Posts Tagged 'Legal Issues'

Start-up companies provide better access to FDA drug/device side-effect database

Two new start-up companies now allow users to search the Food and Drug Administration’s drug and device databases to see side-effects and malfunctions experienced by others. For years, the FDA has accepted reports from patients, doctors, and manufacturers, and stored detailed information as part of its effort to monitor the thousands of drugs and medical devices in use across the country. While the data are available on its web site, a user is required to download dozens of large files ...

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More Details About the FDA Advisory Committee Vote on Yaz: Majority Have Concerns

Background

On December 8, 2011, an FDA advisory committee held hearings on the safety of Yaz and Yasmin. After nearly a full day of testimony, the committee voted 21-5 that the information about the risks of Yaz provided to doctors and patients were inadequate. The panel voted narrowly, however, that the benefits outweigh the risks overall, and therefore voted not to remove Yaz from the market. The second vote was 15-11.

In the weeks ...

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2012 Yaz settlement?

With the recent Yaz settlement news, people are starting to wonder whether there will be a Yaz settlement in 2012. In early January two judges involved in the litigation put trial deadlines on hold and ordered mediation. The both sides were ordered to attempt to negotiation a Yaz settlement in good faith.

To date, there has been no additional public information released regarding a Yaz settlement in 2012, but no news is probably ...

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Yaz Settlement Update – Mediation Continues

There is little official news following the December 30, 2011 and January 6, 2012 mediation orders from two judges involved with the Yaz litigation. The parties were ordered to mediate without delay and in good faith. Since that time, Judge Herndon, the federal judge overseeing Yaz cases has issued what’s known as a “minute order. ” This ordered, entered on January 10, 2012, ...

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Yaz Recall: Majority of Independent FDA Experts Vote to Withdraw Yaz from Market

Based on recent news reports, Lopez McHugh has learned that a majority of independent experts advising the FDA about these safety of Yaz, Yasmin, and Beyaz, believe that a Yaz recall is in order.

The Washington Monthly reported on January 9, 2012, that it has conducted an investigation with the British Medical Journal and found that five experts selected by the FDA to advise it about a Yaz recall had ties to Bayer, the company that manufacturers the drug. Although ...

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Yaz Settlement News: More Mediation Ordered

Following on the heels of the Federal Court ordering mediation in the Yaz/Yasmin litigation, a state court judge has entered a similar order. Judge Moss, who is managing thousands of cases in Philadelphia state court, required mediation in an order published on January 6, 2012. Judge Moss’s order comes just one week after a federal judge entered a similar order. Both judges appointed Professor Stephen Saltzburg of George Washington School of Law, ...

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