Appeal
from Calhoun Circuit Court (CV-17-900399.80)
Thomas
E. Walker of White Arnold & Dowd, P.C., Birmingham; and
Linda E. Maichl, John R. Ipsaro, and Jeffrey F. Peck of Ulmer
& Berne, LLC, Cincinnati, Ohio, for appellant.
Thomas
J. Knight of Hubbard & Knight, Anniston and George D.
Robinson of Robinson Law Firm, LLC, Anniston, for appellee.
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
Page 303
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
Page 304
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
Page 305
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
Page 306
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 ...