Supreme Court Clarifies Preliminary Injunction Standard; Food and Drug Lawyers Should Take Note

By Kurt R. Karst –      

On November 12, 2008, the U.S. Supreme Court issued its opinion in Winter v. Natural Resources Defense Council, Inc.  The case concerns the Navy’s power to use “mid-frequency active” sonar in military training exercises.  The Court, dividing 6-3 (Chief Justice Roberts wrote for the majority), overturned a federal judge’s order against the Navy’s use of the active sonar. 

Okay . . . so what does this have to do with Food and Drug Law, you ask?  Well, the Court clarified the law regarding the standard for obtaining a preliminary injunction.  And motions seeking a preliminary injunction are commonplace in Food and Drug Law litigation – most notably in Hatch-Waxman litigation. 

According to the Court, a plaintiff seeking a preliminary injunction must meet a four-part test.  He must establish: (1) that he is likely to succeed on the merits; (2) that he is likely to suffer irreparable harm in the absence of preliminary relief; (3) that the balance of equities tips in his favor; and (4) that an injunction is in the public interest.  In this case, the district court and the Ninth Circuit held that when a plaintiff demonstrates a strong likelihood of succeed on the merits, a preliminary injunction may be entered based only on a “possibility” of irreparable harm.  In commenting on this “possibility” standard, the Supreme Court concluded that:

[T]he Ninth Circuit’s “possibility” standard is too lenient.  Our frequently reiterated standard requires plaintiffs seeking preliminary relief to demonstrate that irreparable injury is likely in the absence of an injunction. . . .   Issuing a preliminary injunction based only on a possibility of irreparable harm is inconsistent with our characterization of injunctive relief as an extraordinary remedy that may only be awarded upon a clear showing that the plaintiff is entitled to such relief.

Keep this opinion and the Court’s high “irreparable harm” standard in mind the next time you consider seeking injunctive relief.