B.F. et al v. Abbott Laboratories, Inc. et al

Filing 197

MEMORANDUM AND ORDER -...IT IS HEREBY ORDERED that defendant Abbott Laboratories Inc.'s motion to exclude or limit the testimony of Jack Land, M.D. is GRANTED in part and DENIED in part. [Doc. 57] The motion is GRANTED to the extent tha t Dr. Land will not be permitted to: (1) give any testimony regarding whether B.F. will need another surgery for a tethered cord; will need a derotational osteotomy; or will develop scoliosis; (2) testify that B.F. has strabismus and that it resulted from his spina bifida; or (3) testify that B.F. has hearing loss and that it resulted from his spina bifida. The motion is DENIED in all other respects. IT IS FURTHER ORDERED that defendant Abbott Laboratories Inc.'s motion to exclude c ertain opinion testimony of Godfrey P. Oakley, Jr., M.D. is GRANTED. [Doc. 59] IT IS FURTHER ORDERED that defendant Abbott Laboratories Inc.'s motion for oral argument is DENIED as moot. [Doc. 66] Signed by District Judge Charles A. Shaw on 5/6/2016. (MRC)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION
B.F., a minor, BETH FORBES, individually
and as next friend of B.F., and THOMAS
FORBES, individually and as next friend of
B.F.,

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Plaintiffs,
v.
ABBOTT LABORATORIES INC., et al.,
Defendants.

No. 4:12-CV-1760 CAS

MEMORANDUM AND ORDER
This diversity matter is before the Court on defendant Abbott Laboratories Inc.’s
(“Abbott”) (1) motion to exclude the testimony of plaintiffs’ expert witness Jack Land, M.D.,
and (2) motion to exclude certain opinion testimony of plaintiffs’ expert witness Godfrey P.
Oakley, Jr., M.D. pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
(1993). Plaintiffs oppose the motions. Although Abbott has requested oral argument on the
motions, the Court finds it can make a proper Daubert analysis without the need for oral
argument. The parties have submitted a voluminous evidentiary record including exhibits and
testimony.
For the following reasons, Abbott’s motion to exclude plaintiffs’ expert Dr. Land will be
granted in part and denied in part. Abbott’s motion to exclude certain opinion testimony of Dr.
Oakley will be granted.

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I.

Background
In this products liability action, plaintiffs Thomas and Beth Forbes and their minor son

B.F. (“plaintiffs”) assert claims against Abbott arising out of injuries resulting from B.F.’s
exposure in utero to the medicine Depakote. Beth Forbes began taking Depakote two years
before B.F.’s birth to treat her bipolar disorder. Plaintiffs allege B.F. sustained serious and
permanent injures and damages as a result of his mother’s ingestion of Depakote during
pregnancy, specifically that B.F. was diagnosed with spina bifida.
Plaintiffs brought this action against Abbott in seven counts, only two of which remain:
Strict Liability—Failure to Warn (Count I) and Negligence—Failure to Warn (Count III).
II.

Legal Standard
The admission of expert testimony in federal court is governed by Federal Rule of

Evidence 702. In Daubert, the United States Supreme Court interpreted Rule 702 to require
district courts to be certain that expert evidence based on scientific, technical or other specialized
knowledge is “not only relevant, but reliable.” Daubert, 509 U.S. at 589. The district court must
make a “preliminary assessment of whether the reasoning or methodology underlying the
testimony is scientifically valid and of whether that reasoning or methodology properly can be
applied to the facts in issue.” Id. at 592-93.
The Eighth Circuit Court of Appeals has stated that proposed expert testimony must meet
three criteria to be admissible under Rule 702. “First, evidence based on scientific, technical, or
other specialized knowledge must be useful to the finder of fact in deciding the ultimate issue of
fact. This is the basic rule of relevancy.” Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th
Cir. 2001). “Second, the proposed witness must be qualified to assist the finder of fact.” Id.
(citation omitted).

“Third, the proposed evidence must be reliable or trustworthy in an

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evidentiary sense, so that, if the finder of fact accepts it as true, it provides the assistance the
finder of fact requires.” Id. (internal quotation marks omitted). To meet the third requirement,
the testimony must be “based on sufficient facts or data” and be “the product of reliable
principles and methods,” and the expert must have “reliably applied the principles and methods
to the facts of the case.” Fed. R. Evid. 702(b)-(d). “Rule 702 reflects an attempt to liberalize the
rules governing the admission of expert testimony[,]” Weisgram v. Marley Co., 169 F.3d 514,
523 (8th Cir. 1999), and “favors admissibility if the testimony will assist the trier of fact.” Clark
ex rel. Clark v. Heidrick, 150 F.3d 912, 915 (8th Cir. 1998). Doubt regarding “whether an
expert’s testimony will be useful should generally be resolved in favor of admissibility.” Id.
(citation and internal quotation omitted).
Under Rule 702, the trial court has gatekeeping responsibility to “ensur[e] that an
expert’s testimony both rests on a reliable foundation and is relevant to the task at hand.”
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141 (1999) (citing Daubert, 509 U.S. at 597).
“When making the reliability and relevancy determinations, a district court may consider: (1)
whether the theory or technique can be or has been tested; (2) whether the theory or technique
has been subjected to peer review or publication; (3) whether the theory or technique has a
known or potential error rate and standards controlling the technique’s operation; and (4)
whether the theory or technique is generally accepted in the scientific community.” Russell v.
Whirlpool Corp., 702 F.3d 450, 457 (8th Cir. 2012) (citing Daubert, 509 U.S. at 593-94). “This
evidentiary inquiry is meant to be flexible and fact specific, and a court should use, adapt, or
reject Daubert factors as the particular case demands.” Unrein v. Timesavers, Inc., 394 F.3d
1008, 1011 (8th Cir. 2005). “There is no single requirement for admissibility as long as the
proffer indicates that the expert evidence is reliable and relevant.” Id.

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As a general rule “the factual basis of an expert opinion goes to the credibility of the
testimony, not the admissibility, and it is up to the opposing party to examine the factual basis
for the opinion in cross-examination.” Nebraska Plastics, Inc. v. Holland Colors Am., Inc., 408
F.3d 410, 416 (8th Cir. 2005) (quoted case omitted). However, “if the expert’s opinion is so
fundamentally unsupported that it can offer no assistance to the jury, it must be excluded.” Id.
(quoted case omitted).

An expert opinion is fundamentally unsupported when it “fails to

consider the relevant facts of the case.” Id.
III.

Discussion
A.

Abbott’s Motion to Exclude Expert Witness Jack Land, M.D.

Abbott moves to exclude the testimony and evidence from plaintiff B.F.’s treating
pediatrician, Jack Land, M.D.

Abbott states that although Dr. Land treated B.F. for

approximately seven years, from shortly after birth in September 2005 until October 2012, he
treated him for routine pediatric conditions, and not specifically for spina bifida. Abbott says
that because Dr. Land never treated B.F. for his spina bifida or the other conditions resulting
therefrom that are the basis of this lawsuit, he should be barred from testifying. Alternatively, if
Dr. Land were deemed qualified to testify, Abbott states he should not be permitted to give any
testimony regarding B.F.’s future prognosis, testify that B.F. has strabismus (misalignment of the
eyes) and that it resulted from his spina bifida, or testify that B.F. has hearing loss resulting from
his spina bifida.
Plaintiffs respond that Dr. Land was B.F.’s treating pediatrician from birth to age seven,
and his testimony is relevant, reliable, and will assist the jury. Plaintiffs state they designated Dr.
Land to testify as a pediatric expert, particularly as B.F.’s pediatrician.

The scope of his

testimony is describing conditions that he has medical knowledge of and experience with as a

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practicing pediatrician. Plaintiffs state that they have not designated Dr. Land as an expert to
give detailed opinions on spina bifida and its causal link to Depakote. They also recognize that
Dr. Land has not performed the particular specialized surgeries or other specialized treatments to
address B.F.’s spina bifida and other conditions.

But, Dr. Land has treated B.F. as his

pediatrician and has treated and managed his spina bifida. “The fact is that Dr. Land is qualified
and positioned as [B.F.’s] medical provider to explain to the jury [B.F.’s] medical conditions and
treatments in relation to spina bifida.” (Pl. Resp. at 8.)
1.

The evidence would assist the jury

The Court finds that B.F.’s treating pediatrician’s expert testimony regarding his
treatment of B.F.’s spina bifida and other conditions would assist the jury in determining an
ultimate issue of fact in this case. As B.F.’s pediatrician, Dr. Land was responsible for managing
and coordinating B.F.’s overall care. Dr. Land’s proposed testimony is therefore relevant.
2.

Dr. Land is qualified to assist the jury

Abbott does not challenge Dr. Land’s qualifications as an expert in the field of pediatrics.
Dr. Land is a board certified pediatrician and a licensed medical doctor in the states of Missouri
and Mississippi.

Dr. Land founded and operated his own pediatric practice, Crystal City

Pediatrics from 1990 to 2012. Prior to this practice, he was a pediatrician in the Air Force for
eleven years. His pediatric experience includes the care of several patients with spina bifida.
The Court finds Dr. Land is qualified to testify as an expert in pediatrics.
3.

Reliability and Trustworthiness of the Proposed Evidence

Dr. Land intends to testify regarding the conditions of B.F. that relate to his spina bifida
and conditions and treatments that subsequently occurred as a result of his spina bifida, including
(1) hydrocephalus; (2) Chiari Type II malformation; (3) club feet deformity; (4) bilateral hip

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dislocations; (5) tethering of spinal cord; (6) sensorineural hearing loss in the right ear; and (7)
neurogenic bowel and bladder leading to incontinence of feces and urine. The facts and data
considered in forming his opinions are based on his treatment of B.F. as his pediatrician and the
medical records of B.F. up to the present.
Abbott specifically seeks to exclude any testimony regarding (1) whether B.F. may
develop future medical needs, in particular, whether he will need to have his hydrocephalus
shunt revised in the future; whether he may need another surgery for a tethered cord; whether he
may need a derotational osteotomy; or whether he might develop scoliosis in the future; (2)
whether B.F.’s strabismus resulted from his spina bifida; and (3) whether B.F.’s hearing loss
resulted from his spina bifida. In each of these examples, Abbott thoroughly questioned Dr.
Land at deposition regarding his opinions of B.F.’s medical condition and future medical needs.
With respect to the following future medical needs, it is clear that Dr. Land either does
not intend to offer an expert opinion or he cannot offer an expert opinion within a reasonable
degree of medical certainty: (1) whether B.F. may need another surgery for tethered cord; (2)
whether B.F. may need a derotational osteotomy; and (3) whether B.F. might develop scoliosis.
Taking each condition in turn, as to whether B.F. will need additional surgeries for spinal cord
de-tethering, Dr. Land stated he did not intend to testify as to whether B.F. will need these
additional surgery.

(Dr. Land Dep. at 72.)

With respect to B.F.’s hips and a possible

derotational osteotomy surgery, Dr. Land testified that B.F.’s condition is “not currently felt to
be surgically . . . appropriate for the hips, and that they’re stable. . . . I can’t tell what’s going to
happen long-term with that. . . . I can’t say that’s something he will or may not do in the future.”
(Id. at 62.) Finally, with respect to scoliosis, Dr. Land testified that he cannot state with a
reasonable degree of medical certainty that B.F. will develop scoliosis. (Id. at 74.) Based on Dr.

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Land’s deposition testimony, with respect to these potential future medical needs, the Court finds
that Dr. Land does not intend to offer an opinion, or his opinions are not scientifically valid as
applied to the facts of this case. See Daubert, 509 U.S. at 590 (expert testimony must be based
on “more than subjective belief or unsupported speculation”). Therefore, these three opinions
will not assist the jury, and will be excluded.
With respect to whether B.F. will need his shunt revised in the future, Dr. Land testified
that within a reasonable degree of medical certainty, B.F. will need to have his shunt revised.
(Dr. Land Dep. at 70.) Dr. Land states that B.F. has more than a 50 percent chance of requiring a
shunt revision, because statistically speaking patients with hydrocephalous shunts require
revision. (Id.) The Court will allow this testimony as it finds Dr. Land is qualified to testify as
to these facts and opinions. Any objection by Abbott to this testimony can be addressed by its
expert witness or on cross examination of Dr. Land.
Abbott also seeks to exclude any testimony from Dr. Land that B.F.’s strabismus resulted
from his spina bifida. When questioned regarding B.F.’s strabismus Dr. Land testified B.F. had
recently been diagnosed with strabismus, but Dr. Land had not diagnosed this condition and he
did not know which doctor had diagnosed the condition. (Id. at 74.) Dr. Land stated that he was
not an expert in strabismus. (Id. at 50.) Dr. Land did not know whether B.F.’s reported
headaches were related to the strabismus, and he testified that he is not offering a medical
opinion as to whether the strabismus is causing B.F. any problems. (Id. at 75.) His knowledge
regarding B.F.’s strabismus came entirely from interviewing Mrs. Forbes approximately a month
before his deposition, and more than two years after he had stopped treating B.F. Dr. Land was
not questioned regarding whether he believes B.F.’s strabismus resulted from his spina bifida.
To the extent Dr. Land might seek to testify that B.F.’s strabismus results from spina bifida, the

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Court will exclude this testimony as Dr. Land is not qualified to testify as to the cause of B.F.’s
strabismus, a condition of which he was unaware, did not diagnose, and which presented more
than two years after he stopped treating B.F.
Finally, Abbott seeks to exclude any testimony from Dr. Land that B.F.’s hearing loss
results from spina bifida. Dr. Land testified as follows:
Q:

With respect to hearing loss in the right ear, is it your opinion that
that’s related to B.F.’s spina bifida?

A:

I think that’s a real possibility.

Q:

What’s that based on?

A:

There’s an article that I found which is a woman’s doctoral
dissertation through the University of South Florida that looked at
association with unilateral sensorineural hearing loss and
placement of VP shunt for hydrocephalous.
And since the hydrocephalous was a result of the Chiari, which is a
result of the general spina bifida problem, it’s my opinion that you
can make a case that it is related to that.

Q:

When did B.F. first begin experiencing hearing loss?

A.

I think it was documented recently, but I don’t know how long
that’s been going on.

...
Q:

Do you know anything about the methodologies used to form the
conclusions in that [doctoral dissertation through the University of
South Florida]?

A:

I think it was just a statistical study.

Q:

Okay. Was this study published in a journal?

A:

No. I just found it as a doctoral thesis.

Q:

How did you find it?

A:

Google search or .gov search.
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Q:

You’ve not seen any publications in any medical journals; is that
right?

A:

I have not.

(Dr. Land Dep. at 65, 76-77).
Dr. Land did not diagnose B.F. as suffering from hearing loss nor has he conducted any
examination of B.F.’s hearing loss. B.F. developed the hearing loss after Dr. Land had stopped
treating him. Dr. Land’s knowledge of B.F.’s hearing loss was through an interview with Mrs.
Forbes shortly before his deposition. When asked whether the hearing loss was caused by B.F.’s
spina bifida, Dr. Land stated “that’s a real possibility.” (Id. at 65.) Dr. Land’s conclusion was
based on his Google or .gov Internet search that pulled up an unpublished doctoral dissertation of
an unidentified student from the University of South Florida. The Court finds that Dr. Land’s
testimony regarding the cause of B.F.’s hearing loss is not scientifically valid because it is based
on an unidentified student’s doctoral thesis that is untested, not subjected to peer review or
publication, and there is no evidence it has been “generally accepted” in the medical community.
Daubert, 509 U.S at 592-94. The Court will exclude any testimony of Dr. Land regarding the
cause of B.F.’s hearing loss.
For the foregoing reasons, the Court will grant in part and deny in part Abbott’s motion
to exclude or limit the testimony of Dr. Jack Land. Dr. Land will not be permitted to: (1) give
any testimony regarding whether B.F. will need another surgery for a tethered cord; will need a
derotational osteotomy; or will develop scoliosis; (2) testify that B.F. has strabismus and that it
resulted from his spina bifida; or (3) testify that B.F. has hearing loss and that it resulted from his
spina bifida.

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B.

Abbott’s Motion to Exclude Certain Opinion Testimony of Godfrey P. Oakley,
Jr., M.D.

Abbott also seeks to exclude certain testimony of plaintiffs’ expert Godfrey P. Oakley,
Jr., M.D. Dr. Oakley is board certified in pediatrics, preventative medicine, and genetics. He
has worked for the Centers of Disease Control and Prevention, focusing on using epidemiology
to seek causes of birth defects and to prevent birth defects. Plaintiffs have designated Dr. Oakley
as an expert to testify that (1) valproic acid (Depakote) taken early in pregnancy by Mrs. Forbes
caused B.F. to be born with spina bifida, and (2) it was possible and reasonable for Abbott to
have established as early as when valproic acid was first marketed in the United States a registry
of exposed pregnancies. 1
Abbott’s motion seeks to exclude Dr. Oakley’s second opinion, that it was reasonable for
Abbott to have established a pregnancy registry. Abbott states that a pregnancy registry would
have revealed nothing about the risk of spina bifida that was not both generally known and
included in the Depakote label since 1985. That is, assuming Dr. Oakley’s proposed pregnancy
registry had been undertaken by Abbott, the outcome of such registry would have revealed
nothing more than that a woman taking Depakote early in her pregnancy has a 1 to 2 percent risk
of having a child with spina bifida. This risk had been included on the Depakote label since
1985.
Plaintiffs contend that Dr. Oakley’s testimony about the pregnancy registry is relevant
“because it is simply evidence of additional information about Depakote’s risk profile which
should have been available to Abbott.” (Pls.’ Resp. at 5.) “It is by no means a stretch to connect

1

As explained by plaintiffs, a “pregnancy registry” is a method of tracking the effects of a
drug on pregnant women and children exposed to a particular substance in utero. Pregnancy
registries involve contacting women who become pregnant while taking a particular drug and
obtaining information about the pregnancy and resulting child.
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the probability that the more information collected, or vice versa, lack of information collected,
will bear upon the adequacy of the warning.” (Id.)
The admissibility of Dr. Oakley’s testimony regarding the pregnancy registry turns on the
basic rule of relevancy, which is fact specific. The evidence “must be useful to the finder of fact
in deciding the ultimate issue of fact.” See Lauzon, 270 F.3d at 686. In our case, plaintiffs
claim that Abbott failed to warn of the risk of birth defects associated with Depakote. The birth
defect at issue is spina bifida. At deposition, Dr. Oakley testified that the risk of spina bifida
with Depakote exposure is 1 to 2 percent, and that this risk percentage is the same as he and
other doctors had calculated in 1982.
Q:

As we’re sitting here today 33 years later, the recognized absolute risk of
spina bifida with valproic acid [Depakote] is 1 to 2 percent; true?

A:

That’s correct.

(Dr. Oakley Dep. at 34.)
Q:

As of today . . . 2015 . . . your professional opinion is that the absolute risk
of spina bifida with Depakote is 1 to 2 percent, true?

A:

That’s true. 2

...
Q:

And so if those studies had been performed by Dr. McMann and Dr.
Feinstein, we would have known the same thing about the absolute risk of
spina bifida that we know today, true?

...
A:

True. 3

2

In his errata sheet, Dr. Oakley clarifies this answer by stating: “That’s true for the point
estimate, but there is a confidence interval around that estimate.” (Doc. 68-10.)
3

Again in his errata sheet, Dr. Oakley clarifies this answer by stating: “True, but there would
be a confidence interval around that point estimate.” (Doc. 68-10.)

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(Id. at 38.)
Q:

If Abbott had started a [pregnancy] registry in the 1980s or early 1990s
based upon what we know today, would that registry likely have
confirmed the 1 to 2 percent absolute risk of spina bifida?

A:

I believe that to be true. 4

...
Q:

All right. So that’s what I was getting at. If Abbott had started a registry
in the early 1980s or 1990s, that register, as far as you’re concerned,
would have given the same result in terms of the absolute risk of spina
bifida from Depakote as what was known in 1982, true?

A:

True. 5

(Id. at 117-18.)
Since 1985, Depakote’s label has warned of the 1 to 2 percent absolute risk of spina
bifida. According to Dr. Oakley, this absolute risk of spina bifida is still accurate today. If
Abbott had initiated a pregnancy registry in the 1980s, as suggested by Dr. Oakley, it would have
generated the same data that Abbott has included in its warning label since 1985. The registry
would have simply confirmed the absolute risk of spina bifida that was already known and

4

In his errata sheet, Dr. Oakley changes this answer for clarification purposes, stating: “I
believe that to be true but it could have been higher or lower.” (Doc. 68-10). Dr. Oakley’s
clarification changes his testimony without providing the basis on which it relies. His revised
testimony is entirely speculative, and does not quantify the extent to which the absolute risk
“could have been higher or lower.” The Court finds this change to Dr. Oakley’s testimony
fundamentally unsupported, and the Court cannot find the testimony reliable or trustworthy in an
evidentiary sense.
5

Again in his errata sheet, Dr. Oakley changes this answer for clarification purposes, stating:
“True, but it could have been higher or lower.” (Doc. 68-10). The Court does not find this
answer to be clarification of his original answer “True,” but a substantive change to his
testimony. This change does not provide the basis on which it relies, and is entirely speculative.
Dr. Oakley does not quantify the extent to which the risk “could have been higher or lower.”
The Court finds this change to Dr. Oakley’s testimony fundamentally unsupported, and the Court
cannot find the testimony reliable or trustworthy in an evidentiary sense.
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disclosed. The fact that Abbott could have undertaken a registry back in the 1980s, then, is not
relevant in determining the adequacy of the spina bifida warning on the Depakote label when
Mrs. Forbes was taking the medication. If Abbott had initiated a pregnancy registry, the label
would have warned of a 1 to 2 percent risk of having a child with spina bifida; without the
registry, the label already warned of a 1 to 2 percent risk of having a child with of spina bifida.
The pregnancy registry suggested by Dr. Oakley would not have given Mrs. Forbes or her
prescribing physician any more information than Abbott had already provided on its label
regarding the risk to Mrs. Forbes of having a baby with spina bifida. The Court finds that
discussing Abbott’s failure to create such a registry would serve only to prejudice Abbott.
Because Dr. Oakley cannot testify that a pregnancy registry would have altered the spina bifida
warning on Depakote’s label, the Court finds that Dr. Oakley’s expert testimony that it was
possible and reasonable for Abbott to have established such a registry would not assist the jury in
determining any ultimate issue of fact.
IV.

Conclusion
For the foregoing reasons, Abbott’s Daubert motion to exclude or limit the testimony of

Jack Land, M.D. should be granted in part and denied in part. Abbott’s Daubert motion to
exclude certain opinion testimony of Godfrey P. Oakley, Jr., M.D. should be granted.
Accordingly,
IT IS HEREBY ORDERED that defendant Abbott Laboratories Inc.’s motion to
exclude or limit the testimony of Jack Land, M.D. is GRANTED in part and DENIED in part.
[Doc. 57] The motion is GRANTED to the extent that Dr. Land will not be permitted to: (1)
give any testimony regarding whether B.F. will need another surgery for a tethered cord; will
need a derotational osteotomy; or will develop scoliosis; (2) testify that B.F. has strabismus and

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that it resulted from his spina bifida; or (3) testify that B.F. has hearing loss and that it resulted
from his spina bifida. The motion is DENIED in all other respects.
IT IS FURTHER ORDERED that defendant Abbott Laboratories Inc.’s motion to
exclude certain opinion testimony of Godfrey P. Oakley, Jr., M.D. is GRANTED. [Doc. 59]
IT IS FURTHER ORDERED that defendant Abbott Laboratories Inc.’s motion for oral
argument is DENIED as moot. [Doc. 66]

____________________________________
CHARLES A. SHAW
UNITED STATES DISTRICT JUDGE
Dated this 6th day of May, 2016.

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