Today, almost half of all Americans take at least one prescription drug. The sale of medical devices has grown into an $85 billion dollar-per-year industry. Too many people are injured by severe side effects of dangerous drugs and defective medical devices. Drugs and medicines are frequently at the center of products liability suits. Manufacturers of these products have a duty to appropriately test the drugs and medicines before releasing them into the market, using testing criteria from the U.S. Food and Drug Administration (FDA). These criteria are regarded as industry standards, but the fact that a drug was properly licensed by the FDA has no effect on the manufacturer’s liability to an injured plaintiff, if the drug proves to be otherwise defective. The harsh reality is that many companies place the drive for profits over public safety and as a consequence, potentially dangerous drugs and defective products are rushed to market without proper testing. Many consumers wrongfully believe that if the FDA approves a medical device, it is safe. However, the FDA has a much-criticized approval process that does not require manufacturers to perform clinical trials or prove certain products are safe when the device is “substantially equivalent” to another device. The FDA only begins to investigate allegations that a product is defective or dangerous if patients begin reporting injuries, and therefore FDA action only takes place once many innocent people have already suffered harm.
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