Royce v. Wyeth et al
Filing
413
MEMORANDUM OPINION AND ORDER granting plaintiff's 398 EXPEDITED MOTION for clarification or, in the alternative, for reconsideration of the court's memorandum opinion and order granting defendants' motion to preclude the testimony of Dr. Suzanne Parisian, to the extent that it seeks an order clarifying the court's 7/8/2011 392 memorandum opinion and order, and denied in all other respects; directing that Dr. Parisian is permitted to testify as outlined herein, subject to the limitations set forth in the 7/8/2011 memorandum opinion and order. Signed by Judge John T. Copenhaver, Jr. on 7/13/2011. (cc: attys) (taq)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
LEAH ROYCE HINES,
Plaintiff,
v.
Civil Action No. 2:04-0690
WYETH, d/b/a Wyeth, Inc.;
WYETH PHARMACEUTICALS, INC.;
and PHARMACIA & UPJOHN COMPANY,
Defendants.
MEMORANDUM OPINION AND ORDER
Pending is plaintiff’s expedited motion, filed July 11,
2011, for clarification or, in the alternative, for
reconsideration of the court’s memorandum opinion and order
granting defendants’ motion to preclude the testimony of Dr.
Suzanne Parisian.
I.
Background
Defendants moved to exclude the testimony of Dr.
Parisian and two other proposed expert witnesses on May 27,
2011.1
Defendants raised two contentions in their supporting
memorandum.
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First, in Part I of their supporting memorandum,
Inasmuch as plaintiff’s current motion for clarification
or reconsideration concerns only the testimony of Dr. Parisian,
the court will not address the proposed testimony of the two
other expert witnesses.
Defendants contended that the court should exclude Dr. Parisian
from testifying to her opinion that defendants failed to act as
reasonable pharmaceutical manufacturers inasmuch as they did not
adequately test their pharmaceutical drugs.
Mot. at 3-12).
(Mem. Supp. Defs.’
This “failure-to-test” opinion was unreliable,
according to defendants, because Dr. Parisian could not identify
an independent, objective standard by which to judge the
reasonableness of their conduct.
Second, in Part II of their
supporting memorandum, defendants contended that the court should
exclude the testimony of Dr. Parisian in its entirety, reasoning
that the remainder of her testimony was “nothing more than [a]
conduit[] to introduce general ‘bad company’ documents intended
to inflame the jury.”
(Id. at 13).
By memorandum opinion and order entered July 8, 2011,
the court granted defendants’ motion to exclude Dr. Parisian’s
testimony.
The court found defendants’ first contention
meritorious, concluding that Dr. Parisian’s testimony concerning
the reasonableness of defendants’ testing procedures lacked
adequate explanation or analysis, was not confined to her area of
expertise, and would prove unhelpful to the jury.
Order at 11-18).
(Mem. Op. &
The court thus determined that Dr. Parisian’s
testimony in this regard was inadmissible under Federal Rule of
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Evidence 702 and the Supreme Court’s ruling in Daubert v. Merrell
Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Notably,
however, the court neglected to address the defendants’ second
contention, that is, whether the remainder of Dr. Parisian’s
testimony should likewise be excluded.
Instead, the court simply
granted defendants’ motion to exclude the testimony of Dr.
Parisian without further explaining as to what areas, if any, she
could testify.
Understandably, plaintiff has now moved for an order
clarifying the extent of the court’s earlier ruling concerning
the testimony of Dr. Parisian.
Plaintiff does not challenge the
court’s ruling excluding Dr. Parisian from testifying to the
reasonableness of defendants’ testing.
(See Pl.’s Mot. at 17
(“Plaintiff requests that this Court clarify its Order,
permitting Dr. Parisian to provide expert testimony on issues
requiring specialized knowledge in this case, but barring her
from providing an ultimate opinion as to what a reasonable
company would do.”)).
Rather, plaintiff merely requests that the
court resolve the second issue presented by defendants’ motion to
exclude and specify whether the remainder of Dr. Parisian’s
testimony is likewise excluded.
Inasmuch as plaintiff is not revisiting the merits of
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the court’s earlier ruling, but is instead seeking a
clarification due to the court’s failure to resolve the remainder
of defendants’ motion to exclude, the court finds it appropriate
to grant the clarification sought.
II.
Analysis
Having benefitted from extensive briefing and oral
argument on this matter, the court is satisfied to conclude that
Dr. Parisian’s testimony should not be excluded in its entirety.
Rather, for the reasons explained below, Dr. Parisian may offer
testimony on the following matters identified in plaintiff’s
motion:
1. What is the process to obtain [approval by the Food
and Drug Administration (“FDA”)] of prescription drugs?
2. What is an FDA advisory committee and how [does] it
work?
3. What are the “changes being effected” regulation[s]
and how [can] a drug company unilaterally change its
label to strengthen a safety warning?
4. What is a “Dear Doctor” letter? When does a drug
company have to send one? When may a drug company send
one? When does the FDA send one? Is it considered
part of the label?
5.
What is a “Black Box” warning?
6. What is a Phase IV commitment? Could the FDA
enforce any commitment it got from Wyeth?
7.
What does it mean for a drug to be grandfathered
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in? What is DESI? Does that mean that no studies on
the drug are required?
8. Did the FDA have the power to order a study on the
combination of E and P prior to 1994 when the drugs
were not approved for use in combination?
9. What is acceptable promotion of a drug under FDA
rules and practices? What is not appropriate? What is
permissible to tell doctors and what not?
10. What is the purpose of the different mandatory
sections of a drug label? How are “warnings” different
from “precautions” and “contraindications”?
(Pl.’s Mot. at 9).
In addition to these topics, Dr. Parisian may
offer commentary on any document or exhibit in evidence, provided
that her testimony is limited to explaining the regulatory
context in which the document or exhibit was created, defining
any complex or specialized terminology therein, or drawing
inferences that would not be apparent without the benefit of
experience or specialized knowledge.
For example, Dr. Parisian
may testify to the adequacy of defendants’ prescription drug
labels, so long as her opinion is predicated upon her
understanding of the relevant regulatory requirements and not her
general opinion regarding how a responsible or ethical drug
manufacturer should act.
Finally, as explained in the July 8
memorandum opinion and order, Dr. Parisian may not simply
construct a factual narrative based upon recorded evidence, nor
may she offer testimony concerning the reasonableness of
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defendants’ testing procedures or the intent, motives, or
knowledge of defendants or their employees.
1.
Qualifications
The court finds that Dr. Parisian is qualified to offer
testimony concerning the general regulatory requirements
governing defendants and other pharmaceutical manufacturers.
Dr.
Parisian served as a Medical Officer at the FDA, and her
experience there involved various aspects of the regulation of
prescription drugs.
(Pl.’s Mot. at 8).
Moreover, her expert
report demonstrates specialized knowledge of the regulatory
standards applicable to drug manufacturers.
Inasmuch as
defendants do not challenge her qualifications, the court finds
that Dr. Parisian is qualified to testify to the regulatory
framework governing prescription drug manufacturers and its
applicability to defendants.
2.
Relevance
The court further finds that Dr. Parisian’s testimony
in this regard is relevant to this action.
Plaintiff’s causes of
action against defendant are grounded in West Virginia common law
and make no reference to the FDA or any governing regulations.
Nevertheless, both parties intend to offer evidence of
6
defendants’ compliance or noncompliance with relevant industry or
government standards, including regulations promulgated by the
FDA, to demonstrate the reasonableness of defendants’ conduct and
the safety of their prescription drugs.
at 9-10).
(Proposed Pretrial Order
A lay juror, however, can hardly be expected to
understand “the complex regulatory framework that informs the
standard of care in the pharmaceutical industry.”
In re Fosamax
Prods. Liab. Litig., 645 F. Supp. 2d 164, 191 (S.D.N.Y. 2009)
(finding that Dr. Parisian’s testimony concerning “general FDA
regulatory requirements and procedures” would aid the jury).
Accordingly, the court finds that Dr. Parisian’s testimony
concerning generally applicable FDA regulations is relevant to
and will assist the trier of fact in resolving material issues.
3.
Reliability
Finally, the court finds that Dr. Parisian’s opinion is
grounded upon an appropriate and reliable methodology.
An expert
witness is permitted to draw conclusions from a set of
observations based on extensive and specialized experience.
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 156 (1999).
Dr.
Parisian’s testimony concerning the governing regulatory
framework is based upon her experience as an FDA Medical Officer.
Moreover, her expert report demonstrates that she derived any
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opinion concerning defendants’ compliance with the relevant
regulations in the same manner and applying the same methodology
as would a Medical Officer.
(See, e.g., Pl.’s Resp. to Defs.’
Mot. to Suppress, Ex. 23a, Expert Report of Suzanne Parisian,
M.D., at 3 (explaining that Dr. Parisian’s duties with the FDA
included, among other things, assessing prescription drug
labels)).
The court finds that plaintiff has satisfied her
burden in demonstrating the admissibility of Dr. Parisian’s
testimony concerning the FDA, the regulations governing
prescription drug manufacturers, and defendants’ compliance
therewith.
III.
Conclusion
Pursuant to the foregoing analysis, it is ORDERED that
plaintiff’s motion be, and it hereby is, granted to the extent
that it seeks an order clarifying the court’s July 8 memorandum
opinion and order, and denied in all other respects.
It is
further ORDERED that Dr. Parisian be, and she hereby is,
permitted to testify as outlined above, subject to the
limitations set forth in the July 8 memorandum opinion and order.
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The Clerk is directed to forward copies of this written
opinion and order to all counsel of record.
DATED: July 13, 2011
John T. Copenhaver, Jr.
United States District Judge
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