Event Driven Takeaways
- Akorn and Fresenius are required to file their pretrial briefs by 7 p.m. ET on Thursday, July 5. The pretrial briefs are expected to outline the legal strategy that both parties will use during the July 9 trial.
- To prevail, Fresenius will need to show that the severity of Akorn’s data-integrity violations and noncompliance with FDA’s Current Good Manufacturing Practices requirements materially threaten Akorn’s business operations and future earnings potential.
- A total of 68% of FDA warning letters issued in CY2017 included a data integrity component. Moreover, approximately 80% of all warning letters in 2015 and 2016 include a data integrity component.
- The fact that data integrity issues are an industry-wide phenomenon is significant. At a recent hearing, Judge Travis Laster concluded that a “similar magnitude of problems” or “similar types of problems” at Fresenius and other companies would be key to determining whether these data integrity issues will have a “durational significance” in terms of substantially affecting Akorn’s revenues.
According to the latest schedule set by the Delaware Chancery Court, both Akorn and Fresenius are required to file their pretrial briefs by 7 p.m. ET on Thursday, July 5. The pre-trial briefs are expected to outline the legal strategy that both parties will adopt during the four-and-a-half day trial that begins on July 9. As Event Driven analyzed previously (HERE and