Scheinberg v. Merck & Co., Inc.
Filing
86
OPINION AND ORDER re: (26 in 1:08-cv-04119-JFK) MOTION to Set Aside Expert Testimony by Dr. Suzanne Parisian on Daubert Grounds, filed by Merck & Co., Inc., (23 in 1:08-cv-04119-JFK) MOTION to Set Aside Expert Testimony on Daubert Grounds, filed by Merck & Co., Inc., (29 in 1:08-cv-04119-JFK) MOTION for Summary Judgment, filed by Merck & Co., Inc. For the reasons stated above, Defendant's motion for summary judgment is granted with respect to Plaintiff's claims for breach of warranty, fraudulent misrepresentation and concealment, and punitive damages, but denied with respect to Plaintiff's claim for design defect and failure to warn. Merck's motions to preclude expert testimony are granted in part and denied in part. Plaintiff's motion to preclude expert testimony is granted in part and denied in part. (Signed by Judge John F. Keenan on 1/7/2013) (ja)
Case 1:09-md-02013-PAC Document 57
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
UNITED STATES DISTRICT COURT
--------------------------------------SOUTHERN DISTRICT OF NEW YORK
IN RE:
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FOSAMAXrePRODUCTS LIABILITY LITIGATION :
In FANNIE MAE 2008 SECURITIES
--------------------------------------LITIGATION
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This document relates to:
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Scheinberg v. Merck & Co., Inc.,
:
No. 08 Civ. 4119 (JFK)
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Filed 09/30/10 Page 1 of 45
USDC SDNY
DOCUMENT
ELECTRONICALLY FILED
DOC #: _________________
DATE FILED: Jan. 7, 2013
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Master7831 (PAC)
08 Civ. File No.
06 MD 1789(PAC)
09 MD 2013 (JFK)
OPINION & ORDER
OPINION & ORDER
APPEARANCES
HONORABLE PAUL A. CROTTY, United States District Judge:
For Plaintiff Rhoda Scheinberg:
LEVIN, PAPANTONIO, THOMAS, MITCHELL, RAFFERTY &
PROCTOR, P.A.
BACKGROUND1
By: Timothy M. O’Brien, Esq.
Brandon L. Bogle, Esq.
The early years of this decade saw a boom in home financing which was fueled, among
For things, by low interest rates and lax Dohme Corporation:
other Defendant Merck Sharp & credit conditions. New lending instruments, such as
HUGHES HUBBARD & REED LLP
subprime mortgages (high credit risk loans) and Alt-A mortgages (low-documentation loans)
By: Theodore V. H. Mayer, Esq.
William J. Beausoleil, Esq.
kept the boom going. Julia R. Zousmer, Esq. took on unmanageable risks on the
Borrowers played a role too; they
VENABLE would
assumption that the marketLLP continue to rise and that refinancing options would always be
By: Paul F. Strain, Esq.
available in the future.David J. Heubeck,lacking in the system. Mortgage originators did
Lending discipline was Esq.
Stephen E. Marshall, Esq.
not hold these high-risk mortgage loans. Rather than carry the rising risk on their books, the
JOHN F. KEENAN, United States District Judge:
originators sold their loans into the secondary mortgage market, often as securitized packages
I. The Motions
known as mortgage-backed securities (“MBSs”). MBS markets grew almost exponentially.
This is the fifth case selected for trial as a bellwether
But then the housing bubble burst. In 2006, the demand for housing dropped abruptly
in the In re Fosamax Products Liability Litigation multidistrict
and home prices began to fall. In light of the changing housing market, banks modified their
litigation. This MDL involves claims that Fosamax, a drug
lending practices and became unwilling to refinance home mortgages without refinancing.
designed and produced by defendant Merck Sharp & Dohme Corp.
(“Merck”), caused users of Fosamax to suffer from a condition
1
Unless otherwise indicated, all references cited as “(¶ _)” or to the “Complaint” are to the Amended Complaint,
known dated June 22, 2009. For purposes of this Motion, all allegations in the Amended Complaint are taken as true.
as osteonecrosis of the jaw (“ONJ”). In the instant case,
plaintiff Rhoda Scheinberg (“Scheinberg” or “Plaintiff”) brings
1
strict liability and negligence claims on theories of design
defect and failure to warn, in addition to claims for fraudulent
misrepresentation and concealment, and breach of express and
implied warranty.
Plaintiff also seeks punitive damages.
Before the Court are four motions:
(1) Merck’s motion for
summary judgment against Plaintiff on all claims; (2) Merck’s
motion to preclude Plaintiff’s proposed expert testimony of Dr.
Suzanne Parisian; (3) Merck’s motion to preclude Plaintiff’s
proposed expert testimony of Drs. Sanford Buch and Andrew
Breiman; and (4) Plaintiff’s motion to preclude Merck’s proposed
expert testimony from Drs. Barry Gruber and Robert Glickman.
For the reasons set forth below, Merck’s motion for summary
judgment is granted with respect to Plaintiff’s claims for
breach of warranty, fraudulent misrepresentation and
concealment, and punitive damages, but denied with respect to
Plaintiff’s claim for design defect and failure to warn.
Merck’s motions to preclude expert testimony are granted in part
and denied in part.
Plaintiff’s motion to preclude expert
testimony is granted in part and denied in part.
II.
Background
Defendant Merck is a New Jersey-based pharmaceutical
company that makes and distributes the drug alendronate sodium
under the brand name Fosamax.
Fosamax is one of several drugs
known as “bisphosphonates,” and is taken orally, rather than
2
intravenously as are some other bisphosphonates.
Fosamax was
originally approved by the FDA for the treatment of
postmenopausal osteoporosis and Paget’s disease in 1995, and the
FDA has since approved it for additional uses.
Plaintiff contends that Merck has long known of reports
linking bisphosphonate use with the development of ONJ.
According to Plaintiff, Merck was aware that Fosamax could cause
ONJ before Scheinberg suffered her injuries, and Merck failed
adequately to warn the medical community of this risk.
Plaintiff references various adverse event reports suggesting
complications allegedly related to ONJ in persons being treated
with Fosamax, as well as twenty later, more definitive reports
in the 2003-2005 timeframe that Fosamax users were experiencing
symptoms of ONJ.
Merck claims that after receiving reports that Fosamax
users were developing ONJ, its various research teams began to
investigate the reports by calling physicians and attempting to
ascertain “background rates” for the incidence of ONJ in the
population of those who do not use Fosamax.
These research
teams first recommended that Merck change its label to include
an ONJ warning in January 2005.
Eventually, after seeking FDA
approval, Merck modified its label in July 2005, to inform the
public that:
“Osteonecrosis of the jaw, generally associated
3
with tooth extraction and/or local infection, often with delayed
healing, has been reported in patients taking bisphosphonates.”
Scheinberg began taking Fosamax in 2000, and continued
taking it through 2006.
Her prescribing physician between 2004
and 2006 was Dr. Dunn. (Def. 56.1 ¶ 1.)
On October 30, 2006,
Plaintiff had a tooth extraction, after consultation with her
dentist, Dr. Rinaudo and an oral surgeon, Dr. Buch. (Id. ¶¶ 34.)
Plaintiff’s proffered expert, Dr. Richard Kraut, has opined
that the delay Plaintiff experienced in healing from the tooth
extraction was ONJ, and that her use of Fosamax “was a major
contributing factor to her development of ONJ.” (Kraut Report at
8.)
Dr. Kraut also stated that to avoid the onset of ONJ,
Scheinberg would have needed to stop taking Fosamax at least six
months before her tooth extraction, or April 30, 2006. (Kraut
Depo. at 141:2-25, 148:25-149:7.)
III. Defendant’s Motion for Summary Judgment
The parties do not dispute that Plaintiff’s claims are
governed by New York law.
The Court notes that Scheinberg is a
resident of New York. (Compl. ¶ 1.)
A. Design Defect
Merck argues that summary judgment is warranted on
Scheinberg’s design defect claim because she has not presented
any expert testimony that there was a feasible design
alternative.
4
In response, Plaintiff suggests that under New York law, a
feasible design alternative is only one of many factors for a
jury to consider in a design defect claim. Voss v. Black &
Decker Mfg. Co., 450 N.E.2d 204, 208-09 (N.Y. 1983).
In any
event, Plaintiff states, she has adduced evidence of two
alternative designs that Merck could have employed.
First,
Plaintiff avers that for patients like Scheinberg, whose Tscores were better than -2.5, the placebo is just as effective,
and therefore it could constitute a feasible alternative design.
Second, Plaintiff asserts that Dr. Parisian has testified that
Merck should have included a warning about ONJ on its packaging.
As such, Plaintiff proffers that a feasible design alternative
could be the same product (Fosamax), repackaged to include a
much stronger warning.
Under New York law, a plaintiff may recover for a design
defect by showing that the product, as designed, was not
reasonably safe and that the defective design was a substantial
factor causing the plaintiff’s injury. See id. at 108–09.
To
recover under a theory of strict products liability for sale of
a defectively designed product, “it is well established that a
plaintiff must plead and prove that there was a feasible design
alternative that would have made the product safer.” Daley v.
McNeil Consumer Products Co., a Div. of McNeil-PPC, Inc., 164
F.Supp.2d 367, 374 (S.D.N.Y. 2001).
5
Despite Plaintiff’s assertion that he is not required to
prove evidence of alternative machine designs, the Second
Circuit case which she cites for that proposition specifically
provides that “it is true that the plaintiff carries the burden
of showing that an alternative design was feasible and safer,”
in connection with a claim for design defect. Urena v. Biro
Manu. Co., 114 F.3d 359, 365 (2d Cir. 1997).
Indeed, Urena held
only that the plaintiff in that case was able to meet the burden
without considering the testimony of his proposed expert. Id.
Plaintiff has misinterpreted the law as to whether evidence
of a feasible alternative design is a prerequisite for a design
defect claim.
However, she is correct in asserting that a
different label on the outside of the Fosamax container would be
a sufficient “feasible alternative design,” the adequacy of
which is for the jury to decide.
Indeed, the Second Circuit has
held that testimony as to whether a manufacturer could “have
added a sticker or other warning to the machine which would have
made clear” the risk associated with using the product is
sufficient evidence of a feasible alternative design. Urena, 114
F.3d at 365.
Therefore, summary judgment as to the design
defect claim is denied.
B. Failure to Warn
Merck next argues that it is entitled to summary judgment
on Scheinberg’s failure to warn claim because (1) no warning
6
would have changed Scheinberg’s doctors’ prescribing decisions
and (2) Merck’s warnings were sufficient as a matter of law.
In
support of this argument, Merck points to Dr. Dunn’s statements
that Merck’s 2005 label change “apprised” her of the “possible
risk of necrosis of the jaw for patients [who] take Fosamax.”
(Dunn Depo. 138, 246.)
Dr. Dunn also stated that even the 2012
Fosamax label “would not have changed [her] decision to continue
[Plaintiff] on Fosamax from 2004 to 2006.” (Id.)
Plaintiff responds that Merck has misread Dunn’s testimony,
pointing to another two statements Dr. Dunn made:
first, that
if she had “been aware in 2005 or 2006 that Fosamax can induce
death of the jaw bone,” she may have changed her prescribing
practices; second, that a “Dear Doctor” letter would have made
her aware that patients like Scheinberg were at risk for ONJ.
Specifically, Dr. Dunn testified that if she had received a
“Dear Doctor” letter, she would have prescribed Fosamax less
frequently, particularly to patients with suboptimal oral health
or who may need a tooth extraction. (Dunn Depo. 193-94.)
Moreover, Plaintiff maintains that the 2005 label was
inadequate as a matter of law, as there is sufficient evidence
that Merck failed to warn both the medical community as a whole
and Scheinberg’s prescribing physician about the risk of ONJ.
Plaintiff further states that Merck did not take the additional
steps necessary – such as distributing a “Dear Doctor” letter –
7
to convey the risks associated with Fosamax to the medical
community.
To support these allegations, Plaintiff points to
testimony from Dr. Parisian and Dr. Dunn, both of whom
underscored the importance of a “Dear Doctor” letter.
Under New York law, a failure to warn claimant must show
(1) that a manufacturer has a duty to warn (2) against dangers
resulting from foreseeable uses about which it knew or should
have known and (3) that failure to do so was the proximate cause
of harm.
Failure to warn claims are analyzed the same way under
strict liability and negligence theories of recovery. See
Anderson v. Hedstrom Corp., 76 F. Supp. 2d 422, 439 (S.D.N.Y.
1999) (“Where liability is predicated on failure to warn, New
York views negligence and strict liability claims as
equivalent.”); see also Denny, 87 N.Y.2d at 258 (“Failure to
warn claim . . . couched in terms of strict liability, is
indistinguishable from a negligence claim.”).
New York’s “heeding presumption” dictates that the Court
must presume that a user would have heeded warnings if they had
been provided, and that the injury would not have occurred. See
Anderson, 76 F. Supp. 2d at 441.
This presumption may only be
rebutted by specific facts showing that the warning would have
been futile. See id.
Given Dr. Parisian’s testimony that the 2005 label change
was inadequate, the only issue on summary judgment is whether
8
Plaintiff has established proximate cause.
To establish
proximate causation in a failure to warn claim resulting from a
pharmaceutical product, a plaintiff must show that an
appropriate warning would have affected the course of treatment
of the plaintiff’s physician. In re Fosamax Prods. Liab. Litig.,
No. 06-MD-1789, 2010 WL 1257299, at *5 (S.D.N.Y. March 26,
2010).
Although Merck would have the Court consider only Dr.
Dunn’s testimony that supports its position, the fact remains
that she has provided conflicting testimony on whether
additional information about Fosamax would have impacted her
decision making.
Dr. Dunn told attorneys that if she had “been
aware in 2005 or 2006 that Fosamax can induce death of the jaw
bone,” she would have changed her prescribing practices, yet
also testified that the label “apprised” her of the risk of ONJ.
There is obviously a question of fact as to whether different
warnings could have changed Dr. Dunn’s prescribing practice.
It
is for the jury to decide which of her statements to credit. See
Liriano, 92 N.Y.2d at 243 (noting that failure to warn is
typically a fact-intensive inquiry for the jury to decide).
C. Breach of Warranty (Express and Implied)
In moving for summary judgment on the breach of express
warranty claim, Merck argues that it never made any affirmative
statements of fact in connection with Fosamax.
9
Moreover, Merck
notes, the Plaintiff herself admitted that she did not see any
advertisements for Fosamax.
Plaintiff responds that simply because Plaintiff did not
see any advertisements for Merck does not mean that Merck did
not make any express warranties.
In a declaration dated
December 7, 2012, Scheinberg asserts that she “recalls reading”
the Fosamax patient handout from 2000.
Scheinberg further
states that she relied upon the misrepresentation that Fosamax
would prevent fractures, and that if she knew this were false,
she would not have continued taking Fosamax. (Scheinberg Decl.
Dec. 7, 2012.)
This testimony, according to Plaintiff,
establishes that she received an express warranty from Merck.
To state a claim for breach of express warranty, the
plaintiff must show that there was an “affirmation of fact or
promise by the seller, the natural tendency of which [was] to
induce the buyer to purchase, and that the warranty was relied
upon.” Schimmenti v. Ply Gem Indus., Inc., 156 A.D.2d 658 (2d
Dep’t 1989) (quoting Friedman v. Medtronic, Inc., 42 A.D.2d 185
(2d Dep’t 1973)).
Plaintiff testified at deposition that she never read the
2005 patient handout, and did not see any advertisements. The
colloquy went as follows:
Q. I assume you don’t recall when you first heard about
Fosamax. Right?
A. As a drug to take?
10
Q. At all, the first time you ever heard the word Fosamax.
A. I don’t remember, but I remember having a conversation
with someone and it was supposed to be the wonder drug on
the market.
Q. The wonder drug on the market for what?
A. For helping your bones.
Q. And you don’t remember if that conversation was with Dr.
Hupart or with Dr. Kaplan?
A. No. I can’t help you.
Q. Do you remember ever doing any research on your own into
Fosamax?
A. When I was taking it? No.
Q. You indicated in your profile form that you never saw
any advertisements, commercials, or other types of
advertisements for Fosamax before you started taking it.
A. No, I’ve never – I never saw it while I was taking it
either.
(Scheinberg Depo. 218-19.)
Plaintiff’s recently executed declaration states that she
read the patient insert when she began taking the medication.
“In reading the patient insert, it informed me and I understood
from reading it that Fosamax would prevent fractures in patients
like me.” (Scheinberg Decl. Dec. 7, 2012)
She goes on to say
that she relied on this information in taking Fosamax, and that
she would not have taken it if she had known that it did not
prevent fractures.
Under the law in this Circuit, a Court considering a motion
for summary judgment may not rely on an affidavit that
contradicts a party’s deposition testimony. Mack v. United
States, 814 F.2d 120, 124 (2d Cir. 1987) (“It is well settled in
this circuit that a party’s affidavit which contradicts his own
prior deposition testimony should be disregarded on a motion for
11
summary judgment”); Raskin v. The Wyatt Company, 125 F.3d 55, 63
(2d Cir. 1997) (“[W]e follow the rule that a party may not
create an issue of fact by submitting an affidavit in opposition
to a summary judgment motion that, by omission or addition,
contradicts the affiant’s previous deposition testimony.”).
In
the present case, there is a conflict between the plaintiff’s
sworn testimony and her affidavit.
The former indicates that
plaintiff did not receive any express warranties from Merck,
while the affidavit drafted for this motion avers the contrary.
The Court treats plaintiff’s deposition testimony as true for
purposes of this motion.
Accordingly, Plaintiff has failed to
demonstrate that Merck made an affirmation of fact upon which
she relied.
Plaintiff’s motion for summary judgment on the
express warranty claim is therefore denied.
Merck next argues that it is entitled to summary judgment
on the breach of implied warranty claims because the Plaintiff
has failed to show that Fosamax was not minimally safe.
Merck
proffers that 270 reported cases of ONJ among millions of users
of Fosamax is not a significant incidence rate.
Merck argues
that the Plaintiff has presented no authority for the
proposition that such a low number of reports of ONJ should lead
a court to conclude that the product is not minimally safe.
Plaintiff responds that there are issues of fact related to
whether Fosamax is minimally safe, proffering that the incidence
12
rate of ONJ among Fosamax users is not as infinitesimal as Merck
suggests.
Indeed, Plaintiff avers, peer-reviewed prevalence
studies reveal a higher incidence rate:
a study by the
University of Southern California put the incidence rate at 4%
while the National Institutes of Health found that 1 in 952
Fosamax users contracted ONJ.
Moreover, Plaintiff cites various
New York cases for the proposition that courts should not
require a certain number of adverse events per capita before
determining whether a product is minimally safe.
A manufacturer may be held liable under New York law for
breach of implied warranty when its products are not “fit for
the ordinary purposes for which such goods are used.” N.Y.
U.C.C. § 2–314(2)(c).
Specifically, a Plaintiff may recover
“upon a showing that [a] product was not minimally safe for its
expected purpose,” and the focus of a breach of implied warranty
inquiry is whether the product meets “the expectations for the
performance of the product when used in the customary, usual and
reasonably foreseeable manners.” Denny, 87 N.Y.2d at 258–59.
Accordingly, summary judgment on the implied warranty claim
hinges on whether Fosamax was “minimally safe.”
As an initial
matter, the Court notes that it has previously found that “the
risk for ONJ is small.”
The Court has further found that
The FDA approved Fosamax in 1995 for the treatment of
osteoporosis and Paget’s disease and in 1997 for the
prevention of osteoporosis. Fosamax was the first of three
13
nitrogen-containing bisphosphonates approved for oral
administration to treat these conditions. Since their
market introduction, oral bisphosphonates have been
prescribed by doctors over 225 million times. The efficacy
of these drugs in arresting bone loss and reducing the risk
of fracture in osteoporotic persons is well-established.
In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 171
(S.D.N.Y. 2009).
In opposing the instant motion for summary
judgment, Plaintiff has failed to adduce sufficient evidence for
the Court to find that Fosamax is not minimally safe, given that
millions of prescriptions for Fosamax have been issued, and that
Fosamax has been proven effective for fracture reduction.
The
incidence rate of ONJ among Fosamax users is so low that no
reasonable juror could conclude that Fosamax was not minimally
safe. See Daley v. McNeil Consumer Prods. Co., 164 F. Supp. 2d
367, 374 (S.D.N.Y. 2001) (granting summary judgment on
Plaintiff’s breach of implied warranty claim on the grounds that
no more than a small “fraction of potential users” reported an
adverse reaction).
Therefore, Merck is entitled to summary
judgment on the breach of implied warranty claim.
D. Fraudulent Concealment and Fraudulent Misrepresentation
Merck next moves for summary judgment on Plaintiff’s
fraudulent misrepresentation and concealment claims.
The
Complaint alleges that Merck made two misrepresentations that
concealed two valuable pieces of information.
First, Plaintiff
avers that Merck falsely represented that Fosamax was safe for
14
osteoporosis and Paget’s disease, which concealed Fosamax’s
substantial risks.
Second, Plaintiff states that Merck falsely
represented that Fosamax was safer than the alternatives on the
market, concealing the fact that it was not safer than
alternatives.
According to Merck, there is no evidence that
either of those statements is false.
To state a claim for fraudulent misrepresentation under New
York law, a plaintiff must show: “(1) the defendant made a
material false representation, (2) the defendant intended to
defraud the plaintiffs thereby, (3) the plaintiffs reasonably
relied upon the representation, and (4) the plaintiffs suffered
damage as a result of their reliance.” Swersky v. Dreyer &
Traub, 219 A.D.2d 321 (N.Y. 1996).
A claim for fraudulent
concealment requires the same showing as that for fraudulent
misrepresentation, with the additional requirement that the
plaintiff must demonstrate that the defendant had a duty to
disclose material information. See Banque Arabe, 57 F.3d at 153;
Allied Irish Banks, P.L.C. v. Bank of America, N.A., No. 03 Civ.
3748, 2006 WL 278138, at *6 (S.D.N.Y. Feb. 2, 2006).
For both
forms of fraud, the element of damage includes a requirement
that the plaintiff establish proximate causation. See, e.g.,
Hunt v. Enzo Biochem, Inc., 471 F. Supp. 2d 390, 399-400
(S.D.N.Y. 2006) (stating that a claim of common law fraud under
New York law “requires a showing of proximate causation”).
15
Plaintiff has failed to show that Merck’s statement that
Fosamax is “safe and effective for the treatment of osteoporosis
and Paget’s disease” is false.
Specifically, there is no
evidence that Fosamax is ineffective in treating those diseases.
As the Court has found, “[b]y all estimates, the risk of
developing ONJ while taking an oral bisphosphonate for
osteoporosis is very small.” In re Fosamax Prods. Liability
Litig., 645 F. Supp. 2d at 171.
Moreover, Dr. Dunn has testified that she was “apprised” of
the possible risk of ONJ, invalidating Plaintiff’s assertion
that Merck concealed information of the risk of ONJ from
prescribing physicians.
Therefore, Merck is entitled to summary
judgment on the fraudulent concealment and misrepresentation
claims.
E. Punitive Damages
Merck argues that punitive damages are reserved only for
the “singularly rare cases” in which the Defendant is proven to
have acted intentionally or with wanton disregard.
Merck
reminds the Court that it has twice ruled that Merck’s conduct
before the 2005 label change was not wanton or intentional.
Merck urges that the fact that it issued a label change in 2005
provides even more support for the assertion that it did not
“consciously disregard” the safety of others.
16
Plaintiff insists that Merck acted willfully because New
York law provides that fraud may be predicated on a defendant’s
“concealment, if the defendant had a duty to disclose.”
Plaintiff states that Merck continually and systematically
“grossly overstated the efficacy of Fosamax” in an attempt to
“shift the treatment threshold” and persuade doctors to
prescribe Fosamax to more patients.
Plaintiff also points to
evidence that the FDA issued warnings to Fosamax about its
“misleading” advertisements.
Finally, Plaintiff states that
Merck delayed changing the label and “cooked the books” in an
attempt to downplay the incidence of ONJ.
There is no additional evidence in this case to cause the
Court to permit this Plaintiff to assert a claim for punitive
damages.
In denying punitive damages on theories of intentional
and grossly negligent conduct in Boles, the Court found “no
evidence – let alone clear and convincing evidence – that Merck
had ‘actual knowledge’ of the ‘high probability’ that Fosamax
would cause Boles to develop ONJ.” In re Fosamax Prods. Liab.
Litig., 647 F. Supp. 2d 265, 284 (S.D.N.Y. 2009).
Boles
involved a claimed injury date of September 2003, and at that
point in time the only evidence of any possibility that Fosamax
caused ONJ included “a handful of reports of exostosis from the
mid- to late-1990s.” Id.
Here, Plaintiff has not presented any
additional evidence that would lead the Court to believe
17
punitive damages are appropriate.
Indeed, Merck had taken more
steps with respect to informing the medical community of adverse
events by the time of Scheinberg’s injury.
Given the small number of ONJ cases relative to the total
number of Fosamax users, there is no evidence in this case
suggesting that Merck concealed information about the efficacy
of Fosamax.
There is no evidence to suggest that Merck had an
awareness of a “high probability” that Fosamax caused ONJ, and
Plaintiffs’ assertions that Merck simply ignored the reports of
ONJ are without merit.
On the evidence presented by Plaintiff,
no reasonable jury could conclude that Plaintiff would be
entitled to punitive damages.
Therefore, Merck’s motion for
summary judgment is granted with respect to Plaintiff’s claims
for punitive damages.
IV. Defendant’s Daubert Motions
A.
Legal Standard
The presentation of scientific and technical knowledge or
opinion testimony by a “witness qualified as an expert” is
permitted under Rule 702 of the Federal Rules of Evidence where
such testimony:
(1)
(2)
(3)
(4)
will assist the trier of fact to understand the
evidence or to determine a fact in issue
is based upon sufficient facts or data,
is the product of reliable principles and methods; and
results from the reliable application of principles
and methods . . . to the facts of the case.
18
Fed. R. Evid. 702.
In making a determination about whether to
admit proposed expert testimony, the Second Circuit has held
that “the district court should consider the indicia of
reliability identified in Rule 702,” specifically items 2-4
listed above. Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d
256, 265 (2d Cir. 2002) (internal quotation marks omitted).
The
“reliable principles and methods” prong of Rule 702 analysis
requires the Court to look to other factors in order to fulfill
its designated “gatekeeping” role, such as:
(1)
(2)
(3)
(4)
whether a theory or technique has been or can be
tested;
whether the theory or technique has been subjected to
peer review and publication;
the technique’s known or potential rate of error and
the existence and maintenance of standards controlling
the technique’s operation; and
whether a particular technique or theory has gained
general acceptance in the relevant scientific
community
United States v. Williams, 506 F.3d 151, 160 (2d Cir. 2007)
(citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 59394 (1993)).
The purpose of analyzing proposed expert testimony
in light of Rule 702 and Daubert reliability factors is to “make
certain that an expert, whether basing testimony upon
professional studies or personal experience, employs in the
courtroom the same level of intellectual rigor that
characterizes the practice of an expert in the relevant field.”
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).
19
B. Drs. Sanford Buch and Andrew Breiman
Merck asks the Court to preclude both of Plaintiff’s
treating surgeons – Drs. Sanford Buch and Andrew Breiman – from
giving specific causation opinion testimony because neither has
ever diagnosed Plaintiff with ONJ.
Merck argues that these
doctors’ opinions do not satisfy the Daubert test.
At the outset, Plaintiff argues that a treating physician’s
fact testimony or observation testimony does not implicate
Daubert.
Plaintiff urges the Court to refrain from conducting a
Daubert analysis because this testimony “sets a framework and
reference point for subject expert testimony from the parties’
respective expert witnesses.”
Daubert inquiry.
Plaintiff misperceives the
Although Daubert need not apply to a treating
physician’s fact or observation testimony, the testimony at
issue here is Dr. Buch’s opinion that Fosamax caused
Scheinberg’s ONJ.
As this Court previously held, a treating
doctor’s “opinion on causation is subject to the same standards
of scientific reliability that govern the expert opinion of
physicians hired solely for the purposes of litigation.” In re
Fosamax Prods. Liab. Litig., 2009 WL 4042769 (S.D.N.Y. Nov 23,
2009).
Therefore, the testimony in question will be subject to
Daubert.
The Court will now analyze the admissibility of each
doctor’s testimony in turn.
20
i.
Motion To Preclude Dr. Buch from Giving A Specific
Causation Opinion
Dr. Buch, who performed Scheinberg’s tooth extraction on
October 30, 2006, testified that (1) Scheinberg’s jaw bone was
necrotic and (2) her post-tooth extraction delayed healing was
“consistent with Fosamax’s effect on delayed healing following
tooth extraction.”
Merck seeks to preclude this testimony
because Dr. Buch also stated that he never diagnosed Scheinberg
with ONJ and that he could not offer an opinion on whether
Fosamax was related to the ONJ.
His deposition testimony is as
follows:
Q: When you say that you thought there might be a problem,
I don’t see in your note any diagnosis of any specific
problem –
A: I didn’t make any diagnosis. I just – from an extraction
site that long afterwards where the patient was developing
swelling, that something just wasn’t right with it.
***
Q: So earlier and throughout the deposition, when you
mentioned that [Plaintiff] had osteonecrosis of the jaw,
it’s not a condition that you diagnosed her with, right?
A: No, I did not diagnose that.
Q: And when you say that she had osteonecrosis of the jaw,
what is your basis for that?
A: I don’t have a basis. Someone else made the diagnosis. I
very much assume that’s a correct diagnosis.
Q: Do you know that somebody else actually diagnosed her
with that?
A: And I told you I don’t know how I knew, but it was
mentioned.
Q: By whom?
A: I don’t know.
* * *
Q: Since you haven’t seen [Plaintiff] since December 7,
2006, I take it you don’t intend to offer any opinion
21
testimony in this case about whether or not her Fosamax use
was or was not related to her jaw condition?
A: I don’t think I can make that statement.
(Buch Depo. 70–72, 73.)
According to Merck, given that Dr. Buch did not make the
ONJ diagnosis, his testimony that Scheinberg’s jaw condition was
“consistent with Fosamax’s effect on delayed healing” is
insufficient causation evidence because it does not reflect any
“sense of certainty.”
Therefore, Merck avers that Dr. Buch
should be precluded from offering an opinion on specific
causation.
In response, Plaintiff notes that the issue of whether
Scheinberg had ONJ is not disputed in this case.
Plaintiff also
argues that the “consistent with” language has been permitted by
this Court in the past. (Pl. Opp. at 5 (“In the Maley case,
because plaintiff’s expert Dr. Redfern testified as to general
causation, he properly relied on findings of other physicians,
including a ‘pathology report of findings consistent with dead
or dying bone.’”).)
Dr. Buch’s deposition testimony precludes him from drawing
the conclusion that Fosamax caused Scheinberg’s ONJ.
Having
told Merck attorney’s that he “can [not] make [the] statement”
that Scheinberg’s jaw condition was related to her Fosamax use,
he has demonstrated that he is not in a position to render an
22
opinion as to causation.
Therefore, Dr. Buch’s opinion as to
causation is inadmissible.
ii.
Motion To Preclude Dr. Breiman from Giving a Specific
Causation Opinion
Merck next argues that Dr. Breiman’s testimony as to
specific causation does not reflect sufficient medical
certainty.
Dr. Breiman saw Plaintiff on two occasions, December
12 and 13, 2006.
During Scheinberg’s visits, Dr. Breiman
observed swelling in her jaw, determined that there was an
infection, and attempted to drain the excess fluid in her jaw.
He then referred her to another facility for examination.
At
deposition, Dr. Breiman confirmed that he never diagnosed
Scheinberg with ONJ and could not opine about the effects of
Fosamax:
Q: Did you, Doctor, ever diagnose [Plaintiff] with
osteonecrosis of the jaw?
A: No.
Q: Or bisphosphonate related osteonecrosis of the jaw?
A: No.
* * *
Q: Am I correct, you did not make a determination as to
whether [Plaintiff’s] Fosamax use caused her oral cavity
condition?
A: Correct.
* * *
Q: Based on your testimony, you are saying that you do not
know whether Fosamax was or was not the cause of the jaw
problems she presented with in December ’06?
A: Correct.
Q: That, again, is because you just don’t have enough
information to inform you as to that?
A: Correct.
(Breiman Depo. 60-61, 72.)
23
Dr. Breiman also stated at deposition that he did include
bisphosphonate-related ONJ in his differential diagnosis. (Id.
at 60.)
A “differential diagnosis” is a “patient-specific
process of ruling out potential causes of an illness as unlikely
until one case remains.” Ruggiero v. Warner-Lambert Co., 424
F.3d 249, 251 (2d Cir. 2005).
Merck argues that because
bisphosphonates were considered as one of many possible causes
of Plaintiff’s jaw condition, Dr. Breiman’s opinion on specific
causation is not to any degree of medical certainty.
In response, Plaintiff argues that Merck is advancing a
double standard by seeking to exclude evidence that Dr. Breiman
considered Fosamax as a potential cause of Scheinberg’s ONJ
while admitting the fact that he considered other possibilities.
(Pl. Mot. at 11 (“If this Court were to grant Defendant’s
Daubert motion as to the differential testimony, by that same
logic it will also exclude testimony regarding the nonbisphosphonate factors which would have made it on to Dr.
Breiman’s differential list.”).)
Dr. Breiman is precluded from offering specific causation
testimony for the same reason Dr. Buch’s testimony on that
subject is precluded:
Dr. Breiman testified that he did not
“have enough information” to determine whether Fosamax caused
her ONJ.
“While an expert need not rule out every potential
24
cause in order to satisfy Daubert, the expert’s testimony must
at least address obvious alternative causes and provide a
reasonable explanation for dismissing specific alternate factors
identified by the defendant.” Israel v. Spring Indus., No. 98
Civ. 5106, 2006 WL 3196956, at *5 (E.D.N.Y. Nov. 3, 2006).
Here, Dr. Breiman admitted that he could not eliminate other
potential causes, rendering his testimony inadmissible.
Cooper
v. Smith & Nephew, Inc., 259 F.3d 194, 202 (4th Cir. 2001)
(“[I]f an expert utterly fails to consider alternative causes or
fails to offer an explanation for why the proffered alternative
cause was not the sole cause, a district court is justified in
excluding the expert’s testimony.”).
Plaintiff’s argument that Merck is attempting to use
Daubert as both a sword and a shield is irrelevant, as the
Court’s ruling only goes to whether Dr. Breiman can testify as
to specific causation.
The Court will not rule as to other
proposed testimony until it is presented with the deposition
designations.
C.
Dr. Suzanne Parisian
Although Dr. Parisian has been admitted as an expert in
prior bellwether trials, she served a supplemental report in
October 2012, which contains opinions regarding the adequacy of
the 2005 label change.
Merck objects to sixteen of Dr.
Parisian’s newly submitted opinions.
25
i.
Opinion that the 2005 Label Did Not Warn of the Association
Between Fosamax and ONJ
Merck urges the Court to exclude Dr. Parisian’s opinion
that the July 2005 Fosamax label did not inform prescribing
physicians that there was an association between Fosamax and
ONJ.
Merck argues that Dr. Parisian cannot presume to know how
a prescribing physician would interpret the label.
Moreover,
Merck avers that Dr. Parisian’s opinion is irrelevant to the
facts of this case because it would not have affected Dr. Dunn’s
prescription decisions, given that Dr. Dunn testified that she
knew there was a “possible risk of necrosis of the jaw for
patients [who] take Fosamax.”
Plaintiff responds that Dr. Parisian’s testimony is not
premised on the internal thoughts of an individual physician;
rather, it is premised on the fact that Merck used ambiguous
language on the label.
Moreover, Plaintiff asserts that Dr.
Dunn’s testimony clearly demonstrates that she may have changed
her prescribing decisions had she known more about the dangers
of Fosamax.
This Court has found that Dr. Parisian’s expertise and
background “as a Medical Officer at the FDA” qualifies her “to
offer testimony about regulatory requirements relating to the
development, testing, marketing, and surveillance of
prescription drugs.” In re Fosamax Prods. Liab. Litig., 645 F.
26
Supp. 2d 164, 190 (S.D.N.Y. 2009).
Therefore, the only
remaining issue is whether this opinion is relevant in this
case; that is, whether more information in the label would have
changed Dr. Dunn’s prescribing decisions.
As noted above, Dr.
Dunn has offered conflicting testimony about what information
was conveyed to her by the 2005 label.
Depending on which of
Dr. Dunn’s statements the jury decides to credit, Dr. Parisian’s
opinion on the 2005 label be relevant.
Therefore, her testimony
on this issue is admissible.
ii.
Opinion that Merck Should have Used a Different Header for
its ONJ Precaution
At oral argument, Plaintiff’s counsel represented that he
will not elicit testimony from Dr. Parisian related to this
issue.
Therefore, the motion is denied as moot.
iii. Opinion that Merck Should have Warned that Fosamax “Causes”
ONJ
Dr. Parisian testified that the Fosamax label need not have
used the term “causation” in describing the relationship between
Fosamax and ONJ; rather, she stated that the label should
include a warning that Fosamax is “associated” with ONJ.
As a
result, Merck argues, Dr. Parisian should not be permitted to
opine that Merck should have warned prescribing physicians that
Fosamax “causes” ONJ.
27
Plaintiff argues that Dr. Parisian should be permitted to
testify that Merck should have conveyed the causation
information by means other than its label, such as a “Dear
Doctor” letter.
Plaintiff states that Dr. Parisian has made
clear that, while the appropriate language for a drug label is
the term “associate,” other materials distributed by Merck
should have used the term “causation” in describing the link
between Fosamax and ONJ.
Merck’s motion to exclude this testimony is granted for two
reasons.
First, Dr. Parisian’s expert report did not include
the opinion that Merck should have used Dear Doctor letters to
tell physicians that Fosamax “causes” ONJ. LaSalle Bank Nat’l
Assoc. v. CIBC Inc., No. 08 Civ. 8426, 2012 WL 466785, at *9
(S.D.N.Y. Feb. 14, 2012) (“The expert’s report operates to limit
the scope of the testimony that can be elicited from the expert.
Opinions that are not disclosed in the expert’s report cannot be
offered.”).
Second, Dr. Parisian has already testified that the
term “association” is adequate language for the label. It defies
logic that Dr. Parisian would argue that Merck should issue
additional warnings that conflict with the FDA approved
language.
28
iv.
Opinion About a “Black Box” Warning for ONJ
Plaintiff represents that Dr. Parisian does not intend to
discuss a “Black Box” warning.
Therefore, the motion is denied
as moot.
v. Opinion that Merck Should have Warned of the Risk for Jaw
Amputation
Merck urges the Court to exclude Dr. Parisian’s opinion
that Merck should have warned that ONJ could lead to jaw
amputation or other permanent jaw damage.
According to Merck,
such an opinion is irrelevant because Plaintiff did not undergo
a jaw resection.
Plaintiff avers that Dr. Dunn would have discussed the
possibility of jaw amputation with her patients, which
“obviously” would have resulted in Scheinberg’s stopping
Fosamax.
Dr. Parisian’s opinion as to the possibility of jaw
amputation or permanent jaw damage is inadmissible.
This
opinion is irrelevant in this case because, according to
Plaintiff’s expert, her jaw was fully healed by mid 2007.
vi. Opinion that Merck Should have Warned that the Risk for ONJ
Increased with Long-Term Fosamax Usage
Merck states that Dr. Parisian’s opinion that Merck “should
have known through a review of medical literature pertaining to
bisphosphonate-related ONJ” that the risk for ONJ increased the
29
longer one used Fosamax should also be excluded.
According to
Merck, Dr. Parisian bases this opinion on an article that was
published the year after Plaintiff’s tooth extraction and
therefore is irrelevant to the facts of this case.
Plaintiff
suggests that Merck “has simply forgotten” that the position
paper cited by Dr. Parisian included references to numerous
publications that pre-date April 2006.
Dr. Parisian reports that “[b]y 2006 . . . Merck knew (or
should have known through a review of medical literature . . .)
that the risk of ONJ increased with additional usage.”
This
statement indicates that the cumulative effect of the reports on
Fosamax’s efficacy with prolonged usage would have put Merck on
notice of the issues related to prolonged use of Fosamax by
2006.
Plaintiff’s contention that some publications that
reported on the effects of prolonged use of Fosamax predate 2006
is irrelevant, as Dr. Parisian did not state that any single
publication was sufficient to put Merck on notice.
Therefore,
Merck’s motion is granted.
vii. Opinion that Merck Should have Warned that Fosamax is
“Stronger” than Other Oral Bisphosphonates
Merck seeks to exclude Dr. Parisian’s opinion that Merck
should have warned that Fosamax is stronger than other oral
bisphosphonates and had more reports of ONJ than other oral
bisphosphonates.
Merck avers that Plaintiff has not offered any
30
expert testimony that Plaintiff would not have contracted ONJ
had she taken a different oral bisphosphonate.
Plaintiff argues that Dr. Dunn testified that if she had
known that there were more reports of ONJ among Fosamax patients
than patients taking Actonel and Boniva combined, then she
“likely would have changed [her] prescribing practices.” (Bogle
Decl. Ex. 6 at 197-98.)
Therefore, Plaintiff states that
“Scheinberg’s injury clearly could have been avoided if Merck
had notified physicians that Fosamax was stronger than the other
oral bisphosphonates.”
Plaintiff has not presented any evidence to show that
Plaintiff would not have contracted ONJ if she had been on
Actonel or Boniva.
Therefore, testimony as to the relative
strength of the various oral bisphosphonates would have no
effect on proximate cause, rendering this opinion irrelevant.
Accordingly, Merck’s motion is granted.
viii. Opinion that Merck Should have told Physicians that There
were “Hundreds of” or “Frequent” Reports of ONJ
Merck argues that Dr. Parisian should be precluded from
testifying that Merck should have told physicians that there
were “hundreds” of reports of ONJ among Fosamax users.
Merck
states that because Dr. Parisian conceded at deposition that it
is impractical to include a specific number of reports of ONJ on
the Fosamax label, she cannot change her testimony at trial.
31
Merck also asks the Court to preclude Dr. Parisian’s opinion
that there have been “frequent reports” of ONJ among Fosamax
users on the grounds that she has offered no basis for this
opinion.
Dr. Parisian testified that she has not done any
calculation of the prevalence or incidence of ONJ in Fosamax
users, and that ONJ is a “rare event.” (Parisian Depo. at 30:214, 31:16-18.)
According to Plaintiff, Dr. Parisian has “repeatedly
insisted that Merck should have informed physicians by 2006 that
it received hundreds of ONJ reports.”
Plaintiff suggests that
Dr. Dunn’s testimony implies that if she had received
information about these reports, she would have relayed it to
her patients, who may have opted to discontinue Fosamax.
As with any witness, inconsistencies in an expert witness’s
testimony do not implicate Daubert, but rather are properly
addressed during cross examination.
Therefore, this motion is
denied.
ix. Opinion that Merck Should have Distributed a “Dear Doctor”
Letter
During questioning by Merck, Dr. Dunn stated that a “Dear
Doctor” letter would not have made much difference because she
was familiar with the language in the label.
Therefore, Merck
argues, Dr. Parisian’s opinion that Merck should have written a
“Dear Doctor” letter is irrelevant.
32
Plaintiff responds that Dr. Dunn certainly would not have
been swayed by a “Dear Doctor” the way Merck attorneys described
it to her at deposition.
Plaintiff avers that Merck attorneys
described a letter that contained the same information that was
in the 2005 label.
However, Dr. Dunn did state that a warning
with “specific information about the rate, frequency, the
severity and potential causation” may have changed her
prescribing practices.
Thus, Plaintiff avers, if this
information had been conveyed in a “Dear Doctor” letter, it may
have affected Dr. Dunn’s decision making.
This motion is granted for the same reason the Court
granted Merck’s third Daubert motion, above:
Dr. Parisian’s
expert report did not include any discussion of a “Dear Doctor”
letter.
Moreover, Dr. Dunn has testified that it did not make
any difference to her whether she received such a letter.
x. Opinion that Merck Should have done more To Notify Patients
of the 2005 Label Change
Dr. Parisian’s supplemental report states that Merck should
have done more to notify patients of the 2005 change to the
patient package insert.
According to Merck, New York’s “learned
intermediary doctrine” dictates that the “duty to warn” runs to
the prescribing physician, not the patient.
Therefore, Dr.
Parisian’s opinion about Merck’s duty to notify patients is
33
irrelevant because it has nothing to do with Merck’s obligations
under New York law.
Plaintiff states that “defendants may not use the ‘learned
intermediary’ doctrine as a sword,” so the doctrine is intended
for product liability claims, not breach of warranty claims.
Therefore, Plaintiff argues that Merck’s failure to communicate
its label changes to patients is relevant to her asserted claims
of breach of warranty and fraudulent misrepresentation and
concealment.
Because the Court has granted summary judgment on the
breach of warranty and fraud claims, above, the issue of how
Merck notified its patients of a label change is irrelevant.
The “learned intermediary” doctrine, which applies to both
design defect and failure to warn claims, “focuses on the scope
of a drug manufacturer’s duty to warn of the dangers of using
the drug in question.
That duty is fulfilled by giving adequate
warning to the prescribing physician.” See Spensieri v. Lasky,
94 N.Y.2d 231, 239 (1999).
Whether Merck communicated with its
patients would have no effect on Plaintiffs’ claims.
Accordingly, this motion is granted.
xi. Opinion that the FDA was in a “Rush” When it Approved
Merck’s 2005 Label Change
Plaintiff represents that Dr. Parisian does not intend to
testify about the motivations or state of mind of the FDA.
34
However, Plaintiff argues that Dr. Parisian should be able to
testify about Merck’s negotiations with the FDA in 2005 and the
fact that the length of these negotiations resulted in Merck
warning of ONJ in its label several months after the other oral
bisphosphonate manufacturers.
Testimony about the negotiations with the FDA, or how long
the negotiations took, is inadmissible.
As the Court has
previously held, Dr. Parisian may not offer “a narrative history
of Fosamax” because “an expert cannot be presented to the jury
solely for the purpose of constructing a factual narrative based
upon record evidence.” In re Fosamax Prods. Liab. Litig., 645 F.
Supp. 2d 164, 192 (S.D.N.Y. 2009).
The Court has further ruled
that it would limit Dr. Parisian’s comments on exhibits “to
explaining the regulatory context in which they were created,
defining any complex or specialized terminology, or drawing
inferences that would not be apparent without the benefit of
experience or specialized knowledge.” Id.
The negotiations with
the FDA would constitute a narrative history of Fosamax.
Moreover, Dr. Parisian may not opine about negotiations to which
she was not privy.
Therefore, Merck’s motion is granted.
xii. Opinion that Merck was the only Bisphosphonate Whose 2005
Label Differed from the FDA’s Proposed Label
Merck argues that Dr. Parisian should be precluded from
“erroneously” testifying that Fosamax was the only oral
35
bisphosphonate manufacturer who adopted an ONJ precaution that
differed from what the FDA proposed.
Merck avers that Dr.
Parisian conceded at deposition that Actonel also adopted a
precaution that differed from that was originally proposed by
the FDA.
Therefore, Merck proffers that this opinion is wrong
and should be excluded.
Plaintiff responds that Dr. Parisian has consistently
maintained that Merck is the only bisphosphonate manufacturer to
remove “any reference to ONJ” in the label.
Further, although
Actonel’s label was different from the FDA’s proposal, Dr.
Parisian has testified that it label was actually stronger than
the one proposed by the FDA.
Therefore, Plaintiff argues that
she should be permitted to testify as to the “relative weakness
of Merck’s 2005 ONJ precaution for Fosamax” as compared to other
bisphosphonate manufacturers.
This testimony is inadmissible as the language of the
different drug labels speaks for itself.
The jury does not need
Dr. Parisian to compare the strength of the labels; jurors will
be able to read the labels and conduct this comparison on their
own.
xiii. Opinion About Merck’s August 2006 Adjudication of ONJ
Reports
In August 2006, Merck conducted a review of its adverse
event reports to determine how many Fosamax users had contracted
36
ONJ (the “adjudication”).
adjudication.
Dr. Parisian’s report criticizes the
Merck seeks to preclude this criticism as
irrelevant in light of Scheinberg’s injury date.
Another one of
Plaintiff’s experts – Dr. Kraut – testified that Scheinberg
would have needed to stop taking Fosamax six months before her
tooth extraction to avoid ONJ.
Therefore, Merck argues that its
actions after April 30, 2006 cannot be a proximate cause of
Plaintiff’s injury.
In response, Plaintiff urges that Merck was at all times
obligated to “continue to test and study the relationship
between its drug and the adverse events.”
Plaintiff also notes
that the Court “has repeatedly concluded that plaintiffs may
properly produce evidence of Merck’s failure to conduct studies
on Fosamax and ONJ.”
Finally, Plaintiff states that Merck’s
failure to disclose findings of its adjudication impacts
prescribing practices of physicians like Dr. Dunn.
Dr. Parisian’s testimony as to the August 2006 adjudication
has no relevance in this case.
Regardless of what Merck’s
adjudication would have revealed, it could not have affected
Scheinberg a mere two months before her tooth extraction.
This
is particularly true in light of the testimony from Plaintiff’s
expert, Dr. Kraut, that Scheinberg would have had to stop taking
Foasmax six months before October 30, 2006, i.e., April 30,
2006, to avoid ONJ.
37
xiv. Opinion About Merck’s Interactions with the ASBMR
Merck argues that Dr. Parisian’s opinion that Merck
understated the number of ONJ Reports during a November 2006
conference call with ASBMR should be excluded as irrelevant.
an initial matter, Merck denies the allegation.
As
Alternatively,
Merck argues, its actions in November 2006 have no bearing on
this case, where Plaintiff’s tooth extraction occurred before
the call.
Plaintiff states that this testimony is relevant because it
shows that Merck “manipulated” the data about Fosamax and ONJ,
and should be admitted if Defendant “opens the door.”
According
to Plaintiff, it “fully expects Merck to elicit testimony from
Dr. Dunn about the fact that she did not stop prescribing
Fosamax after becoming aware of ONJ.
If Merck elicits any
testimony from Dr. Dunn concerning whether she prescribed
Fosamax after 2006 or uses the ASBMR task force paper, then
Plaintiff must be permitted to show Merck’s manipulation of this
data through testimony from Dr. Parisian.”
Dr. Parisian’s opinion about Merck’s representations during
the November 2006 conference call should be excluded because it
has no relevance to this case.
The conference call occurred
after Plaintiff’s tooth extraction and thus could not have
affected her.
38
xv. Opinion About Merck’s Correspondence with the FDA
As Plaintiff represents that Dr. Parisian does not intend
to offer testimony about whether Merck provided all of its
adverse event reports to the FDA, this motion is denied as moot.
xvi. Opinion About Merck’s Non-Compliance with Federal
Regulations
Finally, Merck argues that Dr. Parisian’s opinion that
Merck violated 21 C.F.R. §§ 314.80(b) and 314.70 should be
excluded because she misinterprets the statutes.
Dr. Parisian
states that section 314.80(b) required Merck to conduct an
epidemiological study of Fosamax after receiving non-ONJ adverse
event reports.
Similarly, Dr. Parisian says that under
§ 314.70, Merck was required to update the “instructions for
use” section of the label with Dr. Mucci’s draft analysis
regarding Fosamax’s fracture reduction efficacy.
Merck avers
that the statutory language merely “permits” label changes, and
the fact that the FDA approved the label demonstrates that the
FDA did not find a regulatory violation.
Plaintiff responds that this Court has consistently
admitted testimony about Merck’s violations of federal
regulations, including § 314.70, finding that it is “qualified
expert opinion” that is based on “appropriate methodology.”
This issue has been directly addressed by the Court and
Merck has merely repeated its prior motions that have previously
39
been denied.
The Court will adhere to its prior rulings:
Dr.
Parisian’s testimony as to Merck’s compliance with these
regulations is grounded in her qualified expert opinion and
therefore admissible.
See In re Fosamax Prods. Liab. Litig., 06
MD 1789, 2010 WL 4242702 at *2 (S.D.N.Y. Oct. 27, 2010)
(“Although the Court takes no position on the accuracy of Dr.
Parisian’s conclusions, Dr. Parisian’s testimony represents her
qualified expert opinion about what reasonable steps drug
manufacturers should take to comply with the legal duties
imposed by the FDCA.”).
V. Plaintiff’s Daubert Motions
A. Dr. Barry Gruber
Plaintiff objects to two issues to which Dr. Gruber –
Defendant’s expert witness on osteoporosis and bisphosphonates –
will testify.
i. Motion To Preclude Dr. Gruber’s Testimony that Plaintiff
Suffered a Fragility Fracture in 1994
Plaintiff argues that Dr. Gruber should not be permitted to
testify to his opinion that Scheinberg suffered a fragility
fracture of her left humerus (upper arm) in 1994.
This fact
comprises part of the foundation for Dr. Gruber’s opinion that
Scheinberg was osteoporotic, not osteopenic.
According to
Plaintiff, at deposition Dr. Gruber only identified an insurance
record to support his statement that Scheinberg suffered a
40
fragility fracture.
Plaintiff avers that Dr. Gruber does not
have an adequate basis to testify as to whether Ms. Scheinberg
suffered a fragility fracture, particularly since the opinion
contradicts Dr. Dunn’s testimony that Scheinberg was osteopenic.
Merck argues that Dr. Gruber’s testimony about the
fragility fracture is admissible because it is based upon his
personal experience.
Dr. Gruber explained that his “experience
in taking histories from patients” is that when a patient does
not remember experiencing a fracture, then that fracture is a
fragility fracture.
Because Scheinberg has no memory of her
1994 fracture, Dr. Gruber concluded that she suffered a
fragility fracture.
Moreover, Merck contends that while Dr.
Gruber relies on both an insurance record and a Montefiore
Medical center record, there is no legal basis for Plaintiff’s
argument that non-medical records are insufficient basis for an
expert opinion.
Finally, Merck asserts that Dr. Dunn’s
conflicting opinion as to the fragility fracture is no basis for
exclusion of Dr. Gruber’s testimony.
“If two contradictory
opinions meet the threshold of reliability, it is the function
of the factfinder” to determine which is credible. (Def. Opp. at
5.)
The motion is denied.
Dr. Gruber’s opinion is based on his
personal and professional experience.
Plaintiff will be able to
cross examine Dr. Gruber about the basis for his opinion,
41
including the records in question.
Moreover, to the extent
there is a suggestion that the fracture happened in the ulna,
not the humerus, this issue may be explored on cross
examination.
ii. Motion To Preclude Dr. Gruber’s Testimony that Scheinberg’s
Diabetes Contributed to or Caused Scheinberg’s Infection or
Slowed Healing Following her Tooth Extraction
Dr. Gruber stated that Scheinberg had “poorly controlled”
diabetes, which was a factor in her infection and/or slowed
healing.
Plaintiff argues that (1) Dr. Gruber is not qualified
to assess whether Scheinberg’s diabetes was “uncontrolled,” and
(2) he has not identified a factual or scientific basis for the
assertion that diabetes contributes to delayed healing or
infection in the mouth.
First, Plaintiff notes that Dr. Rita Louard, “Scheinberg’s
well-credentialed treating endocrinologist” testified that
Plaintiff’s diabetes was “well controlled.”
Plaintiff avers
that Dr. Gruber, who refers his patients with diabetes to a
diabetic specialist, should not be permitted to contradict Dr.
Louard’s testimony.
“Dr. Gruber, by his own admission, seeks to
offer opinion testimony in a field that is outside his area of
expertise.”
Second, Plaintiff points to Dr. Gruber’s statement that
there “is a paucity of data” as to the ability of a diabetic to
42
heal following tooth extraction as ground for exclusion. (Gruber
Depo. at 111.)
Dr. Gruber also stated that there are no studies
that compare the post-tooth extraction healing capability of a
non-diabetic with that of a diabetic. (Id.)
In response, Defendant reiterates that Dr. Louard’s
contrary opinion does not render Dr. Gruber’s opinion
inadmissible.
Moreover, Defendant notes that this Court has
previously held that Dr. Gruber’s expertise extends beyond oral
surgery.
Defendant states that since Dr. Gruber has experience
treating patients with diabetes, he is qualified to offer this
opinion.
With respect to his ability to opine as to the effects
of diabetes on the pace of maxillofacial healing, Dr. Gruber
testified:
Q. And can you just very briefly, if you don’t mind,
explain how your role, your specialty, your expertise as an
immunologist relates to diabetes and the management of
diabetes?
A. I think I can comment on the impact that diabetes might
have on the immune system leading to immunocompromised host
factors because of my background and my understanding of
the immune system, both through rheumatology and diagnostic
and clinically immunology training.
Q. Do you treat patients who have diabetes, Dr. Gruber?
A. Yes.
Q. Do you treat the complications of diabetes in connection
with treating those patients?
A. Yes. There are a number of complications that have their
domain in rheumatology and in musculoskeletal disease that
I treat day in and day out.
Q. And does that include the effect of the disease on the
immune system?
A. Yes.
43
(Gruber Depo. 160:8-161:4.)
Therefore, Defendant argues, Dr.
Gruber’s opinion is “firmly grounded in his experience as a
rheumatologist.”
Next, Merck asserts that Dr. Gruber’s basis for his
contention that diabetes can cause or contribute to delayed
healing is more than adequate.
“[A]lthough Dr. Gruber conceded
that there is a ‘paucity of data’ on that specific point,” he
has coupled scientific data with his rheumatology and immunology
experience to make a “well reasoned inference.”
This motion is granted in part and denied in part.
Dr.
Gruber’s expertise renders him capable of opining on how various
maladies affect maxillofacial healing, specifically whether
diabetes slowed Scheinberg’s healing.
Accordingly, Dr. Gruber
may testify as to the effect of diabetes on the healing process
in the oral cavity.
The fact that Plaintiff’s expert may
disagree with him is no grounds for exclusion.
Dr. Gruber
cannot, however, testify as to whether Scheinberg’s diabetes was
“uncontrolled,” as his expertise does not extend to a patient’s
relative control of her diabetes.
B. Dr. Robert Glickman
Defendant has retained Dr. Glickman as its oral surgery
expert in this case.
Plaintiff seeks to exclude certain parts
of his testimony.
44
i. Motion To Preclude Dr. Glickman from Testifying that
Scheinberg had Osteomyelitis
According to Plaintiff, during the Boles litigation, Dr.
Glickman testified that without a histopathologic confirmation,
he cannot diagnose what type of osteomyelitis a patient has
(histopathology is the microscopic examination of diseased
tissue).
In this case, Dr. Glickman stated that he relied on
radiographs for his opinion that Scheinberg had osteomyelitis
and no histopathology of her jaw bone was conducted.
Plaintiff
proffers that Dr. Glickman testified during Boles that
radiographs were insufficient to diagnose osteomyelitis.
Defendant responds (1) that Dr. Glickman never testified
that a diagnosis of osteomyelitis cannot be made without
histopathology, and (2) Dr. Glickman’s diagnosis of
osteomyelitis is to a reasonable degree of medical certainty,
which is sufficient under Rule 702.
First, Defendant states that Plaintiff has taken Dr.
Glickman’s testimony about histopathology from the Boles
litigation out of context.
According to Defendant, Dr. Glickman
was able to testify that there was “a very high likelihood that”
Boles had osteomyelitis, based upon evidence that did not
include a histopathology report:
Q. Can you say to a reasonable degree of medical certainty
that she had osteomyelitis before the summer of 2002?
45
A. Well, the diagnosis of osteomyelitis would have to be
made in several forms. One would be the clinical
presentation, the other would be the radiographic
interpretation. And the final one, of course, would be the
histopathological interpretation. So if I had bone
specimens before the summer of 2002, then I could answer
you with a definite yes or no. But her clinical
presentation at the time at the need for the extractions
and her subsequent course indicated a very high likelihood
that she had had or was developing an osteomyelitis.
Q. Can you say to a reasonable degree of medical certainty
that she had osteomyelitis before the summer of 2002?
A. I don’t think that would be the way I would answer. I
think the answer would be based on her clinical symptoms
and the radiographic imaging that I’ve seen that the
likelihood of osteomyelitis was very high in this
individual.
Q. But my question – I get to ask the questions, you get to
answer them. My question is, can you say to a reasonable –
listen to my words because they have legal meaning. Can you
say to a reasonable degree of medical certainty that
Shirley Boles had osteomyelitis before the summer of
2002?
A. You can’t answer medical conditions like that because
they require various analyses in order to arrive at a
diagnosis. So the signs and symptoms of osteomyelitis are
so varied and it’s so dependent on the histopathological
confirmation, that the only way I can say definitively yes
or no would be with that. But her presentation was
consistent with osteomyelitis.
Glickman Depo. 33:4-35:6. Defendant avers that Dr. Glickman’s
testimony demonstrates only that histopathology is necessary to
make a definitive diagnosis of osteomyelitis.
Second, Defendant argues that the Court should not require
Dr. Glickman to have consulted a histopathology report to form
the opinion that Scheinberg had osteomyelitis.
In Merck’s view,
Dr. Glickman can determine that there is a “very high
likelihood” that Scheinberg had osteomyelitis, which is a
sufficient basis for admission under Daubert.
46
Merck argues
that, by forcing Dr. Glickman to point to a histopathology
report, Plaintiff is attempting to force Dr. Glickman to satisfy
a “100% certainty” standard.
The motion is denied.
Although Dr. Glickman cannot say
“for certain” that Scheinberg had osteomyelitis, absolute
certainty is not the standard.
Dr. Glickman has testified that
there is a “very high likelihood” that Scheinberg had
osteomyelitis, which satisfies the standard for expert
testimony.
Plaintiff will have the opportunity to question the
certainty of this diagnosis on cross examination.
ii. Motion To Preclude Dr. Glickman’s Testimony that Scheinberg
had Uncontrolled Diabetes and that it Caused or Contributed to
her ONJ
Similar to her motion regarding Dr. Gruber’s testimony on
this issue, Plaintiff argues that Dr. Glickman should not be
permitted to contradict Scheinberg’s doctors’ opinion that
Scheinberg was a controlled diabetic.
Merck represents that Dr.
Glickman does not intend to offer an ultimate opinion on whether
Scheinberg’s diabetes was controlled.
Plaintiff also asks the court to exclude Dr. Glickman’s
“ipse dixit” opinion about diabetes and its effect on delayed
healing.
According to Plaintiff, the only article Dr. Glickman
identified in support of his opinion that diabetes has an effect
on healing was from the mid-1990s and involved an animal study:
47
Q: And do you think that’s good information to look at
animal or rat studies to determine evidence about human
diabetics and their ability to heal?
A: . . . this is core knowledge, this is like, you know,
first day dental school knowledge.
Q: . . . Do you think that’s good science for you to rely
upon in support of this testimony that you’ve got about
diabetics and the capacity to heal in the mouth?
A: No, it wouldn’t be the only article, just one that I
can think of. I mean, there’s thousands of articles. If
you do a Google search on this, I did one a couple weeks
ago and I think I couldn’t even – it just blew the machine,
that’s how many articles there were on it.
(Glickman Depo. 147.)
Merck responds that “questioning relating to support for
the proposition that diabetes has an effect on wound healing is,
in this context, akin to asking a lay witness for support that
the sun rises in the east.”
Defendant states that Plaintiff’s
expert, Dr. Kraut, even agreed with the proposition that
diabetes can be a factor in delayed healing.
(Kraut Depo.
128:6-13 (“Q. So am I correct, then, that you couldn’t determine
whether or not a patient with diabetes would be at an increased
risk for infection? . . . A. Diabetics have an increased risk of
infection. That is known, and I will agree to that.”).
Dr. Glickman’s opinion on the correlation between diabetes
and slowed healing is admissible as specialized knowledge.
His
experience in treating patients with diabetes renders him
capable of opining on the effect of diabetes on maxillofacial
healing.
48
iii. Motion To Preclude Dr. Glickman’s Testimony About
Scheinberg’s Asthma and its Effect on Delayed Healing or ONJ
As Merck has agreed not to raise this issue during the
examination of Dr. Glickman, this motion is denied as moot.
iv. Motion To Preclude Dr. Glickman from Testifying that Smoking
had an Effect on Scheinberg’s Delayed Healing or ONJ
As Merck has agreed not to raise this issue during the
examination of Dr. Glickman, this motion is denied as moot.
v. Motion To Preclude Dr. Glickman’s Testimony that Scheinberg
Had Osteoporosis, or that Osteoporosis Contributed to Her
Delayed Healing or ONJ
Merck states that Dr. Glickman will not testify about (1)
whether Plaintiff had osteoporosis or (2) the effect of
osteoporosis on Plaintiff’s oral condition.
However, Merck
represents that Dr. Glickman will testify regarding the effect
of Plaintiff’s low bone mass on her jaw’s ability to heal,
consistent with his case-specific expert report. (Glickman
Report 1-2.)
Plaintiff responds that this testimony is inadmissible,
because Dr. Glickman does not provide support for his opinion
that low bone mass causes delayed healing.
As Dr. Glickman’s expertise in oral surgery is undisputed,
his opinion as to the effect of various maladies on healing in
the oral cavity is admissible.
Therefore, Dr. Glickman is
49
permitted to address the opinion he asserted in his expert
report as to low bone mass and delayed healing.
vi. Motion To Preclude Testimony that Scheinberg’s Shingles
Contributed to Her Delayed Healing or ONJ
Plaintiff seeks to exclude Dr. Glickman’s opinion that
Scheinberg had cultures which confirmed the presence of the
shingles virus, on the grounds that he could not identify the
cultures, or the physician who took the cultures, at deposition.
Next, Plaintiff asks the Court to preclude Dr. Glickman from
opining that Scheinberg’s shingles caused her ONJ, because he
conceded at deposition that shingles is not a cause of ONJ.
Merck responds that Dr. Glickman does not intend to offer
the opinion that shingles caused or contributed to Plaintiff’s
jaw condition.
Rather, he will testify that her “bout with
[shingles] indicates that her immune system was compromised at
the precise time she needed her immune response to assist with
the healing from her extraction and the surrounding infection.”
(Glickman Report at 3.)
According to Merck, while shingles is
not an element in the causal chain, it is an “indication” of a
compromised immune system, and therefore relevant.
Merck has not demonstrated that shingles has anything to do
with ONJ.
Unless it can demonstrate a connection between
shingles and ONJ, then Dr. Glickman will not be permitted to
opine on this issue.
50
vii. Motion To Preclude Dr Glickman from Relying upon Hearsay
Statements and CTX Testing Data in Support of his Opinions
First, Plaintiff argues that this Court has already
determined that Plaintiff’s witnesses may not cite CTX testing
in support of causation theories; therefore, Plaintiff says that
Dr. Glickman should be precluded from relying on CTX tests
during his testimony.
Second, Plaintiff argues that Dr.
Glickman should not be permitted to testify to his “discussions
with colleagues at conferences,” even if he uses such hearsay as
the basis for his theories.
Finally, Plaintiff argues that when
discussing his opinion that Scheinberg’s six-month cessation of
Fosamax does not explain why Scheinberg’s jaw healed, Dr.
Glickman “cited one article, his own, concerning CTX testing,
hearsay discussions with endocrinologists, surgeons, and
conferences.”
As an initial matter, under Rule 703, Dr. Glickman may rely
upon hearsay in rendering his opinions, but such hearsay may not
be cited to the jury.
As to the CTX reports, Merck represents
that “Merck and Dr. Glickman intend to abide by the Court’s
prior rulings with regard to CTX testing” and will not offer
testimony as to CTX reports and specific causation.
Therefore
the motion is granted in that Dr. Glickman may not cite hearsay
to the jury, and denied as moot in all other respects.
51
viii. Motion To Preclude Dr. Glickman from Offering Testimony
Contrary to the Points he Conceded at Deposition
Plaintiff complains that there were only two hours for the
case-specific discovery deposition of Dr. Glickman.
During that
deposition, Dr. Glickman made three factual concessions upon
which Plaintiff’s counsel “relied.”
Now, Plaintiff argues that
“pursuant to Federal Rule of Civil Procedure 37, this Court
should preclude Dr. Glickman from offering testimony which
conflicts with the points he conceded in discovery depositions.”
Specifically, Plaintiff points to the following statements Dr.
Glickman made at deposition:
1) That he does not intend to testify that Scheinberg’s
Tooth #31 was mobile. During the Boles trial, Dr.
Glickman testified that the presence of mobile teeth,
coupled with radiology, told him that Boles had “chronic
periodontal infection.”
2) That there was no periapical infection, jaw trauma, or
foreign body left behind after Scheinberg’s tooth
extraction. These were included in Dr. Glickman’s
differential diagnosis, but he subsequently ruled them
out, as he testified at deposition.
3) That he cannot say that Scheinberg had osteomyelitis
before the October 30, 2006 extraction.
Merck responds that the Court should not “enter an order
barring alleged unspecified contrary testimony from Dr. Glickman
on the highly specific topics listed.”
According to Merck, none
of the specific topics listed are proper grounds for a Daubert
challenge, and Merck suggests that cross-examination is an
52
appropriate vehicle for Plaintiff to explore any inconsistencies
in Dr. Glickman’s testimony.
This motion is denied.
To the extent that Dr. Glickman’s
statements at trial contradict his deposition testimony,
Plaintiff will have the opportunity to examine Dr. Glickman
about these statements on cross examination.
The Court held as
much in the Secrest case:
Plaintiff does not challenge the scientific reliability of
Dr. Betts’ (or other potential Merck witnesses’) testimony
on this topic. Instead, Plaintiff argues that Dr. Betts has
made statements in the past that may contradict testimony
that Secrest had ONJ prior to spring 2004 or after 2005. To
the extent that these prior statements call into question
any testimony introduced by Dr. Betts at trial, Plaintiff
will have the opportunity to cross-examine Dr. Betts about
these prior statements. However, a jury would not
necessarily have to accept Plaintiff’s characterization of
Dr. Betts’ prior statements as contradicting testimony
about possibly earlier or later onset of Secrest’s
injuries.
In re Fosamax Liab. Litig., 807 F. Supp. 2d 168, 183 (S.D.N.Y.
2011).
ix. Motion To Preclude Dr. Glickman from Using “Consistent With”
Terminology, if Dr. Buch is not Permitted to Use such
Terminology, Pursuant to Merck’s Daubert Motion
Dr. Glickman testified that certain findings are
“consistent with” long-term infection.
Plaintiff states that if
the Court grants Defendant’s motion to exclude Dr. Buch’s
testimony that Scheinberg’s post-extraction delayed healing was
“consistent with Fosamax’s effect on delayed healing following
53
tooth extraction," it must also exclude Dr. Glickman's testimony
that uses the "consistent with" language.
Although the Court has precluded Dr. Buch's testimony on
causation, it did not do so because of the "consistent with"
language.
Therefore, Plaintiff's motion to preclude any
statement by Dr. Glickman on the grounds that it includes the
phrase "consistent with" is without merit.
As there is no other
basis for excluding this testimony, the motion is denied.
VI. Conclusion
For the reasons stated above, Defendant's motion for
summary judgment is granted with respect to Plaintiff's claims
for breach of warranty, fraudulent misrepresentation and
concealment, and punitive damages, but denied with respect to
Plaintiff's claim for design defect and failure to warn.
Merck's motions to preclude expert testimony are granted in part
and denied in part.
Plaintiff's motion to preclude expert
testimony is granted in part and denied in part.
SO ORDERED.
Dated:
New York, New York
January 7, 2013
::r. ~~
~JOHN
;hti
F. KEENAN
United States District Judge
54
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