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In its June 4th announcement that it is taking four synthetic vaginal meshes off the market, Ethicon acts like it is in charge of the FDA. First, the division of Johnson & Johnson (J&J) requests it be given 120 days to “cease commercialization” which essentially means allowing the four defective […]

On Monday, June 4, in a letter to two different courts, Ethicon, a division of Johnson & Johnson (J&J) announced it was removing four synthetic surgical meshes from the market.  All four fall under the Gynecare division – the TVT Secur, Prosima, Prolift and the Prolift+M. In doing so it […]

Late last night, June 4th comes news from Bloomberg, that medical device maker, Johnson & Johnson (J&J) plans to stop selling four transvaginal mesh implants in the face of hundreds of lawsuits and more to come. Ethicon, a unit of J&J, told a federal judge in West Virginia that it […]

Consumers Union has posted an ad in the online news source, Politico, Monday, May 21, asking “Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?” Sounds like the answer should be a resounding […]

The U.S. Food and Drug Administration (FDA) announced on Wednesday, May 9, that patients taking the osteoporosis drug, Fosamax, or any of the bone-building class of drugs known as bisphosphonates, should be reevaluated every three to five years to determine if it is safe for them to remain on the […]

Pradaxa, an anti-coagulant drug marketed by Boehringer Ingelheim Pharmaceuticals, enjoyed an unusually smooth (and quick) ride towards FDA approval.  Rather than spending months pouring over clinical studies and safety data, FDA employees instead approved Pradaxa based primarily on a single study and did so in just six months.  Below are […]

The Institute of Medicine (IOM) is taking the U.S. Food and Drug Administration (FDA) to task. In a new report, the IOM says the FDA should conduct more regular reviews of drugs to better catch and track safety issues. In order to better inform patients and the doctors who treat […]

The Top Ten of anything usually designates the ‘best’ but not in this case. An online report from Adverse Events Inc., an independent company that analyzes the FDA’s database of Adverse Event Reporting System (AERS), has just issued its Top Ten list of Dangerous Drugs for the second quarter Q2 […]

The U.S. Food and Drug Administration (FDA) wants to remind the public what a good job it’s been doing in monitoring drugs both before and after they are marketed. In a report issued over the weekend, April 21, “Advances in FDA’s Safety Program for Marketed Drugs,” the agency pats itself […]

We now have a better idea of how one synthetic mesh medical device maker, American Medical Systems, Inc., plans to defend itself against the 318 lawsuits that have been consolidated in the Southern District of West Virginia before The Honorable Joseph R. Goodwin. In a Position Statement, issued and filed […]