Jan Vallejo v. Amgen, Inc. , 903 F.3d 733 ( 2018 )

United States Court of Appeals
For the Eighth Circuit
___________________________
No. 17-1730
___________________________
Jan Vallejo, Individually and As Personal Representative of Steve Vallejo, estate
of, Steve Vallejo
lllllllllllllllllllllPlaintiff - Appellant
v.
Amgen, Inc.; Wyeth, Inc.; Pfizer, Inc.
lllllllllllllllllllllDefendants - Appellees
___________________________
No. 17-2593
___________________________
Jan Vallejo, Individually and As Personal Representative of Steve Vallejo, estate
of, Steve Vallejo
lllllllllllllllllllllPlaintiff - Appellant
v.
Amgen, Inc.; Wyeth, Inc.; Pfizer, Inc.
lllllllllllllllllllllDefendants - Appellees
____________
Appeals from United States District Court
for the District of Nebraska - Omaha
____________
Submitted: May 15, 2018
Filed: September 10, 2018
____________
Before SMITH, Chief Judge, BEAM and COLLOTON, Circuit Judges.
____________
SMITH, Chief Judge.
In this consolidated products liability suit appeal, Jan Vallejo challenges the
district court’s1 order limiting the scope of her general causation phase discovery. She
also contests the court’s sanctions order against her counsel. We find no abuse of
discretion in either of the court’s decisions and affirm.
I. Background
Steve Vallejo (“Steve”), Vallejo’s husband, began using the biologic Enbrel2
in 2004 to treat psoriasis, a skin condition. At some point between 2004 and 2011,
Steve developed myelodysplastic syndrome (MDS).3 He succumbed to MDS in 2011.
Vallejo, individually and on behalf of Steve’s estate, sued Amgen Inc., Wyeth, and
1
The Honorable John M. Gerrard, United States District Judge for the District
of Nebraska.
2
Enbrel is manufactured and marketed by Amgen Inc. Wyeth LLC (“Wyeth”),
later acquired by Pfizer Inc. (“Pfizer”), promotes Enbrel. We omit Enbrel’s registered
trademark ® symbol in this opinion, including those in quotations.
3
MDS is a blood “disorder characterized by the bone marrow’s inability to
produce a sufficient number of healthy erythrocytes (red blood cells), leukocytes
(white blood cells including neutrophils, lymphocytes, monocytes, eosinophils, and
basophils), and platelets.” Order at 1, Vallejo v. Amgen, Inc., No. 8:14-cv-00050-
JMG-CRZ (D. Neb. Mar. 28, 2016), ECF. No. 83 (“Disc. Order”). MDS could lead
to “anemia, leukemia, thrombocytopenia, pancytopenia, or severe [bone] marrow
failure.” Id. at 2.
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Pfizer (collectively, “Amgen”), alleging that Enbrel caused Steve’s MDS, resulting
in his death.
A. Discovery Disputes
In May 2015, the magistrate judge4 ordered phased discovery. The first phase
addressed general medical causation to determine whether Enbrel can cause MDS.
Vallejo complained that the magistrate judge’s order was unclear, and the magistrate
judge granted her leave to file a motion for clarification. Upon review, the magistrate
judge granted Vallejo’s motion and provided further instructions. After three planning
conferences, the parties still disagreed on the scope of discovery, and the magistrate
judge scheduled a hearing to resolve the issues. Although the magistrate judge ordered
a joint filing outlining the disputed discovery issues, the parties could not agree on a
single list and instead filed separate documents. The magistrate judge also ordered the
parties to file briefs on Amgen’s potential burden and the proportionality of the
discovery requests.
At the hearing, Vallejo’s expert, Dr. Linda Levesque, testified that she needed
everything originally on Vallejo’s request list, which amounted to “every document
the defendants or any of its predecessors have or can access for any person who
ingested Enbrel and reported a symptom or impact on that person’s red blood cells,
white blood cells, platelets, or any precursor cells for these blood cell lines.” Disc.
Order at 3–4. Dr. Levesque told the court that she “is normally provided with ‘every
single clinical trial that has been done with a drug, whether it’s a drug related to
particular disease or disorder or not[.]’” Id. at 3 n.1 (alteration in original). But
Amgen’s cross-examination revealed Dr. Levesque had “never testified before.” Id.
Further, Dr. Levesque would not personally review the discovery; rather, “[s]he would
look at the synthesis of the information prepared by [Vallejo’s] reviewing experts.”
4
The Honorable Cheryl R. Zwart, United States Magistrate Judge for the
District of Nebraska.
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Id. at 4 n.2. The magistrate judge found Vallejo’s expert not credible and her demands
unreasonable, concluding that the “testimony did not assist the court in determining
whether [Vallejo’s] need for the requested information was proportional to the burden
imposed on the defendants in responding to [Vallejo’s] discovery.” Id. at 4.
Amgen objected to many of Vallejo’s demands, claiming the request would cost
millions. The company was willing to produce the Biologic License Application
(BLA)5 for Enbrel, MedWatch reports,6 and the original Investigator’s Brochure7 for
the agent. Amgen also was willing to produce information regarding Enbrel and an
MDS diagnosis, but it objected to the much broader request for all information
regarding Enbrel, an MDS diagnosis, and any reported symptom associated with the
disorder. Associated symptoms for MDS include generic conditions such as shortness
of breath, pallor, and fatigue.
Vallejo attempted to rebut Amgen’s objection by demonstrating at the hearing
“the ease of researching [the] discovery demands.” Id. at 8. The demonstration
backfired. Vallejo had requested 206 search terms of adverse event reports submitted
to the FDA based on Enbrel. Vallejo’s counsel ran 21 of the 206 terms before the
court; the search yielded 4,193 adverse event reports. The magistrate judge noted that
5
Pharmaceutical companies are required to file a BLA with the U.S. Food and
Drug Administration (FDA) for marketing approval of a biological product such as
Enbrel. See 21 C.F.R. § 601 et seq.
6
“A MedWatch report is a voluntary report to the FDA of an adverse event or
undesirable effect associated with using a medical product, including pharmaceuticals
and medical devices.” In re: Benicar (Olmesartan) Prods. Liab. Litig., No. 15-2606
(RBK/JS), 2016 WL 6652358, at *4 n.6 (D.N.J. Nov. 9, 2016).
7
The Investigator’s Brochure is part of a company’s Investigational New Drug
Application and includes “[a] description of possible risks and side effects to be
anticipated on the basis of prior experience with the drug under investigation or with
related drugs.” 21 C.F.R. § 312.23(a)(5)(v).
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“the courtroom search conducted retrieved only reports provided to the FDA, and not
to other entities, and it included only the entry of a report—not the underlying
research and follow up documentation as to each report.” Id. (emphases added). The
overbreadth of the discovery requests was obvious. The magistrate judge thus limited
discovery to 15 search terms that provided the most specificity to MDS.
Vallejo also demanded information on other agents that work similarly to
Enbrel.8 Amgen objected to the relevance of the request and argued that the
information was available in the public domain. The company also represented that
it did not maintain a database on the other agents, and the search would impose an
enormous burden. The search would entail examining the files of nearly 100,000
employees, as well as the files of its predecessor companies. The court, noting that it
could have simply sustained Amgen’s objection, nevertheless required Amgen “to
answer or produce discovery regarding studies on the causal relationship, if any,
between Enbrel and MDS and produce such studies or reports within [Amgen’s]
custody or control that are not available in the public domain” because “the case [was]
languishing.” Id. at 10.
Lastly, Amgen provided Vallejo with the name of one individual who has
knowledge of Enbrel’s safety—Dr. Janet Isles, Amgen’s global safety officer in
charge of Enbrel. Amgen also agreed to supplement individuals to the list as it became
aware of them. Vallejo objected and demanded that Amgen provide
the organizational charts of 1) the persons responsible for determining
whether Enbrel causes and/or is capable of causing MDS, and those
working at their direction; 2) the person in charge of compiling adverse
8
Enbrel is a biological agent commonly known as a TNF blocker. Enbrel works
by neutralizing, or blocking, tumor necrosis factor, a protein produced by the cells of
the immune system. See id. at 1.
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events, and those working at their direction; and 3) the person in charge
of maintaining source documents for MDS adverse events.
Id. at 11 (citation omitted). The magistrate judge concluded that Vallejo’s request was
unreasonable, given “Enbrel’s extensive history going back to the early 1990s and the
fact that there were at least four companies involved with Enbrel’s development and
production since that time.” Id. at 11. She then permitted Vallejo to depose only Dr.
Isles, with the understanding that should Isles be unable to provide Vallejo with
necessary information, Amgen would “need to locate witnesses who can answer
[Vallejo’s] relevant inquiries.” Id. at 12 (citation omitted).
In her discovery order, the magistrate judge noted that Amgen “ha[s] failed to
submit affidavits or sworn information by employees or experts regarding the burden
of searching for and providing information or providing any meaningful estimates for
the time and cost required by the plaintiff’s discovery.” Id. at 6. Further, “the attorneys
in this case put the onerous responsibility on the court to balance proportionality while
failing to provide substantial and reasonable guidance on this key point: In its current
state the court is being forced to ‘wade through generalized and conflated arguments
of need, burden, and relevance.’” Id. at 5 (citation omitted). And, the magistrate judge
emphasized that should further discovery disagreements arise, “the parties must
provide . . . a more thorough proportionality analysis with each side addressing and
shouldering its burden: The party who served the discovery must show why the
information is important to the issues and the party opposing . . . must quantifiably
explain the burden of providing the requested information.” Id. at 12.
Shortly after the discovery order, Vallejo filed a motion seeking clarification
from the magistrate judge; she also promptly filed an objection to the discovery order,
asking the district court to reverse the magistrate judge’s order. Vallejo argued that the
magistrate judge’s order was contrary to the law because Amgen failed to provide
sufficient evidence to support the magistrate judge’s discovery determinations. While
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those motions were pending, Vallejo served Amgen with a notice of deposition of Dr.
Isles, prompting Amgen to move for a protective order seeking to limit the scope of
the deposition to the magistrate judge’s discovery order. The magistrate judge granted
Amgen’s motion and ordered Vallejo to delay the deposition until the district court
ruled on Vallejo’s objections.
The district court overruled Vallejo’s discovery objection. It concluded that
“[t]he parties and the [magistrate judge] have a collective responsibility to consider
the proportionality of all discovery and consider it in resolving discovery disputes.”
Vallejo v. Amgen, Inc., No. 8:14CV50, 2016 WL 2986250, at *3 (D. Neb. May 20,
2016) (first alteration in original) (quoting Fed. R. Civ. P. 26 advisory committee’s
notes to 2015 amendment). It determined that Amgen’s shortcomings in failing to
“quantify [its] burden to the extent [the magistrate judge] would have liked did not
obligate [the magistrate judge] as a matter of law to accept the [Vallejo’s] expert
witness’s testimony in its entirety.” Id. at *4. The district court then overruled
Vallejo’s objections and affirmed the magistrate judge’s discovery order.
Vallejo deposed Dr. Isles in June 2016. About one hour into the deposition, the
parties disputed the scope of Vallejo’s questions to Dr. Isles and sought the magistrate
judge’s intervention. The magistrate judge suspended the deposition and reconvened
it two months later in order to provide “direct judicial supervision.” Vallejo v. Amgen,
Inc., No. 8:14CV50, 2017 WL 3037391, at *2 (D. Neb. May 30, 2017) (“Sanctions
Order”). Prior to the rescheduled deposition of Dr. Isles, Vallejo complained that
Amgen had not complied with the discovery order. The magistrate judge ordered a
briefing schedule in anticipation of Vallejo’s motion to compel.
The magistrate judge presided over the reconvened deposition and “field[ed]
. . . numerous objections, arguments, and re-arguments over the court’s past and
present rulings.” Id. Vallejo’s “counsel argued with the [magistrate judge’s] ruling on
objections approximately 16 times, and on more than one occasion, counsel asked the
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witness questions which were explicitly beyond the scope of discovery as ordered by
the court.” Id. at *5 (citations omitted). At the deposition, Vallejo informed the
magistrate judge that she had a general causation expert.
The following day, the magistrate judge denied Vallejo’s motion to compel,
which requested leave to depose additional Amgen employees and to compel Amgen
to produce additional documents. The magistrate judge noted the “highly
confrontational” tenor of the case. Vallejo v. Amgen, Inc., No. 8:14CV50, 2016 WL
4250285, at *1 (D. Neb. Aug. 11, 2016). She denied Vallejo’s motion because despite
claiming she lacked the necessary information, Vallejo’s
counsel was able to confront Dr. Isles with case reports, letters, and
articles which he claims support a finding that Enbrel can cause MDS.
In addition, [Vallejo’s] counsel [was] able to, and has demonstrated his
ability to independently search and obtain information from drug
reporting databases in the public domain. Dr. Isles testified that Amgen
posts all adverse events on FDA’s site, which is then available to the
public. Finally, [Vallejo’s] counsel has full access to Steve Vallejo’s
medical records and history, and likely to his treating physicians.
Id. at *2. The magistrate judge then ordered Vallejo to disclose all retained and non-
retained experts on the issue of “whether ingesting Enbrel can cause MDS.” Id. The
magistrate judge denied Vallejo’s request to depose more Amgen employees, but she
stated that “[f]urther depositions may later be permitted upon a showing that [Vallejo]
can present scientifically reliable evidence and opinions supporting the allegation that
Enbrel can cause MDS.” Id. Vallejo filed an objection to the magistrate judge’s order
denying her motion to compel discovery. The district court overruled Vallejo’s
objection.
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B. Attorney Sanctions
In its response to Vallejo’s objection to the magistrate judge’s order, Amgen
requested sanctions against Vallejo’s counsel. Vallejo then moved to strike Amgen’s
sanctions request. The district court denied the motion to strike. But, the district court
ordered Amgen to file a separate motion for sanctions, to include requests for fees and
supporting documentation.
In its sanctions motion, Amgen claimed Vallejo “made repeated attempts to
circumvent the court’s limitations on the first stage of discovery and abused the
judicial process.” Sanctions Order, 2017 WL 3037391, at *2 (citations omitted).
Amgen sought an award of $141,257.21 for work performed responding to or filing:
(1) the motion for clarification, (2) objections to the discovery order, (3) the motion
for a protective order, (4) the motion to compel discovery, (5) objections to the denial
of the motion to compel, (6) the motion to strike, (7) the request for sanctions, (8)
expenses incurred for having to reschedule Dr. Isles’s deposition, and (9) the motion
for sanctions. The magistrate judge granted Amgen’s motion for sanctions, citing the
court’s to sanction under Federal Rule of Civil Procedure 11, 28 U.S.C. § 1927, and
the court’s inherent power.
The magistrate judge found that Vallejo’s counsel’s sanctionable conduct
included filing: (1) the motion for clarification, (2) the premature notice of deposition
and refusing to withdraw the notice, (3) the motion to compel discovery, and (4) the
motion to strike. The magistrate judge also awarded Amgen fees for part of Dr. Isles’s
travel and fees related to the motion for sanctions. The award totaled $25,665. The
district court, after a de novo review, overruled Vallejo’s objections to the magistrate
judge’s sanctions order.
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II. Discussion
9
On appeal, Vallejo claims that the district court erred in limiting her discovery
and by imposing sanctions. “We review a district court’s discovery rulings for abuse
of discretion.” Jackson v. Allstate Ins. Co., 785 F.3d 1193, 1202 (8th Cir. 2015)
(quoting Harvey v. Schoen, 245 F.3d 718, 720–21 (8th Cir. 2001)). Our review is
“both narrow and deferential,” and “[r]elief will be granted on the basis of erroneous
discovery rulings only where the errors amount to a gross abuse of discretion resulting
in fundamental unfairness.” Roberts v. Shawnee Mission Ford, Inc., 352 F.3d 358, 360
(8th Cir. 2003) (cleaned up). Likewise, we review for abuse of discretion the district
court’s order for sanctions. Willhite v. Collins, 459 F.3d 866, 869 (8th Cir. 2006)
(citing United States v. Gonzalez-Lopez, 403 F.3d 558, 564 (8th Cir. 2005)). “We give
substantial deference to the district court’s determination as to whether sanctions are
warranted because of its familiarity with the case and counsel involved.” Id. (citing
Lee v. First Lenders Ins. Servs., Inc., 236 F.3d 443, 445 (8th Cir. 2001)).
A. Discovery Disputes
Vallejo contends that the magistrate judge erred when she: (1) assessed the
proportionality of Vallejo’s discovery request without evidence of Amgen’s alleged
burden; (2) based her ruling on Amgen’s factual misrepresentations; (3) denied
Vallejo the opportunity to cross-examine Amgen’s expert witness; and (4) denied
Vallejo’s requests for the same information the FDA considers when the agency
determines medical causation. Vallejo asserts that the discovery ruling caused
significant prejudice to her case.
Unless otherwise limited by court order, . . . [p]arties may obtain
discovery regarding any nonprivileged matter that is relevant to any
party’s claim or defense and proportional to the needs of the case,
considering the importance of the issues at stake in the action, the
9
We deny Vallejo’s motion to amend her reply brief, filed 12 days after the due
date of the original reply brief, which had already received a 21-day extension.
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amount in controversy, the parties’ relative access to relevant
information, the parties’ resources, the importance of the discovery in
resolving the issues, and whether the burden or expense of the proposed
discovery outweighs its likely benefit.
Fed. R. Civ. P. 26(b)(1). “The parties and the court have a collective responsibility to
consider the proportionality of all discovery and consider it in resolving discovery
disputes.” Id., advisory committee’s notes to 2015 amendment. Just as prior to the
2015 amendment to Rule 26,
a court can—and must—limit proposed discovery that it determines is
not proportional to the needs of the case, considering the importance of
the issues at stake in the action, the amount in controversy, the parties’
relative access to relevant information, the parties’ resources, the
importance of the discovery in resolving the issues, and whether the
burden or expense of the proposed discovery outweighs its likely
benefit—and the court must do so even in the absence of a motion.
Carr v. State Farm Mut. Auto. Ins., Co., 312 F.R.D. 459, 468 (N.D. Tex. 2015); see
also id. at 466 (“[T]he existing allocation of burdens to show undue burden or lack of
proportionality have not fundamentally changed.”); Fed. R. Civ. P. 26 advisory
committee’s notes to 2015 amendment (“The considerations that bear on
proportionality are moved from present Rule 26(b)(2)(C)(iii), slightly rearranged and
with one addition.”). “A party claiming requests are unduly burdensome cannot make
conclusory allegations, but must provide some evidence regarding the time or expense
required.” Doe v. Nebraska, 788 F. Supp. 2d 975, 981 (D. Neb. 2011) (citation
omitted). Rule 26 requires “a particular and specific demonstration of fact, as
distinguished from stereotyped and conclusory statements.” Gen. Dynamics Corp. v.
Selb Mfg. Co., 481 F.2d 1204, 1212 (8th Cir. 1973) (citation omitted).
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1. Evidence of Proportionality
Vallejo contends that the district court lacked a basis for weighing
proportionality because Amgen failed to provide affidavits showing Vallejo’s
discovery requests were unduly burdensome. She argues that “particular and specific
demonstration of fact” “mean[s] ‘affidavits which explain[] why the requested
information cannot be reasonably obtained.’” Appellant’s Br. at 11 (second alteration
in original) (quoting Wal-Mart Stores, Inc. v. Vidalakis, No. 5:07-MC-00039-RTD,
2007 WL 4591569, at *5 (W.D. Ark. Dec. 28, 2007)). Vallejo interprets Vidalakis to
mean that affidavits or some form of sworn declarations or statements are the only
acceptable form of evidentiary submission to the court.
Vallejo is mistaken. The party in Vidalakis failed to establish undue burden
because “[t]he only thing[s] [it submitted to] the court [were] the conclusory
statements . . . that the requested information is onerous.” Vidalakis, 2007 WL
4591569, at *5. The Vidalakis court simply restated the well-settled rule that courts
require the party seeking to limit discovery to “establish grounds for not providing the
discovery that are specific and factual; the party cannot meet its burden by making
conclusory allegations as to undue burden.” Hill v. Auto Owners Ins. Co., No.
5:14-CV-05037-KES, 2015 WL 1280016, at *7 (D.S.D. Mar. 20, 2015) (citing Burns
v. Imagine Films Entm’t Inc., 164 F.R.D. 589, 593 (W.D.N.Y. 1996)).
Amgen concedes that it did not provide supporting affidavits to support its
objections to Vallejo’s Rule 26 requests, but it argues that it did not have to submit
affidavits. Amgen argues that under Federal Rule of Civil Procedure 11(b)(3), by
signing a brief, a party’s counsel certifies to the court that “the factual contentions
have evidentiary support.” And, Amgen contends that it provided sufficiently detailed
explanations to Vallejo’s unduly burdensome discovery requests through its briefing
to the court. As support, Amgen cites to persuasive authority where “[a] district court
has . . . accepted [Amgen’s] counsel’s representations—in another suit brought by
Vallejo’s counsel regarding Enbrel—as an adequate demonstration of the burdens
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associated with Vallejo’s counsel’s discovery requests.” Appellees’ Br. at 31 (citing
Small v. Amgen, Inc., No. 2:12-cv-476-FtM-29MRM, 2016 WL 7228863, at *6, *7
n.7, *9–10, *15 (M.D. Fla. Sept. 28, 2016)).
We reject Amgen’s proposition that, as a general rule, attorney assertions in
briefs to the court can adequately substitute for affidavits and other forms of evidence.
By signing a brief, an attorney certifies that the factual assertions contained within the
brief have evidentiary support. But certification that the facts have evidentiary support
may not be helpful in the context of Rule 26(b)(1), where a party’s burden must be
quantified. Amgen insists that “[g]iven the nature and scope of the information
requested, in addition to the multiple Defendants from whom discovery was sought,
consolidated representations from Defendants’ counsel properly conveyed the burdens
posed by Vallejo’s discovery requests.” Id. at 32. But, the district court disagreed. The
magistrate judge and the district court found that “the attorneys in this case put the
onerous responsibility on the court to balance proportionality while failing to provide
substantial and reasonable guidance on this key point: In its current state the court is
being forced to ‘wade through generalized and conflated arguments of need, burden,
and relevance.’” Disc. Order at 5 (citation omitted). Thus, despite Amgen’s assertion
that it provided adequate information through its briefing, the district court disagreed,
finding the information not “objectively quantified.” Id. at 6.
We find no abuse of discretion in the district court’s conclusion that Vallejo’s
discovery requests were “overbroad and unreasonable” despite the lack of affidavits
or other sworn statements. Disc. Order at 12. Contrary to Vallejo’s contention that the
district court had no basis to weigh proportionality, the district court, “based on
common sense and the search conducted by [Vallejo’s] counsel during the [discovery]
hearing,” id., had sufficient information to make an informed decision. See Onwuka
v. Fed. Express Corp., 178 F.R.D. 508, 516 (D. Minn. 1997) (“The[] [Rule 26] factors
are not talismanic. Rather, they are to be applied in a common sense, and practical
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manner.” (citation omitted)); In re Convergent Techs. Sec. Litig., 108 F.R.D. 328, 331
(N.D. Cal. 1985).
2. Attorney Misrepresentations to the Court
Vallejo claims that Amgen, in arguing lack of proportionality, misrepresented
facts to the district court. For example, Vallejo claims that Amgen said Dr. Isles was
“the only Amgen employee who can provide relevant information about Enbrel’s
safety” when in truth at least eight other Amgen employees possessed “relevant
information about Enbrel’s safety.” Appellant’s Br. at 19. Amgen disputes that it ever
claimed Dr. Isles was the sole possessor of knowledge about Enbrel’s safety. Indeed,
the record does not support Vallejo’s claim. At the discovery hearing, Amgen stated
that Dr. Isles “would be the one to . . . talk to the causation point. That said, this is
very early, and as our investigation continues, if there are additional people, we’ll
certainly supplement. But at this point in time, she’s the only company witness who
would speak to the safety of Enbrel.” Tr. of Disc. H’rg at 25, Vallejo v. Amgen, No.
8:14-cv-00050-JMG-CRZ (D. Neb. Dec. 9, 2015), ECF. No. 79. The magistrate judge,
too, interpreted Amgen’s statement to mean that Vallejo should first depose Dr. Isles,
because she was the Amgen global safety officer for Enbrel. However, the magistrate
judge indicated that Amgen “may need to locate witnesses who can answer the
plaintiff’s relevant inquiries” in the event Dr. Isles cannot. Disc. Order at 12 (citation
omitted). We find no misrepresentation by Amgen.
Vallejo also alleges that Amgen falsely represented to the court that it does not
routinely track the studies involving other TNF blockers. According to Vallejo,
Amgen participated in at least one study looking at TNF blockers, including Enbrel.
Amgen does not dispute that it conducted the study, but asserts—and we agree—that
conducting one study does not equate to routinely tracking other TNF blockers. In
another instance, Vallejo says Amgen misrepresented when it asserted that “[m]any
studies done on Enbrel are not designed to examine safety but instead look at other
issues like medication utilization.” Appellant’s Br. at 18 (citation omitted). She cites
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to an Amgen-sponsored study examining “whether Enbrel (and other TNF inhibitors)
increase the risk of serious infection following a prior incident of serious infection.”
Id. (citation omitted). The record contains no statement by Amgen stating no study
ever studied safety effects. Rather, Amgen stated that many studies do not.
A discussion of every accusation of misrepresentation that Vallejo raised
against Amgen is unnecessary. Having thoroughly reviewed the record, we are
satisfied that the district court did not rely on misrepresented facts by Amgen in
issuing its discovery orders.
3. Opportunity to Cross-Examine Amgen’s Expert Witness
Vallejo says the district court erroneously denied her the opportunity to cross-
examine Dr. Peter Greenberg, Amgen’s expert witness, at the discovery hearing. She
alleges that the “error [was] particularly egregious considering Dr. Greenberg’s
scientific opinions were the singular foundation of [Amgen’s] objections to Vallejo’s
discovery requests.” Appellant’s Br. at 22.
Vallejo’s argument is without merit. Even if the court should have afforded
Vallejo an opportunity to cross-examine Amgen’s expert, any error was harmless. See
Hofer v. Mack Trucks, Inc., 981 F.2d 377, 381–82 (8th Cir. 1992) (“If a party can
demonstrate a gross abuse of discretion by the trial court (bearing in mind that in the
discovery arena the trial judge’s discretion is particularly broad), then the complaining
party must also demonstrate prejudice.” (citations omitted)).
Amgen relied on Dr. Greenberg’s opinion that an inquiry into whether Enbrel
causes MDS “does not require an investigation into every symptom that could be
associated with MDS as such an inquiry would not be probative of the causation
question.” Def. Mem. Regarding the Burden Associated with Pl.’s Disc. Reqs. at 6,
Vallejo v. Amgen, No. 8:14-cv-00050-JMG-CRZ (D. Neb. Jan. 19, 2016), ECF. No.
80. Amgen also relied on Dr. Greenberg’s opinion that the Enbrel BLA contains “the
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relevant studies, if any, to determine whether Enbrel causes MDS.” Id. at 10–11. Dr.
Greenberg also opined that “the [Enbrel] BLA would include any information about
pre-approval toxicology studies or in vitro studies, which are the studies that . . . may
be relevant to the causation question.” Id. at 17. Amgen provided the BLA to Vallejo,
and the district court did not rely on Dr. Greenberg’s opinion to reach its discovery
decision. See Disc. Order at 12 (“[B]ased on common sense and the search conducted
by [Vallejo’s] counsel during the hearing, the court finds the burden of [Vallejo’s]
discovery demands is unreasonable.”). Thus, even if the district court erred in failing
to provide Vallejo an opportunity to cross-examine Dr. Greenberg, the error was
harmless. See Hofer, 981 F.2d at 382.
4. Same Information on Causation as the FDA Utilizes
Next, Vallejo contends the district court should have ordered Amgen to provide
her with the same information the FDA considers when it determines medical
causation. In denying her request, Vallejo says the district court “ignored the
relevancy of the pharmacovigilance materials with which the FDA determines general
causation.” Appellant’s Br. at 28. Vallejo refers to the FDA’s Guidance for Industry:
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. In the
section “Interpreting Safety Signals: From Signal to Potential Safety Risk,” the agency
recommends that pharmaceutical companies submit to the agency “a synthesis of all
available safety information and analyses performed, ranging from preclinical findings
to current observations.” J.A. at 821. The FDA then enumerated a list of materials to
include in the submission when evaluating whether “a safety signal . . . may represent
a potential safety risk.” Id. But, throughout the entire document, the FDA placed as
a header a description that the manual “Contains Nonbinding Recommendations.” Id.
at 804–24 (bold omitted).
Vallejo’s argument fails. First, MDS has never been identified as a safety signal
in connection with Enbrel. Second, notwithstanding that the FDA does not require the
information Vallejo suggested it does, the agency “evaluates pharmaceutical drugs
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using a different standard than the causation standard” courts apply. Glastetter v.
Novartis Pharm. Corp., 252 F.3d 986, 991 (8th Cir. 2001) (per curiam). For instance,
“[t]he FDA will remove drugs from the marketplace upon a lesser showing of harm
to the public than the preponderance-of-the-evidence or more-likely-than-not
standards used to assess tort liability.” Id. Third, Vallejo’s contention that the district
court ignored the relevancy of the pharmacovigilance materials used by the FDA is
not supported by the agency’s own statements—the FDA requests are optional and
nonbinding. In other words, the requested materials may be helpful to assess safety
but are not deemed essential.
The district court was under no obligation to order Amgen to provide Vallejo
with materials the FDA requests—but does not require—from pharmaceutical
companies when the agency evaluates safety risks. We find no abuse of discretion.
5. Prejudice
Lastly, Vallejo asserts that the district court’s order limiting the scope of her
discovery prejudiced her case. She argues that the discovery ruling directly and
adversely impacted her case, leading to the court’s grant of summary judgment to
Amgen. We will not reverse the district court’s discovery ruling “absent a ‘gross
abuse of discretion resulting in fundamental unfairness.’” McGowan v. Gen. Dynamics
Corp., 794 F.2d 361, 363 (8th Cir. 1986) (quoting Voegeli v. Lewis, 568 F.2d 89, 96
(8th Cir. 1977)).
Vallejo asserts that the magistrate judge misunderstood her counsel’s statement
at Dr. Isles’s deposition. At the deposition, the magistrate judge asked Vallejo if she
had a general causation expert. Vallejo’s counsel replied, “I have an expert that is part
of it and I’m going to have other experts.” Appellant’s Br. at 29 (citation omitted).
Vallejo says the magistrate judge should not have interpreted the answer to mean that
Vallejo “had an expert who was ready to testify as to general causation.” Id. Vallejo
claims that within the discovery she received, a Pfizer employee filed a Medwatch
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report, stating, “Based on the information provided; drug profile, temporal association
and positive dechallenge result, the events myelodysplastic syndrome and
pancytopenia are considered related to the use of [Enbrel].” Id. at 29–30 (citation
omitted). Vallejo says the employee’s statement amounted to an admission of general
causation and that the magistrate judge’s denial of further depositions severely
prejudiced her case. We disagree.
First, Vallejo indicated to the magistrate judge that she had a general causation
expert. When the magistrate judge ordered Vallejo to disclose all retained and non-
retained experts expected to testify at trial on the issue of general causation, Vallejo
listed one expert, a “John Doe (Pfizer Employee).” Thus, although Vallejo informed
the magistrate judge that she had an expert on causation, in actuality she did not. But
even had the magistrate judge and the district court misunderstood Vallejo’s counsel
on whether she had an expert ready to testify on causation, Vallejo nevertheless failed
to “specify the way in which the . . . discovery denials resulted in fundamental
unfairness.” Moses.com Sec., Inc. v. Comprehensive Software Sys., 406 F.3d 1052,
1060 (8th Cir. 2005). Although “[n]o longer can the time-honored cry of ‘fishing
expedition’ serve to preclude a party from inquiring into the facts underlying his
opponent’s case,” Edgar v. Finley, 312 F.2d 533, 535 (8th Cir. 1963), “[t]he discovery
rules are designed to assist a party to prove a claim it reasonably believes to be viable
without discovery, not to find out if it has any basis for a claim.”Micro Motion, Inc.
v. Kane Steel Co., 894 F.2d 1318, 1327 (Fed. Cir. 1990) (citations omitted). Here,
Vallejo relied on an unidentified Pfizer employee’s Medwatch report to say that
Amgen had an admission on the issue of causation. She is wrong. Neither Amgen nor
any of its employees admitted to causation. At best, the Medwatch report noted one
incident of a temporal association between taking Enbrel and MDS. The law is clear
“that association is not scientifically valid proof of causation.” Glastetter, 252 F.3d
at 990.
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The district court ultimately granted summary judgment to Amgen because
“[t]here is no dispute that Vallejo’s allegations involve complex scientific matters, and
yet inexplicably—throughout the 3-year life span of this litigation—she has failed to
retain an expert.” Vallejo v. Amgen, Inc., 274 F. Supp. 3d 922, 927 (D. Neb. 2017).
Allowing Vallejo to depose the unidentified Pfizer employee would not have supplied
its missing general causation expert witness.
The district court properly exercised its broad discretion in rendering its
discovery rulings.
B. Sanctions
Vallejo contends that the district court erred in imposing sanctions under
Federal Rule of Civil Procedure 11, under 28 U.S.C. § 1927, and under its inherent
power. “Part of the purpose of the sanctioning power . . . is to control litigation and
to preserve the integrity of the judicial process.” Nick v. Morgan’s Foods, Inc., 270
F.3d 590, 594 (8th Cir. 2001) (citing Martin v. DaimlerChrysler Corp., 251 F.3d 691,
695 (8th Cir. 2001)). “A district court . . . abuse[s] its discretion if it based its ruling
on an erroneous view of the law or on a clearly erroneous assessment of the
evidence.” Adams v. USAA Cas. Ins. Co., 863 F.3d 1069, 1076 (8th Cir. 2017)
(quoting Plaintiffs’ Baycol Steering Comm. v. Bayer Corp., 419 F.3d 794, 802 (8th
Cir. 2005)).
1. Rule 11
“[T]he primary purpose of Rule 11 sanctions is to deter attorney and litigant
misconduct, not to compensate the opposing party for all of its costs in defending.”
Kirk Capital Corp. v. Bailey, 16 F.3d 1485, 1490 (8th Cir. 1994) (citation omitted).
In the context of Rule 11, “appellate courts have forcefully suggested that trial courts
consider which sanction ‘constitutes the least severe sanction that will adequately
deter the undesirable conduct.’” Id. (quoting Pope v. Fed. Express, 974 F.2d 982, 984
(8th Cir. 1992)). The rule operates in part on the assumption
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that an attorney [will] conduct a reasonable inquiry of the factual and
legal basis for a claim before filing. To constitute a reasonable inquiry,
the prefiling investigation must uncover a factual basis for the plaintiff’s
allegations, as well as a legal basis. Whether the attorney’s inquiry is
reasonable may depend on factors such as whether counsel had to rely
on a client for factual information, or whether the attorney depended on
forwarding counsel or another member of the bar. The District Court
must determine whether a reasonable and competent attorney would
believe in the merit of an argument.
Coonts v. Potts, 316 F.3d 745, 753 (8th Cir. 2003) (cleaned up). “The [district] court
has broad discretion in the choice of sanctions.” Id. (citing Cooter & Gell v. Hartmarx
Corp., 496 U.S. 384, 400 (1990)).
Vallejo denies her counsel “abused the judicial process in any manner.”
Appellant’s Br. at 35. Rather, she insists that her counsel made good faith attempts to
obtain information in the uphill battle against a “restrictive . . . discovery [process
that] has frustrated all reasonable pursuits of discovery.” Id. We disagree with
Vallejo’s characterization. Vallejo’s counsel filed successive motions to relitigate
issues previously denied by the court. Even after the district court overruled counsel’s
objection to the magistrate judge’s discovery order, Vallejo filed a motion to compel
discovery.
Vallejo argues she had cause to file the motion for clarification. Vallejo asserts
that the discovery order was unclear on whether Vallejo was limited to a single
deposition of Dr. Isles despite her allowance of ten under Federal Rule of Civil
Procedure 30, or whether she was permitted to depose other individuals after seeking
leave from the court. Vallejo offers as further justification for her motion the order’s
“clear[] contemplat[ion] that Dr. I[s]les would identify additional witnesses who
would be deposed.” Id. at 37. As to the motion to compel, Vallejo decries as “utterly
false and offensive” the magistrate judge’s characterization of the motion as an
attempt to reconsider already litigated issues. Id. at 41. Instead, she avers that “[a]ll
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of the discovery sought was carefully crafted to meet previous orders of the Court.”
Id. at 45.
The record belies Vallejo’s contentions. The magistrate judge’s discovery order
clearly permitted Vallejo to depose only Dr. Isles as the initial deponent. See Disc.
Order at 12 (“The plaintiff should instead depose Ms. Isles, and if she cannot provide
the necessary information, [Amgen] may need to locate witnesses who can answer the
plaintiff’s relevant inquiries.” (emphasis added) (citation omitted)). At the discovery
hearing, the magistrate judge explained to Vallejo,
If you’re planning on doing a 30(b)(6) deposition, that’s just another
opening to do exactly what you’ve done today, which is bring in all of
this stuff. There’s no point in going down that path at this point, because
you’ll ask that witness to come up with everything that you’ve said you
need today.
Tr. of Disc. Hr’g at 119 (emphasis added). The magistrate judge did open the prospect
of Vallejo deposing additional Amgen witnesses. But, Vallejo would be permitted to
do so only after first deposing Dr. Isles and if Dr. Isles failed to supply Vallejo with
the necessary information. The magistrate judge’s order was clear and required no
clarification.
Vallejo’s motion to compel also sought to relitigate issues previously decided
by the district court. Again Vallejo argued the issue of whether the district court
permitted deponents other than Dr. Isles. Vallejo sought to compel the supplemental
BLA for psoriasis, but the magistrate judge already limited Amgen’s production to the
original BLA. Vallejo also sought production of the “Canadian Monograph,” Enbrel’s
package insert for products sold in Canada. She argues that “[a]t the time of the
motion to compel, [Amgen] had not provided any discovery on this topic” and that she
thus “was acting within the Court’s boundaries of discovery and substantially justified
in seeking this information.” Appellant’s Br. at 44–45. But, the magistrate judge made
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clear that she “re-craft[ed] [Vallejo’s] discovery to match the case, and . . . order[ed]
[Amgen] to answer or produce discovery . . . that [is] not available in the public
domain.” Disc. Order at 10. The Canadian Monograph is readily available in the
public domain.10 Vallejo defied the court’s discovery order and sought to relitigate the
issue in her motion to compel discovery.
The bulk, if not the entirety, of Vallejo’s motion to compel represented
relitigation of issues already decided by the court. The magistrate judge concluded that
“absent any change in circumstances, filing additional motions raising the same
arguments was harassing, caused unnecessary delay, and needlessly increased the cost
of this litigation.” Sanctions Order, 2017 WL 3037391, at *4. The district court did
not abuse its discretion by imposing sanctions under Rule 11.
2. Statutory Sanction
Congress mandates that “[a]ny attorney . . . who so multiplies the proceedings
in any case unreasonably and vexatiously may be required by the court to satisfy
personally the excess costs, expenses, and attorneys’ fees reasonably incurred because
of such conduct.” 28 U.S.C. § 1927. Sanctions under § 1927 may be imposed
irrespective of “winners and losers, or between plaintiffs and defendants. The statute
is indifferent to the equities of a dispute and to the values advanced by the substantive
law. It is concerned only with limiting the abuse of court processes.” Roadway
Express v. Piper, 447 U.S. 752, 762 (1980). As previously discussed, see supra Part
II.B.1, Vallejo’s attempts to relitigate already decided issues in the form of a motion
for clarification and a motion to compel discovery, as well as her motion to strike,11
10
Enbrel’s Canadian package insert, labeled “Product Monograph,” is found at
https://www.amgen.ca/products/~/media/5d0a40b2b8774fb5994190f97daf7fbd.ashx.
11
Vallejo argues that Amgen’s inclusion of requests for sanctions in its
opposition to her motion to compel discovery was improper. While that may be the
case, as the district court noted, “[o]pposition to a motion can be accomplished simply
by opposing the motion. It is a waste of everyone’s time when one motion
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unreasonably and vexatiously multiplied the proceedings, “wast[ing] . . . everyone’s
time.” Sanctions Order, 2017 WL 3037391, at *7 (citation omitted).
The district court’s imposition of sanctions under § 1927 was not an abuse of
discretion.12
3. Inherent Power
“[T]he district court possesses inherent power ‘to manage [its] own affairs so
as to achieve the orderly and expeditious disposition of cases.’” Adams, 863 F.3d at
1077 (second alteration in original) (quoting Chambers v. NASCO, Inc., 501 U.S. 32,
43 (1991)). The court’s powers include “the ability to supervise and ‘discipline
attorneys who appear before it’ and discretion ‘to fashion an appropriate sanction for
conduct which abuses the judicial process,’ including assessing attorney fees or
dismissing the case.” Id. (quoting Wescott Agri-Prods., Inc. v. Sterling State Bank,
Inc., 682 F.3d 1091, 1095 (8th Cir. 2012)).
Vallejo’s counsel “disregarded or re-argued nearly all unfavorable court
rulings.” Sanctions Order, 2017 WL 3037391, at *5. Further, during the court’s
supervision of Dr. Isles’s deposition, Vallejo’s counsel argued with the magistrate
judge’s ruling approximately 16 times; counsel also repeatedly asked Dr. Isles
questions “explicitly beyond the scope of discovery as ordered by the court.” Id.Vallejo’s counsel faults the district court for “ignor[ing] that the vast bulk of the
metastasizes into two or three.” Order at 1, Vallejo v. Amgen, No. 8:14-cv-00050-
JMG-CRZ (D. Neb. Sept. 29, 2016), ECF. No. 127 (citation omitted).
12
Vallejo argues in her reply brief about the procedural impropriety of the
§ 1927 sanction, because she did not get a fair notice and an opportunity to be heard.
However, we consider the issue waived, as Vallejo did not raise the argument in her
opening brief. See United States v. Brown, 108 F.3d 863, 867 (8th Cir. 1997) (holding
that an argument first raised in the appellant’s reply brief will not be considered
without reason for failure to raise the issue earlier).
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disputes were ruled upon in favor of Vallejo or for which Vallejo simply accepted the
ruling.” Appellant’s Br. at 51.
This argument misses the point. The district court has the discretion to exercise
its inherent power to achieve the orderly and expeditious resolution of cases. In
reviewing sanctions under the district court’s inherent power, we do not look at the
frequency of counsel’s success or compliance. Rather, courts assess whether and when
an attorney’s conduct became not just “merely the disruption of court proceedings. . . .
[but] disobedience to the orders of the Judiciary, regardless of whether such
disobedience interfered with the conduct of trial.” Chambers, 501 U.S. at 44 (quoting
Young v. United States ex rel. Vuitton et Fils S.A., 481 U.S. 787, 798 (1987)). In
addition to filing multiple motions as barely veiled attempts to relitigate decided
issues, Vallejo’s counsel also became unnecessarily argumentative with the magistrate
judge.
Attorneys are entitled to advocate zealously for their clients, but they must do
so in accordance with the law, the court rules, and the orders of the court. The district
court properly exercised its inherent power to sanction Vallejo’s counsel, and we find
no abuse of discretion.
III. Conclusion
Accordingly, we affirm the district court.
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