Product Liability Attorney Blog

According to a 60 Minutes investigation, it is estimated that 22,000 lives would have been saved if Trasylol, the anti-bleeding drug used in heart surgery, had been taken off the market once studies linked it to widespread deaths.

In 2006, a study conducted by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation concluded that patients who were given Trasylol had a higher risk of stroke, heart attack and kidney failure.

With the safety of a drug that was making Bayer hundreds of millions of dollars each year, and projected to hit the billion dollar mark, called into question, the manufacturer conducted its own study. It hired Alexander Walker of Harvard’s School of Public Health. He reviewed a database of 67,000 patients and came to a similar conclusion: Patients who were given Trasylol had a much higher chance of dying than patients who were given a comparable drug.

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Republicans lawmakers would support a contempt citation against the health secretary if he did not produce information requested as part of a Congressional committee investigation involving the antibiotic Ketek, Bloomberg News reports.

The House Energy and Commerce Committee is investigating whether Food and Drug Administration Commissioner Andrew von Eschenbach gave misleading testimony about Ketek during a committee hearing. Made by Sanofi-Aventis SA, Ketek is an antibiotic linked to potentially fatal liver damage.

The committee issued a subpoena for the briefing papers used to prepare von Eschenbach for his testimony. In a letter dated Feb. 11, Health and Human Services Secretary Michael Leavitt objected to the request on the grounds that it could create a “chilling effect.”

In a letter dated Feb. 27, the congressional committee informed Leavitt that lawmakers from both sides of the aisle would support a contempt citation if Leavitt didn’t either produce the briefing papers or allow the lawmakers to see the documents and interview FDA staff.

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Two new studies released last week confirm that patients given Trasylol - a clotting drug used during heart surgery to prevent bleeding - are more likely to die.

The latest studies were published in the Feb. 21 issue of the New England Journal of Medicine. According to the Associated Press, the first study looked at Duke University Medical Center patients who had bypass surgery between 1996 and 2005. Researchers found that patients who were given Trasylol were two-and-a-half times more likely to die than patients who received a different drug or no treatment for excessive bleeding.

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