The Supreme Court has issued a decision that has huge ramifications for the generic drug industry. Specifically, there’s a distinct possibility that it will now become harder for misled consumers to file a legal claim against the makers of a generic drug for a side effect that was not disclosed by the label.
The case decided by the Supreme Court involved a woman who sustained a serious, lifelong disfigurement after taking a generic medication called sulindac to treat pain in her shoulder. Although lower courts believed that the victim was entitled to $21 million for her hardships, the Supreme Court reached a different conclusion, striking down the decision for the plaintiff.
Their argument, dating back to a ruling issued back in 2011, is that generic drug makers can’t be blamed for side effects created by the original drug. They believe that, in essence, the generic version is simply a reproduction of that which has already been created and received the approval of the Food and Drug Administration. Because of this, the label also needs to read like that original label.
Unsafe drug lawyers aren’t thrilled with the decision. The President of the American Association for Justice explained that she can’t think of any other industry that allows a product maker to decline responsibility for their product. That organization is supporting a petition to the FDA asking the agency to take further action on generic drug makers based off of this ruling.