Raskas v. Teva Pharmaceuticals USA, Inc. et al
MEMORANDUM AND ORDER : IT IS HEREBY ORDERED that the motion to dismiss of Teva Pharmaceuticals USA, Inc. [ECF No. 7 ] and the motion to dismiss of Actavis Elizabeth LLC [ECF No. 13 ] are GRANTED in part and DENIED in part as set forth above. IT IS FURTHER ORDERED that Plaintiff is GRANTED twenty days of the date of this Order in which to file a First Amended Complaint within the strictures described above. IT IS FINALLY ORDERED that Plaintiff shall show cause within twenty days of the date of this Order why his claims against the John Doe Defendants should not be dismissed without prejudice for failure to obtain timely service. See Fed.R.Civ. 4(m). Signed by District Judge Ronnie L. White on 01/08/2018. (KCB)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
JONA THAN RASKAS, personally and as
administrator of the ESTATE OF RALPH
TEVA PHARMACEUTICALS USA, INC.;
ACTAVIS ELIZABETH, LLC; and
JOHN DOE DEFENDANTS,
Case No. 4:17-CV-2261 RLW
MEMORANDUM AND ORDER
Teva Pharmaceuticals, USA, Inc. (Teva) and Actavis Elizabeth, LLC (Actavis) move this
Court to dismiss the claims against them pursuant to Rule 12(b)(6) of the Federal Rules of Civil
Procedure. [ECF Nos. 8, 13]
Accepting as true the allegations in the complaint, see Tension Envelope Corp. v JBM
Envelope Corp., 876 F.3d 1112, 1116 (8th Cir. 2017), the following led to the untimely death of
Ralph Raskas (Raskas).
When 19 years of age, Raskas sought emergency room treatment in a Missouri hospital
for nausea and vomiting.
injection of metoclopramide. (Id.
ECF No. 5.)
He was treated with an intravenous
This metoclopramide was manufactured by Teva. (Id.)
On discharge, he was prescribed ten milligram dosages of metoclopramide to be taken four times
a day. (Id.
A five-day supply of the prescription was dispensed by a pharmacy the same
day. (Id.) This metoclopramide was manufactured by Actavis. (Id.
Raskas took the
metoclopramide and subsequently developed a movement disorder.
(Id. ifif 15-17, 19.) The
disorder caused Raskas pain and restlessness in his legs and led to him having to take a medical
leave from a six-year medical school program. (Id. ififl l, 18.)
Raskas pursued treatment at a Movement Disorders Center and with a neuropsychiatrist
specializing in movement disorders.
(Id. if20-2 l.)
The specialist diagnosed him as having
'"drug-induced acute akathisia." (Id. if21.) Because of the pain and akathisia, Raskas attempted
suicide three times; tragically, he succeeded on the third attempt. (Id. if23-25.)
Jonathan Raskas (Plaintiff), his father and the administrator of his estate, alleges that
metoclopramide caused Raskas' neurological injuries and suicide. (Id.
iii! 25-38, 50.)
Plaintiff further alleges that Teva and Actavis, as manufacturers of the generic form of
metoclopramide, breached their duty to report any adverse effects of the drug to the Food and
Drug Administration (FDA) and to propose to the FDA a stronger warning label. (Id. if53-54.)
Plaintiff seeks relief from Teva and Actavis for the death of Raskas under claims of strict
liability for the defective design of metoclopramide (Count I); strict liability for the failure to
warn of the serious health risks resulting from taking metoclopramide (Count 11); negligent
design of metoclopramide (Count III); negligent failure to warn of the serious health risks (Count
IV); a negligent quality system that did not identify the serious health risks (Count V); a
negligent failure to modify the warning labels for metoclopramide, including to incorporate in
those labels the adverse findings of the European Union (Count VI 1); and, pursuant to
Plaintiff mistakenly labels this count as "Count VII."
Mo.Rev.Stat. §§ 537.080, 537.090, the wrongful death of Raskas (Count VII 2). Plaintiff also
brings a claim for loss of consortium (Count VII).
Citing PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharm. Co. v. Bartlett,
133 S.Ct. 2466 (2013), Teva and Actavis seek the dismissal of all claims against them as being
preempted by federal law. Plaintiff argues preemption does not apply.
Rule 12(b)(6) Standard. "To survive a 12(b)(6) 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.'" McShane Constr. Co. v. Gotham Ins. Co., 867 F.3d 923, 927 (8th Cir. 2017) (quoting
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). "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. (quoting Iqbal, 556 U.S. at 678).
whether a complaint states a plausible claim for relief ... [is] a context-specific task that requires
[this] [C]ourt to draw on its judicial experience and common sense."' Id. (quoting Iqbal, 556
U.S. at 678-79) (second and third alterations in original).
Counts I and III: Design. In Count I, Plaintiff alleges Teva and Actavis are strictly liable
for defects in the design of metoclopramide; in Count III, he alleges they were negligent in
designing the drug.
The metoclopramide taken by Raskas was manufactured by Teva or Actavis.
Metoclopramide is a generic form of Reglan. PLIVA, 564 U.S. at 609. Plaintiff alleges the
This count follows Count VI, but is labeled "Count VI." For ease of reference, the Court will
refer to the mislabeled counts by the order in which they appear in the Complaint, e.g., "Count
VII" will be referred to as Count VI and "Count VI" will be referred to as Count VII.
Plaintiff often refers to "Reglan/metoclopramide" in his complaint; however, he specifically
identifies Teva and Actavis as manufacturers of the metoclopramide he was given in May 2015.
metoclopramide "was defective in design and/or formulation." (Compl. if64.) "Missouri ...
imposes design defect liability if the plaintiff establishes 'the product, as designed, is
unreasonably dangerous and therefore "defective," and that the demonstrated defect caused [the
plaintiff's] injuries."' Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1140 (8th Cir. 2014) (quoting
Nesselrode v. Exec. Beechcraft, Inc., 707 S.W.2d 371, 375-76 (Mo. 1986) (en bane)). Teva and
Actavis argue that Plaintiff's design defect claims are preempted by federal law.
"Where state and federal law directly conflict, state law must give way." Mensing, 564
U.S. at 617. "[S]tate and federal law conflict where it is impossible for a private party to comply
with both state and federal requirements." Id. at 618.
"The question for 'impossibility' is
whether the private party could independently do under federal law what state law requires of it."
Id. at 620.
The difference in the procedures of the Food and Drug Administration (FDA) for
approving brand-name drugs and generic drugs informs the Court's consideration of the
A brand-name drug is approved only after a new-drug application is
submitted. Bartlett, 133 S.Ct. at 2470. This application "is a compilation of materials that must
include 'full reports of [all clinical] investigations,' [21 U.S.C.] § 355(b)(l)(A), relevant
nonclinical studies, and 'any other data or information relevant to an evaluation of the safety and
effectiveness of the drug product obtained or otherwise received by the applicant from any
source."' Id. at 2470-71(quoting21 C.F.R. §§ 314.50(d)(2) and (5)(iv)(2012)). The application
"must also include 'the labeling proposed to be used for such drug."' Id. at 2471 (quoting 21
U.S.C. § 355(b)(l)(F) and 21 C.F.R. § 314.50(c)(2)(i)). "The FDA may approve [a new-drug
application] only if it determines that the drug in question is 'safe for use' under 'the conditions
For purposes of the instant motion, therefore, the Court addresses only the issue of
metoclopramide and not the brand-name form, Reglan.
of use prescribed, recommended, or suggested in the proposed labeling thereof.'" Id. (quoting 21
U.S.C. § 355(d)).
On the other hand, "a generic drug may be approved with the same level of clinical
testing required for approval of a new brand-name drug, provided the generic drug is identical to
the already-approved brand-name drug in several key respects." Id. "First, the proposed generic
drug must be chemically equivalent to the approved brand-name drug: it must have the same
'active ingredient' or 'active ingredients,' 'route of administration,' 'dosage form,' and 'strength'
as its brand-name counterpart."
Id. (quoting 21 U.S.C. §§ 355G)(2)(A)(iv)).
proposed generic must be 'bioequivalent' to an approved brand-name drug." Id. (quoting 21
U.S.C. § 355G)(2)(A)(iv)). Third, the labeling proposed for the generic drug must be "the same
as the labeling approved for the [approved brand-name] drug."'
§ 355(J)(2)(A)(v)) (alteration in original).
Id. (quoting 21 U.S.C.
"Generic manufacturers are ... prohibited from
making any unilateral changes to a drug's label." Id. (citing 21 C.F.R. §§ 314.94(a)(8)(iii),
And, "[ o]nee a drug - whether generic or brand-name - is approved, the manufacturer is
prohibited from making any major changes to the 'qualitative or quantitative formulation of the
drug product, including active ingredients, or in the specifications provided in the approved
application."' Id. (quoting 21 C.F.R. § 314.70(b)(2)(i)).
In Fullington v. Pfizer, Inc., 720 F.3d 739 (8 1h Cir. 2013), the court held that a "logical
corollary" of the preemption by federal regulations of suits seeking to impose tort liability on a
generic manufacturer's labeling decisions was "that certain design defect claims are preempted
Id. at 742.
This is so because a generic drug manufacturer is prohibited from
unilaterally redesigning the drug. Id. (citing Bartlett, 133 S.Ct. at 2474-76). In Brinkley, 772
F .3d at 1140-41, the court held that a plaintiffs claims of design defect of metoclopramide were
preempted when the only way the manufacturer could "avoid liability under Missouri law" was
by redesigning the product. In so holding, the court specifically rejected an argument similar to
that of Plaintiffs: that there is no preemption because the imposition of design defect liability in
Missouri is based on '"the concept of unreasonable danger'" and is an ultimate issue to be
decided by the jury. Id. (quoting Nesselrode, 707 S.W.2d at 375-76. "[Plaintiff] places too
much weight on Missouri's approach to determining unreasonable danger."
Id. at 1140.
Moreover, the Court notes that the claim of a defectively-designed generic drug found by the
Supreme Court in Bartlett, 133 S.Ct. at 2473, to be preempted was based on a state's adoption of
Section 402A of the Restatement (Second) of Torts. Plaintiff bases his claim on Missouri's
adoption of Section 402A.
Plaintiff seeks to distinguish his design defect claims from those presented in Bartlett and
Brinkley by arguing that Teva and Actavis are liable for their design defect and negligent design
because they could have "stopped selling metoclopramide to otherwise healthy young people4
suffering from nausea and vomiting." (Pl.'s Resp. at 17, ECF No. 20 (footnote added)). This
effort is unavailing. Neither Teva nor Actavis is required to stop selling metoclopramide in order
to avoid liability under Missouri law for design defect. See Brinkley, 772 F .3d at 1141 (holding
that, under the impossibility preemption doctrine, a manufacturer of a generic drug was not
obligated to leave the market to avoid liability under Missouri law for an alleged design defect);
Bartlett, 133 S.Ct. at 2477 (rejecting '"stop-selling' rationale as incompatible with [the Supreme
Raskas was not within the pediatric age group when taking metoclopramide. See 21 C.F.R. §
201.57(c)(9)(iv)(A) (defining, for purposes of prescription drug labels, the pediatric age group as
being from birth to sixteen (16) years).
Court's] pre-emption jurisprudence"). Insofar as Plaintiffs argument is that the warnings for
metoclopramide should include an-age related caution, his position is addressed below.
Citing Strickland v. Taco Bell Corp., 849 S.W.2d 127 (Mo.Ct.App. 1993), Plaintiff
further argues that Teva may be held liable for a negligent design because it made promises on
its website to exceed regulatory requirements for pharmaceutical drugs.
The question in
Strickland was whether a manager of defendant was entitled to summary judgment on claims he
negligently rendered services to the plaintiffs' semi-conscious father by moving him to a bench,
slumping him over a table, and leaving him there. Id. at 133. The father fell and later died from
his resulting injuries.
The court held that the plaintiffs had stated a claim against the
manager for negligently performing a duty he had gratuitously undertook toward the father. Id.
Assuming, without deciding, that Teva made such promises, its undertaking does not affect the
pre-emption analysis because the only actions he could take to avoid liability under Plaintiffs
theory of a negligent-undertaking-of-an-act are those preempted by impossibility, le.,,
"changing its product, changing its labeling, or leaving the market." Brinkley, 772 F.3d at 1141.
Counts II and IV: Warnings. In these two counts, Plaintiff alleges that Teva and Actavis
are liable for (a) a warning which was insufficient to alert consumers of the health risks
associated with metoclopramide and (b) breaching a duty to the FDA to communicate those risks
and to propose stronger warning labels.
As discussed above, the warning labels on the metoclopramide manufactured by Teva
and Actavis have to be the same as the warning labels on the brand-name form, Reglan. See
Mensing, 564 U.S. at 613.
In Mensing, the Supreme Court "defer[red]" to the FDA's
interpretation of its regulations "allow[ing] changes to generic drug labels only when a generic
drug manufacturer changes its label to match an updated brand-name label or to follow the
FDA's instructions." 5 Id. at 614. "As [Mensing] made clear, federal law prevents generic drug
manufacturers from changing their labels." Bartlett, 133 S.Ct. at 2476. "When federal law
forbids an action that state law requires, the state law is without effect." Id. at 2476-77 (internal
quotations omitted). Thus, Missouri failure to warn claims based on inadequate content "are
squarely preempted by federal law." Brinkley, 772 F.3d at 1139.
Plaintiff argues that Mensing does not control because it is a labeling, not warning, case.
(Pl.' s Resp. at 13.) In the context of impossibility preemption, this is a distinction without a
Labels of prescription drugs are to include warnings about their proper use. See e.g., 21
U.S.C. § 352(f)(2)(classifying a drug as misbranded unless the label includes, inter alia,
"adequate warnings against use in those pathological conditions or by children where its use may
be dangerous to health ... "); 21 C.F.R. § 201.56(e) (requiring specific information be included
in prescription drug labels for older drug products, 6 including indications and usage,
contraindications, warnings, adverse reactions, and dosage and administration).
Strayhourn v. Wyeth Pharms., 737 F.3d 378, 394 (6 1h Cir. 2013) (noting that FDA regulations
consider advertising and promotional materials as labeling).
Plaintiff alleges in his complaint that because the FDA has the power under the Food and
Drug Administration Amendments Act of 2007, Pub.L. No. 110-85, 121 Stat. 823 (FDAAA), to
change the label of Reglan, the reference label drug (RLD) of metoclopramide, without the
involvement of the drug company, Teva and Actavis had a duty - which they breached - to
inform the FDA of the risks associated with metoclopramide and to propose appropriate
Plaintiff s allegations in his Response of a failure to conform or failure to update are addressed
Reglan was approved by the FDA in 1980. Mensing, 564 U.S. at 609.
revisions to the label. In Mensing, 564 U.S. at 646 n.1, the Supreme Court declined to express a
view on the impact of the FDAAA on the question before it because the events at issue took
place prior to 2007. An argument that the FDAAA rendered Mensing and Bartlett outdated was
rejected, however, in Wagner v. Teva Pharms. USA, Inc., 840 F.3d 355 (ih Cir. 2016). The
court held that, although "[t]he FDAAA imposed certain obligations on generic drug
manufacturers when they propose labeling changes," it "did not remove the prohibition against
doing so unilaterally." Id. at 359. "[T]he amendments still forbid a generic-drug maker from
violating the duty of sameness without FDA permission." Id. (internal quotations omitted). See
also Whitener v. PLIVA, Inc., 2011 WL 6056546, *3(E.D. La. Dec. 6, 2011) (rejecting the same
argument and holding that, because the FDAAA did not change a generic drug manufacturer's
ability to alter the FDA-approved brand-name label for a drug, "the Mensing conflict preemption
analysis [did] not change because compliance with both state and federal requirements
remain[ed] impossible"). This conclusion is supported by the pre-FDAAA holding in Mensing
that preemption foreclosed the plaintiff's claims of inadequate warning even if, as the FDA
argued, the generic drug manufacturer had a duty to propose stronger warning labels if the
manufacturer believed such were needed. 564 U.S. at 616.
In support of his position to the contrary, Plaintiff cites Wyeth v. Levine, 555 U.S. 555
In Wyeth, the Supreme Court rejected the drug manufacturer's argument that the
plaintiff's state law claims of injuries caused by that manufacturer's failure to warn against
certain types of drug administration were preempted by the impossibility doctrine. Id. at 568.
The Court noted "an FDA regulation ... permits a manufacturer to make certain changes to its
label before receiving the agency's approval."
Those changes include adding or
strengthening warnings or instructions about dosage and administration "to increase the safe use
of the product." Id. Wyeth could have unilaterally revised the label of the drug at issue and
could have also discharged its state-law duty to provide a stronger warning about the risks of the
type of drug administration at issue. Id. at 569.
Plaintiffs reliance on Wyeth is unavailing. As discussed above, manufacturers of generic
drugs have a duty of sameness that brand-name drug manufacturers do not. See Mensing, 564
U.S. at 613.
See also Bartlett, 133 S.Ct. at 2470 ("[F]ederal law prohibits generic drug
manufacturers from independently changing their drugs' labels.").
The Supreme Court
acknowledged in Mensing that the distinction between generic and brand-name drugs made
"little sense" to the plaintiffs who would have had recourse for their severe injuries had they
taken Reglan rather than metocloprarnide, but concluded that it was not its task "to decide
whether the statutory scheme established by Congress is unusual or even bizarre." 564 U.S. at
625. Similarly, in Bartlett, 133 S.Ct. at 2480, the Court held that, although the plaintiffs tragic
situation "evoke[d] deep sympathy," "a straightforward application of pre-emption law" barred
her state-law tort claims against a generic drug manufacturer for the devastating, life-long
injuries she suffered. 7
Counts V and VII: Negligence and Wrongful Death. The allegations in these counts
echo those of the earlier counts 8 and are similarly unavailing. See Brinkley, 772 F.3d at 1141
(affirming dismissal of amended complaint against generic drug manufacturer; various state-law
In his response to the motion to dismiss, Plaintiff argues that this case is also about preventing
the death of another 19-year individual. (Pl.' s Resp. at 1.) In Bartlett, the Supreme Court held it
was not free to ignore pre-emption law in the case of a woman who was severely disfigured,
developed numerous physical disabilities, and became nearly blind because of the method of
administration of a generic drug. Similarly, the tragic circumstances of Raskas' injuries and
suicide do not excuse this Court from following Supreme Court pre-emption law.
In his response to the motion to dismiss, Plaintiff states that this claim is based on his
allegations of a failure to warn that metoclopramide, injected once or taken orally, could lead to
serious health risks. (Resp. at 16.)
causes of action, including negligence and breach of warranties, were foreclosed by Mensing and
Bartlett because only actions manufacturer could take were preempted by impossibility).
Count VI: Negligence/Violation of FDA Requirements. Plaintiff alleges in this count
that Teva and Actavis failed in their duty to modify the metoclopramide labels to incorporate
certain warnings. (Compl.
These allegations are addressed above.
Plaintiff further alleges that Teva and Actavis had a duty to incorporate in their warnings
the findings of the European Medicines Agency's Committee on Medicinal Products for Human
Use. (See Compl. ~ 43-49.) This argument fails for the reasons discussed above.
Plaintiff also alleges that Teva and Actavis failed to update their labels "as allowed by the
FDA" and that this failure caused injury to Raskas. (Compl.
In his response to the
motion to dismiss, Plaintiff argues that Teva and Actavis failed in their duty to update their label
to conform to the FDA-approved label for Reglan and that he has sufficiently alleged that Teva's
and Actavis' labels were not properly updated to entitle him to discovery of the labels in effect
before May 9, 2015. (See Resp. at 13, 14.) Teva and Actavis counter that the failure-to-update
claims have not been sufficiently pled and are, regardless, futile.
"'The court should freely give leave [to amend a complaint] when justice so requires."'
Kozlov v. Associated Wholesale Grocers, Inc., 818 F.3d 380, 394 (8th Cir. 2016) (quoting
Fed.R.Civ.P. 15(a)) (alteration in original). "A motion to amend should be denied if the plaintiff
is 'guilty of undue delay, bad faith, dilatory motive, or if permission to amend would unduly
prejudice the opposing party."' Id. (quoting Williams v. Little Rock Mun. Water Works, 21 F.3d
218, 224 (8th Cir. 1994)). This case was filed in state court in June 2017; was served in July; and
was removed to this court on August 16. Six days later, Teva moved to dismiss; fourteen days
after removal, Actavis moved to dismiss. The briefing cycle on the two motions was completed
on October 30. There has been no undue delay, and no showing of bad faith or a dilatory motive.
Nor do Teva and Actavis argue that they would be unduly prejudiced by leave to amend
being granted Plaintiff. Rather, they argue that any amendment would be futile. "Denial of a
motion for leave to amend on the basis of futility means the district court has reached the legal
conclusion that the amended complaint could not withstand a motion to dismiss under Rule
12(b)(6)[.]" Zutz v. Nelson, 601 F.3d 842, 850 (8th Cir. 2010) (internal quotations omitted). This
court has not reached that conclusion.
In Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584, 588 (6th Cir. 2013), the court held that the
plaintiffs state-law claims against a manufacturer of metoclopramide were not preempted only
insofar as she argued that the manufacturer's warnings did not include the language of the
Reglan label in distribution at the same time and only to the extent that the failure proximately
caused her injuries. The Fulgenzi holding was noted in Brinkley, as was the opposite conclusion
by the Fifth Circuit in Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (per curiam). 772
F.3d at 1137. The Eighth Circuit then proceeded to address the merits of a failure-to-update
claim, finding that the allegations in the complaint severed any causal relationship between her
injuries and that claim. Id.
In the instant case, there are insufficient allegations from which to determine whether
Plaintiff can establish a failure-to-update claim against Teva and Actavis. Plaintiff has asked for
leave to amend his complaint. Leave shall be granted only as to his failure-to-update and failureto-conform claims. Cf United States ex rel. Amrosecchia v. Paddock Labs.,LLC, 855 F.3d 949,
956 (8th Cir. 201 7) (district court did not abuse its discretion when denying plaintiff leave to file
second amended complaint; leave was sought in a one-line request in brief opposing motion to
dismiss and did not include substance of proposed amendments). He makes reference in his
concluding paragraph to being allowed to amend his claims of a negligent undertaking of an act
and to adding a claim under the Missouri Merchandising Practices Act (MMPA), Mo.Rev.Stat.
§ 407.010 et seq., based on Teva's representations on its website. Leave to amend is not granted
as to these claims for the reasons discussed above.
Brinkley, 772 F.3d at 1138 (affirming
dismissal of MMP A claim arising from use of metoclopramide).
It is beyond dispute that the suffering of Ralph Raskas is tragic.
The law, however,
forecloses all claims in Plaintiffs complaint with the exception of those alleging a failure-toupdate or a failure-to-conform the labels, including the warnings, of Teva's and Actavis'
metoclopramide to match those of Reglan. Plaintiff is granted leave to amend his complaint to
include only those allegations and any related loss of consortium claim. His remaining claims
against Teva and Actavis are dismissed.
Accordingly, for the foregoing reasons,
IT IS HEREBY ORDERED that the motion to dismiss of Teva Pharmaceuticals USA,
Inc. [ECF No. 7] and the motion to dismiss of Actavis Elizabeth LLC [ECF No. 13] are
GRANTED in part and DENIED in part as set forth above.
IT IS FURTHER ORDERED that Plaintiff is GRANTED twenty days of the date of
this Order in which to file a First Amended Complaint within the strictures described above.
IT IS FINALLY ORDERED that Plaintiff shall show cause within twenty days of the
date of this Order why his claims against the John Doe Defendants should not be dismissed
without prejudice for failure to obtain timely service. See Fed.R.Civ. 4(m).
Dated this z!!-day of January, 2018.
RONNIE L. WHITE
UNITED STATES DISTRICT JUDGE
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