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Consumers Lose Big in Supreme Court Decision on Generic Drugs

Posted by Rob Jenner on June 25, 2013 in Consumer Alerts

Americans who take generic medications – and most of us do – have lost again before the U.S. Supreme Court. The Justices on Monday ruled for the second time that companies that make generic drugs are shielded from lawsuits over the safety and marketing of their products.

The case involved a woman named Karen Bartlett, a New Hampshire woman who was prescribed a generic drug, sulindac, for shoulder pain. She later developed a rare complication called Stevens-Johnson syndrome, which caused more than 60% of her skin to burn off. It left her blind, disfigured and in need of care for the rest of her life. A federal jury in New Hampshire found that the drug was unreasonably dangerous and awarded Ms. Bartlett $21 million. However, the Supreme Court decision nullifies that award and eviscerates the rights of consumers nationwide.

The maker of sulindac, Mutual Pharmaceutical, argued successfully to the court that it cannot be sued for “failure to warn” because it is restricted by the FDA to exactly the same labeling as its branded counterpart, Clineril.

The Court has reasoned that because generics are basically “copies” of branded drugs, generic manufacturers can’t be held accountable if the branded drug turns out to be unreasonably risky, falsely marketed, or lacking important warning information. For example, let’s say you are taking the generic version of Lipitor and you develop Type II diabetes. You then read that the maker of Lipitor is being sued for hiding the fact that the drug is linked to a high risk of Type II diabetes. Under this ruling, you can’t file a lawsuit.

Some lawmakers and consumer groups are leading the charge to allow generic drug makers to put different information about safety, risks and complications on their packaging. This ostensibly would allow generic manufacturers to be held accountable for what information they give consumers. This seems only right and reasonable. But given the fact that Congress can’t pass sensible gun legislation or farm legislation or veterans’ rights legislation, who really thinks there’s any shot that Congress will do the right thing and make changes here?  Not me.

The Court was divided 5-4 in its decision, showing that this is a seriously contentious issue that should be clarified through legislation. Currently, 80 percent of all prescription drugs on the market are generics. Americans deserve more than a 20% chance for justice if they are hurt by an unreasonably dangerous drug. But given the way this Supreme Court rules and the fact that our federal government is hopelessly deadlocked on everything, the sad truth is that consumers, once again, will suffer at the hands of corporate protectionism.

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