FDA Approval of Drugs and Devices: Preemption of State Laws for “Parallel” Tort Claims

The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label—does preempt state law as to claims that challenge the warnings that accompany generic drugs. In each of these cases, the underlying issue has been whether the federal regulatory process leading to FDA approval of drugs and medical devices “preempt” state laws as to the safety issues addressed through the approval process. Thus, to summarize the applicable law prior to Bartlett, the Court had upheld failure-to-warn claims against the brand (preemption denied) but denied failure-to-warn claims against the generic (preemption upheld); the Court has also denied device manufacturers’ liability for most product liability-related claims (preemption upheld) pursuant to a specific statutory provision. By a vote of 5-4, Bartlett has now denied liability of generic manufacturers on the basis of design-defect. Following the Supreme Court opinion, however, the FDA set forth its agenda, which includes proposing a rule that would allow generic drug makers to revise their drug labels. If created and adopted, this rule could again alter the landscape of liability for generic manufacturers. Further, the related issue (which is still unresolved by the high court and is the subject of a split among the circuit courts) is whether FDA approval of medical devices preempts all state law actions, thus insulating device manufacturers from product liability claims under all circumstances. This Article will address each of these issues, as well as the related issue of whether off-label use of FDA-approved medical devices give rise to liability

Prescription Data Mining, Medical Privacy and the First Amendment: The U.S. Supreme Court in Sorrell v. IMS Health Inc.

In 2011, the United States Supreme Court in Sorrell v. IMS Health Inc. struck down a Vermont law that would restrict the ability of pharmaceutical companies to purchase certain physician-identifiable prescription data without the consent of the prescriber. The law\u27s stated purpose was threefold: to protect the privacy of medical information, to protect the public health and to contain healthcare costs by promoting Vermont\u27s preference in having physicians prescribe more generic drugs. The issue before the Supreme Court was whether the Vermont law represented a legitimate, common sense regulatory program or a bold attempt to suppress commercial speech when the message is disfavored by the state. Striking down the law, the Supreme Court applied a heightened level of First Amendment scrutiny to this commercial transaction and held that the Vermont law was not narrowly tailored to protect legitimate privacy interests

Prescription Data Mining, Medical Privacy and the First Amendment: The U.S. Supreme Court in Sorrell v. IMS Health Inc.

In 2011, the United States Supreme Court in Sorrell v. IMS Health Inc. struck down a Vermont law that would restrict the ability of pharmaceutical companies to purchase certain physician-identifiable prescription data without the consent of the prescriber. The law\u27s stated purpose was threefold: to protect the privacy of medical information, to protect the public health and to contain healthcare costs by promoting Vermont\u27s preference in having physicians prescribe more generic drugs. The issue before the Supreme Court was whether the Vermont law represented a legitimate, common sense regulatory program or a bold attempt to suppress commercial speech when the message is disfavored by the state. Striking down the law, the Supreme Court applied a heightened level of First Amendment scrutiny to this commercial transaction and held that the Vermont law was not narrowly tailored to protect legitimate privacy interests