Missing After Mensing: A Remedy for Generic Drug Consumers

IntroductionDrug manufacturers spend billions of dollars every year researching and developing new drugs.1 To recoup the invested money, these companies aggressively market their brand name drugs to doctors and patients direcdy.2 New drugs typically enjoy a twenty-year patent, during which the patent holder has the exclusive right to manufacture and market their brand name drug.3 After the patent expires, however, competing manufacturers often create generic duplicates of the drugs and sell them at a much lower price.4 If a generic drug manufacturer can prove that its drug is effectively identical in substance and labeling to the brand name drug, then the U.S. Food and Drug Administration (FDA)-the sole regulatory body responsible for ensuring the safety and efficacy of pharmaceutical drugs on the market-will allow the generic manufacturer to forego the rigorous clinical testing required of the brand name drug.5Largely due to generic substitution laws, generic drugs account for the vast majority of drugs consumed.6 Every state has some form of generic substitution law that allows (and in some instances requires) pharmacists to fill prescriptions with a cheaper generic drug unless the doctor specifically requests the brand name drug.7 As a result, even though many doctors prescribe the brand name drug with which they are familiar,8 approximately seventy-five percent of prescriptions are filled with generics.9The FDA requires new drugs to undergo extensive clinical testing before they can be marketed.10 Nonetheless, plaintiffs sometimes bring claims that the labeling of a drug provided inadequate warning of the drug's known or foreseeable risks.* 11 When the plaintiff consumed a brand name drug, that plaintiff successfully can sue the brand name manufacturer who created the drug's warning label.12 But what happens to the seventy-five percent of prescriptions filled with a generic equivalent-a product manufactured by a different company but using the inadequate warning label created by the brand name manufacturer?13On June 23, 2011, the U.S. Supreme Court held in PLIVA, Inc. v. Mensing (Mensing III) that FDA regulations preempted state tort law failure-to-warn claims against generic manufacturers.14 As a result, the decision effectively foreclosed suits against generic manufacturers because the Supreme Court stated that FDA regulations made it impossible for a generic manufacturer to enhance its warning label unilaterally.15 The Court noted that even if a generic manufacturer notified the FDA of its drug's risks, it could not fulfill its state law duties unless it actually enhanced its label-an action which federal regulations prohibit.16 Moreover, it is unclear whether these plaintiffs can sue the brand name manufacturers for the inadequate warnings.17 The majority of courts to address this issue have held that generic consumers cannot successfully sue brand name manufacturers.18 Consequendy, patients who consume generic drugs appear to be without a remedy if they are harmed by inadequate warning labels.19This Note argues that the FDA should rewrite its regulations to allow all manufacturers unilaterally to enhance their labeling, and thus allow all manufacturers to be subject to state failure-to-warn claims.20 Part I explains the FDA's regulatory scheme and the differences between pre-market and post-market safety risk identification.21 Part II examines how two recent Supreme Court cases interpreting FDA regulations have effectively granted a remedy to brand name consumers, but have foreclosed a remedy for generic consumers.22 Finally, Part III argues that to ensure continued drug innovation and to maintain state law tort principles, the FDA should amend its regulations to allow both brand name and generic manufacturers to be subject to state law liability for failing to provide adequate warning labels.23I. The FDA's Regulatory SchemeThis Part explains the FDA's regulatory scheme designed to ensure the safety and efficacy of drugs. …