CHARLESTON, W.Va. (Legal Newsline) - The West Virginia Supreme Court will hear Johnson & Johnson's appeal of a nearly $4.5 million civil penalty imposed on it in a lawsuit brought by state Attorney General Darrell McGraw.
The justices decided in a 3-1 vote on March 10 to examine the $4,475,000 decision from Brooke County. Only Chief Justice Robin Davis voted against hearing the appeal, while Justice Margaret Workman did not participate.
Justice Thomas McHugh was disqualified from the vote, and Mercer County Judge Omar Aboulhosn replaced him.
McGraw filed the case in 2004, alleging Johnson & Johnson's subsidiary Janssen Pharmaceutica made misleading statements about the antipsychotic drug Risperdal and pain patch Duragesic.
A penalty of $5,000 was assessed by the court in each instance the company delivered promotional materials personally to a state doctor and $500 for each time they were delivered by letter or brochure.
The court noted in its order, "The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however . . . the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale."
The order also said, "The wording of (the defendants') November 2003 Risperdal letter was intentionally constructed to modify the FDA's warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients."
The Washington Legal Foundation has come to the defense of Janssen, filing a brief with the Supreme Court urging it to hear the case. It also plans to file a merits brief.
"(T)he circuit court ignored First Amendment case law that requires heightened First Amendment scrutiny when the speech being regulated touches upon matters of public concern," WLF's brief said.
"The circuit court's determination that Janssen's statements did not involve matters of public concern cannot survive the 'red face' test. WLF can think of few matters of greater public concern than the issues addressed by Janssen's statements: the safety and effectiveness of FDA-approved drugs.
"An appeal is warranted to determine whether, as Janssen contends, the First Amendment permits the imposition of financial penalties only after a court has determined both that the statements in question were false or misleading and that Janssen acted in reckless disregard for the truth of the statements."
From Legal Newsline: Reach John O'Brien by e-mail at firstname.lastname@example.org.