Metz et al v. Wyeth LLC et al
ORDER granting in part and denying in part 91 Motion to dismiss; granting 109 Motion for summary judgment. The clerk is directed to close this case. Signed by Judge James D. Whittemore on 3/28/2012. (KE)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
BARBARA METZ and
Case No.: 8:10-CV-2658-T-27AEP
WYETH, LLC, et al.,
BEFORE THE COURT are Defendant Actavis Elizabeth LLC's Motion to Dismiss
Plaintiffs' First Amended Complaint (Dkt. 91) and Motion for Summary Judgment (Dkt. 109).
Upon consideration, the Motion to Dismiss will be GRANTED in part and DENIED in part. The
Motion for Summary Judgment will be GRANTED.
Plaintiffs, Barbara Metz and Donald Metz, filed this action against Wyeth LLC ("Wyeth"),
Schwarz Pharma, Inc. ("Schwarz") and Actavis Elizabeth, LLC d/b/a Purepac Pharmaceuticals
("Actavis") for injuries arising from the use of metoclopramide, marketed by Wyeth and Schwarz
under the brand name Reglan. 1 Actavis manufactured, marketed, and sold metoclopramide as a
generic equivalent of Reglan.
As discussed below, the majority of Plaintiffs ' claims are impliedly preempted under PLIVA,
Inc. v. Mensing, --- U.S . ---, 131 S. Ct. 2567 (2011). Moreover, to the extent that any of Plaintiffs'
The Court previously granted summary judgment in favor of Schwarz and Wyeth. See Dkt. 95 .
claims survive preemption under Mensing, such claims are barred by the learned intermediary
doctrine under Florida law.
Summary of Plaintiffs' Claims
Plaintiffs' First Amended Complaint (the "Amended Complaint") asserts claims against
Actavis for negligence (Count I), strict liability (Count II), breach of warranties (Count III),
misrepresentation and fraud (Count IV), and negligence per se (Count V).
One February 23,2012, this Court entered an Order directing Plaintiffs to file a more definite
statement (1) separately identifying those claims (i. e. , legal theories) they contend are not preempted
under Mensing, and (2) summarizing the alleged factual basis (including causation) for each such
claim. See Dkt. 122. In response, Plaintiffs furnished a More Definite Statement. See Dkt. 125.
While the Amended Complaint and More Definite Statement purport to assert a variety of claims
based on differing legal and factual theories, Plaintiffs' counsel conceded during oral argument that
each of the substantive claims are based, at least in part, on the failure of Actavis to effectively
communicate to Plaintiffs treating physician the limitation on duration of use added to the label for
metoclopramide in 2004. 2
Motion to Dismiss
Actavis moves to dismiss the Amended Complaint based on the recent decision of the United
States Supreme CourtinPLIVA, Inc. v. Mensing, --- U.S. ---,131 S. Ct. 2567 (2011), which held that
failure to warn claims against generic drug manufacturers were impliedly preempted under the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. ("FDCA").
2 On or about July 26, 2004, the FDA approved a labeling change for brand-name Reglan which stated that
"[t]herapy should not exceed 12 weeks in duration .... "
Rule 8(a)(2) of the Federal Rules of Civil Procedure requires that a complaint provide "a
short and plain statement of the claim showing that the pleader is entitled to relief," in order to "give
the defendant fair notice of what the ... claim is and the grounds upon which it rests." Bell At!. Corp.
v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47 (1957)).
Although a complaint need not include detailed factual allegations, it must contain sufficient
factual allegations, which, when taken as true, "state a claim to relief that is plausible on its face."
Ashcroft v. Iqbal, 556 U.S. 662, 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 the
defendant is liable for the misconduct alleged." Id. "The plausibility standard is not akin to a
'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted
"[W]here the well-pleaded facts do not permit the court to infer more than the
mere possibility of misconduct, the complaint as alleged-but it has not' show[n]' -'that the pleader
is entitled to relief.'" Id. at 1950 (quoting Fed. R. Civ. P. 8(a)(2)). A well-pleaded complaint,
however, may survive a motion to dismiss even if it appears "that recovery is very remote and
unlikely." Bell Atlantic Corp., 550 U.S. at 555 (quoting Scheuer v. Rhodes, 416 U.S. 232, 236
While the Court must accept all factual allegations as true in evaluating a motion to dismiss
under Rule 12(b)(6), the tenet does not apply to legal conclusions. Ashcroft, 129 S. Ct. at 1949.
Similarly, a court may dismiss a complaint on a dispositive issue oflaw. Marshall County Bd. of
Educ. v. Marshall County Gas Dist., 992 F.2d 1171, 1174 (11th Cir. 1993).
Actavis argues that under Mensing, it was required to use the same label as the branded drug
and was not at liberty to communicate information inconsistent with that label. As a result, Actavis
contends the Plaintiffs' claims are preempted by federal law because they all arise from Actavis'
alleged knowledge of certain risks and its failure to communicate those risks to consumers, the
government, and the medical community.
Plaintiffs respond that they have alleged causes of action that are not preempted by federal
law. Specifically, Plaintiffs argue that their claims are not preempted because they do not seek to
hold Actavis liable for failing to take actions that are prohibited by federal law. In addition,
Plaintiffs argue that Mensing only involved the adequacy of a drug label, not the manner in which
warnings relating to a drug were communicated. Thus, Plaintiffs argue their claims based on
Actavis ' failure to provide physicians with any warning relating to metoclopramide, "especially in
light of changes made to the label for metoclopramide in 2004 prohibiting its long-term use," are not
In Mensing, consumers sued generic manufacturers of metoclopramide alleging that the
generic manufacturers violated state tort law (specifically, that of Minnesota and Louisiana) by
failing to provide adequate warnings to consumers, the federal government, and the medical
community. The consumers alleged that "despite mounting evidence that long term metoclopramide
use carries a risk of tardive dyskinesia far greater than that indicated on the label," none of the
manufacturers had changed their labels to adequately warn of the danger.
131 S. Ct. at 2573. Moreover, the consumers in Mensing alleged that the manufacturers ignored
scientific and medical literature establishing a higher risk of developing tardive dyskinesia, failed
to request that the FDA approve a revised label, and failed to report safety information directly to
the medical community. See Demahy v. Actavis, Inc., 593 F.3d 428,430 (5 th Cir. 2010); Mensing
v. Wyeth, Inc., 562 F.Supp.2d 1056, 1058 (D. Minn. 2008).
The manufacturers argued that because federal law required them to use the same safety and
efficacy labeling as their brand-name counterparts, it was impossible to simultaneously comply with
both federal law and a state tort-law duty that required them to use a different label. The Court
agreed and held that federal law preempted the consumers' state law claims. Mensing, 131 S. Ct.
at 2581. The Court based its conclusion on the fact that the manufacturers could not unilaterally
strengthen their warning labels nor could they send additional (i. e., different) warnings to prescribing
physicians and other healthcare professionals advising of new information and increased risks. Id.
at 2575-76. The Court further held that complete preemption existed even assuming that the
manufacturers had a duty to propose stronger warning labels to the FDA if they believed such
warnings were needed. Id. at 2577.
Count I - Negligence
Plaintiffs' claim that Actavis was negligent in failing to take additional steps to warn doctors
and/or consumers of information already appearing in, or recently added to, the label for
metoclopramide, including the prohibition on long-term use added in 2004, may not be preempted
to the extent Actavis could have taken such steps consistent with federal law. See Fisher v.
Pelstring, MD., No. 4:09-cv-00252-TLW, 2011 WL 4552464, at *3, 31-32 (D. S.c. Sept. 30,2011)
(denying motion to dismiss negligence action based on allegations that generic manufacturer should
have done more to communicate FDA approved labeling changes); Brasley-Thrash v. TEVA
Pharmaceuticals USA, Inc., No. 10-00031-KD-N, 2011 WL 4025734, at *3 (S.D. Ala. Sept. 12,
2011) (recognizing that claims based on generic drug manufacturer's failure to provide warnings
consistent with the label and packaging materials were not preempted); see also Lyman v. Pfizer,
Inc., No. 2:09-cv-262, 2012 WL 368675, at *5 (D. Vt. Feb. 3,2012) (denying motion to dismiss state
law claims against generic manufacturers for distributing generic metoclopramide without the
labeling approved for Reglan in 2004); De Valle v. PLIVA, Inc., No. B-ll-l13, 2011 WL 7168620,
at *7-8 (S.D. Tex. Dec. 21, 2011) (recognizing that generic drug manufacturer's failure to update
label based on 2004 amendment could place claims outside of the preemption described in Mensing).
In short, it would not be impossible3 for Actavis to comply with its obligations under federal and
state law to the extent state law is determined to require Actavis to more effectively communicate
the FDA approved label to medical providers and/or consumers. See Couick v. Wyeth, Inc., No.
3:09-cv-210-RJC-DSC, 2012 WL 79670, at *3 (W.D.N.C. Jan. 11, 2012) (noting generic
manufacturer failed to meet burden of proving impossibility).
Plaintiffs' claim that Actavis breached its duty to Plaintiffs because it failed to use due care
in informing itself about the properties of metoclopramide is preempted by federal law to the extent
Plaintiffs contend that Actavis should have used such information to provide different or additional
information to consumers, the medical community, or the FDA. See Lyman, 2012 WL 368675, at
*4 (dismissing state law tort claims based on generic drug manufacturer's failure to review all
adverse drug information). To the extent that Plaintiffs contend that had Actavis remained informed
about the properties of metoclopramide it would have known the importance of providing more
effective notice to physicians, this allegation is related to, and subsumed within, Plaintiffs' overall
negligence theory of liability.
3 "[T]he question for 'impossibility is whether the private party could independently do under federal law what
state law requires of it." Mensing, 131 S.Ct. at 2579.
Count II - Strict Liability
Plaintiffs' strict liability claim is, in essence, a claim based on Actavis' failure to provide an
adequate warning as to the risks associated with the long-term use of metoclopramide. That is,
Plaintiffs do not contend that metoclopramide is unreasonably dangerous when used consistent with
the FDA approved label (i. e., short term use), but rather contend that it was unreasonably dangerous
because Actavis knew that it was being used for longer periods. In essence, Plaintiffs contend that
Actavis should have either (1) redesigned the drug to alleviate the existing design defect,4 or (2)
stopped offering metoclopramide for sale given its knowledge that metoclopramide was often
prescribed for periods exceeding twelve weeks.
A claim that Actavis should have redesigned metoclopramide to alleviate the risks associated
with its long-term use would be preempted under Mensing. See Lyman, 2012 WL 368675, at *4
(dismissing design and manufacturing defect claims as preempted under Mensing because generic
metoclopramide was required to be the bioequivalent to the reference listed drug Reglan); In re
Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), No. 08-008 (GEB-LHG), 2011
WL 5903623, at *6 (Nov. 21, 2011) (same). To the extent Plaintiffs contend that Actavis should
have pulled the generic version of metoclopramide from the market, such claim is also preempted.
See Fullingtonv. PLIVA, Inc., No. 4:10CV00236 JLH, 2011 WL 6153608, at *6 (E.D. Ark. Dec. 12,
2011) (noting that mere fact that manufacturers could pull generic drug from the market did not save
claims from impossibility preemption under Mensing); Gross v. Pfizer, Inc., No.1 O-cv-OO 11 O-A W,
4 Under Florida law, a plaintiff need not identify whether a strict liability claim is based on a design, as opposed
to a manufacturing, defect. McConnell v. Union Carbide Corp., 937 So.2d 148, 152 (Fla. 4th DCA 2006). Nevertheless,
to the extent Plaintiffs purport to state a claim based on an alleged manufacturing defect, the Complaint lacks sufficient
allegations to support such a claim. See Fisher, 2011 WL 4552464, at *33-34 (dismissing manufacturing defect claim
when plaintiff failed to show that metoclopramide plaintiff ingested deviated from design specifications or that it was
rendered unsafe by an error in the manufacturing process).
2011 WL 5865267, at *5 (D. Md. Nov. 22, 2011) (dismissing negligence claim against generic drug
manufacturer based on the continuing sale of metoclopramide, concealment of important safety
information, and failure to test and inspect product). As a result, the Amended Complaint fails to
state a claim against Actavis based on a theory of strict liability.
See Grinage v. Mylan
Pharmaceuticals, Inc., No. CCB-II-1436, 2011 WL 6951962, at *6 (D. Md. Dec. 30, 2011)
(dismissing design defect claim because consumer expectation test considered same factors as
failure-to-warn analysis and plaintiff failed to allege design defect under risk-utility analysis); Fisher,
2011 WL 4552464, at *15 (granting summary judgment for generic drug manufacturer on design
defect claim when plaintiff failed to demonstrate existence of an alternative feasible design).
Count III - Breach of Implied Warranties
Under Mensing, Plaintiffs' implied warranty claim is also preempted by the FDCA to the
extent it stems from Actavis' failure to provide additional warnings relating to the risks associated
with long-term metoclopramide use or Actavis' failure to stop manufacturing and marketing the
generic version of metoclopramide. See Schrock v. PLIVA USA, Inc. , No. eIV -08-453 -M, 2011 WL
6130924, at *2 (W.D. Okla. Dec. 8,2011); cf In re Fosamax Prods. Dab. Litig., No. 08-008 (GEBLHG), 2011 WL 5903623, at * (D. N.J. Nov. 21, 2011) (when breach of implied warranty claim
necessarily alleged that generic manufacturers should have changed product design, such claim was
5 As noted, to the extent Plaintiffs contend that Actavis should have pulled the generic version of
metoc\oprarnide from the market, such claim is preempted. See Fullington, 2011 WL 6153608, at *6 (noting that mere
fact that manufacturers could pull generic drug from the market did not save claims from impossibility preemption under
Mensing); Gross, 2011 WL 5865267, at *5(dismissing negligence claim against generic drug manufacturer based on the
continuing sale ofmetoc\opramide, concealment of important safety information, and failure to test and inspect product).
Unlike Plaintiffs' strict liability claim which must demonstrate that metoclopramide was
unreasonably dangerous when used in a manner consistent with the FDA approved label, an implied
warranty claim may survive preemption based on a showing that Actavis knew metoclopramide was
likely to be used to treat GERD for longer than twelve weeks and implicitly warranted that it was
safe and effective for such use despite the warning to the contrary in the FDA approved label. That
is, it is conceivable that Actavis could have taken additional steps consistent with the FDCA and the
FDA approved label to impact the manner in which physicians prescribed metoclopramide (i. e., the
"intended" use) and that a claim based on this failure to act may survive preemption under Mensing.
See Couick, 2012 WL 79670, at *7 ("While Defendant's labeling and warnings may playa role in
establishing their products' intended purpose or their customer's reliance, Plaintiff s claim is not that
Defendants failed to adequately warn about the risks."); Fisher, 2011 WL 4552464, at *18-19, 29
(denying generic drug manufacturer's motion to dismiss plaintiff s implied warranty claims because
"there is an issue of fact as to whether [the generic manufacturer] knew the metoclopramide it
manufactured was being used for long-term treatment of gastrointestinal issues").
Count IV - Misrepresentation and Fraud
While styled as a claim for misrepresentation and fraudulent concealment, the essence of
Plaintiffs' claim is that Actavis fraudulently concealed the labeling changes made in 2004 together
with other adverse information relating to the long-term use ofmetoclopramide.6 Any claim based
on Actavis' failure to provide additional information regarding the dangers associated with
6 This is not a situation where Plaintiffs allege that Actavis failed to revise its label to conform with the 2004
amendment. Compare Fisher, 2011 WL 4552464, at *3 , 31-32 (denying motion to dismiss fraud claim when Plaintiffs
alleged that generic drug manufacturer concealed facts by failing to include the 2004 warning in its label for
metoclopramide). As Plaintiffs note, those label changes mitigated to a large extent the effect of any prior false
statements of risk appearing in the label for metoclopramide. Of course, any claims relating to false statements remaining
in the label for metoclopramide after 2004 are clearly preempted under Mensing.
metocloprarnide (regardless of whether Actavis had a duty to furnish such information to the FDA)
is preempted under Mensing. See Grinage, 2011 WL 6951962, at *7; Gross, 2011 WL 5865267,
at *4.7 Plaintiffs' claims relating to inadequate post-marketing testing, failure to report adverse
events, and failure to review safety issues relating to metocloprarnide are also preempted under
MenSing. That is, even if Actavis conducted additional testing or was aware of new risks (or
additional adverse events) associated with metocloprarnide, Actavis could not furnish this
information directly to consumers or the medical community. At most, Actavis could have
petitioned the FDA to modify the label for metocloprarnide. Gross, 2011 WL 5865267, at *4. In
any event, the Amended Complaint fails to plead fraud with particularity as required by Rule 9(b),
Federal Rules of Civil Procedure. See Moore v. Mylan Inc., No.1 :11-CV-03037-MHS, 2012 WL
123986, at *9 (N.D. Ga. Jan. 5,2012). As a result, the Amended Complaint fails to state a claim
against Actavis for misrepresentation or fraud.
Count V - Negligence Per Se ("Parallel" State and Federal Law Claims)
Plaintiffs' negligence per se claim is subject to dismissal because Florida law does not
recognize a claim based upon a theory of negligence per se for an alleged violation of the FDCA.
See Pantages v. Cardinal Health 200, Inc., No. 5:08-cv-116-0c-l0GRJ, 2009 WL 2244539, at *2
(M.D. Fla. July 27, 2009) (noting that violation of a federal statute was not negligence per se under
Florida law unless the legislature intended a private right of action under the statute); Blinn v. Smith
& Nephew Richards, Inc., 55 F.Supp.2d 1353, 1361 (M.D. Fla. 1999) ("[a] [p]laintiff cannot use a
negligence per se claim to create a private cause of action for [a] [d]efendant's alleged violations of
7 To the extent Plaintiffs contend that Actavis failed to supply relevant infonnation to the FDA, Plaintiffs' claim
may be viewed as relying on a fraud-on-the-FDA theory of liability. It is undisputed that "fraud on the FDA claims" are
impliedly preempted by the FDCA. See Buckman Co. v. Plaintiffs ' Legal Comm., 531 U.S. 341, 348 (200 I).
the FDCA"); Stevens v. Danek Medical, Inc., No. 95-14293-CIV-PAINE, 1999 WL 33217282, at
*5-6 (S.D. Fla. Apr 16, 1999) (granting motion for summary judgment in favor of defendants
because Florida law does not recognize a negligence per se claim based on a violation of FDCA);
see also Ellis v. CR. Bard, Inc., 311 F.3d 1272, 1285 n.9 (11 th Cir. 2002) (noting in dicta the holding
in Blinn that there is no negligence per se claim under Florida law for a violation of the FDCA); cf
Jupiter Inlet Corp. v. Brocard, 546 So.2d 1,2-3 (Fla. 4th DCA 1988) (OSHA does not provide a
basis for a private right of action and violations of it do not constitute negligence per se). But see
Fisher, 2011 WL 4552464, at *30-31 (citing cases recognizing viability of negligence per se based
on violations of FDA requirements).8 Furthermore, even if Plaintiffs could assert a negligence per
se claim, they must .allege facts supporting causation. Plaintiffs allege no fact supporting their
conclusory allegation that Actavis' failure to obey an FDA requirement caused their injuries. See
Rounds v. Genzyme Corp., No. 8:10-cv-2479-T-23TBM, 2010 WL 5297180, at *3 (M.D. Fla. Dec.
20,2010). As a result, the Amended Complaint fails to state a claim against Actavis based on a
negligence per se theory ofliability.9
8 Similarly, Plaintiffs' negligence per se claim is barred to the extent Plaintiffs rely on Actavis' failure to comply
with administrative regulations rather than substantive regulations establishing a specific standard of care owed by
generic drug manufacturers. See Iacangelo v. Georgetown Univ., 595 F.Supp.2d 87, 92 (D. D.C. 2009).
9 To the extent Plaintiffs attempt to bring a private action to enforce FDA rules and regulations, such an action
is expressly foreclosed by 21 U.S.C. § 33 7(a) ("proceedings for the enforcement, or to restrain violations, of [the Federal
Food, Drug, and Cosmetic Act] shall be by and in the name of the United States"). See Couick, 2012 WL 79670, at *5;
see also Buckman Co., 531 U.S. at 349 ("The FDCA leaves not doubt that it is the Federal Government rather than
private litigants who are authorized to file suit for noncompliance with the medical device provisions."). Thus, a private
action alleging that Actavis breached an independent duty to Plaintiffs by failing to abide by FDA requirements must
be dismissed. Couick, 2012 WL 79670, at *7 (dismissing claim based on generic drug manufacturer's failure to abide
by FDA requirements); see also Morris v. Wyeth, Inc., No. 09-0854, 2012 WL 601455, at *5 (W.D. La. Feb. 23 , 2012)
(dismissing failure to test and warn claim because the FDCA creates no private right of action).
Motion for Summary Jud2ment
While the majority of Plaintiffs' claims, however styled, are preempted under Mensing, it is
arguable that claims based on Actavis' failure to more effectively communicate the warnings
contained in the FDA approved label survive preemption under Mensing. 10 As Actavis argues in its
motion for summary judgment, however, such claims are barred by the learned intermediary doctrine
under Florida law.
Summary judgment is proper if following discovery, the pleadings, depositions, answers to
interrogatories, affidavits and admissions on file show that there is no genuine issue as to any
material fact and that the moving party is entitled to judgment as a matter of law. Celotex Corp. v.
Catrett, 477 U.S. 317,322 (1986); Fed. R. Civ. P. 56. "An issue of fact is 'material' if, under the
applicable substantive law, it might affect the outcome of the case." Hickson Corp. v. N Crossarm
Co., 357 F.3d 1256, 1259-60 (1Ith Cir. 2004) (internal citations omitted). "An issue of fact is
'genuine' if the record taken as a whole could lead a rational trier of fact to find for the nonmoving
party." Id. at 1260. All the evidence and factual inferences reasonably drawn from the evidence
must be viewed in the light most favorable to the nonmoving party. Adickes v. S.H Kress & Co.,
398 U.S. 144,157 (1970); Jackson v. BellSouth Telecomms., 372 F.3d 1250, 1280 (1Ith Cir. 2004).
The Court will not weigh the evidence or make findings of fact. Anderson, 477 U.S. at 249;
Amway Corp., 323 F.3d 920,924 (1Ith Cir. 2003). Rather, the Court's role is limited
10 Courts addressing the issue after Mensing have disagreed whether a "failure to more effectively communicate"
claim is preempted by the FDCA. Compare, e.g., Kelloggv. Wyeth , No. 2:07-cv-82, 2012 WL 368657 (D. vt. Feb. 3,
2012), and Moretti v. Pliva, Inc., No. 2:08-cv-00397-JCM, 2012 WL 628502 (D. Nev. Feb. 27, 2012), with Whitener
v. Pliva, Inc., No. 10-1552,2011 WL 6056546 (E.D. La. 2011)
to deciding whether there is sufficient evidence upon which a reasonable juror could find for the
non-moving party. Id.
The duty of a manufacturer to warn of the risk associated with a prescription drug or medical
device runs to a physician, the so-called "learned intermediary," rather than the patient. See
Christopher v. Cutter Laboratories, 53 F.3d, 1184, 1192 (l1th Cir. 1995) (stating that "a
manufacturer of prescription drugs or products discharges its duty to warn by providing the physician
with information about risks associated with those products"); Felix v. Hoffmann-LaRoche, Inc., 540
So.2d 102 (Fla. 1989); Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1365 (S.D. Fla. 2007). "[T]he
causal link between a patient's injury and the alleged failure to warn is broken when the prescribing
physician had 'substantially the same' knowledge as an adequate warning from the manufacturer
should have communicated to him." Christopher, 53 F.3d at 1192. "Whether the physician in fact
reads the warning, or passes its contents along to the recipient of the drug is irrelevant." E.R. Squibb
and Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997); Felix, 540 So.2d at 102-05. The
adequacy of a warning, i. e., the existence of a "learned intermediary," is an issue of law if the
warning is accurate, clear, and unambiguous. Felix, 540 So.2d at 105; Beale, 492 F.Supp.2d at
1368-69; Buckner v. Allergan Pharm., Inc., 400 So.2d 820 (Fla. 5th DCA 1981).
Plaintiffs do not argue that Actavis failed to update its label for generic metoclopramide to
incorporate the 2004 label revision. As such, the product label furnished by Actavis contained the
accurate, clear, and unambiguous warning that "[t]herapy should not exceed 12 weeks in duration
.... "11 This warning, which was available both in the package insert and on the internet at
www.fda.gov, satisfied Actavis' duty to provide Plaintiffs treating physician with adequate
information about the risks associated with metoclopramide use (including the FDA indicated
prohibition on long term use). See Rounds v. Genzyme Corp., 440 Fed. Appx. 753, 755-56 (11 th Cir.
2011),petitionjor cert.filed, No. 11-971, 11A525 (Feb. 6, 2012).12 The physician then owed a duty
to Plaintiff to apprise himself of the risk associated with metoclopramide and to exercise his
judgment in prescribing the product and informing her of the risk. See Rounds, 440 Fed. Appx.
at756. 13 Thus, Actavis is entitled to summary judgment with respect to all of Plaintiffs' claims that
rely on the theory that Actavis should have more effectively communicated the warnings contained
in the FDA approved label. See Felix, 540 So.2d at 105.
The majority of Plaintiffs' claims are preempted by federal law under Mensing or otherwise
fail to state a claim upon which relief may be granted under Florida law. See, e.g., Guarino v. Wyeth,
LLC, No. 10-cv-2885, 2011 WL 5358709 (M.D. Fla. Nov. 7,2011) (dismissing claims that generic
manufacturer's label was "inaccurate, misleading, materially incomplete, false and otherwise
inadequate" and that manufacturer failed to send Dear Doctor letters to prescribing physicians under
Mensing); Morris v. Wyeth, Inc., 3:09-cv-854, 2011 WL 502448 (M.D. Fla. Oct. 20, 2011)
II To the extent Plaintiffs dispute the adequacy of the post-2004 label, Actavis properly notes that there is no
duty to communicate an inadequate warning. See Bowman v. Wyeth, LLC, No. 10-1046 (JNE/SER), 2012 WL 684116,
at *7 (D. Minn. March 2, 2012) (noting that there is not duty for a manufacturer to provide an inadequate warning). In
any event, claims based on the content of the warning provided by Actavis are preempted by the FDCA under Mensing.
12 This is true even if Actavis knew or should have known that the medical profession was not warning patients
of allegedly known harmful side effects of me to clop rami de use. See Buckner v. Allerrgan Pharm., Inc., 400 So. 2d 820,
823-84 (Fla. 5th DCA 1981).
I3 The fact that federal law, including the FDCA, may have imposed on Actavis a more substantial duty vis-a-vis
a treating physician does not change the analysis of what Florida law requires under the learned intermediary doctrine .
(dismissing plaintiff s claims against generic drug manufacturer for negligence, strict liability, breach
of warranties, misrepresentation, fraud, and negligence per se). To the extent Plaintiffs' claims
based on an alleged failure to effectively communicate the warning contained in the 2004 label
survive preemption, such claims are barred by the learned intermediary doctrine under Florida law.
Accordingly, it is ORDERED AND ADJUDGED:
Defendant Actavis Elizabeth LLC's Motion to Dismiss Plaintiffs' First Amended
Complaint (Dkt. 91) is GRANTED to the extent that the First Amended Complaint purports to
assert state law claims preempted by federal law, including the Federal Food, Drug and Cosmetic
Act, 21 V.S.c. § 301, et seq.
Specifically, Plaintiffs' claims for strict liability (Count II),
misrepresentation and fraud (Count IV), and negligence per se (Count V) are DISMISSED with
The Motion for Summary Judgment of Defendant's Actavis Elizabeth, LLC
(Dkt. 109) is GRANTED. The Clerk is directed to enter final judgment in favor of Defendant
Actavis Elizabeth, LLC and against Plaintiffs Barbara Metz and Donald Metz.
All pending motions are DENIED as moot. The Clerk is directed to CLOSE this
DONE AND ORDERED in chambers this
J. g"'day of March, 2012.
S D. WHITTEMORE
ited States District Judge
Counsel of Record
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?