Do drug labels now need to be localized?
Product labels negotiations are often intense between the FDA and pharmaceutical companies. The language in the label can lead to increased sales and marketing messages or a very narrow indication which would limit it's use. When negotiating with the FDA drug companies try and incorporate language which can be used to market the product to HCP's and consumers as the label is the "bible" for what can be communicated to patients and HCP's. According to an article this morning in the Wall Street Journal:
In 2000, Diana Levine lost a hand and forearm to gangrene after Phenergan was inadvertently injected into an artery during a so-called push IV injection, which is more potent and puts injected drugs into the body faster than a normal injection. Ms. Levine had gone to a medical facility in central Vermont for treatment of nausea.
The drug's labeling, approved by the FDA, included the injection method as an option but warned of risks like gangrene if the drug were injected into an artery. Ms. Levine sued, arguing Phenergan's labeling was unsafe, and a Vermont jury awarded her $6.8 million in damages. On appeal, the Vermont Supreme Court upheld the award, ruling that FDA drug regulations don't prevent a company from being sued under state law over drug labeling.
You can see why the high court might want to get involved here. The potential for endless litigation is staggering adding hundreds of millions of dollars to costs which ultimately will lead to higher drug prices. Now this author doesn't feel that pharma companies should be immune from labeling language missteps that could lead to patients being endangered but at sometime you have to draw a line in the sand and say "enough is enough". The attorney who is suing Lilly for Zyprexa, (he refused to settle with Lilly) leaked information to the press that even a judge said was reprehensible and the commercials recruiting people for class action litigation can be seen throughout the cable channels. There is no excuse for hiding information or misleading HCP's on a drugs side effects but if this lawsuit is heard by the court and upheld it could open the door to massive delays in new drug introductions. Can you imagine the logistics of trying to prepare different labels for different states?
I am studying law and I love what I am learning but the law is supposed to be about the facts not emotion. I am truly sorry that this patient lost a limb because of the use of the drug but all drugs have risks that is why they have to be approved by the FDA. Patients need to understand that and lawyers need to stop looking to big pharma for a new Lexus or Mercedes.