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Defective Products Archives

Pam Menaker Writes ABA Litigation News Article on Fosamax Case

Pamela Sakowicz Menaker, Communications Partner at Clifford Law Offices, recently wrote an article that was published by the American Bar Association Litigation News on a recent court case that held that a defendant cannot be held liable in a products liability multi-district action if the company is compliant with Food and Drug Administration (FDA) rules. In a failure-to-warn complaint alleging the drug company, Merck, was negligent in its labeling following an injury to a patient, a New Jersey district court held the plaintiff's action failed because the original label was complaint with FDA standards. To read more about this interesting case, please read "No Failure-to-Warn if FDA Compliant" 

FDA Releases Data Pertaining to Adverse Drug Event and Medication Errors

Mass quantities of data relating to side effects caused by drugs and other medication errors were publicly released by the FDA with the hope that the information will lead to enhanced research in the area of medication, according to a recent article published by The Hill ("Open FDA Project Releases Millions of Reports," June 2, 2014). The agency has reportedly released over 3 million reports, which were previously only available through tedious Freedom of Information Act requests, on such errors between 2004 and 2013, The Hall reported. The program, titled "openFDA," makes the agency's data available in a structured computer-friendly format, and employs a search-based Application Program Interface (API) that will allow the FDA to collect large amount of data enabling them to rank results much like a common search engine would, according to Reuters ("FDA makes access to public health data easier," June 2, 2014). Patients need not worry because the FDA announced that before launching the program, the agency removed any and all patient identification information, The Hall reported. The FDA apparently also plans to expand this pilot database to include information for consumers relating to product recalls and product labeling, according to Reuters. Further, openFDA is part of a larger movement to make medical data more transparent that expands well beyond the FDA, as several drug manufacturers, working with the help of the National Institutes of Health, have started divulging clinical trial data in an effort to find new uses for older drugs that have been around longer but that are not used as frequently today, according to The Hill.

FDA Concludes that Most American Children Are Exposed to Food Dyes

A recent assessment performed by the Food and Drug Administration (FDA) revealed that 96 percent of all children aged 2-5 years are exposed to food dyes, including Red 40, Yellow 5 and Blue 1, according to Food Safety News. Although there has been no formal, causal link established between the intake of synthetic food dyes and adverse health effects, researchers have suspected for more than 40 years that the over-consumption of synthetic food dyes is linked to hyperactivity, Food Safety News reported. The full results of the exposure study have not yet been published, according to The Food Poisoning Bulletin.   While the FDA allows dyes such as Yellow 5, Yellow 6, Red 40 and the like, the European Union has banned several of these same dyes, and require warning labels for several others, based on the fact that the dyes have never been proven safe, the Food Poisoning Bulletin Reported. According to www.CSPInet.org, Lisa Lefferts of the Center for Science in the Public Interest, stated, "The FDA is failing kids and parents by allowing the use of these purely cosmetic chemicals in food, which trigger behavioral problems in some children, as even the FDA conceded in 2011."   To read the entire article provided by Food Safety News, click here.

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