In April 2011, Jennifer Lacognata was diagnosed with vitamin A deficiency and subsequently prescribed an injectable drug called Aquasol A that is made by Hospira. Shortly afterwards, though, she was unable to obtain the medicine because Hospira was experiencing manufacturing problems (back story). And so, Lacognata filed a lawsuit claiming the drugmaker breached a responsibility to supply its patients with a needed medicine.
The lawsuit was the latest attempt to hold drugmakers accountable for ongoing product shortages that have allegedly caused numerous individuals harm. Last year, a half dozen people who suffer from Fabry disease filed a lawsuit against Genzyme for ongoing shortages of the Fabrazyme treatment (look here). In March, an Idaho woman filed a wrongful-death lawsuit that maintained the Fabrazyme shortage led to the death of her husband (see this).
The lawsuits were filed amid an unprecedented number of shortages over the past two years of numerous medications needed for treating different cancers and attention deficit disorder, among other ailments (here is the latest list). The problem has prompted probes of gray markets (see here); cries that drugmakers should be fined for not reporting looming shortages (read this) and complaints that the FDA is contributing to the mess with overzealous enforcement (back story).
There has also been mounting frustration among patients, some of whom worry about reports that shortages have led to increased deaths (look here) and fear they will meet a similar fate. As for Lacognata, she is now blind in one eye due to vitamin A deficiency, as noted in her lawsuit (which you can read here). Last week, though, a federal court judge in Florida denied her gambit and tossed the suit.
In his order, US District Court Judge James Moody Jr. shot down all of her arguments. For instance, he wrote 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." And he disagreed that Hospira was negligent for failing to stockpile adequate reserves and because its representatives assured Lacognata the shortage would end, but in fact, later did not.
Moody, however, wasn't buying. Lacognata alleges that Hospira patient reps told her that Aquasol A would be backordered until September 2011, but "this hardly amounts to a promise with definite terms. (She) does not allege that she changed her position to her detriment based on the representation. For example, (Lacognata) does not allege that she gave up the opportunity to utilize other treatment options in reliance on Hospira’s alleged promise... Under these circumstances, no set of facts could establish such a claim" (here is the order).
"We are disappointed with the decision," says her attorney, Allen Black, who also represents several Fabrazyme patients who sued not only Genzyme, but also the FDA, the US Department of Health and Human Services and the National Institutes of Health. That lawsuit argues that patient rights were violated because the federal government failed to take adequate enforcement actions against such drugmakers and allow for alternative means to protect supplies (read here).
"But I will keep fighting for Jennifer and the other patients. I am surprised that the court will not even let these drug shortage victims through the door of the court...," he says. "We always anticipated that this case would likely be appealed either by us, or Hospira, so we are not out of the game. At least we have an opinion now and are able to take the next steps to help the victims."
gavel pic thx to walknboston on flickr