California Ruling on Generic Drug Liability a Win for Consumers

Defective Drugs
Generic Drug Liability

By Sandra Dalton, Staff Writer

More than 80% of prescription drugs sold in the U.S are generic versions. Generic is cheaper, and in many cases health insurance will not pay for brand name drugs or pays a smaller portion for them. The U.S. Food and Drug Administration (FDA) says that generic drugs are safe and effective. The agency doesn’t mention that generic drug companies are off the hook if their warning labels are inadequate, leaving those harmed by defective drugs with nowhere to turn for compensation for their injuries. But a recent California Supreme Court ruling could mean that drug injury victims will once again have legal recourse when harmed by generic drugs.

On December 21, 2017, the California Supreme Court ruled that the original brand-name manufacturer of a drug is still responsible for defective labelling, even when the drug is sold by another company as a generic version.

Failure to Warn – Who’s to Blame?

Generic drug manufacturers are required, by federal law, to use the same warning labels as their name-brand equivalents, unless the FDA directs them otherwise. This led the U.S. Supreme Court to rule, in 2011, that generic manufacturers cannot be held liable for defective labelling. Victims of defective drugs cannot sue generic manufacturers for injuries stemming from failure to warn about potential side effects.

Now, the California Supreme Court says that because generic manufacturers must stick with the original warning label, the original manufacturer remains responsible for defects in the warning label when the dangers were foreseeable before the drug was sold to the generic manufacturer.

If you or someone you love has been harmed by a generic drug, you can learn more about your rights and how you can recover damages for your losses by searching our directory to find a lawyer near you.


I'm so glad to read that generic drug manufacturers are required to use the same warning labels as brand-name drug makers. As brand-named drugs are NOT covered by insurance companies, or are prohibitively expensive, it's more important than ever to hold generic manufacturers' feet to the fire. What I'd really like to know is how come generic drugs aren't as good as brand named drugs, even though they're supposed to be bio-identical. In any case, consumers have won a victory in the pro-consumer state of California.

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