Muzichuck v. Forest Laboratories, Inc. et al
Filing
182
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT (DKT. NO. 77 ) AND DISMISSING CASE WITH PREJUDICE. The Court grants Forest's motion for summary judgment, dismisses this case with prejudice, and cancels the final pretrial conference set for 1/22/15 and the trial of this case scheduled to begin on 1/28/15. The Clerk is directed to enter a separate judgment order in this matter. Signed by District Judge Irene M. Keeley on 1/16/15. (mh)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
TAMMY MUZICHUCK, as the
Administratrix of the Estate
of BRUCE MUZICHUCK, AND on behalf
of her minor child, HANNA MUZICHUCK,
Plaintiff,
v.
//
CIVIL ACTION NO. 1:07CV16
(Judge Keeley)
FOREST LABORATORIES, INC. and
FOREST PHARMACEUTICALS, INC.
Defendants.
MEMORANDUM OPINION AND ORDER
GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT [DKT. NO. 77],
AND DISMISSING CASE WITH PREJUDICE
Pending before the Court is the motion for summary judgment
(dkt. no. 77) filed by the defendants, Forest Laboratories, Inc.
and Forest Pharmaceuticals, Inc. (collectively, “Forest”).
After
careful consideration, for the reasons that follow, the Court
GRANTS Forest’s motion.
I. PROCEDURAL BACKGROUND
In December 2006, the plaintiff, Tammy Muzichuck (“Tammy”),
filed a wrongful death action in the Circuit Court of Marion
County, West Virginia, alleging that Forest had failed to warn her
decedent-husband, Bruce Muzichuck (“Bruce”), and his prescribing
physicians
about
the
risk
of
suicide
associated
with
its
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
antidepressant drug, Lexapro.1
After Forest removed the case to
this Court, it was transferred to MDL No. 1736, In re: Celexa and
Lexapro Products Liability Litigation, in the Eastern District of
Missouri in 2007.
Ultimately, Tammy opted out of the global settlement achieved
in the MDL, and, in 2013, her case was remanded to this Court.
In
September 2014, Forest filed the pending summary judgment motion,
in which it asserts that (1) federal law preempts Tammy’s state law
claims, (2) Forest provided Bruce with an adequate warning, (3)
there is no evidence that a different warning would have prevented
Bruce’s suicide, and (4) there is no evidence to support an award
of punitive damages.
The Court heard oral argument on these and
other issues on January 9, 2015.
The motion is now ripe for
review.
1
Her complaint included counts of negligence, strict liability,
fraud, wrongful death, breach of warranty, and punitive damages.
However, the parties have stipulated to the dismissal of Tammy’s claims
for fraud and breach of warranty.
(Dkt. No. 107).
Also, Tammy has
agreed not to seek “any of the wrongful death recovery in this case,” and
has stipulated that her minor daughter, Hanna Muzichuck (“Hanna”), “is
the sole statutory beneficiary for all damages recoverable under the
[Wrongful Death Act].” (Dkt. No. 102).
2
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
II. FACTUAL BACKGROUND
A.
Lexapro Labeling
In August 2002, the Food and Drug Administration (“FDA”)
approved Forest’s new drug application for an antidepressant known
as Lexapro.
(Dkt. No. 81-5).
In July 2003, the FDA requested that
Forest perform “data analyses to assess the risk of pediatric
suicidality with [Lexapro].”
(Dkt. No. 81-16).
As a result of
these analyses, in March 2004, the FDA issued a Public Health
Advisory after making the following determination:
[W]e believe that labeling changes are warranted in order
to caution practitioners and patients about the need for
close observation of patients being treated with
antidepressants for clinical worsening, for the emergence
of suicidality, and for the emergence of a variety of
other symptoms that may represent a precursor to
suicidality.
The committees felt that it would be
important to warn prescribers and families of the need to
be vigilant for such behaviors, regardless of the role
antidepressants may have in the emergence of suicidal
ideation/attempts in patients taking antidepressants.
(Dkt. No. 82-8).
In accordance with that advisory, on April 30, 2004, Forest
utilized the FDA’s “changes being effected” (“CBE”) process to seek
approval for a label change, which, in relevant part, included the
following warning:
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Clinical Worsening and Suicide Risk
Patients with major depressive disorder, both adult and
pediatric, may experience worsening of their depression
and/or the emergence of suicidal ideation and behavior
(suicidality),
whether
or
not
they
are
taking
antidepressant medications, and this risk may persist
until significant remission occurs. Although there has
been a long-standing concern that antidepressants may
have a role in inducing worsening of depression and the
emergence of suicidality in certain patients, a causal
role for antidepressants in inducing such behaviors has
not been established.
Nevertheless, patients being
treated with antidepressants should be observed closely
for clinical worsening and suicidality, especially at the
beginning of a course of drug therapy, or at the time of
dose
changes,
either
increases
or
decreases.
Consideration should be given to changing the therapeutic
regimen, including possibly discontinuing the medication,
in patients whose depression is persistently worse or
whose emergent suicidality is severe, abrupt in onset, or
was not part of the patient’s presenting symptoms.
Because of the possibility of co-morbidity between major
depressive
disorder
and
other
psychiatric
and
nonpsychiatric disorders, the same precautions observed
when treating patients with major depressive disorder
should be observed when treating patients with other
psychiatric and nonpsychiatric disorders.
The following symptoms, anxiety, agitation, panic
attacks,
insomnia,
irritability,
hostility
(aggressiveness), impulsivity, akathisia (psychomotor
restlessness), hypomania, and mania, have been reported
in adult and pediatric patients being treated with
antidepressants for major depressive disorder as well as
for
other
indications,
both
psychiatric
and
nonpsychiatric.
Although a causal link between the
emergence of such symptoms and either the worsening of
depression and/or the emergence of suicidal impulses has
not been established, consideration should be given to
changing the therapeutic regimen, including possibly
discontinuing the medication, in patients for whom such
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
symptoms are severe, abrupt in onset, or were not part of
the patient’s presenting symptoms.
Families and caregivers of patients being treated with
antidepressants for major depressive disorder or other
indications, both psychiatric and nonpsychiatric, should
be alerted about the need to monitor patients for the
emergence of agitation, irritability, and the other
symptoms described above, as well as the emergence of
suicidality, and to report such symptoms immediately to
health-care providers. Prescriptions for LEXAPRO should
be written for the smallest quantity of tablets
consistent with good patient management, in order to
reduce the risk of overdose.
If the decision has been made to discontinue treatment,
medication should be tapered, as rapidly as is feasible,
but with recognition that abrupt discontinuation can be
associated with certain symptoms . . . .
It should be noted that LEXAPRO is not approved for use
in treating any indications in the pediatric population.
A major depressive episode may be the initial
presentation of bipolar disorder.
It is generally
believed (though not established in controlled trials)
that treating such an episode with an antidepressant
alone may increase the likelihood of precipitation of a
mixed/manic episode in patients at risk for bipolar
disorder. Whether any of the symptoms described above
represent such a conversion in unknown. However, prior
to initiating treatment with an antidepressant, patients
should be adequately screened to determine if they are at
risk for bipolar disorder; such screening should include
a detailed psychiatric history, including a family
history of suicide, bipolar disorder, and depression. It
should be noted that LEXAPRO is not approved for use in
treating bipolar depression.
(Dkt. No. 82-10) (emphasis in original). The FDA approved Forest’s
proposed labeling change on May 20, 2004.
5
(Dkt. No. 82-11).
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Following that approval, Forest started distributing Lexapro with
a package insert containing the updated warning no later than May
31, 2004.
(Dkt. No. 82-10).
Later that year, on October 15, 2004, the FDA issued another
Public Health Advisory, and advised Forest that, notwithstanding
its earlier labeling change, “additional labeling changes are
warranted in order to caution practitioners, patients, family
members or caregivers about an increased risk of suicidal thinking
and behavior (suicidality) in children and adolescents with major
depressive disorder (MDD) and other psychiatric disorders who are
taking antidepressant medications.”
(Dkt. No. 82-12).
However,
the FDA cautioned Forest that, “[a]lthough we are still requiring
that sponsors submit this supplement within 30 days of our 10-15-04
letter, the prescriber labeling and Medication Guide should not be
implemented until you have received notification from the Agency.”
(Dkt. No. 82-13).
Forest submitted additional proposed labeling changes to the
FDA for approval on November 12, 2004.
(Dkt. No. 82-14).
On
December 24, 2004, the FDA advised Forest that “there is interest
in re-examining data from trials of antidepressants in adults,” and
requested that Forest perform such analyses.
6
(Dkt. No. 82-15).
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Based on the results of those analyses, in May 2007 the FDA made
the following determination:
[W]e believe that additional changes are needed in
antidepressant labeling and medication guides to alert
practitioners, patients, family members and caregivers
about an increased risk of suicidal thinking and behavior
(suicidality) in young adults with major depressive
disorder (MDD) and other psychiatric disorders who are
taking antidepressant medications.
Changes are also
needed to inform practitioners about an apparent
favorable effect of antidepressants on suicidality in
older adults and to remind them that the disorders being
treated with antidepressants are themselves associated
with an increased risk of suicidality.
(Dkt. No. 83-5). Forest then submitted a proposed labeling update,
which the FDA approved in August 2007.
B.
(Dkt. No. 83-8).
Bruce Muzichuck
Bruce was born in 1957.
While still in high school, he began
dating Tammy in 1974, and the couple married in 1980.
distress
was
evident
early
on,
but
Tammy
Marital
attributed
it
to
“adjusting to living together.” (Dkt. No. 45-20 at 7). The couple
had their only child, Hanna, in 1997.
From the outside, the family
appeared
happy,
and,
she
pretty
to
be
relatively
“[w]hatever
[Hanna]
wanted,
attention.”
as
Tammy
much
got
explained,
[Bruce’s]
Id. at 10.
In 2004, however, Tammy began counseling sessions with Nancy
A. Rush (“Rush”) at Progressive Preventive Health Care, Inc.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
(“Progressive”)
another man.
because
she
Id. at 11.
was
having
romantic
feelings
for
During a visit to Progressive on June
9th, Rush documented that Tammy presented with “decreased mood,
increased
agitation, restlessness
related
to
marital
issues.”
(Dkt. No. 87-7). Tammy informed Rush that “she never loved [Bruce]
because of severe abuse,” that she had “had a long term affair with
a furniture store owner (over 10 years),” and that “[t]here’s been
no marriage in many years.”
Id.
Rush advised Tammy that she
should ask Bruce to move out of their house to give her time to
sort out her feelings.
(Dkt. No. 45-20 at 14).
Pursuant to Rush’s advice, Tammy told Bruce that she had been
attending counseling sessions because she was unhappy with their
marriage, and that she wanted him to move out in order to give her
time to sort things out.
(Dkt. No. 45-20 at 12, 14).
Bruce became
upset at this, and Tammy persuaded him to visit Progressive for
treatment.
Thus, on June 23rd, he presented to Progressive with
complaints of “marital issues/anxiety.”
(Dkt. No. 87-6 at 10).
A
social worker named Greg Sanders (“Sanders”) completed a psychosocial
assessment
thoughts/intent.”
of
Id.
Bruce,
and
noted
“no
destructive
Nevertheless, Sanders referred Bruce to
Medbrook Medical Associates (“Medbrook”), a walk-in clinic in
8
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Bridgeport, West Virginia, for “evaluation for anti-anxiety meds.”
Id.
On the same day, Bruce visited Medbrook, where Dr. Robert
Bowers (“Bowers”) diagnosed him as depressed and suffering from
situational anxiety.
(Dkt. No. 87-10 at 4-5).
Based on this,
Bowers placed Bruce on a prescription of ten milligrams per day of
Lexapro. Id. Although not transcribed in his office notes, Bowers
also gave Bruce a Lexapro sample pack.
(Dkt. No. 91-18 at 2).
After he took some of the pills from the sample pack, Bruce
returned to Progressive on July 6th.
As Sanders noted in Bruce’s
chart, “[h]e reported Lexapro working well. He took it for 2 days,
symptoms lessened, so he stopped.
Symptoms returned, so he began
taking again. [H]as taken for 10 days. [I]t is working well.”
(Dkt. No. 87-6 at 10).
Three days later, Bruce filled his Lexapro
prescription at The Drug Store, and refilled it on August 16th, and
again on September 22nd.
(Dkt. No. 87-11 at 3).
In late August, Bruce moved to a trailer a few miles away from
Tammy.
(Dkt. No. 45-20 at 26).
Tammy explained that “[i]t was
hard on him, you know, but he seemed to be handling it okay.”
Id.
Although at the outset the couple’s separation appeared benign, by
October 2004, Bruce’s behavior began spiraling downward.
9
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
On the night of October 16th, Tammy came home from work to
find that Bruce had broken in and taken two guns.
Id. at 28.
When
she confronted him about it, he told her that he had taken the guns
for her safety because he believed “women that go through menopause
sometimes think about suicide.” Id. at 29. On October 18th, Bruce
showed up at Tammy’s work appearing “very agitated” and pacing back
and forth.
Id.
busy.
Although he eventually left, he told Tammy that he was
Id.
He told Tammy he wanted to talk, but she was too
going to harm himself.
Id. Concerned for his safety, Tammy called
Progressive, but was unable to reach Sanders.
Id.
Later that
night, Bruce showed up at her house and told her he had thought
about committing suicide but could not bring himself to do it.
Id.
at 30.
The following day, Bruce had a “crisis intervention” with
Sanders, who noted that Bruce had “almost ended it yesterday b/c he
can’t deal with all the stress of not being with [Tammy].”
No. 87-6 at 9).
Sanders’s note also stated that “[Bruce] will
consider returning handgun to wife’s possession.”
returned the gun.
(Dkt.
Id.
He never
(Dkt. No. 45-20 at 34).
The next incident occurred on November 6th, while Bruce was
watching Hanna and her friend so Tammy could run errands.
35.
Id. at
The girls were playing and Bruce asked them to quiet down.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Id.
When Hanna talked back to Bruce, he spanked her, which he had
never done before.
Id.
When Tammy came home, Bruce told her he
was “devastated that he had lost it.”
Id.
Six days later, on November 12th, Bruce returned to Medbrook,
where, due to Bowers’s unavailability, he saw another physician,
Dr. Kelly Nelson (“Nelson”). In his medical note, Nelson observed:
“Been on Lexapro since June.
Initially worked real well and now
not working very well.
Bump his Lexapro up to 20 mg [per] day.”
(Dkt. No. 87-10 at 3).
Bruce filled this prescription for what
amounted to a doubled dosage of Lexapro at the Medbrook pharmacy
the same day.
Id.
About a week later, Bruce told Tammy that “they increased his
medicine and that was helping a lot.”
However,
on
December
Tammy’s
house
appearing “agitated, irritable, hostile, and aggressive.”
(Dkt.
No. 45-20 at 39).
4th,
Bruce
(Dkt. No. 91-18 at 21).
showed
up
to
As before, he was pacing back and forth, and
then he became assaultive toward Tammy.
Id. at 40.
her upstairs where they “got into a tussle.”
Bruce forced
Id.
When his
daughter, Hanna, tried to intervene, he locked her in her bedroom.
Id.
While struggling with Tammy, he suddenly collapsed, got up,
and walked out the door.
Id. at 41.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Late that night, Bruce called Tammy.
Id. at 43.
When she
asked him where he was, he replied that “[i]t doesn’t matter.”
Id.
Eventually he said, “I’m with my mom and dad,” at which point Tammy
knew he was at the cemetery where his parents were buried.
Id.
Tammy immediately called the police to tell them where Bruce was,
and that he was potentially suicidal.
Id.
She then left the house
to drive to the cemetery, which was approximately five miles away.
Id. at 44.
While she was on her way, the police arrived at the
cemetery, where they observed Bruce acting irrationally, ranting,
and holding a gun.
Id.
After they attempted to engage him in
conversation, Bruce ran into the woods, shot himself in the chest,
and died within seconds.
later.
Id. at 45.
Tammy arrived a few minutes
Id.
III. STANDARD OF REVIEW
Summary
documents,
judgment
is
electronically
declarations,
stipulations
appropriate
stored
.
.
where
the
information,
.,
admissions,
“depositions,
affidavits
or
interrogatory
answers, or other materials” show 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), (c)(1)(A).
When ruling on
a motion for summary judgment, the Court reviews all the evidence
“in the light most favorable” to the nonmoving party.
12
Providence
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Square Assocs., L.L.C. v. G.D.F., Inc., 211 F.3d 846, 850 (4th Cir.
2000).
The Court must avoid weighing the evidence or determining
the truth and limit its inquiry solely to a determination of
whether genuine issues of triable fact exist.
Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 249 (1986).
The moving party bears the initial burden of informing the
Court
of
the
basis
for
the
motion
and
nonexistence of genuine issues of fact.
477 U.S. 317, 323 (1986).
of
establishing
the
Celotex Corp. v. Catrett,
Once the moving party has made the
necessary showing, the nonmoving party “must set forth specific
facts showing that there is a genuine issue for trial.”
Anderson,
477 U.S. at 256 (internal quotation marks and citation omitted).
The “mere existence of a scintilla of evidence” favoring the
nonmoving party will not prevent the entry of summary judgment; the
evidence
must
be
such
that
a
rational
reasonably find for the nonmoving party.
trier
of
fact
could
Id. at 248–52.
IV. ANALYSIS
Forest posits several arguments on summary judgment.
First,
it asserts that impossibility preemption bars Tammy’s failure to
warn claim because FDA regulations would not have permitted any
warning beyond that already contained in its package insert. Next,
Forest argues that no dispute exists concerning the adequacy of its
13
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
warning
about
the
risk
of
suicide
associated
with
Lexapro.
Further, Forest contends that the evidence is uncontroverted that
Bruce actually read the updated package insert.
A.
Preemption
Tammy eliminated most, if not all, of the debate regarding
preemption by acknowledging in her response brief that she “does
not claim that Forest could have added a BLACK BOX warning to
Lexapro’s label, or could have provided a Patient Medication Guide,
without prior FDA approval.”
(Dkt. No. 91 at 8).
Indeed, it is
hard to see how preemption continues to play any role in this case.
Nevertheless,
Forest
maintains
that
there
is
clear
evidence
demonstrating that the FDA would not have approved any other
warning.
The FDA’s CBE process permits pharmaceutical manufacturers to
“add or strengthen a contraindication, warning, precaution, or
adverse reaction for which the evidence of a causal association
satisfies the standard for inclusion in the labeling.”
§
314.70(c)(6)(iii)(A).
Importantly,
“[w]hen
making
21 C.F.R.
labeling
changes using the CBE process, manufacturers need not wait for
preapproval by the FDA, which ordinarily is necessary to change a
label.”
PLIVA, Inc. v. Mensing, __ U.S. __, __, 131 S. Ct. 2567,
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SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
2575 (2011).
That said, such changes are to be made only “to
reflect newly acquired information.”
§ 314.70(c)(6).
In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court of
the United States addressed whether approval of warning labels by
the FDA provided a pharmaceutical manufacturer with a complete
defense to a consumer’s claims of negligence and strict liability.
In that case, Levine, had received an injection of the drug
Phenergan manufactured by Wyeth for treatment of nausea.
Id. at
559. Because of the way in which Levine’s health care provider had
injected the Phenergan, gangrene had set in and spread throughout
Levine’s arm, ultimately resulting in amputation.
Id.
In her lawsuit, Levine alleged that Wyeth’s labeling regarding
the administration of Phenergan was defective because “it failed to
instruct clinicians to use the IV-drip method of intravenous
administration instead of the higher risk IV-push method.”
560.
Id. at
As Forest has here, Wyeth moved for summary judgment,
“arguing that Levine’s failure-to-warn claims were pre-empted by
federal law.”
Id.
That argument failed before both the trial
court and the state supreme court in Vermont.
Id. at 562-63.
On certiorari to the Supreme Court, Wyeth argued, in pertinent
part, that “Levine’s state-law claims are pre-empted because it is
impossible
for
it
to
comply
with
15
both
the
state-law
duties
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SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
underlying those claims and its federal labeling duties.”
568.
Id. at
Specifically, it relied on the CBE process’s “newly acquired
information” requirement, and urged that “Levine has not pointed to
any
such
information
administration.”
concerning
the
risks
of
IV-push
Id.
Justice Stevens, writing for the majority, first observed that
“newly acquired information is not limited to new data, but also
encompasses new analyses of previously submitted data.” Id. at 569
(internal quotation marks and citation omitted).
With that in
mind, he found that, “as amputations continued to occur, Wyeth
could have analyzed the accumulating data and added a stronger
warning about IV-push administration of the drug.”
Id. at 570.
Next, Stevens reaffirmed that “the manufacturer [not the FDA] bears
responsibility for the content of its label at all times.”
570-71.
Id. at
Finally, he concluded that, “when the risk of gangrene
from IV-push injection of [the drug] became apparent, Wyeth had a
duty to provide a warning that adequately described that risk, and
the CBE regulation permitted it to provide such a warning before
receiving the FDA’s approval.”
Id. at 571.
After rejecting Wyeth’s impossibility preemption argument,
Justice Stevens suggested that the presentation of “clear evidence
that the FDA would not have approved a change to [the drug’s]
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label” might form the basis for impossibility preemption.
Id.
Several years later, in Mensing, the Supreme Court clarified the
suggestion in Levine, explaining that, in order to invoke the
exception to the CBE process, a manufacturer must demonstrate by
clear evidence that “it would in fact have been impossible to do
under federal law what state law required.”
131 S. Ct. at 2581
n.8.
In
this
case,
Tammy
contends
that
the
CBE
process
was
triggered in June 2001, when, based on newly acquired information
about suicidality, Forest was obligated to provide Lexapro patients
with
an
enhanced
warnings/regulatory
warning.
In
expert,
Dr.
his
report,
Michael
Tammy’s
Hamrell
general
(“Hamrell”),
stated:
Had [Forest] reviewed the FDA data, as it should have
done to comply with its post marketing safety
surveillance requirements, it would have observed a
number of positive rechallenge cases. . . . In the scheme
of evidence of a causal relationship with individual
reports, positive rechallenge cases represent some of the
strongest evidence. . . . Overall, the adverse event data
and particularly the dechallenge/rechallenge data are
reasonable evidence of an association between SSRIs and
suicidality. This is true no later than June 30, 2001.
. . . [A] review of the adverse event data as of June
2001 shows that not only were there a significant number
of suicidal related adverse event reports associated with
the use of SSRIs, but there were several reports of
psychiatric and suicidal rechallenge cases.
The
dechallenge/rechallenge data is particularly concerning
because it is suggestive of a direct drug related effect
17
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
as opposed to the underlying condition. This data alone
was sufficient to enhance the warning with respect to
suicidality.
(Dkt. No. 91-20 at 15-18).
Thus, according to Hamrell, Forest
should have strengthened its warning regarding the risk of suicide
associated with Lexapro no later than June 2001.
Despite the newly acquired FDA data advanced by Hamrell,
Forest contends that “there is clear evidence that FDA would have
rejected the precise label changes [Tammy] claims Forest should
have implemented before Lexapro was prescribed to [Bruce].”2
No. 78 at 9).
(Dkt.
Forest contends that “[t]he totality of FDA’s
analysis of the issue - and its conclusions - over several decades
is clear evidence there never was, and is not now, any scientific
substantiation for including a warning that Lexapro increases the
risk of suicide or suicidality in adult patients.” (Dkt. No. 78 at
9).
In support, it cites one district court decision finding
“clear evidence that the FDA would have rejected an expanded
Effexor warning for patients in [the decedent’s] age group prior to
2
Public policy recognizes a danger in “overwarning” consumers of
potential drug-related risks.
See 71 Fed. Reg. 3922, 3935 (Jan. 24,
2006) (“Exaggeration of risk could discourage appropriate use of a
beneficial drug.”); 44 Fed. Reg. 37434, 37447 (June 26, 1979)
(“[I]ncluding theoretical hazards as contraindications in drug labeling
would cause that very important section of the labeling to lose its
significance.”).
18
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
his 2002 suicide.”
1277
(W.D.
Okla.
Dobbs v. Wyeth Pharm., 797 F. Supp. 2d 1264,
2011).
The
Dobbs
court
itself,
however,
explicitly recognized that its decision diverged from that of every
other court that had addressed the issue.
Id. (“[O]ther courts
applying the Levine clear evidence standard in the context of
[anti-depressant] label warnings have universally rejected the
manufacturers’ evidence as insufficient.”) (emphasis added) (citing
Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010);
Baumgardner v. Wyeth Pharm., 2010 WL 3431671 (E.D. Pa. Aug. 31,
2010); Dorsett v. Sandoz, Inc., 699 F. Supp. 2d 1142 (C.D. Cal.
2010); Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010);
Forst v. SmithKline Beecham Corp., 639 F. Supp. 2d 948 (E.D. Wis.
2009)).
The Court is unconvinced by the reasoning in Dobbs, and
concludes that Forest has failed to establish by clear evidence
that the FDA would have rejected an expanded warning concerning the
correlation between adult suicide and antidepressant drugs.
Thus,
Forest’s compliance with any state law duty to warn was not
impossible given federal regulations.
See Baumgardner, 2010 WL
3431671, at *1 (“Other cases examining the warning labels on
antidepressants have reached the same conclusion. The reasoning in
those cases is persuasive.”) (internal citations omitted).
19
Based
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
on
the
foregoing,
the
Court
rejects
Forest’s
impossibility
preemption defense, and turns next to examine Forest’s contention
that there are no material issues of fact are in dispute that would
preclude an award of summary judgment as to Tammy’s failure to warn
claim.
B.
Failure to Warn
Tammy
has
alleged
failure
negligence and strict liability.
to
warn
based on
theories
of
“Each theory contains different
elements which plaintiffs must prove in order to recover.”
Syl.
Pt. 6, Ilosky v. Michelin Tire Corp., 307 S.E.2d 603, 605 (W. Va.
1983).
That said, “[t]he distinction between the two lessens
considerably in failure to warn cases since it is clear that strict
liability adds little in warning cases.” Werner v. Upjohn Co., 628
F.2d 848, 858 (4th Cir. 1980).
Indeed, both theories involve a manufacturer’s duty to warn of
foreseeable risks associated with the product.
See Johnson by
Johnson v. Gen. Motors Corp., 438 S.E.2d 28, 37 n.5 (W. Va. 1993)
(explaining that “we have not addressed the issue of whether the
duty to warn under a negligence theory in a product liability case
differs” from the duty owed under a strict liability theory).
Also, “[u]nder West Virginia law, a claim for negligence . . . and
strict
liability
requires
that
20
the
element
of
causation
be
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
satisfied.”
White v. Dow Chem. Co., 321 Fed. App’x 266, 273 (4th
Cir. 2009) (citing Tolley v. Carboline Co., 617 S.E.2d 508, 511-12
(W. Va. 2005)).
Forest argues that there is no factual dispute in
this case concerning (1) the adequacy of its warning of the risk of
suicidality in its package insert, (2) the adequacy of its efforts
to warn, (3) the fact that Bruce actually read the package insert,
or (4) that the lack of an adequate warning regarding the risk of
suicide associated with the use of Lexapro proximately caused
Bruce’s death.
1. Adequacy of the Warning’s Contents
According to Tammy’s specific causation expert, Dr. Joseph
Glenmullen (“Glenmullen”), Forest’s warning about the risk of
suicide was inadequate because it
provided no information about how the precursor side
effects could be early warning signs of incipient
suicidality, no information about the particularly high
risk in the early months of treatment or whenever the
dose is changed, nor any suggestion that Bruce needed to
be observed closely. Patients need to be specifically
warned that Lexapro may paradoxically make them worse and
suicidal.
(Dkt.
No.
45-20
at
52).
Forest
contends
that
the
warning,
contained in the Lexapro package insert as of May 31, 2004,
included precisely the information that Glenmullen would have
21
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
required.
Specifically, under “Clinical Worsening and Suicide
Risk,” Forest’s warning provided as follows:
[P]atients being treated with antidepressants should be
observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy,
or at the time of dose changes, either increases or
decreases. Consideration should be given to changing the
therapeutic regimen, including possibly discontinuing the
medication, in patients whose depression is persistently
worse or whose emergent suicidality is severe, abrupt in
onset, or was not part of the patient’s presenting
symptoms.
. . .
The following symptoms, anxiety, agitation, panic
attacks,
insomnia,
irritability,
hostility
(aggressiveness), impulsivity, akathisia (psychomotor
restlessness), hypomania, and mania, have been reported
in adult and pediatric patients being treated with
antidepressants for major depressive disorder as well as
for
other
indications,
both
psychiatric
and
nonpsychiatric.
Although a causal link between the
emergence of such symptoms and either the worsening of
depression and/or the emergence of suicidal impulses has
not been established, consideration should be given to
changing the therapeutic regimen, including possibly
discontinuing the medication, in patients for whom such
symptoms are severe, abrupt in onset, or were not part of
the patient’s presenting symptoms.
Families and caregivers of patients being treated with
antidepressants for major depressive disorder or other
indications, both psychiatric and nonpsychiatric, should
be alerted about the need to monitor patients for the
emergence of agitation, irritability, and the other
symptoms described above, as well as the emergence of
suicidality, and to report such symptoms immediately to
health-care providers. Prescriptions for LEXAPRO should
be written for the smallest quantity of tablets
22
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
consistent with good patient management, in order to
reduce the risk of overdose.
(Dkt. No. 82-10 at 9) (emphasis in original).
Hamrell,
Tammy’s
general
warnings/regulatory
expert,
acknowledged that this warning “was placed in [Lexapro’s] April,
2004 label.”3
(Dkt. No. 91-20 at 19).
However, because Forest did
not include a black box warning or an updated medication guide
until February 2005, he concluded that “[a]t no time before 2005
was the Celexa/Lexapro label adequate with respect to suicidality.”
Id. at 22.
Despite Hamrell’s conclusion, Tammy has conceded:
Plaintiff does not claim that Forest could have added a
BLACK BOX warning to Lexapro’s label, or could have
provided a Patient Medication Guide, without prior FDA
approval. Forest relies on the portion of the expert
report of Dr. Hamrell, Plaintiff’s regulatory expert, in
which he addressed the inadequacy of the warning at all
times prior to 2005, and proffered a warning that would
have been adequate. But Dr. Hamrell does not opine, and
Plaintiff does not contend, that Forest could have added
a boxed warning, or a medication guide . . . .
(Dkt. No. 91 at 8).
Without the possibility of a black box warning or an updated
medication guide, Hamrell’s opinion is reduced to a ratification of
3
According to Forest’s documentation, the updated package insert
accompanied all Lexapro product distributed “on or before May 31, 2004.”
(Dkt. No. 82-10).
23
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Forest’s warning that he admits “was placed in [Lexapro’s] April,
2004 label.”
question
of
Thus, the Court concludes there is no material
fact
in
dispute
about
whether
Forest’s
warning
regarding the risk of suicide associated with the use of Lexapro
was adequate.
2. Adequacy of Forest’s Efforts to Warn
In addition to requiring an adequate warning about the risk of
suicide to patients using Lexapro, West Virginia law requires a
manufacturer such as Forest to undertake adequate efforts to
communicate that warning.
In Syl. Pt. 4, Ilosky v. Michelin Tire
Corp., 307 S.E.2d 603, 605 (W. Va. 1983), the West Virginia Supreme
Court of Appeals held that “[t]he determination of whether a
defendant’s efforts to warn of a product’s dangers are adequate is
a jury question.”
It based that holding on the fact that the
plaintiff, through her expert, had “concentrated her case” on
providing the jury with an alternative means of warning.
Id. at
610, 616.
Notably, the two alternatives proposed by Hamrell -- a black
box warning and a medication guide -- have been abandoned by Tammy
in order to avoid Forest’s preemption defense.
Nevertheless,
Tammy’s lawyers, both at oral argument and in their briefing,
contend there are several ways, other than the package insert, by
24
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
which Forest could have more effectively communicated the warning
about the risk of suicidality associated with Lexapro.
First, counsel contend that “[f]ederal law did not prohibit
Forest
from
sending
the
[March
2004]
Public
Health
Advisory
directly to prescribing doctors using a ‘Dear Doctor’ letter,” or
“sending a communication to Bruce Muzichuck.” (Dkt. No. 91 at 10).
Second, counsel point out that Forest’s Medical Affairs Department
actually drafted
a
“consumer
Lexapro
suicidality
standardized
response letter” in the spring of 2004, but decided against sending
it.
(Dkt. No. 91-23 at 4).
Finally, at oral argument, counsel
contended that an updated warning should have been provided based
on the FDA’s October 15, 2004 Public Health Advisory.
Critically, none of these alternatives is based on expert
testimony.
See Morningstar v. Black & Decker Mfg. Co., 253 S.E.2d
666, 682 (W. Va. 1979) (“In [a] product liability case, the expert
witness is ordinarily the critical witness.
He serves to set the
applicable manufacturing, design, labeling and warning standards
based on his experience and expertise in a given product field.”)
(emphasis added).
They also are not viable for other reasons.
A “Dear Doctor” letter, for example, would not have provided
Bruce’s physicians with any information they had not already seen.
Bruce’s prescribing physician, Bowers, confirmed that he routinely
25
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
read package inserts “in order to stay current on antidepressant
medications.”
(Dkt. No. 87-13 at 3).
As for the idea that Forest
should have sent a warning directly to Bruce, there is no evidence
of record that Forest knew or could have known he was a consumer
prior to the date on which he filled his prescription.
Even after
that, it is unclear how Forest could have known to send Bruce any
direct communication.
Tammy also urges that Forest should have sent Bruce the
standardized consumer response letter it had drafted.
Notably,
however, that letter was designed to be sent “in response to
inquiries” about Lexapro, something Bruce never made.
91-23 at 5).
(Dkt. No.
Moreover, it is undisputed that the letter simply
restated the same warning already contained in Forest’s package
insert.
(Dkt. No. 91-24).
Finally, as to the FDA’s October 15, 2004 communication, the
FDA specifically directed Forest not to implement any labeling
changes “until you have received notification from the Agency.”
(Dkt. No. 82-13). That notification was not provided until January
2005, a month after Bruce’s suicide.
(Dkt. No. 82-16).
For these reasons, Tammy’s contention that, based on syllabus
point 4 of Ilosky, the question whether a manufacturer’s efforts to
warn were adequate is always for the jury regardless of the state
26
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
of
the
evidence
is
erroneous.
She
has
submitted
no
expert
testimony supporting her proposed alternative means of warning; nor
is there any evidence that her proposed alternative means of
warning were viable.
Thus, there is no material question of fact
in dispute about whether Forest’s efforts to warn by way of its
package insert were adequate.
3. Bruce Read the Package Insert
Next, Forest contends that the evidence is uncontroverted that
Bruce actually read the package insert that was in his Lexapro
sample pack.
During Tammy’s deposition in 2011, the following
exchange occurred:
Q.
Do you have any knowledge or reason to believe that
[Bruce] actually [read the package insert]?
For
instance, did he ever tell you “I read this”?
A.
Yes, I –- I would say yes to that.
Q.
Well, you said you would say yes.
you that he read –-
A.
Yes.
Q.
–- the package insert? Did you actually see him
read the package insert or he just told you about
it?
A.
He told me some things about it.
Q.
What do you remember him telling you?
A.
That it changed like his sex drive and I think that
he –- there’d be times when he couldn’t sleep.
27
Did Bruce tell
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
(Dkt. No. 93-2 at 3).
Tammy’s
testimony
discusses
the
As Forest points out, corroboration for
exists
potential
because
side
the
effects
updated
(sexual
package
dysfunction
insomnia) she described in her deposition testimony.4
82-10
at
9-10).
Furthermore,
Forest’s
insert
director
and
(Dkt. No.
of
quality
assurance has filed a declaration verifying that, based on its lot
number, the sample pack given to Bruce by Bowers contained the
updated package insert.
(Dkt. No. 80).
Tammy’s effort to controvert her deposition testimony is
unavailing.
In a declaration signed the day before she filed her
responsive brief, Tammy asserts that “the only documents Bruce
Muzichuck could have reviewed prior to his death, that I am aware
of, were the Lexapro Patient Starter Kit/Sample Packet and/or the
‘Guide for Patients,’” but not the package insert.5
(Dkt. No. 91-
13 at 3).
4
Tammy attempts to rebut this by explaining that similar side
effects were also included in the sample pack’s “Guide for Patients.”
However, the Court has stricken that piece of evidence based on Tammy’s
late disclosure of it. (Dkt. No. 76).
5
It is unclear how Tammy is competent to testify as to what Bruce
did or did not read prior to his death.
28
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MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
This attempt by Tammy to create a contested issue of fact by
disputing her own earlier deposition testimony is unconvincing. In
the Fourth Circuit, a plaintiff
cannot create a dispute about a fact that is contained in
deposition testimony by referring to a subsequent
affidavit [or declaration] of the deponent contradicting
the deponent’s prior testimony, for “it is well
established that a genuine issue of fact is not created
where the only issue of fact is to determine which of the
two conflicting versions of a party’s testimony is
correct.”
In re Family Dollar FLSA Litig., 637 F.3d 508, 512 (4th Cir. 2011)
(quoting Erwin v. United States, 591 F.3d 313, 325 n.7 (4th Cir.
2010)).
Therefore, the Court concludes that there is no material
question of fact in dispute concerning whether Bruce read Forest’s
package insert.
4. Heeding Presumption
During oral argument, counsel for Tammy urged the Court to
apply a “heeding presumption,” which would give rise to a legal
conclusion that Bruce did not read the warning since he did not
stop taking Lexapro.
In some states, “[t]here is a presumption in
strict liability cases that a plaintiff would have read and heeded
an adequate warning if it had been given.”
Waterhouse v. R.J.
Reynolds Tobacco Co., 162 Fed. App’x 231, 234-35 (4th Cir. 2006)
(applying Maryland law).
29
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SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Forest’s
Lexapro
“[c]onsideration
regimen,
warning
should
including
be
possibly
provided
given
to
in
relevant
changing
discontinuing
the
the
part
that
therapeutic
medication,
in
patients whose depression is persistently worse or whose emergent
suicidality is severe, abrupt in onset, or was not part of the
patient’s presenting symptoms.”
Because Bruce continued to use
Lexapro even as his depression worsened, Tammy contends that he
could not have read the warning.
As Tammy’s counsel readily conceded at oral argument, however,
the West Virginia Supreme Court of Appeals has never adopted a
heeding presumption. Nevertheless, Tammy urges the Court to follow
the holdings in Giles v. Wyeth, Inc., 500 F. Supp. 2d 1063 (S.D.
Ill. 2007); and Wooderson v. Ortho Pharm. Corp., 681 P.2d 1038
(Kan. 1984), and adopt the presumption. A careful reading of these
cases undermines counsel’s argument.
In Giles, the district court expressly declined to determine
whether a heeding presumption would apply under Illinois law.
500
F. Supp. 2d at 1069 (“For better or worse, the Court need not
decide this issue . . . .”).
681
P.2d
at
1042,
the
Moreover, in Syl. Pt. 11, Wooderson,
Supreme
Court
of
Kansas
adopted
the
presumption, but, in doing so, explained in the same syllabus point
that “[t]his operates to the benefit of the manufacturer where
30
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
adequate warnings are in fact given.”
Indeed, courts that have
applied the presumption generally permit manufacturers to rebut it
with evidence contrary to the presumed fact.
Chem.
Co.
v.
Jacobs,
480
S.W.2d
602,
606
See, e.g., Technical
(Tex.
1972)
(“The
presumption may, however, be rebutted if the manufacturer comes
forward with contrary evidence that the presumed fact did not
exist.”).
Here, as already discussed, there is no genuine dispute that
a warning regarding suicidality was contained in Forest’s package
insert, that the warning was adequate, and that the sample pack
Bruce received from Bowers contained a package insert.
Moreover,
the uncontroverted facts establish that Bruce actually read the
warning
from
the
package
insert.
Thus,
even
if
a
heeding
presumption were applied in this case, based on the evidence of
record, it would not raise a genuine dispute of material fact.6
V. CONCLUSION
Although
Tammy’s
claims
are
not
preempted,
Forest
has
satisfied its burden of demonstrating the absence of any genuine
issue of material fact regarding its alleged failure to warn.
6
Based on its conclusion that no genuine dispute exists regarding
Forest’s alleged failure to warn, the Court need not address the
additional issues of proximate cause and punitive damages briefed by the
parties.
31
MUZICHUCK v. FOREST LABORATORIES, INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS’ MOTION FOR
SUMMARY JUDGMENT, AND DISMISSING CASE WITH PREJUDICE
Therefore, the Court GRANTS Forest’s motion for summary judgment,
DISMISSES this case WITH PREJUDICE, and CANCELS the final pretrial
conference scheduled for January 22, 2015, and the trial of this
case scheduled to begin on January 28, 2015.
It is so ORDERED.
The Clerk is directed to transmit copies of this Memorandum
Opinion and Order to counsel of record, and to enter a separate
judgment order dismissing this case with prejudice and removing it
from the Court’s active docket.
DATED: January 16, 2015.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
32
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