Kellog v. Wyeth et al
Filing
347
MEMORANDUM OPINION AND ORDER granting in part and denying in part 318 Motion to Exclude Certain Testimony of Robert C. Nelson, Ph.C.; granting in part and denying in part 319 Motion to Exclude Expert Opinions of Daniel Tarsy, M.D.; granting in part and denying in part 320 Motion to Exclude the Testimony of Ronald B. Stewart; granting in part and denying in part 317 Motion to Exclude Expert Opinions of Ralph Bernstein, M.D. Signed by Judge William K. Sessions III on 7/20/2012. (law)
UNITED STATES DISTRICT COURT
FOR THE
DISTRICT OF VERMONT
ETHEL KELLOGG,
:
:
Plaintiff,
:
:
v.
:
:
WYETH, Individually and as Successor-in-:
Interest to A.H. ROBINS COMPANY, INC.
:
and AMERICAN HOME PRODUCTS CORPORATION; :
SCHWARZ PHARMA, INC.; ACTAVIS, INC.;
:
ACTAVIS-ELIZABETH, L.L.C.; ALPHARMA,
:
INC.; PUREPAC PHARMACEUTICAL COMPANY,
:
INC.; TEVA PHARMACEUTICALS, USA, INC.; :
BAR PHARMACEUTICALS, INC.; PLIVA, INC.; :
and DRUG COMPANY DOES 1 THROUGH 10,
:
inclusive,
:
:
Defendants.
:
Case No. 2:07-cv-82
Memorandum Opinion and Order
Ethel Kellogg has brought suit against the manufacturers of
metoclopramide for injuries arising from her ingestion of the
drug.
Defendant Wyeth has moved to exclude the testimony of
Plaintiff’s experts Daniel Tarsy, M.D., Ronald Stewart, Ralph
Bernstein, M.D. and Robert Nelson, Ph.D., pursuant to Daubert v.
Merrell Dow Pharmaceuticals., Inc., 509 U.S. 579 (1993).
For the
reasons that follow, the motions, ECF Nos. 317, 318, 319, and
320, are granted in part and denied in part.
The party proffering expert testimony has the burden of
establishing its admissibility “by a preponderance of proof.”
Id. at 592 n. 10.
provides:
Rule 702 of the Federal Rules of Evidence
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
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.”
2
Daubert, 509 U.S. at
595.
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.
Motion to Exclude Certain Testimony of Daniel Tarsy, M.D.
Wyeth moves to exclude certain expert opinions of Dr. Tarsy
pursuant to Rules 401, 403 and 702 of the Federal Rules of
Evidence.
Specifically, Wyeth seeks to exclude “his opinions
regarding metoclopramide that are based upon antipsychotic
studies,” testimony “[a]bout other doctors’ prescribing practices
and understanding of the metoclopramide labeling,” and testimony
“[t]hat side effects reported in studies conducted in the 1970s
were misidentified as ‘restlessness’ or ‘agitation’ and instead
3
are likely akathisia.”
Wyeth’s Mot. to Exclude Expert Ops. of
Daniel Tarsy, M.D. 19, ECF No. 319.
Dr. Daniel Tarsy, a board-certified neurologist who
specializes in movement disorders and a professor of neurology at
Harvard Medical School, is an authority on the neurological
effects of drugs such as metoclopramide.
He will offer the
opinion that the risk of developing tardive dyskinesia from longterm metoclopramide use, based on the then-available data, was
far greater than was reflected in Reglan® labeling at the time
Kellogg was taking the drug.
Wyeth finds fault with Dr. Tarsy’s conclusion that
metoclopramide is a neuroleptic drug, meaning, as he defines it,
that it is capable of causing extrapyramidal symptoms (“EPS”) and
tardive dyskinesia.
This position is hardly controversial, given
that the Food and Drug Administration (“FDA”) requires
metoclopramide labeling to carry a warning about the risk of such
side effects.
See Reglan® Tablets Prescribing Information Nov.
2010, available at http://www.accessdata.fda.gov/
drugsatfda_docs/label/2010/017854s055lbl.pdf; see also PLIVA,
Inc. v. Mensing, 131 S. Ct. 2567, 2572 (“Evidence has accumulated
that long-term metoclopramide use can cause tardive dyskinesia .
. .”).
Because of the dearth of direct studies of
metoclopramide’s potential to cause tardive dyskinesia, Dr. Tarsy
reviewed the data for neuroleptic drugs as a whole, where the
4
overall prevalence of tardive dyskinesia is about fifteen
percent.
Wyeth does not dispute this figure.
It argues that Dr.
Tarsy is not qualified to opine on the similarity of the
pharmacological properties of metoclopramide and other
neuroleptic drugs; that study data about neuroleptic drugs in
general cannot be used to extrapolate the risk associated with
metoclopramide, because the methodology is speculative; it is
scientifically unsound to apply the properties of one drug to a
different drug; and his opinion is not based on sufficient facts
or data.
Dr. Tarsy, a neurologist, concededly is not an expert in
neuropharmacology.
He need not be a specialist in
neuropharmacology if he has “knowledge, skill, experience,
training, or education” that would assist the trier of fact,
however.
Fed. R. Evid. 702; see e.g., Robinson v. GEICO Gen.
Ins. Co., 447 F.3d 1096, 1100 (8th Cir. 2006) (holding that
neurologist with knowledge of causes of shoulder pain was
qualified to testify concerning cause of shoulder injury,
although not an orthopedist); Deutsch v. Novartis Pharm. Corp.,
768 F. Supp. 2d 420, 437 (E.D.N.Y. 2011) (holding that oncologist
and hematologist was qualified to opine on effects of
pretreatment dental screening, although not a dentist or oral
surgeon); Blanchard v. Eli Lilly & Co., 207 F. Supp. 2d 308, 317
5
(D. Vt. 2002) (holding that psychiatrist was qualified to testify
about the cause of a suicide, despite lack of expertise in
pharmacology, epidemiology or toxicology).
Dr. Tarsy is
qualified to testify about the relative risk of tardive
dyskinesia from use of metoclopramide.
Wyeth’s other objections to this opinion attack its
reliability.
In the “conclusions” section of his report, Dr.
Tarsy offers the “supposition” that based on collected and
published data “the incidence of tardive dyskinesia with
metoclopramide exposure is roughly equivalent to the incidence of
tardive dyskinesia after exposure to the neuroleptic
antipsychotic drugs in general.”
Tarsy Report 8, ECF No. 319-1.
Dr. Tarsy explained that he used “supposition” as opposed to
“conclusion” because the studies are a “positive indicator” that
the incidence of tardive dyskinesia with metoclopramide and with
neuroleptic antipsychotic drugs is roughly equivalent.
Tarsy
Dep. 193:7-14, Aug. 18, 2010, ECF No. 319-2.
“To be scientifically valid, the subject of expert testimony
need not be ‘known to a certainty’ because, ‘arguably, there are
no certainties in science.’”
In re Fosamax Prods. Liab. Litig.,
645 F. Supp. 2d 164, 173 (S.D.N.Y. 2009) (quoting Daubert, 509
U.S. at 590).
“[I]n order to qualify as ‘scientific knowledge,’
an inference or assertion must be derived by the scientific
method.
Proposed testimony must be supported by appropriate
6
validation—i.e., ‘good grounds,’ based on what is known.”
Daubert, 509 U.S. at 590.
Wyeth’s contention that Dr. Tarsy’s
opinion is “purely speculative” blurs the distinction between
scientifically grounded theories or ideas on the one hand and
subjective belief or unsupported speculation on the other, a
distinction that the Daubert Court took pains to draw.
See id.
Dr. Tarsy acknowledges that his and others’ opinion that the
incidence of tardive dyskinesia with metoclopramide exposure is
roughly equivalent to the incidence of tardive dyskinesia with
exposure to the neuroleptic antipsychotic drugs is based on the
lack of evidence that one neuroleptic drug is “safer” than
another, and further acknowledges that retrospective studies of
newer antipsychotic drugs suggest that they are associated with a
lower incidence of EPS and possibly also tardive dyskinesia.
These acknowledgments of the limitations of the data do not
render his opinion inadmissible.
See Amorgianos v. Nat’l R.R.
Passenger Corp., 303 F.3d 256, 267 (2d Cir. 2002).
The validity
and strength of Dr. Tarsy’s opinion is a matter for the jury to
assess.
See Daubert, 509 U.S. at 596; Gen. Elec. Co. v. Joiner,
522 U.S. 136, 154-55 (1997) (Stevens, J., concurring in part and
dissenting in part).
Wyeth also seeks to preclude Dr. Tarsy from testifying
regarding how doctors would interpret the metoclopramide
labeling.
Dr. Tarsy may testify about the risks of tardive
7
dyskinesia from metoclopramide use, and he may compare what is or
was known at the time with what was disclosed in the labeling.
He may opine on the label’s accuracy and completeness.
With the
appropriate foundation, he may testify as to what the language
and form of the label suggests to the average doctor.
These
observations do not attempt to predict doctors’ prescribing
practices or understandings, nor do they attempt to suggest what
Kellogg’s doctors understood about metoclopramide at the time.
Such testimony would by contrast be excludable as speculative.
See, e.g., Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420,
442 (E.D.N.Y. 2011); Pfizer Inc. v. Teva Pharm. USA, Inc., 461 F.
Supp. 2d 271, 276 (D.N.J. 2006); In re Rezulin Prods. Liab.
Litig., 309 F. Supp. 2d 531, 556 (S.D.N.Y. 2004); see also
Daubert, 509 U.S. at 589-90 (“[T]he word ‘knowledge’ connotes
more than subjective belief or unsupported speculation.”).
Dr.
Tarsy’s assessment of the metoclopramide label’s communication of
information is admissible, if the testimony focuses on
specialized observation resting on knowledge and experience
“confessedly foreign in kind to the jury’s own.”
Kumho Tire, 526
U.S. at 149 (quotation marks and citation omitted).
Wyeth also seeks to preclude Dr. Tarsy from testifying that
reports from clinical trials in the 1970s that identified
restlessness or agitation as a side effect of metoclopramide use
8
should have been reported as akathisia.1
Kellogg does not intend
to offer this opinion, but expects that Dr. Tarsy may comment
that the existence of these side effects was likely akathisia and
should have prompted further investigation.
Testimony purporting
to characterize side effects recorded more than three decades ago
as more likely than not representing akathisia is not based on
sufficient facts or data, and does not satisfy Daubert’s
reliability requirement.
Daubert, 509 U.S. at 590 (“[I]n order
to qualify as ‘scientific knowledge,’ an inference or assertion
must be derived by the scientific method.”).
Dr. Tarsy may
testify, consistent with his deposition testimony, that the
existence of these side effects was a signal that should have
prompted further investigation into the presence of akathisia.
Tarsy Dep. 171:14-24, Aug. 18, 2010.
He may not testify that the
side effects identified in the Reglan® studies were more likely
than not akathisia.
Accordingly, Wyeth’s Motion to Exclude Expert Opinions of
Daniel Tarsy, M.D., ECF No. 319, is granted in part and denied in
part.
Motion to Exclude the Testimony of Ronald B. Stewart
Kellogg designated Ronald Stewart, a pharmacist and
Professor Emeritus in the College of Pharmacy at the University
1
“Akathisia” may be defined as a disorder characterized by
motor restlessness.
9
of Florida with a Masters Degree in hospital pharmacy
administration, as an expert witness in this case.
In his report
he states that he will testify that “metoclopramide is commonly
used inappropriately for periods greatly exceeding the FDA
approved indications and this leads to adverse reactions.”
Stewart Report 5, ECF No. 320-1.
He will also testify about the
“Taylor Paper,” an article promoting the safety of long-term use
of metoclopramide, published in the journal Clinical Therapeutics
in 1984.
Wyeth seeks the exclusion of both areas of testimony.
Kellogg agrees that her witness, who is not a medical
doctor, may not testify about whether prolonged metoclopramide
therapy is inappropriate.
With that proviso, she argues that
Stewart may testify that metoclopramide was frequently prescribed
for periods of longer than twelve weeks, and that side effects
were frequently experienced.
Wyeth argues that this testimony is
irrelevant to any issue in this case, and that the bases for Mr.
Stewart’s opinion are not reliable.
Evidence is relevant 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.”
Evid. 401.
Fed. R.
The parties agree that at trial Kellogg will seek to
demonstrate that Wyeth was responsible for disseminating
information about metoclopramide that was false or misleading.
To that end, testimony about the way metoclopramide has been used
10
is relevant to the issue of whether Wyeth’s metoclopramide
labeling was inaccurate or misleading.
To be sure, this witness
does not supply evidence that Kellogg’s doctors were
misled—evidence essential to the success of Kellogg’s claims—but
the testimony is not irrelevant to her case.
As to the reliability of Stewart’s opinion that long-term
metoclopramide use and adverse side effects was common or
frequent, Kellogg states that it is “based on his review of
published literature and discovery documents.”
Pl.’s Resp. 26,
ECF No. 329-3; see also Stewart Report 5 (“My testimony will be
based on my own study, my review of published literature and AHR
internal documents that support the conclusions of my own
study.”).
Although an expert may offer an opinion based on a
review of the literature and material provided in discovery, see
Fed. R. Evid. 703 (“An expert may base an opinion on facts or
data in the case that the expert has been made aware of . . .”),
this cursory reference to the sources of his opinion do not
enable the Court to determine that Mr. Stewart’s opinion is based
on sufficient facts or data.
Moreover, the vagueness of the
characterization does not assist the jury to understand the
evidence or to determine a fact in issue.
Fed. R. Evid. 702(a).
Although Mr. Stewart may extrapolate from existing data to opine
on the commonness or frequency of long-term metoclopramide use or
adverse side effects, in this case his opinion appears to be
11
connected to existing data only by his “ipse dixit.”
U.S. at 146.
Joiner, 522
Consequently, although Mr. Stewart may testify that
metoclopramide is prescribed for periods that greatly exceed the
FDA-approved indications, and that patients have suffered adverse
reactions, he may not characterize this as common or frequent,
without specifically disclosing the facts or data upon which he
makes this determination.
With regard to the Taylor Paper, Wyeth contends that Mr.
Stewart’s analysis is irrelevant and unduly prejudicial, and that
he is unqualified to give his opinion about it.
The Taylor Paper
purported to evaluate the safety of metoclopramide for long-term
use in patients with gastroesophageal reflux disease, finding
that “[n]o serious side effects were encountered.”
1, ECF No. 320-7.
Taylor Paper
The article was allegedly ghostwritten by A.H.
Robins (“AHR”) employees while AHR owned the rights to
manufacture Reglan®.2
Kellogg seeks to use Stewart’s critique of
the article as evidence that Wyeth’s dissemination of
information, in its labeling for Reglan® and otherwise, was false
or misleading.
In order for a critique of the Taylor Paper to have any
relevance in this case, Kellogg must be able to demonstrate that
Wyeth bore some responsibility for its creation.
2
Even assuming
Wyeth, formerly known as American Home Products, acquired
AHR in 1989.
12
that Wyeth can be held responsible for AHR’s conduct, Kellogg has
provided only speculation that AHR employees created the article
or influenced its conclusions.
Although there is evidence that
the purported author, David Taylor, did not write the paper,
Kellogg has provided no basis for the conclusion that it was
ghostwritten by AHR employees.
Mr. Stewart states that “AHR
internal documents suggest that [sic] was written by A.H. Robins
company employees.
I believe that would make the paper
fraudulent and very misleading.
It is my belief that A.H. Robins
Company selected a gastroenterologist with no research experience
as the principal investigator on a very complex multicenter
study.”
Stewart Report 5.
Mr. Stewart’s expertise, which may
well qualify him to provide a critique of the paper, does not
extend to the determination of its authorship or sponsorship.
His opinion on that point is “[no] more than subjective belief or
unsupported speculation.”
Daubert, 509 U.S. at 590.
Without
admissible evidence of Wyeth’s connection to the paper, the
paper’s deficiencies have no relevance to any issue in this case.
Mr. Stewart’s opinions on the Taylor Paper are therefore excluded
as irrelevant.
Wyeth’s Motion to Exclude the Testimony of Ronald B.
Stewart, ECF No. 320, is therefore granted in part and denied in
part.
13
Motion to Exclude the Testimony of Ralph Bernstein, M.D.
Wyeth moves to exclude the testimony of Dr. Bernstein for
failure to timely disclose him as an expert witness, and because
his testimony is irrelevant, lacks reliability and consists of
speculation.
Kellogg disclosed three experts on March 24, 2010.
Two
months later, after the deadline for disclosure under Rule
26(a)(2) had passed, she disclosed Dr. Bernstein, a boardcertified practicing gastroenterologist, as an expert witness.
Twenty-two months following the late disclosure, Wyeth now claims
prejudice because it has had no opportunity to depose him or
otherwise prepare for his testimony.3
Under the circumstances,
the Court finds the late disclosure of Dr. Bernstein to be
harmless.
Fed. R. Civ. P. 37(c).
Rule 26(a)(2)(B), however, requires that an expert
disclosure include a written report that among other things
contains the witness’s opinions and the facts or data considered
by the witness.
To date, Kellogg has not supplied Wyeth with a
report from Dr. Bernstein.4
She responds that Dr. Bernstein has
3
It is apparent from Dr. Bernstein’s disclosure that Wyeth
has had an opportunity to depose him in four previous
metoclopramide cases involving Wyeth. See Bernstein letter dated
May 25, 2010, ECF No. 317-1.
4
Dr. Bernstein attached a “Declaration” to his letter
agreeing to testify, which he states reflects the testimony he
expects to give in this case. See Bernstein Decl., ECF No. 3172.
14
been deposed multiple times in other metoclopramide cases, and
that Dr. Bernstein has submitted declarations in this and other
metoclopramide cases in which he has outlined the expected areas
of his testimony.
Essentially she argues that Wyeth has long
known the subject matter of Dr. Bernstein’s expected testimony.
Although ordinarily the Court would regard the failure to
provide an expert report as good grounds for exclusion of the
witness’s testimony, in this case, given Wyeth’s obvious
familiarity with Dr. Bernstein’s opinions, see Wyeth’s Mot. to
Exclude Expert Ops. of Ralph Bernstein, M.D. 6-8, ECF No. 317,
the Court will not exclude Dr. Bernstein’s testimony in its
entirety.
However, Dr. Bernstein’s testimony must be limited to
those topics described in the Declaration dated April 7, 2010,
that he has submitted in this case.
Dr. Bernstein’s Declaration sets forth the fact that a
prescription for a brand-name product such as Reglan® will be
filled at the pharmacy with any one of several generic
bioequivalent products unless the doctor specifies otherwise, as
well as the sources of doctors’ information about prescription
drugs.
Decl. ¶¶ 4-7.
Wyeth argues that his opinions are
irrelevant, that his opinions are statements of subjective
belief, and that he has applied no discernible methodology to
arrive at his conclusions.
The expected testimony is relevant.
15
Kellogg will attempt to
show that Wyeth breached a duty to use reasonable care to avoid
causing injury to consumers of generic bioequivalents to Reglan®.
The jury will probably hear that Kellogg did not take Reglan®,
but generic bioequivalents, and it is entitled to know why in
order to place that information in context.
It will also assist
the jury to know the sources of doctors’ prescription drug
information in general, as well as what Kellogg’s doctors relied
upon.
To be sure, testimony about what doctors do in general
will not supply the necessary element of proximate cause in this
case, but that does not render the testimony irrelevant.
The basis for Dr. Bernstein’s expected testimony is his
personal experience.
“[G]eneral truths derived from specialized
experience,” Kumho Tire, 526 U.S. at 148 (internal quotation
marks and citation omitted), are an acceptable basis for expert
testimony.
Dr. Bernstein does not intend to draw conclusions
about the nature, adequacy or accuracy of the information doctors
may derive about metoclopramide from these sources, nor does he
offer to testify as to what other doctors think.
He may however
draw from his lengthy experience as a practicing
gastroenterologist to tell the jury what sources doctors consult
when making prescription decisions.
Wyeth’s Motion to Exclude Expert Opinions of Ralph
Bernstein, M.D., ECF No. 317, is therefore granted in part and
denied in part.
16
Motion to Exclude the Testimony of Robert Nelson, Ph.D.
Robert Nelson is a clinical pharmacist with a Ph.D. in
epidemiology.
He worked for the FDA for more than twenty years
in positions of increasing responsibility and scope in new drug
review, epidemiology and post-marketing surveillance.
He
currently consults on drug safety, post-marketing surveillance,
pharmacoepidemiology, therapeutic risk management and drug
regulatory issues.
Wyeth seeks to preclude any testimony about Wyeth’s state of
mind, ethics and marketing.
Kellogg agrees that she will not
elicit testimony from Dr. Nelson that draws conclusions about
Wyeth’s intent, motive or state of mind.
She argues, however,
that Dr. Nelson may testify about standards of ethical conduct
for drug companies.
Dr. Nelson does not claim to be an expert on standards of
ethical conduct for drug companies, nor does he offer an opinion
that Wyeth behaved unethically.5
Deviation from industry
standards of ethics is not an issue in this case, and testimony
on that topic, if offered, is excluded as irrelevant.
See, e.g.,
In re Rezulin, 309 F. Supp. 2d at 544.
5
He does opine that Wyeth failed to perform a
comprehensive risk analysis of EPS, including tardive dyskinesia,
and that labeling reporting a one in five hundred rate of
occurrence of EPS was inaccurate and misleading. Nelson Report
4-5. These opinions do not express a view on corporate ethics or
morality.
17
Wyeth also objects to any discussion of AHR marketing
documents from the 1970s and 1980s, and notes that it will move
to exclude the documents before trial.
The Court denies without
prejudice the motion to exclude testimony about the documents
pending a determination of their relevance and admissibility.
In addition, Wyeth seeks to exclude Dr. Nelson’s opinions
regarding Wyeth’s regulatory compliance for failure to articulate
a standard for that compliance and because the opinions are
irrelevant.
If Kellogg is to prevail on a theory that Wyeth
breached a duty of care, her regulatory expert’s opinions that
Wyeth failed to perform a comprehensive risk analysis or allowed
inaccurate or misleading information to be included in its
labeling are certainly relevant.
Kellogg will have to produce expert testimony concerning the
appropriate standard of care, that is, what a reasonable
pharmaceutical company would have done under similar
circumstances.
See, e.g., Bartlett v. Mut. Pharm. Co., 742 F.
Supp. 2d 182, 195 (D.N.H. 2010), aff’d 678 F.3d 30 (1st Cir.
2012); White v. Harris, 2011 VT 115, ¶¶ 12-13, 36 A.3d 203, 20708; Provost v. Fletcher Allen Health Care, Inc., 2005 VT 115, ¶¶
7-9, 890 A.2d 97, 99-100 (entry order).
Dr. Nelson is expected
to testify that while Wyeth held the held the rights to
manufacture the brand name Reglan®, it was responsible for the
accuracy of its product labels, for assuring that its product was
18
being used safely for intended uses, for monitoring adverse
consequences associated with its product, for notifying the FDA
of signals of risk, and to mitigate identified risks.
Report 7-8.
Nelson
Wyeth complains that these opinions lack a
regulatory or other objective standard, but these objections more
properly attack the weight rather than the admissibility of the
evidence.
See Bartlett, 742 F. Supp. 2d at 195 (holding that
pharmacologist with significant experience at the FDA as well as
in pharmaceutical industry had an adequate foundation for his
testimony about standards of care); In re Fosamax, 645 F. Supp.
2d at 191-92 (holding that a medical doctor with experience at
the FDA would be permitted to testify about the reasonableness of
a drug company’s conduct).
Wyeth may offer evidence that Wyeth
in fact complied with FDA regulations; it will be the jury’s
function, if the evidence permits, to determine if an applicable
standard of care was breached.
Concerning the epidemiological evidence, Wyeth concedes that
Dr. Nelson may testify about general causation, but attacks his
conclusion that the risk of developing EPS is much higher than
the “one in five hundred” statement that appears on
metoclopramide labeling.
Dr. Nelson acknowledges that no
incidence studies exist that would indicate the specific rate of
tardive dyskinesia with long-term use.
126:16, ECF No. 318-2.
Nelson Dep. 125:16-
He also points out that at least one
19
published study has reported a prevalence of twenty percent among
patients treated with metoclopramide for at least twelve weeks,
indicating indirectly that tardive dyskinesia is not a rare
occurrence given long-term exposure.
Id. 116:23-117:9.
Attacks on the soundness of Dr. Nelson’s opinion that
metoclopramide-induced tardive dyskinesia is not rare go to the
weight, not the admissibility of this testimony.
See e.g.,
Deutsch, 768 F. Supp.2d at 433-34 (quoting Quiet Tech. v. HubelDubois UK Ltd., 326 F.3d 1333, 1340-41 (11 Cir. 2003)).
Experts
disagree about the accuracy of the “one in five hundred”
statement in the metoclopramide label.
The jury may hear
evidence attacking or supporting its accuracy and/or tendency to
mislead.
The jury may also hear that the FDA did not require the
deletion of the statement when the label was substantially
revised in 2009.
Absent admissible evidence about the FDA’s
reasoning, however, neither side is permitted to speculate why
the statement remains a part of the label.
Wyeth’s Motion to Exclude Certain Testimony of Robert
Nelson, Ph.D., ECF No. 318, is therefore granted in part, granted
in part as unopposed, and denied in part.
Dr. Nelson may provide
background information on the prescription drug industry and
federal drug regulation.
He may opine on the standard of care
for a pharmaceutical manufacturer.
He may testify about general
causation, and to the opinions disclosed in his report, with the
20
exception of those discussed above.
The admissibility of
testimony about AHR’s marketing documents and practices will be
addressed when the admissibility of the underlying documents is
addressed.
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
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