In the past few years, more and more litigation has ensued concerning pharmaceutical drugs and the potential hazards associated with those medications. In a typical situation, a consumer has been prescribed a certain medication and after taking the recommended dosage (by the prescribing physician), the consumer develops some side effect that was omitted from the warning. As a result, the consumer brings suit against the drug’s manufacturer alleging a cause of action predicated on negligence. The consumer must show that the potential Defendant had a drug that it put into the stream of commerce, that there was a negligent design due to the manufacturer’s omission of a meaningful warning, that had the consumer been made aware of the warning he or she would have avoided the product, and that the consumer has been harmed as a result.
With the growing cost of prescriptions, generic drug manufacturers have stepped up to offer alternatives to the high price of name brand drugs. Name brand drugs carry a cachet associated with their usage due to the rigorous testing and studies their drugs go through in order to get approval from the Food and Drug Administration (FDA). After this testing is complete, and the beneficial effects of the drugs are substantiated, the drugs are allowed to be placed on the market for direct buy or prescription. Generic drug manufacturers can circumvent the costly testing process by showing the FDA that they have drugs that are the bio-equivalent of the already approved name brand drug. In addition to showing bio-equivalence (meaning that the substance of the pills are identical), the generic drug manufacturer must agree to have the same label information- including the same warnings. Continue reading →