An article from the Daily Report Online describes a woman in Georgia who filed the first federal claim against one of the Transvaginal mesh manufacturers. The claim against C.R. Bard detailed the health problems she’s endured as a result of receiving a vaginal mesh implant. She explains the Transvaginal mesh device was implanted to solve prior bladder problems, but it only made matters worse. She immediately sought medical help ...
First Federal Transvaginal Mesh Claim Going to Trial
Posted July 12, 2013 in Drug and Medical Device Lawsuits | Product News and Recalls | Transvaginal Mesh Lawsuit
FDA Seeks to Resolve Disparity Between Warnings of Brand Name Drugs and Generics
Posted July 11, 2013 in Drug and Medical Device Lawsuits | Product News and Recalls
In welcome news for patient advocates, the FDA plans to propose rule changes that would require manufacturers of generic drugs to warn patients if they learn of side-effects that doctors may not be aware of.
Currently, manufacturers of brand name drugs are required to immediately modify their product warnings if they receive important new information about risks or side effects. The FDA will then review the label and determine if the modifications ...
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A study published in the medical journal JAMA Internal Medicine concluded that more than half of all U.S. Food and Drug Administration drug recalls between 2004 and 2012 with a potentially dangerous “Class I” designation were for dietary supplements.
Class I is reserved for products with a reasonable possibility of causing “serious health consequences or death.” Of the 465 drugs recalled under that designation, 237 were dietary supplements.
A report on ...
continue reading...FDA proposes warning labels for tanning beds
Posted June 5, 2013 in Drug and Medical Device Lawsuits | Health | Product Liability | Product News and Recalls
The U.S. Food and Drug Administration has proposed requiring tanning beds to include a label warning that the devices increase the risk of skin cancer and shouldn’t be used by people younger than 18.
According to a USA Today story, the FDA currently regulates the sunlamps in tanning beds as class 1 devices, which are considered low risk and don’t require review before going on the market.
The FDA’s proposal would change ...
continue reading...FDA failed to warn about faulty drug testing
Posted April 25, 2013 in Drug and Medical Device Lawsuits | Health | Legal Issues | Product Liability | Product News and Recalls
A ProPublica story says the U.S. Food and Drug Administration found evidence that a Houston-based laboratory called Cetero, which conducted research for drug companies worldwide, tampered with records and manipulated data.
The story says the violations were found to be so pervasive and “egregious” that the FDA concluded studies conducted there between April, 2005, and August, 2009, might be useless. Yet the agency pulled none of the drugs approved as ...
continue reading...A story in the British newspaper Daily Mail deals with mounting concerns about serious side effects related to the popular anti-cholesterol drugs known as statins. The story includes a profile of a Welsh man who began taking statins for high cholesterol at the age of 57. Soon afterward, he began suffering from side effects he blames on the drug.
According to the story, he had troubling bouts of memory loss.
The story quotes him as saying: “I was constantly losing my thread ...
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