Kellog v. Wyeth et al

Filing 302

MEMORANDUM OPINION AND ORDER granting 288 Motion for Judgment on the Pleadings. The deadline for pretrial motions, including Daubert motions and dispositive motions, is March 1, 2012. Signed by Judge William K. Sessions III on 2/3/2012. (law)

UNITED STATES DISTRICT COURT
FOR THE
DISTRICT OF VERMONT
ETHEL KELLOGG,

:
:
Plaintiff,
:
:
v.
:
:
WYETH, Individually and as Successor-in-:
Interest to A.H. ROBINS COMPANY, INC.
:
and AMERICAN HOME PRODUCTS CORPORATION; :
SCHWARZ PHARMA, INC.; ACTAVIS, INC.;
:
ACTAVIS-ELIZABETH, L.L.C.; ALPHARMA,
:
INC.; PUREPAC PHARMACEUTICAL COMPANY,
:
INC.; TEVA PHARMACEUTICALS, USA, INC.; :
BAR PHARMACEUTICALS, INC.; PLIVA, INC.; :
and DRUG COMPANY DOES 1 THROUGH 10,
:
inclusive,
:
:
Defendants.
:

Case No. 2:07-cv-82

MEMORANDUM OPINION AND ORDER
Plaintiff Ethel Kellogg has brought suit against the brand
name and generic manufacturers of metoclopramide for injuries
arising from her ingestion of the drug.

She alleges that the

medication caused her to develop tardive dyskinesia, a
neurological disorder causing involuntary repetitive tic-like
movements.

Following the United States Supreme Court’s decision

in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), Defendants
Actavis Elizabeth LLC, Barr Pharmaceuticals, LLC and PLIVA, Inc.
(collectively “Generic Defendants”) have moved for judgment on
the pleadings pursuant to Federal Rule of Civil Procedure 12(c),
contending that all claims against them are preempted.

For the

reasons that follow, the motion, ECF No. 288, is granted.

Kellogg’s request for permission to move to amend her Second
Amended Complaint (“SAC”) is denied.
I.

Background
The Food and Drug Administration (“FDA”) approved

metoclopramide in tablet form for the treatment of
gastrointestinal disorders under the brand name Reglan in 1980.1
Generic manufacturers received approval to produce metoclopramide
in 1985.

According to Kellogg’s SAC, the Generic Defendants knew

or should have known that the labeling for metoclopramide
substantially understated the risk of developing tardive
dyskinesia, particularly as a result of long-term use of the
drug.
Warnings included in labeling for metoclopramide have been
modified and strengthened over the years, in 1985, in 2004, and
in 2009.

Mensing, 131 S. Ct. at 2572-73.

In 2004, the FDA

approved a change to the label to add that “[t]herapy should not
exceed 12 weeks in duration.”

Id. at 2573; see also Kellogg v.

Wyeth, 612 F. Supp. 2d 421, 427 (D. Vt. 2008).

In 2009, the FDA

required the addition of a “black box warning,” 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
1

The FDA regulates the manufacture, sale, and labeling of
prescription drugs under the Federal Food, Drug, and Cosmetic Act
(“FDCA”), as amended. 21 U.S.C. §§ 301-399d.
2

avoided in all but rare cases.”

Mensing, 131 S. Ct. at 2573.

Ethel Kellogg was prescribed and took metoclopramide from
May 2000 to May 2004 for gastroesophageal reflux disease.

Her

SAC alleges claims against the Generic Defendants for negligence
(Count Four), negligence per se (Count Five), strict products
liability (Count Six), and breach of express and implied
warranties (Counts Seven and Eight).

In her General Allegations

of Fact, she asserts that her injuries “came about as a
foreseeable and proximate result of the drug company defendants’
dissemination to physicians of inaccurate, misleading, materially
incomplete, false, and otherwise inadequate information
concerning the potential effects of exposure to metoclopramide
and the ingestion of metoclopramide products.
85.

SAC ¶ 31, ECF No.

Further, she alleges that the Generic Defendants
knew or should have known about the false and
misleading information and the omitted information in
the package inserts for metoclopramide and the PDR
monograph for Reglan, knew or should have known about
the widespread tendency among physicians to prescribe
metoclopramide for long-term use and knew about the
substantially increased prevalence of tardive
dyskinesia and other serious extrapyramidal side
effects of metoclopramide, particularly when it is
prescribed for long-term use and, notwithstanding this
knowledge, consciously decided to ignore this
information, rather than urgently propose new labeling
to the FDA or send “Dear Healthcare Practitioner”
letters to physicians, in order to warn physicians
about the danger associated with long-term use of
metoclopramide.

Id. ¶ 36.

In their essence, Kellogg’s claims are “traditional

products liability claims for injuries caused by [the Generic
3

Defendants’] . . . failure to provide adequate warnings for their
products,” that allege specifically that her “doctors prescribed
the drug for prolonged use because they were not adequately
informed about the risks of prolonged exposure to the drug.”
Pl.’s Resp. 1-2, 9, ECF No. 289.
Specifically, Kellogg asserts that the Generic Defendants
were negligent in “failing to exercise reasonable care in [their]
labeling of [metoclopramide] products for their effects in
ordinary and foreseeable uses, including long term use, and in
[their] dissemination to physicians of information concerning the
products’ effects. . . .”

SAC ¶ 58.

As negligence per se,

Kellogg asserts that the package inserts and other labeling for
metoclopramide failed to conform to statutory requirements.
¶¶ 63-64.

Id.

In her strict product liability claim, Kellogg asserts

that metoclopramide was defective and unreasonably dangerous
because it was not distributed with adequate warnings and
instructions for use.

Id. ¶ 67.

Kellogg asserts that the

Generic Defendants breached an express warranty because generic
metoclopramide materially failed to conform to their
representations concerning its properties and effects, made in
package inserts and otherwise.

Id. ¶ 70.

She asserts that the

Generic Defendants breached implied warranties that their
products were of merchantable quality and “fit for their common,
ordinary and intended use in long term therapy for the treatment

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of chronic and/or intermittent gastroesophageal reflux and/or
gastroporesis.”

Id. ¶ 75.

On January 13, 2011, this Court granted a partial stay of
proceedings in anticipation of a decision by the United States
Supreme Court in the consolidated cases of Mensing v. Wyeth,
Inc., 588 F.3d 603 (8th Cir. 2009), and Demahy v. Actavis, Inc.,
593 F.3d 428 (5th Cir. 2010), rev’d sub nom. PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567 (2011).
decision on June 23, 2011.

The Supreme Court issued its

See Mensing, 131 S. Ct. at 2567.

In PLIVA, Inc. v. Mensing, the United States Supreme Court
held that federal law preempted state laws imposing a duty on
generic drug manufacturers to provide adequate warning labels for
their products.

Id. at 2572, 2581.

Like Ethel Kellogg, the

plaintiffs in the consolidated cases before the Court were
prescribed and took generic metoclopramide.

After taking the

drug for several years, these women developed tardive dyskinesia.
Id. at 2573.

Their lawsuits alleged “that long-term

metoclopramide use caused [their] tardive dyskinesia and that the
[generic manufacturers] were liable under state tort law . . .
for failing to provide adequate warning labels.”

Id.

The Mensing Court first identified a state tort duty to
warn, that allegedly would require the generic manufacturers to
use a stronger, safer label than the one approved by the FDA.
The Court then summarized the different labeling requirements for
5

brand-name and generic drug manufacturers, observing that under
the Drug Price Competition and Patent Term Restoration Act of
1984,2 a generic drug manufacturer “is responsible for ensuring
that its warning label is the same as the brand name’s.”

Id. at

2574.
The Supreme Court rejected the suggestions that generic drug
manufacturers have opportunities to strengthen their warnings,
either (1) through the FDA’s “changes-being-effected” process, or
(2) through the delivery of “Dear Doctor” letters to healthcare
professionals.

Id. at 2575-76.

It assumed, without deciding,

that generic drug manufacturers have a duty to propose that the
FDA require stronger warning labels, but concluded that complying
with such a duty would not satisfy a state-law duty to provide
adequate labeling.

Id. at 2576-78.

Consequently, the Court

concluded that it is impossible for generic manufacturers to
comply both with state requirements to supply an adequate warning
label and federal requirements that their labels be the same as
the brand name’s label.

Id. at 2577-78.

Given that the

Supremacy Clause establishes that federal law prevails in cases
of direct conflict with a state law, the Court held that the
plaintiffs’ failure to warn claims against the generic
manufacturers were preempted.

Id. at 2577, 2581.

2

Pub. L. No. 98-417, 98 Stat. 1585 (1984), commonly
referred to as the “Hatch-Waxman Amendments.”
6

In their motion, the Generic Defendants argue that the
decision in PLIVA disposes of all of Kellogg’s claims against
them.

Kellogg, however, contends that her claims are preempted

only to the extent that they are based on failure to provide
adequate warnings through the labeling for metoclopramide.

She

argues that federal law permits generic prescription drug
manufacturers to disseminate truthful, nonmisleading information
to doctors about the risks associated with their product through
means other than labeling, and that therefore it was not
“impossible” for the Generic Defendants to comply with both state
and federal requirements.
II.

Discussion
A.

Rule 12(c) Motion

“‘To survive a Rule 12(c) motion, [plaintiffs’] complaint
must contain sufficient factual matter, accepted as true, to
state a claim to relief that is plausible on its face.’”

Hayden

v. Paterson, 594 F.3d 150, 160 (2d Cir. 2010) (quoting Johnson v.
Rowley, 569 F.3d 40, 44 (2d Cir. 2009) (per curiam)).

The Court

accepts as true all well-pleaded factual allegations, and draws
all reasonable inferences in plaintiff’s favor.

L-7 Designs,

Inc. v. Old Navy, LLC, 647 F.3d 419, 429 (2d Cir. 2011).
In considering a motion for judgment on the pleadings, a
court may first identify pleadings that, being no more than
conclusions, are not entitled to the presumption of truth.
7

Id.

at 430; see Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009).
Assuming the truth of well-pleaded factual allegations, a court
may then determine whether they plausibly entitle the pleader to
relief.
1950.

L-7 Designs, 647 F.3d at 430; see Iqbal, 129 S. Ct. at

The Court therefore examines the factual allegations of

Kellogg’s SAC, independent of their characterization as claims of
negligence, product liability or breach of warranty.
B.

The Allegations of Failure to Provide Adequate Labeling

“Label” is defined in the Food, Drug, and Cosmetic Act as “a
display of written, printed, or graphic matter upon the immediate
container of any article . . . .”

21 U.S.C. § 321(k).

“Labeling” “means all labels and other written, printed, or
graphic matter (1) upon any article or any of its containers or
wrappers, or (2) accompanying such article.”

21 U.S.C. § 321(m).

For purposes of regulating prescription drug advertising, the FDA
interprets labeling broadly, to include
[b]rochures, booklets, mailing pieces, detailing
pieces, file cards, bulletins, calendars, price lists,
catalogs, house organs, letters, motion picture films,
film strips, lantern slides, sound recordings,
exhibits, literature, and reprints and similar pieces
of printed audio, or visual matter descriptive of a
drug and references published (for example, the
“Physicians Desk Reference”) for use by medical
practitioners, pharmacists, or nurses, containing drug
information supplied by the manufacturer, packer, or
distributor of the drug. . . .
21 C.F.R. § 202.1(l)(2).

Such labeling must be “consistent with

and not contrary to . . . approved or permitted labeling.”

8

Id. §

201.100(d)(1); see PLIVA, 131 S. Ct. at 2576 (deferring to the
FDA’s interpretation, and concluding that federal law did not
permit drug manufacturers to issue additional warnings through
“Dear Doctor” letters).
Federal law permits drug manufacturers to provide
information about off-label uses3 of their drugs, as long as the
information does not recommend or suggest the unapproved use, and
is not inconsistent with or contrary to the approved labeling for
the drug.

See 21 C.F.R. §§ 201.100(d)(1) (requiring labeling to

be consistent with and not contrary to approved or permitted
labeling); 202.1(e)(4)(i)(a) (prohibiting advertisements that
recommend or suggest any use that is not in the accepted
labeling).
Kellogg concedes that her claims that the Generic Defendants
failed to provide the medical community with adequate warnings
about metoclopramide through labeling or advertising are
preempted.

She contends, however, that Mensing’s holding does

not preclude a claim that the Generic Defendants are liable for
failing to disseminate accurate, nonmisleading information about
metoclopramide, including warning information about dangerous

3

An “off-label” use is a use of the drug that has not been
approved by the FDA. The FDA does not prohibit physicians from
prescribing drugs for off-label uses, but does prohibit drug
manufacturers from promoting off-label uses, through its
misbranding and intended-use regulations. See 21 U.S.C. §
352(a)-(n); 21 C.F.R. § 201.128.
9

side effects, through means other than labeling or advertising.
C.

The Allegations of Failure to Provide Adequate and
Accurate Information Through Other Means

Although Kellogg makes the argument that it was possible for
the Generic Defendants to provide accurate, nonmisleading
information about metoclopramide, she acknowledges that such
distribution can constitute a misbranding of the product if it
includes information that is inconsistent with or contrary to
FDA-approved labeling.
201.100(d)(1).

Pl.’s Resp. 15; see 21 C.F.R. §

She urges recognition of the possibility,

however, that the Generic Defendants could have disseminated
accurate information about the unapproved use of metoclopramide
for long-term therapy without violating the FDCA, as long as the
information did not constitute promotion of the unapproved use.
Pl.’s Resp. 19-30.

In support of this interpretation she offers

statements from the Government’s briefs in a pair of cases which
allow that drug manufacturers do not necessarily violate the
misbranding provisions of the FDCA by making statements about the
safety or effectiveness of an unapproved use of a drug.

See

Supplemental Brief for the United States at 17, United States v.
Caronia, No. 09-5006-cr (2d Cir. Aug. 30, 2011); Defendants’
Memorandum of Points & Authorities in Support of Motion to
Dismiss or for Summary Judgment at 34-35, Allergan v. United
States, No. 09-1879(JDB) (D.D.C. Jan. 11, 2010).

Indeed, the

Government asserts that it has affirmatively encouraged drug
10

manufacturers to disseminate warnings about unapproved uses of
their drugs, Allergan Br. at 36, warnings which obviously do not
appear on any approved labeling.
However valid or reasonable this interpretation of
“labeling” and the federal duty to avoid misbranding may be,
Mensing now bars a lawsuit against a generic manufacturer for
failing to provide additional information about the safety of
metoclopramide, whether for an approved or an unapproved use.

In

Mensing, the Supreme Court concluded that “Dear Doctor” letters,
which qualify as “labeling,” could not transmit “substantial new
warning information” because the letters “would not be consistent
with the drug’s approved labeling.”

Mensing, 131 S. Ct. at 2576.

It is the “federal duty of ‘sameness,’” id. at 2575, that trumps
a state law duty to provide adequate warnings.
Kellogg offers no viable reason to distinguish between “Dear
Doctor” letters and other forms of “labeling,” such as reprints
of journal articles or materials produced in connection with
continuing medical education programs.

See 21 C.F.R. §

202.1(l)(2) (defining labeling to include virtually any type of
audio, visual or printed matter descriptive of a drug and
supplied by a manufacturer).

Regardless of whether the warning

information is offered for promotional or educational purposes;
regardless of whether the warning information is directed toward
an approved or an unapproved use; Mensing declares that material

11

which satisfies the definition of labeling cannot be proffered by
generic manufacturers without running afoul of the requirements
that the information be consistent with and not contrary to the
approved labeling, and that the information not imply a
therapeutic difference between the brand and generic drugs.
Mensing, 131 S. Ct. at 2576.
To the extent the Kellogg’s SAC can be read to assert
liability against the Generic Defendants for failure to provide
adequate warnings through dissemination of nonpromotional
information, these claims are also preempted.4
III. Conclusion and Order
Because state tort claims against generic drug manufacturers
for failure to provide adequate warnings are preempted to the
extent they would require the generic drug manufacturers to
provide stronger or safer labeling than that approved for the
brand name drug, Kellogg’s claims against the generic
4

Given that Kellogg’s claims against the Generic
Defendants must be dismissed on preemption grounds, the Court
does not address their argument, made in their Reply brief, that
Vermont law does not recognize a duty on the part of drug
manufacturers to disseminate information regarding off-label use,
or to disseminate information separate from their products. See
Reply 8-9, ECF No. 294. The Court notes merely that Vermont
recognizes a manufacturer’s duty to warn, see, e.g., McCullock v.
H.B. Fuller Co., 61 F.3d 1038, 1044-45 (2d Cir. 1995) (applying
Vermont law); Webb v. Navistar Int’l Transp. Corp., 692 A. 2d
343, 347 (Vt. 1997). The scope of the duty to warn and the
adequacy of the warnings are “properly left to the jury
deliberating with the guidance of appropriate instructions.”
McCullock, 61 F.3d at 1045 (quotation marks and citation
omitted).
12

manufacturers must be dismissed.

Because amendment of her SAC

would be futile, given that the theories she has asserted in her
SAC and her Response are all preempted, her request for leave to
amend on that basis is denied.

The Generic Defendants’ Motion

for Judgment on the Pleadings, ECF No. 288, is granted.
On September 28, 2011, the Court stayed the filing of
pretrial motions until resolution of any motion filed in
connection with the Mensing decision.

This motion having been

resolved, the deadline for pretrial motions, including Daubert
motions and dispositive motions, is March 1, 2012.

Dated at Burlington, Vermont this 3rd day of February, 2012.

/s/ William K. Sessions III
William K. Sessions III
United States District Judge

13