Akorn, Inc. (AKRX) FDA Violations Results in Termination of Acquisition And Remediation Costs of $900 Million
According to the complaint against the company’s officers and directors for breaches of fiduciary duty from 2014 through the present, on April 24, 2017, Fresenius SE Co. KGaA (“Fresenius”) agreed to acquire Akorn, Inc. (AKRX) in a deal valued at $4.3 billion. While conducting due diligence prior to the merger, Fresenius received three letters from whistleblowers alleging that Akorn’s research and development facilities were significantly flawed and incomplete. When Akorn sued Fresenius to close the deal, the court ruled in favor of Fresenius, finding that Akorn “did not have a well-functioning quality system and lacked a meaningful culture of compliance.” On December 7, 2018, Delaware’s Supreme Court upheld the milestone finding, noting that Fresenius’ termination of the deal was justified based on Akorn’s post-signing financial decline as well as intentional misconduct and regulatory violations, which include fabricated data in reports to the FDA. Since the truth was revealed, Akorn’s market capitalization has plunged from $4.3 billion when the merger was executed to only $720 million, and the company will need to pay an estimated $900 million to remediate its serious regulatory issues.
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