Lyman et al v. Pfizer, Inc. et al

Filing 312

MEMORANDUM OPINION AND ORDER RE: DAUBER MOTIONS granting in part and denying in part 212 Motion to Exclude Testimony of Plaintiffs' Expert Suzanne Parisian; denying 213 Motion to Exclude the Testimony of Plaintiffs' Expert, Danie l Tarsy, M.D.; denying 214 Motion to Exclude Testimony of Plaintiffs' Expert, Philip Seeman, M.D.; denying 224 Motion to Exclude Testimony of Pliva Witness James Morrison (the following motions are denied as moot pursuant to 311 Opinion and Order that dismissed certain defendants: 215 Motion to Exclude Certain Testimony of Suzanne Parisian, M.D.; 217 Motion to Exclude Expert Opinions of Daniel Tarsy, M.D.; 220 Motion to Exclude Testimony of Expert Stephen Fredd; 221 Motion to Exclude Testimony of Expert Peter Moses; 223 Motion to Exclude Testimony of Expert Peter LeWitt; 225 Motion to Exclude Testimony of Expert Danny Shen; 226 Motion to Exclude Testimony of Expert Albert Ehle; 227 Motion to Exclude Expert Test imony of Schwarz Pharma, Inc. witness Lisa Rarick; 230 Motion to Exclude Certain Testimony of Dr. Suzanne Parisia; 232 Joint Motion to Exclude Expert Opinions of Philip Seeman, M.D., Ph.D.; 234 Motion to Exclude Defendants' Expert Judith K. Jones; 235 Motion to Exclude Defendants' Expert Joseph L. Lyon). Signed by Judge William K. Sessions III on 7/20/2012. (law)

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

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

Case no. 2:09-cv-262

Memorandum Opinion and Order Re: Daubert Motions1
In this action seeking to hold certain pharmaceutical
companies responsible for Plaintiff Colleen Lyman having
developed tardive dyskinesia as a result of her long-term
ingestion of the prescription drug metoclopramide, Defendant
PLIVA USA, Inc. (“PLIVA”) has moved to exclude the testimony of
Plaintiffs’ experts Dr. Philip Seeman, Dr. Daniel Tarsy and Dr.
Suzanne Parisian.

Plaintiffs Colleen and Steve Lyman have moved

to exclude the testimony of PLIVA’s expert James Morrison.

All

motions argue that Daubert v. Merrell Dow Pharmaceuticals, Inc.,

1

In its Opinion and Order issued today, the Court has
dismissed Defendants Pfizer, Inc., Wyeth, Inc., Schwarz Pharma,
Inc. and Actavis-Elizabeth, L.L.C. from this case. Their Daubert
motions, and Daubert motions directed against their witnesses,
ECF Nos. 215, 217, 220, 221, 223, 225, 226, 227, 230, 232, 234
and 235, are therefore denied as moot.

509 U.S. 579 (1993), requires the exclusion or limitation of
these witnesses’ testimony.

The motions regarding the testimony

of Dr. Seeman, Dr. Tarsy and James Morrison, ECF Nos. 213, 214
and 224, are denied.

The motion regarding the testimony of Dr.

Parisian, ECF No. 212, is granted in part and denied in part.
The party proffering expert testimony has the burden of
establishing its admissibility “by a preponderance of proof.”
Daubert, 509 U.S. at 592 n. 10.

Rule 702 of the Federal Rules of

Evidence provides:
A witness who is qualified as an expert by knowledge,
skill, experience, training, or education may testify
in the form of an opinion or otherwise if:
(a) the expert’s scientific, technical, or other
specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in
issue;
(b) the testimony is based on sufficient facts or
data;
(c) the testimony is the product of reliable
principles and methods; and
(d) the expert has reliably applied the principles
and methods to the facts of the case.
Fed. R. Evid. 702.

The rule requires a district court to ensure

that scientific or technical evidence is both relevant and
reliable.

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147

(1999); Daubert, 509 U.S. at 589.
In assessing reliability, in addition to the factors set
forth in Rule 702, a district court may consider
(1) whether a theory or technique has been or can be
tested; (2) “whether the theory or technique has been
subjected to peer review and publication;” (3) the
technique’s “known or potential rate of error” and “the
2

existence and maintenance of standards controlling the
technique’s operation;” and (4) 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)
(quoting Daubert, 509 U.S. at 593-94).

Daubert’s factors do not

apply to all experts or in every case, however; the reliability
inquiry is a flexible one.

Id. (quoting Kumho Tire, 526 U.S. at

141; Daubert, 509 U.S. at 594).
The inquiry focuses “solely on principles and methodology,
not on the conclusions that they generate.”
595.

Daubert, 509 U.S. at

In keeping with the “liberal thrust” of the Federal Rules

of Evidence, id. at 588, “[v]igorous cross-examination,
presentation of contrary evidence and careful instruction on the
burden of proof are the traditional and appropriate means of
attacking shaky but admissible evidence.”

Id. at 596; see also

Olin Corp. v. Certain Underwriters at Lloyd’s London, 468 F.3d
120, 134 (2d Cir. 2006) (approving the techniques of crossexamination and presentation of opposing expert testimony to
expose weaknesses in an expert’s testimony).
Nevertheless, “proffered ‘expert testimony should be
excluded if it is speculative or conjectural.’”

Major League

Baseball Props., Inc. v. Salvino, Inc., 542 F.3d 290, 311 (2d
Cir. 2008) (quoting Boucher v. U.S. Suzuki Motor Corp., 73 F.3d
18, 21 (2d Cir. 1996)).

“An expert’s conclusory opinions are

similarly inappropriate.”

Id.
3

Motion to Exclude Testimony of Philip Seeman, M.D.
PLIVA contends that Dr. Seeman’s testimony must be excluded
in its entirety on relevancy grounds; because he is not qualified
to offer epidemiology opinions; his epidemiology opinions are not
based on sufficient facts or data and lack a scientifically valid
basis; and his “mechanism” opinion is an irrelevant hypothesis
that lacks a scientifically valid basis.
Dr. Seeman, a renowned neuropsychopharmacologist, provided
two reports in connection with this case.

In both reports he

describes the mechanism by which daily metoclopramide use causes
tardive dyskinesia:

“the long-term partial blockade of dopamine

D2 receptors by metoclopramide (in the basal ganglia) and the
long-term accumulation of metoclopramide in the neuromelanin (of
the [substantia] nigra) which causes nerve-cell-membrane damage,
combine to lead to dopamine supersensitivity of dopamine
receptors in the motor-controlling regions of the brain,
resulting in clinical tardive dyskinesia.”
Nos. 214-2, 3.

Seeman Report 1, ECF

He opines that metoclopramide shares similar

chemical properties with antipsychotic drugs, and can have a
similar toxic effect on the nervous system.
ECF No. 214-3.

Seeman Report 10,

He also concludes that the occurrence of

extrapyramidal symptoms (“EPS”) in metoclopramide-treated
patients is “common[;] . . . it occurs much more frequently than
one in 500 patients and is comparable to that found for the

4

phenothiazines and other dopamine antagonists.

In actuality, it

occurs in at least 15% of patients being treated with
metoclopramide at doses of 30 to 40 mg per day . . . .”

Id. at

20.
PLIVA argues that Dr. Seeman’s opinion as to the relative
rate at which metoclopramide produces tardive dyskinesia is
irrelevant because Plaintiffs’ claim that it should have
strengthened the warnings on its label for metoclopramide has
been dismissed as preempted.

See Op. & Order 9, ECF No. 192

(citing PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2581 (2011)).
Although it is true that the Lymans are precluded from pursuing
their claim that a generic drug manufacturer such as PLIVA had a
duty to provide stronger warnings than the FDA-approved labeling,
PLIVA takes too narrow a view of relevance.

Evidence is

relevant, of course, if “it has any tendency to make a fact more
or less probable than it would be without the evidence; and []the
fact is of consequence in determining the action.”
401.

Fed. R. Evid.

As PLIVA itself has argued, in order to prove their

remaining claim against PLIVA, Plaintiffs will have to produce
evidence that long-term metoclopramide use can cause tardive
dyskinesia, and that Colleen Lyman’s use of metoclopramide caused
her tardive dyskinesia.

An opinion that the occurrence of EPS in

metoclopramide-treated patients is common is highly relevant.
Moreover, Rule 702 permits testimony that will help the trier of

5

fact understand the evidence, as well as determine a fact in
issue.

Dr. Seeman’s testimony is relevant on both grounds.

As to Dr. Seeman’s qualifications, PLIVA merely argues that
they do not qualify him to testify as an expert on epidemiology.
Plaintiffs do not offer Dr. Seeman as an expert on epidemiology,
and they contend that Dr. Seeman does not offer any
epidemiological opinions in this case.

A medical doctor does not

have to be an epidemiologist in order to testify about
epidemiological studies.

See, e.g., United States v. Thorn, 317

F.3d 107, 114-15 (2d Cir. 2003) (in which a medical doctor
specializing in asbestos-related disease was permitted to testify
about various epidemiological studies of asbestos exposure);
DeLuca v. Merrell Dow Pharm., 911 F.2d 941, 953 (3d Cir. 1990)
(noting that a pharmacologist was qualified to testify about his
interpretation of epidemiological evidence), abrogated on other
grounds, In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 748 (3d
Cir. 1994).
What PLIVA characterizes as an epidemiological opinion is
Dr. Seeman’s numerical comparison of an annual “incidence” of
tardive dyskinesia associated with metoclopramide compared with
tardive dyskinesia associated with certain antipsychotic drugs.
PLIVA contends that this calculation violates fundamental
epidemiology principles, being an attempt to calculate an
incidence rate using prevalence data.

6

Dr. Seeman defines his use

of the term “incidence rate” in his report as patients revealing
tardive dyskinesia per year expressed as a percentage of patients
being treated with metoclopramide.

Seeman Report 5.

PLIVA accurately observes that “incidence rate” and
“incidence study” have specialized meanings in epidemiology.

See

Fed. Judicial Ctr., Reference Manual on Scientific Evidence 389,
392 (2d ed. 2000).

“Incidence rate” refers to the number of

people in a specified population who develop a particular disease
during a given period.

Id. at 392.

“Incidence study” or “cohort

study” is a study in which groups of individuals are identified
who have been differentially exposed to a drug that is
hypothesized to cause a disease, and observed in order to
determine if the exposed group is more likely to develop the
disease.

Id. at 389.

Dr. Seeman’s use of the term “incidence

rate” as he defines it to describe his calculations does not
connote that his examination of various studies constituted an
epidemiological incidence study.

Indeed, because the notion that

long-term metoclopramide use can cause tardive dyskinesia is not
particularly controversial at this point, see Mensing, 131 S. Ct.
at 2572, 2573 (“Evidence has accumulated that long-term
metoclopramide use can cause tardive dyskinesia . . .”),
conducting a classic incidence study to determine if
metoclopramide users were at increased risk for tardive
dyskinesia would not appear to be essential to the Plaintiffs’

7

proof of general causation.
The import of Dr. Seeman’s testimony will be that
metoclopramide use produces tardive dyskinesia at a higher rate
than that of certain other drugs, and an explanation of why that
may be so.

Dr. Seeman has explained his methodology, and his

methods and opinions have been published in peer-reviewed
journals.

PLIVA takes issue with this proposed testimony;

however its attacks on the sufficiency and validity of Dr.
Seeman’s opinions go to the weight, not the admissibility of the
testimony.

See, e.g., Ruiz-Troche v. Pepsi Cola of Puerto Rico

Bottling Co., 161 F.3d 77, 85 (1st Cir. 1998) (reversing for
abuse of discretion a district court’s ruling that an expert’s
technique for calculating drug dosage was insufficiently
reliable); In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1066
(D. Minn. 2007) (holding that the fact that the exact mechanism
of a drug-related injury is not yet known does not preclude a
well-reasoned and scientifically based opinion on the matter);
In re: Phenylpropanolamine (PPA) Prods. Liab. Litig., 289 F.
Supp. 2d 1230, 12247 (W.D. Wash. 2003) (“The fact that the
mechanism remains unclear does not call the reliability of the
opinion into question; “‘[c]ausation can be proved even when we
don’t know precisely how the damage occurred, if there is
sufficiently compelling proof that the agent must have caused the
damage somehow.’”) (quoting Daubert v. Merrell Dow Pharm., Inc.,

8

43 F.3d 1311, 1314 (9th Cir. 1995)).
The motion to exclude the testimony of Dr. Seeman, ECF No.
214, is denied.
Motion to Exclude the Testimony of Daniel Tarsy, M.D.
PLIVA moves to exclude the testimony of Dr. Tarsy on the
grounds that his opinions do not fit the facts of this case, that
his report does not comply with Rule 26 of the Federal Rules of
Civil Procedure and that he should not be permitted to testify
about topics concerning which he has not made the required Rule
26 disclosures.
Dr. Daniel Tarsy, a board-certified neurologist who
specializes in movement disorders, a professor of neurology at
Harvard Medical School, and director of the Parkinson’s Disease &
Movement Disorders Center at Beth Israel Deaconess Medical
Center, routinely treats individuals who have been diagnosed with
movement disorders.

Plaintiffs disclosed Dr. Tarsy as an expert

who would testify about the cause of Colleen Lyman’s tardive
dyskinesia and torticollis, including the relationship of
metoclopramide to her injury and the potential impact of other
medications that may be related to her injury.
Dr. Tarsy testified at his deposition that the development
of tardive dyskinesia usually requires continuous exposure for
several months.

In PLIVA’s view Mrs. Lyman did not take

metoclopramide continuously for a period of several months, and
9

therefore Dr. Tarsy’s opinion does not “fit” the facts of this
case.

See Daubert, 509 U.S. at 591.

As this Court has indicated

in its decision on Defendants’ dispositive motions, whether Mrs.
Lyman took metoclopramide on a daily basis for several months is
a jury question.
ECF No. 311.

See Op. & Order dated July 20, 2012, at III.A.,

If the jury finds that Mrs. Lyman took

metoclopramide continuously for a period of several months, then
Dr. Tarsy’s opinion will “fit” the facts of the case.

If it

fails to so find, then Plaintiffs will have failed to prove that
metoclopramide caused her injuries, and PLIVA will be entitled to
judgment.
Rule 26 of the Federal Rules of Civil Procedure requires
that a witness who will be testifying as an expert must provide a
written report that must contain:
(I) a complete statement of all opinions the witness
will express and the basis and reasons for them;
(ii) the facts or data considered by the witness in
forming them;
(iii) any exhibits that will be used to summarize or
support them;
(iv) the witness’s qualifications, including a list of
all publications authored in the previous 10 years;
(v) a list of all other cases in which, during the
previous 4 years, the witness testified as an expert at
trial or by deposition; and
(vi) a statement of the compensation to be paid for the
study and testimony in the case.
Fed. R. Civ. P. 26 (a)(2)(B).
Dr. Tarsy’s report states that he agrees with the diagnosis

10

that Mrs. Lyman has tardive “dystonia,”2 caused by
metoclopramide.

His opinion is based on his review of medical

records and a video of Colleen Lyman.

Dr. Tarsy’s report also

states that he is prepared to offer testimony on the properties
of neuroleptic medications such as metoclopramide and other
topics involving neuroleptic medications and tardive dyskinesia
if requested.

Dr. Tarsy’s report is accompanied by an extensive

curriculum vitae, listing his qualifications and publications and
the cases in which he has provided testimony.

Although his

report does not list his compensation in this case, Plaintiffs
submitted the information as part of their disclosure.
A party faced with a failure to disclose information
required by Rule 26(a) may move to compel disclosure and for
appropriate sanctions.

Fed. R. Civ. P. 37(a)(3)(A).

was disclosed as a witness on August 11, 2010.
October 25, 2011.

Dr. Tarsy

He was deposed on

Apparently PLIVA did not find the disclosure

and report so deficient as to hamper its ability to explore
through deposition the bases for Dr. Tarsy’s opinion on the cause
of Mrs. Lyman’s condition, nor has it argued that it has suffered
prejudice as a result of the alleged deficiencies.

Instead,

nearly seven months after the disclosure, it chooses to move to

2

Dr. Tarsy defines tardive dystonia as “a variant of
tardive dyskinesia which is well established to be caused by
chronic treatment with antipsychotic drugs and metoclopramide.”
Tarsy Report 2, ECF No. 213-5.
11

exclude Dr. Tarsy’s testimony in its entirety.

Under the

circumstances, with ample time to move for fuller disclosure and
a more detailed report, and with ample time to depose the expert,
any failure to disclose is harmless.

See Fed. R. Civ. P.

37(c)(1); see also, e.g., In re Methyl Tertiary Butyl Ether
(MBTE) Prods. Liab. Litig., 643 F. Supp. 2d 471, 482 (S.D.N.Y.
2009) (holding that deficiencies in expert report were harmless
where there was no evidence of unfair surprise).
PLIVA also argues that Dr. Tarsy may not testify about
“other topics,” such as “the biochemical/medicinal effects and
properties of neuroleptic medications, including Reglan, [and]
their ability or relative propensity to cause TD . . . .,” PLIVA
Mem. 7-8, ECF No. 213-1, because his report did not discuss his
opinions on these topics.

Dr. Tarsy was deposed extensively

concerning among other things, his opinions on dystonias in
general, tardive dystonia, their causes, the propensities of
other drugs to cause tardive dystonia, his familiarity and
agreement or disagreement with the literature, and the theories
about the mechanism in the brain that produces tardive
dyskinesia.

If Dr. Tarsy seeks to testify about additional

topics that were not disclosed or about which he was not deposed,
PLIVA may renew its objection to the proposed testimony at trial.
The motion to exclude the testimony of Dr. Daniel Tarsy, ECF
No. 213, is therefore denied.

12

Motion to Exclude the Testimony of Suzanne Parisian, M.D.
PLIVA moves to exclude the testimony of Dr. Parisian on the
grounds that her methodology is unreliable; her opinions are
contrary to law; and she is not qualified or permitted to testify
about a generic pharmaceutical company’s legal obligations.
Plaintiffs’ disclosure identified Dr. Parisian as an expert in
Federal Drug Administration (“FDA”) rules and regulations that
relate to drug companies.

Dr. Parisian’s 189-page report

included summaries of six opinions, five of which have been
rendered moot by the dismissal of the other defendants in this
case.

With respect to PLIVA, Dr. Parisian offers the opinion

that it
was required by the Food, Drug and Cosmetic Act to
conduct pharmacovigilance, monitor the medical
literature about [metoclopramide], report changes in
the [metoclopramide] safety profile to FDA and
voluntarily update its label to adequately warn about
the increased and permanent risks of chronic
[metoclopramide]. Yet, [PLIVA] continued to fail to
behave as a responsible United States Pharmaceutical
Manufacturer. It failed to conduct adequate
pharmacovigilance and it failed to voluntarily take
steps to update its [metoclopramide] label to
adequately warn physicians and patients like Ms. Lyman
of the unacceptable risks of chronic [metoclopramide]
including tardive dyskinesia.
Parisian Report 21, ECF No. 212-4.
In PLIVA v. Mensing, the United States Supreme Court held
that state tort claims against generic drug manufacturers for
failure to provide adequate warning labels were preempted.
S. Ct. 2567, 2581 (2011).

131

As a consequence, this Court dismissed
13

claims against PLIVA for failure to unilaterally change its
label.

Applying the Mensing holding required dismissal of

negligent design and manufacturing claims as well.
9, ECF No. 192.

Op. & Order

Additional claims relating to a duty to monitor

and report safety information were inadequately pled and also
dismissed.

Id. at 11.

In its ruling on Defendants’ dispositive

motions, the claims against PLIVA for breach of warranties, fraud
and fraudulent and negligent concealment have now also been
dismissed.
One claim remains in the case against PLIVA:

a product

liability failure-to-warn claim based on its failure to update
its label to include FDA-approved warnings against the risk of
developing tardive dyskinesia with use of the drug beyond twelve
weeks.

Testimony about whether a generic drug manufacturer has a

legal duty to conduct pharmacovigilance, monitor medical
literature, report safety changes and unilaterally update its
label is irrelevant, because it cannot form the basis for a
state-law personal injury suit after Mensing.

The testimony is

therefore excluded under Federal Rule of Evidence 401.
Dr. Parisian is also expected to testify about the role of
the FDA, the Food, Drug and Cosmetic

Act, the process by which a

new drug obtains FDA approval, FDA’s oversight of generic drug
manufacturers, “label” and “labeling” as it is used in FDA
regulations, and the history of Reglan® and metoclopramide

14

regulation.

She is qualified to give the testimony.

Dr. Parisian, a pathologist by training, is a former Chief
Medical Officer at the FDA, and clinical instructor for the FDA’s
staff college for FDA reviewers for drug devices.

She worked at

the FDA for four years in a variety of capacities, and dealt with
pre-market and post-market compliance issues for medical devices,
on health risk assessments, product recalls, labeling, and
product safety alerts.

After she left the FDA in 1995 she

founded a regulatory and medical consulting firm specializing in
FDA regulations concerning drugs and drug devices.

She has

considerable experience with the FDA, its regulatory requirements
and procedures, and has been permitted to testify in numerous
cases involving not only medical devices but pharmaceutical
products.

See, e.g., Lemons v. Novartis Pharm. Corp., No. 3:08-

CV-00361,

__ F. Supp. 2d ___, 2012 WL 965977 at *5-6 (W.D.N.C.

Mar. 21, 2012); Kammerer v. Wyeth, No. 8:04CV196, 2011 WL 5237757
at *4 (D. Neb. Nov. 1, 2011); Forman v. Novartis Pharm. Corp.,
794 F. Supp. 2d 382, 383 (E.D.N.Y. 2011); In re Fosamax Prods.
Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009).
The Court finds that Dr. Parisian’s knowledge of the FDA’s
regulatory requirements will assist the jury to understand the
evidence pertaining to drug approval and drug labeling
requirements.

Fed. R. Evid. 702(a); see also id. advisory

committee’s note (noting that it may “be important in some cases

15

for an expert to educate the factfinder about general principles
. . . .”).

Any proffered testimony from Dr. Parisian that

expresses a legal conclusion or communicates a legal standard is
excluded, however.

See Hygh v. Jacobs, 961 F.2d 359, 363-64 (2d

Cir. 1992) (“Whereas an expert may be uniquely qualified by
experience to assist the trier of fact, [s]he is not qualified to
compete with the judge in the function of instructing the
jury.”); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531,
541 (S.D.N.Y. 2004) (“[T]estimony that states a legal conclusion
[will be excluded], although factual conclusions on an ultimate
issue to be decided by the jury are permissible.”); see also In
re Fosamax, 645 F. Supp. 2d at 192 (“Dr. Parisian’s commentary on
any documents and exhibits in evidence will be limited 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.”).
The motion to exclude the testimony of Dr. Parisian, ECF No.
212, is therefore granted in part and denied in part.
Motion to Exclude the Testimony of James Morrison
The Plaintiffs have moved to exclude the expert testimony of
James Morrison on the grounds that his opinions lack foundation,
misstate the law and are based on an incorrect assumption.

James

Morrison, a consultant and expert in drug regulatory matters,
16

worked for the FDA for thirty-seven years.

He chaired the

committee that drafted the FDA’s regulations implementing the
Hatch-Waxman Amendments of 1984, which set forth the process for
generic drug approval.

He opines that PLIVA conformed to FDA

practices, policies and procedures and with industry standards
with respect to the labeling of metoclopramide.

He is prepared

to describe PLIVA’s adverse event reporting and complaint
handling obligations, and to opine that PLIVA is not obligated to
monitor the literature on metoclopramide, or to send out “Dear
Doctor” letters.
Plaintiffs’ objections to Morrison’s testimony go to its
weight, not its admissibility.

They do not challenge his

qualifications as a regulatory expert.

Contrary to their

assertion, Morrison does not offer legal standards or
conclusions.

The Court finds that Morrison’s testimony will

assist the trier of fact.

Plaintiffs’ disagreement with his

opinion that PLIVA complied with FDA requirements will
undoubtedly be subject to rigorous cross-examination, but it is
not grounds for exclusion of his testimony.

See Daubert, 509

U.S. at 595 (“The focus, of course, must be solely on principle
and methodology, not on the conclusions that they generate.”); In
re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 285
(E.D.N.Y. 2007) (“The mere fact that an expert’s testimony
conflicts with the testimony of another expert or scientific

17

study does not control admissibility.”); In re Omeprazole Patent
Litig., 490 F. Supp. 2d 381, 412 (S.D.N.Y. 2007) (quoting
McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1044 (2d Cir. 1995));
see also Fed. R. Evid. 702, advisory committee’s note (“[E]xperts
sometimes reach different conclusions based on competing versions
of the facts.

The emphasis in the [rule] on ‘sufficient facts or

data’ is not intended to authorize a trial court to exclude an
expert’s testimony on the ground that the court believes one
version of the facts and not the other.”).
The motion to exclude the testimony of James Morrison, ECF
No. 224, is denied.
Conclusion
For the foregoing reasons, PLIVA’s motions, ECF Nos. 213 and
214 are denied; PLIVA’s motion, ECF NO. 212, is granted in part
and denied in part.

The Lymans’ motion, ECF No. 224, is denied.

Dated at Burlington, in the District of Vermont, this 20th
day of July, 2012.
/s/William K. Sessions III
William K. Sessions III
U.S. District Court Judge

18