Writing a prescription is generally considered a private activity between doctor and patient. Well, sort of. Although the medical record listing a patient’s medications is protected by the full force of the Health Insurance Portability & Accountability Act (HIPAA) and other laws, several loopholes allow for some exposure of this data. In particular, I am referring to the situation in which pharmacies sell prescription information to data mining companies that aggregate the data collected on individual physicians and then sell it to interested parties, such as pharmaceutical manufacturers. The loop is completed when manufacturers’ representatives are provided with this information to refine their marketing practices focusing on a particular doctor.10 Undoubtedly, most physicians applauded the Vermont Prescription Confidentiality Law requiring that prescriber-identifying information could not be sold without the prescriber’s consent.
Aren’t these data akin to intellectual property owned by the prescriber? Apparently not. The Court ruled that the law infringed on the free speech rights of detailers engaged in marketing on behalf of pharmaceutical manufacturers.11 Chalk this victory up to the business of medicine.
The federalism doctrine, which refers to the constitutional distribution of powers between the federal and state governments, has long played an important role in public health.11 Congress possesses broad constitutional authority to advance population health. At the same time, states also engage in extensive health and welfare regulation, often in ways that overlap with federal law, frequently supplementing federal safeguards. For example, federal law establishes standards for preventing unsafe products from entering the market, and state laws may add remedies for people who are injured by unsafe products. In effect, state laws expand on federal standards, creating individual protections that complement federal regulations.
At times, federal statutes preempt state laws aimed at permitting individuals to seek judicial redress for injuries caused by negligence. These federal statutes expressly bar states from providing additional remedies not recognized under federal law, a concept known as preemption.11
In 2000, a Vermonter named Diana Levine sought treatment for her severe headaches and nausea.11 She was treated with an intravenous bolus of the anti-nausea drug, Phenergan, which can, rarely, cause direct vascular damage when injected. Unfortunately, the patient developed gangrene, requiring a right forearm amputation. She was awarded $7.4 million in damages, but the drug’s manufacturer, Wyeth, appealed the verdict claiming that Vermont courts erred by assuming they had the legal obligation to issue a more strongly worded warning label. They argued that labeling issues fall under the jurisdiction of federal agencies, in this case the Food and Drug Administration, and thus they lacked the authority to make these changes. In this case, common sense prevailed—after all, post-marketing information regarding adverse effects is critical. Turning a blind eye to the findings can be harmful to a patient’s health and to a manufacturer’s finances.
