IN THE UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF TEXAS
AUSTIN DIVISION
MARGARET HALTON PRIEST,
Individually and as Representative of the
Estate of Noel Lajoie Priest
Plaintiff,
vs.
SANDOZ INC.
Defendant.
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CIVIL ACTION NO. 1:15-cv-00822-LY
DEFENDANT SANDOZ INC.’S RESPONSE TO PLAINTIFF’S PARTIAL
OBJECTIONS TO THE MAGISTRATE’S REPORT AND RECOMMENDATION
Case 1:15-cv-00822-LY Document 182 Filed 01/16/18 Page 1 of 11
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Pursuant to Fed. R. Civ. P. 72(a) and (b), 28 U.S.C. § 636(b)(1)(C), Local Rule 72 and
Local Rule for the Assignment of Duties to United States Magistrate Judges 4(b), Sandoz Inc.
(“Sandoz”), by its undersigned counsel, hereby responds to Plaintiff’s Partial Objections to
Magistrate’s Report and Recommendation (Dkt. 120, amended in Dkt. 124) (the “Objection”).
I. INTRODUCTION
Plaintiff has objected to the Magistrate Judge’s December 28, 2017 Order and Report &
Recommendation (Dkt. 119) (the “Order” and “Report & Recommendation”), arguing that it: (i)
improperly granted Sandoz’ Motion to Exclude Plaintiff’s expert, Daniel Buffington, Pharm.D.;
and (ii) erroneously recommended granting Sandoz’ Motion for Summary Judgment on two of
the three grounds asserted. Plaintiff’s grounds for her Objection are presented in a lengthy and
confusing stream of unsupported argument about additional “facts” Plaintiff believes are
admissible at trial, which she believes may preclude entry of summary judgment, without
attaching for the Court’s review any admissible evidence supporting her arguments.
Additionally, Plaintiff’s “objection” to the exclusion of her expert, Dr. Buffington, is argued
briefly in a footnote with no argument, citation to authority, or citation to evidence in the record
to support his qualifications or the admissibility of his opinions. Finally, Plaintiff attaches to her
Objection a proposed Second Amended Complaint, which she asks this Court to permit her to
file on the very eve of trial. The proposed amendment would modify Plaintiff’s sole remaining
claim against Sandoz—for failure to provide Medication Guides to Kroger Pharmacy—into
attacks on Sandoz’ compliance with the broader regulatory scheme for Medication Guides.
These desperate efforts not only fail to meet the requirements of a valid objection to an order or
report and recommendation of the magistrate under Fed. R. Civ. P. 72(a) and 72(b), but also are
entirely lacking in any legal or factual support and raise arguments that Plaintiff had ample
opportunity to make in opposing the underlying Motions, but chose not to. Plaintiff’s Objection
should be overruled in its entirety and the challenged portions of the Order and Report &
Recommendation should be adopted and entered by this Court, and Plaintiff’s requests for leave
to amend her Complaint or to disclose a new expert to replace Dr. Buffington should be denied.
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II. RELEVANT BACKGROUND AND PROCEDURAL HISTORY
Sandoz incorporates by reference the “Relevant Background and Procedural History”
portion of its Partial Objections to Magistrate’s December 28, 2017 Order and Report and
Recommendation (Dkt. 121, pp. 2-3). Plaintiff filed her Objection to the Order and Report &
Recommendation on January 9, 2018 (the “Objection”), arguing Dr. Buffington should not have
been excluded or that if he was then she should be permitted to obtain a replacement expert, and
further arguing summary judgment should be denied and requesting leave to file a Second
Amended Complaint to assert the theories of liability upon which Plaintiff now relies. (Dkt.
120.) After being advised by the clerk of a deficiency for failure to double-space her Objection,
Plaintiff filed a revised Objection on January 12, 2018. (Dkt. 124.) All citations herein are to the
later-filed version of Plaintiff’s Objection.
III. ARGUMENT
A. Standard of Review.
Plaintiff’s objection to the exclusion of Dr. Buffington is governed by Fed. R. Civ. P.
72(a), which provides that for non-dispositive motions, a party may object within 14 days of the
entry of the order. Upon such an objection, the district judge “may modify or set aside a
magistrate judge’s ruling regarding nondispositive pretrial motions only if the ruling is ‘clearly
erroneous or contrary to law.’” Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F.
Supp. 2d 662, 666 (N.D. Tex. 2010)(citing Castillo v. Frank, 70 F.3d 382, 385 (5th Cir. 1995)).
Plaintiff’s objection to the recommendation that summary judgment issue to Sandoz is
governed by Fed. R. Civ. P. 72(b), which permits the district judge to review and decide the
motion de novo. See Fed. R. Civ. P. 72(b). However, “legal arguments not raised before the
Magistrate Judge are waived.” Black v. Pan American Laboratories, LLC, No. A-07-CA-924-
LY, 2009 WL 100669148 (W.D. Tex. May 13, 2009) (Yeakel, J.) (citing Freeman v. County of
Bexar, 142 F.3d 848, 851 (5th Cir. 1998); Cupit v. Whitley, 28 F.3d 532, 535 (5th Cir. 1994)).
Case 1:15-cv-00822-LY Document 182 Filed 01/16/18 Page 3 of 11
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B. Plaintiff Has Not Met Her Burden of Showing Clear Error or a Ruling Contrary to
Law in the Magistrate’s Order Granting the Motion to Exclude Dr. Buffington.
Plaintiff minimally mentions that she “objects to the conclusion of the Magistrate
sustaining Sandoz’ Motion to Exclude the Testimony of Daniel Buffington, Pharm.D. as
unreliable and irrelevant.” (Dkt. 124, p. 5.) However, after stating this objection at the outset,
Plaintiff only argues it briefly in a footnote, stating she, “shows herein the relevance of his
testimony which bears directly on this issue [whether Sandoz complied with all parts of 21
C.F.R. §208.24.]” (Id., p. 10 n. 2.) Plaintiff then transitions in the same footnote into arguing that
the subject of Dr. Buffington’s opinions can be determined by the jury without need for expert
testimony, which Sandoz disputes because, as outlined in its Motion for Summary Judgment, the
interpretation of what federal regulations require is a question of law for the Court to decide.
(Id.) At the end of her Objection, Plaintiff also “requests leave to substitute another expert to
testify in place of Daniel Buffington…within a reasonable time period.” (Id., pp. 17-18.)
Plaintiff’s perfunctory argument as to whether Dr. Buffington should have been excluded
and whether she should be permitted to find a substitute does not cite any relevant case law,
Rules of Evidence, testimony of Dr. Buffington, or other support whatsoever. This Court should
only overturn the Order granting the Motion to Exclude Dr. Buffington if it is “clearly erroneous
or contrary to law,” neither of which has Plaintiff even attempted to demonstrate in her
Objection. See Fed. R. Civ. P. 72(a); Lofton, 682 F. Supp. 2d at 666.1 Rather than re-litigate the
many reasons why Dr. Buffington’s opinions are properly excluded from trial of this matter,
Sandoz refers this Court to its Motion to Exclude Testimony of Daniel Buffington, Pharm.D.
(Dkt. 90) and Reply in Support (Dkt. 113), which articulated a clear basis for his exclusion and
which should be affirmed by this Court in full.
1 Plaintiff’s original three page Response to Sandoz Inc.’s Motion to Exclude Testimony of Daniel Buffington,
Pharm.D.’s Expert Opinion (Dkt. 90), also contained no citations to any Federal Rules of Evidence, case law
applying them, or testimony from Dr. Buffington articulating how or why he was qualified or his opinions reliable,
relevant, and admissible. Despite Plaintiff’s failure to properly oppose Sandoz’ Motion, Magistrate Judge Lane still
considered the merits of his qualifications and testimony in reaching his decision that Dr. Buffington’s opinions are
“entirely without any intellectual rigor or any indicia of reliability.” (Dkt. 119, p. 20.) His determination should be
affirmed in full, as Plaintiff has yet again failed to make any legal or evidentiary showing to the contrary.
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C. Plaintiff Should Not Be Permitted to Substitute Another Expert into This Case.
Dr. Buffington was deposed on July 31, 2017 about his qualifications and the basis for
his opinions interpreting federal regulations and Sandoz’ compliance with them. Sandoz’ Motion
to Exclude Dr. Buffington was filed on September 22, 2017 and detailed the many flaws in his
qualifications, methodology, and the fit of his opinions to this case. (Dkt. 90.) Plaintiff opposed
the motion on October 13, 2017 (Dkt. 100), but did not seek leave to add a new expert if Sandoz’
Motion to Exclude was granted. (Id.) Yet now, two weeks after Magistrate Judge Lane excluded
Dr. Buffington, Plaintiff suddenly requests leave to find and disclose a new expert “within a
reasonable time period,” if this Court grants the Motion to Exclude. (Dkt. 124, p. 18.)
This request is tardy and unreasonable, as Plaintiff has known since at least September
that Dr. Buffington could be excluded by this Court, but took no action to try to replace him until
January when the Order actually excluded him. Many courts have denied replacement of an
excluded expert where the “Plaintiff[] had been on notice for months that [her] expert might be
excluded, yet [she] did nothing to find a back-up and thus mitigate the harm to [her] should he be
excluded.” Pena v. Leombruni, 200 F.3d 1031, 1035 (7th Cir. 1999) (upholding denial of new
expert after original expert was properly excluded). If Plaintiff were allowed to disclose a new
expert now, this would substantially prejudice Sandoz and this Court by disrupting the current
trial schedule. Sandoz would need time to investigate, depose, and challenge (if appropriate) the
qualifications and opinions of the new expert, and thus a continuance would have to accompany
leave to disclose a replacement. This Court should not permit Plaintiff to belatedly shore up her
expert support when there was nothing preventing her from asking earlier, and doing so now
would result in prejudice and delay. See, e.g., Rink v. Cheminova, Inc., 400 F.3d 1286, 1296 (11th
Cir. 2005) (affirming denial of replacement expert where “allow[ing] [plaintiffs] to find another
expert would have required the Court, as well as [defendant] to invest more time and effort to
determine the new expert’s reliability,” which “would represent a substantial inconvenience”)
(citing Weisgram v. Marley Co., 528 U.S. 440, 455-456 (2000)). The Court should reject this late
request for leave to find a new expert and affirm the exclusion of Dr. Buffington.
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D. Plaintiff’s Objection to the Report & Recommendation on Summary Judgment
Lacks Legal or Evidentiary Support and Asserts Waived Arguments.
The vast majority of Plaintiff’s Objection focuses on Magistrate Judge Lane’s Report &
Recommendation finding that “Sandoz has shown it is entitled to summary judgment on the
issues of whether it breached its duty to provide Medication Guides and whether Plaintiff can
show a breach of that duty by clear and convincing evidence.” (Dkt. 119 at p. 24.) And yet,
Plaintiff does not cite a single case in support of her argument that Magistrate Judge Lane’s
application of law to the evidence in this case was flawed, aside from two cases directed to the
standard of review (Dkt. 124, p. 4), nor does she submit to the Court for review any evidence in
the record to support her factual assertions. (See generally Dkt. 124.) Thus, much as she did in
opposing the Motion for Summary Judgment (Dkt. 92), Plaintiff squanders her Objection’s
protracted argument by attempting to articulate disputes of fact, while failing to put those facts
before this Court through testimony or documents in the evidentiary record, and failing to
identify a single authority supporting her view of the case.2 Sandoz incorporates herein by
reference its Motion for Summary Judgment (Dkt. 92), evidence in support as attached to its
Motion to Seal (Dkt. 93), and Reply in further support (Dkt. 116). Magistrate Judge Lane’s
recommendation is clearly supported by all the record facts and legal authorities before the
Court, and this Court should affirm and adopt it and enter judgment for Sandoz.
Even if Plaintiff had provided the Court with record evidence to support her factual
arguments, many of the purported facts she asserts in the Objection were not raised in her
Opposition to the Motion for Summary Judgment, and thus these arguments are waived. While a
Plaintiff may, in some rare instances, put new facts in an objection to the district judge that were
not argued first to the magistrate, the Fifth Circuit has discouraged this, holding “litigants may
2 Plaintiff’s burden in opposing Sandoz’ Motion for Summary Judgment was clear: she “must go beyond the
pleadings and designate specific facts in the record showing that there is a genuine issue for trial. Knight v. Kellogg
Brown & Root Inc., 333 Fed. Appx. 1, 6 (5th Cir. 2009) (citing Adams v. Travelers Indem. Co., 465 F.3d 156, 164
(5th Cir. 2006.)) Her burden is “not satisfied with conclusory allegations, unsubstantiated assertions, on only a
scintilla of evidence.” Knight, 333 Fed. Appx. at 6 (citing Baranowski v. Hart, 486 F.3d 112, 119 (5th Cir. 2007)).
Yet conclusory allegations and unsubstantiated assertions were all Plaintiff offered in her Opposition to the Motion
for Summary Judgment, which Magistrate Judge Lane properly recognized as a basis for granting the Motion.
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not, however, use the magistrate judge as a mere sounding-board for the sufficiency of the
evidence.” Freeman, 142 F.3d at 852. A district court considering an objection to a
recommendation to grant summary judgment that introduces new facts not previously argued to
the magistrate “should consider…the reasons” for the previous failure to introduce them, “the
importance of the omitted evidence to the non-moving party’s case, whether the evidence was
available to the non-movant before she responded to the summary judgment motion, and the
likelihood [of]…unfair prejudice.” Id. at 853. Plaintiff cannot explain under these factors, and
does not even attempt to explain, why this Court should consider any new facts not already
submitted to Magistrate Judge Lane as part of Plaintiff’s original Opposition. Thus, the various
putative facts asserted for the first time in Plaintiff’s Objection should be disregarded.
Similarly, to the extent Plaintiff now argues that her First Amended Complaint can be
interpreted to impliedly include two new theories, a “failure to comply with the spirit of the
Medication Guide regulations” cause of action and a “failure to comply with 21 C.F.R. §
208.24(d)” cause of action, these are new legal arguments asserted to this Court for the first time.
Plaintiff did not raise either of these arguments in her Opposition to the Motion for Summary
Judgment (Dkt. 110), even though Sandoz argued in its Motion for Summary Judgment that such
claims are not contained within Plaintiff’s operative complaint. (Dkt. 92, p. 3, n.4). This Court
has held that any legal arguments not made to the magistrate in the first instance are waived and
may not be raised for the first time objections to this Court. Black, 2009 WL 10669148, at *4
(Yeakel, J.) (legal argument in objection to magistrate’s report and recommendation not raised in
summary judgment response and not raised before magistrate is “waived,” citing Freeman, 142
F.3d at 851 and Cupit, 28 F.3d at 535). Thus, Plaintiff has waived her request that this Court
interpret her First Amended Complaint to encompass the non-compliance theories of liability she
now also requests leave to amend into her operative pleading. The objection to Magistrate Judge
Lane’s recommendation that summary judgment be granted should be overruled in its entirety,
and this Court should enter summary judgment on all claims, without leave to amend.
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E. Plaintiff’s Attempt to Amend Her Complaint on the Eve of Trial Should Be Denied.
Perhaps belatedly recognizing that this Court may not consider un-pled theories of
liability in deciding whether summary judgment should issue to Sandoz, Plaintiff also has now
requested leave to amend her complaint just before the scheduled start of trial, claiming that her
non-compliance theories of liability were only recently discovered:
[W]hen this case was filed and initially pled, Plaintiff had no knowledge about the
procedure for development, approval and dissemination of FDA required
Medication Guides with Amiodarone, but knew only that Priest did not get one.
However, extensive facts developed in the course of discovery have taken
Plaintiff’s understanding of Sandoz’ conspiracy to violate the letter and the spirit
of FDA regulations…to places it did not expect to go, quite some time after the
Scheduling Order dates for amending pleadings.
(Dkt. 124, p. 2.) This is inconsistent with the testimony of her expert, Dr. Buffington, that he
began work on an “amiodarone mass tort” in 2013 and presented his opinions about amiodarone
Medication Guide non-compliance at a 2016 meeting of plaintiffs’ attorneys, including several
counsel in this case. (See Deposition of Dr. Buffington, excerpts of which are attached as Exhibit
A, pp. 20, 75-82.) His presentation to a group of plaintiffs’ attorneys at Kirk Wood’s office in
March 2016 included his opinions regarding whether Medication Guides distributed by Sandoz
and other manufacturers comply with FDA regulations. (Id., pp. 80-81.)
Plaintiff’s assertion that she only learned of her new non-compliance theories of liability
after taking depositions of Sandoz’ corporate representatives in May 2017 is both inaccurate and
fails to explain why she waited until now to act on it. Plaintiff’s counsel did not glean any new
information from Sandoz’ corporate representatives that suddenly revealed these new theories of
liability, nor did she attach any examples of such testimony to either her Opposition to the
Motion for Summary Judgment or her Objection.3 It is simply false for Plaintiff to claim she only
recently learned of the new theory of liability she asks to add to her Complaint on the eve of trial.
3 Plaintiff also had all of Sandoz’ regulatory submissions, labeling and Medication Guide documents, and publicly
available information regarding the content of Sandoz’ Medication Guides and other labeling, by May 2017. Sandoz
also previously produced most of those same documents in the Rusk amiodarone suit involving the same counsel,
and Dr. Buffington testified much of this information was also available to him via databases. (Ex. A, pp. 24-26.)
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Even if Plaintiff could explain why she was not already on notice of these potential new
theories of liability well before May 2017, she cannot and has not even tried to articulate any
reason why she waited until the Magistrate Judge recommended entry of summary judgment
before seeking leave to amend to add these supposed fundamental theories of liability to her
operative complaint. “At some point in the course of litigation, an unjustified delay preceding a
motion to amend goes beyond excusable neglect, even when there is no evidence of bad faith or
a dilatory motive.” Daves v. Payless Cashways, Inc., 661 F.2d 1022, 1024-1025 (5th Cir. 1981)
(affirming denial of motion for leave to amend on eve of trial, considering the potential prejudice
to the opposing party); see also Southmark Corporation v. Schulte Roth & Zabel, 88 F.3d 311,
316 (5th Cir. 1996) (a trial court may consider an unexplained delay in moving for leave to
amend and whether facts underlying the proposed amendment were known to plaintiff when they
filed the original complaint, in denying leave to amend.) Even putting aside Plaintiff’s likely
awareness of her new theories of liability before May 2017, Plaintiff offers no credible
explanation why she failed to seek leave to amend in the eight months between the purported
discovery of these theories and the present. During those eight months, her expert offered
opinions directed to these theories, Sandoz moved to exclude those opinions, Plaintiff opposed
such motion, Sandoz moved for summary judgment and highlighted that such theories were not
pled in the Complaint, and Plaintiff opposed that Motion as well. See McGee v. Simpson
Pasadena Paper Co., 158 F.3d 583 (5th Cir. 1998) (affirming denial of leave to amend to add
new claim where discovery was complete five months prior). This request to amend is untimely.
In addition to being untimely, leave to amend should be denied because it would
prejudice Sandoz and the proposed amendment would be futile. Allowing amendment to add
these new theories of liability would require Sandoz to file new dispositive motions challenging
the legal sufficiency of such a claim and arguing that it is preempted. (See Dkt. 119, p. 22
(recognizing “this new theory of the case raises preemption issues that were not previously
before the court” on motions to dismiss.) Unlike the “failure to deliver Medication Guides” claim
that this Court permitted to survive Sandoz’ Motion to Dismiss based on its interpretation of
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Eckhardt v. Qualitest Pharms., Inc., 751 F.3d 674, 679 (5th Cir. 2014), this claim that Sandoz
was obligated to ensure pharmacies understood and fulfilled their federal regulatory obligations
to deliver Medication Guides with each prescription has no legal or regulatory support and is
obviously premised entirely upon alleged violations of federal regulations that only the federal
government may enforce.4 If this Court permits Plaintiff to add this preempted and legally
unsound claim, then Sandoz will have the right to assert its preemption and other defenses to it in
a motion to dismiss or motion for summary judgment. If such motions are denied, then Sandoz’
experts will need to address this new claim in supplemental reports. This will delay trial,
prejudice Sandoz and inconvenience this Court. Plaintiff’s request to amend should be denied.
IV. CONCLUSION
Magistrate Judge Lane correctly excluded that Plaintiff’s proffered expert Daniel
Buffington, Pharm.D., because Plaintiff failed to meet her burden to show he was qualified and
his opinions were relevant and admissible. Plaintiff has done nothing to counter that conclusion
in her Objection, and fell far short of showing the ruling was clearly erroneous or contrary to
law. Similarly, while Plaintiff laboriously recounts purported “facts” she believes create a
dispute of material fact that might preclude entry of summary judgment, she does not provide
citations to record evidence or case law to support her assertions, and also fails to explain why
such arguments were not first made when Plaintiff had the burden of countering Sandoz’ Motion
for Summary Judgment with record evidence demonstrating a dispute of material fact, thereby
waiving them. Plaintiff does not present any new evidence at all, and cannot justify her failure
until now to seek leave to plead her newly asserted theories of liability in her operative
complaint. Her request for leave to amend is untimely, would prejudice Sandoz, and amendment
would be futile. Thus, this Court should overrule Plaintiff’s objections, adopt those portions of
the Order and Report & Recommendation and enter judgment in favor of Sandoz, with prejudice.
4 As Magistrate Judge Lane recognized, the duty plaintiff asserts is inconsistent with federal regulations governing
Sandoz’ obligations for medication guides. (Dkt. 119 at p. 23) (“However, that is not the duty.”)
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Dated this 16th day of January, 2018.
/s/ Sara K. Thompson
Gregory J. Casas
State Bar No. 00787213
E-Mail: casasg@gtlaw.com
Elizabeth Ross Hadley
State Bar No. 24063085
E-Mail: hadleye@gtlaw.com
GREENBERG TRAURIG LLP
300 West 6th Street, Suite 2050
Austin, Texas 78701
Telephone: (512) 320-7200
Facsimile: (512) 320-7210
OF COUNSEL:
Lori G. Cohen*
E-Mail: cohenl@gtlaw.com
Sara Thompson*
E-Mail: thompsons@gtlaw.com
GREENBERG TRAURIG, LLP
3333 Piedmont Road, NE
Suite 2500
Atlanta, Georgia 30305
Telephone: (678) 553-2100
Facsimile: (678) 553-2212
* Admitted Pro Hac Vice
Attorneys for Sandoz Inc.
CERTIFICATE OF SERVICE
I hereby certify that Defendant Sandoz Inc.’s Response to Plaintiff’s Partial Objections to
the Magistrate’s December 29, 2016 Report and Recommendation was electronically filed with
the Court and that counsel of record, who are deemed to have consented to electronic service in
the above-referenced case, are being served this 16th day of January, 2018 with a copy of the
above-document via the Court’s CM/ECF System.
.
/s/ Sara K. Thompson
Sara K. Thompson
Case 1:15-cv-00822-LY Document 182 Filed 01/16/18 Page 11 of 11
