Muzichuck v. Forest Laboratories, Inc. et al
Filing
44
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF'S MOTION, CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT CONSTRUED AS A MOTION TO STRIKE: It is ORDERED that Plaintiff's 36 Motion for Judgment on the Pleadings, construed as a Motion to Strike, is hereby granted. Signed by District Judge Irene M. Keeley on 7/15/14. (cnd)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
TAMMY MUZICHUCK, Individually,
as Administratrix of the
Estate of Bruce Muzichuck,
and on behalf of her minor
child, Hannah Muzichuck,
Plaintiff,
v.
//
CIVIL ACTION NO. 1:07CV16
(Judge Keeley)
FOREST LABORATORIES, INC. and
FOREST PHARMACEUTICALS, INC.,
Defendants.
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S
MOTION [DKT. NO. 36], CAPTIONED AS A MOTION FOR JUDGMENT
ON THE PLEADINGS, BUT CONSTRUED AS A MOTION TO STRIKE
The
plaintiff
Muzichuck”),
has
in
sued
this
the
case,
defendants
Tammy
(1)
Muzichuck
in
her
(“Mrs.
individual
capacity, (2) in her capacity as the administratrix of the estate
of her deceased husband, Bruce Muzichuck (“Mr. Muzichuck”), and (3)
on behalf of her minor child, Hannah Muzichuck. Pending before the
Court is Mrs. Muzichuck’s motion, which is incorrectly captioned as
a motion for judgment on the pleadings.
(Dkt. No. 36).
The
motion, nevertheless, seeks to strike an affirmative defense raised
in the answer of one of the defendants, Forest Laboratories, Inc.
(“Forest”).
(Dkt. No. 37).
Therefore, the Court construes the
motion as a motion to strike under Fed. R. Civ. P. 12(f),1 and, for
the following reasons, GRANTS the motion.
I. BACKGROUND
In 2006, Mrs. Muzichuck filed a complaint in the Circuit Court
of
Marion
County,
West
Virginia,
alleging
that
Forest
had
manufactured an anti-depressant drug, known as “Lexapro,”2 that
caused Mr. Muzichuck to commit suicide by gunshot in 2004.
Prior
to shooting himself, Mr. Muzichuck recently had been prescribed an
increased dosage of Lexapro by his physician.
The complaint
alleges claims of negligent failure to warn, strict liability,
fraud, wrongful death, breach of implied warranty, and punitive
damages.
After removing the case to this Court, Forest filed an
answer, asserting
several
affirmative
“learned intermediary doctrine.”3
defenses,
including the
(Dkt. No. 37 at 12).
1
A Rule 12(f) motion to strike is more appropriate than a Rule
12(c) motion for judgment on the pleadings “where a plaintiff challenges
only some of the defenses raised in a defendant’s pleading.” Haley Paint
Co. v. E.I. Du Pont De Nemours & Co., 279 F.R.D. 331, 335 (D. Md. 2012);
see also 5C Charles Alan Wright & Arthur R. Miller, Federal Practice and
Procedure § 1380 (3d ed. 2004) (“A motion to strike under Federal Rule
12(f) . . . is the primary procedure for objecting to an insufficient
defense.”).
2
According to the complaint, Lexapro is in a class of drugs known
as selective serotonin reuptake inhibitors, which also includes Prozac,
Paxil, and Zoloft. (Dkt. No. 1-1 at 6-7).
3
“‘The learned intermediary doctrine provides an exception to the
general rule imposing a duty on manufacturers to warn consumers about the
risks of their products.’” West Virginia ex rel. Johnson & Johnson Corp.
v. Karl, 647 S.E.2d 899, 902 (W. Va. 2007) (quoting In re Norplant
Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 803 (E.D. Tex.
2002)). Under the doctrine, a drug manufacturer is excused from warning
every customer if it properly warns prescribing physicians of the drug’s
dangers. Id. at 901 n.1.
2
Due to a flurry of similar products liability actions against
Forest,
in
Litigation
March
2007,
(“JPML”)
the
Judicial
consolidated
Panel
the
on
cases
Multidistrict
for
pre-trial
proceedings in the United States District Court for the Eastern
District of Missouri.
After the case had spent several years in
the transferee court, in August 2013, the JPML remanded it to this
Court for further proceedings.
Mrs. Muzichuck filed her motion to strike on November 22,
2013.
In it, she argues that, based on the decision of the West
Virginia Supreme Court of Appeals in West Virginia ex rel. Johnson
& Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), the learned
intermediary
doctrine
substantive law.”
argues that
Karl’s
“does
not
exist
under
(Dkt. No. 36-1 at 1).
holding
is
limited
to
West
Virginia
In response, Forest
cases
that
present
evidence of direct-to-consumer advertising, and that the learned
intermediary doctrine does not violate West Virginia’s public
policy.
II. STANDARD OF REVIEW
Federal Rule of Civil Procedure 12(f) allows a district court,
either “on its own” or “on motion made by a party,” to strike from
any pleading “an insufficient defense.”
Although Rule 12(f)
motions to strike are generally viewed with disfavor, “a defense
that might confuse the issues in the case and would not, under the
facts alleged, constitute a valid defense to the action can and
should be deleted.”
Waste Mgmt. Holdings, Inc. v. Gilmore, 252
3
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
F.3d 316, 347 (4th Cir. 2001) (internal citation and quotation
marks omitted).
Moreover, “[a] court may strike a defense that is
clearly insufficient as a matter of law.”
Hanzlik v. Birach, No.
1:09CV221, 2009 WL 2147845, at *3 (E.D. Va. July 14, 2009).
III. DISCUSSION
The
only
question
presented
is
whether
the
learned
intermediary doctrine is cognizable where there is no evidence that
the defendant-drug manufacturer marketed its prescription drug
directly to consumers. A thorough discussion, however, requires an
analysis of the decision of the West Virginia Supreme Court of
Appeals in Karl, a review of several post-Karl decisions, and an
examination of the West Virginia legislature’s 2011 enactment in W.
Va. Code § 55-8-16.
A.
Karl
When West Virginia’s highest court rendered its decision in
West Virginia ex rel. Johnson & Johnson Corp. v. Karl in 2007, the
issue of “whether [the learned intermediary doctrine] should be
adopted into the common law of West Virginia” was “one of first
impression.”
647 S.E.2d at 902.
That said, prior to 2007, the
federal district courts within West Virginia had speculated that
the state would adopt the doctrine.
4
See, e.g., Ashworth v. Albers
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
Med., Inc., 395 F. Supp. 2d 395, 407 (S.D.W. Va. 2005); Pumphrey v.
C.R. Bard, Inc., 906 F. Supp. 334, 338 (N.D.W. Va. 1995).
Their
speculation proved erroneous, however, when, in Karl, the West
Virginia Supreme Court of Appeals declined to validate those
opinions.
647 S.E. 2d at 913 n.18.
In Karl, the respondent-patient had been prescribed Propulsid®
by her physician for treatment of digestive issues.
After three days of use, she suddenly died.
Id.
Id. at 901.
Her estate filed
a products liability and medical malpractice action against the
drug’s manufacturer and the prescribing physician.
Id.
The
manufacturer filed a motion for summary judgment on the basis that,
under the learned intermediary doctrine, it had satisfied its duty
to warn the physician of the drug’s potential dangers.
Id.
The
circuit court denied the manufacturer’s motion. Id. Subsequently,
the manufacturer filed a motion in limine to exclude any evidence
of its failure to warn the decedent.
denied the motion.
Id.
Id.
Again, the circuit court
Thereafter, the manufacturer filed a writ
of prohibition asking the West Virginia Supreme Court of Appeals to
prohibit enforcement of the circuit court’s order denying its
motion in limine, and to adopt the learned intermediary doctrine.
Id.
5
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
In denying the manufacturer’s writ, the court stated as
follows:
Given the plethora of exceptions to the learned
intermediary doctrine, we ascertain no benefit in
adopting a doctrine that would require the simultaneous
adoption of numerous exceptions in order to be justly
utilized. . . . Furthermore, we believe that if drug
manufacturers are able to adequately provide warnings to
consumers under the numerous exceptions to the learned
intermediary doctrine, then they should experience no
substantial impediment to providing adequate warnings to
consumers in general. . . . Finally, because it is the
prescription drug manufacturers who benefit financially
from the sales of prescription drugs and possess the
knowledge regarding potential harms, and the ultimate
consumers who bear the significant health risks of using
those drugs, it is not unreasonable that prescription
drug manufacturers should provide appropriate warnings to
the ultimate users of their products. . . . West Virginia
physicians naturally have duties and responsibilities
regarding their role in providing prescription medicines
to consumers. It would be unreasonable not to require
the manufacturers to accept similar responsibilities.
Based upon the foregoing, we now hold that, under West
Virginia products liability law, manufacturers of
prescription drugs are subject to the same duty to warn
consumers about the risks of their products as other
manufacturers.
We decline to adopt the learned
intermediary exception to this general rule.
Id. at 913-14.
B.
Post-Karl Decisions
As Forest correctly points out, the Karl court relied, in
significant
part,
advertising
in
on
the
declining
proliferation
to
adopt
6
the
of
direct-to-consumer
learned
intermediary
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
doctrine.
See
Karl,
647
S.E.2d
at
909.
However,
Forest’s
assertion that “Karl did not kill the learned intermediary doctrine
in West Virginia[] because of the specific direct to consumer
marketing context” is incorrect.
(Dkt. No. 38 at 7).
In an effort
to exhume the doctrine from its judicially-dug grave, Forest cites
two post-Karl cases - one published, the other unpublished - from
the United States District Court for the Southern District of West
Virginia.
In the first of these cases, the estate of a decedent-employee
sued the chemical manufacturer-employer and one of its chemical
suppliers after the decedent died from exposure to vinyl chloride
monomer (“VCM”).
Roney v. Gencorp, 654 F. Supp. 2d 501, 502
(S.D.W. Va. 2009) (Chambers, J.).
failure
to
warn
claim,
the
“sophisticated user” defense.4
In defense of the plaintiff’s
chemical
Id.
supplier
asserted
the
The district court observed
that, contrary to the learned intermediary doctrine, which “the
4
Although related to the learned intermediary doctrine, the
sophisticated user defense differs significantly. “In its purest form,
the sophisticated user defense discourages direct warning by allowing
manufacturers to rely on purchasing claims to relay warnings to end
users.
The defense relieves manufacturers of liability for injuries
caused by intermediate purchasers’ failure to warn the next purchaser in
line. Initial manufacturers are thus not liable for such breaks in the
chain of warnings.”
Kenneth M. Willner, Failures to Warn and the
Sophisticated User Defense, 74 Va. L. Rev. 579, 580 (1988).
7
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
[Karl] court decided not to adopt,” the sophisticated user defense
“has not been explicitly adopted or rejected in West Virginia.”
Id. at 502, 504.
In offering its best judgment as to whether West Virginia
courts would adopt or reject the sophisticated user defense, the
district court looked closely at the reasoning in Karl.
504-05.
Id. at
It observed that “[c]entral to the reasoning was the fact
that drug companies now engage in extensive direct-to-consumer
advertising,”
specific.”
and
Id.
“through such
it
described
Karl
as
“extremely
context
The court further noted Karl’s recognition that
advertising
pharmaceutical
companies
had
gained
direct access to patients, a relationship starkly different than
that which had existed when the doctrine was developed - when
patients
doctors.”
received
drug
information
exclusively
through
their
Id. at 505.
It went on to distinguish the facts of its case by analogizing
the relationship of worker to employer in the chemicals industry to
the relationship of patient to doctor in the days when the learned
intermediary doctrine was developed. Id. In other words, chemical
plant
workers
“were
insulated
from
the
manufacturer
of
the
chemicals they used, much as the patient used to be insulated from
8
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
the drug manufacturer.”
Id.
Thus, the court was unpersuaded that
Karl portended West Virginia’s rejection of the sophisticated user
defense.
Id.
The second of the two cases relied on by Forest is Vagenos v.
Alza Corp., No. 1:09CV1523, 2010 WL 2944683 (S.D.W. Va. July 23,
2010) (Faber, J.).
In Vagenos, the estate of a decedent whose
death allegedly was due to her use of a fentanyl patch sued the
manufacturer, the distributor, and the retailer of the patch.
at *1.
Id.
The retailer successfully moved to dismiss the case based
on the learned intermediary doctrine.
Id.
In granting the motion
to dismiss, the district court reasoned that, “[g]iven the [directto-consumer advertising] rationale underpinning the [Karl] decision
and the fact that the Karl court did not discuss the doctrine in
the context of a pharmacist’s duty to warn, . . . the court
predicts that the West Virginia Supreme Court of Appeals would find
that the learned intermediary doctrine shields [the retailerpharmacy] from liability on the failure to warn claim.”
Id. at *5.
Relying on the rationale of Roney and Vagenos, Forest urges
that, “[a]bsent evidence of direct to consumer marketing of Lexapro
to the end user prior to decedent’s death on December 5, 2004, the
learned intermediary doctrine should remain a viable affirmative
9
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
defense under West Virginia law.” (Dkt. No. 38 at 9).
Both cases,
however, differ from the instant case, and the Court is unpersuaded
that they support the conclusion Karl does not apply here.
In Karl, the West Virginia Supreme Court of Appeals did not
distinguish between cases that present evidence of direct-toconsumer advertising and those that do not.
Indeed, as Forest
argues, the dissent in Karl highlighted the majority’s failure to
draw such a distinction:
What the majority overlooks by emphasizing the direct
marketing of drugs to consumers is that the doctrine may
still serve a useful purpose for prescription drugs that
are not heavily marketed and in those circumstances where
a physician’s expertise is relied upon to make the allimportant selection of which particular drug(s) to
prescribe; to interpret contraindicative information; and
to interpret the myriad of warning-related information
distributed by a pharmaceutical manufacturer.
Karl, 647 S.E.2d at 914-15 (Albright, J., dissenting).
Whether
Karl’s failure in this regard was prudent or not has no bearing on
the Court’s application of the majority’s holding.
Moreover,
despite Forest’s reliance on Roney and Vagenos, neither case
recognized the distinction in the context of a prescription drug
manufacturer’s assertion of the learned intermediary doctrine.
In Roney, Judge Chambers declined to extend the presumption of
direct-to-consumer
advertising
to
10
the
chemical
manufacturing
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
industry because workers in that industry “were insulated from the
manufacturers of the chemicals they used.”
654 F. Supp. 2d at 505.
Instead, he recognized that Karl’s reasoning “is not applicable to
a scenario outside of the prescription pharmaceutical context.”
Id.
Vagenos is distinguishable from Karl to the extent that the
party asserting the learned intermediary doctrine in that case was
a retailer-pharmacy.
In contrast, here, as in Karl, the party
asserting the defense is the pharmaceutical manufacturer.
And, as
acknowledged by Judge Faber, “the Karl court abolished the doctrine
as to manufactures [sic] only.”
Vagenos, 2010 WL 2944683, at *5.
Despite their holdings, Roney and Vagenos both explicitly
recognize
that
Karl
prohibits
defendant-prescription
drug
manufacturers from asserting the learned intermediary doctrine.
Thus, the Court rejects Forest’s argument that a plaintiff must
proffer
evidence
of
direct-to-consumer
advertising
manufacturer in order for Karl to apply.
by
a
drug
Rather, because the
instant case involves the assertion of the learned intermediary
doctrine by a defendant-prescription drug manufacturer, the holding
of Karl applies squarely to prohibit the defense.
11
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
C.
Public Policy
Like Roney and Vagenos, several other cases, including two
from this Court, have noted the unavailability of the learned
intermediary doctrine for prescription drug manufacturers in West
Virginia.
Notably, these cases have concluded that the bar of the
doctrine is grounded in public policy, in addition to direct-toconsumer advertising.
See Locklear v. Mylan, Inc., No. 1:10CV164,
2011 WL 3296635, at *5 (N.D.W. Va. Aug. 1, 2011) (“[T]he West
Virginia Supreme Court of Appeals has declared that the learned
intermediary
doctrine
violates
the
state’s
public
policy.”);
Vitatoe v. Mylan Pharm., Inc., 696 F. Supp. 2d 599, 609 (N.D.W. Va.
2010) (“[T]he public policy of West Virginia bars the application
of Louisiana’s learned intermediary doctrine.”); Woodcock v. Mylan,
Inc., 661 F. Supp. 2d 602, 607 (S.D.W. Va. 2009) (“The analysis in
Karl
reveals
that
West
Virginia’s
rejection
of
the
learned-
intermediary doctrine is grounded in public policy.”).
Forest
argues
extensively
that
these
cases
were
wrongly
decided, and that public policy was not a basis for the Karl
decision.5
Forest argues that this conclusion is evidenced by
5
The Court need not reach the issue of whether Karl was decided on
public policy grounds in order to render its decision in this case.
12
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
recent legislation, entitled “Choice of Law in Pharmaceutical
Product Liability Actions,” which provides as follows:
(a) It is public policy of this state that, in
determining the law applicable to a product liability
claim brought by a nonresident of this state against the
manufacturer or distributor of a prescription drug for
failure to warn, the duty to warn shall be governed
solely by the product liability law of the place of
injury (“lex loci delicti”).
(b) This section shall be applicable prospectively to all
civil actions commenced on or after July 1, 2011.
§ 55-8-16.
decision.
According to Forest, the statute has “gutted” the Karl
(Dkt. No. 38 at 12).
Far from gutting Karl, § 55-8-16 simply provides a choice of
law rule with respect to prescription drug products liability
actions.
If in such cases the plaintiff is not a West Virginia
resident, and the case was filed on or after July 1, 2011, pursuant
to the statute the court shall apply the product liability law of
the state where the injury occurred.
Aside from any effect it
might have on Karl, § 55-8-16 does not come close to applying to
the facts at issue here.
Not only is Mrs. Muzichuck a West
Virginia resident, but she filed this action nearly five years
prior to the effective date of the statute.
Moreover, even if the
statute were applicable, because Mr. Muzichuck’s suicide occurred
13
MUZICHUCK V. FOREST LABS., INC., ET AL.
1:07CV16
MEMORANDUM OPINION AND ORDER GRANTING PLAINTIFF’S MOTION,
CAPTIONED AS A MOTION FOR JUDGMENT ON THE PLEADINGS, BUT
CONSTRUED AS A MOTION TO STRIKE
_________________________________________________________________
in West Virginia, this state’s products liability law, i.e., Karl,
would apply.
IV. CONCLUSION
Despite Forest’s urging to the contrary, Karl remains the
applicable
substantive
law
doctrine in West Virginia.
regarding
the
learned
intermediary
That case forthrightly rejects the
doctrine as a cognizable defense to be asserted by prescription
drug manufacturers.
Furthermore, § 55-8-16 does not abrogate
Karl’s holding, nor does it apply to the case at bar.
Therefore,
for the reasons discussed, the Court GRANTS Mrs. Muzichuck’s motion
to strike the learned intermediary doctrine from Forest’s answer.
It is so ORDERED.
The
Court
directs
the
Clerk
to transmit
copies
of
Memorandum Opinion and Order to counsel of record.
DATED: July 15, 2014.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
14
this
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