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Drugmaker May Be Liable for Generic Pill Label Info

(CN) - A child who needed a liver transplant after taking generic ibuprofen and going into organ failure can pursue failure-to-warn claims under state law against the drug manufacturer, the 9th Circuit ruled on Monday.

With the ruling the federal appeals court in San Francisco becomes the third circuit to apply the 2009 U.S. Supreme Court decision Wyeth v. Levine to both name-brand drug manufacturers and those who make and sell the cheaper generic versions.

The high court determined in Levine that approval of medication by the Federal Drug Administration does not preempt or shield a manufacturer of brand-name medications from liability under state law. Since the 2009 ruling, two courts of appeals - the 5th and the 8th Circuits - have applied it to generic drugs as well.

After A.G., a minor child, had two benign moles removed in 2004, his doctor gave him a prescription for ibuprofen for the pain. His parents, the Gaetas, bought an over-the-counter generic ibuprofen manufactured by Perrigo Pharmaceuticals. Later, A.G. developed a high fever and had to be rushed to the hospital and treated for liver failure. A.G. needed a liver transplant less than two weeks after the mole surgery and later had dead tissue from his fingers and toes amputated. Doctors determined that the ibuprofen had clashed with the anesthetic Halothane, which had been administered during the mole-removal surgery. Halothane is hepatotoxic or known to cause liver failure in some circumstances, according to the ruling.

The Gaetas sued Perrigo and other manufacturers of generic ibuprofen, alleging defective design, defective marketing, breach of express and implied warranty, negligence and gross negligence, and deceit by concealment. The family claimed that Perrigo had failed to warn doctors and consumers that ibuprofen could cause liver injury if mixed with other drugs.

Perrigo argued that the Gaetas' state-law failure-to-warn claims were preempted by the FDA's labeling and marketing regulations governing generic drugs. The district court agreed, concluding that since federal law required generic drugmakers to conform to the approved labeling of brand-name drugs, Perrigo could not have changed its labeling without violating federal law.

While the Gaetas' appeal was pending, the U.S. Supreme Court issued its opinion on Levine, and the family won a limited remand from the 9th Circuit so that the district court could reconsider its decision with the Supreme Court ruling in mind. The district court denied the family's motion for reconsideration, however, and ruled that the high court's decision only applied to brand-name drug manufacturers.

When the Gaetas appealed again, the three-judge panel decided the issue of first impression in favor of the Gaetas and reversed the district court's ruling.

In Levine the high court reasoned that manufacturers are primarily responsible for warning consumers about possible drug dangers because they have better access to information about their products than the FDA has, according to the ruling.

But there is nothing in the decision that limits this responsibility to brand-name drug manufacturers, the panel found.

"Indeed, the regulatory framework makes clear that generic manufacturers, just like their brand name counterparts, must take specific steps when they learn of new risks associated with their products," Judge David Thompson wrote for the panel. "Thus, both sets of manufacturers must record and report to the FDA certain adverse effects."

Thompson added that Perrigo had at least three "mechanisms to warn consumers and health care professionals of the risks associated with using ibuprofen concurrently with other drugs known to be hepatotoxic," including a "prior approval" process that would have applied the generic manufacturer's proposed changes to the drug's warning label to both the name-brand and generic drugs.

Perrigo would not have run afoul of federal regulations if it simply suggested that the FDA send a "Dear Doctor" letter to heath care professionals, warning them of the risks associated with using ibuprofen concurrently with other drugs, the panel found.

"The state-law duty to warn by an appropriate label on the generic ibuprofen drug was not preempted by federal law," the ruling states. "Compliance with both state and federal law was not 'impossible.' Additional warnings would not stand as an obstacle to the accomplishment of purposes and objectives of Congress. Perrigo failed to present clear evidence that the FDA would have rejected the specific hepatotoxicity warnings proposed by the Gaetas."

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