B.F. et al v. Abbott Laboratories, Inc. et al
MEMORANDUM AND ORDER: IT IS HEREBY ORDERED that defendant Abbott Laboratories, Inc.'s motion for summary judgment as to plaintiffs' claim of punitive damages is DENIED. [Doc. 64 ] Signed by District Judge Charles A. Shaw on 4/8/16. (JWD)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
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.,
ABBOTT LABORATORIES, INC.,
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 on plaintiffs’ claim for punitive damages.
The motion is fully briefed and ready for decision.
Plaintiffs oppose the
For the following reasons, the
motion will be denied.
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. was diagnosed with spina
bifida as a result of his mother’s ingestion of Depakote during pregnancy.
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).
both of these counts, plaintiffs seek an award of punitive damages.
Abbott moves for summary
judgment on plaintiffs’ claim for punitive damages, stating they have failed to present sufficient
evidence to support such a claim under Missouri law.
Summary Judgment Standard
The standards applicable to summary judgment motions are well settled.
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).
Corp. v. Catrett, 477 U.S. 317, 322 (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.
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).
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,
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.
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.
The black box
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
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
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
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
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
(Abbott SOF ¶¶ 16-17.)
In its motion, Abbott seeks summary judgment on plaintiffs’ claim for punitive damages,
stating that the claim fails as a matter of law because the Depakote labeling has always contained
safety information about the risks of spina bifida, the precise injury suffered by B.F.
respond that they are entitled to punitive damages because they have presented substantial
evidence that demonstrates Abbott acted with conscious disregard and reckless indifference for
the safety of B.F.
Under Missouri law the test for punitive damages is a strict one.
Beiersdorf, Inc., 723 S.W.2d 392, 397 (Mo. banc 1987) (holding that inadequate warnings does
not amount to conscious disregard). Punitive damages may be awarded in a negligence case or
a products liability case.
See Ford v. GACS, Inc., 265 F.3d 670, 677-78 (8th Cir. 2001).
“Punitive damages are appropriate under either theory of recovery only if the defendant showed
a complete indifference to or conscious disregard for the safety of others.
defendant must have acted with some degree of wantonness or bad motive.” Id. at 678 (internal
punctuation and citations omitted); see also Drabik v. Stanley-Bostitch, Inc., 997 F.2d 496 (8th
Cir. 1993) (vacating award of punitive damages, finding no indication of complete indifference
and an element of outrage).
Abbott argues that at the time Mrs. Forbes was prescribed Depakote, the label included a
FDA-mandated black box warning regarding teratogenicity, and specifically warned of the risk
of spina bifida, the very injury suffered by B.F. Because Abbott warned of the known risks and
of the harm suffered by plaintiff, it argues that it cannot be found to have acted outrageously due
to evil motive or reckless indifference to the rights of plaintiffs.
Plaintiffs have presented evidence, however, that Abbott knew as early as the 1980s that
(1) there was a cause and effect relationship between Depakote and serious birth defects; (2) if
used in women of childbearing age, Depakote should only be used with effective contraception;
(3) the risk of spina bifida in children exposed to Depakote in utero is a 10 to 20 fold increase
over the background rate; and (4) Depakote can produce multiple congenital malformations in
the same child.
Plaintiffs submit evidence that Abbott strategically diluted Depakote’s warning
and disseminated misleading information regarding the risks posed by Depakote.
submit evidence that Abbot’s failure to warn of the full extent of Depakote’s teratogenic danger
Plaintiffs’ evidence of Abbott’s alleged dilution of Depakote’s warning and
its dissemination of misleading information associated with Depakote use during pregnancy
creates a genuine issue of material fact regarding whether Abbott’s actions rose to a level of
Abbott’s contention that it could not be subject to punitive damages because the FDA
expressly approved the marketing and labeling of Depakote is not dispositive.
In Blanks v.
Flour Corporation, 450 S.W.3d 308, 402-04 (Mo. Ct. App. 2014), for example, defendants
argued that they could not be subject to punitive damages because they had done everything that
was required by the EPA and the DNR, and had cooperated with federal, state, and local
authorities concerning lead contamination.
The Blanks defendants, like Abbott here, argued
that punitive damages were unavailable against a party that complied with an ongoing regulatory
program intended to address the issues on which plaintiffs based their claims.
however, presented evidence that defendants had hidden information from regulators, resisted
regulatory changes, and had not complied with industry standards.
Thus, even though
defendants arguably complied with regulatory programs, plaintiffs presented sufficient evidence
of defendants’ evil motives or reckless disregard to submit the claim of punitive damages to the
Here, the fact that the FDA approved the marketing of Depakote and allowed for it to be
prescribed to women of child-bearing age for treatment of bipolar disorder weighs against the
submission of the punitive damages claim to the jury, but it does not foreclose it.
Alcorn v. Union Pacific R.R. Co., 50 S.W.3d 226, 248 (Mo. 2001)).
See id. (citing
Abbott’s compliance with
FDA requirements does not necessarily negate a jury finding that Abbott acted with complete
indifference to or conscious disregard for the safety of others, particularly in light of plaintiffs’
evidence that Abbott diluted Depakote’s warning and disseminated misleading information
regarding its risks.
Viewing the evidence in the light most favorable to plaintiffs, it remains a disputed issue
whether Abbott knew or had reason to know that there was a high degree of probability that its
conduct would result in injury.
The Court will deny Abbott’s motion for summary judgment on
plaintiffs’ claim for punitive damages.
For the foregoing reasons, Abbott has not established a right to summary judgment with
respect to the issue of punitive damages.
IT IS HEREBY ORDERED that defendant Abbott Laboratories, Inc.’s motion for
summary judgment as to plaintiffs’ claim of punitive damages is DENIED.
CHARLES A. SHAW
UNITED STATES DISTRICT JUDGE
Dated this 8th day of April, 2016.
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