Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, September 11, 2018

Causation discovery properly limited in suit alleging Enbrel® caused MDS

By Robert B. Barnett Jr., J.D.

A Nebraska federal court properly limited causation discovery by the deceased’s wife in a suit against Amgen contending that its drug Enbrel® caused the myelodysplastic syndrome (MDS) that killed her husband, the Eighth Circuit has ruled, because the court had sufficient evidence to conclude that the wife’s discovery request for all information regarding Enbrel, an MDS diagnosis, and any reported symptom associated with the disorder was overbroad and unreasonable. Furthermore, the trial court did not err when it imposed more than $25,000 in sanctions on the wife’s attorney for repeatedly seeking to relitigate discovery matters the court had previously ruled upon (Vallejo v. Amgen, Inc., September 10, 2018, Smith, L.).

Background. A man began taking Enbrel in 2004 to treat his psoriasis. He later developed MDS and died in 2011. His wife sued Amgen, Wyeth, Inc., and Pfizer, Inc. (Wyeth and Pfizer had been involved in Enbrel’s development decades before) in Nebraska federal court, asserting that Enbrel caused her husband’s MDS. The magistrate judge ordered a phased discovery, with the first phase devoted to the medical question whether Enbrel can cause MDS. The wife’s efforts at the hearing to establish the reasonableness of her discovery requests did not go well. For example, the wife’s claim that Amgen could easily search for adverse event reports on the FDA backfired when the court ran 21 terms (of the 206 terms that the wife demanded that Amgen use), and the search revealed 4,193 adverse event reports.

The magistrate judge ruled that the wife’s discovery requests were overly broad and burdensome. She then entered an order that (1) limited the search that Amgen would have to undertake to 15 terms, (2) ordered Amgen to produce any studies on the causal relationship, if any, between Enbrel and MDS that were not available in the public domain, and (3) permitted the wife to depose only the single individual Amgen named as the person with knowledge of Enbrel’s safety, while allowing the wife to depose others if the deponent could not provide all answers. In so ruling, the magistrate judge noted that Amgen had failed to submit affidavits or other sworn information by employees or experts regarding the burden of searching for the requested information, but it concluded that it had enough information to determine that the discovery requests were overly broad.

Not satisfied with the ruling, the wife continued to seek clarification of the order, and she continued to seek information that had been excluded by the magistrate judge’s order. The matter became so confrontational that the magistrate judge had to attend the Amgen employee’s deposition in order to make rulings throughout on the scope of discovery. As a result of these actions, the magistrate judge granted Amgen’s motion for sanctions against the wife’s attorney and awarded Amgen $25,665 for the extra costs associated with efforts to oppose the wife’s continuing discovery requests. Throughout the process, the trial judge upheld the magistrate judge’s rulings. The wife appealed both the limitations on discovery and the award of sanctions.

Discovery limitations. The wife argued on appeal that the court erred when it ruled that the discovery was overly burdensome without affidavits or other evidence from Amgen establishing burdensomeness. The court first rejected the wife’s contention that affidavits and other sworn statements are the only acceptable forms of evidentiary court submissions. The court also, however, rejected Amgen’s contention that its attorney’s signature on the brief arguing that the requests were burdensome was an adequate substitute for the affidavits and other forms of evidence. Nevertheless, the Eighth Circuit concluded, the lower court’s conclusion that the discovery requests were overbroad and burdensome was not error because the court had sufficient evidence before it to make an informed decision. The sufficient evidence existed in the form of a combination of the court’s own common sense and the search conducted at the hearing.

The Eighth Circuit also rejected the wife’s additional arguments for reversal: (1) that the lower court’s ruling was based on Amgen’s factual misrepresentations, (2) that the lower court improperly denied her request for cross-examine Amgen’s expert witness, and (3) that the lower court improperly denied her request for the same information that the FDA considers when it determines medical causation. Amgen made no factual misrepresentations. Any error in not permitting the wife to cross-examine the expert witness was harmless error because the court did not rely on the expert’s opinion in making its ruling. And, finally, the information that the FDA uses in determining causation was irrelevant because the FDA uses a different causation standard than the one a court uses.

Sanctions. The Eighth Circuit also upheld the lower court’s imposition of sanctions, rejecting the wife’s contention that the attorney’s efforts did not abuse the judicial process. The attorney repeatedly attempted to relitigate matters previously decided, and he repeatedly attempted to obtain information excluded from discovery. His efforts caused Amgen to incur additional expenses. As a result, the court had the right to sanction him and to order him to reimburse Amgen for those additional expenses. A court has the right to take steps to achieve an orderly and expeditious resolution to its cases.

The Eighth Circuit, therefore, affirmed the lower court ruling on both matters.

The case is No. 17-1730.

Attorneys: Keith L. Altman (Excolo Law Office) for Jan Vallejo. Lauren S. Colton (Hogan Lovells) and Edward M. Fox, II (Kutak Rock LLP) for Amgen, Inc., Wyeth, Inc. and Pfizer, Inc.

Companies: Amgen, Inc.; Wyeth, Inc.; Pfizer, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews PrescriptionDrugNews PLDrugNews SafetyNews ArkansasNews IowaNews MinnesotaNews MissouriNews NebraskaNews NorthDakotaNews SouthDakotaNews

Back to Top

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.


A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.