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The Law Offices of James Sokolove Highlights Trajedy of Trasylol

02-22-2008 02:22 PM CET | Politics, Law & Society

Press release from: The Law Offices of James Sokolove

Newton, Mass., Feb. 21, 2008 − The Law Offices of James Sokolove (LOJS), dedicated to providing equal access to the civil justice system, expressed its continuing dismay following a recent report on the tragedy linked to the drug Trasylol®. According to a recent segment that aired on the CBS program 60 Minutes, the drug’s manufacturer failed to adequately warn doctors and patients of the risks involved in its use resulting in thousands of deaths and cases of kidney failure.

Manufactured by Bayer Pharmaceuticals, Trasylol is used to control bleeding in patients undergoing coronary-artery bypass grafting (CABG) surgery. In further reporting on February 21, 2008, the New York Times cites 2 new studies in the New England Journal of Medicine on this drug, one of which from Duke University notes that 6.4 percent of CABG patients who were given Trasylol died within 30 days of the surgery, a rate nearly 2.5 times higher than patients who got another drug or who received no treatment.

“Heart surgery patients who received this drug in the operating room may never have connected their subsequent kidney failure with Trasylol administration,” says Attorney Jim Sokolove, principal and founder of the LOJS. “When you consider that this drug was on the market for fourteen years the scope of individual tragedies is immense and needless.”

Although the drug was removed from the market in 2007, early safety concerns were raised by a German researcher who discovered severe kidney damage in animals given Trasylol and subsequent studies yielded similar results in humans.

In 2006, Dr. Dennis Mangano completed an observational study of 5,065 patients in 17 countries. The results of Mangano’s study, which were published in the New England Journal of Medicine, also showed an increased rate of kidney failure and death in patients who were treated with Trasylol. Dr. Mangano filed a report with the Food and Drug Administration (FDA) and that agency advised doctors of those findings.

In 2007, a clinical trial conducted by the Canadian government was halted early due to the high number of deaths among subjects who took Trasylol. The FDA convinced Bayer to stop marketing the drug, and Bayer finally removed Trasylol from the market in November 2007. Today, surgeons use the drug only under special circumstances and the manufacturer recommends that notification of its administration be given to the patient and placed in their medical chart.

“For a drug manufacturer to withhold information that could have saved as many as 1,000 lives per month over a period of two years is incomprehensible,” Sokolove says. “They put innocent consumers at risk with their shameless favor of profits over patients.”

The Law Offices of James Sokolove
1340 Centre Street
Newton Center, MA 02459
Ellen Fletcher
efletcher@jimsokolove.com
617 467 6967

About The Law Offices of James Sokolove
For almost 30 years, The Law Offices of James Sokolove (LOJS) has focused on reinventing how people obtain legal services. Equality of access, irrespective of ethnicity or income, and superior quality of representation and service within our civil justice system is our mission. Within an ever-changing legal profession, the LOJS business model is a proven success strategically matching specific client needs with particular law firm expertise and service quality. LOJS is the nation’s largest and fastest growing marketer of legal services.

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