The recent approval of a drug for use in combating leukemia by the US Food and Drug Administration has shed light on the relatively controversial, albeit common practice by that organization of using surrogate markers of efficacy for determining the benefit of a given drug or therapy. Some believe this constitutes a low bar for
Jared Fink is Legal Reader’s Editor in Chief and pharmacovigilance specialist. He is a graduate of the College of Wooster and has a strong background in scientific research and writing.
Tort reform has sullied the political landscape of this country for years. A set of proposed laws and regulations at both the state and federal level, one central aim of tort reform is to limit the compensation an injured party can recover in a personal injury lawsuit, or “tort,” attempting to “save” health care from
This week, the United States National Highway Transportation Safety Administration (NHTSA) widened the scope of a dangerous airbag system recall, now including 7.8 million BMW, Chrysler, Ford, Honda, GM, Mitsubishi, Mazda, Subaru, Nissan, and Toyota cars and trucks, model years 2000 to 2008. Manufactured by the Japanese multinational Takata Corporation, these airbags use a defective
In January, 2014, an article published in The Journal of Neuropsychiatry and Clinical Neurosciences titled “Long-Term Duloxetine Withdrawal Syndrome and Management in a Depressed Patient” reported on a depressed patient who used Cymbalta (duloxetine), discontinued the drug, and faced long-term withdrawal symptoms. After using Cymbalta (60mg/day) for one year, the patient, called “Miss B” in
Because Eli Lilly, manufacturer of the psychiatric drug Cymbalta (duloxetine), has failed to provide adequate instruction as to properly taper the drug at discontinuation, thousands of patients across the country and around the world have faced serious withdrawal symptoms unnecessarily, prompting large numbers of Cymbalta withdrawal lawsuits. According to MedlinePlus, a medical encyclopedia curated by
Since the late 1800’s, medical professionals and commercial manufacturers have known that asbestos is dangerous, linked to a variety of pulmonary ailments. Since the middle of the 20th century, these groups have known that exposure to asbestos is linked to mesothelioma, a cancer of organ lining that is almost always fatal. Most often, mesothelioma results
WARNING: Xarelto Linked to Fatal Internal Bleeding, No Reversal Agent Recently, the anticoagulant drug Xarelto (rivaroxaban) has come under increased scrutiny by both the United States Food and Drug Administration and medical professionals alike, citing an increased risk for internal bleeding. Unfortunately, there is as yet no reversal agent for the drug. Due to inadequate
Last month, the UK newspaper The Telegraph reported on asbestos, “the killer that still surrounds us”. It is incredibly sad that though asbestos has been know to be deadly for well over a hundred years, people are still exposed to and harmed by asbestos today. A naturally-occurring fiber with amazing heat-resistant capacity and the ability
Though most car accident claims are settled before a trial, some cannot be. Sometimes, it isn’t clear who caused the accident. Other times, it is clear who caused the accident but there is disagreement over a fair settlement. Every state’s court system is different, but the general process is fairly similar. The case will most
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