Lawsuit filed against Bayer over drug risks
CTV.ca News Staff
Published Sunday, December 7, 2008 11:03PM EST
Lawyers have filed a multi-million dollar lawsuit against drug giant Bayer Inc. and related companies because one of its drugs, which was given to patients to inhibit bleeding during cardiac surgery, has been linked to a higher risk of death.
Bayer voluntarily withdrew the drug, known as Trasylol, from the market a year ago after a clinical trial found that patients treated with the drug were 53 per cent more likely to die than those treated with older, less expensive anti-bleeding medications.
That study, known as the BART trial, was stopped early and Trasylol was pulled from the market in several countries, including Canada. However, the drug is still available in Canada to some doctors via special-access programs.
Trasylol was originally approved for patients who were at an increased risk of blood loss and blood transfusion while undergoing heart surgery, particularly cardiopulmonary bypass. It is estimated that 4.3 million patients worldwide were given the drug since it was approved in 1993.
Before the drug was approved, early animal studies suggested the drug was associated with increased risks, such as heart attack.
The class action lawsuit, which has yet to be certified, claims that the drug maker failed to adequately warn physicians and patients about the risks of the drug. "We say the company had an early red flag, that they knew there were problems with the drug, that it was a very profitable drug and that they either suppressed or chose not to do the research necessary," Charles Wright, a lawyer with Siskinds LLP, the firm that has filed the lawsuit, told CTV News.
Trasylol costs about $1,400 per dose, while similar drugs cost about $4 per dose.
According to a colleague of Wright's at Siskinds, sales of Trasylol totalled about US$293 million in 2005, with forecasts predicting future annual sales of at least $600 million.
Wright and his firm have filed the lawsuit on behalf of the family of Betty Lang, a 67-year-old woman who had surgery in London, Ont., to repair a damaged heart valve in 2003.
Her son, Jeff Lang, said the surgeon told him afterwards that the operation had gone well. However, before she could be discharged, Betty, who was a subject in the BART study, suffered a fatal heart attack.
Earlier this year, not long after the drug was pulled from the market, Betty's family received a letter from the hospital saying she had been given Trasylol during her operation.
"It makes me think the drug should not have been used in the first place and that was a contributing factor to my mom's death," Jeff told CTV News.
A number of class-action lawsuits are already underway in the United States. When contacted about the new Canadian lawsuit, Bayer officials sent an email to CTV News that simply stated: "We have not been notified of any legal action in Canada."
The timing of the lawsuit corresponds with a Health Canada expert advisory panel (EAP) into the use of Trasylol in Canada. Officials from Bayer were scheduled to attend and make a presentation at that meeting.
The lawsuit also corresponds with the early release of an article to be published in the Canadian Medical Association Journal that reviewed 49 randomized clinical trials on Trasylol and found that cheaper alternatives to the drug work nearly as well and should be recommended over Trasylol.
"It's more expensive, no more effective than other drugs and possibly unsafe," Dr. David Henry of the Institute for Clinical and Evaluative Sciences and an author of the CMAJ review, told CTV News. "Consequently, the decision not to use it is an easy one to make."
Bayer representatives would not comment on the CMAJ review until officials could study the findings. However, according to a statement issued by the company, "Bayer will continue to work with Health Canada and other health authorities, to determine what impact, if any, the data and information discussed in the EAP meeting might have on the benefit-risk profile of Trasylol." (For a full statement, find the link on the right-hand side of the page.)
In the meantime, family members will have to check hospital records to find out if a deceased relative was given Trasylol during surgery.
Anyone interested in more information on the lawsuit can use the link on the right-hand side of the page.
With a report from CTV medical specialist Avis Favaro and senior producer Elizabeth St. Philip