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

November 13, 2008

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. 

Categories: Miscellaneous