Keffer v. Wyeth et al
Filing
172
MEMORANDUM OPINION AND ORDER denying defendants Pfizer Inc., Pharmacia & Upjohn Company, Wyeth, Wyeth Pharmaceuticals, Inc.'s 156 UNOPPOSED MOTION for hearing on Dispositive Motions to the extent Upjohn seeks a hearing on its motion for summary judgment; denying Upjohn's 121 MOTION for Summary Judgment. Signed by Judge John T. Copenhaver, Jr. on 5/13/2011. (cc: attys) (mkw)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF WEST VIRGINIA
AT CHARLESTON
ROSEMARY KEFFER,
Plaintiff,
v.
Civil Action No. 2:04-0692
WYETH, d/b/a Wyeth, Inc.;
WYETH PHARMACEUTICALS, INC.;
and PHARMACIA & UPJOHN COMPANY,
Defendants.
MEMORANDUM OPINION AND ORDER
Pending is the motion for summary judgment of defendant
Pharmacia & Upjohn Company (“Upjohn”), filed March 28, 2011.
(Doc. No. 121).1
I.
Background
This is a pharmaceutical products liability action in
which plaintiff Rosemary Keffer alleges that she developed breast
cancer as a result of ingesting hormone replacement therapy
(“HRT”) medications.
HRT consists of two medications, estrogen
and progestin, which are commonly used in combination to treat
1
Also pending is the unopposed motion of Upjohn and the
Wyeth defendants for a “hearing” on dispositive motions, filed
April 20, 2011. (Doc. No. 156). Inasmuch as the court concludes
that the parties’ briefings adequately present the legal and
factual issues discussed herein, it is ORDERED that defendants’
motion for a hearing be, and it hereby is, denied to the extent
Upjohn seeks a hearing on its motion for summary judgment.
symptoms of menopause.
Upjohn manufactured and distributed
Provera, a progestin drug.
The chemical name for Provera is
medroxyprogesterone acetate (“MPA”).
In the early 1980s, 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
October 16, 1991, to approximately November 7, 1999.
After being diagnosed with breast cancer in 1999,
plaintiff stopped taking HRT drugs.
She thereafter instituted
this action on July 7, 2004, invoking the court’s diversity
jurisdiction.
Her complaint asserts claims against defendants
for negligence, strict liability (design defect and failure to
warn), and breach of implied warranties.
Defendant Upjohn2 moved for summary judgment on March
28, 2011, asserting that plaintiff has failed to carry her burden
of showing that she ingested Provera or any other Upjohn product.
Plaintiff responded in opposition to the motion on April 11,
2011, and Upjohn replied on April 27, 2011.
2
Although Pfizer also moved for summary judgment, the
parties have since stipulated to the dismissal of any claims
against Pfizer. (Doc. Nos. 160, 162, 169). The court
accordingly dismissed Pfizer from this action by order dated May
12, 2011. (Doc. No. 171).
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) (holding that “a plaintiff seeking to
recover for an injury by a product [must] demonstrate that the
defendant manufactured the product at issue” under Maryland law);
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 nor Schwarz
4
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
October 1991 until November 1999, plaintiff relies on her
prescribing doctor’s medical records and her own deposition
testimony.
The medical records document six doctor visits --
occurring from October 16, 1991 to July 30, 1998 -- that all note
prescriptions to plaintiff for “Provera” in varying doses.
Pl.’s Opp., Ex. 12, Keffer Medical Records).
(See
And plaintiff’s
deposition testimony indicates that she always received Provera,
not a generic substitution, from her pharmacist:
Q.
Do you remember if the amount that you would pay
[for the medications] depended on whether you got a
generic brand versus a name brand drug?
A.
There was never generic.
Q.
You never got generic drugs?
A.
No.
Q.
So with respect to Provera, you always got the name
brand Provera drug, correct?
A.
Yes.
Q.
Did you -- was there a reason for that? . . .
5
* * * *
A.
That’s what they give me.
on generic.
There was no discussion
(Pl.’s Opp., Ex. 13, Keffer Dep. at 288).
Upjohn argues that plaintiff has not carried her burden
of establishing product identification based upon the following
grounds: (1) there are no pharmacy records confirming that she
was prescribed Provera and her “sworn Fact Sheet” does not
“provide any National Drug Codes” for Provera; (2) her deposition
testimony shows that she could not “sufficiently recall” her HRT
regimen; and (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 in this case.
(Def.’s Mem. at 3-5).
For the reasons that follow, the court
finds none of these grounds persuasive at this stage.
First, plaintiff explains that there are no pharmacy
records confirming her Provera prescriptions because her
pharmacies did not maintain such records.
Upjohn does not dispute this point.
(Pl.’s Opp. at 8).
The court is not inclined,
in any event, to endorse the broad proposition apparently urged
by Upjohn that a plaintiff in a pharmaceutical products liability
action must offer pharmacy records to prove that she ingested the
6
defendant’s drugs.
Nor does the court consider plaintiff’s
failure to include the National Drug Codes for Provera in her
sworn fact sheet as a reason to grant summary judgment for
Upjohn.
In the court’s view, plaintiff’s medical records and
deposition testimony are sufficient to raise genuine issues of
material fact.
Second, Upjohn attacks the reliability of plaintiff’s
deposition testimony by pointing out that she thought Provera was
the estrogen component of her HRT regimen, when Provera is, in
fact, the progestin component.
Plaintiff also testified that her
Provera prescription strength never changed, that she took the
pill every day of the month, and that it was always a “small
white pill.”
Attempting to discredit this testimony, Upjohn
notes that plaintiff’s medical records show that her progestin
prescription strength did change, that she was prescribed the
drug only 9 days out of the month, and that the particular pill
she claimed to have ingested was peach colored, not white.
These
arguments are unavailing at the summary judgment stage, however,
where the court is not at liberty to make credibility
determinations concerning plaintiff’s testimony and must resolve
internal conflicts in the plaintiff’s favor.
Third, Upjohn’s invocation of West Virginia’s generic
substitution statute is not persuasive.
7
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 since 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.
Upjohn essentially reads § 30-5-12b to create a
presumption that a pharmacist, who fills a prescription,
substituted generic drugs, which a plaintiff may rebut by showing
that the physician wrote “Brand Medically Necessary” on the
prescription form.
However, the statute creates no such
presumption and the court declines to recognize one.
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 also
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
8
expensive drug is not suitable for the particular patient.”
Va. Code § 30-5-12b(b).
W.
Thus, the absence of a notation from
plaintiff’s physician that brand name Provera was medically
necessary does not presumptively establish, as Upjohn suggests,
that the pharmacist dispensed generic drugs to plaintiff.
Even
if it did, plaintiff’s deposition testimony still creates an
issue of fact as to whether she received Provera from her
pharmacist.
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
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
9
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.
This case is distinguishable from Zandi.
Unlike the
plaintiff in Zandi, the plaintiff here explicitly testified that
she received “Provera” only and that she never received generic
drugs.
(Pl.’s Opp., Ex. 13, Keffer Dep. at 288).
There is also
no testimony from the prescribing physician in this case that the
“Provera” notations in plaintiff’s medical records actually
referred to the generic form of the drug.
And 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
10
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.
The Clerk is directed to forward copies of this written
opinion and order to all counsel of record.
DATED: May 13, 2011
John T. Copenhaver, Jr.
United States District Judge
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