Harrison v. Pharmaceutical Associates, Inc. et al
Filing
50
ORDER AND REASONS dismissing as moot 49 Motion to Amend/Correct. Signed by Judge Ivan L.R. Lemelle on 12/3/2012. (caa, )
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
DAWN HARRIS,on behalf of
her minor child, COY CALLAHAN
CIVIL ACTION
VERSUS
NO. 10-3159
PHARMACEUTICAL ASSOCIATES, INC., et al.
SECTION “B”(5)
ORDER AND REASONS
Before the Court is Defendant Pharmaceutical Associates, Inc.,
Defendant
Beach
Products,
Inc.,
and
Defendant
Morton
Grove
Pharmaceuticals, Inc.’s (“Defendants”) Motion to Amend Order,
seeking to amend this Court’s previous denial of Plaintiff Dawn
Harris’ (“Harris”) Motion to Reopen this administratively closed
case.1
(Rec. Doc. No. 49).
Also before the Court is briefing by
both sides on the impact of the U.S. Supreme Court’s ruling in
PLIVA, Inc., v. Mensing, 131 S.Ct. 2567 (2011) (“Mensing”) on the
instant case.
48).
(Rec. Docs. No. 27, 28, 29, 34, 37, 40, 43, 45, &
Accordingly, and for the reasons articulated below,
IT IS ORDERED that Harris’ state law claims are DISMISSED due
to preemption by federal law, as interpreted by the Mensing Court.
IT IS FURTHER ORDERED that Defendants’ motion is DISMISSED as
moot in view of the above ruling.
1
Defendants seek an order from this Court denying Harris’ motion to
reopen the case with prejudice.
1
Procedural History and Facts of the Case:
Harris filed the present action in this Court on September 17,
2010, on behalf of her minor child, Coy Callahan (“Callahan”),
claiming that the drug metoclopramide2, manufactured by Defendants,
caused Callahan to suffer from tardive dyskinesia.
1 at 1).
Louisiana
(Rec. Doc. No.
Harris sought damages against Defendants under the
Products
Liability
failure-to-warn claims.
Act3
(“LPLA”),
alleging
various
Id. at 9. On January 26, 2011, this Court
granted defendant Morton Grove Pharmaceutical Inc.’s motion to stay
the proceedings and administratively closed the case pending the
U.S. Supreme Court’s ruling in Mensing, which addressed preemption
issues also implicated by Harris’ claims.
(Rec. Doc. No. 15).
Following the U.S. Supreme Court’s ruling in Mensing, Harris filed
a Motion to Reopen the case on July 28, 2011.
(Rec. Doc. No. 17).
On September 14, 2011, this Court denied the motion to reopen
without prejudice to reurge, and ordered the parties to provide
additional memoranda on the Mensing case’s impact on the preemption
issues.
(Rec. Doc. No. 26).
The Court subsequently allowed both
parties to file supplemental memoranda on the Mensing case, its
progeny, and the impact on the instant matter. (Rec. Docs. No. 27,
28, 29, 34, 37, 40, 43, 45, & 48).
Based on said supplemental
2
The drug is also referred to by its brand name, “Reglan.”
are manufacturers of the generic version of the drug.
3
La. Rev. Stat. Ann. § 9:2800.54, et seq. (2012).
2
Defendants
memoranda, Defendants filed the instant motion to amend the Court’s
previous denial of Harris’
prejudice.
motion to reopen to be a denial with
(Rec. Doc. No. 49).
Law & Analysis
A. Denial of Reopening with Prejudice
Defendants seek denial with prejudice of Harris’ Motion to
Reopen, submitted to this Court on the briefs. (Rec. Doc. No. 49).
Defendants claim they are entitled to such denial because Harris’
claims should be dismissed with prejudice, on the basis of conflict
preemption under the U.S. Supreme Court’s ruling in Mensing. (Rec.
Doc. No. 48 at 7); PLIVA, Inc., v. Mensing, 131 S.Ct. 2567 (2011).
Therefore, this Court applies the legal standard it would employ
for dismissal with prejudice under Federal Rule of Civil Procedure
12.
In determining whether dismissal is appropriate, the court
must decide whether the facts alleged in the pleadings, if true,
would entitle the plaintiff to some sort of legal remedy. Ramming
v. U.S., 281 F.3d 158, 162 (5th Cir. 2001); Cinel v. Connick, 15
F.3d 1338, 1341 (5th Cir. 1994). The Supreme Court has put it this
way: “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) (citing Bell Atlantic Corp. v. Twombly, 550
U.S. 544, 570 (2007)).
3
B. Preemption
Under the U.S. Constitution, federal law “shall be the supreme
Law of the Land.”
U.S. Const. art. VI, cl. 2.
Therefore, when
federal law conflicts with state law, state law must “give way.”
Mensing, 131 S. Ct. at 2577, citing Wyeth v. Levine, 555 U.S. 555,
583 (2009); Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995).
In Mensing, the U.S. Supreme Court held that state law failure-towarn claims against generic drug manufacturers are preempted by
federal drug regulations.
Mensing, 131 S. Ct. at 2572.
Under
federal law, “generic drug manufacturers have an ongoing federal
duty of ‘sameness.’” Id. at 2575.
a
generic
drug
counterpart.
must
Id.
That is, the warning labels of
exactly
match
those
Therefore,
the
Court
of
its
found
brand-name
that
it
was
“impossible” for generic drug manufacturers to comply with state
laws imposing a duty to warn while adhering to federal drug
regulations
labels.
requiring
exact
sameness
with
brand-name
warning
Id. at 2574-75, 2579, citing Wyeth, 555 U.S. at 573 (“The
question of ‘impossibility’ is whether the private party could
independently do under federal law what state law requires of it;”
“We find impossibility here.
It was not lawful under federal law
for the [generic manufacturers] to do what state law required of
them.”).
Applying the Supreme Court’s ruling in Mensing, several
district courts have held that any state law claims against generic
drug manufacturers based on a theory of inadequate warnings are
4
preempted by federal law.
See Jacobsen v. Wyeth, LLC, et al., No.
10-0823, 2012 WL 3575293 (E.D. La. Aug. 20, 2012); Guilbeau v.
Wyeth, Inc., et al., No. 09-1652, 2011 WL 4948996 (W.D. La. Oct.
14, 2011); Waguespack v. Plivia, USA, Inc., et al., No. 10-692,
2011
WL
5826015
(E.D.
La.
Nov.
3,
2011);
Beck
v.
Teva
Pharmaceutical Industries, Ltd., No. 10-1901, 2011 WL 4062219 (E.D.
La. Sept. 13, 2011).
In Mensing, the Supreme Court consolidated cases from the
Fifth and Eighth Circuit Courts of Appeal, in which plaintiffs
brought suit against the generic manufacturers of metoclopramide,
a drug designed to speed the movement of food through the digestive
system,
which
Administration
was
first
(“FDA”)
approved
in
1980
Mensing 131 S.Ct. at 2572.
under
by
the
the
Food
brand
and
name
Drug
Reglan.
The plaintiffs in each case sued the
generic drug manufacturers alleging that long-term use of the drug
caused a neurological disorder, and that the manufacturers were
liable under state tort law for inadequate warning labels.
2573.
Both
the
Fifth
and
Eighth
Circuits
Id. at
rejected
the
manufacturers’ arguments that the state tort claims were preempted
by FDA regulations.
Id.
In the case arising out of the Fifth
Circuit, the plaintiff’s claims were based on Louisiana law,
specifically the LPLA.
Id.
Among the claims alleged under the
LPLA was the argument that the generic drug manufacturers could
have used “Dear Doctor” letters to warn prescribing physicians and
5
healthcare professionals about the risk associated with the drug.
Id. at 2576. However, the U.S. Supreme Court rejected these claims
as preempted, accepting the FDA’s assertion that any such letters
qualified as “labeling.” Id. (“... If generic drug manufacturers,
but not the brand-name manufacturer, sent such letters, that would
inaccurately imply a therapeutic difference between the brand and
generic drugs and thus could be impermissibly ‘misleading.’”).
Accordingly, the Court reversed the judgments of the Fifth and
Eighth Circuits and held that federal law preempted the plaintiffs’
state tort lawsuits.
Id. at 2581.
The facts of Harris’ claims are similar to those at issue in
Mensing.
Harris’ state law claims are based on a theory of:
“Defendants’ total failure to provide physicians with any warning
or instructions for proper use of their drug.”4
at 3 & 40 at 1).
(Rec. Docs. No. 27
Harris asserts that the means Defendants could
have employed to minimize the identified risks associated with the
drug
include
“Dear
Doctor”
letters,
training
programs
for
healthcare practitioners, and specialized packaging, in addition to
other similar steps to warn physicians and patients about the drug.
(Rec. Docs. No. 27 at 17 and 40 at 16-17).
4
Harris claims that the
The Court rejects Harris’ argument that she asserts theories of
liability distinct from state failure-to-warn claims. Harris’ factual
allegations are based entirely on failure-to-warn claims. (See Complaint,
Rec. Doc. No. 1). Harris’ description of a failure to “communicate” risks of
the drug is in essence identical to a failure to warn, as is the “breach of
express warranty claim” which essentially restates a breach of a state law
duty to warn. (Rec. Doc. No. 40 at 1 & 10).
6
Defendants should have widely disseminated information about the
risks of the drug independent of their brand-name counterparts.
(Rec. Doc. No. 27 at 16).
Harris’ interpretation of the Supreme
Court’s holding is misguided.
It is precisely this kind of
independent action that Mensing prohibits.
Under the federal duty of “sameness” imposed by the FDA
regulations
on
generic
drug
manufacturers,
Defendants
are
prohibited from taking actions which imply any differences between
their generic drug and the brand-name drug originally approved by
the FDA.
Mensing, 131 S. Ct. at 2581.
Therefore, the proposed
avenues which Harris cites in her briefs to this Court, including
but not limited to “Dear Doctor” letters and informational sessions
for physicians and healthcare professionals, are unavailable to
generic drug manufacturers such as the Defendants.
All of the
means suggested by Harris in one form or another address an
inadequacy in warnings about the dangers of the drug.
Court
has
adopted
the
FDA’s
position
that
such
The Supreme
actions
are
“labeling” in the sense that they must be consistent with the
brand-name warnings and labels. Because it would be impossible for
Defendants to have adopted the efforts Harris suggests to comply
with state law, and still adhere to the federal duty of “sameness,”
all of Harris’ state law claims against Defendants are preempted.
Under the U.S. Supreme Court’s ruling in Mensing, Harris’
claims under state law are preempted by federal drug regulations.
7
Accordingly, Harris’ state law claims are dismissed as preempted by
federal law and the latter ruling in Mensing.
New Orleans, Louisiana, this 3rd day of December, 2012.
____________________________
UNITED STATES DISTRICT JUDGE
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