Willenken Wins Critical Liability Phase of High-Profile Lupron Supply Shortage Trial in Delaware Chancery Court

Willenken secured a significant trial victory in the first phase of a closely watched case recognized by the pharmaceutical industry as “one of the five big healthcare lawsuits” of the year.

On behalf of AbbVie Endocrine, Inc., Willenken brought a high-stakes breach of contract case against Takeda Pharmaceutical Company, accusing Takeda of failing to supply AbbVie’s requirements for Lupron, the leading androgen deprivation therapy for the treatment of advanced prostate cancer, uterine fibroids, endometriosis, and precocious puberty.

After an FDA inspection in November 2019 found serious quality deficiencies at one of Takeda’s Japanese Lupron manufacturing facilities, production and supply disruptions caused a world-wide Lupron supply shortage. Takeda then allocated the scarce Lupron supply in favor of its own markets and to the grave detriment of AbbVie’s exclusive U.S. and Canadian markets. As a result, tens of thousands of physicians and patients, who rely upon AbbVie for Lupron, are no longer able to obtain timely, sufficient quantities of this potentially life-saving drug.

Led by partner Paul Loh, the 100-percent-diverse Willenken trial team filed suit in Delaware Chancery Court in late 2020. After a four-day trial, significant post-trial briefing, and oral argument, the Court ruled in favor of AbbVie, finding that Takeda:

  1. Failed to operate its manufacturing facility in compliance with FDA regulations;
  2. Failed to fulfill AbbVie’s firm orders of Lupron; and
  3. Failed to maintain mandated levels of Lupron safety stock to mitigate the impact of production disruptions, in violation of the parties’ Supply Agreement.

See Law360 article titled “Chancery Says Takeda Liable For AbbVie’s Lupron Supply Lag.”

The case will now proceed to a trial on the amount of damages to be awarded to AbbVie for Takeda’s breaches. 

In its September 22 decision, the Court expressly rejected Takeda’s central argument that the supply agreement merely required Takeda to exert its “best efforts” to timely fulfill AbbVie’s Lupron requirements, describing Takeda’s proffered contract construction as an “absurdity.” 

Drawing upon its unparalleled trial experience and in-house capabilities in electronic document management, the Willenken team effectively marshalled testimonial and documentary evidence from more than three dozen fact and expert depositions taken remotely of witnesses from across seven countries, and over 145,000 documents—all under the case’s expedited schedule and during the restrictions of the COVID-19 pandemic.

This culminated in a four-day, virtual trial featuring the testimony of fifteen witnesses, who were expertly questioned or defended by partners Paul Loh, Jason Wilson, and Amelia Sargent; of counsel Ashley Kirk; and senior associate Kenneth Trujillo-Jamison. The team further included partner Peter Shimamoto, of counsel Lika Miyake, and staff attorney Sherin Varghese.

Click here for the September 22, 2021 Delaware Chancery Court decision in this case.