In welcome news for patient advocates, the FDA plans to propose rule changes that would require manufacturers of generic drugs to warn patients if they learn of side-effects that doctors may not be aware of.
Currently, manufacturers of brand name drugs are required to immediately modify their product warnings if they receive important new information about risks or side effects. The FDA will then review the label and determine if the modifications ...
continue reading...On June 24, 2013 the United States Supreme Court decided the case Mutual Pharmaceutical v. Bartlett, and held that the manufacturer of a generic version of a drug could not be held liable for injuries cause by the defective design of that drug. In 2011, the Court had also held that generic drug manufacturers could not be held liable for defective (incomplete) warning labels accompanying their products. The end result is that manufacturers of generic drugs are almost completely protected ...
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In a closely decided ruling issued on June 24, 2013, the Supreme Court voted 5-4 that generic drug makers cannot be sued for adverse reactions to their products. This follows a 2011 ruling in which the Supreme Court decided that makers of generic drugs could not be sued for inadequate warnings as long as they were identical to the warnings on the brand name drugs.
According to the consumer ...
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