Tennessee Injury Law Center
Imagine you are standing at the counter at Walgreens or CVS and the pharmacist offers you a choice: you can purchase either the brand name version of your drug for $400 or you can purchase a generic alternative for $50. Very few people would not opt for the less expensive generic version. But, there is something you should know before making a decision between generic and brand name drugs.
Generic drugs manufacturers are not responsible for drug defects or for failing to warn about such defects. So, if the drug poses a substantial risk of harm for diabetics but the label does not warn about it, the generic drug manufacturer is not responsible. The injured diabetic has no recourse. Think about that. Not only did the generic manufacturer not have to invest any money in researching and developing the drug, but then if they copy the drug they are not responsible for any harm caused by it (unless the generic drug manufacturer makes a mistake in the formulation process and does not accurately copy the drug). This crazy result is based on a 2011 U.S. Supreme Court decision, Mutual Pharmaceutical v. Bartlett.
In November of last year, the FDA announced a proposed change to the current rule which would make generic manufacturers responsible for labeling in the same fashion as brand name manufacturers. The original comment period for the proposed rule was 60 days but the deadline was extended. The new deadline is March 13, 2014. We will keep you posted about this important safety issue for drug consumers.