Michael et al v. Wyeth Pharmaceuticals, Inc. et al
Filing
219
MEMORANDUM OPINION AND ORDER denying defendant Upjohn's 149 MOTION for Summary Judgment. Signed by Judge John T. Copenhaver, Jr. on 5/23/2011. (cc: attys) (tmh)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
CAROLYN MICHAEL,
Plaintiff,
v.
Civil Action No. 2:04-0435
WYETH, LLC, and
PHARMACIA & UPJOHN COMPANY
(n/k/a PHARMACIA & UPJOHN
COMPANY LLC),
Defendants.
MEMORANDUM OPINION AND ORDER
Pending is the motion for summary judgment of defendant
Pharmacia & Upjohn Company (“Upjohn”),1 filed March 28, 2011.
I.
Background
This is a pharmaceutical products liability action in
which plaintiff Carolyn Michael alleges that she developed breast
cancer as a result of ingesting hormone replacement therapy
(“HRT”) medications.
HRT here consists of two medications,
estrogen and progestin, which are commonly used in combination to
treat symptoms of menopause.
1
Upjohn manufactured and distributed
Although the motion was originally filed by former
defendant Pfizer Inc., the parties have since agreed that Upjohn
should be substituted in this action in place of Pfizer. Pfizer
was accordingly dismissed by agreed order dated May 12, 2011, and
Upjohn was added as a defendant by way of plaintiff’s fourth
amended complaint, filed May 18, 2011.
Provera, a progestin drug.
The chemical name for Provera is
medroxyprogesterone acetate (“MPA”).
In 1994, plaintiff’s physician began prescribing HRT
drugs to treat her menopausal symptoms.
Plaintiff claims that
Provera was one of the HRT drugs that her doctor prescribed for
her, and that she ingested the drug from 1994 to 1996.
After being diagnosed with breast cancer in November
2001, plaintiff stopped taking HRT drugs.
She thereafter
instituted this action on May 6, 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 warranty (express and implied).
Defendant Upjohn has moved for summary judgment,
asserting that plaintiff has failed to carry her burden of
showing that she ingested Provera or any other Upjohn product.
2
The case was transferred to multidistrict litigation in
the United States District Court for the Eastern District of
Arkansas on July 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
II.
A.
Motion for Summary Judgment
Governing Standard
A party is entitled to summary judgment “if the
pleadings, the discovery and disclosure materials on file, and
any affidavits show that there is no genuine issue as to any
material fact and that the movant is entitled to judgment as a
matter of law.”
Fed. R. Civ. P. 56(c).
Material facts are those
necessary to establish the elements of a party’s cause of action.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
A genuine issue of material fact exists if, in viewing
the record and all reasonable inferences drawn therefrom in a
light most favorable to the non-moving party, a reasonable factfinder could return a verdict for the non-movant.
Id.
The
moving party has the burden of showing -- “that is, pointing out
to the district court -- that there is an absence of evidence to
support the nonmoving party’s case.”
477 U.S. 317, 325 (1986).
Celotex Corp. v. Catrett,
If the movant satisfies this burden,
then the non-movant must set forth specific facts as would be
admissible in evidence that demonstrate the existence of a
genuine issue of fact for trial.
Id. at 322-23.
A party is
entitled to summary judgment if the record as a whole could not
lead a rational trier of fact to find in favor of the non-movant.
3
Williams v. Griffin, 952 F.2d 820, 823 (4th Cir. 1991).
A court must neither resolve disputed facts nor weigh
the evidence, Russell v. Microdyne Corp., 65 F.3d 1229, 1239 (4th
Cir. 1995), nor make determinations of credibility.
Murphy, 797 F.2d 179, 182 (4th Cir. 1986).
Sosebee v.
Rather, the party
opposing the motion is entitled to have his or her version of the
facts accepted as true and, moreover, to have all internal
conflicts resolved in his or her favor.
Charbonnages de France
v. Smith, 597 F.2d 406, 414 (4th Cir. 1979).
Inferences that are
“drawn from the underlying facts . . . must be viewed in the
light most favorable to the party opposing the motion.”
United
States v. Diebold, Inc., 369 U.S. 654, 655 (1962).
B.
Product Identification
To succeed in a products liability action, a plaintiff
must show that the defendant manufactured the product that
injured her.
See Foster v. American Home Prods. Corp., 29 F.3d
165, 168 (4th Cir. 1994) (applying Maryland law and holding that
“a plaintiff seeking to recover for an injury by a product [must]
demonstrate that the defendant manufactured the product at
issue”); Meade v. Parsley, No. 09-388, 2009 WL 3806716, at *3
(S.D. W. Va. Nov. 13, 2009) (following Foster in case applying
West Virginia law and concluding that “[b]ecause neither Wyeth
4
nor Schwarz manufactured the product that injured plaintiffs,
there is no proximate cause.”).
And so, as both parties seem to
acknowledge, Upjohn is not a proper party to this action if
plaintiff did not ingest any of its drugs.
The only issue before the court is whether plaintiff
has offered sufficient evidence to show that she ingested
Provera.
In support of her claim that she ingested Provera from
1994 to 1996, plaintiff relies primarily on her prescribing
doctors’ medical records.
Those records document three doctor
visits -- occurring from January 17, 1995 to July 11, 1996 -that all note prescriptions to plaintiff for “Provera” in varying
doses.
(See Pl.’s Opp., Ex. 12, Michael Medical Records).
There
is also deposition testimony in the evidentiary record from
plaintiff’s physicians, Dr. Alexander Wanger and Dr. Jane Park,
confirming prescriptions to plaintiff for “Provera.”
(Doc. No.
134, Ex. 4, Dr. Wanger Dep. at 94; Ex. 5, Dr. Park Dep. at 40).
Upjohn argues that plaintiff has not carried her burden
of establishing product identification based upon the following
grounds: (1) the “Provera” notations in plaintiff’s medical
records do not constitute evidence that her pharmacist filled
prescriptions with brand name Provera; (2) plaintiff’s deposition
testimony shows both that she received a generic form of Provera
and that she could not sufficiently recall her HRT regimen; and
5
(3) West Virginia law requires pharmacists to fill prescriptions
with generic drugs unless the physician specifically notes “Brand
Medically Necessary” on the prescription form, and there was no
such notation shown in this case.
Reply at 3-5).
(Def.’s Mem. at 19-20; Def.’s
For the reasons that follow, the court finds none
of these grounds persuasive at this stage.
First, Upjohn cites no authority in support of its
contention that plaintiff cannot rely on notations of “Provera”
in her medical records as circumstantial evidence that she
ingested the drug.
Rather, it maintains that a notation for
“Provera” should be looked at no differently than a reference to
“Kleenex” or “Xerox,” inasmuch as it is merely a shorthand
reference for a product that comes both in generic and brand name
forms, but that is often identified by a more popular brand name.
While that generally may be the case, there is no evidence in the
record showing that the particular “Provera” notations at issue
referred to the generic form of the drug.
On the contrary,
plaintiff’s physicians confirmed that they prescribed Provera in
their depositions.
They were not asked and did not go on to
explain whether they actually meant for the pharmacist to
dispense a generic form of the drug.
In the court’s view,
plaintiff’s medical records and her physicians’ testimony give
rise to a genuine issue of fact as to whether plaintiff ingested
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Provera.
Second, Upjohn argues that plaintiff’s testimony shows
both that she received a generic form of Provera and that she
could not sufficiently recall her HRT regimen.
To show that
plaintiff received generic drugs, Upjohn cites the following
exchange from plaintiff’s deposition:
Q
Okay. From 1994 to '98 where did you have your
prescriptions filled?
A
Probably at Rite Aid.
Q
Okay. During that time period do you know if you
would receive a generic equivalent of a brand
named product? And, for instance, what I'm saying
is Provera is the brand-name. Would you receive a
generic?
A
Yes.
Q
You would have -- if the pharmacy filled it for a
generic you would have received it and taken the
generic form?
A
Yes.
Q
Okay.
A
Yes.
Is that still your practice today?
(Pl.’s Opp., Ex. 13, Michael Dep. at 321-22).
Upjohn also cites
passages suggesting that plaintiff has little recollection of the
specific HRT drugs she ingested:
Q
. . . your records indicate that you took Provera
and Premarin.
Do you have any recollection,
independent recollection of that other than by your
medical records?
7
A
Yes, it’s coming back to me little by little —* * * *
Q
Okay. There was actually two pills . . . you took;
is that correct?
A
I’m not sure.
Q
Do you remember taking Provera?
what the pill looked like?
A
No.
Q
The color?
A
No.
Q
The shape?
A
No.
Q
The size.
A
No.
Do you remember
(Def.’s Mot. Summ. J., Ex. 11, Michael Dep. 318-19).
Plaintiff
further testified that, other than Prempro, she could not recall
the names of the HRT medications she ingested.
(Pl.’s Opp., Ex.
13, Michael Dep. at 28).
Viewing this testimony in the light most favorable to
the plaintiff, the court finds that genuine issues of fact
persist.
Plaintiff’s answer of “Yes” in response to counsel’s
inartfully phrased double question (“During that time period do
you know if you would receive a generic equivalent of a brand
named product?
And, for instance, what I'm saying is Provera is
8
the brand-name.
Would you receive a generic?”) does not appear
to be conclusive testimony from plaintiff that she ingested only
generic rather than brand name Provera.
And the other deposition
passages cited above indicate that plaintiff’s recollection of
her HRT regimen from the 1990s is incomplete at best.
Meanwhile,
there is sufficient evidence in the form of plaintiff’s medical
records and her doctors’ testimony to create an issue of fact as
to her ingestion of Provera.
Third, Upjohn’s invocation of West Virginia’s generic
substitution statute is not persuasive.
That statute generally
requires, subject to certain exceptions, that prescriptions for
brand name drugs be substituted for less expensive generic
equivalents when economically advantageous to the buyer.
Va. Code § 30-5-12b.
See W.
If, however, the prescribing physician
writes “Brand Medically Necessary” on the prescription form, the
pharmacist is required to dispense the brand name drug and may
not make a generic substitution.
Id. § 30-5-12b(b)-(c).
Upjohn
contends that inasmuch as plaintiff has offered no evidence
showing that her physician wrote “Brand Medically Necessary” on
her prescriptions, plaintiff’s pharmacists must have filled her
prescriptions with generic MPA rather than brand name Provera.
The court notes that none of the prescriptions are in evidence.
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Upjohn essentially reads § 30-5-12b to create a
presumption that any pharmacist who fills a prescription did so
with generic drugs, which a plaintiff may rebut by showing that
the physician wrote “Brand Medically Necessary” on the
prescription form.
presumption.
However, the statute creates no such
Upjohn also incorrectly reads § 30-5-12b as
allowing a pharmacist to dispense a brand name drug if and only
if the physician writes “Brand Medically Necessary” on the
prescription.
But the statute grants the pharmacist discretion
to dispense a brand name drug instead of a generic substitution
if “in the exercise of his or her professional judgment the
pharmacist believes that the less expensive drug is not suitable
for the particular patient.”
W. Va. Code § 30-5-12b(b).
Thus,
even if it were established that there was no notation on the
prescription from plaintiff’s physician that brand name Provera
was medically necessary, a presumption does not arise, as Upjohn
suggests, that the pharmacist dispensed generic drugs to
plaintiff.
The court’s conclusion is not affected by the
unpublished Minnesota state court decision relied upon by Upjohn,
Zandhi v. Wyeth, No. A08-1455, 2009 WL 2151141 (Minn. Ct. App.
July 21, 2009).
There, in a case applying New York’s generic
substitution statute, the Minnesota Court of Appeals upheld the
10
trial court’s decision to grant summary judgment to three
defendants (who were HRT drug manufacturers) on the grounds that
the plaintiff failed to show that she had ingested their drugs.
In so holding, the court noted the following relevant factors:
(1) generic versions of MPA were available on the market during
the time she took HRT drugs; (2) the physicians who made
“Provera” notations in the plaintiff’s medical records testified
that this word was intended to refer to the generic drug, MPA;
(3) New York’s generic substitution law generally required
pharmacies to fill prescriptions with the generic drug unless the
prescription slip was marked “d.a.w.” (“dispense as written”),
and plaintiff’s prescription slips did not say “d.a.w.”; and (4)
although the New York law had an exception allowing the
pharmacist to dispense a brand name drug (even without a “d.a.w.”
notation) if the generic drug was unavailable and the pharmacist
sold it at the generic drug’s price, the mere existence of this
exception only allowed for “speculation” that the plaintiff
“might have sometimes received Provera.”
Id. at *4.
The court
ultimately concluded that the plaintiff failed to present
admissible evidence showing that she had received and ingested
drugs manufactured by the defendants.
Id.
In contrast to Zandhi, there is no testimony from the
prescribing physicians here that the “Provera” notations in
plaintiff’s medical records actually referred to the generic form
11
of the drug.
Furthermore, the West Virginia generic substitution
statute is, apart from its overall objectives, not entirely
comparable to the New York statute.
Among other differences, the
West Virginia statute grants the pharmacist some discretion in
making generic substitution decisions, whereas the New York
statute appears to place greater restrictions on a pharmacist’s
ability to dispense brand name drugs.
Compare W. Va. Code § 30-
5-12b(b) (generally requiring that prescriptions be filled
generically but permitting pharmacist to dispense brand name
drugs if he believes the generic version is unsuitable for the
patient), with N.Y. Educ. Law § 6810(6)(a) (generally requiring
that prescriptions be filled generically and only allowing
pharmacist to unilaterally decide to dispense brand name drugs
when the generic drug is unavailable and other conditions are
met).
III.
Conclusion
In sum, viewing the record in the light most favorable
to the plaintiff, genuine issues of material fact persist as to
whether plaintiff ingested Provera.
The court accordingly ORDERS
that Upjohn’s motion for summary judgment be, and it hereby is,
denied.
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The Clerk is directed to forward copies of this written
opinion and order to all counsel of record.
DATED: May 23, 2011
John T. Copenhaver, Jr.
United States District Judge
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