Title: Forest Laboratories, LLC v. Feheley, Sr.
Citation: N/A
Docket Number: 1180387
State: Alabama
Issuer: Alabama Supreme Court
Date: October 25, 2019

Rel: October 25, 2019
Notice: This opinion is subject to formal revision before publication in the advance
sheets of Southern Reporter.  Readers are requested to notify the Reporter of Decisions,
Alabama Appellate Courts, 300 Dexter Avenue, Montgomery, Alabama 36104-3741 ((334)
229-0649), of any typographical or other errors, in order that corrections may be made
before the opinion is printed in Southern Reporter.
SUPREME COURT OF ALABAMA
 OCTOBER TERM, 2019-2020
_________________________
1180387
_________________________
Forest Laboratories, LLC
v.
Kevin J. Feheley, Sr., as administrator and personal
representative of the Estate of Sheila Clay Joubran,
deceased, and as guardian and conservator of Kevin J.
Feheley, Jr., an incapacitated person
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
1180387
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
1Evidence was presented indicating that, although Elias
and Sheila were married at the time, Sheila was in the process
of separating from Elias.
2
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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
2In an affidavit, Feheley asserted that he is Sheila's ex-
husband; that he is the father of Kevin J. Feheley, Jr.; that
Kevin J. Feheley, Jr., is Sheila's son and sole surviving
heir; and that Kevin J. Feheley, Jr., is incapacitated.  
3
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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,
4
1180387
"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
5
1180387
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
6
1180387
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: 
7
1180387
"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
3"Forest" is used collectively in the complaint for the
defendants referred to as "Forest" and "FPI" in this opinion.
8
1180387
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.
9
1180387
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
filed in the federal district court.   
On February 26, 2018, Feheley and Forest entered into the
following stipulation:
"1. 
Elias 
Joubran's 
prescription 
for
Lexapro/escitalopram 
was 
filled 
with 
generic
escitalopram manufactured and sold by a company
other than Forest.
"2. In the interest of conserving the resources
of the Court and the parties, the issue of whether
Forest is entitled to judgment solely based on the
fact that Forest did not manufacture or sell the
escitalopram that Elias Joubran received will be
pled and briefed in the near future without
prejudice to Forest's ability to file a subsequent
dispositive motion in the event Forest's motion on
the product use issue is denied."
10
1180387
On the same day, Forest filed a "Motion for Summary
Judgment Based on Lack of Product Use."4  In that motion,
Forest alleged that the injury claimed by Feheley was not
caused by a product that was sold or manufactured by Forest. 
In its memorandum in support of that motion, Forest stated
that it markets the brand-name prescription pharmaceutical
Lexapro, which is generically known as escitalopram; that
escitalopram has been available in generic form for many
years; that Feheley and Forest agreed that Forest did not
manufacture or sell the escitalopram at issue in this case;
and that the prescription at issue in this case was filled
with a generic escitalopram that was manufactured and sold by
a competitor of Forest's.  Forest also asserted that it could
not be liable for the alleged injuries caused by another
manufacturer's product.  It went on to argue:
"For decades, a well-established principle of
Alabama tort law has been that for a manufacturer to
owe a duty (or have any liability) to a consumer,
the manufacturer must have manufactured or sold the
product that allegedly caused the consumer harm.  As
the Alabama Supreme Court explained decades ago:
4Forest asserted that, although FPI had also been named
as a defendant, FPI had not been served.
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"'The breach of duty charges against
defendants is the failure to give notice to
or warn plaintiffs of the dangerous nature
of the vine killer.  Do the facts alleged
in the complaint show that the defendant,
Bertolla, owed a duty to warn plaintiffs? 
As plaintiffs candidly admit in brief, it
is not alleged that plaintiffs purchased
the vine killer from Bertolla.  It is not
alleged that Bertolla ever had possession
of or any connection whatsoever with the
particular 
substance 
which 
plaintiffs
sprayed and which allegedly caused the
death of plaintiffs' cattle.  The rule,
upon which plaintiffs' right to recover is
based, imposes the duty on one who, with
knowledge 
of 
its 
dangerous 
quality,
manufactures 
or 
sells 
an 
imminently
dangerous article and fails to warn.  It is
not alleged that Bertolla manufactured the
dangerous article.  It is not alleged that
Bertolla sold it.  How, then, did Bertolla
owe a duty to warn?'
"See Thompson-Hayward Chemical Co. v. Childress, 169
So. 2d 305, 312 (1964)(emphasis added).
"Federal 
courts in 
Alabama understood that to 
be
Alabama 
law 
in 
cases 
involving 
prescription
medications.  See Mosley v. Wyeth, Inc., 719 F.
Supp. 2d 1340 (S.D. Ala. 2010) (holding where
consumer ingested generic prescription drug product,
manufacturer of brand-name drug had no relationship
to consumer and owed no duty to consumer).  But in
August 2014, the Alabama Supreme Court carved out a
narrow exception to that well-established principle
in the context of prescription medications.  See
Wyeth, Inc. v. Weeks, 159 So. 3d 649 (2014).
"In Weeks, based on the federal regulatory
scheme for prescription medicines and the United
States Supreme Court's decision in PLIVA, Inc. v.
12
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Mensing, 564 U.S. 604, 131 S. Ct. 2567 (2011), the
Alabama Supreme Court held that a brand-name-drug
company 
may 
be 
held 
liable 
for 
fraud 
or
misrepresentation (by misstatement or omission),
based on statements it made in connection with the
manufacture of a brand-name prescription drug, by a
plaintiff claiming physical injury caused by a
generic drug manufactured by a different company.
"The Court[5] in Weeks stressed the limited
scope of its holding:
"'Our answer to this certified question ...
is extraordinarily narrow in scope.  The
posture in which the certified question is
asked (assuming a fraud cause of action),
the facts of this case, and the impact of
strict 
federal 
regulation 
on 
the
prescription-drug 
industry 
drastically
confine our holding and wholly remove the
facts of this case from situations where
parties are allegedly being held liable
under general products-liability theories
for products they did not make.  I cannot
see our answer to the certified question as
in any way speaking to the applicability of
Alabama law outside the narrow context
created by federal law in this case.'
"Id. at 680.
"The court further noted:
"'Nothing in this opinion suggests that a
plaintiff can sue Black & Decker for
injuries 
caused 
by 
a 
power 
tool
manufactured by Skil based on labeling or
otherwise. 
 
The 
unique 
relationship 
between
5The 
quotation that 
follows 
is 
actually 
taken 
from 
Justice
Shaw's special concurrence, not the opinion of the Court.
13
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brand-name and generic drugs as a result of
federal 
law 
and 
[Food 
and 
Drug
Administration] regulations, combined with
the learned-intermediary doctrine and the
fact 
that 
representations 
regarding
prescription drugs are made not to the
plaintiff but to a third party, create the
sui generis context in which we find
prescription medication.'
"Id. at 677.
"Justice Murdock's dissent in Weeks noted that
the majority's decision ran contrary to a 'mountain
of authority' and 'overwhelming national consensus.'
Id. at 702-706.  The Alabama legislature agreed with
Justice Murdock and acted swiftly to abrogate Weeks.
"It quickly passed Alabama Code 1975[,] §
6-5-530, which became effective November 1, 2015. 
The statute provides, in pertinent part:
"'(a) In any civil action for personal
injury, death, or property damage caused by
a product, regardless of the type of claims
alleged 
or 
the 
theory 
of 
liability
asserted, the plaintiff must prove, among
other 
elements, 
that 
the 
defendant
designed, 
manufactured, 
sold, 
or 
leased 
the
particular product the use of which is
alleged to have caused the injury on which
the claim is based, and not a similar or
equivalent 
product. 
 
Designers,
manufacturers, sellers, or lessors of
products not identified as having been
used, ingested, or encountered by an
allegedly injured party may not be held
liable for any alleged injury.' (Emphasis
added.)
"[Section 6-5-530] is dispositive in this case. It
is undisputed that Forest did not manufacture or
14
1180387
sell the product plaintiff alleges caused the harm.
Forest therefore is entitled to judgment as a matter
of law."  
(Footnotes omitted.)
Feheley filed a response in opposition to Forest's motion 
for a summary judgment.  In his response, Feheley argued that
§ 6-5-530, Ala. Code 1975, did not abrogate this Court's
decision in Wyeth, Inc. v. Weeks, 159 So. 3d 649 (2014), and
that, if it did, § 6-5-530 "would be unconstitutional as to
the claims made in the case now before the Court." 
On June 6, 2018, Forest filed a reply to Feheley's
response.  On June 29, 2018, Forest filed a reply memorandum
in support of its motion for a summary judgment.  Forest
attached affidavits from two Alabama legislators to support
its assertion that Senate Bill 80 ("S.B. 80"), which was
introduced during the 2015 Regular Session of the Alabama
Legislature and was subsequently enacted and then codified as
§ 6-5-530, was a direct result of this Court's decision in
Weeks.  Feheley filed a motion to strike those affidavits,
which the trial court granted.
On August 13, 2018, Feheley filed his response to
Forest's June 29, 2018, memorandum.  In that response, Feheley
15
1180387
asserted that discovery should be allowed for a factual
development of 
the 
statutory 
and, 
if 
necessary, 
constitutional
issues.  
On February 8, 2019, the trial court entered the
following order denying Forest's motion for a summary
judgment:
"[A motion for s]ummary judgment was filed by
Defendant Forest Pharmaceuticals in the above-styled
matter on the limited issue of whether under current
Alabama law a pharmaceutical manufacturer can be
liable for a product it did not manufacture.  After
considering the testimony and the filings and giving
deference to the non-moving party, this Court denies
summary judgment on this issue. ... 
"Based on the conflict between Alabama Code 1975, §
6-5-530, and Wyeth, Inc. v. Weeks, 159 So. 3d 649
(Ala 2014), this interlocutory order involves a
controlling question of law as to which there is a
substantial ground for difference of opinion that an
immediate appeal from the order would materially
advance the ultimate termination of the litigation,
and the appeal would avoid protracted and expensive
litigation.  The controlling question is whether
Alabama Code 1975, § 6-5-530, abrogated the Weeks
decision and whether under current Alabama law a
pharmaceutical manufacturer can have liability for
a product it did not manufacture."
Subsequently, Forest filed a petition for permission to
appeal in this Court, which this Court granted. 
Discussion
With regard to permissive appeals, this Court has stated:
16
1180387
"In the petition for a permissive appeal, the
party seeking to appeal must include a certification
by the trial court that the interlocutory order
involves a controlling question of law, and the
trial court must include in the certification a
statement of the controlling question of law. Rule
5(a), Ala. R. App. P.  In conducting our de novo
review of the question presented on a permissive
appeal, 'this Court will not expand its review ...
beyond the question of law stated by the trial
court. 
Any 
such 
expansion 
would 
usurp 
the
responsibility entrusted to the trial court by Rule
5(a).'  BE&K, Inc. v. Baker, 875 So. 2d 1185, 1189
(Ala. 2003). ..."
Alabama Powersport Auction, LLC v. Wiese, 143 So. 3d 713, 716
(Ala. 2013).  
In this case, the trial court certified the following
question for permissive appeal:
"The controlling question is whether Alabama Code
1975, § 6-5-530, abrogated the Weeks decision and
whether under current Alabama law a pharmaceutical
manufacturer can have liability for a product it did
not manufacture."
On appeal, Forest argues that § 6-5-530 abrogated this Court's
decision in Weeks and that, under current Alabama law, a
pharmaceutical manufacturer cannot be held liable for a
product it did not manufacture.  Thus, it argues that it is
entitled to a judgment as to all the claims against it.  This
case presents a pure question of law.  This Court has held
that, "'"[o]n appeal, the ruling on a question of law carries
17
1180387
no presumption of correctness, and this Court's review is de
novo."'  Rogers Found. Repair, Inc. v. Powell, 748 So. 2d 869,
871 (Ala. 1999) (quoting Ex parte Graham, 702 So. 2d 1215,
1221 (Ala. 1997))."  City of Prattville v. Corley, 892 So. 2d
845, 847 (Ala. 2003). 
In answering the trial court's question, we are guided by
the following principles of statutory construction:
"'In determining the meaning of a statute, this
Court looks to the plain meaning of the words as
written by the legislature.'  DeKalb County LP Gas
Co. v. Suburban Gas, Inc., 729 So. 2d 270, 275 (Ala.
1998).
"'"Words used in a statute must be given
their 
natural, 
plain, 
ordinary, 
and
commonly understood meaning, and where
plain language is used a court is bound to
interpret that language to mean exactly
what it says. If the language of the
statute is unambiguous, then there is no
room for judicial construction and the
clearly 
expressed 
intent 
of 
the 
legislature
must be given effect."'
"Blue Cross & Blue Shield of Alabama, Inc. v.
Nielsen, 714 So. 2d 293, 296 (Ala. 1998) (quoting
IMED Corp. v. Systems Eng'g Assocs. Corp., 602 So.
2d 344, 346 (Ala. 1992))."
City of Prattville v. Corley, 892 So. 2d at 848.
"In Archer v. Estate of Archer, 45 So. 3d 1259, 1263
(Ala. 
2010), 
this 
Court 
described 
its
responsibilities when construing a statute:  
18
1180387
"'"'[I]t 
is 
this
Court's responsibility
in 
a 
case 
involving
statutory construction
to give effect to the
legislature's intent in
enacting a statute when
t h a t  
intent 
is
manifested 
in 
the
wording of the statute.
... 
"'"'[I]f 
the
language of the statute
is 
unambiguous, 
then
there is no room for
judicial 
construction
and 
the 
clearly
expressed intent of the
legislature 
must 
be
given effect.'"'" ... 
In 
determining 
the
i n t e n t  
o f  
t h e
legislature, 
we 
must
examine the statute as
a 
whole 
and, 
if
possible, give effect
to each section.'
"'"Ex parte Exxon Mobil Corp.,
926 So. 2d 303, 309 (Ala. 2005). 
Further, 
"'"'when 
determining
legislative intent from
the language used in a
statute, a court may
explain the language,
but it may not detract
from or add to the
statute. ...  When the
language 
is 
clear,
there is no room for
judicial construction.
...'
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1180387
"'"Water Works & Sewer Bd. of
Selma v. Randolph, 833 So. 2d
604, 607 (Ala. 2002)."'
"(Quoting Ex parte Birmingham Bd. of Educ., 45 So.
3d 764, 767 (Ala. 2009).)  Similarly, in Lambert v.
Wilcox County Commission, 623 So. 2d 727, 729 (Ala.
1993), the Court stated:
"'"The fundamental rule of
statutory construction is that
this Court is to ascertain and
effectuate the legislative intent
as expressed in the statute. ...
In this ascertainment, we must
look to the entire Act instead of
isolated phrases or clauses ...
and words are given their plain
and usual meaning. ... Moreover,
just as statutes dealing with the
same subject are in pari materia
and should be construed together,
... parts of the same statute are
in pari materia and each part is
entitled to equal weight."'
"(Quoting Darks Dairy, Inc. v. Alabama Dairy Comm'n,
367 So. 2d 1378, 1380-81 (Ala. 1979).)"
First Union Nat'l Bank of Florida v. Lee Cty. Comm'n, 75 So.
3d 105, 111-12 (Ala. 2011).
This Court released its original decision in Weeks on
January 11, 2013.  On August 15, 2014, on application for
rehearing, this Court withdrew that opinion and substituted
another opinion.  In Weeks, Danny and Vicki Weeks sued five
current and former drug manufacturers in the United States
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District Court for the Middle District of Alabama, Southern
Division ("the federal court"), for injuries Danny allegedly
suffered as a result of his long-term use of metoclopramide,
the generic from of the brand-name drug Reglan.   The Weekses
conceded that Danny did not ingest any Reglan that had been
manufactured by the three brand-name defendants -- Wyeth,
Inc., Pfizer, Inc., and Schwarz Pharma, Inc.  However,
"'[t]he Weekses nonetheless assert[ed] that the
brand-name defendants [were] liable for Mr. Weeks's
harm on fraud, misrepresentation, and/or suppression
theories 
because 
they 
at 
different 
times
manufactured 
or 
sold 
brand-name 
Reglan® 
and
purportedly 
either 
misrepresented 
or 
failed
adequately to warn Mr. Weeks or his physician about
the risks of using Reglan® long-term.'"
159 So. 3d at 653 (quoting federal district court's
certification).  The brand-name defendants moved to dismiss
the claims against them, arguing that the Weekses' claims
were, in fact, product-liability claims that were 
barred "'for
failure of "product identification"'" and that they did not
have any duty to warn about the risks associated with the
ingestion of their competitors' generic products.  
The federal
court granted the brand-name defendants' motion in part and
denied it in part.  The federal court held that the Weekses
might be able to state a claim under Alabama law if they could
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prove that the brand-name defendants had a duty to warn
Danny's physician about the risks associated with the long-
term use of Reglan and that the Weekses, as third parties, had
a right to enforce an alleged breach of that duty.  The
federal court certified the following question to this Court:
"'Under Alabama law, may a drug
company be held liable for fraud or
misrepresentation 
(by 
misstatement 
or
omission), based on statements it made in
connection 
with 
the 
manufacture 
or
distribution of a brand-name drug, by a
plaintiff claiming physical injury from a
generic drug manufactured and distributed
by a different company?'"
159 So. 3d at 653.  In answering that certified question, this
Court stated:
"We answer the certified question as follows:
Under Alabama law, a brand-name-drug company may be
held liable for fraud or misrepresentation (by
misstatement or omission), based on statements it
made in connection with the manufacture of a
brand-name 
prescription 
drug, 
by 
a 
plaintiff
claiming physical injury caused by a generic drug
manufactured by a different company.  Prescription
drugs, unlike other consumer products, are highly
regulated by the FDA [Food and Drug Administration]. 
Before a prescription drug may be sold to a
consumer, a physician or other qualified health-care
provider must write a prescription.  The United
States Supreme Court in Wyeth v. Levine[, 555 U.S.
555 (2009),] recognized that Congress did not
preempt common-law tort suits, and it appears that
the FDA traditionally regarded state law as a
complementary form of drug regulation:  The FDA has
limited resources to monitor the approximately
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11,000 drugs on the market, and manufacturers have
superior access to information about their drugs,
especially in the postmarketing phase as new risks
emerge; state-law tort suits uncover unknown drug
hazards 
and 
provide 
incentives 
for 
drug
manufacturers to disclose safety risks promptly and
serve a distinct compensatory function that may
motivate injured persons to come forward with
information.  Wyeth v. Levine, 555 U.S. at 578–79.
"FDA 
regulations 
require 
that 
a 
generic
manufacturer's labeling for a prescription drug be
exactly the same as the brand-name manufacturer's
labeling.  The Supreme Court in PLIVA[, Inc. v.
Mensing, 564 U.S. 604 (2011),] held that it would
have been impossible for the generic manufacturers
to change their warning labels without violating the
federal requirement that the warning on a generic
drug must match the warning on the brand-name
version, preempting failure-to-warn claims against
generic manufacturers.
"In the context of inadequate warnings by the
brand-name manufacturer placed on a prescription
drug manufactured by a generic manufacturer, it is
not fundamentally unfair to hold the brand-name
manufacturer liable for warnings on a product it did
not produce because the manufacturing process is
irrelevant to misrepresentation theories based, not
on manufacturing defects in the product itself, but
on information and warning deficiencies, when those
alleged misrepresentations were drafted by the
brand-name manufacturer and merely repeated, as
allowed by the FDA, by the generic manufacturer.
"In answering the question of law presented to
us by the federal court, we emphasize the following:
We are not turning products-liability law (or tort
law for that matter) on its head, nor are we
creating a new tort of 'innovator liability' as has
been suggested.  Instead, we are answering a
question of law involving a product that, unlike any
other product on the market, has unprecedented
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federal regulation.  Nothing in this opinion
suggests that a plaintiff can sue Black & Decker for
injuries caused by a power tool manufactured by Skil
based on labeling or otherwise.  The unique
relationship between brand-name and generic drugs as
a result of federal law and FDA regulations,
combined with the learned-intermediary doctrine and
the fact that representations regarding prescription
drugs are made not to the plaintiff but to a third
party, create the sui generis context in which we
find prescription medication.  Again, the fraud or
misrepresentation claim that may be brought under
Alabama law against a drug manufacturer based on
statements 
it 
made 
in 
connection 
with 
the
manufacture of a brand-name prescription drug by a
plaintiff claiming physical injury caused by a
generic drug manufactured by a different company is
premised upon liability not as a result of a defect
in the product itself but as a result of statements
made by the brand-name manufacturer that Congress,
through the FDA, has mandated be the same on the
generic version of the brand-name drug."
Weeks, 159 So. 3d at 676–77.
S.B. 80 was introduced in March 2015.  After passing the
Senate and the House, it was assigned Act No. 2015-106.  Act
No. 2015-106 was approved by the Governor on May 1, 2015. 
Section 4 of Act No. 2015-106 provides:
"This act shall become effective six months
following its passage and approval by the Governor,
or its otherwise becoming law, and shall apply to
civil actions filed thereafter."
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Act No. 2015-106 was codified as § 6-5-530, Ala. Code 1975,
and became effective on November 1, 2015.  Section 6-5-530(a)
provides:
"In any civil action for personal injury, death, or
property damage caused by a product, regardless of
the type of claims alleged or the theory of
liability asserted, the plaintiff must prove, among
other 
elements, 
that 
the 
defendant 
designed,
manufactured, sold, or leased the particular product
the use of which is alleged to have caused the
injury on which the claim is based, and not a
similar 
or 
equivalent 
product. 
 
Designers,
manufacturers, sellers, or lessors of products not
identified as having been used, ingested, or
encountered by an allegedly injured party may not be
held liable for any alleged injury.  A person, firm,
corporation, association, partnership, or other
legal or business entity whose design is copied or
otherwise used by a manufacturer without the
designer's express authorization is not subject to
liability for personal injury, death, or property
damage caused by the manufacturer's product, even if
use of the design is foreseeable."
This Court has stated:
"'[T]he Legislature is presumed to be aware of
existing law and judicial interpretation when it
adopts a statute,' Carson v. City of Prichard, 709
So. 2d 1199, 1206 (Ala. 1998), and 'we presume "that
the legislature does not intend to make any
alteration in the law beyond what it explicitly
declares."'  Ware v. Timmons, 954 So. 2d 545, 556
(Ala. 2006)(quoting Duncan v. Rudulph, 245 Ala. 175,
176, 16 So. 2d 313, 314 (1944))." 
Grimes v. Alfa Mut. Ins. Co., 227 So. 3d 475, 489 (Ala. 2017).
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In Arthur v. Bolen, 41 So. 3d 745 (Ala. 2010), the
plaintiffs, Samuel and Julie Bolen, had purchased a house that
had been built by Tom Arthur.  As Samuel was climbing into the
attic, the pull-down ladder, which had been installed by
Arthur, separated and fell from the attic opening to which it
was attached.  The Bolens sued Arthur.  Before trial, Arthur
filed a motion in limine to prevent the Bolens' expert,
Michael Van Bree, from testifying as to the cause of the
failure of the attic stairway.  Arthur argued that § 34-11-
1(7), Ala. Code 1975, prohibited Van Bree from providing
expert testimony because Van Bree was not a licensed
professional engineer in Alabama or any other state.  Arthur
renewed his objection to Van Bree's proposed testimony at
trial.  Counsel for the Bolens asserted that Arthur's motion
was based on this Court's decision in Board of Water & Sewer
Commissioners v. Hunter, 956 So. 2d 403 (Ala. 2006), and that
that case was no longer good law because § 34-11-1, Ala. Code
1975, in Chapter 11, "Engineers and Land Surveyors," had been
amended since that decision had been released.  The trial
court allowed Van Bree to testify.  The jury returned a
verdict in favor of the Bolens. 
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On appeal, Arthur argued that the trial court should not
have allowed Van Bree to testify as to the cause of the
failure of the attic stairway.  In addressing that issue, this
Court stated:
"As the colloquy in the trial court revealed, §
34–11–1(7)[, Ala. Code 1975,] was amended in 2007 in
response to Board of Water & Sewer Commissioners of
Mobile v. Hunter, 956 So. 2d 403 (Ala. 2006), which
applied, as written, the former version of the
statute defining the rendering of expert testimony
as the 'practice of engineering,' for which an
Alabama engineering license was essential.  By Act
No. 2007–365, Ala. Acts 2007, the legislature
deleted the reference to 'testimony' from the
definition of 'practice of engineering' in the
introductory portion of subsection (7) and added the
paragraph quoted by the Bolens' counsel in the trial
court.  It also added subpart d. to subsection (7),
which states:  'The practice of engineering shall
include the offering of expert opinion in any legal
proceeding 
in 
Alabama 
regarding 
work 
legally
required to be performed under an Alabama engineer's
license number or seal, which opinion may be given
by an engineer licensed in any jurisdiction.' 
(Emphasis added.)  Thus, § 34–11–1, as amended and
as applicable to this case, differs considerably
from its predecessor.
"Arthur contends that 'Van Bree's testimony,
that the subject attic [ladder] was not installed in
accord with the manufacturer's specifications ...,
constitutes "the review of construction or other
design products for the purpose of monitoring
compliance with drawings and specifications."' 
Reply brief, at 9 (quoting § 34–11–1(7)).  According
to Arthur, such testimony triggered the provision in
§ 34–11–1(7)d., which, he contends, required Van
Bree to be licensed in at least one state.  The
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Bolens disagree with this construction of the
statute.   Because the resolution of this issue is
a matter of mere statutory construction, the
standard of review is de novo.  Ex parte Birmingham
Bd. of Educ., 45 So.3d 764, 767 (Ala. 2009) (when
issues on appeal '"concern only questions of law
involving statutory construction, the standard of
review is de novo"').
"'The intent of the Legislature is the polestar
of statutory construction.'  Sigelman v. Alabama
Ass'n of School Bds., 819 So. 2d 568, 579 (Ala.
2001).  In construing this statute, we are hardly
writing on a clean slate.  The substantial amendment
to § 34-11-1, coming, as it did, on the heels of
this Court's decision in Hunter, reveals much
regarding legislative intent." 
41 So. 3d at 748-49 (final emphasis added).
Similarly, the enactment of § 6-5-530, coming on the
heels of this Court's decision in Weeks, clearly demonstrates
the legislature's intent in enacting that statute.  Weeks held
that the manufacturer of a brand-name drug could be held
liable for fraud or misrepresentation based on 
statements made
in connection with the manufacture of the brand-name
prescription drug, even 
though the plaintiff's claim was based
on a physical injury that had been caused by a generic drug
manufactured by a different company.  In reaching that
decision, this Court rejected Wyeth's argument that the
Weekses' claims were, in essence, product-liability claims,
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noting that a 
fraudulent-suppression claim is separate from an
Alabama Extended Manufacturer's Liability Doctrine ("AEMLD")
claim.  This Court noted that that case did not involve a
claim that the drug ingested by one of the plaintiffs was
defective.  Rather, it was a claim that Wyeth had fraudulently
misrepresented or suppressed information about the manner in
which the drug was to be taken.  This Court went on to state:
"Because a warning label is not a part of the
manufacturing process, we do not agree that the fact
that a brand-name manufacturer did not produce the
version of the drug ingested by the plaintiff bars
the plaintiff's tort action when the plaintiff is
arguing that he or she was injured by a failure to
warn."
159 So. 3d at 670.  However, § 6-5-530 specifically provides
that a plaintiff who is suing based on personal injury, death,
or property damage caused by a product "must prove ... that
the defendant designed, manufactured, sold, or leased the
particular product the use of which is alleged to have caused
the injury on which the claim is based" regardless of the type
of claims or theory of liability the plaintiff asserts.  It
goes on to provide that "that ... manufacturers ... of
products not identified as having been ... ingested ... by an
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allegedly injured party may not be held liable for any alleged
injury."  (Emphasis added.)  
Further, in reaching its decision in Weeks, this Court
also stated:
"A brand-name manufacturer is well aware of the
expiration of its patent and well aware that a
generic version of the drug will be made when that
patent expires.  It is recognized that the generic
substitutions are allowed in all 50 states.  A
brand-name manufacturer could reasonably foresee
that a physician prescribing a brand-name drug (or
a generic drug) to a patient would rely on the
warning drafted by the brand-name manufacturer even
if the patient ultimately consumed the generic
version of the drug."
159 So. 3d at 670.  However, § 6-5-530(a) provides, in
pertinent part:
"A 
person, 
firm, 
corporation, 
association,
partnership, or other legal or business entity whose
design is copied or otherwise used by a manufacturer
without the designer's express authorization is not
subject to liability for personal injury, death, or
property 
damage 
caused 
by 
the 
manufacturer's
product, even if use of the design is foreseeable."
(Emphasis added.)  Thus, it appears that, in enacting § 6-5-
530, the legislature also incorporated provisions that
rejected some of the reasoning this Court relied upon in
reaching its decision in Weeks.   Based on the foregoing, it
is clear that, in enacting § 6-5-530, the legislature intended
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to abrogate this Court's decision in Weeks.  Further, under
the plain language of § 
6-5-530, a pharmaceutical manufacturer
cannot be held liable for injury caused by a product it did
not manufacture. 
Because this is a permissive appeal, the questions before
us are limited to whether § 6-5-530 effectively overruled this
Court's decision in Weeks and whether a manufacturer can be
held liable for an injury caused by a product it did not
manufacture.  Any questions as to whether Forest was excluded
from the protections of § 6-5-530 because it was the designer
of the generic escitalopram and of the labeling, warnings, and
package inserts for the generic escitalopram, or whether drug
labeling, warnings, and package inserts actually constitute a
"product" as that term is used in § 6-5-530, or regarding the
constitutionality of § 6-5-530 are not properly before this
Court.  See Alabama Powersport Auction, supra; BE&K, Inc. v.
Baker, 875 So. 2d 1185, 1189 (Ala. 2003) (noting that "this
Court will not expand its review on permissive appeal beyond
the question of law stated by the trial court").6
6In his brief to this Court, Feheley argues that
"[d]iscovery should be allowed for a factual development of
the statutory and if necessary, constitutional, issues in 
this
case with regard to the issues presented by Forest and by the
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Conclusion
Section 6-5-530 abrogates this Court's prior decision in
Weeks.  Further, under the plain language of § 6-5-530, a
pharmaceutical manufacturer cannot be held liable for injury
caused by a product it did not manufacture.  Based on our
answer to the trial court's certified question in the
permissive appeal, we reverse the trial court's order denying
Forest's motion for a summary judgment and remand this case
for proceedings consistent with this opinion.  
REVERSED AND REMANDED.
Parker, C.J., and Bolin, Bryan, Sellers, and Mitchell,
JJ., concur.  
Mendheim and Stewart, JJ., concur in the result.
plaintiff."  (Feheley's brief at p. 12.)  Feheley also argues
that Forest would be excluded from the protections of § 6-5-
530 because it was the designer of both the warning labels
used and the generic escitalopram ingested by Elias.  Feheley
further argues that "an issue not presently before this Court
is 
the 
statute's 
unconstitutionality 
if 
Forest's
interpretation is accurate and 6-5-530 has any application
here."  (Feheley's brief at p. 34.)  However, those issues are
not part of the questions of law certified by the trial court. 
As we noted previously, "this Court will not expand its review
on permissive appeal beyond the question of law stated by the
trial court." BE&K, Inc. v. Baker, 875 So. 2d at 1189. 
Therefore, we will not address those issues.
32