Baycol: A Sudden Rush to Settle

'The pressure is on Bayer to settle,' said David Sampedro, a partner at Panter & Panter. But he could not say why the pace has picked up in recent weeks. The settled cases involved injuries related to a condition called rhabdomyolysis, which the patients developed after taking the drug. None of these patients died.

Nationally, the pharmaceutical companies have settled 450 Baycol cases for amounts ranging from $200,000 to $1 million.

Plaintiff lawyers have lauded Bayer for acknowledging the problems quickly and settling lawsuits rapidly, in contrast to other pharmaceutical companies in product liability cases which long deny fault. 'The [comparison] between these companies and American Home Products, which we sued in fen-phen, is a world of difference,' said John Ruiz, who related that he's still waiting for settlements in those cases 6 years later. Metabolife International also is fighting all allegations about its ephedrine-based diet product, Ruiz said. 'Bayer has responded with good conscience,' he said. 'They knew they had a problem and admitted they were wrong. In general, the plaintiffs' lawyers are pretty satisfied [with them].'

Dangerous in Higher Doses

Millions of patients, mostly elderly, switched to Baycol shortly after it went on the market in 1997 because it was cheaper than other cholesterol-lowering drugs. But it was more effective at higher doses, which is when problems occurred.

In some patients, the higher dosages led to a breakdown in muscle tissue, a condition called rhabdomyolysis. The patients grew weak and lost their ability to walk. Hospitalization quickly followed, and doctors would pull the patients off the drug after performing a blood test and diagnosing the condition. Some patients died, and many others suffered renal failure and required dialysis. But many fully recovered.

When the Food and Drug Administration noticed that higher doses of the drug appeared to be leading to complications, it pressed Bayer to pull the drug off the market. About 56% of the cases have been consolidated in multi-district litigation in Minneapolis, said a Bayer spokeswoman. The first Baycol trial began this month in state court in Corpus Christi, TX.

Documents recently leaked to the news media by plaintiff lawyers indicate top executives at Bayer knew about the dangers associated with the drug but promoted it anyway. Shares in Bayer fell nearly 10% just after The New York Times and other newspapers reported on the documents.

Philip S. Beck, primary legal counsel to Bayer, said that many of the documents leaked to the news media were incomplete and that jurors in Texas would see the full documentation. He suggested that some of the blame for the patients' problems lay with how doctors and pharmacists dispensed Baycol. When Bayer became aware of the problem with rhabdomyolysis, it 'strengthened the labeling, undertook comprehensive scientific studies to analyze the problem, and took a series of increasingly strong steps to educate doctors, pharmacists and other health care professionals,' Beck said. When Bayer concluded that despite these efforts the drug continued to be prescribed in unsafe ways, the company withdrew the product, Beck noted.

New Class Action Planned

Ruiz has filed two Baycol lawsuits, both of which were removed from Miami-Dade Circuit Court to the federal multidistrict litigation. He filed the first suit in February 2000 on behalf of Charles Feingold, a 77-year-old Miami man who died while taking the drug. He filed the other suit on behalf of a 70-year-old woman, Maria Josefa Rodriguez of Miami, who was diagnosed with rhabdomyolysis after taking the drug. She was hospitalized for 10 days. 'She is slowly [recovering],' Ruiz said.

One-third of Panter & Panter's cases are in litigation in Minneapolis. The law firm made the decision not to file any cases in state court, which would have made the patients' doctors defendants in the cases. 'The doctors are not to blame for this,' Sampedro said. 'The sales representatives were instructed not to tell doctors about the problems. We're not going to go after the doctors just to get the cases in state court.'

Ruiz said he plans to file a separate lawsuit against Bayer next week in Miami-Dade Circuit Court over Baycol, seeking class-action status under the Florida Deceptive and Unfair Trade Practices Act. He's seeking reimbursement for the cost of Baycol on behalf of 1 million Florida customers over 2 years. The damages could reach $100 million, he said.

In the last several weeks, Pittsburgh-based Bayer Corp. has been rapidly settling federal lawsuits and claims involving Baycol, the anti-cholesterol drug it pulled off the market in August 2001 after it was linked to 100 deaths worldwide, two Miami law firms say.

About 8000 patients who took Baycol or the families of those who died have filed product liability lawsuits against Bayer and GlaxoSmithKline, which participated in marketing the drug. More than half the suits have been consolidated in multi-
district litigation in U.S. District Court in Minneapolis. Worldwide, 100 deaths and 1600 injuries have been linked to the drug. The drug was prescribed for more than 6 million patients.

The law firm of John H. Ruiz in Miami has 200 Baycol cases, while Miami-based Panter & Panter has 20. Each firm has one wrongful death claim. Both law firms say Bayer, whose international headquarters is in Germany, has made a rush of settlement offers in the last month or two. During that period, Ruiz has obtained settlements in nine cases, for an average amount of $300,000. Panter & Panter has obtained two settlements, for $850,000 and $375,000.

'The pressure is on Bayer to settle,' said David Sampedro, a partner at Panter & Panter. But he could not say why the pace has picked up in recent weeks. The settled cases involved injuries related to a condition called rhabdomyolysis, which the patients developed after taking the drug. None of these patients died.

Nationally, the pharmaceutical companies have settled 450 Baycol cases for amounts ranging from $200,000 to $1 million.

Plaintiff lawyers have lauded Bayer for acknowledging the problems quickly and settling lawsuits rapidly, in contrast to other pharmaceutical companies in product liability cases which long deny fault. 'The [comparison] between these companies and American Home Products, which we sued in fen-phen, is a world of difference,' said John Ruiz, who related that he's still waiting for settlements in those cases 6 years later. Metabolife International also is fighting all allegations about its ephedrine-based diet product, Ruiz said. 'Bayer has responded with good conscience,' he said. 'They knew they had a problem and admitted they were wrong. In general, the plaintiffs' lawyers are pretty satisfied [with them].'

Dangerous in Higher Doses

Millions of patients, mostly elderly, switched to Baycol shortly after it went on the market in 1997 because it was cheaper than other cholesterol-lowering drugs. But it was more effective at higher doses, which is when problems occurred.

In some patients, the higher dosages led to a breakdown in muscle tissue, a condition called rhabdomyolysis. The patients grew weak and lost their ability to walk. Hospitalization quickly followed, and doctors would pull the patients off the drug after performing a blood test and diagnosing the condition. Some patients died, and many others suffered renal failure and required dialysis. But many fully recovered.

When the Food and Drug Administration noticed that higher doses of the drug appeared to be leading to complications, it pressed Bayer to pull the drug off the market. About 56% of the cases have been consolidated in multi-district litigation in Minneapolis, said a Bayer spokeswoman. The first Baycol trial began this month in state court in Corpus Christi, TX.

Documents recently leaked to the news media by plaintiff lawyers indicate top executives at Bayer knew about the dangers associated with the drug but promoted it anyway. Shares in Bayer fell nearly 10% just after The New York Times and other newspapers reported on the documents.

Philip S. Beck, primary legal counsel to Bayer, said that many of the documents leaked to the news media were incomplete and that jurors in Texas would see the full documentation. He suggested that some of the blame for the patients' problems lay with how doctors and pharmacists dispensed Baycol. When Bayer became aware of the problem with rhabdomyolysis, it 'strengthened the labeling, undertook comprehensive scientific studies to analyze the problem, and took a series of increasingly strong steps to educate doctors, pharmacists and other health care professionals,' Beck said. When Bayer concluded that despite these efforts the drug continued to be prescribed in unsafe ways, the company withdrew the product, Beck noted.

New Class Action Planned

Ruiz has filed two Baycol lawsuits, both of which were removed from Miami-Dade Circuit Court to the federal multidistrict litigation. He filed the first suit in February 2000 on behalf of Charles Feingold, a 77-year-old Miami man who died while taking the drug. He filed the other suit on behalf of a 70-year-old woman, Maria Josefa Rodriguez of Miami, who was diagnosed with rhabdomyolysis after taking the drug. She was hospitalized for 10 days. 'She is slowly [recovering],' Ruiz said.

One-third of Panter & Panter's cases are in litigation in Minneapolis. The law firm made the decision not to file any cases in state court, which would have made the patients' doctors defendants in the cases. 'The doctors are not to blame for this,' Sampedro said. 'The sales representatives were instructed not to tell doctors about the problems. We're not going to go after the doctors just to get the cases in state court.'

Ruiz said he plans to file a separate lawsuit against Bayer next week in Miami-Dade Circuit Court over Baycol, seeking class-action status under the Florida Deceptive and Unfair Trade Practices Act. He's seeking reimbursement for the cost of Baycol on behalf of 1 million Florida customers over 2 years. The damages could reach $100 million, he said.