Kennedy v. Pfizer Inc

Filing 15

MEMORANDUM RULING: Motion to dismiss 11 filed by Pfizer is hereby GRANTED and all of Plaintiffs' claims are hereby DISMISSED. Signed by Judge S Maurice Hicks on 8/28/2013. (crt,Joffrion, B)

UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF LOUISIANA
SHREVEPORT DIVISION
ANNIE V. KENNEDY as Tutrix and on
behalf of the minor child, LAJERRION
KENNEDY, minor child of the decedent
LASHUNDA RENEE KENNEDY
VERSUS
PFIZER, INC.

CIVIL ACTION NO. 12-01858

JUDGE S. MAURICE HICKS, JR.
MAGISTRATE JUDGE HORNSBY

MEMORANDUM RULING
Before this Court is a FRCP Rule 12(b)(6) Motion to Dismiss (Record Document 11)
filed by Defendant, Pfizer, Inc. (“Pfizer”). The motion avers that this Court should dismiss
Plaintiffs’ Complaint because “(1) [P]laintiffs impermissibly plead product liability claims that
fall outside the Louisiana Product Liability Act, La. Rev. Stat. §§ 9:2800.51-60 (“LPLA”) and
(2) to the extent they do attempt to plead LPLA claims, they have failed to plead them with
the required reference to the applicable provisions of the LPLA and sufficient facts to put
Pfizer on notice of their bases.”(Record Document 11-1). For the reasons which follow,
Pfizer’s motion is GRANTED and Plaintiffs’ claims are DISMISSED.
I.

Background
On or about July 9, 2011, LaShunda Renee Kennedy (“Kennedy”) allegedly suffered

a seizure for which she was admitted to Louisiana State University Health Science Center
in Shreveport (LSUHSC-S). While admitted to LSUHSC-S, Kennedy allegedly ingested the
prescribed anti-seizure medication Dilantin, manufactured by Pfizer. (Complaint ¶ 3).
Plaintiffs allege that almost two weeks later on or about July 20, 2011, as a result of using
the allegedly defective drug, Kennedy was diagnosed with having Stevens-Johnson

Syndrome (“SJS”).1 (Complaint ¶ 3). SJS caused her to suffer from a “burning sensation
from the inside out of her body beginning in her throat area.” (Complaint ¶ 3). Kennedy also
“suffered hair loss, coughed up black objects and went into a coma.” (Complaint ¶ 3).
Plaintiffs additionally allege that the drug ultimately caused the death of Kennedy.2 On July
9, 2012, Annie V. Kennedy, as Tutrix and on behalf of LaJerrion Kennedy, minor child of
the decedent, filed the instant action against Pfizer.
II.

Law and Analysis
A.

Legal Standard

Rule 12(b)(6) allows for dismissal of an action “for failure to state a claim upon which
relief can be granted.” While a complaint attacked by a Rule 12(b)(6) does not need to
detail factual allegations in order to avoid dismissal, Plaintiffs’ factual allegations “must be
enough to raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly,
550 U.S. 544, 555, 127 S.Ct. 1955, 1964-1965 (2007); see also Cuvillier v. Taylor, 503 F.
3d 397, 401 (5th Cir. 2007). A plaintiff’s complaint must contain “more than labels and
conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Id.
The Supreme Court expounded on the Twombly standard, explaining that a complaint must
contain sufficient factual matter to state a claim to relief on its face. See Ashcroft v. Iqbal,
556 U.S. 662, 678, 129 S.Ct. 1937, 1949 (2009). “A claim has facial plausibility when the
plaintiff pleads factual content that allows the court to draw the reasonable inference that

1

The Complaint alleges that Kennedy was diagnosed with SJS. The Court
understood this to be Stevens-Johnson syndrome, as no syndrome called Steven
Johnson Syndrome could be found in the 2013 Physicians’ Desk Reference.
2

The Complaint fails to allege a specific date of Kennedy’s death.
Page 2 of 10

the defendant is liable for the misconduct alleged.” Id. In evaluating a motion to dismiss,
the Court must construe the complaint liberally and accept all of the plaintiff’s factual
allegations in the complaint as true. See In re Katrina Canal Breaches Litigation, 495 F.3d
191, 205 (5th Cir. 2009).
The LPLA provides “the exclusive theories of liability for manufacturers of products
and establishes the exclusive theories of liability for manufacturers for damage caused by
their products.” La. R.S. § 9:2800.52. A product is unreasonably dangerous if and only if:
(1) The product is unreasonably dangerous in construction or composition as
provided in R.S. 9:2800.55;
(2) The product is unreasonably dangerous in design as provided in R.S.
9:2800.56;
(3) The product is unreasonably dangerous because an adequate warning
about the product has not been provided as provided in R.S. 9:2800.57; or
(4) The product is unreasonably dangerous because it does not conform to
an express warning of the manufacturer about the product as provided in
R.S. 9:2800.58.
La. R.S. § 9:2800.54. Because the LPLA provides the exclusive theories of liability for
manufacturers of products, recovery “from a manufacturer for damage caused by a product
on the basis of any theory of liability that is not set for in” the LPLA is not possible. La. Rev.
Stat. § 9:2800.52.
B.

Analysis

Here, the complaint contains claims arising under the LPLA and several claims that
do not arise under the LPLA. Pfizer argues that all of the claims should be dismissed
because (1) “Plaintiffs impermissibly plead product liability claims that fall outside the
[LPLA]” and (2) “to the extent they do attempt to plead LPLA claims, they have failed to
plead them with the required reference to the applicable provisions of the LPLA and
sufficient facts to put Pfizer on notice of their bases.” (Record Document 11-1).
Page 3 of 10

This Court will first address the claims which fall outside of the LPLA. Plaintiffs allege
that Pfizer “through advertising, label promotion, and other communications...made
intentional misrepresentations to physicians and the public...about the safety and efficacy
of Dilantin.” (Record Document 1 at ¶ 10). Additionally, Plaintiffs allege that compensation
should be awarded for Pfizer’s “negligence.” (Record Document 1 at ¶ 16). This allegation
includes negligence for the failure “to perform adequate testing.” (Record Document 1 at
¶ 5). Plaintiffs did not contest the fact that these claims fall outside of the LPLA in their
response to the Pfizer’s Rule 12(b)(6) Motion. (Record Document 13). Because the LPLA
provides the exclusive theories for recovery, these claims are statutorily impermissible.
Accordingly, all claims which fall outside of the LPLA are dismissed.
The Court next turns its attention to the claims made under the LPLA. Through
applying the legal standard to the four individual bases for recovery, it is clear that the LPLA
allegations are legally insufficient to withstand a FRCP Rule 12(b)(6) Motion to Dismiss
under Twombly.
1.

Construction or Composition

The first theory for recovery under the LPLA is realized if the Plaintiffs can show that
a product is unreasonably dangerous in construction or composition. A claim under this
theory provides a remedy “for harm caused by a product defect ‘due to a mistake in the
manufacturing process.’” Stahl v. Novartis Pharma. Corp., 283 F. 3d 254, 261 (5th Cir.
2002).To prevail on a claim under this theory, Plaintiffs must show that “at the time the
product left the manufacturer’s control, the product deviated in a material way from the
manufacturer’s specifications or performance standards for the product or from otherwise

Page 4 of 10

identical products manufactured by the same manufacturer.” La. Rev. Stat. § 9:2800.55;
see also Stahl at 261; Reed v. Bio Orthopedics, No. 08-30893, 318 Fed. Appx. 305 (5th Cir.
2009).
This Court found two recent cases particularly on point: Watson v.Bayer Healthcare
Pharmaceuticals, Inc., 2013 WL 1558328, E.D. La. April 11, 2013 and Harris v. Merck &
Co., Inc., 2012 WL 5384720 (W.D. La. November 1, 2012). In Watson, the court found a
plaintiff’s bald allegation legally insufficient to demonstrate a mistake in the manufacturing
process of a drug when she “fail[ed] to cite facts about the ‘condition’ or suggest how [the
drug] deviated from its intended design.” Watson at 4. Similarly, the Harris court plainly
stated that merely “reciting the allegations that a defendant is liable to plaintiff for ‘providing
a product that was unreasonably dangerous in construction or composition...” is insufficient.
Harris at 2.
Plaintiffs allege that Dilantin was the cause of the decedent’s SJS and subsequent
death. (Record Document 1 and 2). Similar to the cases cited above, Plaintiffs fail to
articulate how the Dilantin allegedly ingested by the decedent deviated from its intended
composition or construction. Although Plaintiffs’ Response in Opposition to Pfizer’s 12(b)(6)
Motion claims to have addressed the defect in construction of the drug, it merely recites a
superficial allegation without support. (Record Document 13, p. 3, ¶ 1). Therefore, this
LPLA theory of recovery fails to reach the standard necessary to survive a FRCP Rule
12(b)(6) Motion under the Twombly standard.

Page 5 of 10

2.

Design

The second theory for recovery under the LPLA is for a design defect. The statute
provides:
a product is unreasonably dangerous in design if, at the time the product left
its manufactuer’s control: (1) there existed an alternative design for the
product that was capable of preventing the claimant’s damage; and (2) the
likelihood that the product’s design would cause the claimant’s damage and
the gravity of that damage outweighed the burden on the manufacturer of
adopting such alternative design and the adverse effect, if any, of such
alterative design on the utility of the product. An adequate warning about a
product shall be considered in evaluating the likelihood of damage when the
manufacturer has used reasonable care to provide the adequate warnings
to users and handlers of the product.
La. Rev. Stat. §9:2800.56.
Similar to a dangerous construction or composition claim, Plaintiffs must allege how
the design defect is either caused by or relates to the injury in question. Watson at *5. The
LPLA “does not allow a fact finder to presume an unreasonably dangerous design soley
from the fact that the injury occurred.” Id. at *4 (citing McCarthy v. Danek Medical, Inc., 65
F. Supp. 2d 410, 412 (E.D. La. 1999)). The courts, though, have deemed an allegation of
inaccurate dosage amount to meet this requirement. Harris at *3. In Harris, the plaintiff
specifically asserted that her 80 milligram dosage was the cause of her injury and that
other, smaller dosages would have prevented the injury. Id. As a result, the court denied
the defendant’s 12(b)(6) motion with regard to this theory of recovery. Id.
In this instance, Plaintiffs have neither alleged a dosage amount, nor identified who
prescribed or administered the drug. Rather, Kennedy only asserted Dilantin was “defective
in design or formulation in that [when] it left the hands of the manufacturer and/or distributor
the foreseeable risks exceeded the benefits associated with the design or formulation.”
Page 6 of 10

(Record Document 1 at ¶ 8). Alternatively, Plaintiffs stated that the drug was “unreasonably
dangerous, such that it was more dangerous than an ordinary consumer would expect and
more dangerous than other drugs in the same class.” Id. Plaintiffs’ statements, however,
fail to allege how the design is defective or what aspect of the design caused the injury. As
specifically directed by McCarthy, this Court cannot link an injury to a defective design
without factual support. Therefore, with regard to this theory of recovery, the 12(b)(6) must
be granted.
3.

Inadequate Warning

The third theory for recovery under the LPLA is for an inadequate warning. The
statute provides:
a product is unreasonably dangerous because an adequate warning about
the product has not been provided if, at the time the product left its
manufacturer’s control, the product possessed a characteristic that may
cause damage and the manufacturer failed to use reasonable care to provide
an adequate warning of such characteristic and its danger to users and
handlers of the product.
La. Rev. Stat. § 9:2800.57.
In Harris, the court stated that a warning that failed to indicate the negative side
effects of taking an 80-milligram dosage was found to be “barely sufficient.” Harris at *4.
The court reasoned that the doctor would not have prescribed that dosage and the plaintiff
would not have suffered the resulting injuries had the manufacturer rendered an adequate
warning. Id. In declining to grant the defendant’s 12(b)(6) motion with regard to this issue,
the court held that the defendant’s argument that the plaintiff must “allege what warning
would have been adequate” was misguided. Id. The court found “no citing authority wherein
dismissal was deemed appropriate on the basis that plaintiff’s complaint did not offer an
Page 7 of 10

alternative warning, which, having not been used by the manufacturer, rendered the
manufacturer’s conduct unreasonable. Id.
Similarly reasoned but with the opposite result, the court in Watson granted the
12(b)(6) motion due to the plaintiff’s “failure to allege facts suggesting how [the
manufacturer’s] allegedly inadequate warning caused her specific injury.” Watson at *5.
There, the plaintiff only stated that the label did not warn of the exact injury she sustained
from using the medical device without articulating any causal connection. Id.
Plaintiffs claim in their complaint:
The drug Dilantin was unaccompanied by proper warnings regarding the
injuries associated with the drug...The warnings given did not accurately
reflect the symptoms...or severity of the injuries...full and proper warning
should have been given with respect to the use of this drug.
Record Document 13 (citing Record Document 1 ¶ 8). This assertion is far more similar to
the facts in Watson, than in Harris. Plaintiffs fail to articulate a causal connection between
the claimed inadequate warning and Kennedy’s resulting damage. In this instance, Plaintiffs
have not alleged a dosage amount; plaintiffs have not alleged who administered the drug.
In fact, there is not even an allegation that a physician prescribed the medication for the
decedent. This Court will not presume those facts. In stark contrast to Harris, the Plaintiffs
fail to plead even “barely sufficient facts.” The finding of this Court is, therefore, the same
as Watson regarding this theory of recovery. Pfizer’s 12(b)(6) Motion to Dismiss Kennedy’s
claim for inadequate warning is granted.3

3

However, Pfizer’s contention that the Plaintiffs must state what warning would
have been adequate is misguided. See Harris, 2012 WL 5384720.
Page 8 of 10

4.

Express Warranty

The fourth theory for recovery under the LPLA is a lack of express warranty. The
statute provides:
a product is unreasonably dangerous when it does not conform to an
express warranty made at any time by the manufacturer about the product
if the express warranty has induced the claimant or another person or
entity to use the product and the claimant’s damage was proximately
caused because the express warranty was untrue.
La. Rev. Stat. § 9:2800.58.
In order to prove a breach of an express warranty, plaintiffs are not required to
identify specific language offered by a manufacturer. Rather, this Court endorses and
adopts the requirement that a manufacturer may not “suppress information” and “make
false representations of...superiority and efficacy” when gaining significant market share
with a defective product. Harris, 2012 WL 5384720, at *5. The logic that market share
would not have been possible without engaging in such activity meets “the very basest
requirements” in order to deny a 12(b)(6) motion with respect to a LPLA express
warranty claim. Id. Specifically, the plaintiffs in Harris explained that the defendant
marketed a drug “under the vise [sic] that it was safe and efficacious for persons.” Id. In
other words, the marketing appears to rise to the level of an express warranty if that
marketing makes claims as to the product’s safety.
Kennedy alleges that, although Pfizer should have known of the risk of serious
injury, it continued to aggressively promote the dangerously defective product Dilantin.
While this Court acknowledges that it is unnecessary for the Plaintiffs to cite a specific
express warranty, it is necessary to articulate how the equivalent marketing materials

Page 9 of 10

are false. Plaintiffs, however, failed to reach even this minimum standard. Rather,
Plaintiffs assert that Pfizer promoted a product that it should have known was
dangerous, but did not specifically explain that the content of their promotion
contradicted what it knew or should have known to be true. (Record Document 1 at 3).
Unlike Harris, Plaintiffs failed to show how the marketing of Dilantin by Pfizer
suppressed information, helped the company gain a market share, or induced persons
to use the drug under the ruse of safety. As a result, Pfizer’s 12(b)(6) motion with regard
to this theory of recovery is granted.
III.

Conclusion
Based on the foregoing, the Court finds that certain of Plaintiffs’ product liability

claims fall outside the LPLA’s exclusive theories of liability and are dismissed. Further,
each of the claims brought pursuant to the LPLA have insufficient factual support under
the Twombly standard, and thus fail to satisfy the Rule 12(b)(6) pleading standard.
Therefore, the FRCP Rule 12(b)(6) Motion to Dismiss (Record Document 11) filed by
Pfizer is hereby GRANTED and all of Plaintiffs’ claims are hereby DISMISSED.
A judgment consistent with the terms of the instant Memorandum Ruling shall
issue herewith.
THUS DONE AND SIGNED, in Shreveport, Louisiana, this 28th day of August,
2013.

Page 10 of 10