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

Filing 94

MEMORANDUM AND ORDER: IT IS HEREBY ORDERED that defendant Abbott Laboratories, Inc.'s motion for summary judgment is DENIED. [Doc. 61 ] Signed by District Judge Charles A. Shaw on 3/31/16. (JWD)

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

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No. 4:12-CV-1760 CAS

MEMORANDUM AND ORDER
This matter is before the Court on defendant Abbott Laboratories, Inc.’s (“Abbott”)
motion for summary judgment.
ready for decision.

Plaintiffs oppose the motion. The motion is fully briefed and

For the following reasons, the motion will be denied.

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).
Abbott moves for summary judgment on these remaining counts, asserting that (1) Depakote’s

warnings were adequate as a matter of law; and (2) plaintiffs cannot establish that the alleged
inadequate warnings were the proximate cause of plaintiffs’ injuries.
Summary Judgment Standard
The standards applicable to summary judgment motions are well settled.

Pursuant to

Federal Rule of Civil Procedure 56(c), a court may grant a motion for summary judgment if all
of the information before the court shows "there is no genuine issue of material fact and the
moving party is entitled to judgment as a matter of law."

Fed. R. Civ. P. 56(c).

See Celotex

Corp. v. Catrett, 477 U.S. 317, 322 (1986).
The initial burden is placed on the moving party.

City of Mt. Pleasant, Iowa v.

Associated Elec. Co-op., Inc., 838 F.2d 268, 273 (8th Cir. 1988) (the moving party has the
burden of clearly establishing the non-existence of any genuine issue of fact that is material to a
judgment in its favor). Once this burden is discharged, if the record does in fact bear out that
no genuine dispute exists, the burden then shifts to the non-moving party who must set forth
affirmative evidence and specific facts showing there is a genuine dispute on that issue.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).
In passing on a motion for summary judgment, this Court is required to view the facts in
a light most favorable to the non-moving party and the Court must give the non-moving party the
benefit of any inferences that can logically be drawn from those facts.

Matsushita Electric

Industrial Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Buller v. Buechler, 706
F.2d 844, 846 (8th Cir. 1983).

Moreover, this Court is required to resolve all conflicts in favor

of the non-moving party. Robert Johnson Grain Co. v. Chemical Interchange Co., 541 F.2d
207, 210 (8th Cir. 1976).

Facts
Beginning in 1999, Beth Forbes began suffering from mental illness, for which she
received medical treatment.

During a June 2002 hospitalization, she was diagnosed as suffering

from bipolar disorder/manic depression.
In or around April 2003, Beth Forbes came under the care of Dr. Raziya Mallya (“Dr.
Mallya”), a psychiatrist, who began treating Mrs. Forbes for her bipolar disorder. Starting in
April 2003, Dr. Mallya prescribed Depakote Extended Release (“Depakote”) tablets, as well as
Geodon and Wellbutrin, for treatment of Mrs. Forbes’ bipolar disorder.

Dr. Mallya prescribed

Depakote as a mood stabilizer.
In January 2005, Mrs. Forbes became pregnant with B.F. She testified that she had been
taking Depakote at that time for treatment of her bipolar disorder. Mrs. Forbes stopped taking
Depakote after she found out that she was pregnant with B.F.
In September 2005, Beth Forbes gave birth to B.F.

B.F. has been diagnosed with spina

bifida as well as some other conditions that plaintiffs claim are secondary to spina bifida,
namely:

hydrocephalus, Chiari type II malformation, club feet deformity, bilateral hip

dislocations, tethering of spinal cord (now untethered), sensorineural hearing loss in right ear,
and neurogenic bowel and bladder leading to incontinence of feces and urine.

Plaintiffs claim

all of B.F.’s physical limitations stem from and are attributable to B.F.’s spina bifida.
At all relevant times when Mrs. Forbes was taking Depakote from 2003 to 2005,
Depakote’s label included specific warnings regarding the risk of spina bifida due to in utero
exposure. The Depakote prescribing information (often referred to as “the label”) included a
Block Box warning in all caps that warned of the risks of neural tube defects.
provided:
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The black box

TERATOGENICITY:
VALPROATE [DEPAKOTE] 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 CONTEMPLATED. SEE WARNINGS, INFORMATION
FOR PATIENTS.
AN INFORMATION SHEET DESCRIBING THE TERATOGENIC
POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS.
(Abbott SOF ¶ 15.)
A ten-paragraph warning in the “Usage in Pregnancy” subsection of the 2003 and 2004
Depakote labels provided in relevant part:
ACCORDING TO PUBLISHED AND UNPUBLISHED REPORTS,
VALPROIC ACID MAY PRODUCE TERATOGENIC EFFECTS IN THE
OFFSPRING OF HUMAN FEMALES RECEIVING THE DRUG DURING
PREGNANCY.
THE DATA DESCRIBED BELOW WERE GAINED
ALMOST EXCLUSIVELY FROM WOMEN WHO RECEIVED VALPROATE
TO TREAT EPILEPSY. 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.
THE INCIDENCE OF NERUAL TUBE DEFECTS IN THE FETUS MAY BE
INCREASED IN MOTHERS RECEIVING VALPROATE DURING THE
FIRST TRIMJESTER 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 (EG, 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.
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*****
The prescribing physician will wish to weigh the benefits of therapy against the
risks in treating or counseling women of childbearing potential. If this drug is
used during pregnancy, or if the patient becomes pregnant while taking this drug,
the patient should be apprised of the potential hazard to the fetus.
*****
Tests to detect neural tube and other defects using current accepted procedures
should be considered a part of routine prenatal care in childbearing women
receiving valproate.
(Abbott SOF ¶¶ 16-17.)
Discussion
(A)

Failure to Warn
Abbott moves for summary judgment on the adequacy of its warning because the

Depakote label expressly warned of the risks of spina bifida, the injury experienced by B.F., and
thus Abbott asserts its warning was adequate as a matter of law. Plaintiffs respond that there
remains a genuine dispute regarding the adequacy of Abbot’s warning, as demonstrated by
expert evidence that Abbott’s warning was informationally deficient, inaccurate, and misleading.
Under Missouri law, the elements of a cause of action for strict liability for failure to
warn are: (1) the defendant sold the product in question in the course of its business; (2) the
product was unreasonably dangerous at the time of sale when used as reasonably anticipated
without knowledge of its characteristics; (3) the defendant did not give adequate warning to the
danger; (4) the product was used in a reasonably anticipated manner; and (5) the plaintiff was
damaged as a direct result of the product being sold without an adequate warning.
v. Ford Motor Co., 332 S.W.3d 749, 756 (Mo. 2011).

See Moore

“In applying these elements, Missouri

law recognizes that a product may be rendered unreasonably dangerous and therefore actionable
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because of the absence of a warning concerning use or misuse, or because the warning that has
been given is informationally deficient.”

Id. (internal quotations omitted) (citing Nesselrode v.

Exec. Beechcraft, Inc., 707 S.W.2d 371, 382 (Mo. banc 1986)).
Abbott states that its label featured a clear and prominent warning regarding the precise
risk at issue in this case—the risk of spina bifida—and clearly alerted physicians of the risk of
birth defects.

Further, based on Dr. Mallya’s testimony, she was aware of Depakote’s

teratogenicity and the risk of spina bifida at the time she prescribed Depakote to Ms. Forbes.
Abbott asserts that the adequacy of Depakote’s warning cannot be a jury question in this case
because Dr. Mallya was aware of the risk of spina bifida when she prescribed Depakote to Mrs.
Forbes, and Dr. Mallya agreed that the Depakote warning label warned of the risk of spina
bifida.
Plaintiffs have produced the expert opinions of Cheryl D. Blume, Ph.D., to establish that
Abbott’s label was inadequate for the following reasons, among others:
(1)

Abbott’s labeling should have included a statement that Depakote should
only be used as a “last line” treatment (i.e., only if other treatment options
have failed) in women of childbearing potential;

(2)

Abbott should have included the background rate for the incidence of
spina bifida to allow for a proper risk-benefit analysis by doctors and their
female patients;

(3)

Abbott failed to correct the misleading assertion that the relationship
between congenital malformations and Depakote was only possible;

(4)

Abbott improperly diluted the congenital malformation risk by stating that
the rate of spina bifida was 1 percent to 2 percent and that the incidence of
other congenital anomalies was unknown. This did not provide all of the
information that Abbott knew or should have known about the risk of
spina bifida because studies had reported spina bifida/neural tube defect
rates as high as 3.8 percent following Depakote monotherapy during
pregnancy;
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(5)

Abbott failed to provide current, complete and accurate information in the
labeling and failed to correct obsolete data and information; and

(6)

Abbott’s labeling failed to advise on the importance of contraceptive use.

While Abbott is correct that Dr. Mallya testified that she knew of the risk of spina bifida,
and advised Mrs. Forbes of the risk, this does not necessarily render the Depakote warning label
adequate as a matter of law.
informationally deficient.

There is a still a question of fact whether the warning was

In particular, it is questionable whether warning the patient of 1 to 2

percent chance of having a baby with spina bifida if taking Depakote fulfills Abbott’s duty under
Missouri law to properly warn the doctor of the dangers involved. Under Missouri law, “it is
incumbent upon the manufacturer to bring the warning home to the doctor.”

Doe v. Alpha

Therapeutic Corp., 3 S.W.3d 404, 419 (Mo. Ct. App. 1999) (quoting Krug v. Sterling Drug, Inc.,
416 S.W.2d 143, 146 (Mo. 1967)).

Dr. Mallya testified that additional warnings such as

“Depakote should only be used to treat pregnant women with epilepsy or bipolar disorder if other
medications have failed to control their symptoms,” “Depakote should not be administered to a
woman of child-bearing potential unless the drug is essential to the management of her
condition,” or a warning that women should use contraception while using Depakote would have
made a difference in her attitude toward Depakote and would have changed her approach to
prescribing Depakote. (Mallya Dep. at 81-83.)
Resolving all conflicts in favor of plaintiffs, the Court finds there are genuine issues of
material fact which preclude the entry of summary judgment on this claim, including but not
limited to whether Abbott should have included on its warning that Depakote should only be
used as a last line treatment in women of childbearing potential, the background rate of the
incidence of spina bifida in the general population, whether Abbott improperly diluted the
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congenital malformation risk, and whether Abbot’s warning failed to advise on the importance of
contraceptive use.

As a result, Abbott’s motion for summary judgment as to liability for failure

to warn will be denied.
(B)

Proximate Cause
To prevail on their failure to warn claims, plaintiffs must establish proximate cause.

“To do this, they have to show that the warnings would have altered the behavior of the
individuals involved . . . .” Johnson v. Medtronic, Inc., 365 S.W.3d 226, 232 (Mo. Ct. App.
2012) (internal quotation omitted). Missouri law supplies the presumption that a warning, if
provided, will be read and heeded. Id.
Abbott claims that the record establishes that Mrs. Forbes’ prescribing physician, Dr.
Mallya, was fully aware of the risk of spina bifida associated with Depakote when she prescribed
the medication.

Abbott argues that due to Dr. Mallya’s awareness of the risk, no alleged failure

to warn by Abbott could have been the proximate cause of B.F’s injury.

Abbott argues that

plaintiffs cannot establish that an adequate warning would have altered Dr. Mallya’s decision to
prescribe Depakote, and plaintiffs submit no evidence that Abbott’s alleged failure to warn
caused plaintiffs’ injuries.
Contrary to Abbott’s assertion, plaintiffs offered evidence to support their position that
had Abbott included additional information regarding the teratogenic effects of Depakote on its
warning, Dr. Mallya might not have prescribed this medication to Mrs. Forbes. At deposition,
Dr. Mallya stated that if Abbott would have included on its warning, “[Depakote] should not be
administered to a woman of child-bearing potential unless the drug is essential to the
management of her condition,” this would have definitely changed her approach to prescribing
the medication.

(Mallya Dep. at 82.)

Dr. Mallya also testified that if the label would have
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included a warning that women should use effective contraception while using Depakote, this
would also have affected her prescription approach.

(Id. at 83.)

Neither party asked Dr. Mallya specifically with respect to Mrs. Forbes whether these
additional warnings would have changed her decision to prescribe Mrs. Forbes Depakote.

Nor

did either party ask whether the additional warnings would have caused Dr. Mallya to
recommend Mrs. Forbes use contraception to avoid pregnancy.

On summary judgment,

however, the Court must view the facts in the light most favorable to plaintiffs and give them the
benefit of any logical inference.

It is logical to infer from Dr. Mallya’s testimony that the

additional warnings suggested by plaintiffs’ expert would have changed Dr. Mallya’s approach
to prescribing Depakote to Mrs. Forbes.

The Court concludes there are genuine issues of

material fact which preclude the entry of summary judgment on this claim.

Abbott’s motion for

summary judgment on the issue of proximate cause will therefore be denied.
Conclusion
For the foregoing reasons, Abbott=s motion for summary judgment will be denied.

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Accordingly,
IT IS HEREBY ORDERED that defendant Abbott Laboratories, Inc.’s motion for
summary judgment is DENIED.

[Doc. 61]

______________________________
CHARLES A. SHAW
UNITED STATES DISTRICT JUDGE

Dated this 31st day of March, 2016.

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