Scheinberg v. Merck & Co., Inc.

Filing 166

MEMORANDUM OPINION AND ORDER. For the reasons stated above, Defendant's motion for judgment as a matter of law is denied. Re: 156 MOTION for Judgment as a Matter of Law filed by Merck & Co., Inc. (Signed by Judge John F. Keenan on 7/1/2013) (rjm)

Case 1:09-md-02013-PAC Document 57

Filed 09/30/10 Page 1 of 45
USDC SDNY
DOCUMENT
ELECTRONICALLY FILED
DOC #: _________________
DATE FILED: July 1, 2013

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT DISTRICT YORK
UNITED STATES OF NEW COURT

x
SOUTHERN DISTRICT OF NEW YORK
IN RE:
-----------------------------------------------------------x
FOSAMAX FANNIE MAE 2008 SECURITIES
In re PRODUCTS LIABILITY LITIGATION :
LITIGATION
:
This document relates to:
:
Scheinberg v. Merck & Co., Inc.,
:
No. 08 civ. 4119 (JFK)
-----------------------------------------------------------x
--­ ---­ -­ ---­ -­ - -­ ----­ X

Master File No.
08 Civ. 7831 (PAC)
06 MD 2013 (PAC)
09 MD 1789 (JFK)
MEMORANDUM
ORDER
OPINION & & ORDER
OPINION ORDER

JOHN F. KEENAN, United States District Judge:

HONORABLE PAUL A. CROTTY, United States District Judge:
Before the Court is Defendant's motion for judgment as a
matter of law under Rule 50(b) on Plaintiff's failure to warn
BACKGROUND1
claim.

For the reasons that follow, the motion is denied.
The early years of this decade saw a boom in home financing which was fueled, among

I. Background
other things, by low interest rates and lax credit conditions. New lending instruments, such as

This was the fifth case selected for trial as a bellwether
subprime mortgages (high credit risk loans) and Alt-A mortgages (low-documentation loans)
in the In re Fosamax Products Liability Litigation multidistrict
kept the boom going. Borrowers played a role too; they took on unmanageable risks on the
litigation ("MDLII). This MDL involves claims that Fosamax, a
assumption that the market would continue to rise and that refinancing options would always be
drug designed and produced by defendant Merck Sharp & Dohme
available in the future. Lending discipline was lacking in the system. Mortgage originators did
Corp. ("Merck"), caused users of Fosamax to suffer from a
not hold these high-risk mortgage loans. Rather than carry the rising risk on their books, the
condition known as osteonecrosis of the jaw ("ONJ
In the
originators sold their loans into the secondary mortgage market, often as securitized packages
instant case, plaintiff Rhoda Scheinberg ("Scheinberg" or
known as mortgage-backed securities (“MBSs”). MBS markets grew almost exponentially.
"Plaintiff") brought strict liability and negligence claims on
But then the housing bubble burst. In 2006, the demand for housing dropped abruptly
theories of design defect and failure to warn, in addition to
and home prices began to fall. In light of the changing housing market, banks modified their
claims for fraudulent misrepresentation and concealment, and
lending practices and became unwilling to refinance home mortgages without refinancing.
breach of express and implied warranty.
She also sought
II

).

punitive damages.
1

Scheinberg began taking Fosamax in 2000, and

Unless otherwise indicated, all references cited as “(¶ _)” or to the “Complaint” are to the Amended Complaint,
dated Junetaking For purposes of this Motion, all allegations in the Amended Complaint are taken as true.
continued 22, 2009. it through 2006. Her prescribing physician

1

between 2004 and 2006 was Dr. Dunn.

~

(Def. 56.1

1.)

On October

30, 2006, Plaintiff had a tooth extraction and subsequently
suffered from delayed healing.

(Id. "3-4.)

Plaintiff's

expert, Dr. Richard Kraut, opined that the delay Scheinberg
experienced in healing from the tooth extraction was ONJ, and
that her use of Fosamax caused it.
Plaintiff, Dr. Suzanne Parisian

l

Another expert proffered by

testified that the Fosamax

label was insufficient to warn of the risk of ONJ.
Prior to trial, Defendant moved for summary judgment on all
claims.

The Court granted the Defendant's motion with respect

to Plaintiff's claims for breach of warranty, fraudulent
misrepresentation and concealment, and punitive damages

I

but

denied it with respect to Plaintiff's claims for design defect
and failure to warn.
Merck twice moved for judgment as a matter of law during
trial pursuant to Rule 50(a):

at the close of Plaintiff's case,

and again after both sides rested.

The Court denied both

motions and the case was submitted to the jury.

On February 5,

2013, the jury returned a verdict in favor of Merck on the
design defect claim and in favor of Scheinberg on the failure to
warn claim, awarding Scheinberg $285,000.
II. Discussion

Merck timely filed the instant motion pursuant to Rule
50(b) on March 5, 2013.

It contends that it is entitled to
2

judgment as a matter of law on Plaintiff's failure to warn
claim.
A. Rule 50

"Under Rule 50{a), a party may move for judgment as a
matter of law during trial at any time prior to the submission
of the case to the jury." Galdieri-Ambrosini v. Nat'l

&

Dev. Corp., 136 F.3d 276, 286 (2d Cir. 1998); see Fed. R. Civ.
P. 50(a).

Under Rule 50(b)

if the Court does not grant the

t

Rule 50(a) motion at the close of evidence, the moving party may
renew its motion for judgment as a matter of law under Rule
50{b) within 25 days of an unfavorable judgment, but it "is
limited to those grounds that were specifically raised in the
prior [Rule 50(a) motion]." Galdieri-Ambrosini, 136 F.3d at 286;
see Fed. R. Civ. P. 50(b).
The movant faces a "high bar," Lavin-McEleney v. Marist
ColI., 239 F.3d 476, 479 (2d Cir. 2001)

i

motions for judgment as

a matter of law "should be granted cautiously and sparingly."
Me off v.

.Y. Life Ins. CO'

I

240 F.3d 138, 145 (2d Cir. 2001).

In deciding the motion, the Court "must view the evidence in a
light most favorable to the non-movant and grant that party
every reasonable inference that the jury might have drawn in its
favor." Merrill Lynch Interfunding, Inc. v. Argenti
113

1

120-21 (2d Cir. 1998)

504,
_...c:.-;;-,-,---,,--,--­

l

155 F.3d

(quoting Samuels v. Air Transport

992 F.2d 12, 14 (2d Cir. 1993».
3

The Court "may not

itself weigh the credibility of witnesses or consider the weight
of the evidence." Galdieri-Arnbrosini, 136 F.3d at 286.

The

Court may properly grant such a motion only where it "finds that
a reasonable jury would not have a legally sufficient
evidentiary basis to find for" the non-movant. Fed. R. Civ. P.
50(a)

i

see Arlio v. Lively, 474 F.3d 46, 51 (2d Cir. 2007)

(holding that judgment as a matter of law should be granted when
"the evidence, viewed in the light most favorable to the
nonmoving party is insufficient to permit a reasonable juror to
find in [the non-moving party's] favor").
B. Analysis
Merck argues that it is entitled to judgment as a matter of
law because the Fosamax label was sufficient under New York law.
According to Merck, the label warned doctors of the "precise
malady" incurred by plaintiff, which is the New York standard.
Therefore, Merck avers, no reasonable juror could have concluded
that the label was inadequate.

Merck points to nine cases where

labels that include the "precise malady" alleged by Plaintiff
were determined adequate as a matter of law.
Merck is correct that courts applying New York law have
held that "prescription medicine warnings are adequate when
. information regarding the precise malady incurred was
communicated in the prescribing information." Alston v. Caraco
Pharm.

Inc., 670 F. Supp. 2d 279, 284-85 (S.D.N.Y. 2009)
4

i

see

~

1999)

Sita v. Danek Med., Inc., 43 F. Supp. 2d 245, 260

(E.D.N.Y.

(granting summary judgment to drug manufacturer where

manufacturer had warned physician "against the precise usage and
injuries in question").

But a warning is not automatically

sufficient simply because it includes certain "magic words."
While "the language

these decisions might at first seem to

indicate that a manufacturer satisfies its duty to warn of a
drug's side effects simply by mentioning those side effects in
the drug's label," courts have recognized the importance of
considering "not merely the existence of a pertinent warning,
but also the qualitative adequacy of the warning. DiBartolo v.
Abbott Laboratories, No. 12 Civ. 900, 2012 WL 6681704 at *7
(S.D.N.Y. Dec. 21, 2012).
Indeed, in determining whether a warning is adequate as a
matter of law, the court should "evaluate the [warning] 's
language for its accuracy, clarity and relative consistency.n
Martin v. Hacker, 83 N.Y.2d I, 11 (1993).

A warning is accurate

if it is "correct, fully descriptive and complete, and . .
convey[s] updated information as to all of the drug's known side
effects.n Id.

(citation omitted).

It is clear if it employs

language that is "direct, unequivocal and sufficiently forceful
to convey the risk.n Id.

An otherwise clear warning "may be

obscured by inconsistencies or contradictory statements made in
different sections of the package insert regarding the same side
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effect or from language in a later section that dilutes the
intensity of a caveat made in an earlier section." Id.

A

warning with such contradictions may nonetheless be adequate "if
the language of a particular admonition against a side effect is
precise, direct, and unequivocal and has sufficient force." Id.
at 12.

Courts must evaluate the entire warning, as any

vagueness that appears from reading individual sentences in
isolation "may be overcome if, when read as a whole, the warning
conveys a meaning as to the consequences that is unmistakable."
Id.
Merck has emphasized the phrase "precise malady," while
disregarding the other elements set forth in New York.

The

Court does not accept that simply because the Fosamax label
mentions the malady "osteonecrosis of the jaw," it is sufficient
as a matter of law.

Rather, whether the name of the malady

incurred by Plaintiff was included is but one consideration in
evaluating the Fosamax label "as a whole."
Merck attempts to support its position by citing to a
multitude of cases that apply New York law, despite conceding
that failure to warn is a fact-specific inquiry.

It relies

heavily on Martin v. Hacker, 83 N.Y.2d 1 (1993), a case in which
the Court of Appeals affirmed the lower court's grant of summary
judgment on Plaintiff's f

lure to warn claim.

another court more recently noted,
6

However, as

"in the Martin case the Court

of Appeals considered a situation where the plaintiff presented
no expert evidence as to the adequacy of the manufacturer's
warning and therefore the court held the warning adequate based
on its analysis.· Smith v. Johnson & Johnson Co., 800 N.Y.S.2d
357 (Table)

(Sup. Ct. 2004).

The court in Smith found that

"Plaintiff's submission of an expert opinion as to the
inadequacy of defendants' warnings is sufficient to raise an
issue of fact precluding summary judgment where the alleged
deficiency in the warnings is related to the condition which is
alleged to have caused the decedent's death." rd.

This case is

distinguishable from Martin for the same reason set forth in
Smith:

Plaintiff called an expert witness.

New York courts have routinely advised that the sufficiency
of a label is a factual determination to be made by a jury.
"Under New York law, the jury does not need expert testimony to
find a label inadequate, but may use
considering all the circumstances.·
and

s own judgment
Billiar v. Minnesota Min.

Co., 623 F.2d 240, 247 (2d Cir. 1980).
The jury was presented with testimony regarding all aspects

of the Fosamax label.

Dr. Dunn and Dr. Parisian testified on

the issue of Fosamax's efficacy for patients with low body mass
but without vertebral fractures.

Dr. Parisian testified that

the label failed to include information about the "limited
efficacy· of Fosamax.

(Tr. at 1094:4-1096:14).
7

Dr. Dunn

testified that if she had been aware that the risk of ONJ in
Fosamax users increases as the duration of use increases, she
would not use Fosamax.

(Tr. at 892:25-893:14.)

Dr. Dunn later

reiterated that if she had known that Fosamax was less effective
for patients with a T-score of better than
taken Scheinberg off Fosamax.

2.5, she would have

(Tr. at 902:19-903:11.)

The jury also heard testimony from Dr. Parisian and Dr.
Dunn that the label was inadequate.

As discussed above, a

factor to be considered in a failure to warn claim is whether
the label is "sufficiently forceful to convey the risk." Martin,
83 N.Y.2d at 11

During her testimony, Dr. Parisian questioned

whether the label properly conveyed the causal relationship
between Fosamax and ONJ, noting that the label did not make
clear that there had been reports of ONJ by patients taking
Fosamax.

Dr. Parisian said the following about the 2005 label:

Well, it doesn't convey that it's been associated with
Fosamax and ONJ.
It doesn't convey that it's been
associated with an oral bisphosphonate like Fosamsax.
It
doesn't talk about the seriousness or didn't talk about the
adverse event reports that the company's receiving.
So it
doesn't convey the information that the company has in
terms of their documents about the risk of ONJ.
(Tr. at 1077:17-19-1079:9.)

Similarly, Dr. Dunn testified that

the label did not inform her of the severity or seriousness of
ONJ.

(Tr. at 892:22 24.)

Both doctors testified at length about

the fact that the label did not convey the seriousness and

8

frequency of ONJ among Fosamax users.

This testimony was

properly submitted to the jury as evidence of failure to warn.
Finally, the jury was presented with testimony from Dr.
Parisian about other drugs' labels that addressed ONJ and oral
bisphosphonates.

Under New York law, evidence that a

manufacturer "diluted" a label or introduced confusion or
inconsistencies is relevant to the failure to warn inquiry.

The

Plaintiff introduced evidence to show that the FDA had suggested
a label change to include language that most cases of ONJ "have
been in patients treated with bisphosphonates intravenously, but
some have been in patients treated orally."
that Merck rejected this proposed change.

The jury learned
Dr. Parisian also

spoke to the jury about the labels that were used by Fosamax
competitors, namely Actonel and Boniva.

These drug labels

reflected the FDA's proposed language almost verbatim.

In

considering the competitors' labels and the suggestions made by
the FDA, a reasonable juror could have concluded that Merck's
ONJ precaution was inadequate.

Indeed, as the Court noted in

its Daubert opinion, "jurors will be able to read the labels and
conduct this comparison on their own."
It is worth noting that the jury, which Merck now contends
was "unreasonable," returned a verdict in Merck's favor on the
design defect claim.

Additionally, in finding Merck liable on a

failure to warn theory, it awarded Plaintiff only a modest
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amount in damages.

It would be a gross abuse of discretion for

the Court to find only a portion of the jury's verdict
unreasonable, eschewing evidence that the jury prudently weighed
the case presented to them.

III. Conclusion

For the reasons stated above, Defendant's motion for
judgment as a matter of law is denied.

SO ORDERED.

Dated:

New York, New York
July I, 2013

United States District Judge

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