Dangerous drugs come with a package insert that sets forth the indications, contraindications, drug interactions and side effects. When the medication poses an imminent risk of harm, drug manufacturers are required to prominently display a boxed warning, sometimes called a black box warning, on the package insert to alert physicians and pharmacists about the risk. When a healthcare provider ignores a boxed warning, a claim for medical negligence may arise.
A recent article in the New England Journal of Medicine (JAMA) reports that black box warnings are becoming more commonplace. In the JAMA article, researchers found that over one-third of drugs approved by the F.D.A. between 1996 and 2012 were given black box warnings. About half the time, there was a delay of 4 years on average between the time the medication was approved and the appearance of the warning. The researchers warned that doctors and nurse practitioners “should be aware of the prevalence and growing numbers of boxed warnings and the importance of continued adverse event reporting for identifying new safety concerns.”
Powerful pharmaceutical companies have successfully introduced a rash of new medicines that are not ready for prime time. When adverse reactions, injuries and fatalities pile up, drug companies try to insulate themselves from liability by including warnings and disclaimers in their package inserts. When this occurs, patients are left to rely on their doctor to guide them to medicines that are safe. If a physician or pharmacy fails to heed a boxed warning, resulting in injury or death from a dangerous drug, a claim for medical negligence or wrongful death may exist under Ohio law.
Powerful pharmaceutical companies have lobbied the FDA to allow manufacturers of dangerous drugs to provide medical literature to doctors that shows that risks for a given drug are lower than what the FDA-approved label says. Past evidence shows that industry-provided literature can be manipulated to promote a drug company’s interests.
At the end of the day, doctors owe their primary allegiance to their patient. This includes the duty to thoroughly understand prescription medicines before recommending them, to prescribe their use in a safe manner, and to disclose all risks in a fair and objective manner.