The Growing Threat of Substandard and Falsified Drugs: A Patient Safety Crisis in 2025
As medical malpractice lawyers in NYC, we are seeing an alarming rise in cases tied to substandard and falsified (SF) medications — counterfeit or fake drugs designed to resemble legitimate pharmaceuticals. The World Health Organization has called the fight against these dangerous products one of the most urgent health challenges of the next decade.
Globally, SF drugs have become a multibillion-dollar black market, with an estimated worth of $431 billion annually. Increasingly, these medications are purchased from unregulated online marketplaces posing as legitimate pharmacies — many using deceptive tactics such as Canadian branding or maple leaf logos to gain trust. The U.S. Food and Drug Administration reports that approximately 95% of online pharmacies selling prescription drugs are operating illegally.