In this case, Jennifer Lacognata had been diagnosed with vitamin A deficiency and subsequently prescribed an injectable drug called Aquasol A that is made by Hospira. But shortly afterwards, she was unable to obtain the medicine because Hospira HSP) has had numerous manufacturing problems, which has prompted some Wall Street analysts to speculate the FDA may issue a consent decree (read this).
In filing her lawsuit, Lacognata, who is now blind in one eye due to vitamin A deficiency, highlighted a dilemma resulting from a large and persistent number of shortages over the past two years of numerous medications needed for treating different cancers and attention deficit disorder, among other ailments (see the list).
The crisis has led to patient deaths; gray market price gouging; an increased reliance on compounding pharmacies that have raised safety questions; Congressional probes; calls to fine drugmakers that fail to provide early notice of shortages, and accusations that the FDA has been overzealous in pursuing manufacturing gaffes, a charge the agency has denied. Amid this swirling controversy, Lacognata charged drugmakers that are licensed by the FDA have a duty to maintain supplies of a medication that is required for patient health. Specifically, she argued that Hospira violated its duty by switching manufacturing sites for Aquasol A in late 2010 without stockpiling adequate supplies to avoid what became a significant shortage.
Last summer, a federal district court judge tossed the case by determining that "there is no authority that supports (her) argument that a drug manufacturer, like Hospira, has a duty to continue supplying a patient with a drug that it knows the patient relies upon for his or her medical health" (here is the order).
However, the US Court of Appeals for the 11th Circuit has allowed an appeal to go forward. "The issue of whether drug shortage victims can recover can be decided," says her attorney Allen Black. "It's very fundamental. Is there a duty of someone who takes an FDA license to supply the drug? The doors were shut closed in district court, but were reopened by the circuit court" (here is the appeals court brief).
[UPDATE: A Hospira spokesman sent us this statement: "Hospira recognizes there are patients in need of this product and we are working diligently to return Aquasol A to market as soon as possible."]