In a recent decision by a Florida federal judge, Abilify maker Otsuka Pharmaceuticals was absolved of responsibility to preserve company e-mails that might have served as evidence for plaintiffs in current Abilify litigation. The reason: the emails were written years ago, long before the company could reasonably have anticipated having to defend itself against lawsuits.
In 2007, company policy required that emails be preserved no longer than 60 days. According to plaintiffs, Otsuka's failure to retain those email records constituted “spoliation” of evidence – in other words, those seeking damages had reason to believe that Otsuka had willfully destroyed proof of their knowledge of Abilify's possible side effects.
They asked the judge to impose sanctions on the defendant, which typically takes the form of a monetary fine. Plaintiffs counsel cited Federal Rule of Civil Procedure 37(e), which specifically deals with the preservation of electronic data and documents. This part of the law allows the Court to take action when a party to a lawsuit fails to preserve electronic information if all of four conditions are present:
- it should have been preserved in anticipation of a lawsuit
- the party failed to take reasonable steps to safeguard the data
- it cannot be restored or retrieved
- the data cannot be recreated or replaced
If all four elements can be demonstrated and proven, the affected party is legally considered to have had a duty to preserve the data in question.
Attorneys for the defense focused on that rule. They successfully argued that 12 to 16 years ago Otsuka could not have reasonably foreseen being sued over Abilify, citing an earlier case in which the 11th Circuit Court ruled that no such duty exists unless and until “litigation is pending or reasonably foreseeable.”
It is worth noting that Otsuka's U.S. partner, Bristol-Meyer Squibb, is a corporate recidivist. In 2007, the company paid $515 million to the Department of Justice in order to resolve a number of allegations over its behavior between 2000 and 2005. This behavior included illegal payments to physicians, price gouging, and most significantly, the marketing and promotion of Abilify for unapproved, “off-label” purposes.
However, according to the judge, this settlement was irrelevant to current litigation, as it did not involve the side effects of Abilify that include a range of compulsive behaviors. There were also concerns raised about early studies suggesting a link between the use of atypical antipsychotics (the class of medications to which Abilify belongs) and obsessive and compulsive behaviors. The Court nonetheless ruled that neither of those elements gave Otsuka reason to believe they would be sued over its product.
This ruling does not mean that Otsuka and Bristol-Meyer Squibb are off the hook – only that they will not be suffering any penalties for failure to save potentially pertinent email communications. There is still the matter of why the drugmaker issued warnings about compulsive behaviors as a possible side effect of using Abilify in the European Union in 2012 and Canada in 2015, while no such warnings were given in the U.S. until 2016.
Between 2005 and 2013, the F.D.A. received well over 100 adverse event reports on Abilify, half of which involved compulsive gambling. This is an indication that if Otsuka was unaware of these side effects, they most certainly should have been.