Attorney Praises 3rd Circuit Sheller Decision
Attorney James Beck (Reed Smith) says the 3rd Circuit Court of Appeals properly rejected the Sheller law firm’s appeal of a lower court decision saying it lacked standing to sue FDA to compel the agency to approve its citizen petition on Risperdal use in children. Writing in a Drug and Device Law blog post, Beck says that “attempts of this nature to embroil FDA in mass tort prescription medical product litigation are part of the other side’s play book.”
Sheller, which says it represents hundreds of children harmed by taking Risperdal, had petitioned FDA to either revoke the drug’s indication for use in children and adolescents or to require that the drug’s label include a Boxed Warning based on the lack of sufficient data to prove the indication’s safety.
In its suit, the firm claimed that Janssen, Risperdal’s manufacturer, used FDA’s refusal to approve the petition in its defense in the mass tort litigation, thus increasing Sheller’s costs to defend against Janssen’s position.
“Plaintiff chose to file the citizen petition, lost, and thus handed mass tort litigation defendants a weapon they were entitled to use in their own defense,” Beck writes. He also noted the court’s statement that there is no basis to say that a favorable decision in the case would be likely to redress the law firm’s injury.
“Another abusive lawsuit comes to an end, and rightfully so,” Beck concludes. “If FDA is to maintain its status as a neutral third party in prescription medical product liability litigation, then it cannot be subject to lawsuits seeking ‘damages’ for increased litigation costs based on use of contingent fee arrangements. That’s a classic one-way argument available to plaintiffs but not defendants. As the district court recognized, lawyers litigating ‘on an hourly fee basis … would presumably benefit from, not be injured by, the additional effort. Thus, only contingent fee lawyers would be able to threaten FDA in this fashion. This litigation was really an elaborate attempt by the other side to put a thumb on the scale of FDA regulatory actions beyond the ability of their junk science to influence.”