By Kurt R. Karst –
On January 24th, the U.S. Court of Appeals for the Ninth Circuit issued its decision in Gaeta v. Perrigo, reversing a decision from the U.S. District Court for the Northern District of California (San Jose Division) that Plaintiff-Appellant Gaeta’s state law causes of action were preempted by the FDC Act to the extent that they allowed for liability based on a lack of adequate warning on Perrigo’s Over-the-Counter (“OTC”) ibuprofen drug product. With its decision, the Ninth Circuit joins the Fifth and Eighth Circuits, which ruled in Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) and Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), that the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine “extends with equal force to claims against generic manufacturers.” In Levine, the U.S. Supreme Court ruled, in the context of a brand-name prescription drug, that FDA labeling approval does not preempt state laws. In December 2010, the U.S. Supreme Court decided to hear appeals in both the Mensing and Demahy cases.
By way of background, the decision in Gaeta stems from an alleged injury from consuming OTC ibuprofen that led to a liver transplant and other complications. The Gaetas allege that Perrigo and several other generic ibuprofen manufacturers failed to warn physicians and consumers of an increased risk of acute liver injury and renal failure when ibuprofen is taken with other drug products. As we previously reported, the district court found that Gaeta’s state law causes of action were preempted to the extent that they allowed for liability based on a lack of adequate warning on Perrigo’s drug product. Gaeta had argued that “although the specific facts of Levine involved a brand-name drug, the Court’s holding was broad enough to also encompass the interaction between FDA regulations and state tort law with regard to generic drugs.” The court disagreed, however, ruling that “Levine does not govern whether the Court may grant summary judgment on Plaintiff’s state tort claims,” because “Levine did not address a dispositive issue in this case, namely, whether a generic drug manufacturer may use the [Changes Being Effected (‘CBE’)] process to make warning-label changes without prior FDA approval.”
In reversing the district court’s decision, the Ninth Circuit rejected both of Perrigo’s conflict preemption arguments – that the Gaetas’ claims are conflict preempted because (1) “it is impossible for Perrigo to comply with both the state-law duties to warn and the federal regulatory regime governing generic drugs,” and, alternatively, (2) “they obstruct the full accomplishment of the purposes and objectives of Congress in enacting the Hatch-Waxman Amendments.”
The Ninth Circuit’s decision that there is no impossibility of compliance in this case (as in Demahy and Mensing) is based on the Court’s determination that the FDC Act provides generic drug manufacturers “with at least three separate mechanisms by which they can discharge their state-law duty to warn of additional risks associated with their products: (a) the CBE process approved by the Supreme Court in Levine; (b) the ‘prior approval’ process; and (c) by asking the FDA to send ‘Dear Doctor’ warning letters to health care professionals.” Interestingly, however, both the U.S. Solicitor General and FDA have recently stated in amicus briefs (here and here) that although FDA may coordinate appropriate Dear Health Care Professional letters or take other action with respect to labeling, the CBE and prior approval supplement processes are not available to generic drug sponsors.
The Ninth Circuit also joined the Fifth and Eighth Circuits in ruling that there is no obstruction of purpose of the Hatch-Waxman Amendments in exposing generic drug manufacturers to liability. “We join those two circuits in concluding that while the Hatch-Waxman Amendments were meant to provide an inexpensive and easy way for generic drugs to enter the market, they were not intended as a relief from the fundamental requirement of the FDCA that all marketed drugs remain safe,” says the Circuit Court. Moreover, according to the Court, “Perrigo’s argument that consumers will lose confidence in generic drugs if they contain warnings different from those of the brand name drugs also fails” for three reasons. “First, it is purely speculative that consumers will opt for a more expensive brand name product . . . if the less expensive generic product contains additional warnings.” Second, “there is no indication Congress intended consumers to have access to low cost drugs at the expense of safety.” Third, “by using the ‘prior approval’ process,” which we note once again FDA has said is not available to generic drug sponsors, “a generic manufacturer can avoid consumer confusion because, if the FDA accepts the proposed change, that change would be imposed uniformly on both generic and brand name manufacturers.”