide three of these motions to exclude in order to
effectively decide the summary judgment motions: those in relation to Dr. Michael Cecil (DN
87), Dr. Robert J. Lerer (DN 89), and Dr. Michael Privitera. (DN 92.) Therefore, the Court will
defer consideration of any other motion to exclude or limit testimony until after the motions for
summary judgment have been decided. Further, the Court will only consider the arguments
made to exclude opinions related to causation at this time, as only those arguments are relevant

5

to deciding the motions for summary judgment. Any other arguments to exclude or limit
testimony will be considered in a separate order.
II. STANDARD OF REVIEW
Before the Court may grant a motion for summary judgment, it must find that there is no
genuine dispute as to any material fact and that the moving party is entitled to judgment as a
matter of law. Fed. R. Civ. P. 56(a). The moving party bears the initial burden of specifying the
basis for its motion and identifying that portion of the record that demonstrates the absence of a
genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). Once the
moving party satisfies this burden, the non-moving party thereafter must produce specific facts
demonstrating a genuine issue of fact for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
252 (1986).
Although the Court must review the evidence in the light most favorable to the nonmoving party, the non-moving party must do more than merely show that there is some
“metaphysical doubt as to the material facts.” Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio
Corp., 475 U.S. 574, 586 (1986). Instead, the Federal Rules of Civil Procedure require the nonmoving party to present specific facts showing that a genuine factual issue exists by “citing to
particular parts of materials in the record” or by “showing that the materials cited do not
establish the absence . . . of a genuine dispute[.]” Fed. R. Civ. P. 56(c)(1). “The mere existence
of a scintilla of evidence in support of the [non-moving party’s] position will be insufficient;
there must be evidence on which the jury could reasonably find for the [non-moving party].”
Anderson, 477 U.S. at 252.

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III. DISCUSSION
Abbott has moved for summary judgment as to all counts. The plaintiffs have conceded
any claims for breach of warranty (DN 141, at 39 n. 10); therefore, only Counts I–IV remain.
The Court will first address the motions for summary judgment as to Abbott’s preemption
defense.

Next, it will consider Abbott’s argument regarding the plaintiffs’ strict products

liability – design defect claim. It will then consider Abbott’s argument as to whether there is any
evidence of causation, which will require the Court to decide the motions to exclude the
testimony of Drs. Cecil, Lerer, and Privitera. Finally, the Court will address the plaintiffs’
claims for negligent misrepresentation and fraud.
A. PREEMPTION
Abbott argues that any claim that is based upon its failure to adequately warn of the risk
of cognitive developmental delay from in utero exposure to Depakote is preempted by federal
law. A drug “manufacturer bears responsibility for the content of its label at all times.” Wyeth v.
Levine, 555 U.S. 555, 570–71 (2009). However, the FDA “has the authority to reject any
labeling changes,” creating the possibility that a drug manufacturer’s ability to change its label to
comply with state tort law may be impeded by the FDA’s labeling requirements. Rheinfrank v.
Abbott Labs., 680 F. App’x 369, 385 (6th Cir. 2017). Thus, if a drug manufacturer can “show by
‘clear evidence,’ that the FDA would have rescinded any change in the label,” then the
manufacture has sufficiently “demonstrate[d] that it would in fact have been impossible to do
under federal law what state law required,” and the requirements of the FDA preempt those of
state tort law. PLIVA, Inc. v. Mensing, 564 U.S. 604, 624 n. 8 (2011) (quoting Wyeth, 555 U.S.
at 571).

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In deciding whether Abbott has presented clear evidence that the FDA would have
rejected any label changes to address the risk of cognitive developmental delay, the Court does
not write on a blank slate. In Rheinfrank, the Sixth Circuit affirmed the conclusion, by Judge
Dlott of the Southern District of Ohio, that all claims based upon the failure to warn of the risk of
cognitive developmental delay from in utero exposure to Depakote were preempted. 680 F.
App’x at 385. Further, the “clear evidence” in that case is identical to the evidence Abbott has
submitted in this case to demonstrate that the FDA would not have approved a change to the
Depakote label to include a warning about the risk of cognitive developmental delay.

In

Rheinfrank, the district court considered Abbott’s 2005 correspondence with Dr. Katz of the
FDA that sought to add a warning about developmental delay (DN 95-10) and the FDA’s
subsequent rejection of this language.

(DN 95-11.)

It also considered Abbott’s 2007

correspondence with the FDA that once again sought to strengthen the Depakote label as it
pertained to developmental delay (DN 95-12) and the FDA’s response that it “can not approve
this labeling change at this time.” (DN 95-13.) Finally, the district court considered Abbott’s
2009 request for guidance from the FDA as to what should be included in the Depakote label
regarding developmental delay (DN 95-14, 95-15) and the FDA’s response that it was not ready
at this time to support any label changes. (DN 94-16.) Based upon this evidence, the district
court concluded that “[p]reemption is warranted because there is clear evidence the FDA would
not have approved a change to the Depakote label adding a developmental delay warning prior
to” the plaintiff’s injuries. Rheinfrank v. Abbott Labs., Inc., 119 F. Supp. 3d 749, 766 (S.D. Ohio
2015). The Sixth Circuit affirmed, stating that “Abbott has met its burden under Wyeth’s clearevidence standard” and specifically noting the 2005 and 2007 rejections by the FDA of Abbott’s
proposed changes. Rheinfrank, 680 F. App’x at 386.

8

The record in Rheinfrank on this issue is identical to the record currently before the
Court. Therefore, the Court concludes that any state law tort claim that is premised upon
Abbott’s failure to warn of the risk of developmental delay is preempted, as there is clear
evidence that the FDA would not have approved such a warning. See also In re Depakote, 87 F.
Supp. 3d 916, 922 (S.D. Ill. 2015) (“The Court finds that there is clear evidence that the FDA
would not have approved a change to the 1999 label to include a warning of developmental
delay”); Hutchens v Abbott Labs., Inc., 2016 WL 5661582, at *8 (N.D. Ohio Sep. 30, 2016)
(“Therefore, the Court finds Plaintiffs’ claim that Defendants’ failure to warn of the risks of
cognitive developmental delay from use of Depakote by women of childbearing age renders its
label inadequate is preempted by federal law”).
The plaintiffs present numerous arguments in opposition to summary judgment; some of
these were considered and rejected by the Sixth Circuit in Rheinfrank, while others are new. The
Court will address each in turn.
First, in its own motion for partial summary judgment on the issue of preemption, the
plaintiffs argue that “Abbott’s First Amendment right to speak gave Abbott the means of
complying with Kentucky law and warning about Depakote’s risks of developmental delay,
autism, and/or autism spectrum disorder.” (Pl.’s Mot. for Summ. J. [DN 80-1] at 7.) They argue
that, because Abbott has a First Amendment right to speak in a truthful and non-misleading
manner about Depakote, it cannot claim that the FDA’s rejection of its label changes made it
“impossible” for it to comply with the requirements of Kentucky law.
The plaintiffs cite to no standard the Court should look to in evaluating whether Abbott
has a First Amendment right to include a warning about developmental delay in the Depakote
label or whether the FDA’s rules and practices regarding drug labeling unconstitutionally

9

infringe upon that right. Compare with Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 553
(2001) (providing standard for First Amendment challenges to commercial speech, including
whether speech “concern[s] lawful activity” and is “not . . . misleading,” whether “governmental
interest is substantial,” whether regulation “directly advances” that interest, and whether it is
“more extensive” than necessary”) (citations omitted).

Instead, they cite to a line of cases

which pertain exclusively to the marketing, as opposed to labeling, of drugs and seek to apply
them to the present case. See Sorrell v. IMS Health Inc., 564 U.S. 552, 557 (2011) (finding law
that “restricts the sale, disclosure, and use of pharmacy records that reveal the prescribing
practices of individual doctors” unconstitutionally infringes on protected “speech in aid of
pharmaceutical marketing”); United States v. Caronia, 703 F.3d 149, 169 (2d Cir. 2012) (holding
that “the government cannot prosecute pharmaceutical manufacturers . . . for speech promoting
the lawful, off-label use of an FDA-approved drug”); Amarin Pharma, Inc. v. U.S. Food & Drug
Admin., 119 F. Supp. 3d 196, 226 (S.D.N.Y 2015) (enjoining action for misbranding against drug
manufacturer, as “truthful and non-misleading speech promoting the off-label use of an FDAapproved drug . . . cannot be the act upon which an action for misbranding is based”).
The Court finds each of these cases, as well as the other out-of-circuit district court cases
cited, to be distinguishable and unpersuasive. The plaintiffs essentially ask the Court to find that
the FDA’s authority to reject proposed label changes regarding drug safety amounts to an
unconstitutional suppression of a drug manufacturer’s speech. None of the cases cited by the
plaintiffs support such a broad proposition, and understandably so, given the recognition courts
have long given to the role of the FDA in regulating the labeling of drugs. See Mensing, 564
U.S. at 612 (“Federal law imposes far more complex drug labeling requirements”). Nor can the
plaintiffs argue that Abbott has a First Amendment right to speak outside of the label, as the

10

FDA still considers such speech to be a part of the drug’s “label.” Id. at 615 (deferring to FDA’s
opinion that “Dear Doctor letters qualify as ‘labeling.’ Thus, any such letters must be consistent
with and not contrary to [the drug’s] approved . . . labeling. A Dear Doctor letter that contained
substantial new warning information would not be consistent with the drug’s approved labeling”)
(citations and quotations omitted); Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 581 n. 1 (6th Cir.
2011) (“The FDA construes labeling broadly, to include not just the written label associated with
the drug, but communications with physicians and other healthcare professionals containing
additional warnings (‘Dear Doctor’ letters) and information published in the Physician’s Desk
Reference”) (citing Mensing, 564 U.S. at 615). Thus, the cases cited by the plaintiffs are not
persuasive.
Comparatively, the Supreme Court in Wyeth and Mensing spoke directly on the FDA’s
power to regulate what speech appears in a drug’s “label” and when that power takes preemptive
effect over what is required by state tort law. The plaintiffs’ argument would require the Court
to cast aside both cases and the scheme of preemption that they endorse. The Court is not
persuaded that the First Amendment requires it to do so. Therefore, the Court rejects the
plaintiffs’ First Amendment argument.
Second, the plaintiffs argue that preemption is a question of fact that must be submitted to
a jury, and that a jury must find that federal law would have prohibited Abbott from complying
with state law by “clear and convincing evidence,” as opposed to merely “clear evidence.” First,
as to the standard to be applied, the plaintiffs cite to a Third Circuit case, In re Fosamax, 852
F.3d 268, 285–86 (3d Cir. 2017), for the proposition that the “clear evidence” standard stated by
the Supreme Court in Wyeth is commensurate with the more traditional “clear and convincing”
evidentiary standard. The Court need not resolve whether “clear” means “clear and convincing,”

11

as the Sixth Circuit has already determined that the evidence in Rheinfrank, which is identical to
the evidence in this case, met the “clear evidence” standard. Therefore, whatever “clear” means,
it has been met. As to whether preemption is a question of fact, the plaintiffs cite to Brown v.
Earthboard Sports USA, Inc., 481 F.3d 901, 912–13 (6th Cir. 2007), which notes the following
standard for evaluating a motion for summary judgment on preemption grounds:
[T]he basic principles for successfully asserting federal preemption
as an affirmative defense on summary judgment are sufficiently
clear: it is first incumbent on the party moving for summary
judgment to demonstrate that federal preemption potentially
applies to the facts and circumstances of the suit, and, if so, the
movants must adduce sufficient evidence, interpreted in a light
most favorable to the non-moving party, to prove that there is no
genuine issue of material fact contradicting the claim that the case
at bar actually and unquestionably qualifies for federal preemption.
The first step presents a purely legal determination, but the second
raises a mixed question. Should the movants fail to meet their
burden with respect to the latter step, such as if a genuine issue of
material fact exists regarding the claim's actual qualification for
federal preemption, the matter must be determined by the
factfinder.
Id. at 913 (citations omitted). Abbott argues that this is a pre-Wyeth case, and that the postWyeth body of case law that has developed, including Rheinfrank, establishes that preemption is
purely a question of law. But again, regardless of whether the Sixth Circuit in Rheinfrank was
viewing the issue as purely legal or a mixed question of law and fact, it found the record to be
sufficient to grant Abbott’s motion for summary judgment on preemption grounds. Here, Abbott
has met its burden under Wyeth to show by clear evidence that the FDA would not have
approved any changes to the label that added a warning regarding the risk of developmental
delay, and it has also met its burden under Brown by first showing that preemption potentially
applies to the facts of the case and then adducing sufficient evidence to show that preemption

12

“actually and unquestionably” applies.4 Whichever standard the Sixth Circuit actually applied is
of no import, since both lead to the same outcome: preemption. Therefore, the plaintiffs’
argument on this point is without merit.
Third, the plaintiffs argue that even if preemption applies, it only applies to their claims
that the warnings regarding “developmental delay” were inadequate, and that “developmental
delay” does not include autism or autism spectrum disorder. They argue that Abbott has not
presented clear evidence that the FDA would not have approved a label change that included a
warning about autism, and their claims based upon Abbott’s failure to warn of this risk are not
preempted. Abbott argues in response that the FDA clearly included autism within the umbrella
of “developmental delay” when it rejected Abbott’s proposed label changes.
The plaintiff in Rheinfrank did not suffer specifically from autism. See Rheinfrank, 119
F. Supp. 3d at 756 (the plaintiff “has been diagnosed with congenital malformations, facial
dysmorphisms, cognitive impairment, developmental delay, and Fetal Valproate Syndrome”).
Thus, the Sixth Circuit did not face the issue of whether autism is included within the umbrella
term of “developmental delay” for preemption purposes. However, based upon the record
presently before the Court, there is clear evidence that the FDA would not have approved a label
change to include a warning for autism before the plaintiffs were injured. Abbott has produced
its meeting minutes from a teleconference with representatives from the FDA’s Division of
Neurology Products, including Dr. Katz, from September 2009, the same minutes relied upon by
the district court in Rheinfrank. (2009 FDA Contact Report [DN 95-16] at 3–5.) The minutes
raise questions as to whether the FDA included autism under the umbrella of “developmental
delay.” (See id. at 4) (“Dr. Katz indicated that the data available [for autism] are not sufficiently
The Court is inclined to agree with Abbott that Wyeth’s “clear evidence” standard likely abrogates Brown’s
“actually and unquestionably” language in regards to preemption cases involving FDA labeling requirements. But
again, this need not be answered definitively at this time, as both standards have been met.
4

13

compelling to be combined with Developmental Delay at this time”). But more importantly, the
minutes show that the FDA would not have approved a label change to include a warning of the
risk of autism from in utero exposure to Depakote. Under the heading “Autism,” the minutes
state, “Dr. Katz indicated that the data available is not sufficiently compelling to warrant any
language in the label[.]” This language is sufficient to meet the “clear evidence” standard of
Wyeth, as it demonstrates that the FDA would not have approved a warning in the Depakote
label about the risk of autism. This language is very similar to the rejection language regarding
developmental delay that both the Sixth Circuit and district court in Rheinfrank found sufficient
to establish preemption. (Compare with 2008 FDA Contact Report [DN 95-13] at 3) (“Dr. Katz
stated they can not approve this labeling change at this time.”) Nor is this statement merely an
example of the FDA having “paid no more than passing attention” to the issue. Wyeth, 555 U.S.
at 563. Instead, the minutes note that the FDA viewed the data as “worth following up on and is
currently under discussion within the Agency. Dr. Katz specifically identified there may be data
available from Dr. Holmes (registry); he indicated that in the absence of these data, they may
consider an epidemiological study.” (2009 FDA Contact Report [DN 95-16] at 5.) Taken
together, this is clear evidence that the FDA would not have approved a label change to include a
warning of the risk of autism in 2009, as the FDA considered the data available at this time to be
insufficient to warrant language on autism in the label. Likewise, this means the same would
have been true during Susan Willis’ pregnancies. See Rheinfrank, 680 F. App’x at 386 (“Given,
then, that as of 2008 the FDA did not believe the state of the data supported a developmental
delay warning, it stands to reason that as of 2003 [during plaintiff’s pregnancy], with even less
data to go on, the FDA would similarly have rejected a developmental delay warning”). Thus,

14

the Court finds that any claims based upon Abbott’s failure to warn of the risk of autism are
likewise preempted.
Fourth, the plaintiffs argue that evidence of what Abbott knew or should have known
prior to the plaintiffs’ injuries precludes summary judgment on preemption grounds. They argue
that there are factual disputes as to what Abbott knew about the risk of Depakote to the
developing fetus, what it should have known, what it could have known had it conducted certain
types of testing, and what the FDA could have done with this information. This argument was
explicitly rejected by the Sixth Circuit in Rheinfrank as speculative and ultimately irrelevant to
the issue of preemption:
Rheinfrank further argues that Wyeth makes relevant to a “clear
evidence” inquiry not just what Abbott knew but also what it
should have known, and that under that standard Abbott fell well
short of its responsibility under federal labeling law by refusing to
fund or conduct studies probing Depakote’s effects on
developmental delay. But this argument is too conjectural to defeat
preemption. As the Court has explained, speculation as to what a
third party or the Federal Government might do that would make it
lawful for a private party to accomplish under federal law what
state law requires of it cannot thwart a claim of preemption, as
evidence of that kind would make most conflicts between state and
federal law illusory, and thus render conflict pre-emption all but
meaningless. That, however, is exactly what Rheinfrank asks this
court to accept: a series of speculations as to what the FDA could
have done with different evidence that Abbott might have collected
if it had run its own studies. Because such speculations are not
enough to undermine the clear evidence that the FDA would have
rejected a strengthened warning on Depakote’s label prior to
M.B.D.’s injury, Rheinfrank’s failure-to-warn claim is preempted
by federal law.
Rheinfrank, 680 F. App’x at 387–88 (citations and quotations omitted). Likewise, in this case,
there is clear evidence that the FDA would have rejected a strengthened label prior to the
plaintiffs’ injuries, and any speculation as to what the FDA may have done had Abbott

15

performed certain testing remains just that: speculation.

Therefore, the Court rejects this

argument.
Fifth, the plaintiffs raise evidentiary challenges to some of the documents Abbott uses to
show that the FDA would have rejected any proposed label changes. They argue that three of the
documents are inadmissible hearsay: the FDA’s response to Abbott’s proposed label change in
2005 (DN 95-11), the contact report detailing the FDA’s rejection of Abbott’s proposed label
change in 2007 (DN 95-13), and the contact report showing that the FDA would not have
approved a label change in 2009.5 (DN 95-16.) Abbott provides a number of theories under
which these documents could be admissible, arguing (1) that the documents contain verbal acts
of legal significance that are not considered hearsay, (2) that preemption is a threshold issue for
which can be decided purely as a matter of law without applying the rules of evidence, (3) that
the alleged hearsay is a command that cannot be hearsay, (4) that the documents fall within the
business records exception, (5) that the documents fall within the public records exception, (6)
that the Court should apply the residual hearsay exception, and (7) that the plaintiffs have not
shown that the evidence contained within the documents could not be presented at trial in an
admissible form.
The Court finds the verbal acts doctrine to be applicable to these three documents and the
statements contained therein, taking them outside the realm of hearsay.

An out-of-court

statement is only hearsay if it is offered “to prove the truth of the matter asserted.” Fed. R. Evid.
801(c)(2). However, when “legal consequences flow from the fact that words were said,” then
the statement is not an assertion but rather a verbal act that is not considered hearsay. Preferred

5

The plaintiffs challenge the admissibility of other documents, but only the above three were used by the Court to
conclude that clear evidence existed that the FDA would not have approved a label change. Therefore, the Court
need not consider the challenge to any other documents, since the plaintiffs only challenge their admissibility in
relation to the issue of preemption.

16

Prop., Inc. v. Indian River Estates, Inc., 276 F.3d 790, 798 n. 5 (6th Cir. 2002). Here, the
relevant statements by the FDA, all indicating that it either cannot or will not approve a label
change that includes a warning of the risk of cognitive developmental delay or autism, “carr[y]
significant legal consequences,” as the rejection of the proposed label changes caused the FDA’s
labeling requirements to preempt state tort law. Guardian Ins. & Annuity Co., Inc. v. White,
2014 WL 2515406, at *2 (S.D. Ohio June 3, 2014).

While the correspondence and meeting

minutes do not fall into the traditional category of documents with independent legal
significance, such as a contract, see Roberson v. U.S. Bank, N.A., 831 F.3d 757, 764 (6th Cir.
2016), these out-of-court statements by representatives of the FDA affected Abbott’s legal rights
and potential liabilities under the law, which is all that is required for the verbal acts doctrine to
apply. Thus, the documents have independent legal significance and are not hearsay. See
Zeneca Inc. v. Eli Lilly and Co., 1999 WL 509471, at *3 (S.D.N.Y. July 19, 1999) (FDA
documents were not hearsay, since “the plaintiff seeks to admit the FDA documents for the fact
of what the FDA said to Eli Lilly about Evista . . . Thus, the documents are admissible as nonhearsay”).
Finally, the plaintiffs argue that Abbott’s evidence is not “indisputable,” making it
insufficient to meet the “clear evidence” standard under Wyeth.

Again, this argument is

substantially undermined by the Sixth Circuit’s conclusion that this exact same evidence did
constitute “clear evidence” that the FDA would not have approved a label change regarding the
risk of developmental delay. Rheinfrank, 680 F. App’x at 386. The plaintiffs raise specific
arguments regarding certain documents, which the Court will again limit to only the three
documents in which the FDA indicated it would not approve a label change. See supra note 5.
Generally, the plaintiffs argue that there are questions regarding the credibility of the meeting

17

minutes and that, because emails and phone calls are not the method by which the FDA formally
rejects a proposed label change, they do not indisputably establish that the FDA would not have
approved a label change. As to the second of these arguments, the Sixth Circuit explicitly
rejected it in Rheinfrank:
[T]he Court in Wyeth did not say that for evidence to be clear it
must result from a formal procedure of approval or disapproval.
Indeed, to require as much would appear to require a rewriting of
the Court’s chosen test – from whether “the FDA would not have
approved a change” to a drug’s label . . . to whether the FDA had
not approved it . . . all that Abbott need have done – and did do
here – is show that the FDA would have rescinded any change in
the label, a showing that does not appear the exclude the kind of
informal communications from FDA higher-ups that Abbot
provided.
Rheinfrank, 680 F. App’x at 386–87 (citations and quotations omitted). The Court holds the
same here, as Abbott has provided clear evidence that the FDA would not have approved a
change. And as to the first argument challenging the credibility of the documents, the questions
raised by the plaintiffs are nothing more than “metaphysical doubt[s] as to the material facts”
that the Supreme Court has rejected as insufficient to defeat a motion for summary judgment.
Matsushita, 475 U.S. at 586. The only evidence related to whether the FDA would have
approved a label change for Depakote is Abbott’s records of the FDA refusing to permit such a
change both before and after the plaintiffs’ injuries.

The plaintiffs’ questions about who

recorded this information and how it should be read in conjunction with the FDA’s later approval
of such warnings does not make the evidence any less clear.
Therefore, the plaintiffs’ motion for partial summary judgment as to Abbott’s preemption
defense is DENIED. Abbott’s motion for summary judgment is GRANTED to the extent that
any claims that seek to hold Abbott liable for its failure to warn of the risk of developmental
delay or autism from in utero exposure to Depakote are preempted.

18

B. DESIGN DEFECT
Abbott argues that summary judgment is appropriate for the plaintiffs’ design defect
claim. It makes three arguments on this point: (1) comment k to § 402A to the Restatement
(Second) of Torts precludes a design defect claim; (2) the plaintiffs have no expert proof of a
feasible alternative design, and (3) design defect claims for prescription drugs after they receive
FDA approval are preempted under Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281,
298–99 (6th Cir. 2015). The plaintiffs respond by arguing that Abbott’s failure to contraindicate
Depakote for women of childbearing potential made its design defective and that
contraindication would have been a feasible alternative design for the drug. In its reply, Abbott
takes issue with what it views as an attempt to rename what is essentially a failure to warn claim
as a defective design claim, since a drug’s indications have nothing to do with the composition of
the drug but rather its label and warnings.
The Court agrees with Abbott that the plaintiffs cannot pursue a design defect claim
based upon the drug’s indications. The plaintiffs cite to no cases that support this attenuated
definition of “design.”6 Further, a drug’s indications and contraindications must be included in
its label. See 21 C.F.R. § 201.57(a)(6) and (9). Design defect claims focus on the “qualitative or
quantitative formulation of the drug products,” not information that if included would allow the
drug to be used in a safer manner. Yates, 808 F.3d at 298. The plaintiffs point to Kentucky cases
that seem to endorse a less rigid framework for proving a products liability claim.
6

E.g.,

The plaintiffs cite to C & S Fuel, Inc. v. Clark Equip. Co., 552 F. Supp. 340, 247 (E.D. Ky. 1982), and its
statement that “a drug might be dangerous to a small percentage of the population with unusually high blood
pressure. In such a situation, it might be unreasonably dangerous to market the product without a warning, and the
design of the product would be defective if it were marketed in that manner.” However, this single statement
appears in a discussion of whether a manufacturer of a tractor had a duty to warn of the risk of fire, an issue that the
court ultimately found irrelevant, and cites to a law review article that, upon the Court’s inspection, does not appear
to stand for the proposition that a product’s lack of warnings render its design defective. Phillips, Jerry J., The
Standard for Determining Defectiveness in Products Liability, 46 U. CIN. L. REV. 101, 106 (1977) (“the plaintiff
may be able to avoid the complexities of proving design deficiency by alleging warning inadequacy instead”). Thus,
the Court does not find the comment in C & S equating design and failure to warn defects to be persuasive.

19

Montgomery Elevator Co. v. McCullough, 676 S.W.2d 776, 780–81 (Ky. 1984) (“Considerations
such as feasibility of making a safer product, patency of the danger, warnings and instructions,
subsequent maintenance and repair, misuse, and the product’s inherently unsafe characteristics,
while they have a bearing on the question as to whether the product was manufactured ‘in a
defective condition unreasonably dangerous,’ are all factors bearing on the principal question
rather than separate legal questions”). But even if the Court were to examine the plaintiffs’
claim under this more holistic approach, the lack of contraindications for the drug would still not
be considered a part of its design but rather its “warnings and instructions.” Thus, the Court will
not let the plaintiffs’ claim proceed under a theory that the failure to contraindicate Depakote
made the drug’s design defective, making Abbott’s arguments regarding comment k, feasible
alternative designs, and Yates preemption moot.

Therefore, Abbott’s motion for summary

judgment as to Count I for strict products liability – design defect is GRANTED.
C. CAUSATION
Abbott argues that all claims that seek to hold it liable for the plaintiffs’ developmental
delay, behavioral conditions, and clinodactyly must be dismissed, as there is no admissible
evidence showing that these conditions were caused by the plaintiffs’ exposure to Depakote.
This argument is premised upon the Court concluding that the plaintiffs’ proposed expert
opinions as to causation are inadmissible. Therefore, the Court will first consider the relevant
motions to exclude or limit the testimony of Drs. Cecil, Lerer, and Privitera.
1. STANDARD OF REVIEW
Fed. R. Evid. 702 permits opinion testimony by witnesses who are sufficiently qualified
to testify as experts.

The Sixth Circuit has interpreted Rule 702 so as to impose three

requirements for expert testimony:

20

First, the witness must be qualified by “knowledge, skill,
experience, training, or education.” Fed. R. Evid. 702. Second,
the testimony must be relevant, meaning that it “will assist the trier
of fact to understand the evidence or to determine a fact in issue.”
Id. Third, the testimony must be reliable. Id.
In re Scrap Metal Antitrust Litig., 527 F.3d 517, 528–29 (6th Cir. 2008). Under Rule 702, the
trial judge acts as a gatekeeper to ensure that expert evidence is both reliable and relevant.
Mike’s Train House, Inc. v. Lionel L.L.C., 472 F.3d 398, 407 (6th Cir. 2006) (citing Kumho Tire
Co., Ltd. v. Carmichael, 526 U.S. 137 (1999)).
In determining whether testimony is reliable, the Court’s focus “must be solely on
principles and methodology, not on the conclusions that they generate.” Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579, 595 (1993). The Supreme Court identified a non-exhaustive list of
factors that may help the Court in assessing the reliability of a proposed expert’s opinion,
including: (1) whether a theory or technique can be or has been tested; (2) whether the theory has
been subjected to peer review and publication; (3) whether the technique has a known or
potential error rate; and (4) whether the theory or technique enjoys “general acceptance” within a
“relevant scientific community.” Id. at 592–94. Whether the Court applies these factors to assess
the reliability of an expert’s testimony “depend[s] on the nature of the issue, the expert’s
particular expertise, and the subject of his testimony.” Kumho, 526 U.S. at 150 (quotation
omitted). “Red flags that caution against certifying an expert include reliance on anecdotal
evidence, improper extrapolation, failure to consider other possible causes, lack of testing, and
subjectivity.” Newell Rubbermaid, Inc. v. Raymond Corp., 676 F. 3d 521, 527 (6th Cir. 2012).
While Rule 702 “does not require anything approaching absolute certainty,” it requires
more than speculation. Tamraz v. Lincoln Elec. Co., 620 F.3d 665, 671–72 (6th Cir. 2010).
Specifically as to an opinion on causation, the Sixth Circuit has stated the following:

21

The expert’s conclusions regarding causation must have a basis in
established fact and cannot be premised on mere suppositions. An
expert’s opinions, where based on assumed facts, must find some
support for those assumptions in the record. However, mere
weaknesses in the factual basis of an expert witness’ opinion . . .
bear on the weight of the evidence rather than on its admissibility.
McLean v. 988011 Ontario, Ltd., 224 F.3d 797, 800–01 (6th Cir. 2000) (internal quotations and
citations omitted). See also In re Scrap Metal Antitrust Litig., 527 F.3d at 530 (any weakness in
the underlying factual basis bears on the weight, as opposed to admissibility, of the evidence).
Finally, while the parties have requested oral arguments on these motions, the Court finds
that it is sufficiently informed, through the briefing of all the motions to exclude and the
extensive record developed that includes depositions and expert reports, to rule upon the motions
without conducting a hearing or oral arguments. Nelson v. Tenn. Gas Pipeline Co., 243 F.3d
244, 248–49 (6th Cir. 2001) (within discretion of district court to hold Daubert hearing when
issue has been fully briefed by both parties and the record contains “adequate basis” from which
to decide the motion) (citations omitted).
2. ANALYSIS
I. DR. ROBERT LERER

The Court begins with the motion to exclude Dr. Lerer’s expert testimony on causation,
as Abbott argues that other experts improperly relied on Dr. Lerer’s inadmissible opinions. Dr.
Lerer is a board-certified pediatrician with a subspecialty in developmental pediatrics. (Lerer
CV [DN 132-1] at 3.) He performed an in-person pediatric assessment of the plaintiffs. (Lerer
Report [DN 115-2] at 17.) In his expert report for this case, he opines “to a reasonable degree of
medical certainty” and “in the absence of other possible causes” that the injuries to K.R.W.
(diminished intellectual function, and a severe learning disability) and K.W.W. (autism
spectrum, attention deficit disorder, and low intelligence) “are the result of in utero exposure to

22

Depakote.”7 (Id. at 20–21.) Abbott does not contest that Dr. Lerer is qualified to offer this
opinion, or that the opinion is relevant to the issues in the case; rather, it seeks to exclude this
opinion on the basis that Dr. Lerer’s methodology is unreliable.
Abbott argues that Dr. Lerer’s opinion on causation was not the product of a proper
differential diagnosis. Differential diagnosis is “a standard scientific technique of identifying the
cause of a medical problem by eliminating the likely causes until the most probable one is
isolated.” Haryman v. Norfolk & W. Ry. Co., 243 F.3d 255, 260 (6th Cir. 2001) (quotations
omitted). “[A] physician who applies differential diagnosis to determine causation considers all
relevant potential causes of the symptoms and then eliminates alternative causes based on a
physical examination, clinical tests, and a thorough case history.” Pluck v. BP Oil Pipeline Co.,
640 F.3d 671, 678 (6th Cir. 2011) (quotations omitted). When differential diagnosis is used to
determine causation, the Court must answer three questions to determine if the opinion is
sufficiently reliable:
(1) Did the expert make an accurate diagnosis of the nature of the
disease? (2) Did the expert reliably rule in the possible causes of
it? (3) Did the expert reliably rule out the rejected causes? If the
Court answers “no” to any of these questions, the court must
exclude the ultimate conclusion reached.
Tamraz, 620 F.3d at 674. Abbott’s motion does not argue that the diagnosis of the plaintiffs’
cognitive impairments was inaccurate8 or that in utero exposure to Depakote was unreliability
ruled in as a cause of the plaintiffs’ injuries. Instead, it argues that Dr. Lerer’s methodology
failed to reliably rule out other causes of their injuries. Abbott argues that Dr. Lerer failed to rule

7

While Dr. Lerer notes that K.R.W. suffers from clinodactyly of the fifth toes and that K.W.W. suffers from
physical anomalies and stigmata, he offers no opinion on the cause of these injuries in his report. (Lerer Report [DN
115-2] at 20–21.)
8
It does argue that the diagnosis of K.R.W.’s clinodactyly was inaccurate, but because Dr. Lerer’s report does not
make a conclusion as to whether that was caused by in utero exposure to Depakote, the Court need not consider
whether Dr. Lerer’s opinion that K.R.W. suffers from clinodactyly is admissible at this time.

23

out potential genetic causes, family history, and environmental and social factors that could
better explain the plaintiffs’ cognitive impairments. The plaintiffs argue that Dr. Lerer did
sufficiently rule out other causes, such as Susan’s ingestion of Dilantin during her pregnancy
with K.R.W., genetic causes such as Fragile X syndrome and Angelman syndrome, and maternal
and paternal history of developmental disorders.
The Court finds that Dr. Lerer’s opinion on causation is sufficiently reliable to be
admissible under Rule 702. His report and deposition demonstrate that he did consider possible
alternative causes that would explain the plaintiffs’ cognitive impairments and provided a basis
for ruling them out. (See Lerer Report [DN 115-2] at 18, 22 (ruling out paternal educational
history and K.R.W.’s Dilantin exposure as causes); Dep. Lerer [DN 155-1] at 112:11–19 (ruling
out genetic causes).) While Abbott takes issue with how Dr. Lerer ruled out these alternative
causes and how much weight and attention he gave to certain evidence and other potential
causes, those are “weaknesses in the factual basis of [his] opinion [that] bear on the weight of the
evidence rather than on its admissibility.” McLean, 224 F.3d at 800–01. See Best v. Lowe’s
Home Centers, Inc., 563 F.3d 171, 181 (6th Cir. 2009) (“But doctors need not rule out every
conceivable cause in order for their differential-diagnosis-based opinions to be admissible”).
Abbott may contest Dr. Lerer’s conclusions regarding other possible causes of the plaintiffs’
injuries through cross-examination. See Rheinfrank v. Abbott Labs., Inc., 2015 WL 13022172, at
*7 (S.D. Ohio Oct. 2, 2015) (denying motion to exclude plaintiff’s causation expert, as “the fact
that other potential causes may remain ‘uneliminated’ goes to the accuracy of the conclusion, not
the soundness of the methodology, and would be properly addressed on cross-examination”)
(citations omitted). Therefore, Abbott’s motion to exclude Dr. Lerer’s opinion that the plaintiffs’
cognitive impairments were caused by in utero exposure to Depakote is DENIED.

24

II. DR. MICHAEL C. CECIL

Next, Abbott challenges the opinion of Dr. Michael Cecil. Dr. Cecil is a psychologist
with a specialization in clinical neuropsychology. (Cecil CV [DN 117-4] at 1.) He performed
numerous tests to evaluate the plaintiffs for neuropsychological disorders and diagnosed K.R.W.
with an unspecified neurodevelopmental disorder; specific learning disability in the area of
reading, writing, and math; and mood disorder secondary to brain dysfunction, while diagnosing
K.W.W. with autism spectrum disorder and specific learning disability in mathematics. (Cecil
Reports [DN 118-3, 188-4] at 5–6.) However, he also opined in his reports that K.R.W.’s
impairments “may be a result of exposure to Depakote in utero” and that K.W.W.’s brain
dysfunction “may stem from exposure to Depakote in utero.” (Id. at 5–6.) Abbott makes three
arguments in favor of excluding this opinion on causation. First, it argues that Dr. Cecil is not
qualified to offer an opinion on the cause of the plaintiffs’ injuries. Second, it argues that Dr.
Cecil’s methodology in making his causation conclusion is not reliable. And third, it seeks
exclusion on the basis that Dr. Cecil changed his opinion that Depakote “may” have caused the
injuries in his reports to “more likely than not” in his deposition.
The Court has doubts as to whether Dr. Cecil has the requisite “knowledge, skill,
experience, training, or education” to offer an opinion on what caused the plaintiffs’ cognitive
impairments. Fed. R. Evid. 702. As Abbott points out, almost all of Dr. Cecil’s experience and
practice has been in diagnosing whether a patient has a neuropsychological disorder, not what
could have caused that disorder.9 (See Dep. Cecil [DN 118-1] at 35:13–55:21) (discussing
practice.) Further, his knowledge of Depakote and the risks associated with in utero exposure
are the product of only twelve articles that he first read while working on his report for the

Abbott raises no objection to Dr. Cecil’s opinions as to what injuries the plaintiffs have, only his opinion as to what
caused those injuries.
9

25

present case. (Id. at 198:8–199:15.) The Sixth Circuit “has recognized for some time that expert
testimony prepared solely for purposes of litigation, as opposed to testimony flowing naturally
from an expert’s line of scientific research or technical work, should be viewed with some
caution.”

Johnson v. Manitowoc Boom Trucks, Inc., 484 F.3d 426, 434 (6th Cir. 2007)

(compiling cases). Dr. Cecil’s opinion on causation, as opposed to his diagnosis of the plaintiffs’
injuries, does not appear to flow naturally from his expertise.
However, even if Dr. Cecil is qualified to offer an opinion on causation, the Court finds
his methodology to be unreliable. Beginning with Dr. Cecil’s reports, he offers no methodology
as to how he concluded that Depakote “may” have caused the plaintiff’s injuries. The entirety of
Dr. Cecil’s report on K.R.W. that pertains to causation reads as follows: “The results of the
current evaluation are consistent with neuropsychological impairment that is likely
developmental and may be a result of exposure to Depakote in utero in the absence of strong
findings consistent with some other neurological process (e.g., traumatic brain injury).” (Cecil
Report [DN 118-3] at 5.) Likewise, his discussion of causation in his report on K.W.W. consists
of the following: “Overall, it is my opinion that [K.W.W.] has suffered brain dysfunction likely
secondary to developmental issues and may stem from exposure to Depakote in utero based upon
the extant scientific literature, review of records, as well as his overall neuropsychological
profile.” (Cecil Report [DN 118-4] at 6.) While his report on K.W.W. provides some detail on
what materials were used in forming his opinion, there is no detail at all as to how those
materials were used and why they led him to conclude that Depakote may have caused the
plaintiffs’ injuries. The reports simply mention at the beginning that the children were exposed
to Depakote in utero, and at the end it concludes that their injuries may have been caused by that.

26

Without providing a methodology as to how he reached this conclusion, the report does not
“reliably rule in” Depakote as a potential cause. Tamraz, 620 F.2d at 674.
Further, Dr. Cecil’s deposition does not adequately address the methodological
shortcomings of his report, as it does not “reliably rule out” other possible causes. For example,
he did not consider family history of academic achievement as a potential alternate cause
because “there’s so many different variables that go into that, it’s hard to sort of make a general
statement about that[.]” (Dep. Cecil [DN 118-1] at 104:11–13.) But Dr. Cecil’s reason for not
considering this factor was not because it does not explain the plaintiffs’ injuries, but rather
because it is difficult to apply. This is not reliably excluding an alternative cause; it is failing to
consider it at all. Dr. Cecil was asked directly what his methodology was in determining
causation, and he replied, “I don’t know of any other neurological issues that those children have
been diagnosed with.” (Id. at 208:15–17.) He later added, “I’m just not aware of anything else
that would explain the likelihood of those deficits.” (Id. at 211:18–19.) But these are vacuous
statements that do not offer any substantive evidence of what he did consider and reliably rule
out as possible alternative causes. Dr. Cecil’s conclusion that Depakote may have caused the
plaintiffs’ injuries “is a plausible hypothesis. It may even be right. But it is no more than a
hypothesis, and thus it not ‘knowledge,’ nor is it based on sufficient facts or data or the product
of reliable principles and methods . . .” Tamraz, 620 F.3d at 670 (quotations omitted). Dr. Cecil
seemed to confirm as much in his deposition:
I didn’t say it was the cause. You’re asking me, if you’re asking
me, what do I most likely think that produced these
neuropsychological deficits that these children particularly have, I
would say that at the end of the day, that would be the most likely
thing that caused their difficulties.

27

(Dep. Cecil [DN 118-1] at 210:21 – 211:3.) If Dr. Cecil could not then say that Depakote caused
the plaintiffs’ injuries, then neither can he say it now. Therefore, Abbott’s motion to exclude the
opinion of Dr. Cecil that Depakote either “may” have caused the plaintiffs’ injuries or “more
likely than not” was the cause is GRANTED.
III. DR. MICHAEL PRIVITERA

Finally, Abbott moves to exclude the opinion of Dr. Michael Privitera that the plaintiffs’
“injuries and disabilities are as a result of exposure to valproate in the pregnancies, rather than
from any cause, including any exposure to other AEDs during the pregnancy.” (Privitera Report
[DN 112-2] at 25.) Abbott argues that Dr. Privitera’s methodology is unreliable, as he fails to
effectively rule out other potential causes of the plaintiffs’ injuries.
Part of Abbott’s argument rests upon the reliance Dr. Privitera placed on the findings and
report of Dr. Lerer. Because Dr. Lerer’s opinion and report are based upon an unreliable
methodology, according to Abbott, Dr. Privitera’s reliance on that opinion and report is likewise
unreliable. However, the Court has already determined that Dr. Lerer’s opinion is admissible.
See supra sec. III.C.2.i. Therefore, Dr. Privitera’s opinion is not inadmissible for having utilized
Dr. Lerer’s report. See Tamraz, 620 F.3d at 675 (“an expert may in some circumstances rely on
other experts’ testimony – see Fed. R. Evid. 703”).
However, Dr. Privitera’s methodology must still otherwise be reliable. In his report, he
states that “to a reasonable degree of medical certainty that the physical, cognitive and
behavioral abnormalities suffered by [the plaintiffs] are characteristic of and caused by Depakote
exposure.” (Privitera Report [DN 112-2] at 26.) He explains that this conclusion is based upon
the plaintiffs suffering from “physical, cognitive and behavioral features commonly reported
among children exposed to Depakote in utero.” (Id. at 25.) He rules out K.R.W.’s exposure to

28

Dilantin (referred to as “phenytoin” in the report) as a possible cause of his injuries since that
drug “is not associated with a reduction in the full scale IQ of children exposed in utero.” (Id.)
He also explains that
[t]his case presents a notable example of the dose response and
length of exposure effects from in utero Depakote exposure[, as
K.R.W.], who was only exposure during the first 8.5 – 9 weeks of
pregnancy to 1000 mg a day, suffers from mild-moderate injuries,
while [K.W.W.], who was exposed to 2000 mg a day throughout
the entire pregnancy, suffers from severe injuries, including autism
spectrum disorder.
(Id. at 26.) He further clarified in his deposition that he excluded parental IQ and educational
achievement on the father’s side as a potential cause since his understanding of peer-reviewed
literature establishes that “you get more of your cognitive and intelligence function from your
mother than your father,” so that in “a statistical assessment, the mother’s IQ, when you do a
multivariate analysis . . . the father’s IQ falls out[.]” (Dep. Privitera [DN 112-1] at 108:2–20.)
The Court finds Dr. Privitera’s methodology to be sufficiently reliable under Fed. R.
Evid. 702. Dr. Privitera’s report adequately outlines his methodology and considerations in
forming his opinion. While his conclusions may not be the product of a true differential
diagnosis, an opinion on medical causation does not necessarily have to be produced through a
differential diagnosis. Daugherty v. Chubb Grp. Of Ins. Cos., 2011 WL 552738, at *7 (W.D. Ky.
Nov. 14, 2011) (citing Best, 563 F.3d at 176). What matters is that the methodology is reliable,
and the plaintiffs have adequately demonstrated that Dr. Privitera’s methodology in this case
was. He clearly outlines what factors he considered (the patients’ symptoms, length and dosage
of exposure, medical literature) in concluding that Depakote was the cause while also clearly
explaining why the other potential causes he considered (Dilantin exposure, paternal IQ) were
rejected.

This is a sufficient factual basis upon which his conclusions can rest, and any

29

shortcomings can be addressed on cross examination. See Rheinfrank, 2015 WL 13022172, at
*7. Therefore, Abbott’s motion to exclude the opinion of Dr. Privitera that Depakote caused the
plaintiffs’ injuries is DENIED.
3. EVIDENCE OF CAUSATION
Because Drs. Lerer and Privitera may present their opinions that Depakote caused the
plaintiffs’ cognitive injuries, the Court rejects Abbott’s argument that there is no admissible
evidence of causation. However, as noted in the discussion of Dr. Lerer, he has not opined that
the plaintiffs’ clinodactyly was caused by in utero Depakote exposure. See supra note 8. While
Dr. Privitera does offer an opinion on Depakote causing the plaintiffs’ clinodactyly, the plaintiffs
assert that they “are not seeking to prove that the clinodactyly of toes was caused [by] in utero
exposure to Depakote.” (Pl.’s Resp. to Mot. to Exclude Privitera [DN 148] at 26.) Given this
concession, the Court accepts Abbott’s argument as to there being no admissible evidence of
causation in regards to the plaintiffs’ clinodactyly, and the motion for summary judgment is
GRANTED as to any claim that seeks to recover for the plaintiffs’ clinodactyly.
D. NEGLIGENT MISREPRESENTATION AND FRAUD
Finally, Abbott argues that summary judgment is appropriate on Count IV under both of
plaintiffs’ theories of recovery: negligent misrepresentation and fraud.

It argues that the

plaintiffs’ have not identified any affirmative false statements that would support a negligent
misrepresentation claim. It further argues that there is no evidence upon which the jury could
find that such statements were made knowingly or recklessly or that they were relied upon by
Susan Willis’ prescribing doctors, as is required for a fraud claim. The plaintiffs respond by
identifying several statements in the Depakote label they allege are false, pointing to the

30

depositions of Susan’s prescribing doctors to demonstrate reliance, and arguing that Abbott
either knew or should have known these statements were false.
First, as to the claim of negligent misrepresentation, Kentucky follows the Restatement
(Second) of Torts § 552. Presnell Const. Mgrs., Inc. v. EH Const., LLC, 134 S.W.3d 575, 580–
81 (Ky. 2004). Section 552 reads in pertinent part:
One who, in the course of his business, profession or employment,
or in any other transaction in which he has a pecuniary interest,
supplies false information for the guidance of others in their
business transactions, is subject to liability for pecuniary loss
caused to them by their justifiable reliance upon the information, if
he fails to exercise reasonable care or competence in obtaining or
communicating the information.
Further, “negligent misrepresentation requires an affirmative false statement,” not merely an
omission.

Giddings & Lewis, Inc. v. Indus. Risk Ins., 348 S.W.3d 729, 746 (Ky. 2011).

Plaintiffs allege that the Depakote label contains the following false statements:


“Although data are more extensive with respect to trimethadione, paramethadione,
phenytoin, and phenobarbital, reports indicate a possible similar association [between
use and birth defects] with the use of other antiepileptic drugs”



“Sufficient data to determine the incidence of these congenital anomalies is not
available”



“The higher incidence of congenital anomalies in [AED]-treated women with seizure
disorders cannot be regarded as a cause and effect relationship”



“There are intrinsic methodological problems in obtaining adequate data on drug
teratogenicity in humans”

(Pl.’s Resp. to Mot. for Summ. J. [DN 141] at 12.) Abbott’s objections to these statements as
being affirmatively false is general, as it simply notes that there is insufficient evidence to prove
that these statements were false.

The Court rejects this argument, as the plaintiffs’ have

submitted expert testimony that, if believed by the jury, would allow jurors to conclude that the
statements were false. (See Privitera Report [DN 112-2] at 7) (arguing data was available in

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1999 showing Depakote caused more malformations than other AEDs.) Likewise, these experts
can argue that Abbott either knew or should have known they were false when conveying them.
(See id.)
Further, there is sufficient evidence of reliance on these statements by Dr. Chou, Susan’s
doctor during her pregnancy with K.W.W.

He testified that, in 2005, he was under the

assumption that all AED’s had similar risks regarding potential birth defects. (Dep. Chou [DN
65-1] at 67:3–68:14.) This statement supports the claim, as it is evidence that Dr. Chou relied on
the information in the label. Thus, the plaintiffs may argue that Dr. Chou relied on the alleged
falsities in the Depakote label, and Abbott’s motion for summary judgment as to the claim for
negligent misrepresentation is DENIED. However, the alleged misrepresentations all pertain to
the risk of birth defects. There is no admissible evidence that Depakote exposure caused
clinodactyly, K.R.W.’s only alleged birth defect. See supra sec. III.C.3; Pl.’s Resp. to Mot. for
Summ. J. [DN 141] at 7–8 (listing injuries as clinodactyly and various cognitive disabilities).
Therefore, K.R.W. cannot assert a claim for negligent misrepresentation, as he suffered no
cognizable injury that was allegedly caused by the misrepresentations, and the motion for
summary judgment is GRANTED as to K.R.W.’s claim.
As for the fraud claim, Kentucky law requires the plaintiff to establish six elements by
clear and convincing evidence: “(1) a material misrepresentation, (2) which is false, (3) known to
be false or made recklessly, (4) made with inducement to be acted upon, (5) acted in reliance
thereon, and (6) causing injury.” Derby City Capital, LLC v. Trinity HR Servs., 949 F. Supp. 2d
712, 726 (W.D. Ky. 2013) (citations omitted). In addition to the statements supporting the
negligent misrepresentation claim, the plaintiffs also reference numerous omissions of material
fact that support their claim of fraud, including Abbott’s failure to disclose the elevated risk of

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using Depakote as compared to other AEDs, as well as the risk of autism and decreased IQ
scores.
First, the plaintiffs’ fraud by omission claims pertaining to the risk of developmental
delay and autism are preempted for the same reasons that the strict products liability and
negligence claims based upon the failure to warn of the risk of developmental delay and autism
are preempted. Abbott cannot be held liable under state tort law for not saying something about
the risk of developmental delay and autism that federal law prevented it from saying. However,
the Court will allow the fraud by misrepresentation claims to proceed for reasons similar to the
negligent misrepresentation claims. The same expert testimony that supports the negligent
misrepresentation claim supports the fraud by misrepresentation claims, as it can be used to
prove that these statements were material, actually false, and that Abbott knew or should have
known this. (See Privitera Report [DN 112-2] at 7). Likewise, the same evidence as used to
support the reliance element in the negligent misrepresentation claim supports the reliance
element here. And the plaintiffs cite to internal Abbott documents that tend to show that these
statements were made with the intent to induce additional sales of Depakote. (DN 141-11, 14112.). Therefore, the plaintiffs’ fraud claim may proceed as limited by the Court’s findings
regarding preemption, and the motion for summary judgment as to the fraud by
misrepresentation claims is DENIED.
Again, though, the Court notes that the alleged fraudulent statements all pertain to birth
defects, meaning that K.R.W.’s claim for fraud must be dismissed due to a lack of any evidence
that Depakote caused his only alleged birth defect, clinodactyly. This will result in a total
dismissal for K.R.W.’s claims: the claims based on his developmental delay are preempted, and

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the claims based on his clinodactyly fail from their lack of causation evidence. Therefore,
K.R.W. is DISMISSED as a plaintiff.
IV. CONCLUSION
Therefore, for the foregoing reasons, the Court orders the following:
(1) The plaintiffs’ motion for partial summary judgment (DN 80) is DENIED;
(2) The defendants’ motion for summary judgment (DN 95) is GRANTED IN and PART
DENIED IN PART to the following extent:
(a) The motion for summary judgment as to Count I for strict products liability (design
defect) is GRANTED;
(b) The motion for summary judgment as to Count II for strict products liability (failure
to warn) is GRANTED as to any theory of recovery based upon the defendants’ failure
to warn of the risk of developmental delay and autism;
(c) The motion for summary judgment as to Count III for negligence is GRANTED as to
any claim based upon the defendants’ failure to warn of the risk of developmental delay
and autism;
(d) The motion for summary judgment as to Count IV for negligent misrepresentation
and fraud is GRANTED as to K.R.W.’s claims and DENIED as to K.W.W.’s claims;
(e) The motion for summary judgment as to Counts V–VII for various breach of warranty
claims is GRANTED; and
(f) Plaintiff K.R.W. is DISMISSED as a plaintiff from this action;
(3) The defendants’ motion to exclude the expert testimony of Dr. Robert Lerer on causation
(DN 89) is DENIED;

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(4) The defendants’ motion to exclude the expert testimony of Dr. Michael Cecil on causation
(DN 87) is GRANTED; and
(5) The defendants’ motion to exclude the expert testimony of Dr. Michael Privitera on causation
(DN 92) is DENIED.

December 1, 2017

cc: counsel of record

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