In the wake of last month's Supreme Court decision in Riegel v. Medtronic, holding that Federal Drug Administration approval of medical devices shielded manufacturers from product liability lawsuits by injured patients, concerns have mounted that the Court will confer similar protection to drug manufacturers whose products have received FDA approval. This would leave injured consumers to the...
Today's New York Times reports that as many as 21 deaths may be linked to the drug heparin, and the number of reported adverse reactions (mostly decreased or low blood pressure and fast heart rate) has risen to 448, according to the FDA. Baxter International, whose heparin seems to be involved with the problems, announced that it was expanding a recall to include most of its heparin products,...
Stay tuned this Sunday for another FDA failure story on 60 Minutes in which Dr. Dennis Mangano, a respected drug researcher, asserts that 22,000 Trasylol deaths could have been avoided if the Food and Drug Administration had paid heed to his published research about Trasylol's dangers, and removed the heart surgery drug from the market two years ago, when his study revealed its widespread...
A lawsuit was filed this week against the makers of Ketek on behalf of the widow of Otto J. Laven, a Milwaukee man who died of respiratory arrest shortly after taking the antibiotic for treatment of his bronchitis. The suit, filed in the Milwaukee County Circuit Court, alleges that Ketek (also known as "Telithromycin") was defective and unreasonably dangerous for use by patients with a...
The nation's leading makers of microwave popcorn are removing the flavoring chemical diacetyl from their recipes. ConAgra announced the change Monday and similar moves have been made by General Mills, American Pop Corn Co. and Weaver Popcorn Company.I have commented previously on the dangers to consumers and food industry workers, many of whom have suffered serious injuries or died due to the...
The Associated Press has reported that Con Agra, maker of Banquet pot pies, has voluntarily stopped production due to reports of consumers contracting salmonella. The Centers for Disease Control and Prevention have reportedly investigated numerous cases in Wisconsin, Missouri and Pennsylvania. The Banquet pot pies under investigation are of the chicken and turkey varieties and have a "P-9" code...
The Consumer Products Safety Commission has announced a voluntary recall of Simplicity and Graco cribs after three infant deaths. According to the CPSC news bulletin announcing the recall, "The drop-side can detach from the crib, which can create a dangerous gap and lead to the entrapment and suffocation of infants... The drop-side failures result from both the hardware and crib design, which...
I have previously blogged about the lung disease danger to workers in the microwave popcorn manufacturing industry exposed to diacetyl, a food flavoring. Now there is a story reporting that eating microwave popcorn may potentially cause obstructive lung disease. Because Wisconsin is one of a handful of states where microwave popcorn is manufactured, Milwaukee Journal Sentinel reporter Raquel...
The LA Times has reported that numerous deaths across the country have been linked to the drug Fentanyl, a narcotic delivered through a pain patch. According to the article, medical experts are concerned that the pain patch, though a convenient method of delivering pain medication, can deliver the drugs too fast and that other variables, such as skin temperature and skin thickness can affect...
More than 50 lawsuits have been filed across the country claiming that Fleet Phospho-soda, a laxative made by C.B. Fleet Co. Inc. of Lynchburg, Va.,caused serious kidney damage, sometimes leading to death, reports the Associated Press. According to the lawyers that filed the suits, the Food and Drug Administration lists Phospho-soda as safe when used as a single-dose laxative, but in the early...
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