Barcal v. Aventis Inc et al
MEMORANDUM OPINION. Signed by Judge Madeline Hughes Haikala on 3/21/2016. (KEK)
2016 Mar-21 AM 11:43
U.S. DISTRICT COURT
N.D. OF ALABAMA
UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
ASHLYE M. BARCAL,
EMD SERONO, INC.,
Case No.: 5:14-cv-01709-MHH
Plaintiff Ashlye M. Barcal brings this products liability action against
defendant EMD Serono, Inc.
EMD Serono manufactures the fertility drug
Serophene. Ms. Barcal alleges that she suffered severe cardiac birth defects as a
result of her mother’s ingestion of Serophene, and Ms. Barcal asserts thirteen
causes of action against the company.
EMD Serono moved to dismiss the action pursuant to Fed. R. Civ. P.
12(b)(6). EMD Serono attached to its motion the Serophene label in effect when
Ms. Barcal’s mother used the fertility drug and several journal articles that Ms.
Barcal mentioned in her complaint. Because of EMD Serono’s reliance on the
label and the articles, the Court converted EMD Serono’s motion to dismiss into a
motion for summary judgment pursuant to Fed. R. Civ. P. 12(d) and 56 and
provided the parties an opportunity to file supplemental materials pertaining to the
summary judgment motion. After consideration of the parties’ submissions, the
Court will grant EMD Serono’s converted motion for summary judgment in part,
defer consideration of it in part, and grant Ms. Barcal’s request for discovery
pursuant to Fed. R. Civ. P. 56(d).
STANDARD OF REVIEW
“If, on a motion under Rule 12(b)(6) or 12(c), matters outside the pleadings
are presented to and not excluded by the court, the motion must be treated as one
for summary judgment under Rule 56. All parties must be given a reasonable
opportunity to present all the material that is pertinent to the motion.” Fed. R. Civ.
The Court must grant summary judgment “if the movant shows that there is
no genuine dispute as to any material fact and the movant is entitled to judgment as
a matter of law.” Fed. R. Civ. P. 56(a). The Court must “examine the evidence in
the light most favorable to the non-moving party,” drawing all inferences in favor
of that party. Earl v. Mervyns, Inc., 207 F.3d 1361, 1365 (11th Cir. 2000).
“If a nonmovant shows by affidavit or declaration that, for specified reasons,
it cannot present facts essential to justify its opposition, the court may defer
considering the motion or deny it; allow time to obtain affidavits or declarations or
to take discovery; or issue any other appropriate order.” Fed. R. Civ. P. 56(d).
“The party opposing a motion for summary judgment has a right to challenge the
affidavits and other factual materials submitted in support of the motion by
conducting sufficient discovery so as to enable him to determine whether he can
furnish opposing affidavits,” so “summary judgment should not be granted until
the party opposing the motion has had an adequate opportunity for discovery.”
Snook v. Trust Co. of Ga. Bank of Savannah, 859 F.2d 865, 870 (11th Cir. 1988).
RELEVANT FACTS AND PROCEDURAL HISTORY
In 1982, EMD Serono received approval from the FDA to market and sell
under the name Serophene a fertility medication known as clomiphene citrate.1
(Doc. 1, ¶ 13). From August 1993 through January 1994, Mary Durham, Ms.
Barcal’s mother, was prescribed and took Serophene to help her conceive. (Doc. 1,
¶ 14). Ms. Durham became pregnant in February 1994, and Serophene was still
present in her system. (Doc. 1, ¶¶ 16-17). Ms. Barcal was born prematurely on
September 8, 1994, at approximately 34 and 3/7ths weeks. (Doc. 1, ¶ 18).
On September 23, 1994, doctors diagnosed Ms. Barcal with a heart murmur
and a large ventricular septal defect (VSD). This defect is characterized as a hole
in the septum—the wall of the heart—causing blood to flow between the lower
chambers of the heart instead of properly entering the aorta for distribution
throughout the body. (Doc. 1, ¶ 19). Shortly after she was born, Ms. Barcal was
Clomiphene citrate was initially approved by the FDA in 1967 under the brand name Clomid,
manufactured by Aventis, Inc. (Doc. 1, ¶¶ 3-4, 12). Ms. Barcal initially named Aventis as a
defendant in this action, asserting the first thirteen causes of action only against Aventis. The
Court previously dismissed all claims against Aventis without prejudice, consistent with the
parties’ joint stipulation of dismissal. (See Docs. 32, 33).
diagnosed with Tetralogy of Fallot, a form of congenital heart disease that consists
of high pulmonic stenosis, VSD, dextroposition of the aorta, and right ventricular
hypertrophy. (Doc. 1, ¶ 20). Ms. Barcal had to undergo surgery in 1995 to address
her cardiac issues.
She has dealt with cardiac complications her entire life,
dramatically affecting her quality of life. (Doc. 1, ¶¶ 21-26).
EMD Serono provided a label that the company asserts it attached to all
Serophene containers during the period in which Ms. Durham took the drug. (Doc.
19-2). The label mentions that congenital heart defects were observed in children
whose mothers’ pregnancies had been induced by clomiphene citrate, but “[t]he
cumulative rate of congenital abnormalities does not exceed that reported in the
general population.” (Doc. 19-2 at 4). The label also states: “Although no direct
effect of clomiphene citrate therapy on the human fetus has been established,
clomiphene citrate should not be administered in cases of suspected pregnancy as
such effects have been reported in animals.” (Doc. 19-2 at 3).
Ms. Barcal initiated this suit against EMD Serono on September 4, 2014,
asserting thirteen causes of action. The claims are primarily based on two distinct
theories: (1) Serophene is a defective product because it unreasonably increases the
risk of cardiac birth defects,2 and (2) Serophene’s warning label is inadequate
The Court considers the following claims to fall under the first theory: Count XIV (AEMLD
Design Defect); Count XVI (Implied Warranty of Fitness for a Particular Purpose), because the
warranty turns on the suitability of the product, see Ala. Code § 7-2-315; and Count XX (Implied
because it does not sufficiently warn physicians and consumers of the increased
risk of cardiac birth defects caused by the drug.3 In support of her causation
theory, Ms. Barcal cites several journal articles in her complaint which, in her
mind, demonstrate the increased risk and put EMD Serono on notice of the risk,
either actually or constructively.
EMD Serono moved to dismiss the action on various grounds.
notably, it attached to its motion the articles that Ms. Barcal referenced in her
complaint and argued that the articles do not provide factual support for her
causation theory and did not put EMD Serono on notice of any increased risk of
cardiac birth defects. (Docs. 18-19). The parties submitted briefing, and Ms.
Barcal attached to her submission an affidavit under Fed. R. Civ. P. 56(d), in which
her attorney contends that summary judgment in this action would be premature
because the parties have not conducted discovery. (Doc. 39-1). She asks the Court
to deny EMD Serono’s motion without prejudice to the company’s right to file
another summary judgment motion after the parties engage in discovery.
Warranty of Merchantability), because the warranty turns on the fitness of the product, see Ala.
Code § 7-2-314. Counts XVIII (Negligence) and XXV (Unjust Enrichment) fall under both
The Court considers the following claims to fall under the second theory: Count XV (AEMLD
Warning); Count XVII (Express Warranty); Count XIX (Failure to Warn); Count XXII (Fraud),
to the extent the alleged fraud is based on misrepresentations in the warning label; Count XXIII
(Negligent Misrepresentation); and Counts XXIV (Negligence per se) and XXVI (ADTPA
Violation), because both are premised on the label’s false representations. Counts XVIII
(Negligence) and XXV (Unjust Enrichment) fall under both theories.
Ms. Barcal’s Rule 56(d) request is well-taken. The Court will grant the
motion. The Court will not require Ms. Barcal to present evidence in support of
her claims when she has not had the opportunity to discover relevant evidence. See
Snook, 859 F.2d at 870. Pursuant to Rule 56(d), the Court will therefore review
Ms. Barcal’s claims for legal sufficiency, dismissing only those claims with defects
that cannot be cured by discovery. The Court will defer consideration of EMD
Serono’s motion for summary judgment until after the parties conduct discovery.
A. Design Defect Claims
EMD Serono presents two legal challenges to Ms. Barcal’s claims that
Serophene is defectively designed. Because the Court finds both grounds to be
meritorious, the Court will dismiss all of Ms. Barcal’s claims premised upon her
design defect theory.
1. Unavoidably Unsafe Products
In defining the contours of the Alabama Extended Manufacturer’s Liability
Doctrine in Stone v. Smith, Kline & French Labs., the Alabama Supreme Court
recognized a category of products that are “unavoidably unsafe,” that is, products
that “are quite incapable of being made safe for their intended and ordinary use.”
447 So. 2d 1301, 1303 n.1 (Ala. 1984); see also Restatement (Second) of Torts §
402A cmt. k (Am. Law Inst. 1965). The Alabama Supreme Court found that
prescription drugs fall within this category and held: “in the case of an
‘unavoidably unsafe’ yet properly prepared prescription drug, the adequacy of the
accompanying warning determines whether the drug, as marketed, is defective, or
unreasonably dangerous.” Id.at 1304. Therefore, no AEMLD design defect claim
for prescription drugs exists apart from a challenge to the adequacy of the warning,
a claim that Ms. Barcal has separately stated.
EMD Serono argues that this principle operates as a bar to all of Ms.
Barcal’s design defect claims, whether premised on the strict liability of the
AEMLD or on a negligence theory. The Court agrees. All of the design defect
claims, no matter the cause of action under which they are presented, hinge on the
safety of the product.4 The Alabama Supreme Court has found the safety element
common to both strict liability and negligence claims. See McMahon v. Yamaha
Motor Corp., 95 So. 3d 769, 772 (Ala. 2012). Indeed, in Stone, the Alabama
Supreme Court specifically linked the exception to negligence principles. Stone,
447 So. 2d at 1303 (“The requirement that the product be unreasonably dangerous,
as amplified by comments j and k, produces essentially the same result as
traditional negligence theory.”) (quoting R. Merrill, Compensation for Prescription
Drug Injuries, 59 Va. L. Rev. 1, 31 (1973)). Because the rationale of the exception
As stated above, the implied warranty claims turn on the suitability or fitness of the drug. Ms.
Barcal’s negligence claim, as related to design defects, centers on the drug not being “reasonably
safe.” (Doc. 1, ¶ 198). Her unjust enrichment claim focuses on the quality and fitness of the
drug. (Doc. 1, ¶ 255).
turns on the notion that prescription drugs are desirable even though they may
never be made fully safe, the Court finds the exception equally applicable to design
defect claims outside of the AEMLD. All of Ms. Barcal’s design defect claims
will accordingly be dismissed.
Alternatively, EMD Serono correctly argues that federal law preempts Ms.
Barcal’s design defect claims. “Under the Supremacy Clause, state laws that
require a private party to violate federal law are pre-empted and, thus, are ‘without
effect.’” Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2470 (2013) (quoting
Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). “[S]tate law [is] impliedly
preempted where it is ‘impossible for a private party to comply with both state and
federal requirements.’” Id. at 2473 (quoting English v. Gen. Elec. Co., 496 U.S.
72, 79 (1990)). “The question for ‘impossibility’ is whether the private party could
independently do under federal law what state law requires of it.” PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567, 2579 (2011). “[W]hen a party cannot satisfy its state
duties without the Federal Government’s special permission and assistance, which
is dependent on the exercise of judgment by a federal agency, that party cannot
independently satisfy those state duties for pre-emption purposes.” Id. at 2581.
Neither is impossibility preemption avoided if the party may comply with both
federal and state law by ceasing to act altogether. Bartlett, 133 S. Ct. at 2477.
The FDA approved Serophene’s composition in 1982.
(Doc. 1, ¶ 13).
“Once a drug—whether generic or brand-name—is approved, the manufacturer is
prohibited from making any major changes to the ‘qualitative or quantitative
formulation of the drug product, including active ingredients, or in the
specifications provided in the approved application.’” Bartlett, 133 S. Ct. at 2471
(quoting 21 C.F.R. § 314.70(b)(2)(i)).
Alabama tort design defect claims,
however, would essentially require EMD Serono to redesign Serophene. See id. at
2479 (rejecting the dissent’s characterization of state tort law as “merely creat[ing]
an incentive” to change the drug rather than imposing an actual “legal obligation”).
This is precisely the kind of impossibility in which the Supreme Court has found
Id. (“[W]e hold that state-law design-defect claims like New
Hampshire’s that place a duty on manufacturers to render a drug safer by either
altering its composition or altering its labeling are in conflict with federal laws that
prohibit manufacturers from unilaterally altering drug composition or labeling.”).
The fact that the FDA may approve an alteration does not negate the present
impossibility. See PLIVA, 131 S. Ct. at 2581. Ms. Barcal’s design defect claims
Ms. Barcal argues that the cases cited above do not apply to her claims
because all of those cases regard failure-to-warn claims against manufacturers of
generic drugs approved under the FDA’s Abbreviated New Drug Application,
while Serophene was approved under the standard New Drug Application process,
and EMD Serono is asserting preemption of design defect claims, not failure-towarn claims. These assertions do not negate the fact that any approved drug,
whether through the NDA or ANDA process, cannot be altered without the FDA’s
prior permission, rendering compliance with both state and federal law impossible.
Wyeth v. Levine, 555 U.S. 555 (2009), is not to the contrary. In that case, the Court
found no preemption of failure-to-warn claims against an NDA drug manufacturer
because a process existed by which the manufacturer could strengthen the label
warnings unilaterally and seek subsequent FDA approval. No such process exists
for changes to a drug’s chemical composition, however, so the Levine holding is
B. Adequacy of Warning Label Claims
In contrast to its challenge to the design defect claims, EMD Serono asserts
no legal challenges to Ms. Barcal’s claims regarding the adequacy of the
Serophene label (apart from the fraud and statutory claims discussed below).
Instead, it contends that the warning claims fail because the journal articles cited
by Ms. Barcal do not establish an increased risk of cardiac birth defects and thus
could not have put the company on notice of those risks. This is essentially a
factual challenge to the sufficiency of the evidence submitted by Ms. Barcal
because EMD Serono seeks to use the studies to contradict Ms. Barcal’s assertions
that the label did not adequately warn of the increased risk. Ms. Barcal, however,
has not had the opportunity to conduct discovery and therefore cannot be expected
to submit evidence in support of her claims. Consequently, the Court will defer
consideration of EMD Serono’s converted motion for summary judgment as to the
warning label claims until the parties have conducted discovery.
Lest EMD Serono feel slighted by the Court’s conversion of its motion to
dismiss into a motion for summary judgment and subsequent use of that
conversion to defer the motion, the Court also finds that Ms. Barcal’s failure-towarn claims would survive EMD Serono’s Rule 12(b)(6) motion. Ms. Barcal
alleged that the articles she cites in her complaint placed EMD Serono on notice
that Serophene increased the risk of the occurrence of cardiac birth defects. (See,
e.g., Doc. 1, ¶¶ 86, 115).
This notice was either actual (prompting the
misrepresentation theories) or constructive (prompting the negligence/strict
liability theories). Thus, Ms. Barcal plausibly alleges her failure-to-warn claims.
EMD Serono argues that the journal articles do not actually support the
liability theory that Ms. Barcal advances. That may be true, but this is not a proper
juncture for the Court to make such a determination. EMD Serono would have the
Court reject Ms. Barcal’s view and find her causation and notice theories
implausible because none of the articles explicitly link Serophene to an increased
risk of cardiac birth defects. In Ms. Barcal’s view, however, the articles function
as building blocks to that ultimate conclusion.5 Disagreeing with this view is not,
as EMD Serono suggests, simply an exercise in resolving a contradiction between
pleadings and exhibits in favor of the exhibits. See Griffin Indus., Inc. v. Irvin, 496
F.3d 1189, 1206 (11th Cir. 2007). Rather, it requires a factual determination
regarding the import of the articles that the Court cannot make at this stage. These
are arguments better suited to summary judgment, so the Court will defer
consideration of them until that time.
Neither is EMD Serono absolved from liability simply because of the
presence of a warning on the label regarding cardiac birth defects and ingestion
during pregnancy. Ms. Barcal contends that the warning is inadequate because it
fails to properly convey the full extent of the risks of cardiac birth defects allegedly
caused by the drug. That a warning regarding these issues was present does not
conclusively establish that it was adequate.
C. Fraud Claim
“In alleging fraud or mistake, a party must state with particularity the
circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). “Particularity
means that a plaintiff must plead facts as to time, place, and substance of the
defendant’s alleged fraud, specifically the details of the defendant[’s] allegedly
Contrary to EMD Serono’s assertions, even the articles that post-date Ms. Durham’s ingestion
of Serophene are not wholly irrelevant. While they cannot have served to put the company on
notice of an increased risk of cardiac defects, the articles could support Ms. Barcal’s theory that
an increased risk is present and could potentially show that EMD Serono may have discovered
the risk by conducting additional testing.
fraudulent acts, when they occurred, and who engaged in them.” United States ex
rel. Atkins v. McInteer, 470 F.3d 1350, 1357 (11th Cir. 2006) (internal quotations
omitted). Ms. Barcal has alleged fraud based on EMD Serono’s statements made
on the Serophene label, in advertisements, and in other acts of concealment and
suppression. Her claims concerning the warning label have been set forth with
particularity, but the others have not. Ms. Barcal has not alleged any specific
fraudulent advertisements or acts apart from the label. Instead, she seeks discovery
to uncover the statements made in the relevant advertisements, but this is not
permitted by Rule 9(b). See id. at 1359 (“The particularity requirement of Rule 9
is a nullity if Plaintiff gets a ticket to the discovery process without identifying a
single claim.”) (quoting United States ex rel. Clausen v. Lab. Corp. of Am., 290
F.3d 1301, 1307 (11th Cir. 2002)). Therefore, Ms. Barcal’s fraud claim (Count
XXII), except as regarding the Serophene label, will be dismissed.
D. Statutory Claims
In Count XXVI, Ms. Barcal asserts a claim under the Alabama Deceptive
Trade Practices Act. See Ala. Code § 8-19-1 et seq. She also asserts a statutory
negligence claim in Count XXIV, which she later clarified is only brought under
the ADTPA. (See Doc. 34 at 20). As discussed above, Ms. Barcal asserts common
law fraud and negligence claims. The ADPTA’s savings clause provides:
An election to pursue any civil remedies available at common law, by
statute or otherwise, for fraud, misrepresentation, deceit, suppression
of material facts or fraudulent concealment arising out of any act,
occurrence or transaction actionable under this chapter shall exclude
and be a surrender of all rights and remedies available under this
Ala. Code § 8-19-15(b). Although the ADPTA’s savings clause would preclude
Ms. Barcal from ultimately obtaining relief under both the ADPTA and her
common law claims, Federal Rule of Civil Procedure 8 allows parties to plead
alternative, even inconsistent, theories. See Fed. R. Civ. P. 8(d)(3) (“A party may
state as many separate claims or defenses as it has, regardless of consistency.”).
Therefore, at this stage, the Court will allow Counts XXIV and XXVI to move
forward as alternatively pled claims.
E. Punitive Damages Claim
In Count XXI, Ms. Barcal asserts a claim for punitive damages. Under
Alabama law, however, punitive damages are merely a remedy, not a cause of
action, so she may not assert a claim solely for punitive damages. See Ala. Code §
6-11-28 (“Nothing contained in this article shall be construed to grant or create a
cause of action or right to recover punitive damages.”).
Count XXI will
accordingly be dismissed.
For the reasons discussed above, the Court will dismiss Ms. Barcal’s design
defect and punitive damages claims, and will partially dismiss her fraud claim.
The action will proceed on the balance of Ms. Barcal’s claims. The Court will
enter a separate order consistent with this memorandum opinion.
DONE and ORDERED this March 21, 2016.
MADELINE HUGHES HAIKALA
UNITED STATES DISTRICT JUDGE
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