Lyman et al v. Pfizer, Inc. et al

Filing 192

OPINION AND ORDER granting in part and denying in part 182 Motion for Judgment on the Pleadings. The stay is lifted and the deadline for pretrial motions, including Daubert motions and dispositive motions, is 3/1/2012. Signed by Judge William K. Sessions III on 2/3/2012. (law)

UNITED STATES DISTRICT COURT
FOR THE
DISTRICT OF VERMONT
COLLEEN AND STEVE LYMAN
Plaintiffs,
v.
PFIZER, INC., WYETH, INC.,
SCHWARZ PHARMA, INC.,
TEVA PHARMACEUTICALS
USA, INC., PLIVA USA, INC.,
ACTAVIS-ELIZABETH, L.L.C.
Individually and as a
subsidiary of ACTAVIS, INC.
and as successor TO PUREPAC
PHARMACEUTICAL, INC,
Defendants.

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Case No. 2:09-cv-262

Opinion and Order
Plaintiffs Colleen and Steve Lyman have brought suit against
the brand name and generic manufacturers of metoclopramide for
injuries arising from Colleen Lyman’s ingestion of the drug.
They allege that the medication caused her to develop tardive
dyskinesia, a severe 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 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 by federal
law.

For the reasons that follow, the motion, ECF No. 182, is

granted in part and denied in part.

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 the Lymans’ Complaint, 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
avoided in all but rare cases.”

Mensing, 131 S. Ct. at 2573.

Colleen Lyman was prescribed and took metoclopramide from
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

2003 until at least 2006.

The Lymans filed suit against the name

brand and generic manufacturers of metoclopramide on November 25,
2009.

Their Complaint alleges claims against the Generic

Defendants for negligence; strict liability; breach of an implied
warranty of merchantability; breach of an implied warranty of
fitness for a particular purpose; misrepresentation, suppression
of evidence and fraud; and gross negligence.

In their Statement

of Facts, they assert that Colleen Lyman’s injuries
came about as a foreseeable and proximate result of
Defendants’ dissemination of inaccurate, misleading,
materially incomplete, false and otherwise inadequate
information concerning the potential effects of
exposure to and long-term ingestion of
Reglan/metoclopramide to the medical community, Colleen
Lyman, and other foreseeable users of the drug.
Compl. ¶ 3.19, ECF No. 1.

In essence, the Lymans’ claims arise

from the Defendants’ “failure to warn doctors and patients of
information within their knowledge or possession which indicated
that the subject Reglan/metoclopramide, when taken for long
periods of time, caused serious, permanent and debilitating side
effects, including tardive dyskinesia.”

Id. ¶ 3.22.

Specifically, the Lymans’ Complaint alleges that the Generic
Defendants disseminated false and misleading information about
the risks of metoclopramide through their package inserts.
¶¶ 3.67-69.

Id.

They also allege that the Generic Defendants failed

to review and report on adverse drug event information, relevant
scientific literature and material safety information; and failed

3

to conduct and report post-market safety surveillance on
metoclopramide.

Id. ¶¶ 3.72-77.

They allege that the Generic

Defendants knowingly concealed from physicians material facts
pertaining to the risk of serious side effects resulting from use
of the drug for longer than twelve weeks.

Id. ¶¶ 3.78-81.

Within their negligence claim, the Lymans assert failure to
exercise reasonable care in the design, manufacture, marketing
and testing of metoclopramide, as well as failure to provide
adequate warnings.

Id. ¶¶ 4.02-03.

In their strict product

liability claim, the Lymans assert that metoclopramide was
defective in design and marketing and unreasonably dangerous, and
failure to provide adequate warnings rendered the drug
“unreasonably dangerously defective as designed and marketed.”
Id. ¶ 4.08.

The Lymans’ breach of an implied warranty of

merchantability claim asserts that metoclopramide was not
merchantable as fit for safe use because, as designed, it was
capable of causing serious injury as suffered by Colleen Lyman.
Id. ¶ 4.11.

Their breach of an implied warranty of fitness for a

particular purpose asserts that they relied on the Generic
Defendants’ skill and judgment when purchasing metoclopramide,
which was not fit for its particular purpose.

Id. ¶ 4.14.

Within their fraud and misrepresentation claim, the Lymans assert
that the Generic Defendants made false material representations
and omitted material information concerning the risk of serious

4

permanent side effects, the inadequacy of testing, and the
inadvisability of use for longer than twelve weeks.
23.

Id. ¶ 4.17-

The Lymans also assert that the Generic Defendants’

negligent acts or omissions amount to gross negligence,
warranting exemplary damages.

Id. ¶ 4.26-27.

On February 15, 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.

131 S. Ct. at 2572, 2581.

Like Colleen Lyman,

the plaintiffs in the 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
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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
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

2

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

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.

In their motion, the Generic Defendants argue that Mensing
requires dismissal of all of the Lymans’ claims against them.
The Lymans concede that they cannot pursue claims against the
Generic Defendants for failure to add new or strengthened
warnings to their labeling for metoclopramide that did not appear
in the labeling for Reglan.

Nevertheless, they argue that their

complaint also alleges viable claims that the Generic Defendants
failed to correct the label for metoclopramide to reflect that
therapy with the drug should not exceed twelve weeks, actively
concealed information that metoclopramide was not safe for longterm use, and failed to perform their duties to monitor and
report information on the safety of metoclopramide to the FDA.
These allegations, they contend, are not preempted.
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
7

all reasonable inferences in plaintiffs’ 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.

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 first examines the factual allegations

of the Lymans’ Complaint, independent of their characterization
as claims of negligence, strict product liability, breach of
warranty or fraud.3

3

The Generic Defendants have argued that the Lymans’
claims for negligence, strict liability, breach of implied
warranties and gross negligence are considered as merged into one
strict product liability action under Vermont law. This is
incorrect. When the Vermont Supreme Court adopted the doctrine
of strict product liability as set forth in section 402A of the
Restatement (Second) of Torts in Zaleskie v. Joyce, 333 A.2d 110,
113-14 (1975), it “expanded [Vermont] common law to include
strict product liability,” Hay v. Med. Ctr. Hosp. of Vt., 496
A.2d 939, 945 (Vt. 1985); it did not eliminate traditional
negligence and warranty claims for injuries to consumers. See
Webb v. Navistar Int’l Transp. Corp., 692 A.2d 343, 350 (Vt.
1996); see also Huey v. Bates, 375 A.2d 987, 990 (Vt. 1977)
(noting that causes of action for negligence, breach of implied
warranties and strict product liability are recognized in
Vermont); Kellogg, 762 F. Supp. 2d at 704 (observing that
“[n]either the Vermont Courts nor the Vermont legislature have
collapsed negligence actions into strict liability actions where
products are involved,” citing Webb).
8

B.

The Allegations of Failure to Strengthen or Add to the
Labeling

As the Lymans concede, their claims that the Generic
Defendants failed to strengthen or add to the federally-approved
warnings that they provided in package inserts and other labeling
are preempted.

See Mensing, 131 S. Ct. at 2581.

It is

irrelevant whether such claims sound in negligence, strict
product liability or breach of implied warranties.

See id. at

2572 (holding that state tort-law claims against generic drug
manufacturers based on failure to provide adequate warning labels
were preempted).
C.

The Design and/or Manufacturing Defect Allegations

The Lymans’ claims that the Generic Defendants’
metoclopramide should have been designed or manufactured
differently, see Compl. ¶¶ 4.02-03, 4.05, 4.07-09, 4.11, are
preempted as well by Mensing’s logic.

Generic metoclopramide is

required by federal law to be bioequivalent to the reference
listed drug Reglan.

See Mensing, 131 S. Ct. at 2574 & n.2; see

also 21 U.S.C. § 355(j)(2)(A)(iv).

The Generic Defendants’

“federal duty of sameness,” see Mensing, 131 S. Ct. at 2575,
therefore applies to the design or composition of the drug as
well as to its labeling.

Applying the Mensing holding requires

dismissal of the Lymans’ design claims as well.4
4

The Lymans have not adequately pled claims for
manufacturing or design defects, in any event. In their
9

D.

The Allegation of Selling an Unreasonably Dangerous
Product

The Lymans also argue that they may still seek to hold the
Generic Defendants liable for selling an unreasonably dangerous
product without adequate instructions for use, by having
concealed important safety information and provided a label
containing false information.

See Compl. ¶ 3.23.

They contend

that, as a panel of the Eighth Circuit Court of Appeals
commented, “[i]f [the generic defendants] realized their label
was insufficient . . ., they could have simply stopped selling
the product.”

Mensing, 588 F.3d at 611.5

These claims, however,

remain based upon a state law duty to provide stronger or safer
warnings, and are preempted under Mensing, to the extent that the
Lymans claim that the instructions, information or labeling
should have provided more or different information than that

Complaint, they mention only that “Defendants” (presumably
including both generic and name brand manufacturers) failed to
use due care in developing, designing and manufacturing
Reglan/metoclopramide, and that Reglan/metoclopramide was
unreasonably defective in design. See Compl. ¶¶ 4.03a, 4.08-09.
These conclusory statements do not satisfy Rule 8's requirement
that a complaint contain factual matter “that allows the court to
draw the reasonable inference that the defendant is liable for
the misconduct alleged.” Iqbal, 129 S. Ct. at 1949. The Lymans
do not allege facts from which the Court could conclude that the
Generic Defendants developed or designed metoclopramide, that
they failed to exercise due care in these activities, or that a
manufacturing defect caused Colleen Lyman’s injuries.
5

Upon remand from the United States Supreme Court, the
Eighth Circuit Court of Appeals vacated the portion of its
opinion that included this statement. Mensing v. Wyeth, Inc.,
658 F.3d 867, 867 (8th Cir. 2011).
10

approved by the FDA for Reglan.

See Mensing, 131 S. Ct. at 2577;

see also Gross v. Pfizer, Inc., ___ F. Supp. 2d ___, ___, No. 10cv-00110-AW, 2011 WL 5865267, at *3 (D. Md. Nov. 22, 2011)
(rejecting a state law duty to stop production of a federallyapproved drug).
E.

The Allegations That the Generic Defendants Failed to
Monitor and Report Safety Information, to Review
Adverse Drug Event Information or to Conduct Safety
Surveillance

The Lymans also state that the Generic Defendants violated
“numerous other provisions of federal law,” including “failure to
perform post-marketing surveillance for their drugs, to ensure
the accuracy of statements appearing in their package insert, to
review all adverse drug event information, and to report
important information relating to the safety of their drug
products.”

Pls.’ Mem. in Opp’n 20, ECF No. 183.

To the extent

that these contentions support a claim of breach of a state tort
duty to provide different or additional information or warnings
than those approved by the FDA for Reglan, the claim is precluded
under Mensing.

Mensing, 131 S. Ct. at 2572.

If these

contentions are intended to support a different theory of relief,
they are inadequately pled, as the Complaint merely asserts
generally that these violations support the contention that all
drug manufacturer defendants were negligent in the design and
marketing of Reglan/metoclopramide, and failed to warn that it
was capable of causing injuries such as those suffered by Colleen
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Lyman.

Compl. ¶¶ 4.02-03.

See Iqbal, 129 S. Ct. at 1949

(“Threadbare recitals of the elements of a cause of action,
supported by mere conclusory statements, do not suffice.”).
F.

The Allegation that the Generic Defendants Failed to
Provide Warnings That Were Consistent with FDA-Approved
Labeling

The Lymans also argue that by 2004 when the FDA approved a
label change for Reglan to add that “[t]herapy should not exceed
12 weeks in duration,” the Generic Defendants could and should
have disseminated information through labeling and otherwise that
was consistent with the updated and strengthened warning.

They

contend that no manufacturer of metoclopramide communicated this
information to healthcare providers or to consumers, and that
long-term therapy remained a common practice as a result.
Mem. in Opp’n 19.

Pls.’

If the Lymans’ Complaint can be read to assert

that the Generic Defendants are liable for failure to update
their labeling in 2004, or to otherwise inform physicians or
consumers from that point on that metoclopramide should not be
prescribed for more than twelve weeks, Mensing does not require
dismissal of these claims.
Although the Mensing Court concluded that generic drug
manufacturers were precluded from issuing substantial additional
warnings that were inconsistent with or contrary to the drug’s
approved labeling, it did not rule that generic drug
manufacturers were precluded from issuing “labeling,” as that
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term is defined in 21 U.S.C. § 321(m) and 21 C.F.R. §
202.1(l)(2), that is “consistent with and not contrary to . . .
approved or permitted labeling.”

21 C.F.R. § 201.100(d)(1).

Had

the Mensing Court been presented with this precise question, it
could not have used the same rationale to find preemption,
because the Mensing Court based its decision on “impossibility.”
Mensing, 131 S. Ct. at 2577.

Because it was not only possible--

but required by federal law--to provide updated labeling that
contained the new caution against use for longer than twelve
weeks, the Generic Defendants cannot argue that it was not
possible for them to change their labeling without violating
federal law.

See Wyeth v. Levine, 555 U.S. 555, 573 (2009)

(holding that a brand name drug manufacturer had failed to
demonstrate that it was impossible for it to comply with a state
law duty to provide a stronger warning and a federal duty to
avoid misbranding, remarking that “[i]mpossibility pre-emption is
a demanding defense”); see also Fisher v. Pelstring, ___ F. Supp.
2d ___,___, No. 4:09-cv-00252-TLW, 2011 Wl 4552464 at *3 (D.S.C.
Sept. 30, 2011) (finding that a generic manufacturer’s deviation
from the approved Reglan labeling rules out impossibility
preemption); Brasley-Thrash v. Teva Pharm. USA, Inc., No. 1000031-KD-N, 2011 WL 4025734 at *3-4 (S.D. Ala. Sept. 12, 2011)
(allowing a plaintiff leave to amend her complaint to assert
liability based on failure to communicate stronger warnings
13

contained in the FDA-approved label, finding no preemption).
Moreover, the Mensing holding does not prevent the Lymans
from asserting liability against the Generic Defendants for
distributing a drug that is misbranded.

Federal law prohibits a

manufacturer from introducing into commerce a misbranded drug.
21 U.S.C. § 331(a).

A drug is misbranded “[i]f its labeling is

false or misleading in any particular,” id. § 352(a), or does not
provide adequate directions for use and adequate warnings.
352(f).

Id. §

A drug’s “labeling must be updated when new information

becomes available that causes the labeling to become inaccurate,
false, or misleading,” 21 C.F.R. § 201.56(a)(2); moreover, its
“labeling shall be revised to include a warning as soon as there
is reasonable evidence of an association of a serious hazard with
a drug.”

21 C.F.R. § 201.80(e).

Although Mensing precludes a state tort claim based on the
contention that the federally approved labeling for
metoclopramide was false or misleading, the Lymans may, without
running afoul of Mensing, pursue state tort claims against the
Generic Defendants for distributing metoclopramide without the
labeling approved for Reglan in 2004.

See Riegel v. Medtronic,

Inc., 552 U.S. 312, 330 (2008) (noting that the preemption
provision of the Medical Device Amendments of 1976 did not
“prevent a State from providing a damages remedy for claims
premised on a violation of FDA regulations,” because “the state

14

duties in such a case ‘parallel,’ rather than add to, federal
requirements”); accord Hughes v. Boston Scientific Corp., 631
F.3d 762, 769 (5th Cir. 2011) (holding in a medical device case
that a state failure to warn claim based on an assertion that the
defendant violated a relevant federal statute or regulation was
not preempted).
Although such claims are not preempted by the holding in
Mensing, the Lymans’ Complaint does not plead sufficient facts
under Iqbal to survive the motion for judgment on the pleadings.
See Iqbal, 129 S. Ct. at 1949-50.

The factual allegations

supporting the Lymans’ claims, filed before the Supreme Court’s
decision in Mensing, understandably do not distinguish between
the Generic Defendants’ conduct before and after the Reglan label
change in 2004, and therefore do not supply sufficient
information to conclude that the complaint states a plausible
claim for relief.

See id. at 1950.

Accordingly, the Lymans have

leave to move to amend their Complaint within ten days of the
date of this order.
III. Conclusion and Order
For the reasons stated above, the Generic Defendants’ Motion
for Judgment on the Pleadings, ECF No. 182, is granted in part
and denied in part.

If the Lymans do not move to amend their

Complaint within ten days, the Court will amend its order to
grant the motion in its entirety.
15

On September 16, 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 stay is lifted, and 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

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