Appeal
from Calhoun Circuit Court (CV-17-900399.80)
WISE,
Justice.
Forest
Laboratories, LLC ("Forest"), filed a permissive
appeal pursuant to Rule 5, Ala. R. App. P., from the Calhoun
Circuit Court's order denying Forest's motion for a
summary judgment. We reverse and remand.
Facts
and Procedural History
Lexapro
is the brand name of a prescription drug used to treat
depression. It appears that Forest manufactured and marketed
Lexapro and that Forest Pharmaceuticals, Inc.
("FPI") sold and distributed Lexapro. Escitalopram
is the generic form of Lexapro.
On
December 29, 2015, Elias Joubran's physician prescribed
Lexapro for Elias's depression. Elias's prescription
was filled with generic escitalopram that was manufactured
and sold by a company other than Forest. On December 30,
2015, Elias entered the house belonging to him and his wife,
Sheila Clay Joubran; he shot and killed Sheila and then shot
and killed himself.[1]
On July
13, 2017, Kevin J. Feheley, Sr., as administrator and
personal representative of Sheila's estate and as
guardian and conservator of Kevin J. Feheley, Jr., an
incapacitated person, [2] filed suit in the Calhoun Circuit Court
against Mary Joubran, in her capacity as the personal
representative of Elias's estate, Forest, FPI, and
fictitiously named defendants. The complaint alleged that, at
the time of the murder/suicide, Elias "was under
prescription for, and was ingesting, under certain
physicians' prescription, certain pharmaceuticals,
including those pharmaceuticals manufactured by the
defendants as described more particularly herein." The
complaint went on to allege that "Forest's Lexapro[]
enhanced, enabled and aggravated [Elias's] depression and
violent behaviors." The complaint alleged, in part:
"Defendants [FPI] and [Forest] (collectively
hereinafter, 'Forest') were severally, the marketer,
promoter, seller, manufacturer, distributor, and entity which
did manufacture, create, design, test, label, package,
distribute, market, sell, advertise, fail to warn, and
otherwise handle and distribute in commerce, the products,
Lexapro 10 mg tablets."
After
including extensive allegations regarding Forest's
marketing activities, Feheley alleged:
"32. The foregoing and similar activity has continued in
an effort to induce physicians to prescribe Lexapro and to
increase sales to persons such as [Elias Joubran] as a matter
of specific intent by the Defendants. Defendants suppressed
the true facts as to the dangers of Lexapro, while at the
same time, communicating to physicians and to the body of
physicians generally that Lexapro was safe and effective with
the specific intent to enlarge and enhance the market for
Lexapro and with the proximate result that the prescriptions
of Lexapro were in fact greatly increased and enhanced, the
drug much more generally accepted by the prescribing
physician public, and that customers such as Elias Joubran
would be prescribed Lexapro by physicians who were not aware
of all of the true dangers of the drug including:
"a. That the drug was particularly dangerous for
patients who were already experiencing unusual agitation and
upset,
"b. That the drug was particularly dangerous during the
time period shortly after its use was commenced by a patient,
and shortly after the dose was increased, in either case, a
greater risk for suicide and violence was and is enhanced by
the drug,
"c. That the drug heightened the risk of increased
agitation, suicidal behaviors, violent behaviors, and
patients acting on thoughts that would otherwise be mediated
or restrained by the patient, but in the presence of this
drug would, instead, be acted upon. Defendants misrepresented
that the increased risk of suicide was essentially, solely, a
product of younger age when in fact [D]efendants knew or
should have known that the risk was related to factors that
occurred more commonly, but not at all uniquely, with younger
age, and these factors existed in Elias Joubran and other
vulnerable populations who were targeted consumers of the
drugs, and,
"d. On information and belief, Plaintiff avers that
neither Elias Joubran, nor his prescribing physician were
aware of the extent and true nature of the facts which were
misrepresented and or suppressed by Defendants and neither
discovered the true facts at any time before the prescription
and the acts described elsewhere in this Complaint, all with
the proximate result and consequence that the killing of
[Sheila Joubran] and the suicide of Elias Joubran took place
as elsewhere described herein."
The
complaint alleged that Forest
"was aware that when new doses are given or increased,
there is an enhanced risk period for suicide or violence, but
failed to warn adequately of this risk, and actively
suppressed, concealed and misrepresented the extent of this
enhanced danger."
It
further alleged:
"42. The pharmaceutical product manufactured by
[D]efendants and sold by them, being placed in the stream of
commerce by them, were dangerous and defective in that each
was unreasonably unsafe when put to the ordinary use and
purpose for which it was sold and designed.
"43. The said drug was dangerous and defective in that
it did not meet the reasonable expectations of the ordinary
consumer as to safety, and that further it was not
accompanied by the proper and necessary warnings that should
have been provided with the said drugs to prevent harm and
injury by consumers of the said drugs to persons like [Elias
Joubran], all of which was reasonably foreseeable to the
[D]efendants. Plaintiffs further allege and aver that
[D]efendants were negligent and wanton in their design,
manufacture, sale, advertising, failure to warn, and other
dealing with, and handling of, the subject products, all of
which combined and concurred to be a substantial proximate
cause of the harm and injury suffered by [P]laintiffs as
complained of herein.
"44. The [D]efendants, including named and fictitious
defendants, were negligent, careless, wanton, and violated
the Alabama Manufacturers Extended Liability Doctrine, and
their conduct combined and concurred, with the conduct of
Defendant's decedent, Elias Joubran, to proximately cause
the injuries and damages and losses and the death suffered by
the [P]laintiff's decedent, Sheila Clay Joubran,
deceased, on December 30, 2015, as described herein.
"45. The conduct of the [D]efendants was gross,
oppressive, burdensome, willful, intentional, wanton, and
otherwise such as to justify the imposition of punitive
damages under applicable law."
The
complaint asserted various claims against Forest, including
various products-liability claims, negligence and wantonness
claims, breach-of-express- and implied-warranty claims, and a
civil-conspiracy claim. Count II alleged a claim of
"Product Liability (Failure to Warn)":
"57. Defendants are designers, developers,
manufacturers, testers, marketers, distributors, promoters,
and sellers of the pharmaceutical product Lexapro.
"58. The pharmaceutical product Lexapro, designed,
developed, manufactured, tested, marketed, distributed,
promoted, and sold by Defendants was and is unaccompanied by
proper warnings regarding all possible adverse side effects
associated with the use of pharmaceutical product Lexapro,
and the comparative severity and duration of such adverse
effects; the warnings given did not accurately reflect the
symptoms, scope or severity of the side effects.
"59. Defendants failed to perform adequate research,
investigation and testing, in that adequate testing, research
and investigation would have shown that, used individually
and/or in any combination thereof, [Lexapro] possessed
serious potential hazards with respect to which full and
proper warnings accurately and fully reflecting hazards,
symptoms, scope and severity should have been made, both with
respect to the use of the pharmaceutical product Lexapro,
individually and with respect to any combination use with any
other pharmaceutical products.
"60. Defendants also failed to effectively warn users
and physicians that numerous other suitable pharmaceutical
products made by other manufacturers, did not have such
severe side effects.
"61. The pharmaceutical product Lexapro, designed,
developed, manufactured, tested, marketed, distributed,
promoted, and sold by Defendants was defective due to
inadequate post-marketing research and warning or instruction
because, after the manufacturer, developer, designer, and
marketer knew or should have known of the risk of injury from
the pharmaceutical product Lexapro, it and they failed to
provide adequate warnings to users or consumers of the
product and continued to aggressively promote the product,
and no accurate or appropriate warning was given to [Elias
Joubran] or his physicians by Defendants Forest
Pharmaceuticals, Inc., and Forest Laboratories, Inc., or the
other defendants at the point and time of sale or by anyone
else."
Count
VII alleged claims of misrepresentation, fraud, suppression,
and deceit:
"87. Forest[3] and fictitious Defendants were aware that
when new doses are given or increased, there is an enhanced
risk period for suicide or violence, but fraudulently
suppressed information about this risk. Defendants have made,
and some of them continue to make, false and fraudulent
misrepresentations to physicians and general public
including, but not limited to, that the pharmaceutical
product Lexapro, is safe, fit and effective for its uses and
is not hazardous to the health of users.
"88. At all pertinent times, Defendants conducted,
and/or conspired jointly to conduct, a sales and marketing
campaign to promote the sale of the pharmaceutical product
Lexapro, through advertisements and other promotional
literature and fraudulently deceived the Plaintiff, [Elias
Joubran], physicians and the general public as to the health
risks and consequences of the pharmaceutical product Lexapro.
Defendants also failed to disclose other effective methods
for treating depression. Defendants suppressed material facts
that, if disclosed to [Elias Joubran] or his Physician would
have resulted in refusal of use of the pharmaceutical product
Lexapro. Forest was aware that when new doses are given or
increased, there is an enhanced risk period for suicide or
violence, but failed to warn adequately of this risk, and
actively suppressed, concealed and misrepresented the extent
of this enhanced danger.
"89. Defendants Forest Pharmaceuticals, Inc., and Forest
Laboratories, Inc., and fictitiously designated
defendants' misrepresentation and suppressions of
material facts were done intentionally, willfully, wantonly
and/or negligently. Plaintiff alleges in the alternative or
in addition that even if the misrepresentations and
suppressions made by Defendants Forest Pharmaceuticals, Inc.,
and Forest Laboratories, Inc., and fictitious defendants,
were merely negligent or even innocent misrepresentations
they are nonetheless actionable under Alabama and other
applicable law. [Elias Joubran] and his physician reasonably
relied upon the representations based on the skill and
judgment of said Defendants as to whether the pharmaceutical
product Lexapro, was of merchantable quality, safe and fit
for its intended uses.
"90. In reliance of the foregoing misrepresentation
whether innocent, negligent, wanton, or not by Defendants,
[Elias Joubran] was induced to and did subject himself to the
use of pharmaceutical product Lexapro, and committed homicide
and suicide. If [Elias Joubran] and physician had known the
true facts, he would not have taken such action and subjected
himself to the aforesaid risks."
On August 8, 2017, Forest filed a notice of removal in the
United States District Court for the Northern District of
Alabama. On August 25, 2017, Forest filed its answer to the
complaint in the federal district court. In its affirmative
defenses, Forest asserted:
"Forest did not manufacture the product allegedly
ingested by Mr. Joubran. Accordingly, Forest may not be held
liable to plaintiff for any of the alleged injuries or
damages in this lawsuit."
On October 20, 2017, the United States District Court for the
Northern District of Alabama, Eastern Division, remanded the
case to the Calhoun Circuit Court.
On
December 1, 2017, Feheley filed an amendment to the
complaint. The amended complaint substituted Camber
Pharmaceutical for one of the fictitiously named defendants.
In the amended complaint, Feheley alleged that Camber was
"the marketer, manufacturer, promoter, seller,
distributor, and entity which did manufacture, create,
design, test, label, package, distribute, market, sell,
advertise, fail to warn, and otherwise handle and distribute
in commerce, the products escitalopram tablets."
Forest
subsequently filed its response and answer to the amended
complaint, incorporating the answer it had previously ...