Vallejo v. Amgen, Inc.

Citation903 F.3d 733
Decision Date10 September 2018
Docket NumberNo. 17-1730, No. 17-2593,17-1730
Parties Jan VALLEJO, Individually and As Personal Representative of Steve Vallejo, estate of, Steve Vallejo, Plaintiff-Appellant v. AMGEN, INC.; Wyeth, Inc.; Pfizer, Inc., Defendants-Appellees Jan Vallejo, Individually and As Personal Representative of Steve Vallejo, estate of, Steve Vallejo, Plaintiff-Appellant v. Amgen, Inc.; Wyeth, Inc.; Pfizer, Inc., Defendants-Appellees
CourtUnited States Courts of Appeals. United States Court of Appeals (8th Circuit)

Counsel who presented argument on behalf of the appellant was Daniel W. Weininger, of Southfield, MI. The following attorney(s) appeared on the appellant brief; Keith L. Altman, of Southfield, MI.

Counsel who presented argument on behalf of the appellee was Catherine Emily Stetson, of Washington, DC. The following attorney(s) appeared on the appellee brief; Sean Marotta, of Washington, DC., Edward M. Fox, II, of Omaha, NE., Lauren S. Colton, of Baltimore, MD.

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 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." 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 "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 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 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...

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