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Trasylol lawsuits against Bayer mount

May 6, 2008

Trasylol lawsuits against Bayer mount

As 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.

Continue reading, Trasylol lawsuits against Bayer mount

Trasylol kidney failure death unnecessary

May 2, 2008

Trasylol kidney failure death unnecessary

Hayti, MO — Although Trasylol has been recalled, many people are only now realizing that they or their loved ones may have been given the drug during open heart surgery and may have suffered serious adverse reactions to the drug, including kidney failure.

Like many other people, Gigi B. is now trying to determine whether or not Trasylol caused a loved one’s death. Gigi’s mother passed away 18 months ago, shortly after open heart surgery. Gigi says that at first her mother seemed to be recovering well, but two weeks later she died of kidney failure. After watching the 60 Minutes segment on Trasylol, Gigi says she thinks her mother may have been given the drug.

“I saw [Trasylol coverage] on 60 Minutes and it’s identical to our situation,” Gigi says. “They had a guy who was given Trasylol and it seemed like the same exact thing that we went through.”

Gigi says she was very surprised about her mother’s death, especially considering she was told there was a very low risk of death involved in the surgery and her mother had never had kidney problems. Unfortunately, about 10 days after her quadruple bypass surgery, Gigi’s mother experienced a severe decline in her health.

“They [doctors] thought she was well enough to be in her own room, but that’s when she started going downhill.” Only a few days later, Gigi’s mother died. The official cause of death was kidney failure. Prior to her death, Gigi’s mother was on 24 hour dialysis.

“I just hope that they don’t give that drug to people with heart surgery anymore,” Gigi says. “I believe they took it off the market now, didn’t they? I wouldn’t want anyone else to go through that unnecessary death.”

Kidney failure is one of the more serious adverse reactions to Trasylol, and is a main reason why Trasylol has now been recalled. Unfortunately, it was used for a long time during open heart surgery to prevent bleeding and was often given to patients without their knowledge.

Patients and their family members are also investigating a possible lawsuit against the maker of Trasylol, alleging they were not adequately warned of the risks associated with the drug. If you or someone you love may have been given Trasylol during open heart surgery and suffered a negative reaction contact a lawyer to discuss your legal options.

Bayer CEO says faces 78 Trasylol lawsuits in U.S.

April 25. 2008

Bayer CEO says faces 78 Trasylol lawsuits in U.S.

COLOGNE, Germany (Reuters) – Germany’s Bayer AG is facing 78 lawsuits in the United States linked to its Trasylol drug used to stem bleeding during open heart surgery, its chief executive said on Friday.

“We are not aware of any lawsuit outside the United States,” Werner Wenning told a shareholders’ meeting.

Bayer in November temporarily suspended global marketing of Trasylol after preliminary results from a Canadian study linked its use to a higher risk of kidney damage and death.

It said it would vigorously defend itself.

At the meeting, Wenning also said the market environment for its plastics unit could improve next year. Bayer expected lower profit from the unit this year.

Bayer shares rose 4.9 percent to 56.32 euros at 1200 GMT, outpacing a 1.6 percent gain in the German blue-chip DAX index after it published forecast-beating results on Thursday.

Lawsuits seek damages from Bayer over anti-bleeding drug Trasylol

April 22, 2008

WEST PALM BEACH, Fla. — Eight lawsuits filed in a Florida federal court are seeking damages from Bayer AG over a controversial anti-bleeding drug.

The lawsuits involving the drug Trasylol were filed in federal court in West Palm Beach by St. Louis-based law firm Carey & Danis. The firm represents families of people who died after they were given the drug following heart surgery.

Trasylol was on the market for 14 years until 2007, when Bayer stopped selling it. Several studies have documented the drug’s dangers, but Bayer has challenged some of those findings.

The lawsuits seek unspecified damages. They claim Bayer sold a defective drug and failed to issue warnings about its risks. Bayer officials did not immediately respond to an e-mail Tuesday seeking comment.

Heart drug Trasylol pulled from market after 50 percent increase in death rate discovered

April 20, 2008

Pharmaceutical giant Bayer AG has announced that it is withdrawing its drug Trasylol from the market in response to a request by the FDA, in the face of increasing evidence that the drug increases patients’ risk of death.

“[The] FDA could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks,” an agency official said.

Trasylol, known by the generic name aprotinin, is given to patients before major heart surgeries in order to reduce bleeding. It was first approved by the FDA in 1993, and is prescribed to approximately 200,000 patients per year, 55 percent of those in the United States.

The FDA’s request to Bayer came after the early abortion of a study by the Ottawa Health Research Institute, when researchers discovered that heart bypass and valve surgery patients given Trasylol were 50 percent more likely to die than patients not given the drug, even though they experienced less bleeding.

The study was halted early out of concern for the lives of other participants. Because of the early conclusion, however, researchers still do not know why taking Trasylol increases a patient’s risk of dying.

Prior studies have also indicated that Trasylol is a risky drug. A 2006 study in the “New England Journal of Medicine” found that Trasylol is responsible for 10,000 to 11,000 cases of kidney failure each year, in addition to heart attacks and strokes. Another study, conducted by Bayer and initially concealed from the FDA, found that taking the drug increased the risk of stroke and death.

Because many doctors are used to prescribing Trasylol as a matter of course before heart surgeries, the FDA anticipates that phasing the drug out will be difficult. Two FDA panels convened after reports of health risks first surfaced and both concluded that the drug should remain on the market; only after the Canadian study results emerged did the agency ask Bayer to withdraw the drug.

In response to the same study and in contrast to the FDA’s request for voluntary removal, German health regulators withdrew Trasylol’s approval immediately.

Trasylol Lawsuits Filed, Bayer Stock Price Drops Slightly

April 1, 2008

Bayer Pharmaceuticals (BAY GY), Germany’s largest drugmaker, was sued over claims the company misled consumers about the safety and efficiency of Trasylol, its bleeding medication that was used in heart surgery. The shares retreated 8 cents, or 0.2 percent, to 50.76 euros. Continue reading, ‘Trasylol Lawsuits Filed, Bayer Stock Price Drops Slightly’

Trasylol (aprotinin injection): Protect Consumers' Right to Sue Drugmaker

March 14, 2008

Can you imagine what would happen if three jumbo jets crashed in one month? A thousand people dead. Uproar at the FAA. Planes grounded. Immediate comprehensive inspections of all aircraft. Congressional hearings and investigations. Everything possible would be done to immediately assure public safety.

But what if, within one month’s time, a thousand people were seriously injured or died from a known side-effect of a prescription drug that, perhaps, should have never been on the market? In a recent case, nothing happened.

And, depending on how the Supreme Court rules in a case before it, individuals affected by such FDA-approved prescription drugs would have no right to sue, no right to hold a company accountable for a dangerous drug.

Consider the twisted saga of the drug Trasylol (generic name Aprotinin), used to prevent bleeding in heart-bypass surgery. Most people never heard of it until stories appeared on major TV networks recently.

Despite knowledge as early as 1993 from Bayer studies that Trasylol was toxic to the kidneys, the Food and Drug Administration approved the drug, and it went to market. What’s worse, although the drug’s initial use was for high-bleed bypass operations, the FDA in 1998 approved it for any type of heart bypass operation, triggering a rapid growth in its use, with an estimated 350,000 patients, often unknowingly, receiving it in 2005.

Yet the drug company and the FDA did little to investigate the problems with the drug. Not until Dennis Mangano, an independent researcher, published an article in the New England Journal of Medicine in 2006 demonstrating the higher risk of death from Trasylol than from cheaper generic drugs did the FDA issue a health advisory.

Bayer then decided to jump in, commissioning its own study to defend its product. Yet, even though Bayer had the study results, which supported Mangano, the findings and the study’s existence were never mentioned at an FDA advisory committee meeting where a vote kept Trasylol on the market. You don’t have to be on CSI to figure out the motives behind not mentioning your own study.

Another year and another FDA sign-off on this drug went by. Not until fall 2007 did an independent study in Canada prompt suspension of the drug – 14 years after the first red flags were raised. Mangano estimates that about 1,000 patients have died each month as result of Trasylol remaining on the market. One thousand a month, like three jumbo jets falling out of the sky every month.

The Trasylol story is just one of a dozen prescription drug stories we could tell.
Continue reading, ‘Trasylol (aprotinin injection): Protect Consumers’ Right to Sue Drugmaker’

A Lone Holdout? The Duke Doc & Bayer’s Trasylol

March 5, 2008

March 5th, 2008 11:23 am By Ed Silverman (Blog) — There’s nothing like irony, is there? Last September, Peter Smith stood before an FDA advisory committee and attested to the safety and effectiveness of Trasylol, the controversial med that was approved in the US in 1993 to reduce transfusions and bleeding during open-heart surgery, but was later linked to kidney failure and death. Smith, the chief of thoracic and cardiovascular surgery at Duke University Medical Center, was present on behalf of Bayer, which had already weathered a scandal over safety data that wasn’t provided to the FDA and was again defending the drug’s usefulness.

Here’s what Smith had to say: Trasylol “has a favorable risk-benefit profile when used in accordance with the label. It reduces blood loss, transfusion, re-exploration and it may reduce stroke. It is effective in patients with complex and evolving anti-platelet therapies that we have to deal with every day…It is an essential therapeutic option for CABG-surgery patients at increased risk for bleeding and transfusion,” according to the FDA transcript of the meeting (pages 153-154).

At the same time, however, 11 of Smith’s colleagues from Duke’s anesthesiology and surgery departments were wrapping up a review of 10,275 patients at Duke and found that Trasylol posed a 27 percent greater likelihood of death than a rival drug a decade after open-heart surgery. They presented their findings to the New England Journal of Medicine in November, when Bayer suspended sales after a pivotal Canadian trial linked the drug to higher death rates. Bayer promptly dismissed the Duke study.

Continue reading, ‘ A Lone Holdout? The Duke Doc & Bayer’s Trasylol.’

Bayer Posts 'Best Ever' Yearly Results, Expect Trasylol Lawsuits

February 28, 2008

The German group Bayer said on Thursday that 2007 was its best ever year as a major acquisition in its drugs business paid off and a boom in biofuels boosted the agro-chemicals division.

Net profit almost tripled to 4.7 billion euros (7.1 billion dollars) and operating profit before exceptional items, Bayer’s benchmark for forecasts, rose by 21 percent to 6.8 billion euros, a statement said.

Sales gained 12 percent to 32.4 billion euros, while the company’s profit margin reached 20.9 percent, meaning the maker of Aspirin attained its targets of a margin of at least 20.3 percent and sales of more than 32 billion euros.

Continue reading, ‘Bayer Posts ‘Best Ever’ Yearly Results, Expect Trasylol Lawsuits.’

Studies Link Bayer Drug Trasylol to Patient Deaths

February 21, 2008

Boston (dbTechno) – Two new U.S. studies have linked the Bayer AG drug Trasylol to numerous deaths of patients. Bayer AG stopped selling the drug last fall after the deaths took place. It has now been confirmed that the drug, which was an anti-bleeding drug used on heart surgery patients, increased their risk of death.

Trasylol was found in the study to increase the risk of death in heart surgery patients given the drug.

The first of two studies looked at over 10,000 patients who had to go through heart surgeries.

They found that 6.4% of the patients who were given the drug Trasylol died within 30 days of the surgery.

Compared to patients who receievd a different drug, or no drug at all for their bleeding, the death risk for those who took Trasylol was 2.5 times higher.

A second study, which was actually funded by Bayer, found that out of a group of 78,000 patients, the risk of death following surgery was 64% higher in the group that took the drug Trasylol.

Continue reading, ‘Studies Link Bayer Drug Trasylol to Patient Deaths.’