A story in The Scientist magazine says some medical professionals are concerned about health risks attendant with the U.S. Food and Drug Administration’s heavy reliance on the fast-track review process for new medications.
The Scientist cites an article in the Journal of the American Medical Association, which states that the FDA fast-tracked nearly half of all the 35 drugs it reviewed in 2011.
Among them was the blood thinner dabigatran, sold ...
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The Australian Broadcasting Corporation reports on a class action lawsuit that Johnson & Johnson faces in Australia over the company’s transvaginal mesh implants.
According to the report, the mesh devices have caused “life-changing harm” for a significant number of the women who received them because of their tendency to erode in patients’ bodies.
The implants are sling-like devices designed to treat urinary incontinence and pelvic organ prolapse, which ...
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European Union officials are calling for stricter rules governing the safety and monitoring of medical devices, Reuters reports.
The proposals come in the wake of a global scandal in which hundreds of thousands of women around the world received breast implants prone to rupture and leaking, made by defunct French company Poly Implant Prothese.
Critics say that because of weak EU safety standards, regulators had failed to stop the implants for more ...
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Insurance companies, which often end up on the hook for expenses when a medical device fails, are pursuing legal action to recoup more of the health services costs from manufacturers.
According to a Reuters report, the biggest recalls can lead to billions of dollars in expenses, and medical device makers are already worried about weaker global demand for many of their products and the impact of a new U.S. tax on ...
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Johnson & Johnson has agreed to settle five lawsuits in Philadelphia Court of Common Pleas, based on claims that its antipsychotic drug Risperdal caused five boys to grown breast tissue.
Terms of the settlement weren’t disclosed, Bloomberg reports.
The lawsuits are among more than 400 in which J&J and its Janssen unit were accused of injuries caused by Risperdal. More than 100 of those suits involve claims that the drug caused young ...
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According to a story posted on Fox News, the U.S. Food and Drug Administration has issued a warning letter to medical device maker Zimmer Holdings Inc., mentioning concerns about the manufacture of certain hip implants.
The letter was sent following an agency inspection of the company’s plant in Puerto Rico, which found manufacturing and testing issues related to the company’s Trilogy Acetabular System products — implanted in hip-replacement surgery.
The report came ...
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