FDA database that tracks medical device harms may miss red flags, safety experts warn
CBSN
Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year.
The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards.
The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMate 3 prevented the device from sealing, causing multiple strokes and leading to a severe brain injury and multiorgan failure. Herrman "could not have anticipated the danger this defect … created for him," the lawsuit said.
The Food and Drug Administration said Wednesday that the U.S. food supply is still "one of the safest in the world," in the wake of a number of foodborne disease outbreaks affecting items ranging from organic carrots to deli meats to McDonald's Quarter Pounders. E. coli, listeria and other contaminants have sickened thousands of people and forced a number of recalls in recent months.
An Indian businessman who is one of the world's richest people has been indicted in the U.S. on charges he duped investors by concealing that his company's huge solar energy project on the subcontinent was being facilitated by an alleged $265 million bribery scheme.
We just had another election with a clear and verifiable victor, overseen by hundreds of thousands of election officials. Those public servants have suffered years of harassment, and despite their successes, are still being accused of taking part in a massive and impossible conspiracy — a conspiracy led by the party out of power to steal an election and cover up all evidence.
Giraffe populations are in trouble — and the U.S. Fish and Wildlife Service on Wednesday proposed listing three subspecies of the tall animals as endangered and two species as threatened under the Endangered Species Act.
A village in Sardinia, Italy, called Ollolai, is dangling an offer it says is for politics-weary Americans in search of a reprieve: houses for next to nothing.
President-elect Donald Trump has vowed to start the largest deportation effort in American history — his signature 2024 campaign promise — as soon as he takes office, signaling this week that he would enlist the help of the U.S. military for the massive operation to deport undocumented immigrants.
Washington — The House Ethics committee, meeting to consider the release of a report on its investigation into former Rep. Matt Gaetz, did not reach an agreement on Wednesday afternoon, the committee chairman said.
McDonald's customers may have to go elsewhere for now if they have a yen for frothy caffeinated drinks.
President-elect Donald Trump is expected to name Russ Vought to lead the Office of Management and budget, according to two sources close to the transition.
Washington — Former Republican Rep. Matt Gaetz is meeting with senators on Capitol Hill on Wednesday as he seeks to shore up support for his nomination for attorney general amid calls for the House Ethics Committee to release a report on allegations he engaged in sexual misconduct and illicit drug use.
Thanksgiving dinner ingredients will cost more this year compared with last, even as food inflation cools. Fortunately, there's one simple way to save money without skimping on staple dishes for the food-driven holiday: store brands.