A Florida woman who is now blind in one eye says it is because there was a shortage of Hospira ($HSP) drug Aquasol A that she needed for a vitamin A deficiency.
But drugmakers whose poor quality manufacturing leads to closed plants and drug shortages are not responsible for the deteriorating health of patients. At least Hospira is not, a federal judge in Tampa, FL, has ruled.
Jennifer Lacognata claimed that Hospira was the sole supplier of Aquasol A and had a responsibility to supply drugs that it knows patients rely on and that it should have an adequate inventory to deal with "supply disruptions during the transition between manufacturing sites," according to her lawsuit, which is reported on and linked to by Pharmalot. U.S. District Judge James Moody Jr. disagreed and ruled against her.
Hospira, which makes generic sterile injectables, has been addressing plant problems raised by the FDA and shortages have resulted in the process. "We are pleased with the outcome of this case and we are working hard to make this medication available as soon as possible," Daniel Rosenberg, a spokesman for the company told FiercePharmaManufacturing via email.
The worst part of the shortages situation is that some patients may have their health compromised, and there may even be some premature deaths because essential drugs are not available. Pharmalot reports that Lacognata's lawyers are handling some of the cases against Genzyme over a shortage of its drug Fabrazyme needed for Fabry disease, an often painful condition. An Idaho woman claims that her husband died because of the shortage and that Genzyme was negligent for allowing a viral contamination of its plant that led to supply disruptions and shortages.
The fallout over drug shortages has landed in the political arena as well as in the courts. A recent report by a House committee says that nearly 60% of current drug shortages stem from plants that were closed by FDA enforcement. It suggests that the agency has been overzealous in its oversight. The agency acknowledges that the majority of shortages are tied to manufacturing issues but says shoddy practices and outdated plants were turning out substandard drugs that put patients at risk. The agency has pointed out that there have been fewer shortages reported this year as it has encouraged companies to let it know quicker about situations that could lead to shortages and has been able to find alternate supplies from domestic and foreign suppliers.
As for how much responsibility drugmakers bear, Judge Moody says, "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."
- here's the Pharmalot story
Litigation: Sanofi, Genzyme 'negligently allowed a virus contamination in the manufacturing facility'
House report blames FDA actions for drug shortages