Drug Safety Developments

Regulator urges lifting Bayer heart drug suspension

Quoted from http://www.reuters.com/article/2012/02/17/ema-bayer-idUSL5E8DH1Q220120217

Regulator urges lifting Bayer heart drug suspension

 

LONDON/FRANKFURT, Feb 17 (Reuters) - The European drugs regulator has recommended lifting the suspension on Bayer's heart-surgery drug Trasylol, saying the results of a study that led to its being taken off the market were unreliable.

Trasylol, based on the active ingredient aprotinin, prevents excessive blood loss during surgery by halting the breakdown of fibrin, a protein found in blood clots.

The drug had been widely used since the 1990s during heart bypass surgery. Bayer pulled the drug globally in November 2007, after preliminary results of a Canadian study known as BART appeared to show an increased death rate in patients 30 days after taking the medicine.

That was followed by detailed assessments of the BART study by several health regulators across the globe.

The European Medicines Agency (EMA) on Friday concluded that there were a number of problems with the way the study was conducted and its findings had not been replicated in other studies.

It said the drug's benefits in preventing blood loss therefore outweighed its risks in patients undergoing isolated heart bypass surgery who were at high risk of heavy blood loss.

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Bayer Settles Cases Over Clotting Drug

Quoted from http://www.law.com/jsp/article.jsp?id=1202471992353

Bayer Settles Cases Over Clotting Drug

Amaris Elliott-Engel

The Legal Intelligencer

September 14, 2010

Drugmaker Bayer AG has agreed to settle about 200 of 2,000 cases in which plaintiffs alleged that the use of Trasylol to control bleeding during their heart surgeries caused injuries such as kidney failure and fatal heart problems.

One Pennsylvania lawyer, James R. Ronca of Anapol Schwartz Weiss Cohan Feldman & Smalley, said he has settled 39 cases for a total of $19.9 million, which would work out to an average settlement of $510,000.

Ronca, who is co-lead plaintiffs counsel for the Trasylol multidistrict litigation centered in the U.S. District Court for the Southern District of Florida and plaintiffs' liaison counsel for the Philadelphia Common Pleas Court Trasylol mass tort program, said he has settled his entire inventory except for one case. Twenty of the cases were federal cases, and 19 of the cases were state cases.

Bloomberg reported in August that Bayer, which has its U.S. headquarters in Pittsburgh, had agreed to settle 150 cases for $60 million.

Neal L. Moskow of Ury & Moskow in Fairfield, Conn., said that he has settled 60 cases so far in the MDL, but he did not want to release the aggregate amount of the settlements.

Moskow said that the first Trasylol case scheduled to go to trial earlier this year was his firm's case and that case involved a much more serious injury than other plaintiffs'; the plaintiff in that case is on permanent dialysis and now is on the kidney transplant list.

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Bayer Said to Pay $60 Million to Settle Suits Over Bleeding-Control Drug

Quoted from http://www.bloomberg.com/news/2010-08-17/bayer-said-to-pay-60-million-to-settle-suits-over-bleeding-control-drug.html

Bayer Said to Pay $60 Million to Settle Suits Over Bleeding-Control Drug

By Jef Feeley - Aug 17, 2010 12:04 PM ET

Bayer AG agreed to pay at least $60 million to settle about 150 lawsuits over Trasylol, a drug used to control bleeding during heart surgeries, people familiar with the accords said.

The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who weren’t authorized to speak publicly about them. Bayer pulled Trasylol off the market in 2007 after researchers found the medicine posed a higher risk of death than competing drugs.

Bayer halted Trasylol sales after studies linked the product to a 50 percent higher risk of death than rival treatments in patients undergoing heart surgery. Trasylol was approved in the U.S. in 1993 to reduce bleeding and cut the need for transfusions during open-heart surgery.

“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by- case basis,” Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement. She declined to comment on the size of the settlements.

Sales of the injectable drug were 230 million euros ($292 million) in 2005, before falling 34 percent the next year after researchers raised safety concerns. Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks and strokes, according to a February filing with the U.S. Securities and Exchange Commission.

1,600 Suits

Leverkusen, Germany-based Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida, for pre-trial proceedings.

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Bayer Faces Nearly 1,000 Trasylol Cases in Florida

Quoted from http://industry.bnet.com/pharma/10004977/bayer-faces-nearly-1000-trasylol-cases-in-florida/

Bayer Faces Nearly 1,000 Trasylol Cases in Florida

By Jim Edwards | Oct 26, 2009

Bayer faces almost 1,000 lawsuits in a Florida federal district court regarding its anti-bleeding drug Trasylol, according to the docket in the case (1:08-md-01928-DMM).

• Download the Trasylol docket here.

While there have been sporadic reports in local media of people filing claims against Bayer alleging Trasylol contributed to renal failure, there has been little overall publicity to what is clearly a massive multi-district litigation effort going on in Judge Donald Middlebrooks’ Southern District federal court.

The above docket shows 952 cases. Not all of those are Bayer Trasylol cases, but the vast majority are. In addition, as BNET has previously noted, cases are being filed in state courts all over the country. They all allege something similar: That a patient went in for surgery, was given Trasylol to prevent bleeding, and suffered renal failure or some other complication as a result.

An anonymous source tells BNET:

Bayer now has close to a 1,000 lawsuits related to Trasylol (consolidated into federal multi-district litigation (MDL) in Florida), plus an unknown but not insignificant number in state courts. Many of these are expected to be dismissed due to the expected difficulty with proving causation. The first trial is expected in March next year.

Bayer has denied that Trasylol is more risky.

On the federal court’s system’s PACER web site, some of the cases have already been dismissed. But Bayer is still in the process of replaying to may of the complaints.

The litigation is so massive that plaintiffs no longer have to write their own complaints. They can use a short-form complaint that is only four pages long. Plaintiffs simply check the boxes on it to allege their injuries.