Supreme Court rules in favor of pharmaceutical company over product labels

Accurate drug labels are a necessity, especially as patients can have severe allergic or otherwise adverse reactions to medication. Without detailed pharmacy labels, individuals could fall ill and the manufacturing company could face a serious lawsuit.

That is what happened in the recent Supreme Court case Mutual Pharmaceutical v. Bartlett. Karen Bartlett was prescribed sulindac, a generic form of the painkiller Clinoril. She subsequently suffered from Stevens-Johnson Syndrome, with burns over 65 percent of her body and became legally blind. Bartlett sued the drug company, stating that the label did not warn against the possibility of that disease.

New Hampshire Superior Court ruled in her favor, awarding her $21 million in damages. However, the ruling was reversed by the Supreme Court in a 5-4 decision at the end of June. Led by Justice Samuel Alito, the Court explained that avoiding liability under New Hampshire law would require the manufacturer to either alter the composition of the drug or alter its label, both of which federal law prohibits.

As explained by the Supreme Court blog, federal law requires that generic drugs remain consistent with their name brand counterparts in terms of ingredients and drug labels. Thus, generic manufacturers cannot alter the composition or labeling on their own accord. 

In her dissent, Justice Maria Sotomayor said that “the Court has left a seriously injured customer without any remedy despite Congress’ explicit efforts to preserve state common-law liability.”

Drug companies that want to adhere to all legal standards, yet ensure that their recommended dosages and all label details are accurate can invest in a color label printer. With an Epson TM-C3400 label printer, companies can create unique and detailed pieces of information for their customers. That way, issues similar to this Supreme Court case can hopefully be avoided.