Harden Manufacturing Corporation v. Pfizer, Inc. et al

Filing 3469

Judge Patti B. Saris: ORDER entered DENYING #1796 Motion for Reconsideration re #1780 Memorandum & ORDER. "Having found that plaintiffs cannot satisfy the Rule 23(b)(3) superiority requirement, and in light of the fact that there are no remaining named class representatives with viable claims, the Court DENIES the motion for reconsideration (Docket No. #1796 ). The parties shall propose a form of judgment within two weeks." (Anderson, Jennifer)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
)
IN RE NEURONTIN MARKETING
)
AND SALES PRACTICES LITIGATION ) MDL NO. 1629
_______________________________)
)
THIS DOCUMENT RELATES TO:
) CIVIL ACTION NO. 04-cv-10981-PBS
)
ALL SALES & MARKETING ACTIONS )
)
MEMORANDUM AND ORDER
May 17, 2011
Saris, U.S.D.J.
In this proposed nationwide class action, plaintiffs,
consumers and third party payors (“TPPs”) who paid for a
prescription for the drug Neurontin, allege that defendants
Warner-Lambert and Pfizer, the manufacturers of Neurontin,
systematically and knowingly engaged in a fraudulent campaign to
market and sell Neurontin for treatment of “off-label”
indications – conditions for which the Food and Drug
Administration (“FDA”) had not approved Neurontin – even though
defendants knew Neurontin was not effective for those conditions.
The Court denied plaintiffs’ renewed motion for class
certification on May 13, 2009.

In re Neurontin Mktg., Sales

Practices & Prods. Liab. Litig., 257 F.R.D. 315 (D. Mass. 2009).
Plaintiffs moved for reconsideration of that decision, only as to
the TPP bipolar and mood disorder subclass (Docket No. 1796).
(See also Hr’g Tr. 5, May 4, 2011.)
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As a threshold issue, defendants argue that plaintiffs’
motion for reconsideration of the Court’s denial of class
certification is now moot, as the Court recently issued an
opinion allowing defendants’ motion for summary judgment as to
all class TPP plaintiffs.

See In re Neurontin Mktg. & Sales

Practices Litig., __ F. Supp. 2d __, 2010 WL 5037005 (D. Mass.
Dec. 10, 2010).

As there are no adequate class representatives

remaining, defendants contend that the Court need not decide
plaintiffs’ motion for reconsideration.

See Cowen v. Bank United

of Texas, FSB, 70 F.3d 937, 941-42 (7th Cir. 1995) (holding that
the effect of dismissing the class representatives’ case is to
moot the question whether to certify the suit as a class action
unless the lawyers for the class manage to find another
representative).

Plaintiffs concede that in order to prevail on

their motion for reconsideration of the Court’s denial of class
certification, the Court must also reconsider its December 2010
decision on defendants’ motion for summary judgment.
After a review of the voluminous record and multiple
hearings in this multi-district litigation, the Court DENIES
plaintiffs’ motion.
I.

DISCUSSION

In the Court’s May 2009 denial of class certification, I
wrote, “TPPs exhibit a great degree of heterogeneity” in terms of
their placement of Neurontin on drug formularies.

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In re

Neurontin, 257 F.R.D. at 332.

In support of defendants’

opposition to the motion for class certification, their expert,
Dr. Gregory K. Bell, submitted a report to the Court that focused
heavily on the differences among TPP formularies, describing
their varying use of preferred and nonpreferred tiers, prior
authorization, step therapy and other tools to control the use of
pharmaceutical products by beneficiaries.
¶¶ 53-54).

Id. (citing Bell Decl.

Relying on Dr. Bell’s report, the Court concluded

Given this background information, formularies, and
hence the decision making of the P & T Committees that
created the formularies, become central to plaintiffs’
claims. To prevail, plaintiffs must prove that
defendants’ fraudulent omissions or representations
caused these committees to approve the use and
reimbursement of Neurontin for off-label indications in
a manner that was different from what would have
occurred absent the alleged fraudulent marketing.
Id. at 333.
Submissions related to this motion for reconsideration,
along with plaintiffs’ submissions opposing defendants’ motion
for summary judgment (Docket No. 1689) and the evidence produced
in the recent Kaiser trial, which is part of this multi-district
litigation, have presented a more expansive record and have
provided the Court with a more nuanced understanding of the
placement of Neurontin on drug formularies by TPPs.

It is now

undisputed that virtually every TPP initially placed Neurontin on
its drug formulary with few restrictions in the mid-1990s in
order to facilitate access to the drug for patients with
epilepsy, which was Neurontin’s sole on-label indication after it
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received FDA approval in 1993.

See Kaiser Foundation Health

Plan, Inc. v. Pfizer, Inc., 748 F. Supp. 2d 34, 40 (D. Mass.
2010).

The Court discussed the need for access to epilepsy drugs

in its recent opinion on defendants’ motion for summary judgment:
Epilepsy is considered to be a very serious condition
that, when untreated, can have significant consequences
for patients such as loss of driver's licenses and/or
employment. In addition, when patients suffer a seizure
or convulsion, they almost always need to go to the
emergency room, which drives up health costs.
Therefore, because epilepsy is difficult to treat and
has potentially disastrous consequences for patients,
TPPs were often reluctant to place any restrictions or
prior authorization measures on the anticonvulsant
class of drugs, including Neurontin.
In re Neurontin Mktg. & Sales Practices Litig., 677 F. Supp. 2d
479, 488 n.4 (D. Mass. 2010).

Contrary to my earlier

understanding from the not-so-clear-as-a Bell report, the TPPs
exhibited homogeneity in their initial decisions to place
Neurontin on the formulary in the mid-1990s.
During the recent trial, Kaiser Foundation Health Plan
presented evidence that it adopted a hands-on approach to
managing the prescribing of Neurontin after it was placed on the
drug formulary.

Kaiser regularly reviews drugs on its formulary

and produces drug monographs for off-label indications for which
a drug might be used.

Kaiser relied directly on

misrepresentations made by Pfizer in its formulations of these
drug monographs.

In this case, Kaiser also engaged in a

successful information campaign to reduce off-label prescribing
of Neurontin to its members once it learned of defendants’
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fraudulent marketing scheme.
40, 66-67.

See Kaiser, 748 F. Supp. 2d at 39-

Both the Court and the jury found that, with respect

to the Kaiser case, defendants had engaged in fraudulent
marketing of Neurontin for certain off-label indications.
Compelling evidence of fraudulent marketing was with respect to
bipolar disorder.

Id.

The question, then, is whether Kaiser was an outlier or if
it was typical of other TPPs.

The plaintiffs argue that the

typical TPP takes a hands-off approach, stating, “When prescribed
by a licensed physician, virtually every TPP in the country
reimburses for [Neurontin], and always has, never even knowing
the condition for which it was prescribed.”

(Pl.’s Mot. for

Reconsideration at 16 (citing Expert Report of Kimberly P.
McDonough).)

For example, Aetna, a large TPP, chose not to

“manage,” or monitor, prescribing of Neurontin at all once it was
placed on the drug formulary.
2d at 487-88.

See In re Neurontin, 677 F. Supp.

Aetna produced no evidence that it relied on any

misrepresentations when it made reimbursements regarding the use
of Neurontin for the treatment of bipolar disorder.

Many other

TPPs, such as the Guardian Life Insurance Company of America and
Blue Cross Blue Shield of Louisiana, relied on a pharmacy benefit
manager (“PBM”) to manage their drug formularies.

Similarly,

there is no evidence in the record that PBMs typically took a
proactive approach to managing off-label prescriptions of
Neurontin, or relied on any misrepresentations made by Pfizer.
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Defendants’ expert, Dr. Gregory Bell, initially claimed that
“there was variation in how TPPs chose to restrict - or encourage
(even after this litigation was filed) - the prescribing of
Neurontin for specific off-label uses.”
No. 1175, Ex. 35).)

(Bell Decl. ¶ 8 (Docket

He relied in large part on generalities in

the prescription drug market as opposed to specifics about the
anticonvulsant class of drugs.

(See, e.g., id. ¶ 31 (“The

insurance companies have a variety of tools at their disposal to
manage prescription benefits and there exists considerable
variability in the net reimbursement cost of prescriptions for
specific products, such as Neurontin, across TPPs and over
time.”); id. ¶ 45 (“There is substantial diversity . . .
regarding how TPPs use formularies to influence physicians’
prescribing behavior and how that may have affected the
prescribing of Neurontin.”) (emphasis added); id. ¶ 48 (“It is
thus apparent that formulary design varies among TPPs and their
clients.

As a result, Neurontin’s position on those formularies

can be expected to be different.”) (emphasis added).)
Significantly, the examples that Dr. Bell uses of restrictions
placed on Neurontin by TPPs are largely outside the class period.
(See id. ¶ 59.)

Moreover, he has never dealt with the specific

evidence in this case.
Accordingly, based on the broader record, the Court finds,
for purposes of class certification, that the greater weight of

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the evidence is that the typical TPP put Neurontin on its
formulary without restrictions due to its use as an anticonvulsant drug, and subsequently did not actively manage
Neurontin during the class period, or directly rely on any Pfizer
misrepresentations in making formulary or drug management
decisions.

See In re Initial Public Offering Secs. Litig., 471

F.3d 24, 41 (2d Cir. 2006) (holding that a district judge may
certify a class only after resolving factual disputes to make
determinations as to whether each of the Rule 23 requirements has
been met).

Thus, with respect to liability, the Court finds that

the common issues predominate over individual TPP issues.

Kaiser

represents the atypical situation.
Nonetheless, the question remains whether plaintiffs can
satisfy Rule 23(b)(3)’s predominance requirement with respect to
damages, and whether a nationwide class of TPPs is a superior way
of managing the litigation.

Fed. R. Civ. P. 23(b)(3) (“A class

action may be maintained if Rule 23(a) is satisfied and if . . .
the court finds . . . that a class action is superior to other
methods of adjudication for fairness and efficiency.”); see also
UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121, 131-32 (2d Cir.
2010) (noting that, “[i]n order to pursue their claims as a class
rather than as individual plaintiffs,” a TPP class must be able
to prove the damages suffered by “generalized proof”); cf. Hemi
Group, LLC v. City of New York, 130 S. Ct. 983, 990 (2010)

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(rejecting causation where the theory of liability relied on the
independent actions of third parties).
Plaintiffs have wisely narrowed the requested class to the
bipolar indication, their strongest case.

There was no reliable

scientific evidence to support the use of Neurontin to treat
bipolar disorder and attenuated reasons for Pfizer to detail
psychiatrists to sell Neurontin.
73-74.

See Kaiser, 748 F. Supp. 2d at

In the case of the TPP subclass here, because the TPP

plaintiffs agree that they did not rely directly on Pfizer
misrepresentations, they would need to show that the prescribing
physicians relied on fraudulent communications or suppression of
evidence by Pfizer regarding the negative clinical trials showing
Neurontin to be ineffective in treating bipolar disorder.

Class

plaintiffs must also show how much damage was caused by such
reliance.
Aggregate proof has generally been held not to be sufficient
to prove causation.

See Eli Lilly, 620 F.3d at 133-36.

In

Lilly, TPP plaintiffs argued that defendant’s misrepresentations
caused doctors to prescribe drug more often for off-label
indications, which in turn caused the TPPs to pay for more units
of that drug.

The Second Circuit wrote

The nature of prescriptions, however, means that this
theory of causation is interrupted by the independent
actions of prescribing physicians, which thwarts any
attempt to show proximate cause through generalized
proof. Plaintiffs argue that “the ultimate source for
the information on which doctors based their
prescribing decisions was Lilly and its consistent,
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pervasive marketing plan.” Lilly was not, however, the
only source of information on which doctors based
prescribing decisions. An individual patient's
diagnosis, past and current medications being taken by
the patient, the physician's own experience with
prescribing Zyprexa, and the physician's knowledge
regarding the side effects of Zyprexa are all
considerations that would have been taken into account
in addition to the alleged misrepresentations
distributed by Lilly.
Furthermore, additional variables interfere further
with plaintiffs' theory of causation. As the district
court noted, the evidence showed that at least some
doctors were not misled by Lilly's alleged
misrepresentations, and thus would not have written
“excess” prescriptions as identified by the plaintiffs.
This makes general proof of but-for causation
impossible.
Id. at 135.
In attempting to meet their burden, plaintiffs rely heavily
on Dr. Meredith Rosenthal’s analysis, which used national data
correlated with information about Pfizer’s promotional spending
to determine the percentages of Neurontin prescriptions that were
“caused” by Pfizer’s fraud.

She concluded that 99.4% of bipolar

prescriptions resulted from Pfizer’s off-label promotion.

At the

instruction of plaintiffs’ attorneys, Dr. Rosenthal assumed that
all off-label promotion was fraudulent.

Her testimony

demonstrates the likelihood of injury to TPPs from fraudulent
promotion of the use of Neurontin to treat bipolar disorder.
But, it does not suffice to demonstrate the extent of harm caused
by the fraud, as opposed to run-of-the-mill off-label detailing.
The record shows that treating physicians varied widely in
their reasons for prescribing Neurontin.
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Doctors who were

deposed during the MDL litigation testified repeatedly that they
relied on their own clinical experience or the clinical
experience of trusted colleagues, rather than Pfizer’s misleading
advertising, skewing of information in medical journals,
suppression of negative results of clinical trials, or Dear
Doctor letters distributed by the defendants during details.
While some of this testimony is not entirely credible,
particularly from heavily detailed doctors, it is significant in
light of the Court’s previous rulings in this case.

In the

Court’s December 2010 summary judgment opinion, the Court
differentiated between off-label promotion and fraudulent
promotion, finding in cases where the TPPs did not directly rely
on misrepresentations, “plaintiffs must show that the defendants’
alleged fraud caused the treating physician to prescribe
Neurontin when he or she otherwise would have used alternative
treatments.”

2010 WL 51037005, at *9.

There, the Court found

that evidence that a doctor was detailed by a Pfizer sales
representative was not sufficient to survive summary judgment,
even when the doctor’s Neurontin prescriptions increased after
the detailing visit.

The two consumer plaintiffs who survived

summary judgment were prescribed Neurontin by physicians who
received “Dear Doctor” letters that included half-truths and
misrepresentations about off-label uses of Neurontin.

In re

Neurontin, 2010 WL 5037005, at *9.
Thus, in order to differentiate those prescriptions that
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were caused by fraud from those that were attributable to nonfraudulent off-label marketing or other independent factors, a
factfinder would have to perform a granular doctor-by-doctor
analysis.

This would be unmanageable.

See Fed. R. Civ. P.

23(b)(3)(D) (stating that a district court must consider “the
likely difficulties in managing a class action” in making a
certification decision); see also Eli Lilly, 620 F.3d at 135
(rejecting causation theory of the putative class because “[a]n
individual patient’s diagnosis, past and current medications
being taken by the patient, the physician’s own experience with
prescribing Zyprexa, and the physician’s knowledge regarding the
side effects of Zyprexa are all considerations that would have
been taken into account in addition to the alleged
misrepresentations distributed by Lilly”); McLaughlin v. Am.
Tobacco Co., 522 F.3d 215, 223 (2d Cir. 2008) (in a putative
class action by smokers of “light” cigarettes against tobacco
company, the court held that because each individual consumer
might have purchased light cigarettes for any number of reasons
other than the purported health claim, individualized proof was
necessary to prove causation).
The question posed by plaintiffs’ motion, however, is very
difficult, both because Pfizer did engage in a nationwide
fraudulent marketing campaign and because there is no reliable
scientific evidence to support the use of Neurontin to treat

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bipolar disorder.1

Plaintiffs have proved that it is more likely

than not likely that they were harmed by Pfizer’s conduct because
many doctors would not have prescribed Neurontin for bipolar
disorder if they had known there was no reliable scientific
evidence supporting its use.
Still, complex issues related to calculating damages make
the class unmanageable.

The TPP subclass, even for bipolar and

mood disorders, cannot satisfy Rule 23(b)(3)'s “superiority”
requirement, and the Court will not reconsider its denial of
class certification to the TPP bipolar and mood disorder
subclass.
II.

ORDER

Having found that plaintiffs cannot satisfy the Rule
23(b)(3) superiority requirement, and in light of the fact that
there are no remaining named class representatives with viable
claims, the Court DENIES the motion for reconsideration (Docket
No. 1796).

The parties shall propose a form of judgment within

two weeks.

1

In post-judgment motions in the Kaiser case, defendants
emphasize a 1999 study by Dr. Atul Pande, which suggested that
Neurontin was an effective treatment for social phobia (a
condition that is distinct from, but often co-morbid with,
bipolar disorder), in support of their argument that Pfizer had
non-fraudulent reasons for detailing psychiatrists. (See Docket
No. 3365 at 15.) However, there is no evidence that a
significant number of the prescriptions written by psychiatrists
were for “social phobia.”
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/s/ PATTI B. SARIS
PATTI B. SARIS
United States District Judge

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