Preemption, Tort Reform, And Pharmaceutical Claims: Part Two: Has the Food and Drug Administration Shown It is Solely Responsible for the Protection of Patients? can It Do So? will It Do So?(Medicolegal Issues)

Preemption, Tort Reform, And Pharmaceutical Claims: Part Two: Has the Food and Drug Administration Shown It is Solely Responsible for the Protection of Patients? can It Do So? will It Do So?(Medicolegal Issues)

Preemption, Tort Reform, And Pharmaceutical Claims: Part Two: Has the Food and Drug Administration Shown It is Solely Responsible for the Protection of Patients? can It Do So? will It Do So?(Medicolegal Issues)

There should be no question that adverse drug events are a significant issue. A recent report indicated that in 2005 there were 89,842 serious adverse drug-related events (1), and 15,107 of these adverse events were deaths (1). In 2002, adverse drug events were associated with more than 3 million hospital admissions and increased the US hospitalization bill by $17 billion (2). Non-hospitalization-related medication injuries cost $76.6 billion (2). Data show that 3% to 4% of medications are withdrawn for safety reasons (3). With facts such as these, it should be no surprise that adverse drug events are the most common iatrogenic cause of patient injury (4). Traditionally, patients have been able to pursue legal action if they were harmed by a medication side effect about which they were not adequately warned (5). In such circumstances, patients have been able to pursue a “failure-to-warn” claim against the medication’s manufacturer and/or the health care provider who prescribed the medication.

Preemption, Tort Reform, And Pharmaceutical Claims: Part Two: Has the Food and Drug Administration Shown It is Solely Responsible for the Protection of Patients? can It Do So? will It Do So?(Medicolegal Issues)

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