Trasylol Lawsuit News | Trasylol Recall

Patients and families nationwide have looked at filing a Trasylol lawsuit based on the often fatal side effects of the drug Trasylol. Currently no Trasylol class action suits have been filed by Fields Law Firm and claims are being made individually.

The lawsuits claim that Bayer, the drug’s manufacturer, was negligent in several ways including:

• marketing and selling Trasylol as a safe and effective drug for heart surgery patients
• failing to adequately warn patients of unreasonable and dangerous side effects some of which were fatal
• failing to conduct adequate pre-clinical testing and post-marketing studies to determine the safety and side effects of Trasylol
• failing to use ordinary care in designing, testing and manufacturing Trasylol

Trasylol Recall

Bayer’s Trasylol heart surgery side effects have recently been linked to an increased rate of kidney failure, heart attack, and death in the five years following a patient undergoing heart surgery.

In 1993, Trasylol (also referred to as “aprotinin”) received FDA approval for use in certain types of heart surgeries. Until recently, Trasylol was used to reduce the amount of blood a patient loses both during and after a surgery. However, a mounting controversy surrounded the continued use of Trasylol, and in February of 2006, the FDA issued a public health advisory warning physicians to limit use of Trasylol.

A recent study based on observations at 69 leading cardiac centers around the world was published regarding Bayer Pharmaceutical’s heart surgery drug Trasylol. Kidney failure, heart failure, and stroke are side effects associated with Trasylol heart surgery patients according to the study published by Mangano et al. in January 2006 in the New England Journal of Medicine (NEJM).

On September 21, 2006, the FDA met to investigate the dangers of Trasylol. Although Bayer appeared to cooperate with this FDA investigation, it was later learned that Bayer was withholding data from a study which revealed Trasylol causes serious and potentially deadly side-effects. The FDA learned that Bayer did not disclose this important data shortly after the FDA completed its investigation. However, the FDA learned about this data only because a scientist from Bayer’s study tipped off the FDA. Bayer failed to willingly disclose the data to the FDA even when Bayer representatives met with FDA officials to go over the dangers of Trasylol, and even though numerous FDA officials commented to Bayer that they needed more data. Following increasing studies showing the serious risks of Trasylol, Bayer finally removed Trasylol from the marketplace in November 2007 which was essentially a Trasylol recall.

Most heart surgery patients don’t know if they were given Trasylol during their open heart surgery. Many patients suffering from Trasylol kidney failure side effects don’t know if they were given Trasylol during their surgery because the surgeon made the decision whether to administer the drug to stop excessive bleeding during surgery.