In an unexpected move, the Department of Justice has suspended its four-year civil and criminal investigation into allegations of off-label marketing by Medtronic Inc. concerning its Infuse bone graft product. No charges have been issued and there was no settlement reached after the company was notified by the U.S. Attorney […]
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 […]
If you blinked you may have missed this news item but it’s important to understand how government inaction hurts its citizens and this is a prime example. On Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds […]
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 […]
With hundreds if not thousands of lawsuits filed against transvaginal mesh manufacturers, the first trial date has been set for cases to be heard against C.R. Bard Inc. February 5, 2013 is the first date set for bellwether trials filed by women who claims injuries after they were implanted with […]
So far this week, our firm has filed three new DePuy ASR hip implant cases in the MDL proceedings pending before Judge David A. Katz of the United States District Court in the Northern District of Ohio. These multi-district litigation proceedings related to DePuy’s recalled ASR hip implants are also […]
There have been some significant developments in the bisphosphonate litigation over the past few months. Now that the two-year anniversary of the FDA’s safety alert over atypical femur fractures has passed, we anticipate that nearly 70 to 80% of the bisphosphonate cases in the country have now been filed. The […]
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 […]
I was thrilled to hear that some of our elected members of Congress are finally working on proactive legislation that might benefit all of us. This is especially encouraging after watching with much discouragement the high level of discord and dysfunction that has become commonplace in the Capitol. Recently, some […]
