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Austin victims of the FDA’s guessing game can get help

In 2011, some big, nationally respected newspapers went to bat for the public with articles slamming the U.S. Food and Drug Administration (FDA) for not protecting the American public.

The papers carried stories about the findings of 12 medical experts attacking the FDA for clearing medical devices when it cannot “…ensure they are safe and effective.”  That same year, the Institute of Medicine called the FDA’s approval process for medical devices “hopelessly flawed.”

Fast forward to 2014. Researchers at the Yale University School of Medicine did a study of the FDA’s approval process and found wide variances in the way it allowed new drugs on the market.  The researchers discovered that “more than one third of the drugs” were approved on the basis of a single trial.  They announced the public’s faith in FDA approved drugs was not “necessarily justified.”

Move on to 2015. That year The New York Times took the FDA to task for approving high risk medical devices on the basis of “just one clinical trial.”

When did attacks against the FDA begin?

The attacks gained steam in 2004 when an FDA senior scientist jeopardized his reputation and his job to attack the FDA before Congress. Dr. David Graham was working in the FDA’s Office of Drug Safety when he testified against the federal agency before Congress.  In an interview with 60 Minutes, Dr. Graham was asked if his testimony had taken a “baseball bat” to the FDA’s reputation.  He agreed it hit the agency hard.

The epidemiologist told Congress the FDA was ignoring “its own safety experts,” leaving harmful drugs on the market. He testified he had tried for some years to get the FDA to recall VIOXX, an arthritic pain medication that was causing heart attacks and strokes.  But theFDA left it on the market for five years.

A New York Times investigation charted the “long path” the FDA allowed Merck to take before the pharmaceutical company finally recalled VIOXX in late 2004. Lawsuits were filed around the country by the hundreds after the recall on behalf of VIOXX’s victims.

Wayne Wright knows the situation could easily get worse

Critics say if the  21st Century Cures Act becomes law, it will increase risks to Americans by accelerating FDA approval of new drugs and medical devices.  Wayne Wright is ready to help anyone injured by the FDA’s flawed system.  His successful record representing clients is reflected in his membership in the Multi-Million Dollar Advocates Forum.  Only lawyers who have won multi-million dollar cases can join the forum.

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