The National Park Service is celebrating its centennial – an historic occasion that will culminate Aug. 25. On that date in 1916, President Woodrow Wilson signed into law an act creating a new bureau within the Department of the Interior that would bear responsibility for protecting the then-35 parks in […]
Author: Cal Warriner
The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less. Consumer clarity on how certain products make […]
The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional statements about certain medications’ unintended uses. In the federal case of Amarin Pharma Inc. […]
The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are rare, fortunately, but the fact that some are failing to follow it can spell danger […]
Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant. According to the company’s lawyers, the damages should be stricken because of the learned intermediary doctrine. “It’s the […]
One of the foremost father figures in the history of medicine famously said, “There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.” Hippocrates, the ancient Greek physician revered for high ethical and moral standards that are the reason every doctor in America pledges […]
If the bellwether trial of a plaintiff who suffered complications from a metal-on-metal hip implant is any indication of future verdicts, Wright Medical Technology should be worried. A jury awarded $11 million to a woman suing for damages following surgery to replace her joint with the company’s Conserve system. The […]
In February 2015, sixteen plaintiffs sued Pfizer, the maker of Viagra, alleging that their ingestion of Viagra between 1998 and 2013 caused them to develop melanoma. Plaintiffs asserted the following cause of actions: breach of implied warranties, breach of express warranties, fraudulent concealment, gross negligence, loss of consortium, negligence, reckless […]
Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits outweigh its risks? Questions such as those and a flurry of others have made […]
An inferior vena cava (IVC) filter is used to prevent life threatening pulmonary emboli. Once installed, the filter’s arms and legs open and anchors it to the walls of the IVC. The filter then catches blood clots that would otherwise flow into the heart and lungs as pulmonary emboli. […]
