News & Commentary on Prescription Drug & Medical Device Lawsuits
I was not aware that Avandia was the #2 seller for GSK. This is really going to hurt for them:
(Reuters) – European officials moved to pull GlaxoSmithKline’s diabetes drug Avandia off the market and U.S. authorities imposed tight restrictions over heart risks, effectively spelling the commercial end to the once-lucrative medicine.
Once a top
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I got an email from the FDA alerting me to new warnings about the usage of Avandia. Apparently, the FDA has not decided to withdraw Avandia, but is severely restricting who may use it:
FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS.
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The FDA is reviewing the results of a study that may link bladder cancer with the diabetes drug Actos:
The agency said Friday that five-year results from an ongoing study show that patients who have taken Actos for the longest period of time had a higher risk of bladder cancer. Bladder cancer was also more
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If there is a Holy Grail among pharmaceutical companies, it isn’t a cure for cancer, AIDS, or another fatal disease. It’s a weight-loss pill. As any Fen Phen lawyer can tell you, the history of weight loss drugs has been mild weight loss and severe health risks. Some are concerned that the Fen Phen story…
Back in 2008, I wrote about the sad story of Trasylol. (I’ll wait if you want to read that post as background.) Fast forward a little over two years, and many of the lawsuits filed over Trasylol are starting to settle. That’s good news for the patients injured by Trasylol:
Drugmaker Bayer AG has
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Gadolinium exposure can cause Nephrogenic Systemic Fibrosis (NSF), which is a horrible and fatal disease. People with NSF can turn into “living statues” because their limbs become as hard as wood or stone. I’ve seen pictures of people affected by the disease, and I wouldn’t wish it on my worst enemy. Thankfully, the FDA is…
Some people don’t understand why pharmaceutical companies shouldn’t be allowed to engage in off-label marketing. Here’s one reason:
Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the
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I’ve chatted with several Avandia lawyers about the fact that the FDA isn’t allowing anyone else to enroll in the TIDE study:
WEDNESDAY, July 21 (HealthDay News) — No new patients will be permitted to enroll in a safety study of the controversial diabetes drug Avandia until further notice, the U.S. Food and Drug Administration
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There are still thousands of Avandia lawsuits pending, but apparently 10,000 of them will be settled:
On Tuesday, Glaxo agreed to pay $460 million to settle thousands of lawsuits over Avandia, Bloomberg reported, citing people familiar with the settlements.
Glaxo will settle about 10,000 suits for an average of $46,000 each, Bloomberg said. A source
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If it weren’t for the Avandia lawyers who are suing GSK, this deposition would have never been taken. That’s because, surprisingly, the FDA can’t subpoena GSK employees and records while any Avandia lawyer can.
WASHINGTON—A former Food and Drug Administration official said the maker of diabetes drug Avandia withheld from regulators information suggesting the drug
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