Royce v. Wyeth et al

Filing 417

MEMORANDUM OPINION AND ORDER granting defendants' 254 MOTION to exclude the causation testimony of Dr. William Burns; and denying defendants' request for oral argument as to the present motion. Signed by Judge John T. Copenhaver, Jr. on 7/14/2011. (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 defendants’ motion to exclude the causation
testimony of Dr. William Burns (Doc. No 254), filed May 27,
2011.1
I.

Background

This is a pharmaceutical products liability action in
which plaintiff Leah Royce Hines alleges that she developed
breast cancer as a result of ingesting hormone replacement
therapy (“HRT”) drugs manufactured by defendants.

1

HRT here

At a pretrial conference on June 17, 2011, the court
conferred with counsel regarding the necessity of an evidentiary
hearing on the various Daubert motions currently pending before
the court. (See Doc. No. 343). The parties made clear that such
a hearing was not necessary. Defendants have, however, requested
oral argument on the motions. Inasmuch as the parties’ briefs
and supporting exhibits adequately present the issues ripe for
adjudication, the court finds that oral argument would not aid
the decisional process and accordingly denies defendants’ request
for oral argument as to the present motion.

consists of two medications, estrogen and progestin (“E+P”), that
are commonly prescribed in combination to treat menopausal
symptoms.

This action concerns three HRT drugs: Premarin,
Prempro, and Provera.

Defendant Wyeth, LLC (“Wyeth”)

manufactured Premarin, an estrogen drug, and Prempro, a
combination estrogen and progestin drug.

Defendant Pharmacia &

Upjohn Company (“Upjohn”) manufactured and distributed Provera, a
progestin drug.

The generic name for Provera is

medroxyprogesterone acetate (“MPA”).

Plaintiff’s physician prescribed HRT drugs to treat her
menopausal symptoms from approximately July 1994 to April 1999.
She was diagnosed with breast cancer in July 1999, and thereafter
instituted this action on July 7, 2004, invoking the court’s
diversity jurisdiction.2

Her complaint asserts claims against

defendants for negligence, strict liability (design defect and
failure to warn), and breach of implied warranty.

2

The case was transferred to multidistrict litigation in
the United States District Court for the Eastern District of
Arkansas on October 26, 2004. Over five years later, on April
13, 2010, it was remanded to this court for the completion of
discovery, pretrial activity, and trial.
2

Defendants seek to exclude the causation testimony of
one of plaintiff’s surgeons, Dr. William Burns.

II.

Governing Standard

The admission of expert testimony is governed by
Federal Rule of Evidence 702 and the Supreme Court’s decision in
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579
(1993).

Under Rule 702 and Daubert, expert testimony must

satisfy a two-prong test: (1) the testimony must concern
“scientific, technical, or other specialized knowledge”; and (2)
it must “aid the jury or other trier of fact to understand or
resolve a fact at issue.”

Westberry v. Gislaved Gummi AB, 178

F.3d 257, 260 (4th Cir. 1999) (citing Daubert, 509 U.S. at 592);
Fed. R. Evid. 702.

“The first prong of this inquiry necessitates

an examination of whether the reasoning or methodology underlying
the expert’s proffered opinion is reliable -- that is, whether it
is supported by adequate validation to render it trustworthy.”
Westberry, 178 F.3d at 260.

“The second prong of the inquiry

requires an analysis of whether the opinion is relevant to the
facts at issue.”

Id.

Thus, an expert’s testimony is admissible

under Rule 702 if it “rests on a reliable foundation and is
relevant.”

Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141

3

(1999).

As to the reliability prong, the Court in Daubert
announced a non-exhaustive list of factors to guide the trial
judge’s inquiry, including “(1) whether a theory or technique can
be or has been tested; (2) whether it has been subjected to peer
review and publication; (3) whether a technique has a high known
or potential rate of error and whether there are standards
controlling its operation; and (4) whether the theory or
technique enjoys general acceptance within a relevant scientific
community.”

Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 199

(4th Cir. 2001) (citing Daubert, 509 U.S. at 592-94).

As to the relevancy prong, “the expert’s proffered
scientific testimony must be sufficiently tied to the facts of
the case that it will be of assistance to the factfinder in
resolving a disputed fact.”

Bourne ex rel. Bourne v. E.I. Dupont

de Nemours & Co., 189 F. Supp. 2d 482, 495 (S.D. W. Va. 2002).
“That is, there must be a ‘valid scientific connection to the
pertinent inquiry’ before the testimony is admissible.”

Id.

(quoting Daubert, 509 U.S. at 591-92).

Our court of appeals has summarized the overarching
duties of a trial court in resolving Daubert motions as follows:

4

A district court considering the admissibility of expert
testimony exercises a gate keeping function to assess
whether the proffered evidence is sufficiently reliable
and relevant . . . The inquiry to be undertaken by the
district court is “a flexible one” focusing on the
“principles and methodology” employed by the expert, not
on the conclusions reached. Daubert, 509 U.S. at 594-95
. . . In making its initial determination of whether
proffered testimony is sufficiently reliable, the court
has broad latitude to consider whatever factors bearing
on validity that the court finds to be useful . . . The
court, however, should be conscious of two guiding, and
sometimes competing, principles. On the one hand, the
court should be mindful that Rule 702 was intended to
liberalize the introduction of relevant expert evidence.
. . . [T]he court need not determine that the expert
testimony a litigant seeks to offer into evidence is
irrefutable or certainly correct . . . As with all other
admissible evidence, expert testimony is subject to being
tested by “[v]igorous cross-examination, presentation of
contrary evidence, and careful instruction on the burden
of proof.” Daubert, 509 U.S. at 596 . . . On the other
hand, the court must recognize that due to the difficulty
of evaluating their testimony, expert witnesses have the
potential to “be both powerful and quite misleading.”
Id. at 595 . . . [G]iven the potential persuasiveness of
expert testimony, proffered evidence that has a greater
potential to mislead than to enlighten should be
excluded.
Westberry, 178 F.3d at 261 (some citations and footnotes
omitted).

Ultimately, “[t]he proponent of the [expert] testimony

must establish its admissibility by a preponderance of proof.”
Cooper, 259 F.3d at 199.

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III.

A.

Motion to Exclude

Background

Dr. Burns is a board certified general surgeon who
served as one of plaintiff’s treating physicians.
Ex. 3, Dr. Burns Dep. at 27).

He first saw plaintiff in August

of 1998 and continued to treat her until 2005.
3).

(Pl.’s Opp.,

(Pl.’s Opp. at

During that time, Dr. Burns performed diagnostic breast

biopsies on plaintiff; diagnosed her with Grade II infiltrating
ductal carcinoma with major tubular component and ductal
carcinoma in situ in plaintiff’s left breast; and performed a
double mastectomy and removed lymph nodes for pathology testing
to ensure that there had been no metastatic spread of the cancer.
(Id.).

Plaintiff seeks to admit Dr. Burns’ testimony to
demonstrate, among other things, specific causation.
at 2).

(Pl.’s Opp.

According to plaintiff, Dr. Burns “concluded to a

reasonable degree of medical certainty that E+P caused [her]
breast cancer” after performing a differential diagnosis based on
his review of plaintiff’s medical record.

(Id. at 3).

Claiming

that Dr. Burns adhered to a reliable methodology in reaching his
conclusion, plaintiff maintains that his expert testimony is

6

relevant to, and will aid the jury in, resolving whether her use
of HRT drugs caused her to develop breast cancer.

Defendants have asserted a number of contentions in
opposing Dr. Burns’ causation testimony.

Defendants argue that

Dr. Burns’ causation opinion does not rest on a reliable
foundation, inasmuch as he did not conduct a reliable
differential diagnosis of plaintiff to determine the cause of her
breast cancer.

Defendants further contend that Dr. Burns’

causation testimony is irrelevant because it is not stated to a
reasonable degree of probability.
Exclude at 8).

(Mem. Supp. Defs.’ Mot. to

Specifically, defendants maintain that Dr. Burns

testified only that HRT possibly caused plaintiff’s breast
cancer, an opinion that is “too tentative to be admissible.”
(Id.).

B.

The court assesses these contentions in turn.

Reliability of Dr. Burns’ Causation Testimony

Plaintiff claims that Dr. Burns reached his specific
causation opinion by way of a methodology called differential
diagnosis.

(Pl.’s Opp. at 2).

Defendants respond that Dr. Burns

did not conduct a reliable differential diagnosis of plaintiff to

7

determine the cause of her breast cancer.3

(Defs.’ Reply 9-10).

The court finds that Dr. Burns’ causation testimony does not pass
the Daubert reliability threshold.

The Fourth Circuit has explained that differential
diagnosis “is a standard scientific technique of identifying the
cause of a medical problem . . . by determining the possible
causes for the 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.”

Westberry, 178 F.3d at 262.

“A reliable

differential diagnosis provides a valid foundation for an expert
opinion under Rule 702.”
original).

Cooper, 259 F.3d at 200 (emphasis in

To satisfy the Daubert reliability standard, an

expert conducting a differential diagnosis must adequately “rule
in” and “rule out” alternative causes.

See Tamraz v. Lincoln

Elec. Co., 620 F.3d 665, 674 (6th Cir. 2010); In re Paoli
Railroad Yard PCB Litigation, 35 F.3d 717 (3d Cir. 1994).

This

entails compiling a “list of possible causes that are generally

3

Defendants also maintain that the use of differential
diagnosis to determine the cause of an individual’s breast cancer
is per se unreliable. However, the court has already rejected
this contention in a memorandum opinion and order previously
entered in this action. See Hines v. Wyeth, No. 04-690, slip op.
at 9-11 (S.D. W. Va. July 8, 2011) (Doc. No. 393).
8

capable of causing the illness or disease at issue, and then
systematically and scientifically ruling out specific causes
until a final, suspected cause remains.”

Kilpatrick v. Breg,

Inc., 613 F.3d 1329, 1342 (11th Cir. 2010).

The following exchange constitutes the entirety of Dr.
Burns’ deposition testimony concerning differential diagnosis:
Q.
Did you ever do a differential diagnosis at the time
you were treating [plaintiff] to determine what the cause
of her breast cancer was?
* * * *
A.
Yeah. When I did her history and physical exam, I
asked her when she first started having periods,
menarche, which hers was late. And how many pregnancies
she had, multiple, seven. And when she had menopause,
and that was at age 48. And I asked her if she ever took
hormone replacement therapy, and she said yes, for 22
years, but she had recently stopped it. I asked her if
anybody in her family had breast cancer. At that point,
she said no.
(Pl.’s Opp., Ex. 3, Dr. Burns Dep. at 86).

Dr. Burns later

testified that late menarche, multiple pregnancies, and early
menopause are all risk factors for breast cancer.

(See id. at

91-92).

At most, this deposition testimony shows that, in Dr.
Burns’ opinion, plaintiff had several baseline risk factors for
breast cancer.

Yet in reaching his tentative conclusion

(discussed supra) that HRT drugs “contributed to the growth of
9

[plaintiff’s] tumor,” (id. at 95), Dr. Burns does not explain how
or why he ruled out these non-HRT risk factors.

Moreover, later

portions of his testimony indicate that he did not reliably rule
in alternative causes.

When asked if he was “aware of anything

else [other than HRT] that would have contributed to the growth
of the tumor,” Dr. Burns simply responded “No.”

(Id. at 96).

A

review of the record in this case, however, reveals that there
were several plausible, alternative causes of plaintiff’s breast
cancer, including endogenous estrogen (i.e., estrogen naturally
produced by the body) and plaintiff’s dense breasts.

Indeed, as

discussed in a prior memorandum opinion and order entered in this
action, plaintiff’s specific causation expert, Dr. Michael
Wertheimer, devotes a substantial part of his report assessing
and excluding these alternative causes.

See Hines v. Wyeth, No.

04-690, slip op. at 19-23 (S.D. W. Va. July 8, 2011) (Doc. No.
393).

Dr. Burns provides no such analysis.

It appearing that

Dr. Burns did not “systematically and scientifically” rule in and
rule out specific causes until a final cause remained, the court
concludes that Dr. Burns’ differential diagnosis does not satisfy
the Daubert reliability standard.

C.

Relevance of Dr. Burns’ Testimony

Defendants also challenge the relevance of Dr. Burns’
10

causation testimony.

Defendants maintain that Dr. Burns failed

to testify in his deposition to a reasonable degree of medical
probability that plaintiff’s use of HRT drugs caused her breast
cancer.

Inasmuch as the law of West Virginia is clear that

“indeterminate expert testimony on causation that is based solely
on possibility . . . is not sufficient to allow a reasonable
juror to find causation,”

Tolley v. ACF Indus., Inc., 575 S.E.2d

158, 168 (W. Va. 2002), defendants assert that Dr. Burns’
causation testimony would not aid the jury in resolving a
material issue and is therefore irrelevant under Daubert.

Dr. Burns first discussed his causation opinion in
response to an inquiry from defendants’ counsel concerning his
(Dr. Burns’) conversations with plaintiff’s counsel before
plaintiff initiated this action:
Q. Did you tell [plaintiff’s counsel] what the cause
of her breast cancer was?
A.

What my opinion was?

Q.

Yeah.

A.

Yes.

Q.

And what did you tell him?

A. I told him that she had breast cancer that could
have been exacerbated or had causative effect due to
hormone replacement therapy.
(Pl.’s Opp., Ex. 3, Dr. Burns Dep. at 12-13).
11

Dr. Burns’ opinion

on the causal relationship next arose in a lengthy exchange with
defendants’ counsel, interrupted by several objections by counsel
for plaintiff:
Q. Okay. And you agree that medical test[ing] cannot
specifically say, hey, because you took -- your tumor’s
ER positive and PR positive, that it had to come from
[HRT]. You agree with that; right?
* * * *
A. If it’s ER/PR positive, and you’re taking that
medication, I personally can’t see how it couldn’t be - have some effect on the tumor. Whether it’s a
causative effect or an additive effect, I’m not sure.
Q. Okay. Well, let’s focus on that; all right? So do
you have an opinion within a reasonable degree of
medical certainty that [HRT] causes the initial tumor?
Can you say that?
A. I don’t have scientific data to determine that, and
I have not seen any literature that says specifically
that it’s causative. . . .
* * * *
Q. Do you have an opinion within a reasonable degree
of medical certainty that the use of [HRT] causes
breast cancer?
* * * *
A. I think women that take hormone replacement therapy
have an increased incidence of development of breast
cancer to their peers. So I think with a reasonable
degree of medical certainty, then I would think that
there is a causative and additive, both, what degree -I’m not sure -- effect on breast cancer by [HRT]. . . .
Q. Okay. Let’s break that down a little bit. . . .
Do you believe that the use of Premarin and Provera
causes breast cancer? That is, that it initiates the
12

cancer cells.

Is that what you believe?
* * * *

A. I’m trying to see in my mind if there’s a difference
between causes and initiates, probably not. I’d say
dual replacement therapy causes an increase in
incidents of breast cancer.
* * * *
Q. All right. Well, I’ll ask you again. Is it your
opinion sitting here today that the use of [HRT]
initiates the breast cancer?
* * * *
A. I think it’s one of the multiple components
potentially that could initiate cancer.
(Id. at 34-38).

Dr. Burns’ opinion as to the causal relationship

arose again later in the deposition on examination by plaintiff’s
counsel:
Q. You mentioned earlier in the deposition that you
had an opinion that her combination [HRT] contributed
to the growth of her tumor from the time of her last
mammogram to the time of her -- prior to diagnosis to
the time of diagnosis; is that correct?
A.

Yes.

Q. Are you aware of anything else that would have
contributed to the growth of the tumor during that
time?
A.

No.

Q. You mentioned that you
Health Initiative (“WHI”)]
opinion about causation in
also rely on that study to
was five years or greater,

rely on the [2002 Women’s
study to support your
this case . . . . Did you
say if the duration of use
you would think that the HRT
13

could be causal?
A. That’s my opinion, yeah. I don’t have any
scientific data to prove that.
* * * *
Q. All right. Your opinion about the causal role of
[HRT] and breast cancer in [plaintiff’s] case, are you
expressing that to a reasonable degree of medical
certainty?
A.

Yes.

(Id. at 95-98).

Finally, counsel for defendants raised the topic

one last time at the conclusion of Dr. Burns’ deposition:
Q. And is it accepted in your profession now that the
WHI and the other literature shows that combination
[HRT] can cause breast cancer?
* * * *
A. It causes an increase incidence of breast cancer.
I can’t say it’s a direct cause.
(Id. at 102).

Dr. Burns has offered a rather imprecise opinion.

With

respect to the general causal relationship between HRT drugs and
breast cancer, Dr. Burns offered at least three opinions.

He

first testified that HRT drugs “have some effect on the tumor,”
be it “a causative effect or an additive effect.”

(Id. at 34).

He then offered a more definitive opinion, asserting that “there
is a causative and additive . . . effect on breast cancer by
[HRT]” but adding, “what degree -- I’m not sure.”
14

(Id. at 35).

Shortly thereafter, he reverted to his original opinion, noting
that HRT is “one of the multiple components potentially that
could initiate cancer.”

(Id. at 38).

Of course, Dr. Burns is offered not for general
causation purposes but for specific causation.

And not unlike

his testimony concerning the general causal relationship between
HRT drugs and breast cancer, Dr. Burns’ opinion concerning
whether these drugs specifically caused plaintiff’s breast cancer
is less than clear.

Dr. Burns first opined in effect that HRT

drugs possibly caused her breast cancer.

Early in the

deposition, Dr. Burns testified that, in his opinion, plaintiff
“had breast cancer that could have been exacerbated or had
causative effect due to [HRT].”

(Pl.’s Opp., Ex. 3, Dr. Burns

Dep. at 12-13 (emphasis added)).

Near the conclusion of the

deposition, plaintiff’s counsel summarized Dr. Burns’ causation
opinion in somewhat firmer terms:
Q. You mentioned earlier in the deposition that you
had an opinion that her combination [HRT] contributed
to the growth of her tumor from the time of her last
mammogram to the time of her -- prior to diagnosis to
the time of diagnosis; is that correct?
A.

Yes.

Q. Are you aware of anything else that would have
contributed to the growth of the tumor during that
time?

15

A.

No.

(Id. at 95-96 (emphasis added)).

Notwithstanding the apparent inconsistences in Dr.
Burns’ testimony, the court is not inclined at this juncture to
find that his causation testimony is irrelevant as too
speculative.

Rather, in light of the earlier determination that

Dr. Burns’ differential diagnosis was inadequate under Daubert
and Rule 702, the court excludes his causation testimony on
reliability grounds alone.

IV.

Conclusion

For the foregoing reasons, the court ORDERS that
defendants’ motion to exclude the causation testimony of Dr.
Burns be, and it hereby is, granted.4

4

The court’s ruling obviates the need to address
defendants’ alternative contentions that Dr. Burns’ testimony
should be excluded because plaintiff failed to disclose him as an
expert witness as required by Federal Rule of Civil Procedure
26(a)(2)(A) and because he is not qualified to render causation
testimony. Additionally, the court’s finding that Dr. Burns’
causation testimony is unreliable does not preclude Dr. Burns
from testifying in his role as plaintiff’s treating physician.
16

The Clerk is directed to forward copies of this written
opinion and order to all counsel of record.

DATED: July 14, 2011
John T. Copenhaver, Jr.
United States District Judge

17