A month ago, when the nation’s attention was affixed on the Trayvon Martin case, the Supreme Court issued a ruling in a little noticed case. Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett came and went without much notice in the background of a national debate about race, replete with hyperbole on both sides. It shouldn’t have been that way, because the case is ultimately more important than any shooting in Florida. It holds implications for the safety of every generic drug consumed in the United States.
Karen L. Bartlett
In 2004, Karen L. Bartlett, a New Hampshire resident, was dealing with shoulder pain. Her doctor prescribed Clinoril, and her pharmacist dispensed the generic version of Clinoril (sulindac) manufactured by Mutual Pharmaceutical. Bartlett developed toxic epidermal necrosis, a flesh-eating condition, and she was left permanently disabled, disfigured, and blind. Bartlett did what most people would do: she sued Mutual Pharmaceutical. Mutual successfully petitioned to remove the case from New Hampshire state court to federal court. In federal court, a jury found Mutual liable, and awarded Bartlett over $21 million.
Not surprisingly, Mutual appealed, only to have the First Circuit affirm the jury’s finding and award. Mutual then petitioned the Supreme Court for certiorari, which was granted. In a 5-4 decision, the Supreme Court overturned the First Circuit and the lower court. Their grounds for doing so were chilling.
Samuel Alito Gives a Reason without Reason.
In prior cases, the Supreme Court had held that state law was superseded by federal law under the Supremacy Clause of the United States Constitution, which is by itself a non-controversial idea. The plain language of the Constitution expressly pre-empts state laws that conflict with federal law, where the federal government has jurisdiction over the subject matter in question.
New Hampshire’s design-defect cause of action factors in whether or not the risk of danger as it relates to a product could be reduced without affecting the product’s effectiveness or cost. It also considers whether or not the presence of a warning would result in the lessening or avoidance of risk from hidden dangers or foreseeable uses. If a manufacturer could have reduced the risk of danger without affecting effectiveness or cost, then the manufacturer’s failure to take action will give rise to liability under the design-defect cause of action.
Justice Alito chose to interpret this as a mandate from the state of New Hampshire requiring drug manufacturers to change the formula of their drugs, or to slap warnings on the labels of their prescriptions. As such, he rejected New Hampshire’s design-defect cause of action, and its affirmative duty requirement for manufacturers to “design [their products] reasonably safely for the uses which [they] can foresee.” The problem is simple: New Hampshire’s design-defect cause of action requires no such action at all. It simply says that if you want to avoid liability for the defective design of your product, you can lessen or eliminate your liability by designing the product to be reasonably safe for the foreseeable uses.
If you don’t want to avoid liability, you can simply choose to pay the costs of manufacturing an unsafe product that is unsafe by its very design. If you want to avoid liability, you can stop manufacturing the drug, or avoid marketing it in jurisdictions that impose liability for the manufacture of defective drugs.
For Justice Alito, however, the mere imposition of liability for damage done by a defective product constitutes an affirmative requirement on drug manufacturers to either reformulate their drug, or re-label it. As such, the state law that imposes such liability and the affirmative requirement he perceives is in direct conflict with the Federal Food, Drug, and Cosmetic Act’s (FCDA) prohibition on major changes to the formulation of a drug after its approval by the FDA. The FCDA also bars unilateral changes to a drug’s labeling from the brand name to generic versions.
Justice Alito takes this to mean that if a drug causes flesh-eating toxic epidermal necrosis, and a state law imposes liability for the design defect thereof if manufacturers don’t take steps to make their product reasonably safe for the foreseeable use of that drug, then the state law is a challenge to federal law and must be preempted. Under Alito’s reasoning, the FCDA is transformed from legislation designed to keep Americans safe from defective drugs that will cause harm when used as directed into a law designed to remove liability from the manufacturers of those drugs when those drugs cause harm. Mutual Pharmaceutical could have chosen not to market its drug in New Hampshire in order to avoid liability under New Hampshire’s design-defect cause of action, but Justice Alito also rejects this option and comes to the conclusion that Mutual was under no obligation to cease acting altogether.
Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacture from independently changing their drugs’ labels. Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.” Maryland v. Louisiana, 451 U. S. 725, 746 (1981).
If Mutual changed its the label of sulindac to avoid liability under New Hampshire’s design-defect cause of action, it would be in violation of the FCDA’s express requirement that generic drug manufacturers keep their labels the same as those of the brand name version of the drug in question. As such, the FCDA should be taken to prohibit actions that would increase consumer safety and negate liability for design defects under state law. The absurdity of Alito’s reasoning is obvious: a federal law intended to promote consumer safety and protection from unsafe drugs pre-empts state laws designed to do the same thing by providing an incentive in the form of reduced civil liability.
Alito further concludes that New Hampshire’s design-defect cause of action would require Mutual to redesign sulindac’s molecular formula, which would also require Mutual to violate federal prohibitions against altering the generic drug’s molecular structure in a way that departs from the brand name version.
In the present case, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based. 21 U. S. C. §§ 355(j)(2)(A)(ii)-(v) and (8)(B); 21 CFR § 320.1(c). Consequently, the Court of Appeals was correct to recognize that “Mutual cannot legally make sulindac in another composition.” 678 F. 3d, at 37. Indeed, [*8] were Mutual to change the composition of its sulindac, the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce. See 21 CFR § 310.3(h) (giving examples of when the FDA considers a drug to be new, including cases involving “newness for drug use of any substance which composes such drug, in whole or in part”). Second, because of sulindac’s simple composition, the drug is chemically incapable of being redesigned. See 678 F. 3d, at 37 (“Mutual cannot legally make sulindac in another composition (nor it is apparent how it could alter a one-molecule drug anyway)”).
The drug is so simple it can’t be redesigned! That means that even though it’s dangerous, and causes flesh-eating toxic epidermal necrosis when used as directed, Mutual shouldn’t have to redesign it in order to avoid liability under New Hampshire’s design-defect cause of action. No, Mutual should be able to keep the deadly design the same as it’s always been, because a federal law intended to keep deadly drugs from harming consumers bars Mutual from altering the content of its deadly drug.
This is a Yale Law School education in action, ladies and gentlemen. That stellar bit of reasoning, vacuous as it is, is what passes for jurisprudence these days at the Supreme Court. The justices of the Supreme Court are widely hailed as the finest legal minds around, and the sophistry of the above quote should not lessen your opinion of our highest court or its present justices.
The absurdity of Alito’s reasoning is made even more obvious by two very simple realities: existing precedent relating to the FDA outlines Congress’s preservation of state law even as the FDA’s powers were expanded. In 1962, when Congress established the FDA’s premarketing review via amendments to the FCDA, a saving clause was included. The clause explicitly stated that absent “a direct and positive conflict” between state and federal law, the amendments should not be construed to invalidate state law.
The historical trend has been for the FCDA to work in tandem with state law, as opposed to overriding and eroding state law when consumer safety is the end goal of both the federal and state laws in question. There is no direct and positive conflict between New Hampshire’s imposition of liability for a defective product’s damage, and the FCDA’s requirement that generic manufacturers keep their drug’s content and labeling consistent with its brand name counterpart. The FCDA’s requirement is not intended to erode state efforts to incentivize consumer safety by imposing strict liability for injuries caused by defective drugs or products.
In fact, since the FCDA contains no federal cause of action for damages from defective or unsafe drugs, it is rather obvious that Congress did not intend to replace state causes of action. Yet Justice Alito gives us a reasoning that is void of reason, in an opinion that effectively destroys state causes of action and thereby eliminates the possibility of a state level cause of action for consumers harmed by unsafe drugs. If the state cause of action could be read as incentivizing any change in labeling or formulation by drug companies, Justice Alito would have us believe that such incentives would constitute a command by states to drug companies to violate federal law.
This is in spite of the fact that any manufacturer could go to the FDA and apply for approval on a reformulated drug that would be safe, or simply stop making an unsafe drug that could not be reformulated into a safer version. Either of these options is reasonable, and perfectly consistent with existing law, but Justice Alito interprets the FCDA as a catalyst for the continued manufacture of unsafe drugs rather than a prohibition or impediment to such drugs.
The incoherence of Alito’s reasoning is astounding to behold. A federal law designed to protect consumers from unsafe drugs has been reinterpreted by its letter to violate its spirit. The Supremacy Clause of the United States Constitution, intended to preserve the federal government’s enumerated powers from challenge by states, has been re-interpreted to eliminate the states’ legitimate power to protect their citizens and afford them a means of legal redress from unsafe or defective products. Since the federal law in question contains no cause of action, those citizens could not sue in federal court under a federal cause of action.
Put simply, Alito’s opinion, which is the law of the land, eviscerated any attempt at the state level to impose liability for defective drugs. A drug company can simply say that the incentive to avoid liability by re-designing a drug to be safe, or providing a warning on the label to make consumers aware, constitutes a state command to violate the FCDA. As such, the state level cause of action must give way to the FCDA under the Supremacy Clause.
If this is so, then the FCDA is no longer a law to protect consumers from unsafe drugs. It is instead the very means by which consumers are exposed to unsafe drugs, and stripped of any legal means to sue for damages. While you were staring at the dead black kid and the white man who killed him, your Supreme Court did this.
Jay Batman is a graduate of the Texas Tech University School of Law, where he attained his J.D. in May 2013. He completed a B.A. in English with a minor in Political Science at the University of Montevallo in 2002. He is employed with Dustin Stockton Political Strategies, LLC, and presently resides in West Texas with his dog and co-author, Buddy Love
