In re: Avandia Marketing v.

NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
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No. 15-2059
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IN RE: AVANDIA MARKETING, SALES PRACTICES
AND PRODUCTS LIABILITY LITIGATION
Linda Schatz; John Schatz,
Appellants
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APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
(D.C. Nos. 2:12-cv-01588, 2:07-md-01871)
District Judge: Honorable Cynthia M. Rufe
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Submitted Under Third Circuit LAR 34.1(a)
January 29, 2016
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Before: VANASKIE, SHWARTZ, and RESTREPO, Circuit Judges.
(Opinion Filed: February 12, 2016)
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OPINION*
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SHWARTZ, Circuit Judge.
Linda and John Schatz appeal from the orders: (1) striking their sur-reply and
physician’s affidavit submitted in opposition to Glaxosmithkline LLC’s (“GSK”) motion
*
This disposition is not an opinion of the full Court and, pursuant to I.O.P. 5.7,
does not constitute binding precedent.
for summary judgment and (2) granting GSK’s summary judgment motion. For the
reasons that follow, we will affirm both orders.
I
Mrs. Schatz suffers from Type II diabetes. Her physician, Dr. Scott McKimm,
prescribed her Avandia, a GSK diabetes medication, starting in 2002. Mrs. Schatz
responded well to Avandia and continued on the medication for several years. In
February 2007, GSK informed doctors of a 2006 study that found women taking Avandia
had increased risk of bone fractures, and in March 2007, GSK updated the Avandia
Package Insert and the Patient Information Leaflet to include a warning about fractures.1
Dr. McKimm testified that he regularly read letters from pharmaceutical companies and
considered label warnings in making prescription decisions. Dr. McKimm could not
recall whether or when he read the letter GSK issued in response to the 2006 study, but
he testified that the updated Avandia label would have been available to him as of March
2007.
In May and October 2007, respectively, Mrs. Schatz had accidents and fractured
first her spine, and then her ribs and scapula. According to Mrs. Schatz’s medical
records, she ceased taking Avandia at some point in 2007,2 but in November 2007 she
1
In December 2006, the New England Journal of Medicine published a diabetes
study which found that women taking Avandia had an increased risk of fractures in the
upper arm, hand, and foot.
2
According to Mrs. Schatz’s medical records, she stopped taking Avandia
sometime between March and July 2007, although the Amended Complaint, Avandia
litigation Plaintiff Fact Sheet, and expert report indicate that she continuously took
Avandia between March and November 2007.
2
resumed taking the drug for approximately four weeks before Dr. McKimm switched her
to a different medication due to the risk of bone fractures from Avandia use.
The Schatzes filed suit against GSK, asserting claims of negligence, negligent
misrepresentation, strict products liability, breach of warranty, fraud, and unjust
enrichment arising out of Mrs. Schatz’s use of Avandia, which allegedly made her bones
more susceptible to fracture. During discovery, GSK deposed Dr. McKimm. Dr.
McKimm testified that even if GSK had warned of the risks of bone fracture associated
with Avandia, he would still have prescribed the drug to Mrs. Schatz. The Schatzes’
counsel did not ask Dr. McKimm any questions. Following the close of discovery, GSK
moved for summary judgment. After the Schatzes filed a response in opposition to
GSK’s motion, GSK filed a motion for leave to file a reply in accordance with the
District Court’s case management rules. While GSK’s motion for leave was pending, the
Schatzes filed a sur-reply, to which they attached an affidavit from Dr. McKimm
(“McKimm Affidavit”),3 without seeking leave of court. Two days later, the District
Court granted GSK’s motion for leave and deemed the reply filed.
Thereafter, GSK filed a motion to strike the Schatzes’ sur-reply, or in the
alternative, for leave to re-depose Dr. McKimm. The District Court granted both GSK’s
motion to strike and its motion for summary judgment and dismissed all of the Schatzes’
claims with prejudice. The Schatzes appeal the orders granting these two motions.
3
In his affidavit, which was filed seven months after his deposition, Dr. McKimm
stated that had GSK provided a different and more thorough warning of the risks of bone
fracture associated with Avandia, he never would have prescribed the drug to Mrs.
Schatz.
3
II4
A
The Schatzes contend that the District Court abused its discretion in granting
GSK’s motion to strike their sur-reply and the accompanying McKimm Affidavit.
Fed. R. Civ. P. 16 authorizes a court to enter orders that govern pretrial
proceedings. To this end, the District Court’s individual case management rules notify
parties that the District Court will issue a scheduling order directing them to use one of
two methods to file a motion for summary judgment. The rules explain that the District
Court will generally direct the parties to use an “alternative” method and that a
“traditional” method will be used in rare cases. Under the District Court’s alternative
method, a moving party must identify the issues in outline form in no more than five
double-spaced pages, and replies and sur-replies are permitted as of right. By contrast, its
traditional method permits a motion for summary judgment to reach twenty-five double-
spaced pages, and provides that any reply or sur-reply “may be filed only after obtaining
leave of Court.” App. 414. In its scheduling order, the District Court did not specify the
4
The District Court had jurisdiction pursuant to 28 U.S.C. § 1332. We have
jurisdiction under 28 U.S.C. § 1291. We review the District Court’s decision to strike the
Schatzes’ sur-reply and accompanying affidavit for abuse of discretion. See Meditz v.
City of Newark, 658 F.3d 365, 367 n.1 (3d Cir. 2011). We review the District Court’s
decision on summary judgment de novo. Dee v. Borough of Dunmore, 549 F.3d 225,
229 (3d Cir. 2008). Summary judgment is appropriate where, drawing all reasonable
inferences in favor of the non-moving party, “there is no genuine dispute as to any
material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). “An issue is
genuine only if there is a sufficient evidentiary basis on which a reasonable jury could
find for the non-mov[ant.]” Kaucher v. Cnty. of Bucks, 455 F.3d 418, 423 (3d Cir. 2006)
(citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)).
4
method to be used, directing only that “[a]ll Daubert or dispositive motions shall be filed
by May 30, 2014.” Schatz v. GSK, No. 12-1588, ECF No. 5 at 3 (E.D. Pa. Feb. 11,
2014).
When GSK moved for summary judgment, it chose the traditional method, filing a
fourteen-page memorandum that did not use the alternative outline format, which the
District Court accepted and to which the Schatzes did not object. Consistent with the
traditional method, GSK also moved for leave to file a reply to the Schatzes’ response, a
request the District Court ultimately granted. The Schatzes, however, deviated from the
District Court’s case management rules when they filed their sur-reply without seeking
leave of court. The District Court granted GSK’s motion to strike because the Schatzes
failed to comply with the traditional method’s requirement that they seek leave of court to
file a sur-reply, and because they sought to offer a contradictory affidavit from Dr.
McKimm even though they had the opportunity to elicit testimony from him at his
deposition.
Because the traditional method was employed, the Schatzes had no basis to
unilaterally attempt to use the alternative method to file their sur-reply and the McKimm
Affidavit, and the District Court acted within its discretion to strike them for failure to
comply with its rules. Cf. Knoll v. City of Allentown, 707 F.3d 406, 411 (3d Cir.
2013)(finding no abuse of discretion where the trial court dismissed post-trial motions for
failure to comply with local rules). It was also within the District Court’s discretion to
strike the sur-reply because it sought to introduce the McKimm Affidavit, which
contradicted Dr. McKimm’s deposition testimony.
5
When a deponent’s post-deposition affidavit conflicts with his prior testimony, a
district court may disregard the affidavit to prevent a party from “creat[ing] a material
issue of fact to defeat summary judgment by filing an affidavit disputing his or her own
sworn testimony without demonstrating a plausible explanation for the conflict.”5 Baer v.
Chase, 392 F.3d 609, 625 (3d Cir. 2004) (citation omitted); EBC, Inc. v. Clark Bldg.
Sys., Inc., 618 F.3d 253, 269-70 (3d Cir. 2010); Jiminez v. All Am. Rathskeller, Inc., 503
F.3d 247, 253 (3d Cir. 2007). A district court may strike such an affidavit based upon the
timing of the affidavit, whether any other record evidence supports the affidavit, and
whether there is a plausible explanation for the contradiction. See Clark Bldg. Sys., 618
F.3d at 269-70; Jiminez, 503 F.3d at 253; see also In re Fosamax Prods. Liab. Litig., 707
F.3d 189, 195 (2d Cir. 2013) (“The timing of the testimony recanting the prior sworn
testimony clearly increased the likelihood that it was intended solely to defeat the motion
for summary judgment.”).
Each of these considerations supports striking the McKimm Affidavit. The
McKimm Affidavit was produced more than seven months after the doctor’s deposition.
Moreover, the Schatzes could have, but did not, question Dr. McKimm at his deposition.
Furthermore, Dr. McKimm was informed that he had thirty days to review his deposition
5
This is known as the “sham affidavit” doctrine. This Court defines a “sham
affidavit” as “a contradictory affidavit that indicates only that the affiant cannot maintain
a consistent story or is willing to offer a statement solely for the purpose of defeating
summary judgment.” Jiminez v. All Am. Rathskeller, Inc., 503 F.3d 247, 253 (3d Cir.
2007); see also Martin v. Merrell Dow Pharm., Inc., 851 F.2d 703, 706 (3d Cir. 1988) (“If
a party who has been examined at length on deposition could raise an issue of fact simply
by submitting an affidavit contradicting his own prior testimony, this would greatly
diminish the utility of summary judgment.” (internal quotation marks omitted)).
6
transcript and submit any changes. He submitted none. While the Schatzes claim before
us that “the sur-reply and affidavit directly address arguments made by GSK in its reply
brief that Dr. McKimm’s testimony was unequivocal in GSK’s favor,” Appellants’ Br.
20, GSK argued this point in its opening brief before the District Court, see App. 52-53,
and thus the Schatzes were on notice of GSK’s position and had the opportunity to
present their arguments in their response. Additionally, the Schatzes admit that Dr.
McKimm did not author his affidavit until the day they filed their sur-reply, suggesting
that the affidavit might simply be a belated attempt to avoid a damaging admission made
by their witness. Finally, the Schatzes failed to provide an “explanation for the conflict
between the prior deposition and the affidavit.” Jiminez, 503 F.3d at 253 (internal
quotation marks omitted). For these reasons, the District Court did not abuse its
discretion in striking the Schatzes’ sur-reply and McKimm Affidavit.
B
The Schatzes also challenge the District Court’s order granting GSK’s motion for
summary judgment. The Schatzes allege that GSK failed to warn of the risk of bone
fractures posed by taking Avandia. A drug manufacturer has a duty to warn a prescribing
physician of a drug’s dangerous side effects, rather than the patient taking the drug.
Incollingo v. Ewing, 282 A.2d 206, 220 (Pa. 1971). A manufacturer is subject to liability
for failure to warn only where it “fails to exercise reasonable care to inform [the
physician] of the facts which make the product likely to be dangerous.” Lineberger v.
Wyeth, 894 A.2d 141, 150 (Pa. Super. Ct. 2006).
7
To prove a failure to warn claim, a plaintiff must establish proximate cause by
showing that had the manufacturer issued a proper warning to the plaintiff’s prescribing
physician, the physician would not have prescribed the drug to the plaintiff and the injury
would have been avoided.6 Demmler v. Smithkline Beecham Corp., 671 A.2d 1151,
1155 (Pa. Super. Ct. 1996); Lineberger, 894 A.2d at 150 (explaining that a prescribing
physician “is expected to make an independent medical judgment in determining whether
a given drug is appropriate for a particular patient”); see Cochran v. Wyeth, Inc., 3 A.3d
673, 676 (Pa. Super. Ct. 2010) (describing physician’s duty to understand a drug’s
characteristics). Summary judgment is properly granted on a failure to warn claim where
the record “is devoid of evidence to support [the] argument that a different warning
would have altered [the physician’s] prescribing methods . . . .” Lineberger, 894 A.2d at
150; Demmler, 671 A.2d at 1156.
The Schatzes contend, among other things,7 that the District Court erred in
granting summary judgment because Dr. McKimm’s testimony that he would have
prescribed Avandia to Mrs. Schatz notwithstanding the risk of fractures was equivocal.8
6
This is known as the “learned intermediary” doctrine. Lineberger, 894 A.2d at
150.
7
The Schatzes do not appeal the District Court’s ruling that all of their claims
were grounded in GSK’s alleged failure to warn. Because we conclude that the Schatzes’
failure to warn claim fails, we need not address other arguments, such as their argument
that GSK failed to exercise reasonable care because it did not conduct safety studies
related to skeletal risks in a timely manner, and therefore did not disclose a complete risk
profile to prescribing physicians.
8
Because the District Court properly struck the Schatzes’ sur-reply and the
McKimm Affidavit, the affidavit does not impact the proximate cause analysis. The
Schatzes’ expert’s opinion also has no impact on this subject. The expert opined that the
Avandia label should have warned of the risk of hip and spine fractures in older women,
8
The record, however, shows that his testimony was clear. At his deposition, Dr.
McKimm was asked “[c]onsidering what you know about Avandia today, do you have
any reason to believe that a different warning would have changed your decision to
prescribe Avandia to Mrs. Schatz?” App. 279. In response, Dr. McKimm first discussed
how a black box warning “certainly would have caught [his] eye.”9 App. 279. When
counsel rephrased the question to ask “[i]f a patient presented to you today with the same
clinical course as Mrs. Schatz presented to you with back in 2002 . . . would you
prescribe Avandia to that patient today?” App. 279-80, Dr. McKimm responded “to be
honest with you, I would.” App. 280.
The context demonstrates that counsel’s question was aimed at ascertaining what
Dr. McKimm would do based on his current knowledge of Avandia’s fracture risks, not
his knowledge when he initially prescribed the drug to Mrs. Schatz. Dr. McKimm
unequivocally testified that he would prescribe Avandia today to a patient who presented
as Mrs. Schatz did in 2002. Moreover, beyond referencing the usefulness of a black box
warning, Dr. McKimm never suggested that any other type of warning would have
impacted his prescribing decision. Although Dr. McKimm may have taken Mrs. Schatz
but his opinion was based upon studies published after Mrs. Schatz stopped taking
Avandia, and dealt with a population of which Mrs. Schatz was not a part, namely older
women. See Leibowitz v. Ortho Pharm. Corp., 307 A.2d 449, 458 (Pa. Super. Ct. 1973)
(“A warning should not be held improper because of subsequent revelations.”); see App.
240 (2011 letter from Dr. McKimm to the Schatzes’ counsel describing Mrs. Schatz as a
“young female”).
9
Only the FDA may issue a black box warning, however, so GSK could not have
included such a warning absent a directive from the FDA. See PLIVA Inc. v. Mensing,
131 S. Ct. 2567, 2577 (2011) (holding that a finding of liability may not be based on a
manufacturer’s alleged failure to strengthen a warning label where FDA regulations
prohibit it from doing so).
9
off of Avandia for some period in 2007, the record is clear that Dr. McKimm prescribed
it to her again in November 2007—after she had sustained multiple fractures, after the
publication of a fracture study, after GSK informed physicians like Dr. McKimm of the
risk of fractures, and after GSK updated the Avandia Package Insert and Patient
Information Leaflet.10
Because the Schatzes failed to adduce evidence sufficient to establish “some
reasonable likelihood that an adequate warning would have prevented [Mrs. Schatz] from
receiving the drug,” Demmler, 671 A.2d at 1155 (internal quotation marks omitted), the
District Court appropriately granted summary judgment in favor of GSK.
III
For the foregoing reasons, we will affirm the orders of the District Court granting
GSK’s motion to strike the Schatzes’ sur-reply and McKimm Affidavit and granting
GSK’s motion for summary judgment.
10
The Schatzes also argue that the fact that Dr. McKimm took Mrs. Schatz off of
Avandia “immediately after” discovering the increased risk of fractures through his own
research creates a genuine issue of material fact regarding his prescribing decision.
Appellants’ Br. 23-27. This assertion fails to account for the fact that Dr. McKimm
continued to prescribe Avandia after GSK disseminated information about fracture risks,
and even after Mrs. Schatz experienced fractures.
10