Reviewing Refusal: Lethal Injection, the FDA, and the Courts
Most death row inmates today face execution by lethal injection through a series of compounded lethal drugs. Compounded lethal drugs are mixed by individuals at local shops according to their own specifications and are widely regarded to be less safe than manufactured drugs. These drugs receive little government oversight in their production. Although the Food and Drug Administration (FDA) has statutory authority to regulate compounded lethal drugs, it has consistently refused to do so. Non‐regulation of compounded lethal drugs has contributed to a disturbing series of botched executions. Non‐regulation of compounded lethal drugs also poses profound dangers to the public.
The FDA can refuse to regulate these drugs because the law insulates its inaction from judicial review. While courts regularly conduct arbitrary and capricious review of agency enforcement actions, they are far more reluctant to review agency inaction. In fact, the Supreme Court has created a presumption against judicial review of agency inaction.
The presumption against judicial review seems unreasonable when the stakes are so high for death row inmates and the public at large. Although the presumption against judicial review may be a sound principle generally, the FDA’s refusal to regulate compounded lethal drugs is the kind of agency inaction that one might think necessitates at least some judicial scrutiny.
I therefore propose creating a narrow avenue of judicial review for cases like these. My rule, what I will call “discrete look,” identifies opportunities for judicial review that are sensible and manageable for the courts to engage in, while also keeping these avenues sufficiently narrow to respect the underlying policy rationales of the existing doctrine. Under discrete look, when death row inmates sue the FDA for its failure to regulate compounded lethal drugs, courts can no longer treat the FDA’s inaction as an exercise of unreviewable enforcement discretion.
Trolls & The Preemption Dilemma
Patent trolls account for most patent assertions and are often blamed for the increased costs of patent litigation. Congress and the courts have tried to wrangle the abusive practices of trolls. Through a post‐grant review system, Congress tried to combat the growing litigation costs by streamlining invalidity challenges. The Supreme Court has also tackled the patent‐troll problem in seminal remedy and venue cases, hampering trolls’ ability to get injunctions and use certain venues. Yet the problem persists. Although Congress and federal courts recognize and sometimes try to alleviate the patent‐troll problem, what can states do to protect small‐ and medium‐sized businesses from these pesky trolls? For now, probably nothing. The Federal Circuit, through a preemption analysis influenced by the First Amendment’s Petition Clause, often invalidates state laws that could regulate the problem. Still, states continue to try: most states have passed statutes regulating demand letters asserting patent infringement. These state anti‐patent laws’ goal is to protect companies and consumers from patent trolls. Regardless of whether the current state anti‐patent laws will effectively deter egregious patent‐troll behavior, the Federal Circuit’s current preemption doctrine doesn’t seem to let states promote a legitimate state interest— protecting businesses from bad‐faith behavior so that the businesses can innovate.
But is the Federal Circuit properly reading Supreme Court precedent on preemption and the Petition Clause? Or are they unnecessarily developing a rigid rule to help ex ante patentholder decisionmaking? As this Comment argues, even though the Federal Circuit has improperly morphed the Noerr test into conflict preemption and doesn’t effectively analyze whether Noerr applies to prelitigation communication and non‐antitrust claims, the Federal Circuit’s results aren’t far off. There’s good reason for petition immunity to apply to prelitigation activity, like demand letters, but the analysis should be separate from conflict preemption. It turns out that the Supreme Court’s rigid approach to the sham exception is partly to blame.
This Comment makes three contributions. The first contribution is putting a state anti‐patent law through a full implied‐preemption analysis in accordance with Supreme Court precedent. The second contribution is giving and applying a proper framework to determine whether the Petition Clause applies to prelitigation communication and non‐antitrust claims. The third contribution is suggesting a flexible petitioning‐immunity framework that will leave states room to regulate patent‐troll demand letters.
Should Dissimilar Uses Of Trade Secrets Be Actionable?
Joseph Fishman and Deepa Varadarajan address a critical question in their new article, Similar Secrets: should trade secret law prohibit substantially dissimilar uses of trade secret information by those who took that information through improper means or in violation of a duty of confidentiality to the information’s owner, particularly when those dissimilar uses result in innovative new pursuits of high social value? Under current doctrine such an action would likely lead to a viable claim of trade secret misappropriation. But should this type of “retooling” really be discouraged by trade secret law?
This Response shows that the article’s thesis—that trade secret law should imitate copyright law’s willingness to permit substantially dissimilar uses of content—conflicts with trade secret law’s fundamental purpose: to protect the integrity of secret information. Whereas Fishman and Varadarajan have turned to copyright law for help, it makes more sense to focus on improving the doctrines we already have. Improving existing doctrines will do more to ameliorate concerns about hindering innovative new uses, while maintaining trade secret law’s fundamental goals.