Stoddard v. PLIVA, Inc. et al
Filing
182
ORDER granting in part and denying in part 155 Motion in Limine to exclude the testimony of Plaintiffs' expert, Robert C. Nelson, Ph.D. and denying 157 Motion in Limine to exclude the testimony of Plaintiffs' expert, David Ross, M.D. Signed by Magistrate Judge Kimberly A. Swank on 11/27/2013. (Lee, L.)
UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
EASTERN DIVISION
No. 4:08-CV-173-H
GARY JOSEPH STODDARD and
wife, PATRICIA ANN STODDARD,
Plaintiffs,
PLIVA USA, INC.,
Defendant.
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ORDER
This matter is currently before the court on Defendant’s motions to exclude the testimony
of Plaintiffs’ experts, Robert C. Nelson, Ph.D., and David Ross, M.D. [DE #155 & 157], which
were referred to the undersigned for ruling pursuant to 28 U.S.C. § 636(b)(1)(A) and Rule 72(a)
of the Federal Rules of Civil Procedure. Plaintiffs have responded, Defendant has replied, and
the motions are ripe for ruling.
BACKGROUND
Gary Stoddard (“Stoddard”), together with his wife Patricia Ann Stoddard (collectively
“Plaintiffs”), filed the complaint giving rise to this action in the Superior Court of Pitt County,
North Carolina, alleging that Stoddard developed tardive dyskinesia, a neurological movement
disorder, from his use of the prescription drug metoclopramide, the generic equivalent of
Reglan®. Plaintiffs sued Defendant PLIVA USA, Inc. (“PLIVA”), the alleged manufacturer of
the metoclopramide taken by Stoddard, as well as the manufacturers of Reglan® (“brand-name
manufacturers”). The action was removed to this court based on diversity jurisdiction, and on
June 24, 2009, the court entered an order dismissing Plaintiffs’ strict-liability claims as to all
defendants and granting the brand-name manufacturers’ motion for summary judgment as to the
claims against them. PLIVA subsequently filed a motion for judgment on the pleadings, arguing
that all of Plaintiffs’ claims are precluded by conflict preemption, as well as a motion for
summary judgment; and Plaintiff filed a motion for partial summary judgment with respect to
their claim that PLIVA failed to provide adequate warnings. Following the Supreme Court’s
decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the court entered an order granting
in part and denying in part Defendant’s motion for judgment on the pleadings and motion for
summary judgment and denying Plaintiffs’ motion for partial summary judgment.
As a
consequence of the court’s ruling, the following claims were dismissed or summarily denied:
(1) Plaintiffs’ claims based on PLIVA’s alleged failure to comply with state law requirements to
provide adequate warnings of the risks of metoclopramide, the claims having been dismissed on
the ground they are preempted by federal law; (2) Plaintiffs’ claim for breach of undertaking a
special duty, which was dismissed as not cognizable under North Carolina law; and
(3) Plaintiffs’ emotional distress claims, which were summarily disposed of due to a lack of
evidence of “severe emotional distress.”
Presently before the court are Defendant’s motions to exclude the testimony of Plaintiffs’
experts, Robert C. Nelson, Ph.D., and David Ross, M.D.
DISCUSSION
I.
Legal Standard
The admissibility of expert testimony is governed by Rule 702 of the Federal Rules of
Evidence, which provides as follows:
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;
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(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. “[F]ederal judges are to act as gatekeepers to determine whether an expert’s
opinion is reliable and whether his testimony will be helpful to the jury.” Sheffield v. West Am.
Ins. Co., No. 7:08-CV-191-H, 2010 WL 2990012, at *3 (E.D.N.C. July 27, 2010) (citing
Daubert v. Merrell Dow Pharms., 509 U.S. 579, 589 (1993)). In making this determination, the
court should consider whether the reasoning or methodology underlying the expert’s opinion is
reliable – whether it is supported by adequate validation to render it trustworthy. Daubert, 509
U.S. at 590. Additionally, the court must consider the relevancy of an expert’s opinion. Id. at
591-92. Expert testimony is admissible only if it is “sufficiently tied to the facts of the case that
it will aid the jury in resolving a factual dispute.” United States v. Downing, 753 F.2d 1224,
1242 (3rd Cir. 1985), cited with approval in Daubert, 509 U.S. at 2795-96.
II.
Plaintiffs’ Expert Dr. Robert C. Nelson
Dr. Robert C. Nelson (“Dr. Nelson”) is a clinical pharmacist with extensive experience in
the areas of pharmacology and epidemiology and holds a Ph.D. in epidemiology from the
University of Minnesota. He was employed by the Food and Drug Administration (“FDA”) for
over twenty years in positions of increasing responsibility and scope in the areas of new drug
review, epidemiology, and post-marketing surveillance. During his tenure with the FDA, Dr.
Nelson served as Associate Director of Epidemiology, Director of the Office of Professional
Development and Staff College, Assistant Director of the Office of Drug Evaluation II, and
Assistant Director of the Office of Biologics Research and Review. He also worked in the
FDA’s Office of New Drug Evaluation and Division of Neuropharmacological Drug Products.
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As Associate Director of Epidemiology, Dr. Nelson led the reengineering of the FDA’s Post
Marketing Drug Safety Surveillance Program, was responsible for strategic planning and policy
formulation for epidemiology within the agency’s Center for Drug Evaluation and Research, and
managed the development and implementation of the agency’s Adverse Event Reporting System.
He
currently
consults
on
issues
of
drug
safety,
post-marketing
surveillance,
pharmacoepidemiology, therapeutic risk management, pharmacovigilance practices, and drug
regulation.
PLIVA seeks to exclude Dr. Nelson’s testimony in its entirety. PLIVA argues that Dr.
Nelson’s opinions should be excluded because they are outside the area of his expertise and they
are nothing more than inadmissible “legal” opinions. Alternatively, PLIVA argues that the court
should exclude (1) Dr. Nelson’s proffered regulatory opinions because they concern alleged
inadequacies of the product labeling and, therefore, relate to matters preempted by federal law as
explained in Mensing; and (2) any general causation and epidemiology opinions relating to the
alleged risk of developing tardive dyskinesia by persons taking metoclopramide long-term
because the opinions are not based on proper epidemiological principles and methods and, to the
extent they criticize the product labeling, are preempted by federal law.
Dr. Nelson is highly educated, a veteran of the FDA, and a seasoned trial expert on the
type of issues presented in the instant action. Plaintiffs seek to offer his testimony on a variety of
highly technical topics about which the average layperson has virtually no knowledge. The court
concludes that Dr. Nelson is qualified to testify as a general matter because his testimony is both
relevant and reliable. Exclusion of his testimony, in its entirety, would therefore be improper. In
so finding, the court specifically rejects PLIVA’s argument that Dr. Nelson does not possess the
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requisite experience to offer testimony regarding the FDA’s regulation of generic drugs generally
or the post-marketing surveillance of generic drugs.
That said, the court finds that Dr. Nelson’s report contains a number of opinions that are
inadmissible because they concern claims that have been dismissed as preempted by federal law.
The only claims remaining before the court in this case are Plaintiffs’ state-law claims of
negligence, unfair or deceptive trade practices and loss of consortium.1 (Apr. 5, 2013 Order
[DE #149] at 5; Nov. 21, 2013 Order [DE #181] at 3.) At the heart of these claims are Plaintiffs’
allegations (1) that PLIVA had a duty to conduct post-market surveillance, to review all adverse
drug event information, and to report to the FDA any information bearing on the risk or
prevalence of side effects caused by metoclopramide (Compl. ¶¶ 73, 74), (2) that PLIVA
breached its duty of reasonable care by failing to conduct such post-market surveillance/review,
and (3) that PLIVA failed to report to the FDA drug risks of which it knew or should have
known. To the extent Dr. Nelson’s proffered testimony relates to matters outside the scope of
the claims remaining before the court, the testimony is not “sufficiently tied to the facts of the
case . . . [to] aid the jury in resolving a factual dispute,” Downing, 753 F.2d at 1242, and must be
excluded. Additionally, Dr. Nelson may not be allowed to offer an opinion that is in direct
conflict with the Supreme Court’s decision in Mensing.
Dr. Nelson may provide testimony concerning such issues as the general regulatory
scheme for the approval and review of drugs, including post-marketing surveillance; the
development and FDA-approval of Reglan® and its generic equivalent, metoclopramide; the side
effects associated with metoclopramide; the accuracy of the Reglan® drug label and the
1All
other claims raised in Plaintiffs’ complaint were dismissed in light of Mensing.
(Jan. 31, 2013 Order [DE #131]; Apr. 5, 2013 Order [DE #149]; Nov. 21, 2013 Order
[DE #181].)
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historical changes made thereto; and the etiology and epidemiology of tardive dyskinesia. He
may also testify concerning the post-marketing surveillance/reporting by PLIVA. He may not,
however, provide any opinion with regard to PLIVA’s alleged failure to perform a
comprehensive risk analysis of tardive dyskinesia prior to the approval of metoclopramide, nor
may he testify in any manner that would suggest PLIVA had a duty to provide consumers (or
their physicians) with warnings other than those approved for the brand-name label.
Also inadmissible are any “opinions” that constitute pure legal conclusions concerning
the applicability of the laws or regulations involved in this case. As a consequence, Dr. Nelson
will not be allowed to testify to such statements as “There is no provision of the Hatch-Waxman
amendment to the FDCA that overrides the basic and fundamental safety provisions (1938 and
1962) of that Act,” “Past or present lax practices by FDA cannot be interpreted as policy or law,”
or “Operational policy by FDA organizational units cannot alter or function contrary to the law,
be they statutory or administrative.” These are legal matters best left for counsel’s argument to
the jury.
Furthermore, Dr. Nelson may not testify that the “Changes Being Effected” procedure
allows a generic manufacturer, such as PLIVA, to unilaterally change its drug label, an argument
the Supreme Court rejected in Mensing. See Mensing, 131 S. Ct. at 2575 (accepting the FDA’s
interpretation that changes unilaterally made by a generic manufacturer would violate federal
requirements that the generic label be the same as the brand-name label).
He may testify,
though, concerning the availability of procedures for a generic drug manufacturer to request
FDA assistance in strengthening the corresponding brand-name label and the FDA’s practices
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with regard thereto. See Mensing, 131 S. Ct. at 2578 (recognizing that the Mensing plaintiffs’
claims were not based on a failure to ask the FDA for assistance in changing the labels). 2
The court rejects PLIVA’s contention that Dr. Nelson’s general causation and
epidemiology opinions are inadmissible. Contrary to PLIVA’s argument, Dr. Nelson’s opinion
that the risk of developing tardive dyskinesia is much greater than the 1-in-500 indicated in the
FDA-approved drug label is not preempted by federal law. It is true that Dr. Nelson may not
testify that PLIVA could have or should have changed its label to reflect the “true” risk of
metoclopramide. Nevertheless, principles of federal preemption do not preclude Plaintiffs from
offering evidence of metoclopramide’s “true” risk to support their claim that PLIVA breached its
standard of care or to establish causation in this case. Moreover, the fact that no study exists
regarding the incidence of tardive dyskinesia in diabetics does not render incompetent Dr.
Nelson’s opinion concerning the incidence and prevalence of tardive dyskinesia in the general
population. The court finds no basis for PLIVA’s claim that general causation requires a
showing that metoclopramide is capable of causing tardive dyskinesia in the particular subpopulation of which Stoddard is a member. Additionally, Dr. Nelson’s epidemiological opinions
appear to rest on the same principles and methodologies utilized by the FDA. Any challenge to
the soundness of Dr. Nelson’s opinion that the incidence of metoclopramide-induced tardive
2
In its reply brief, Defendant states that both the FDA and the Supreme Court in Mensing
rejected the argument that a generic drug manufacturer could or should approach the “FDA to
seek a change in the Reglan/metoclopramide labeling to add warnings.” (Reply Mem. Supp.
Mot. Exclude Dr. Nelson [DE #172] at 6, n.2.) In fact, in Mensing, the FDA argued that generic
manufacturers not only could propose stronger warning labels but were required to do so if they
believed such warnings were needed. Mensing, 131 S. Ct. at 2576. The Mensing Court having
deferred to the FDA’s interpretations of its “Changes Being Effected” procedure, generic
labeling regulations and “Dear Doctor” letters, the court has no reason to believe that the
Supreme Court would not also defer to the FDA’s interpretation of a generic manufacturer’s duty
to request a strengthened label.
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dyskinesia is greater than indicated on the drug label go to the weight, not the admissibility of the
testimony.
II.
Plaintiffs’ Expert David Ross, M.D.
PLIVA also seeks to exclude the testimony of Plaintiffs’ expert, David Ross, M.D., on
several grounds. First, PLIVA argues that he is not qualified to diagnose movement disorders,
such as tardive dyskinesia because he is a neuropsychiatrist, not a neurologist. Second, PLIVA
contends that his opinions are unreliable because there is no competent evidence of general
causation, he did not conduct a proper differential diagnosis, and the facts do not support his
opinion.
Dr. Ross is a board-certified psychiatrist who specializes in neuropsychiatry. He is
currently the Director of the Virginia Institute of Neuropsychiatry in Midlothian, Virginia, and a
Clinical Assistant Professor of Psychiatry at the Medical College of Virginia, Virginia
Commonwealth University. He has substantial experience with movement disorders, including
tardive dyskinesia, tardive akathisia, and traumatic brain injury. He has been working with
tardive dyskinesia patients for approximately twenty years and over ten years with patients
whose tardive dyskinesia was caused by Reglan® or metoclopramide. Over the course of his
career, he has seen hundreds, if not thousands, of tardive dyskinesia patients.
He is well
published, with a number of peer-reviewed articles on the topic of tardive dyskinesia. His
testimony is being offered by Plaintiffs on the following topics: (1) the development and onset
of tardive dyskinesia caused by Reglan®/metoclopramide, generally, and, specifically, with
regard to Stoddard; (2) the symptoms and severity of tardive dyskinesia exhibited by Stoddard;
and (3) the diagnosis, treatment and prognosis of Stoddard. Dr. Ross’ background and extensive
experience with movement disorders make him more than qualified to provide expert testimony
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on the topic of tardive dyskinesia, its diagnosis, treatment and psychological effects. The court,
therefore, rejects PLIVA’s argument that Dr. Ross is not qualified to testify as an expert in this
case.
Bootstrapping its objection to Dr. Nelson’s epidemiology testimony, PLIVA next argues
that Dr. Ross’ testimony should be excluded because there is no evidence of general causation –
that metoclopramide is capable of causing tardive-dyskinesia in the sub-population of which
Stoddard is a member (diabetics). As set forth above, however, the court finds no basis to
support PLIVA’s assertion that general causation evidence must relate to the plaintiff’s subpopulation, as opposed to the general population.
“General causation is established by
demonstrating, often through a review of scientific and medical literature, that exposure to a
substance can cause a particular disease (e.g., that smoking cigarettes can cause lung cancer).”
Mary Sue Henifen et al., Reference Guide on Medical Testimony, in Reference Manual on
Scientific Evidence 439, 444 (Fed. Jud. Ctr., 2d ed. 2000), quoted in Fisher v. Pelstring, 817 F.
Supp. 2d 791, 815 (D.S.C. 2012). In this case Plaintiffs have presented ample evidence, through
expert testimony and research, to support a finding of general causation.
Next PLIVA argues that Dr. Ross did not perform a proper differential diagnosis because
he did not properly “rule out” other potential causes for Stoddard’s alleged movement disorder.
Specifically, PLIVA asserts that Dr. Ross failed to rule out Stoddard’s hypoglycemia, the
possibility of Wilson’s disease or Huntington’s disease or Stoddard’s use of other drugs, such as
promethazine, as possible causes of Stoddard’s movement disorder.
Differential diagnosis, or differential etiology, is a standard scientific
technique of identifying the cause of a medical problem by eliminating the likely
causes until the most probable one is isolated. A reliable differential diagnosis
typically, though not invariably, is performed after physical examinations, the
taking of medical histories, and the review of clinical tests, including laboratory
tests, and generally is accomplished by determining the possible causes for the
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patient's symptoms and then eliminating each of these potential causes until
reaching one that cannot be ruled out or determining which of those that cannot be
excluded is the most likely. . . .
....
. . . A differential diagnosis that fails to take serious account of other
potential causes may be so lacking that it cannot provide a reliable basis for an
opinion on causation. However, [a] medical expert's causation conclusion should
not be excluded because he or she has failed to rule out every possible alternative
cause of a plaintiff's illness. The alternative causes suggested by a defendant
affect the weight that the jury should give the expert's testimony and not the
admissibility of that testimony, unless the expert can offer no explanation for why
she has concluded [an alternative cause offered by the opposing party] was not the
sole cause.
Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262-65 (4th Cir. 1999) (alterations in original)
(internal quotation marks and citations omitted) (quoting Heller v. Shaw Indus., 167 F.3d 146,
156-57 (3d Cir. 1999)).
Dr. Ross’ expert report in this case indicates that he considered Stoddard’s other medical
conditions and took into account other possible causes of Stoddard’s movement disorder. The
fact that he may not have ruled out every possible cause does not mean that he failed to perform
a proper differential diagnosis. Nor does the fact that he examined Stoddard on only one
occasion render his diagnosis “so lacking that it cannot provide a reliable basis for an opinion on
causation.” Westberry, 178 F.3d at 265. The Federal Rules of Evidence permit an expert to base
his opinion on facts or data of a type reasonably relied upon by experts in the particular field.
Fed. R. Evid. 703. In this case, Dr. Ross bases his opinions not simply on his single examination
of Stoddard, but also upon his review of Stoddard’s medical records, including another
physician’s diagnosis of tardive dyskinesia, and his extensive clinical experience in the treatment
of patients with similar disorders. Any criticisms of Dr. Ross’ methodology or diagnosis may be
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appropriately addressed through cross-examination and do not affect the admissibility of Dr.
Ross’ testimony.
PLIVA takes a final shot at Dr. Ross’ testimony, arguing it is irrelevant because Dr. Ross
cannot state with a reasonable degree of medical certainty that “PLIVA’s metoclopramide caused
Mr. Stoddard’s alleged injuries . . . [when] Mr. Stoddard showed no signs or symptoms of
tardive dyskinesia or dystonia until late 2003 – nearly one year after he last took PLIVA’s
metoclopramide product and after a six-month break from taking any metoclopramide.” (Mem.
Supp. Mot. Exclude Dr. Ross [DE #158] at 14 (emphases added).) The court finds there is a
sufficient factual basis to support Dr. Ross’ opinion and that his opinion provides a sufficient
causal link to be admissible at the trial of this action. Accordingly, the court rejects PLIVA’s
argument that Dr. Ross’ testimony is irrelevant to the issues in the case.
CONCLUSION
For the foregoing reasons and as set forth in detail above, Defendant’s motion to exclude
the testimony of Plaintiffs’ expert, Robert C. Nelson, Ph.D. [DE #155] is GRANTED IN PART
and DENIED IN PART; and Defendant’s motion to exclude the testimony of Plaintiffs’ expert,
David Ross, M.D. [DE #157] is DENIED.
This 27th day of November 2013.
__________________________________
KIMBERLY A. SWANK
United States Magistrate Judge
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