Drug shortages tied to manufacturing foul-ups continue to be a significant issue in the U.S., but the legal question of whether patients can sue drugmakers when they can't get a med has come to a close. The case of a Florida woman who claimed she is now blind in one eye because of a shortage of Hospira ($HSP) drug Aquasol A has fallen just short of the Supreme Court.
According to Pharmalot, the nation's highest court this week declined to take up the case from Jennifer Lacognata. She had appealed a federal court ruling from last year that ruled against her position. Lacognata contended that as the sole supplier of Aquasol A, Hospira had a responsibility to maintain an adequate inventory to deal with "supply disruptions during the transition between manufacturing sites." She said she needed the drug for a vitamin A deficiency, but it was unavailable when manufacturing problems led the company to stop production. The company has been making upgrades to facilities for several years.
Lacognata's is not the only lawsuit to test the matter. An Idaho woman sued Genzyme, saying that her husband died after its Fabry disease drug Fabrazyme was in short supply after viral contamination led the drugmaker to close a plant in 2009. Genzyme last year opened a new plant to manufacture Fabrazyme and this week said it is expanding the plant because of demand for the drug.
Drugmakers may have to be licensed to manufacture drugs, but that does not mean they have to make them, U.S. District Judge James Moody Jr. ruled in the Lacognata case. In his ruling, he wrote, "There is no authority that supports plaintiff's 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."
http://www.fiercepharmamanufacturing.com/story/federal-case-over-drug-shortage-comes-end/2013-10-17
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