The Food and Drug Administration is considering some very important changes to its internal rules that would help to eliminate a loophole in accountability for defective drugs.   Under current law, only the brand name manufacturer is permitted to change the warning label for a particular drug.   After a drug is […]

Whether a smoker is trying to quit tobacco or just trying to be fashionable, you may have noticed more e-cigarettes being smoked or “vaped” in public. Electronic cigarettes (e-cigarettes) are a trendy, non-offensive way to display the panache of smoking without inhaling the chemically-laced nicotine from a tobacco cigarette. Though […]

Because the dangers of electronic cigarettes are unknown, attorneys general from 40 states have called on the Food and Drug Administration (FDA) to restrict the sale of electronic cigarettes to minors. Electronic cigarettes or e-cigarettes (e-cigs) are battery operated chambers that deliver a heated liquid formulation of nicotine from tobacco […]

When our clients discover that their metal-on-metal (MoM) hip has failed and never went through U.S. Food and Drug Administration (FDA) approval for safety and efficacy, they ask – how did that happen? Most Americans do not understand that medical devices are largely unregulated, even for those devices that are […]

Although the following was a parody published in the New York Bar Journal, it rings amazingly true for the thought process used in decisions to send products into the market place: “Remember when some bad tires exploded and killed a few people?  Lawsuits uncovered the defect.  Nobody would have known […]

New lung cancer screening “guidelines” from three medical groups recommend annual scans but only for an older group of current or former heavy smokers. The advice only applies to ages 55 to 74.  The risks of screening younger or older smokers or nonsmokers outweigh any benefits according to the guidelines.  […]

The Surgeon General today released a new report on youth smoking.  The 2012 Report, entitled Preventing Tobacco Use Among Youth and Young Adults, updates the 1994 Report, which was the first comprehensive Surgeon General’s report on youth smoking.  In ‘94, the Surgeon General concluded that if young people can remain […]

The Food and Drug Administration has proposed a new rule, which includes changes to the warnings on cigarette packaging; warnings that have remained largely the same for decades. These proposed new warnings are obviously intended to be graphic motivation for smokers to quit and for those who have not yet […]

A substance that most of us cannot pronounce, has caused Kellogg’s to recall more than 28 million boxes of its popular cereals such as Froot Loops, Apple Jacks, Corn Pops, and Honey Smacks. The recall came from consumers complaining of a funny smell, nausea and diarrhea, and a wax-like taste […]

AstraZeneca has agreed to pay fines totaling $520 million in settlement of charges made by the Food & Drug Administration (FDA) that AstraZeneca illegally marketed Seroquel; a prescription drug used for the treatment of schizophrenia. Although Seroquel had not been approved by the FDA, AstraZeneca marketed and continued to market […]