After Three Years and Two Trials, High-Stakes Litigation Over Shortage of Cancer Drug Ends Favorably for Willenken Client AbbVie Endocrine, Inc.
A December 2023 consent judgment awarding AbbVie $448 million and waiving appeal closed the final chapter of three years of litigation between AbbVie and its manufacturer Takeda Pharmaceutical Company over an unprecedented, worldwide supply shortage of Lupron®, the leading androgen deprivation therapy for treatment of advanced prostate cancer.
AbbVie is Lupron’s exclusive distributor in the United States, and the parties’ supply agreement required Takeda to maintain its manufacturing facility in compliance with FDA regulations and fulfill all AbbVie’s firm orders for this life-prolonging drug. In November 2019, however, an FDA inspection found serious quality deficiencies at Takeda’s main Lupron-production facility in Japan, necessitating prolonged shutdowns of the plant while Takeda engaged in extensive remediation efforts. Takeda then allocated the scarce Lupron supply to its own markets to the detriment of the tens of thousands of patients and doctors who relied on AbbVie for Lupron in the United States.
In late 2020, Willenken, led by partner Paul Loh, filed suit against Takeda for breach of contract in Delaware Chancery Court, seeking expedited relief. The Court held a four-day virtual trial in April 2021, which featured the testimony of fifteen witnesses expertly questioned or defended by Willenken’s 100% diverse trial team. Although the Court declined to enjoin Takeda to fulfill AbbVie’s orders, which it deemed unworkable, it found Takeda liable for breaching the supply agreement and ordered a second phase of the case to determine the amount of damages to award. Read more about the phase one trial here.
The second phase was no less contested than the first, as Takeda employed a sprawling defense to try to relitigate responsibility for the shortage. Under Paul’s leadership, partner Amelia Sargent orchestrated the affirmative damages strategy with top economic and industry experts to evaluate the massive market losses suffered by AbbVie—more than half of which Takeda’s expert was forced to concede in its rebuttal report. Partner Jason Wilson and counsel Ashley Kirk reprised their quality-focused roles from phase one to rebut Takeda’s defense strategy, while partner Kenneth Trujillo-Jamison defended against Takeda’s speculative arguments that Lupron’s market share would have naturally fallen. Associates Breeanna Brewer and Caitlin Lynch supported the team while partners Eileen Ahern and Peter Shimamoto spearheaded third-party discovery and legal research. The team was further supported by e-discovery manager and staff attorney Sherin Varghese, senior trial paralegal Susan Hardman, and legal assistant Lisa Gibbons.
A three-day damages trial was held in person in Georgetown, Delaware in January 2023 and followed by extensive post-trial briefing. Paul presented the final oral argument in May 2023. The Court’s opinion, issued September 5, 2022, adopted AbbVie’s economic model of damages almost wholesale, asking for minor adjustments that brought the final verdict to $448 million, plus pre- and post-judgment interest at Delaware’s legal rate. The parties’ negotiated interest payment, struck in exchange for Takeda’s waiver of appeal, brings the final total judgment to at least $489 million.