Too Good to Last? Will the FDA'S Proposed Rule Put an End to Generic Drug Preemption under Mensing and Bartlett?

By Diab, Tony M. | Defense Counsel Journal, January 2015 | Go to article overview

Too Good to Last? Will the FDA'S Proposed Rule Put an End to Generic Drug Preemption under Mensing and Bartlett?


Diab, Tony M., Defense Counsel Journal


UNDER Mensing and Bartlett, state law generic drug product liability claims sounding in failure to warn are currently preempted. Simply put, because generic drug manufacturers cannot simultaneously comply with federal drug labeling regulations and state failure to warn laws, the state laws give way. A proposed FDA rule, however, may soon put an end to preemption of claims arising out of generic drug labels.

On November 13, 2013, the Food and Drug Administration ("FDA") proposed a rule that would reestablish failure to warn liability for generic drug manufacturers. The proposed rule would allow generic drug manufacturers to participate in the "changes being effected" ("CBE") process, thereby closing the gap between PLTVA, Inc. v. Mensing and Wyeth v. Levine} In Mensing, the Supreme Court held failure to warn claims against generic drug manufacturers preempted as a result of the duty of sameness applicable to generic drug labels based on the abbreviated new drug application ("ANDA") regulations. In essence, generic drug manufacturers are required to use the same language as in the warning labels of the reference listed drug ("RLD") identified by the FDA (generally, the brand-name drug).3 This decision was strengthened by Mutual Pharmaceutical Company v. Bartlett,4 which extended Mensing to cover design defect claims against generic drug manufacturers.

In Wyeth, the Supreme Court found that the CBE process, which allows brand drug manufacturers the ability to unilaterally change a drug's label pending FDA review of a proposed labeling change, precluded a finding of preemption in the context of failure to warn claims.5 The Supreme Court reasoned that brand drug manufacturers were not bound by federal law to promulgate a defective warning label, but rather had the ability to alter a warning label to comply with the state law requirements by using the CBE process.6

The FDA's proposed rule seeks to close the gap between Mensing!Bartlett and Wyeth by including ANDA holders (generic drug manufacturers) in the CBE process - essentially imposing increased obligations on the generic manufacturers. Such a rule, however, may run afoul of the duty of sameness required by the ANDA process as set forth in Hatch-Waxman Amendments,7 and thus lies beyond the power of the FDA. This article analyzes the FDA's attempt to undermine Mensing and Bartlett and whether such an effort is likely to succeed.

I. Wyeth v. Levine

The Supreme Court first reviewed the question of federal preemption of state law failure to warn claims in Wyeth v. Levine.8 There, the question presented was whether state law failure to warn claims were preempted by a drug manufacturer's duty to use only the FDA-approved warning label.9

On April 7, 2000, Diane Levine received an injectable form of Demerol and Phenergan from her physician as treatment for migraine headaches.10 Levine returned for a second treatment that same day, and "[tjhis time, the physician assistant administered the drugs by the IVpush method, and Phenergan entered Levine's artery, either because the needle penetrated an artery directly or because the drug escaped from the vein into surrounding tissue [] where it came in contact with arterial blood."11 Levine's arm became infected and would have to be amputated.12 Levine filed suit against Wyeth, alleging the warning label accompanying Phenergan did not warn of the risks of IVpush administration of Phenergan.13

Prior to trial, Wyeth moved for summary judgment, arguing both express and implied preemption.14 The trial court rejected both arguments, finding that Wyeth had made no effort to strengthen its warnings post-approval, which it was permitted to do under FDA regulations (i.e., the CBE process).15 The evidence presented at trial showed that risks associated with the IV-drip method were substantially lower than that of the IVpush method.16 The evidence also showed that while the Phenergan label warned against use of intra-arterial injection, it "did not contain a specific warning about the risks of IV-push administration. …

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