Fulgenzi v. Pliva, Inc., et al.
Memorandum Opinion: Defendant PLIVA's motion to dismiss is granted. (Related Doc. # 61 ). Judge Sara Lioi on 3/31/2012. (P,J)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF OHIO
PLIVA, INC., et al.,
JUDGE SARA LIOI
OPINION AND ORDER
Before the Court is the motion of Defendant PLIVA, Inc. (PLIVA) to
dismiss all claims on the ground of federal preemption. (Doc. No. 61.) Plaintiff Eleanor
Fulgenzi (Plaintiff or Fulgenzi) opposes the motion (Doc. No. 63), and PLIVA has filed a
reply (Doc. No. 64). PILVA has also filed a Notice of Supplemental Authority. (Doc. No.
66.) At the parties’ request, the Court stayed the matter pending a ruling from the United
States Supreme Court in two consolidated cases. It was anticipated that a ruling in these
cases would resolve the question of whether regulations promulgated by the Federal Drug
Administration (FDA) relating to the labeling of generic medication preempt state laws
that may require generic drug manufacturers to provide more stringent safety warning
labels on their products.
On June 23, 2011, the Supreme Court issued its decision in PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567 (2011), wherein the Court held that state-law causes of action
alleging that generic manufacturers of prescription medication failed to provide adequate
warnings on their labels relating to possible risks and side effects of the mediation are
preempted by federal law. Id. at 2572-73. Following the ruling, PLIVA filed the present
motion to dismiss. Because the Supreme Court’s ruling in Mensing forecloses the statelaw claims raised in the Second Amended Complaint, PLIVA’s motion to dismiss is
granted and this case is dismissed.
Pursuant to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301
et. seq., the FDA is charged with the responsibility of approving new drugs. See 21
U.S.C. § 355(a); Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008); Merck KGaA v.
Integra Lifesciences I, Ltd., 545 U.S. 193, 196 (2005). A manufacturer seeking to market
a new drug must file a New Drug Application (NDA) with the FDA. 21 U.S.C. § 355(b).
As part of its application, the manufacturer must demonstrate through pre-market trials
and other relevant evidence that the drug is safe, and that the proposed labeling properly
sets forth the correct dosage and possible risks. The NDA requires, among other things,
that the manufacturer supply the agency with “full reports of investigations which have
been made to show whether or not such drug is safe for use and whether such drug is
effective in use” and “specimens of the labeling proposed to be used for such drug.” §
In contrast, drug manufacturers seeking to market a generic drug must file
an Abbreviated New Drug Application (ANDA). The ANDA procedure, codified as
amended in the Hatch-Waxman Act, 21 U.S.C. § 355, sets forth an expedited review
process. To obtain approval, the manufacturer must demonstrate that the generic drug it
seeks to market is approved as a listed drug, meaning that the new drug is the functional
equivalent of a name-brand drug already approved by the FDA. 21 U.S.C. § 355(j)(2).
“One of the benefits to manufacturers who opt for the ANDA procedure is that they are
required only to conduct ‘bioequivalency’ studies that establish that the generic and the
reference-listed drug are pharmaceutically equivalent . . ..” Stacel v. Teva Pharms., USA,
620 F. Supp. 2d 899, 905 (N.D. Ill. 2009). So long as the manufacturer can demonstrate
that the generic drug is the pharmaceutical equivalent of its name-brand counterpart, the
generic manufacturer need not duplicate the pre-market trials conducted by the namebrand manufacturer. This advantage serves the purpose of the Hatch-Waxman Act to
increase the availability of low cost generic drugs. See id. at 907.
Federal regulations further require that “[a generic drug’s] [l]abeling
(including the container label, package insert, and, if applicable, Medication Guide)
proposed for the drug product must be the same as the labeling approved for the reference
listed drug, except for changes required because of differences approved under a petition
filed under [21 C.F.R.] § 314.93 or because the drug product and the reference listed drug
are produced or distributed by different manufacturers.” 21 C.F.R. § 314.94(a)(8)(iv).
The FDA can reject an ANDA application if the information submitted by the generic
manufacturer is “insufficient to show that the labeling proposed for the drug is the same
as the labeling approved for the listed drug . . ..” 21 C.F.R. § 314.127(a)(7).
According to the Second Amended Complaint, metoclopramide is a
medication prescribed to treat symptomatic gastroesogphageal reflux and acute and
recurrent diabetic gastric stasis. (Second Amended Complaint (SAC) at ¶ 19, Doc. No.
60.) The FDA first approved metoclopramide, under the name-brand Reglan, in 1980.
The drug has been available in its generic form since 1985. Mensing, 131 S. Ct. at 2572.
Emerging studies have shown that extended use of metoclopramide can lead to a
condition known as tardive dyskinesia, a severe neurological disorder, which presents
symptoms that include involuntary and uncontrollable movements of the head, neck, and
face, as well as grotesque facial grimacing and tongue thrusting. Patients who take
metoclopramide for extended periods of time are 29 percent more likely to contract this
incurable neurological disorder. Id. at 2572 (internal citations omitted).
In light of this risk, warning labels for the drug have been strengthened
several times. In 2004, the FDA approved a label adding the warning that “[t]herapy
should not exceed 12 weeks in duration.” Mensing, 131 S. Ct. at 2572-73 (quoting
Physician’s Desk Reference 1635-36 (41st ed. 1987)). In 2009, the warning on the label
was strengthened further by the addition of a black box warning--the strongest available
under the FDA regulatory scheme—stating that “Treatment with metoclopramide can
cause tardive dyskinesia, a serious movement disorder that is often irreversible . . ..
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but
rare cases.” Id. at 2573 (quoting Physician’s Desk Reference 2902 (65th ed. 2011)).
After taking metoclopramide for an extended period of time, Fulgenzi
alleges that she developed tardive dyskinesia. (SAC at ¶ 17.) Fulgenzi initially brought
the action against certain manufacturers of the generic metoclopramide and the namebrand Reglan. At the core of all of Fulgenzi’s claims is the basic assertion that the drug
manufacturers should have provided warnings alerting doctors and patients to the
heightened risk of developing neurological complications from long-term use of
metoclopramide. Because it is undisputed that Fulgenzi had been treated exclusively with
the generic version of metoclopramide, Fulgenzi dismissed with prejudice the
manufacturers of the name-brand drug. (See Stipulation and Order, Doc. No. 27.) One of
the remaining defendants, PLIVA, a manufacturer of generic metoclopramide, now seeks
dismissal of all claims under Rule 12(b)(6) of the Federal Rules of Civil Procedure.
II. STANDARD OF REVIEW
A complaint must contain “a short and plain statement of the claim
showing that the pleader is entitled to relief[,]” Fed. R. Civ. P. 8(a)(2), in order to “give
the defendant fair notice of what the plaintiff’s claim is and the grounds upon which it
rests.” Conley v. Gibson, 355 U.S. 44, 47 (1957). Although this pleading standard does
not require great detail, the factual allegations in the complaint “must be enough to raise a
right to relief above the speculative level . . ..” Bell Atlantic Corp. v. Twombly, 550 U.S.
544, 555 (2007) (citing authorities). In other words, “Rule 8(a)(2) still requires a
‘showing,’ rather than a blanket assertion, of entitlement to relief.” Id. at 556, n.3
(criticizing the Twombly dissent’s assertion that the pleading standard of Rule 8 “does not
require, or even invite, the pleading of facts”).
“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.’”
Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (quoting Twombly, 550 U.S. at 570). Rule
8 does not “unlock the doors of discovery for a plaintiff armed with nothing more than
conclusions.” Id. at 1950. “While legal conclusions can provide the framework of a
complaint, they must be supported by factual allegations. When there are well-pleaded
factual allegations, a court should assume their veracity and then determine whether they
plausibly give rise to an entitlement to relief.” Id.
State law that conflicts with federal law is preempted under the
Supremacy Clause of the United States Constitution. The Supremacy Clause provides
that the Constitution, federal law, and all treaties “shall be the supreme law of the Land;
and the Judges in every State shall be bound thereby, any Thing in the Constitution or
Laws of any State to the Contrary notwithstanding.” U.S. CONST. art. VI, cl. 2; see
Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000). “Consideration of
issues arising under the Supremacy Clause ‘start[s] with the assumption that the historic
police powers of the States [are] not to be superseded by . . . Federal Act unless that [is]
the clear and manifest purpose of Congress.’” Cipollone v. Liggett Group, Inc., 505 U.S.
504, 516 (1992) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)).
Accordingly, congressional intent to preempt state law is the “ultimate touchstone” of the
pre-emption analysis. Id. (internal citation omitted).
Federal law may preempt state law either expressly or impliedly. Fidelity
Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 152-53 (1982). One form of
implied preemption is conflict preemption, which occurs “where compliance with both
federal and state regulations is a physical impossibility, or where state law stands as an
obstacle to the accomplishment of the full purposes and objectives of Congress.” Grade
v. Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 98 (1992) (internal citation and quotation
omitted); see Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (federal and state
law conflicts when it is “impossible for a private party to comply with both state and
federal requirements”) (internal citation and quotation omitted).
In Mensing, the Supreme Court addressed two cases involving plaintiffs
who had ingested the generic form of metoclopramide for long periods of time and
developed tardive dysknesia. See Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010);
Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009). Both plaintiffs alleged that the drug
manufacturers responsible for producing the metoclopramide they consumed violated
state tort law by failing to adequately warn patients and doctors of the risks associated
with long-term use of the medication. The drug manufacturers argued that they could not
simultaneously comply with FDA regulations requiring them to use the same safety and
efficacy labeling as the name-brand Reglan and any state-law tort duty that may require
more stringent warnings. The Court agreed with the manufacturers, finding that “[i]f the
[generic] Manufacturers had independently changed their labels to satisfy their state-law
duty, they would have violated federal law.” Mensing, 131 S. Ct. at 2578. Ultimately, the
Court concluded that it was “impossible for the [generic] Manufacturers to comply with
both their state-law duty to change the label and their federal law duty to keep the label
the same.” Id.
In finding compliance with state law impossible, the Supreme Court
rejected the plaintiffs’ argument that the generic drug manufacturers could have (and
should have) requested that the FDA consider including more stringent warnings in the
labeling. While the manufacturers of name-brand drugs may unilaterally update and
strengthen their warning without FDA approval, see 21 C.F.R. 314.70(c)(6)(iii), the
generic drug manufacturers were tied to the name-brand labeling and required the FDA’s
approval to change the labeling. Because there was no guarantee that the FDA would act
on such a request, the Court noted that relying on the possibility that the actions of a third
party would permit the generic drug manufacturers to comply with both state and federal
law would “render conflict pre-emption largely meaningless because it would make most
conflicts between state and federal law illusory.” Id. at 2579. Such a conclusion meant
that the availability of state-law remedies turned on whether the pharmacist filled the
prescription with the name-brand or the generic drug:
Had [the plaintiffs] taken Reglan, the brand-name drug prescribed by their
doctors, Wyeth [v. Levine, 555 U.S. 555 (2009)]1 would control and their
lawsuits would not be pre-empted. But because pharmacists, acting in full
accord with state law, substituted generic metoclopramide instead, federal
law pre-empts these lawsuits.
Id. at 2581. While acknowledging “the unfortunate hand that federal drug regulation has
dealt [the plaintiffs], and others similarly situated[,]” it found that the plaintiffs were left
without a state-law remedy because generic drug manufacturers were obligated to ensure
that their labeling matched that of the name-brand drug. Id.
Following the decision in Mensing, courts have consistently concluded
that state-law failure-to-warn claims were preempted in cases, such as the present one,
In Levine, the Supreme Court ruled that FDA regulations relating to the warning labels on name-brand
prescription medications did not preempt state failure-to-warn claims brought against name-brand
manufacturers, noting that “Congress took care to preserve state law” in this area. 129 S. Ct. at 1196. In so
ruling, the Court rejected the drug manufacturer’s argument of impossibility on the ground that the
“changes being effected” (CBE) regulation permitted a name-brand drug manufacturer to unilaterally
strength a warning label before receiving the FDA’s approval. Id. at 1199.
where the plaintiffs have consumed generic medication. See, e.g., Smith v. Wyeth, Inc.,
657 F.3d 420, 423 (6th Cir. 2011) (state-law failure-to-warn claims preempted by
Mensing); Moore v. Mylan, Case No. 1:11CV3037-MHS, 2012 WL 123986, at *7, n.11
(N.D. Ga. Jan. 5, 2012) (in denying plaintiffs’ motion to amend, the court held that
proposed claims relating to “the duty and ability of generic manufacturers to
communicate existing warnings to the medical community, or to alert individuals to
important safety related labeling changes made by the brand name labels[,]” would be
preempted by Mensing); Fullington v. PLIVA, Inc., No. 4:10CV236 JLH, 2011 U.S. Dist.
LEXIS 142931, at *10-*11 (E.D. Ark. Dec. 12, 2011) (collecting cases); Whitener v.
PLIVA, Inc., Case No. 10-1552 Sec. L(4), 2011 U.S. Dist. LEXIS 140053, at *8 (E.D. La.
Dec. 6, 2011) (“the holding [in Mensing] is clear: state-law failure-to-warn claims against
a generic drug manufacturer are preempted by federal law”); Waguespack v. PLIVA USA,
Inc., Case No. 10-692, 2011 U.S. Dist. LEXIS 135710 (E.D. La. Nov. 3, 2011) (granting
generic metoclopramide manufacturers’ motion for judgment on the pleadings because
the plaintiff’s claims involving inadequate warnings were preempted under Mensing);
Richardson v. Wyeth, Inc., Case No. 6:10CV883, 2011 U.S. Dist. LEXIS 128544, at *5
(W.D. La. Oct. 20, 2011) (the plaintiff’s failure-to-warn claim against a generic
metoclopramide manufacturer preempted by Mensing), adopted by 2011 U.S. Dist.
LEXIS 128529 (W.D. La. Nov. 7, 2011).
In the Second Amended Complaint, Fulgenzi sets forth claims for relief
under Ohio common law for strict products liability, strict liability-manufacturing defect,
strict liability-design defect, breach of express warranty, breach of implied warranties,
negligence, negligent misrepresentation, breach of undertaking special duty, fraud and
misrepresentation, constructive fraud, fraud by concealment, and intentional infliction of
emotional distress. (See SAC.) She also raises four statutory claims under the Ohio
Product Liability Act (OPLA), Ohio Rev. Code § 2307.71 et seq., for defective
manufacturing, pursuant to Ohio Rev. Code § 2307.74; design defect, pursuant to §
2307.75; defect due to inadequate warning, pursuant to Ohio Rev Code § 2307.76; and
non-conformance with representations, pursuant to Ohio Rev. Code § 2307.77. A fifth
statutory claim is brought under the Ohio Consumer Sales Practice Act (OCSPA), Ohio
Rev. Code § 1345.01 et seq.
“In Ohio, three basic theories of liability exist ‘under which a claimant
may assert a product liability action: (1) under the Ohio Product Liability Act; (2)
negligence; and (3) breach of warranty.’” Wimbush v. Wyeth, 619 F.3d 632, 636-37 (6th
Cir. 2010) (quoting Christopher M. Ernst, et al., Baldwin’s Ohio Practice, Ohio Tort
Law, § 6.1 (2009)). “The Ohio Products Liability Act defines a statutory product liability
claim.” Id. at 639 (citing Ohio Rev. Code § 2307.71(M)).
Plaintiff’s common law tort claims are abrogated by the OPLA. Ohio
Revised Code § 2307.71(B) was revised in 2005 to provide that “Sections 2307.71 to
2307.80 of the Revised Code are intended to abrogate all common law product liability
claims or causes of action.” Ohio Rev. Code § 2307.71(B). This amendment to the statute
eliminated common law torts as an avenue for relief from injuries suffered from allegedly
defective products. See Wimbush, 619 F.3d at 639; Younker v. Ohio State Univ. Med.
Ctr., Case No. 2:11CV749, 2011 U.S. Dist. LEXIS 113196, at *6 (S.D. Ohio Sept. 29,
2011); see, e.g., Erie Indem. Co. v. Keurig, Inc., Case No. 1:10CV2899, 2011 U.S. Dist.
LEXIS 76998, at *16 (N.D. Ohio July 15, 2011) (dismissing plaintiffs’ claims for
negligent manufacture, design defect, inadequate testing, improper sale, and failure-towarn as prototypical product liability claims abrogated by the OPLA). The OPLA also
abrogates Plaintiff’s product liability claim brought under the OCSPA. See, e.g., Mitchell
v. Proctor & Gamble, Case No. 2:09CV426, 2010 U.S. Dist. LEXIS 17956, at *11-*13
(S.D. Ohio Mar. 1, 2010) (finding OCSPA “claims primarily rooted in product liability”
abrogated by OPLA); Bourchard v. Am. Home Prods. Corp., Case No. 3:98CV7541,
2002 U.S. Dist. LEXIS 27517, at *33 (N.D. Ohio May 24, 2002) (dismissing plaintiff’s
OCSPA claim as foreclosed by OPLA).
The remaining statutory claims sound in defective design, defective
manufacturing, inadequate warnings, and non-comformance with representations. While
the OPLA recognizes such causes of action, the defective design and manufacturing
claims are not sufficiently plead. For example, in her defective manufacturing claim,
Plaintiff merely recites the statutory requirements for a defective manufacturing claim,
and alleges that the product was defective because it deviated from the product
specifications. (SAC at ¶¶ 97-101.) Such a conclusory allegation, unsupported by any
facts, is not sufficient to state a manufacturing defect claim. See Ashcroft, 129 S. Ct. at
1949-50 (noting that “[t]hreadbare recitals of the elements of a cause of action, supported
by mere conclusory statements, do not suffice”); see, e.g., Morris v. Wyeth, Inc, Case No.
3:09CV854, 2011 U.S. Dist. LEXIS 121052, at *8 (W.D. La. Oct. 19, 2011) (mere recital
of the elements of claims for defective design, breach of express warranty, and
inadequate warning was insufficient to satisfy pleading requirements); Boroff v. Alza
Corp., 685 F. Supp. 2d 704, 708 (N.D. Ohio 2010) (“The complaint in this case, however,
is bereft of any allegation that the Duragesic used by the decedent deviated from any
design specifications, formula, or performance standards, or any factual allegations that
would support such a claim. Plaintiff thus fails to state a claim for violation of Ohio Rev.
Code § 2307.74.”). Plaintiff’s statutory design defect claim suffers from the same
pleading deficiencies. The pleaded allegations do little more than set forth the test for
determining whether a product is unreasonably dangerous, and offer the conclusion that
PLIVA’s product was dangerous under the test. 2 (SAC at ¶ 114.)
Tellingly, one of the only factual allegations offered in support of the
statutory design defect claim alleges that defendant manufacturers failed to “include the
FDA approved warning against therapy in excess of 12 weeks that was included in
Schwarz’s warning labels . . ..” (SAC at ¶ 114(b)). There is, however, no requirement
under Ohio law that a generic manufacturer’s label mirrors that of the name-brand label.
Instead, the requirement that the generic manufacturer’s label match that of the namebrand label flows from federal regulations governing prescription medication. There is no
private cause of action for violations of FDA regulations.3 Further, a similar argument
Count 5 provides that “[t]he Reglan/Metoclopramide manufactured and supplied by Defendants was
defective in design or formulation, in that, when it left the hands of the Defendants, the foreseeable risks of
the product, as defined by Ohio Rev. Code §§ 2307.75(B) exceeded the benefits associated with its design
or formulation, as defined by Ohio Rev. Code §§ 2307.75(C), or it was more dangerous than an ordinary
consumer would expect.” (SAC at ¶ 113.)
Specifically, 21 U.S.C. § 337(a) provides that the enforcement of FDA regulations is reserved for the
federal government. See 21 U.S.C. § 337(a). “Courts interpret 21 U.S.C. § 337(a) to restrict enforcement of
the FDCA to the FDA, and that ‘no private cause of action exists for a violation of the FDCA.’” Loreto v.
Procter & Gamble Co., 737 F. Supp. 2d 909, 918-19 (S.D. Ohio 2010) (quoting Kemp v. Medtronic, Inc.,
231 F.3d 216, 236 (6th Cir. 2000)).
that the failure to include the 2004 amendment to the warning label gives rise to a state
failure-to-warn claim was raised in supplemental briefing in Smith v. Wyeth, and was
implicitly rejected by the Sixth Circuit. (Aug. 15, 2011 Supplemental Brief Letter from
Plaintiffs/Appellants, Doc. No. 64, Ex. 4 at 3-4.) In ultimately finding all of the claims
preempted by Mensing, the Sixth Circuit failed to carve out an exception for state-law
warning claims tied to alleged failures to comply with FDA regulations. See Smith, 657
F.3d at 423-24.
Even if the pleading deficiencies could be remedied, dismissal of these
claims would still be appropriate because, regardless of how Plaintiff attempts to cast
these claims, they are, at the core, failure-to-warn claims that are clearly preempted by
Mensing. See Grinage v. Mylan Pharms,, Inc., Case No. CCB-11-1436, 2011 U.S. Dist.
LEXIS 149667, at *18 (D. Md. Dec. 30, 2011) (rejecting design claim as failure-to-warn
claims preempted by Mensing); Stevens v. PLIVA, Inc., Case No. 6:10-886, 2011 U.S.
Dist. LEXIS 147684, at *5-*6 (W.D. La. Nov. 15, 2011) (report recommending the
dismissal of design defect claim, reasoning that “a generic pharmaceutical product must
be the same as the referenced listed drug . . . in active ingredients, safety and efficacy and
hence, as was the case with labeling, federal law pre-empts state laws imposing the duty
to change a drug’s design upon generic manufacturers”), adopted by Case No. 6:10-886
(W.D. La. Dec. 2, 2011) (Doc. No. 66, Ex. H); Morris, 2011 U.S. Dist. LEXIS 121052, at
*2 (The court granted an opposed motion for judgment on the pleadings, finding the
plaintiff’s claims for defective destruction or composition, defective design, breach of
express warranty, and inadequate warning all “sounded in failure to warn” and were,
therefore, preempted under Mensing.). Likewise, Plaintiff’s final two statutory causes of
action are preempted by Mensing. Count Six (defect due to “inadequate warning”) and
Count Eight (“nonconformance with representations”) are both premised on an alleged
failure-to-warn of the risks associated with use of the product. (SAC at ¶¶ 119-128, 141.)
In fact, a review of the allegations supporting each claim in the Second
Amendment Complaint reveals that all of the claims, including those otherwise abrogated
by the OPLA, hinge on the warnings the drug manufacturers gave, or from Plaintiff’s
perspective, failed to give. Because the essence of these claims is that PLIVA and others
marketed and sold a product as safe when they should have advised doctors and patients
of the risk created by long-term use of the medication, the case comes down to the
warning.4 See, e.g., Gross v. Pfizer, Inc., Case No. 8:10CV10, 2011 U.S. Dist. LEXIS
134895, at *11 (D. Md. Nov. 22, 2011) (allegations that drug manufacturers failed to
continue to monitor, test and inspect the product post-market are “but a piece of
Plaintiff’s larger failure to warn claims”). As such, the claims in this action are preempted
Analysis of the SAC’s shared factual allegations as to wrongdoing by defendants drives this point home.
These allegations provide that defendants: “had a duty to ensure their warnings to the medical community
[were] accurate and adequate” (SAC at ¶ 40); “failed to communicate the true and accurate risks” (id. at ¶
59); “failed to update its/their label(s) as to metoclopramide to include the July, 2004 label change warning
…” (id. at ¶ 60); “failed to disclose material safety information” (id. at ¶ 69); “failed to report data …
regarding the adequacy and/or accuracy of its warnings ….” (id. at ¶ 70); “knowingly concealed from
physicians material facts bearing on the interpretation of package insert disclosures that exposure to
Reglan/metoclopramide can lead to Tardive Dyskinesia …” (id. at ¶ 71); “concealed the fact that earlier
false information … representing long term Reglan/metoclopramide therapy to be reasonably safe, was
unscientific and false” (id. at ¶ 72); “concealed the fact that Reglan/metoclopramide is a neuroleptic agent
and dopamine antagonist, which can be excepted to lead to Tardive Dyskinesia …” (id. at ¶ 73); and
“concealed the fact that treatment … with Reglan/metoclopramide products for longer than 12 weeks is
unlikely to be reasonably safe.” (id. at ¶ 74.) Coupled with the shared causation paragraph that provides
that Plaintiff’s injuries were the foreseeable result of defendants’ “dissemination of inaccurate, misleading,
materially incomplete, false, and other inadequate information ….” (SAC at ¶ 76), these factual allegations
leave little doubt that each claim rises and falls with the adequacy of the warnings.
by Mensing.5 See, e.g., Schrock v. PLIVA USA, Inc., Case No. CIV-08-452-M, 2011 U.S.
Dist. LEXIS 141171, at *6-*7 (W.D. Ok. Dec. 8, 2011) (dismissing claims for breach of
express and implied warranties as preempted by Mensing, finding that the “gravamen” of
the claims was a challenge to the manufacturers’ representations as to the safety of the
medication); Metz v. Wyeth, Case No. 8:10-CV-2658, 2011 U.S. Dist. LEXIS 121549
(M.D. Fla. Oct. 20, 2011) (dismissal of claims against the generic drug manufacturer for
negligence, strict liability, breach of warranties, misrepresentation and fraud, and
negligence per se as preempted); Guarino v. Teva, Case No. 8:10-CV-2885-T-30TGW,
2011 U.S. Dist. LEXIS 128630, at *5 (M.D. Fla. Nov. 7, 2011) (dismissing negligence,
strict liability, breach of warranty, misrepresentation, and fraud claims as “on their face,
premised on an allegedly inadequate warning”).
For the reasons set forth above, PLIVA’s motion to dismiss is
IT IS SO ORDERED.
Dated: March 31, 2012
HONORABLE SARA LIOI
UNITED STATES DISTRICT JUDGE
Finally, the Court rejects Plaintiff’s argument that impossibility preemption does not apply because
PLIVA could have complied with both state and federal law by choosing to stop selling metoclopramide.
While such an argument was embraced by the Eight Circuit in Mensing v. Wyeth, Inc., 588 F.3d 603, 611
(8th Cir. 2009), the Supreme Court did not find the argument persuasive as it reversed the Eighth Circuit
and dismissed all of the claims as preempted under federal law. “Thus, [this argument] has been overruled.”
Fullington, 2011 U.S. Dist. LEXIS 142931, at *18 (rejecting a similar argument under Mensing).
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