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WASHINGTON — Generic drug makers cannot be held liable if patients suffer harmful side effects after taking their drugs, the Supreme Court has ruled in a 5-4 decision.
The court announced Monday that it had handed down the ruling in the case of Mutual Pharmaceutical v. Bartlett, delivering a victory to the drug maker. Karen Bartlett was prescribed the Merck drug Clinoril (sulindac) and given a generic version of the drug made by Mutual to treat shoulder pain. After taking the drug, she developed Stevens-Johnson syndrome and toxic epidermal necrolysis, causing most of her skin to become burned or fall off, as well as near-blindness, esophageal burns and lung damage. A jury awarded her $21 million, and the Supreme Court heard the case in mid-March.
However, while Bartlett suffered the injuries after taking Mutual's drug, under federal regulations governing generic drugs, a generic drug company typically does not have to conduct clinical trials — only demonstrate that its product is identical to the branded drug. It relies on the safety and efficacy data collected by the developer of the original branded drug.
The Generic Pharmaceutical Association, a trade group representing the generic drug industry, heralded the ruling, saying it upheld the principle that decisions about the safety and efficacy of prescription drugs should be left with the Food and Drug Administration.
"When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients," GPhA president and CEO Ralph Neas said. "The experts at FDA alone have the scientific knowledge, regulatory experience and complete data to make these decisions."