Trasylol: Bayer Bracing for Lawsuits

Miami, FLAs Bayer AG continues to study the results of the Canadian BART trial on Trasylol, and whether or not those findings may compel the manufacturer to lobby health regulators as to the merits of re-marketing a now-vilified drug, its legal arm prepares for its day in court as lawsuits against Bayer mount.

One of those lawsuits was filed in March in Federal court in St. Louis on behalf of the family of the late Samuel Nakis, age 81, a heart surgery patient who went under the knife in December of 2005. However, soon after surgery the senior began to suffer from renal failure, and was placed on dialysis but to no avail. He died within a month of his surgery.

Nakis' story mirrors those of thousands of other Trasylol patients, whose lives were alleged to have been seriously compromised—or ended early—as the result of the use of the expensive anti-bleeding drug, made by Bayer, during surgery.

Trasylol was originally approved for certain surgeries based on its capacity to control bleeding in high-risk patients, and to mitigate the need for blood transfusions. While there was concern over risk to the kidneys early on, the data was insufficient to raise a red flag for the US Food and Drug Administration (FDA) at the time, which ultimately deemed that the benefits of Trasylol outweighed the risks.

It was later approved for an expanded roster of surgeries, before a staggering series of events, alleged misdeeds, and miscues in the face of mounting evidence that suggested Trasylol was a killer, finally resulted in a halt to the marketing of the drug this past November.

One of the most damning reports, authored by noted researcher Dr. Dennis Mangano, was exhaustive in scope and suggested that Trasylol not only risked as many as a thousand lives per month, with dangers lying in wait for heart and kidneys, it was vastly expensive and at about $1,000 per dose did not prove any more effective than older alternatives that came in at a fraction of the cost, and without the risks.

An FDA review panel summarily dismissed his report in the fall of 2006 due to a lack of comparable studies, even though Bayer had a study in hand which agreed with Mangano's findings, but was withheld by Bayer from the proceedings. Bayer was given a tongue-lashing by the FDA for that oversight, but was never formally censured.

Trasylol was given a passing grade yet again at a review panel in 2007 before mounting evidence became so substantial that Bayer could no longer ignore it.

Earlier this month the US Judicial Panel on Multidistrict Litigation (MDL) consolidated 18 lawsuits filed in 14 federal courts and transferred them to the Miami-based court, a move requested by plaintiff attorneys. Bayer is reported to have wanted the proceedings consolidated to either the District of Connecticut, or the Northern District of Georgia.

It should be noted that the judge presiding over the MDL, Donald M. Middlebrooks, was originally appointed by President Bill Clinton and has a reputation for moving cases through the docket quickly. There is no expectation that cases will drag along for years and years, according to one attorney, with Judge Middlebrooks at the helm.

Good thing for that. The lawsuits against Trasylol are expected to number into the thousands. There are already several million documents produced, in support of the various litigation efforts.

Plaintiffs allege that Bayer marketed and distributed Trasylol without warning doctors and patients of the increased risk of death, associated with the drug.