The U.S. Supreme Court ruled that generic-drug companies, unliketheir brand-name rivals, can't be sued for failing to warn patientsabout the risk of dangerous side effects.

The 5-4 ruling bars two women from suing units of Mylan Inc. andTeva Pharmaceutical Industries Ltd. over metoclopramide, a stomachdrug they say caused them to contract a severe neurologicaldisorder.

The decision limits the reach of a 2009 Supreme Court rulingthat required brand-name drugmakers to defend againstfailure-to-warn suits filed under state product liability law.Generic drug companies successfully argued that they shouldn't beheld to the same standard because federal law requires them to copythe packaging inserts used by brand-name manufacturers.

“If the manufacturers had independently changed their labels tosatisfy their state-law duty, they would have violated federallaw,” Justice Clarence Thomas wrote for the court.

The ruling divided the court along familiar lines, with ChiefJustice John Roberts and Justices Antonin Scalia, Anthony Kennedyand Samuel Alito joining Thomas in the majority.

Patient advocates argued that a decision shielding generic-drugcompanies would leave many injured people with little recourse.Generic drugs are used to fill 75 percent of U.S. prescriptions,according to the lawyers pressing the suit.

'Makes Little Sense'
Thomas said the court recognized that it “makes little sense” tobar suits against generic-drug makers while allowing cases againstbrand-name drugmakers. Mensing and Demahy would have been able tosue had they taken Reglan, the brand-name version ofmetoclopramide, he said.

“We acknowledge the unfortunate hand that federal drugregulation has dealt Mensing, Demahy and others similarlysituated,” Thomas wrote. “But it is not this court's task to decidewhether the statutory scheme established by Congress is unusual oreven bizarre.”

The ruling leaves open the possibility that the Food and DrugAdministration could change its regulations in a way that wouldopen generic-drug companies to suits. Thomas's opinion relied onthe agency's interpretation of its rules as barring those companiesfrom unilaterally changing their warnings.

“As always, Congress and the FDA retain the authority to changethe law and regulations if they so desire,” Thomas wrote.

'Absurd Consequences'
In dissent, JusticeSonia Sotomayor said the ruling “leads to so many absurdconsequences that I cannot fathom that Congress would have intendedto preempt state law in these cases.”

She said the ruling “could have troubling consequences for drugsafety” by eliminating “the traditional state-law incentives forgeneric manufacturers to monitor and disclose safety risks.”

Justices Ruth Bader Ginsburg, Stephen Breyer and Elena Kaganjoined Sotomayor in dissent.

The ruling “creates an absolutely untenable distinction in thelaw between name-brand and generic drugs,” said Louis Bograd, whoargued the case on behalf of the women. “Three out of four patientsin America have just lost the right to sue for inadequatewarnings.”

Bograd, a lawyer with the Center for Constitutional Litigationin Washington, said that in some states patients who sufferinjuries stemming from generic drugs may be able to sue thebrand-name company that manufactured the original medicine. He said1,000 lawsuits are pending over metoclopramide alone.

'Nail on the Head'
Mensing was suing privately held Actavis Group as well as units ofCanonsburg, Pennsylvania-based Mylan and Petah Tikva, Israel-basedTeva. Demahy was suing an Actavis unit.

Teva's lawyer, Jay Lefkowitz of Kirkland & Ellis LLP inWashington, said the court “hit the nail on the head today bymaking clear that federal law does not permit states to holdgeneric-drug manufacturers liable for using the very warningsfederal law required of them.”

Actavis's chief executive officer, Doug Boothe, said the ruling“furthers meaningful consumer protection while also safeguardingagainst lawsuits that threaten the availability of safe andaffordable pharmaceutical products by misconstruing the labelingresponsibilities of generic manufacturers.”

The cases are Pliva v. Mensing, 09-993; Actavis Elizabeth v.Mensing, 09-1039; and Actavis v. Demahy, 09-1501.

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