Judge blocks Massachusetts ban on powerful new painkiller

A federal judge on Tuesday blocked the state of Massachusetts from banning the powerful new painkiller Zohydro, capping a tense back-and-forth between the court and state over a medication whose potency has raised alarm amid increasing reports of prescription drug abuse around the country.

U.S. District Court Judge Rya Zobel issued the preliminary injunction after the drug’s maker, Zogenix, said in a lawsuit that the ban ordered in March by Gov. Deval Patrick was unconstitutional. Patrick had ordered the ban after declaring a public health emergency because of widespread prescription drug abuse in the state. The ban was thought to be the first attempt by a state to block a federally approved drug, according to the National Alliance for Model State Drug Laws.

Judge Zobel said Massachusetts appeared to have overstepped its authority in banning the drug, which had been approved by the U.S. Food and Drug Administration (FDA). He said federal law pre-empted the state's order.

Secretary of Health and Human Services John Polanowicz said the administration would review the judge's ruling.

Zohydro is a narcotic that is especially helpful in treating pain in patients who cannot take acetaminophen. But the state has argued that the drug could ‘‘exacerbate a severe public health crisis’’ because it can be easily crushed, then snorted or injected to create an immediate and potentially lethal high.

Zogenix argued Monday that the medication has already been approved by the FDA. Stephen Hollman, an attorney for the company, suggested that giving states latitude to regulate prescription drugs would erode federal authority.

‘‘Congress intended FDA approvals to have nationwide effect,’’ Hollman said. ‘‘Imagine 50 states each imposing a different formulation requirement ... That’s the too-many-cooks situation.’’

He argued that the Supreme Court has ruled that the FDA establishes a national ‘‘floor’’ for drug regulation. States can impose additional safety restrictions, such as better warning labels, but cannot ‘‘eviscerate the floor established by FDA approval,’’ Hollman said.

Assistant State Attorney General Jo Ann Shotwell Kaplan countered that the Massachusetts ban does not affect the federal approval process or the company’s ability to sell the drug elsewhere in the United States. She said the ban simply represents ‘‘another hurdle’’ the company must surpass in order to market the drug in Massachusetts.

Patrick has said he would lift the ban on Zohydro if the drugmaker developed a more abuse-resistant form.

Al Jazeera and The Associated Press