Tillman et al v. Woldenberg Village, Inc. et al
ORDER & REASONS that Mylan Pharmaceuticals, Inc.'s 52 Motion to Dismiss; Caraco Pharmaceutical Laboratories, Ltd.'s 61 Motion to Dismiss for Failure to State a Claim; Wockhardt USA, LLC's 65 Motion to Dismiss for Failure to St ate a Claim; Baxter Healthcare Corporation's 88 Motion to Dismiss for Failure to State a Claim and Taro Pharmaceuticals, U.S.A., Inc.'s 92 Motion to Dismiss for Failure to State a Claim are GRANTED. IT IS FURTHER ORDERED that Pfizer, Inc.'s 101 Motion for Judgment on the Pleadings is GRANTED. IT IS FURTHER ORDERED that Jefferson Parish Hospital District No. 1's 72 Motion to Dismiss for Lack of Jurisdiction is GRANTED. Signed by Judge Eldon E. Fallon on 11/27/13. (dno, )
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
TILLMAN, ET AL
WOLDENBERG VILLAGE, INC., ET AL
SECTION “L” (2)
ORDER AND REASONS
Before the Court are seven pending motions – five motions to dismiss filed by
Defendants Mylan Pharmaceuticals, Inc., Caraco Pharmaceutical Laboratories, Ltd., Wockhardt
USA, LLC, Baxter Healthcare Corporation, and Taro Pharmaceuticals, U.S.A., Inc. (collectively
the "generic manufacturers") (Rec. Docs. 52, 61, 65, 88, 92); one motion for judgment on the
pleadings filed by Defendant Pfizer Inc. (Rec. Doc. 101); and one motion to dismiss for lack of
jurisdiction filed by Defendant Jefferson Parish Hospital Service District No. 1, doing business
as West Jefferson Medical Center, ("West Jefferson") (Rec. Doc. 72). The Court has reviewed
the briefs and the applicable law and, having heard oral argument on four of the motions, now
issues this Order and Reasons.
This Wrongful Death and Survival Action arises from the death of Rose Tillman, the
mother of Plaintiffs Jahmal and Jirus Tillman. According to Plaintiffs, Rose Tillman died as a
result of an adverse reaction to a prescription drug, phenytoin. Phenytoin sodium is an
anticonvulsant drug used to treat seizures. (Rec. Doc. 61-1 at 6). In the 1950s the FDA
approved a New Drug Application for phenytoin sodium under the brand name Dilantin.
Defendant Pfizer Inc. designed and manufactured Dilantin. (Rec. Doc. 5 at 2). Since the 1950s,
phenytoin has been marketed in various forms, both branded and generic, by numerous
companies. Plaintiffs claim that one in every ten people who take this drug have an adverse
reaction to it. (Rec. Doc. 1-1 at 3).
According to Plaintiffs' complaint, on or about March 25, 2012, Rose Tillman was taken
to the emergency department of West Jefferson Medical Center after suffering a stroke. There,
she was treated by Doctors Frank Culicchia and Michael Puente. Plaintiffs allege that one of
these doctors prescribed Dilantin or its generic version phenytoin. Plaintiffs claim that this
prescription was contrary to the standard of care for this patient because the doctors should have
known that it could cause dangerous side effects. Plaintiffs further allege that these two doctors
failed to properly monitor Mrs. Tillman, even though she immediately showed signs of an
allergic reaction to the drug in the form of a rash. Plaintiffs claim that Mrs. Tillman was then
discharged from West Jefferson Medical Center and transported to Woldenberg Village in an
ambulance, where she was treated by Doctor Lowentritt. Plaintiffs explain that Mrs. Tillman's
rash worsened into hives, she suffered renal failure, lost mental functions and became essentially
unresponsive. She was transferred back to West Jefferson Medical Center for more intensive
treatment. Mrs. Tillman developed hives, blisters, bleeding and exfoliation over her entire body.
On May 22, 2012, she died. Plaintiffs claim that throughout her stay at West Jefferson Medical
Center and Woldenberg Village, the doctors and nurses improperly continued to administer
Dilantin or phenytoin, despite Mrs. Tillman's reaction. Plaintiffs claim that this drug caused her
Plaintiffs filed a complaint on May 22, 2013, in which they named the hospitals, doctors,
and various drug manufacturers as defendants. Plaintiffs are asking to be compensated for pain
and suffering, mental anguish, loss of love and affection, loss of services, loss of support,
medical expenses and funeral expenses, all incurred as a result of their mother, Rose Tillman's
death. Plaintiffs do not know which specific drug manufacturing company produced the drugs
that were given to Mrs. Tillman and they do not know whether it was Dilantin or the generic
form, phenytoin. Therefore, they name ten drug manufacturers who they believe manufacture
phenytoin as well as Pfizer Inc., the manufacturer of Dilantin. On June 6, 2013, Defendant
Pfizer, Inc. removed the case to this Court, pursuant to the Court's diversity jurisdiction. 28
U.S.C. §1332. The claims against the treating doctors and Woldenberg Village were dismissed
and are proceeding instead in an administrative forum.1 (Rec. Doc. 67).
The motions that are pending in this case can be grouped into three categories. Five of
the motions are nearly identical and were all filed by the generic manufacturers. One motion
was filed by Defendant Pfizer, Inc., the brand-name drug manufacturer. The last motion was
filed by West Jefferson Medical Center. The Court will discuss each group in turn.
Motions to Dismiss Filed by Generic Manufacturers
Between September 24, 2013 and October 22, 2013, five of the generic drug
manufacturers filed motions to dismiss. (Rec. Docs. 52, 61, 65, 88, 92). The generic
manufacturers essentially make two arguments. First, they ask the Court to dismiss Plaintiffs'
claims because Plaintiffs failed to allege that a specific defendant manufactured the prescription
These Defendants filed motions to dismiss, arguing that pursuant to the Louisiana
Medical Malpractice Act, Plaintiffs had to receive an opinion from a medical review panel
before commencing the present action in court. Judge Feldman granted the motions as
unopposed, but he noted that the motions appeared to have merit. Plaintiffs likely did not
challenge Defendants' motions because they agreed that the present action was premature, as the
administrative procedure had not yet completed. Plaintiffs confirmed this understanding during
drug that Mrs. Tillman ingested. According to the generic manufacturers, in order to hold a
defendant liable in a product-liability case, the plaintiff must identify the particular manufacturer
of the product that caused the injury.
Second, the generic manufacturers claim that two recent Supreme Court decisions have
made it clear that federal law preempts design-defect and failure-to-warn claims against generic
prescription-drug manufacturers. They explain that there are four theories of liability for
manufacturers of products: (1) manufacturing-defect, (2) design-defect, (3) failure-to-warn, (4)
breach-of-express-warranty. The generic manufacturers contend that the only theories that could
possibly apply in this case are design-defect and failure-to-warn. However, they argue that the
Supreme Court's recent decisions in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) and
Pharmaceutical Company, Inc. v. Bartlett, 133 S.Ct. 2466 (2013) preclude claims being brought
against generic pharmaceutical companies on either of these two theories. According to the
generic manufacturers' interpretation, the Supreme Court held in Mensing that federal law
preempts failure-to-warn claims against generic drug manufacturers because federal law does not
permit generic drug manufacturers to make any changes to the labels that are placed on the
drugs. (Rec. Doc. 52-1 at 6). The generic manufacturers argue that in Bartlett, the Supreme
Court similarly held that federal law preempts design-defect claims against generic drug
manufacturers because these manufacturers are not allowed to alter the drug's design. (Rec. Doc.
52-1 at 6).
Plaintiffs filed one opposition in response to three of the motions to dismiss.
(Rec. Doc. 79). As to the first argument, Plaintiffs claim that they have sufficiently alleged that
the generic manufacturers are the proximate cause of Mrs. Tillman's death. Plaintiffs point to
paragraph 26 of their complaint, in which they state "upon information and belief, the phenytoin
administered to Mrs. Tillman during her stay at Woldenberg and WJMC was manufactured and
sold by one or more of the defendant Manufacturers." Plaintiffs explain that once discovery
reveals which manufacturer made the drug that was ingested by Mrs. Tillman, the rest of the
defendants will be voluntarily dismissed. In response to the generic manufacturers' second
argument, Plaintiffs agree with their interpretation and application of the two recent Supreme
Court decisions, Mensing and Bartlett. However, Plaintiffs argue that these decisions are
"manifestly unfair and legally incorrect, especially as applied in this case." (Rec. Doc. 79 at 2).
The Federal Rules of Civil Procedure permit a defendant to seek a dismissal of a
complaint based on the "failure to state a claim upon which relief can be granted." Fed. R. Civ.
P. 12(b)(6). A district court must construe facts in the light most favorable to the nonmoving
party. The court must accept as true all factual allegations contained in the complaint. Ashcroft
v. Iqbal, 556 U.S. 662, 678 (2009). "To survive a motion to dismiss, a complaint must contain
sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face. A
claim has facial plausibility when the plaintiff pleads factual content that allows the court to
draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. (citing
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)). Dismissal is appropriate only if the
complaint fails to plead "enough facts to state a claim to relief that is plausible on its face." Bell
Atl. Corp. 550 U.S. at 570.
Liability of Generic Drug Manufacturers
The Louisiana Products Liability Act, the substantive law that applicable in this case,
states that "the manufacturer of a product shall be liable to a claimant for damage proximately
caused by a characteristic of the product that renders the product unreasonably dangerous...."
La. Rev. Stat. § 9:2800.54. Pursuant to this Act, there are four exclusive theories of liability.
The Act states:
A product is unreasonably dangerous if and only if: (1) The product is
unreasonably dangerous in construction or composition... (2) The product is
unreasonably dangerous in design... (3) The product is unreasonably
dangerous because an adequate warning about the product has not been
provided... (4) The product is unreasonably dangerous because it does not
form to an express warranty of the manufacturer...."
La. Rev. Stat. § 9:2800.54(B). The thrust of Plaintiffs' complaint against the generic
manufacturer is a design defect claim. In their complaint, Plaintiffs state that "[p]henytoin is a
defective drug because one in every ten persons who takes it has an adverse reaction in the form
of a rash of varying degrees of severity." (Rec. Doc. 1-1 at 3). Plaintiffs do not claim that the
particular drug that was ingested by Mrs. Tillman was manufactured improperly or that she was
not adequately warned about the side effects. Rather, they claim that the design of the drug is
defective because of these side effects. However, as the generic manufacturers point out, the
Supreme Court in Bartlett held that "state-law design-defect claims...that place a duty on
manufacturers to render a drug safer by either altering its composition or altering its labeling are
in conflict with federal laws that prohibit manufacturers from unilaterally altering drug
composition or labeling." Bartlett, 133 S.Ct. at 2478. Plaintiffs admitted to the Court in their
opposition as well as during oral argument, that this Supreme Court decision does apply in this
case. However, Plaintiffs argue that the law should be changed because of its unfair
While the Court sympathizes with the position that Plaintiffs find themselves in, it is
beyond this Court's authority to do anything but apply the established Supreme Court precedent.
For this reason, the Court finds that Plaintiffs' claims against the generic manufacturers are preempted and voided by federal law. Accordingly, the generic manufacturers' motions to dismiss
Motion for Judgment on the Pleadings Filed by Defendant Pfizer Inc.
Defendant Pfizer Inc. ("Pfizer") filed a motion for judgment on the pleadings. (Rec. Doc.
101). Pfizer argues that the Plaintiffs' complaint sets forth no valid claim under the Louisiana
Product Liability Act ("LPLA"). First, Pfizer points to the Plaintiffs' complaint which says that
Mrs. Tillman died "as a direct and proximate result of an adverse reaction to the prescription
drug, phenytoin (marketed as the generic for Dilantic)." Since Pfizer does not manufacture
phenytoin, it argues that it cannot be held liable under the LPLA. Second, Pfizer claims that
Plaintiffs do not allege sufficient factual allegations to support the elements of a claim under
LPLA. Pfizer describes the four theories of liability under the LPLA--(1) defect in construction
or composition, (2) defect in design, (3) inadequate warning, (4) failure to comply with an
express warranty. Pfizer analyzes each of these four theories in more detail, and alleges that
Plaintiffs have failed to provide sufficient factual allegations to meet any of these four theories.
Lastly, Pfizer argues that if Plaintiffs are asserting non-LPLA claims, they should be dismissed
because Louisiana law disallows all theories of recovery against a manufacturer other than those
set forth in the LPLA.
In opposition, Plaintiffs argue that their complaint includes specific allegations that are
sufficient to meet the requirements for a design defect claim under the Louisiana Products
Liability Act.2 Second, Plaintiffs argue that the Federal Rules of Civil Procedure do not require
Specifically, Plaintiffs point to four paragraphs in their complaint which state:
Phenytoin is a defective drug because one in every ten persons who
takes it has an adverse reaction in the form of a rash of varying degrees of
9. Phenytoin is also known to produce a reaction, which is the most sever
form of this rash, known as Stevens Johnson Syndrome ("SJS") and / or
that a claimant mention a specific statute in his complaint.
The Federal Rules of Civil Procedure allow a Court to enter a judgment on the pleadings.
Fed. R. Civ. P. 12(c). The Court should evaluate a motion under Rule 12(c) using the same
standard as a motion to dismiss under Rule 12(b)(6). Gentilello v. Rege, 627 F.3d 540, 544 (5th
Cir. 2010). "As with a Rule 12(b)(6) motion to dismiss, the question is whether, viewed in the
light most favorable to the plaintiffs, the complaint states a valid claim for relief." Lott v.
Edenfield, No. 12-10844, 2013 WL 5495563, at *2. "To avoid dismissal, a plaintiff must plead
sufficient facts to 'state a claim to relief that is plausible on its fact.'" Gentilello v. Rege, 627
F.3d 540 (5th Cir. 2010). "A claim has facial plausibility when the plaintiff pleads factual
content that allows the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged." Id. "We do not accept as true conclusory allegations, unwarranted factual
inference, or legal conclusions." Id. (quoting Plotkin v. IP Axess Inc., 407 F.3d 690, 696 (5th
Liability of Pfizer Inc. Under the Louisiana Product Liability Act
The Louisiana Products Liability Act ("LPLA") states that "the manufacturer of a
product shall be liable to a claimant for damage proximately caused by a characteristic of the
product that renders the product unreasonably dangerous..." La. Rev. Stat. § 9:2800.54. The Act
Toxic Epidermal Necrolysis ("TEN"), which kills approximately fifteen
percent of those afflicted by it.
10. Phenytoin is known to be most dangerous to African Americans who
are more likely to experience allergic reactions than those of other ethnic
11. There are other drugs available with fewer and less harmful side effects
than phenytoin, yet the Manufacturers continue to produce, market, and sell
phenytoin, knowing of its dangerous side effects.
defines "manufacturer" as "a person or entity who is in the business of manufacturing a product
for placement into trade or commerce. 'Manufacturing a product' means producing, making,
fabricating, constructing, designing, remanufacturing, reconditioning or refurbishing a product."
La. Rev. Stat. § 9:2800.53(1).
Plaintiffs allege that "Mrs. Tillman died as a direct and proximate result of her adverse
reaction to phenytoin." (Rec. Doc. 1-1 at 6). In their briefings to the Court, Plaintiffs explain
that "in light of the fact that virtually every private medical insurer as well as government
sponsored insurance pays only for generics where available, it is a safe assumption that the drug
that Mrs. Tillman received was one of the generics." (Rec. Doc. 79 at 2). Counsel for Plaintiffs
repeated this statement during oral argument as well.
In light of Plaintiffs' admission, Plaintiffs fail to plead sufficient facts to state a claim to
relief against Pfizer Inc. under the LPLA. In order to state a claim for relief under the LPLA, a
plaintiff must establish that the defendant is the manufacturer of the product. See Ayo v. Triplex,
Inc., 457 Fed.Appx. 382, 385 (2012) (quoting Jack v. Alberto-Culver USA, Inc., 2006-1883, p. 4
(La. 2/22/07)). Pfizer Inc. did not manufacture or market the generic form the drug, phenytoin.
Therefore, Pfizer Inc. cannot be held liable under the LPLA for the damage that was caused by
the generic version of the drug.
Liability of Pfizer Inc.Under Non-LPLA Claim
The Court does not find that Plaintiffs have stated a claim for relief under any non-LPLA
theories of liability. As stated previously, the thrust of Plaintiffs' complaint against the drug
manufacturers is a design-defect claim. This is apparent from the complaint which discusses the
well-known side effects of phenytoin. This is also apparent from Plaintiffs' opposition to the
present motion. Plaintiffs' sole argument against a judgment on the pleadings is that they have
put forth sufficient facts to state a design defect claim under the LPLA. (Rec. Doc. 111 at 2).
Furthermore, at oral argument, counsel for Plaintiffs conceded that they are not pursuing any
non-LPLA claims. For this reason, the Court finds that there are no viable non-LPLA claims in
Motion to Dismiss Filed by West Jefferson
On October 8, 2013, Defendant West Jefferson filed a motion to dismiss for lack of
subject matter jurisdiction. (Rec. Doc 72). West Jefferson claims that the Louisiana Medical
Malpractice Act, La. R.S. 40:1299.41, provides a set of administrative procedures that must be
completed in a medical malpractice case before the commencement of a court action. West
Jefferson argues that this court does not have subject mater jurisdiction over the claim until the
administrative procedures are completed. Here, the claim has been submitted to a malpractice
review panel, but the procedures have not yet been completed. Therefore, West Jefferson asks
the Court to dismiss the claims against it.
This motion is currently unopposed by Plaintiffs. Furthermore, during oral argument,
Plaintiffs admitted to the Court that the administrative procedure has not been completed.
Therefore, West Jefferson's unopposed motion to dismiss is granted.
For the foregoing reasons, IT IS ORDERED that the generic manufacturers' motions to
dismiss (Rec. Docs. 52, 61, 65, 88, 92) are GRANTED.
IT IS FURTHER ORDERED that Defendant Pfizer Inc.'s motion for judgment on the
pleadings (Rec. Doc. 101) is GRANTED.
IT IS FURTHER ORDERED that the motion to dismiss for lack of jurisdiction filed by
Defendant Jefferson Parish Hospital Service District No. 1, doing business as West Jefferson
Medical Center, (Rec. Doc. 72) is GRANTED.
New Orleans, Louisiana, this 27th day of November, 2013.
UNITED STATES DISTRICT JUDGE
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