Wednesday, January 26, 2011

While We Wait On Mensing, Another Circuit Shoots Down Generic Preemption

We’re all curious to see what the Supreme Court does with the generic prescription drug manufacturers’ preemption defense in Actavis Elizabeth, LLC v. Mensing, which is scheduled for argument on March 30. In the meantime, the Ninth Circuit has weighed in on the issue, aligning with the Fifth Circuit and the Eighth Circuit and rejecting the generics’ preemption defense.

The case was filed by the guardians of a child who developed liver complications after taking OTC ibuprofen. See Gaeta v. Perrigo Pharms. Co., __ F.3d __, 2011 WL 198420, at *1 (9th Cir. Jan. 24, 2011). The Gaetas claimed that Perrigo should have warned of the increased risk of liver injury and renal failure when ibuprofen is taken concurrently with other hepatotoxic drugs. Id. The district court held, pre­-Wyeth v. Levine, that the conflict preemption doctrine barred failure to warn claims against Perrigo. Id. at *2. Even after Levine, the district court stuck to its guns and denied the plaintiffs' motion for reconsideration. Id.

The Ninth Circuit reversed, acknowledging that the Supreme Court’s Levine decision does not control the issue, but “does foreshadow a similar disposition” with respect to the preemption defense in both the brand name and generic contexts. Id. at *4. In quick order, the Ninth Circuit surveyed the state of the law, found that every post-Levine decision agreed there was no generic preemption (other than the Gaeta district court), and rejected Perrigo’s conflict preemption arguments:

(1) It was not impossible for Perrigo to comply both with state-law warning duties and FDA regulations. Perrigo could have provided additional warnings through a “changes being effected” (CBE” ) label change, requested a label change through the “prior approval” process, or requested FDA to send “Dear Doctor” letters to health care professionals. Id. at *5-8.

(2) There was no “clear evidence” that FDA considered and rejected stronger warnings. Although FDA in 2002 and 2006 considered additional hepatotoxicity warnings relating to ibuprofen, “[n]owhere does Perrigo point to any evidence that the FDA was presented with and actually considered the risk of hepatotoxicity due to concomitant use of ibuprofen and other drugs known to be hepatotoxic, which is the specific warning requested by the Gaetas in this case.” Id. at *10.

(3) Allowing state-law warning claims to proceed would not frustrate the purposes and objectives of FDA’s regulatory scheme. Although Perrigo argued that expanding liability would force generics out of business and remove low-cost drugs from the market, the court found that Congress’s goal of delivering low-cost drugs did not supplant the FDCA’s overarching goal of ensuring the safety and efficacy of those drugs. Id. at *11. The court also found it “speculative” to assume that “consumers will lose confidence in generic drugs if they contain warings different from those of the brand name drugs.” Id. at *12.

We’ll have to wait a few more months to see if the Supreme Court agrees with the Gaeta court’s decision or its underlying rationales, but in the meantime, add the Ninth Circuit to the roster of courts rejecting genericss’ preemption defense.

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