Yourlawyer.com (Baycol News) http://www.yourlawyer.com/topics/overview/baycol Sat, 21 Nov 2009 01:52:52 -0800 pixel-app en Bayer's filings with SEC reveal two subpoenas http://www.yourlawyer.com/articles/read/11460 Wed, 08 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11460
The German-based drug and chemicals firm was subpoenaed by the Department of Justice last month in connection with alleged price-fixing of plastics products. Bayer said it was a defendant in multiple class-action lawsuits that have been consolidated in federal court in Kansas.

Separately, the company was subpoenaed by the U.S. attorney in New Jersey in connection with an earlier federal subpoena over its withdrawn cholesterol drug, Baycol.

Bayer said in the SEC filings that it had exhausted its insurance coverage and could be subject to further payments in 5,900 pending suits that involve Baycol.]]> Bayer gets second subpoena over withdrawn Baycol drug http://www.yourlawyer.com/articles/read/11456 Tue, 07 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11456
Bayer received the subpoena last month, according to the company's annual report filed with the federal Securities and Exchange Commission.

The German-based pharmaceutical and chemical company had received a subpoena in January 2004 also related to its Baycol drug from the Defense Criminal Investigative Service of the U.S. Department of Defense Inspector General.

Bayer withdrew Baycol from the market in August 2001 after it was allegedly linked to about 100 deaths.

The company said that as of Jan. 13, it had paid $1.15 billion to settle 3,082 Baycol cases, without acknowledging any liability.]]> Bad Day All Around for Bayer with Announcements of $1.1 Billion in Baycol-Related Settlements and the Indictment of Two Former Executives for Price-Fixing http://www.yourlawyer.com/articles/read/10486 Fri, 12 Aug 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10486
On the pharmaceutical side, the company announced, that as of June 30, it has paid some $1.138 billion to settle 3,017 personal injury cases worldwide stemming from its ill-fate cholesterol drug, Baycol, which was pulled from the market in 2002 as a result of serious safety problems.

The settlements have averaged about $378,000 and the company still faces significant exposure in thousands of remaining cases in and outside of the U.S.

On the chemical side, the Justice Department (U.S.) announced that two former Bayer executives have been indicted on charges of participating in a conspiracy to fix the prices of chemicals used in the rubber industry.
Jürgen Ick, former head of Bayer’s Rubber Business Group, is charged with conspiring to fix rubber chemical prices in the U.S. and elsewhere between 1995 and 2001 in an effort to suppress competition. Gunter Monn, former head of marketing for the Rubber Group, is charged with joining the conspiracy in 1997.

According to the Justice Department, the investigation that led to these indictments remains active and is continuing.]]> Bayer Pays 1.138 Bln Usd to Settle 3,017 Baycol Cases http://www.yourlawyer.com/articles/read/10471 Wed, 10 Aug 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10471
The chemicals and pharmaceutical hybrid has paid on average 377,195 usd to settle each case.

It said there are now 5,986 cases pending compared to 'fewer than 6,000' as announced at the annual general meeting.

On May 10, Bayer said it had paid 1.133 bln usd to settle 2,995 cases worldwide.

''After nearly four years of litigation we are currently aware of fewer than 50 cases in the US that in our opinion hold a potential for settlement,' Bayer said, adding 'although we cannot rule out the possibility that additional cases involving serious side effects from Lipobay/Baycol may come to our attention'.

In addition, there could be further settlements of cases outside the US.

Bayer has made 371 mln eur in total provisions for the settlements, 300 mln eur of which was in 2003 and 47 mln eur in 2004, with an additional 24 mln charge to the operating result in the second quarter this year.

This is on top of Bayer's insurance cover of 1.2 bln usd for Baycol.]]> Bayer Pays 1.133 Bln Usd to Settle 2,995 Baycol Cases http://www.yourlawyer.com/articles/read/9698 Tue, 10 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9698
The figures show the chemicals and pharmaceutical hybrid has paid on average 381,224 usd to settle each case.

At the annual general meeting in late April, Bayer said there are now fewer than 6,000 Baycol cases pending, compared to 6,174 cases in March.

On March 15, Bayer said it had paid 1.126 bln usd to settle 2,972 cases worldwide.

'After more than three years of litigation we are currently aware of fewer than 50 cases in the US that in our opinion hold a potential for settlement,' Bayer said, adding 'although we cannot rule out the possibility that additional cases involving serious side effects from Lipobay/Baycol may come to our attention'.

In addition, there could be further settlements of cases outside the US, it added.

Bayer has made 347 mln eur in total provisions for the settlements, 300 mln eur of which was in 2003 and 47 mln eur in 2004.

This is on top of Bayer's insurance cover of 1.2 bln usd for Baycol.]]> Bayer Settles More Than 2,900 Lawsuits http://www.yourlawyer.com/articles/read/9241 Wed, 26 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9241
Bayer pulled Lipobay, marketed as Baycol in the United States, in 2001 after it was linked to a rare muscle-wasting syndrome and about 100 patient deaths.

In a regular posting to its Web site, the Leverkusen-based company said it has now settled 2,933 cases and agreed to pay a total of US$1.113 billion without admitting liability. Some 6,359 cases are still pending.

In November the company said it had reached settlements in 2,895 cases and paid some US$1.1 billion in out-of-court deals. ]]> Crestor Gives AstraZeneca A Big Headache http://www.yourlawyer.com/articles/read/9192 Wed, 12 Jan 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9192
The latest negative sign came in a report this week by Deutsche Bank, Astra Zeneca's broker, highlighting that the company had informed regulators in December of a case of a patient taking Crestor who died in late 2004. While there is considerable debate about the significance of the case, it follows a string of bad news over the drug.

Last autumn David Graham, a scientist at the US Food and Drug Administration, darkened the mood when he told a congressional hearing that Crestor also known as rosuvastatin was one of five medicines that should be withdrawn from the market on health grounds.

The FDA, which played down Mr Graham's general criticisms, refuses to comment on the specific case, but it may not yet have had its last word. Sidney Wolfe from Public Citizen, a consumer watchdog that has waged a war against the drug, says: "The FDA is intensively looking at Crestor."

Public Citizen, which lobbied the FDA to make AstraZeneca remove a statement on its website claiming that the regulators had no safety concerns with Crestor, argues that it should be withdrawn.

Dr Wolfe says: "It is a doomed drug. It is not going to survive." He suggests it has caused more than 100 life threatening incidents.

AstraZeneca rejects such claims. Gunnar Olsson, vice-president of the company's cardiovascular division, stresses that Crestor was authorised during a climate of heightened sensitivity, just as the FDA was withdrawing Baycol, a rival drug in the same class of 'statins', from the market.

Mr Olsson says the company used a far larger group of patients in clinical trials some 12,500 than is normal to test its efficacy and safety, and has ongoing trials with 45,000. There are 15m prescriptions of Crestor to 4m patients in 50 countries.

By this summer, he says AstraZeneca should have detailed safety results, but autopsies showed that so far the only two previous suspicious deaths of patients taking Crestor were the result of other factors. He points out that many other explanations may have been behind the latest case.

The principal concern with the statins is that in rare cases they can cause a potentially life-threatening muscle condition known as rhabdomyolysis, triggering kidney failure.

Mr Olsson says that the results for Crestor suggest a lower risk than other statins. Baycol, which had 10m prescriptions, was linked to 31 deaths, for example.

"The key is to look at the data," he says. "I'm scared that if we have a lot of negative publicity about statin risks that forces people to stop therapy, the net effect will be very bad for society. Their beneficial effects are so well documented."

Aside from public health, it is precisely this kind of press that could damage AstraZeneca's financial position. Sales of Crestor this year are projected to reach about $900m (480m), and to peak at up to $3.4bn by 2008, making it one of the company's top three drugs.

"The question is whether the publicity which has helped cut Crestor's US market share from 8.5 per cent to 5.6 per cent will be sustained," says one analyst. "If it becomes a $1.5bn drug, that could cut AstraZeneca's earnings per share from 12 per cent to 10 per cent."

In the months ahead, medical researchers will be scrutinising the safety data closely and investors will in turn be studying their analyses more closely than ever.]]> Interview With Dr. David Graham http://www.yourlawyer.com/articles/read/9078 Thu, 16 Dec 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9078
Drugs, the legal ones, are a huge business in the country and a huge part of our lives. The question on the table tonight is simple, though the answer is not. Is the government doing its job keeping the pipeline of good drugs open and keeping the dangerous ones off the market?

Vioxx, the pain medication pulled by Merck because of increased risk of heart attack, is the best current example. To critics of the FDA it is the tip of the iceberg.

A survey of FDA scientists found that two-thirds are less than fully confident in the safety of drugs on the market. Nearly 20 percent said they felt pressure to approve drugs they thought might be unsafe.

In a moment, the FDA's leading critic, a 20-year employee, Dr. David Graham, first some background from CNN's Elizabeth Cohen.

ELIZABETH COHEN, CNN MEDICAL CORRESPONDENT: Tillman and Mary Harris were married for 47 years, raised a daughter, had grandchildren.

UNIDENTIFIED FEMALE: I miss him terribly, wish he were here.

COHEN: Tillman Harris isn't here because after taking a cholesterol-lowering drug called Baycol, he developed an unusual muscle wasting condition called rabdomyolysis. He became so weak his wife and daughter rushed him to the hospital where he died ten days later.

Six months after his death, Bayer pulled Baycol off the market. At that point, 31 people taking the drug had died of rabdomyolysis. And now the question is could Bayer have prevented those deaths?

Tillman Harris died in February, 2001. In March, 2000, nearly a year earlier, an internal Bayer memo that was quoted in the journal of the American Medical Association this month stated: "Baycol substantially elevates the risk for rabdomyolysis compared with other cholesterol-lowering drugs."

Dr. Jerry Avorn is a professor at Harvard Medical School and author of the book "Powerful Medicines."

DR. JERRY AVORN, AUTHOR, "POWERFUL MEDICINES": Baycol is one of several drugs that we are asking ourselves how in the world did this drug stay on the market as long as it did?

COHEN: The answer, he and others say, is complicated. When drug companies hear of serious side effects they have to by law report them to the Food and Drug Administration but connecting the dots and analyzing the data is time consuming.

AVORN: They haven't had the person power to receive and deal with all of these thousands and thousands of spontaneous reports that the companies send in.

COHEN: If a drug company finds a side effect before a drug goes on the market, it legally has to show that study to the FDA but the law prevents the FDA from making those studies public. Drugs companies say the studies contain trade secrets. Pharmaceutical companies say they reliably report side effects both before and after a drug is put on the market.

ALAN GOLDHAMMER, PH.D., ASSOC. V.P. FOR REGULATORY AFFAIRS: These are significant reporting requirements that companies engage on, on an ongoing basis.

COHEN: Concerning Baycol, Bayer says they kept the FDA fully informed about all pertinent safety information, including adverse event reports. When Bayer became aware of an increased rate of reports of rabdomyolysis it took appropriate action. But the Harris family is left wondering what if Bayer, what if the FDA had taken quicker action before there were 31 deaths.

ROSE HARRIS, DAUGHTER: Somewhere between the one and the 31 there were probably people who wouldn't have passed away.

BROWN: It's a reality, if not always a welcome reality that stories like this one rarely take off until there's a media moment, if you will, even if a lot of people are hurt, some die, moments like the Army reservist in Kuwait or, in this case, an FDA whistleblower testifying before the Congress.

DR. DAVID GRAHAM, FDA SCIENTIST: I was pressured to change my conclusions and recommendations. One drug safety manager recommended that I should be barred from presenting the poster at the meeting and also noted that Merck needed to know our study results.

BROWN: That was Dr. David Graham and Dr. Graham joins us from Washington tonight. Sir, it's nice to see you. GRAHAM: Thank you.

BROWN: I suppose to one degree or another all drugs on the market have some risk associated with them and presumably if they got to market they have some reward. Is the basic allegation that you make that this risk/reward balance is out of balance at the FDA? They're more concerned about reward than the risk.

GRAHAM: That's partially correct. What I maintain is, is that the FDA places almost complete attention and focus and value on what they perceive to be the benefit of a product and discount almost completely the risk side, the safety side, a consequence of a drug.

But, in addition to that, they don't adequately measure what the actual benefit of a drug is. When a clinical trial is done they're measuring what is called the effect of the drug.

The effect of a drug is sort of does it lower your blood cholesterol? Does it lower your blood pressure? Does it lower your blood sugar? That would be the effect of a drug. The benefit of the drug is would it help you to live longer, to live healthier?

And, FDA only measures efficacy. It doesn't measure benefit and yet when a safety problem emerges there we're talking about real lives lost, real lives ruined. FDA typically places a very high value on the efficacy and translates that into saying there's a benefit when they have no established evidence of a benefit and this was the case with Vioxx (UNINTELLIGIBLE) Vioxx.

BROWN: I want to talk about Vioxx a little bit here and perhaps drugs generally as well. In the case of Vioxx, first of all, the number 100,000 heart attacks and the like has been thrown out. Are those actual people or is this a statistical model? Is it a best guess? Do we actually know the names of 100,000 people?

GRAHAM: Well, no. We don't know the names of 100,000 people. The government does this all the time in epidemiology, which is you can't be out there with people counting every person who has a heart attack from Vioxx.

So you take the data that you have at hand, such as the clinical trials that Merck did that showed that Vioxx increased the risk of heart attack for high dose Vioxx 500 percent or the lower dose Vioxx by 200 percent.

And then you determine how many people were treated with the high and the low dose and it's a very simple matter then to calculate out the number of heart attacks that would have resulted.

BROWN: Is it a larger we seem to take drugs longer. We're on anti-cholesterol drugs the rest of our lives that sort of thing. Is the problem greater in drugs that are on the market or drugs coming to the market?

GRAHAM: Well, there are several aspects to that question. FDA when it's looking at a drug for the pre-approval side before it comes to the market says that a drug is both safe and effective before they put it on the marketplace.

Well, they've got the efficacy part right. There they're 90 percent sure or better that the drug works. But when it comes to safety, they're not 95 percent sure that the drug is safe. Instead, what FDA is really saying is, is we don't have 95 percent confidence that the drug will kill you and that's a very different standard.

Now, on the post approval side, once a drug gets to the market drugs that are widely marketed, your blockbuster drugs have the potential theoretically at least to effect a much wider number of patients and with Vioxx that was precisely the reason why so many people were hurt by the drug.

It was a blockbuster drug. It increased the risk of heart attack by a very large amount and heart attack itself is a fairly common event in the general population. You put those things together and you have the formula for a national disaster.

BROWN: Is this about money in the end that the drug industry is powerful, that the agency in your view, people disagree with this I assume, is just simply too close to the industry it's supposed to regulate?

GRAHAM: My own view, and I'm not speaking for the agency of course, is that FDA views industry as its client and this is official FDA, not the FDA scientists. You mentioned the survey in your lead-in to our interview and there we see that many FDA scientists have experienced what I've experienced and that they realize and recognize that FDA is not doing what it needs to do to protect Americans from unsafe drugs.

In fact, I think what that survey demonstrates is, is that FDA is more interested in serving its business clients than it is from protecting the American public from unsafe drugs.

BROWN: There's another way to look at that. I mean in the I think it was 18 percent of scientists said they felt some pressure to approve a drug they felt was unsafe. That means there is 80 percent who did not feel that pressure and how ought we look at that number?

GRAHAM: I think the American people should be appalled by the thought that only 82 percent felt no pressure to change their opinion. Think about this. FDA is a scientific organization. In a scientific organization, the science should speak for itself. No one should feel pressured to change their opinion.

The fact that you've got 18 percent of FDA scientists saying that they felt this pressure is an appalling statistic but consider this also. Most drugs that FDA reviews don't have safety problems to begin with. They're me-too drugs, so they're very similar to other drugs that are already on the market where the problems have already been worked out.

So, the majority of drugs that FDA reviews nobody has a question about them, so we're talking about a subset and in that subset, that subset might just be 18 percent of the drugs that FDA sees and then what you can see is that virtually all the drugs where there is a question about safety, if the scientist raises that question, that scientist will experience pressure to change their opinion.

BROWN: Let's...

GRAHAM: So, it's a misleading statistic.

BROWN: I'm sorry. Dr. Graham, just as a final question, let's talk about the pressure a little bit. Since you testified before Congress or since it was clear you were going to testify before Congress, have they pretty much put you in a closet?

GRAHAM: Well, my supervisors have canceled all their meetings with me. Yesterday I was at a research seminar that we hold in our department and one of our senior managers came into the meeting and there was one empty seat, which was next to me. I greeted this manager with a hello and the manager just basically looked the other way, sat in the seat and didn't say a word to me the entire meeting.

So, it's basically being put into the gulag out in Siberia. I have plenty of work to do and I'm happy to do it and I do it well and my colleagues are very pleased to have me there to help them do the important business of monitoring drug safety in the United States.

BROWN: And we're happy you were with us tonight. We appreciate your time. Thank you, sir, very much.

GRAHAM: Thank you very much.

BROWN: Dr. David Graham, who has been at the FDA for 20 years, his view of the agency. ]]> Merck Short On Moral Values http://www.yourlawyer.com/articles/read/8923 Sun, 28 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8923
According to the Senate testimony by Dr. David Graham, associate director for science and medicine in the Food and Drug Administration's Office of Drug Safety, as many as 55,000 patients may have died as a result of taking Vioxx. Shocking. But not to Merck.

The most loathsome aspect of the Vioxx affair is the way Merck used a $500 million marketing campaign to persuade more than 20 million Americans to pop its noxious little pill before it withdrew the painkiller from the shelves in September. Company executives continued to run these ads long after they knew that there was big trouble brewing. There ought to be a special place in hell for corporations that show such a wanton disregard for human life.

How many times do we have to travel down this deadly path?

The Vioxx affair is certainly giving me a profound sense of drug company dj vu, with the tragic stories of Baycol, Rezulin and Duract still fresh in my mind. After each case come the inevitable calls for accountability and promises to reform the system promises that are then forgotten until the next killer drug hits the headlines.

During the hearings on the Vioxx scandal, Graham, while citing an additional five drugs that he feels pose a danger to the public, said that the nation's compromised drug oversight system had left Americans "virtually defenseless" against killer drugs and warned that we are facing "the single greatest drug safety catastrophe in the history of this country or the history of the world."

And you thought our biggest problem with pharmaceuticals was President Bush refusing to allow us to get cheap drugs from Canada, which he justifies because of concerns about the safety of Canadian drugs.

So why don't things ever change, even as the death toll mounts? As always, the answer can be found by following the money. The big pharmaceutical companies continue to be the 800-pound gorillas of American politics their power stemming from a muscular combination of lobbying ($150 million a year), campaign contributions (close to $50 million doled out to federal candidates over the past four years) and powerful friends in very high places (Don Rumsfeld was formerly CEO of drug industry powerhouse G.D. Searle, and Mitch Daniels, the former White House budget director and now governor-elect of Indiana, was a senior vice president at Eli Lilly).

In a 2000 E-mail, Merck's chief of research called Vioxx's propensity to cause heart attacks and strokes "a shame." Something his company clearly lacks. Of course, the real shame is that we continue to have a regulatory system in which corporate greed, political timidity and a culture of cronyism have rendered the public good a quaint afterthought. ]]> FDA Reviews When Bayer Revealed Drug Risks http://www.yourlawyer.com/articles/read/8920 Fri, 26 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8920
If this week's allegations prove true that the company knew but was slow to inform the government that its drug was riskier than comparable drugs, the Food and Drug Administration could begin a criminal investigation, one official said this week.

Bayer internal company records now in the public domain indicated that by May 28, 1998, three months after the drug went on the market, people who took the drug with gemfibrozil, another cholesterol-lowering drug, had elevated levels of an enzyme that accompanies muscle injury or had developed a rare muscle-wasting disorder. Bayer did not warn doctors and patients not to take the two drugs together until December 1999, four scientists wrote in a Journal of the American Medical Association paper released this week.

In addition Bayer scientists knew in late 1999 and early 2000 that using Baycol alone "substantially increased the risk" of people getting a rare muscle-wasting condition, compared with a rival drug, but they did not immediately alert physicians or patients. FDA rules require speedy notification of serious side effects linked to drugs.

The JAMA article alleged that "before the agency was aware of the data, the company knew that the drug was more dangerous than others. If this allegation is correct, the FDA takes it extremely seriously and we're going to have our criminal investigators look into this," Dr. Steven Galson said during a C-SPAN appearance. Galson is acting director of the FDA's Center for Drug Evaluation and Research.

"Right now, we don't really know whether that's true or not," said Galson. "We read about it in this level of detail for the first time" in the JAMA papers, he said.

FDA spokeswoman Kathleen Quinn said, "Bottom line: We have to go back and look at all the data (to) see what we have and compare and make sure we had all we could have - which we think we did."

Bayer said in a statement that the JAMA articles "contain no new information regarding Baycol and Bayer's timely reporting of data. Bayer kept the FDA fully informed about all pertinent safety information, including adverse event reports. Indeed, an FDA audit of Bayer's postmarketing practices during the time Baycol was on the market demonstrated no deficiencies."

Its pharmaceutical division withdrew Baycol from the market on Aug. 8, 2001, after it was linked to a sometimes fatal muscle-wasting condition, rhabdomyolysis. By then, the FDA had received reports that 31 Americans died from severe rhabdomyolysis after using Baycol. Twelve of those people used Baycol in combination with gemfibrozil.

The company reported it paid $1.1 billion, without admitting liability, in out-of-court settlements of 2,895 cases related to Baycol side effects. The suits were filed after Baycol was withdrawn from the market. Some 7,169 cases are still pending.

Besides published scientific reports and FDA data, the authors of the JAMA paper reviewed internal Bayer documents that entered the public record due to lawsuits filed against the company.

In long-term clinical trials, cholesterol-busting statins atorvastatin, lovastatin, pravastatin and simvastatin were associated with lower risks of causing patients to develop the muscle-wasting condition, the JAMA paper said. Baycol represented only 2 percent of market share - 9.8 million of 484 million statin prescriptions written. Yet Baycol was linked to 57 percent of the muscle-wasting side effects reported by statin users between January 1990 and March 2002.

In an accompanying paper in JAMA, however, an attorney defended the company's actions and noted that at least two of the authors of the JAMA article had been paid experts in plaintiffs' lawsuits against Bayer.

"It always is possible to second guess decision-making after the fact," wrote Joseph D. Piorkowski Jr., outside counsel in Baycol litigation for Bayer Corp., the German drug maker's U.S. subsidiary. "However, when judged fairly by all the facts in their proper context, Bayer's conduct in the marketing of (Baycol) from 1997 to its voluntary withdrawal from the market in August 2001 was responsible, appropriate, and consistently motivated by concern about the safety and welfare of patients."]]> Report: Bayer Held Back on Drug Dangers http://www.yourlawyer.com/articles/read/8902 Tue, 23 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8902
Baycol was pulled from the market in 2001, but an analysis released Monday by the Journal of the American Medical Assn. argued there were strong indications of its dangers three months after its introduction in 1998.

The report adds to concerns that the Food and Drug Administration's drug monitoring system is too lax. The FDA is being criticized for its handling of Vioxx, the arthritis drug that remained on the market after concerns were raised that it increased the risk of heart attacks and strokes. Its manufacturer, Merck & Co., pulled Vioxx off the market in September.

Baycol belongs to a class of cholesterol-lowering drugs known as statins, which have been shown to reduce the risk of heart attacks, but have also been linked to a toxic muscle degeneration known as rhabdomyolysis, which can cause kidney problems and death.

Baycol had by far the highest rate of rhabdomyolysis of any statin, said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington and the report's coauthor.

In a response to be published in the Dec. 1 issue of JAMA but released early with the other reports, a lawyer for Bayer, Joseph Piorkowski, questioned the objectivity of the authors, who had served as expert witnesses in lawsuits against the company.

Piorkowski argued that muscle degeneration was a known risk of all statins, that FDA surveillance had worked effectively, and that the company's conduct "was responsible, appropriate and consistently motivated by concern about the safety and welfare of patients."

The dangers of Baycol, known generically as cerivastatin, cast suspicion over all statins. But a separate study in the same issue of JAMA analyzed data from 250,000 patients who took statins between 1998 and 2001 and showed that three of the most common Lipitor, Pravachol and Zocor proved to be relatively safe.

The risk of the rhabdomyolysis rose slightly when combined with medications known as fibrates, which lower triglyceride fats and are often prescribed in conjunction with statins.

Baycol, taken alone, posed 10 times the risk of other statins, the study said. When taken with fibrates, the danger was enormous: 10% of patients got the muscle disorder.

The study was led by Dr. David J. Graham, the FDA scientist who told a Senate panel last week that his agency was failing to monitor the safety of drugs it had approved.

His analysis did not look at the most powerful statin, Crestor, which was introduced last year. Graham has said that Crestor should be studied further. Its manufacturer, AstraZeneca, has stated that the drug is safe.

Dr. Benjamin Ansell, a cholesterol expert at UCLA, said that the risk posed by statins was far outweighed by their benefits. "More people die every month from aspirin, which is considered to be relatively safe, than have ever died from the statins," he said.

During clinical trials to win FDA approval for Baycol, there were no signs of serious side effects. When the drug was released in February 1998, it carried a standard warning that statins had been linked to muscle degeneration.

But in the first three months of sales, seven cases of rhabdomyolysis were collected through the FDA's adverse-event reporting system. Six of the patients had also been taking a fibrate, according to Psaty.

Psaty, whose analysis was partially based on internal Bayer documents made public during a lawsuit, said the six cases should have been a serious warning.

"There were opportunities to advance science and protect patients that were missed," he said.

In December 1999, Bayer changed the label to warn against an interaction with the fibrate gemfibrozil.

By the time Bayer removed the drug in 2001, the number of rhabdomyolysis cases was estimated to have reached the tens of thousands. By this fall, the company had settled 2,861 lawsuits over Baycol.

A JAMA editorial questioned the FDA's system of monitoring drug safety. The editors said the FDA relied too much on the drug companies to collect information about dangerous side effects of their products. They supported calls for an independent body to monitor drugs on the market.]]> Report Faults Bayer on Baycol Withdrawal http://www.yourlawyer.com/articles/read/8897 Mon, 22 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8897
This time it's Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001 after some who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.

The study concludes that today's top-selling statins are very safe, but could be risky when taken with other drugs called fibrates by older people with diabetes.

It also reveals that fibrates alone can be dangerous. These drugs lower triglycerides and often are taken by diabetics.

Six papers on the issue were to be released Monday and will be published Dec. 1 in the Journal of the American Medical Association. Its editors called for a new, independent office separate from the FDA to monitor drugs after they're on the market.

"It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong," they write.

Merck & Co. and the FDA have been accused of moving too slowly to stop sales of the arthritis drug Vioxx, which Merck withdrew in September after revealing it raised the risk of heart attacks and strokes. Some scientists claim that pain killers similar to Vioxx, especially Pfizer Inc.'s Bextra, also carry risks.

On Thursday, Dr. David Graham, associate director of science in the FDA's Office of Drug Safety, told a Senate panel that the FDA was incapable of protecting the public, and that dangerous drugs are being sold now. Bextra and AstraZeneca PLC's statin, Crestor, were among the five he named.

Crestor wasn't part of the new study that Graham and nine other government and private scientists published Monday because the drug was only approved in August 2003 and their study started in 2001, just after Bayer withdrew Baycol.

They checked records from 11 large health insurance companies on more than 250,000 statin-users from 1998 to 2001. Statins lower LDL or "bad" cholesterol, and fibrates lower a different kind of fat in the blood, triglycerides. People often are prescribed both.

Those taking the top-selling statins Lipitor Pravachol and Zocor had an extremely low risk of the muscle disorder. But it was five times more common in people taking a fibrate, and an additional two-fold greater in people taking both types of drugs.

The risk with Baycol was 10 times higher than for other statins, and astronomical when it was combined with a fibrate: one out of 10 patients taking these for a year would have developed the dangerous side effect.

"I can't think of another drug safety combination where the level of risk is this high," Graham said.

Some popular brand names of fibrates are Abitrate, Atromid, Lopid and TriCor. As for Crestor, the newest statin on the market, its label already warns that people over 65 and those with diabetes or kidney problems are at greater risk of the muscle disorder.

Bayer added a similar warning to Baycol's label but not for more than a year and a half after it had evidence of the risk, Dr. Bruce Psaty of the University of Washington in Seattle and three other drug safety experts write in another article in the medical journal.

As proof, they cited published studies on Baycol and internal company documents that have become public as part of a lawsuit in Texas against Bayer over the drug.

There is a "striking asymmetry" between what the company knew within three months of putting Baycol on the market and what it told the public and physicians, they write. Companies have financial motives to keep such damaging information quiet, and should not be in charge of monitoring the safety of their own drugs an independent group needs to do this, they write.

A lawyer for Bayer, Joseph Piorkowski, wrote a response noting that Psaty and another author have been experts for people who unsuccessfully sued Bayer over Baycol. He also defended the company's actions, saying it labeled and disclosed risks appropriately.

In a separate article, Dr. Brian Strom of the University of Pennsylvania acknowledged the conflict of interest in allowing drug companies to monitor their own products, but said the solution is more support for the FDA and its work not another oversight agency.

Graham, the FDA whistleblower, said people taking statins or fibrates should watch for signs of the life-threatening muscle disorder, which can be treated if caught early. Patients should immediately tell doctors of any muscle pain, weakness, fever, dark urine, nausea or vomiting. ]]> Bayer Says Settlements Over pPulled Cholesterol Drug Total Nearly $1.1 Billion http://www.yourlawyer.com/articles/read/8552 Mon, 20 Sep 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8552
Bayer pulled Lipobay, marketed as Baycol in the United States, after it was linked to a rare muscle-wasting syndrome and about 100 patient deaths.

In a regular update posted on its Web site, the Leverkusen-based company said it has now reached 2,861 settlements and agreed to pay a total of $1.094 billion without admitting liability. Some 7,577 suits are still pending, it said.

Earlier this year, Bayer reached an agreement with most of its insurers on coverage of around $1.2 billion for litigation related to the Lipobay withdrawal. ]]> More Bayer Drug Claims Are Settled http://www.yourlawyer.com/articles/read/8162 Wed, 16 Jun 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8162
Bayer pulled Lipobay, marketed as Baycol in the United States, in August 2001 after it was linked to the syndrome and about 100 patient deaths.

In a regular update on its Web site, the company said 8,563 lawsuits are still pending, compared to the 8,895 it reported in May.
]]> Settlement Reached For Some Plaintiffs In Baycol National Class Action http://www.yourlawyer.com/articles/read/7786 Thu, 18 Mar 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7786
Toronto lawyers said Thursday they have reached a proposed settlement on behalf of plaintiffs across the country who contracted the muscle disease rhabdomyolysis after taking the drug.

A parallel settlement has been reached in proceedings brought on behalf of residents of Quebec.

The settlement does not include complainants in British Columbia, who have launched a separate suit.

Baycol was voluntarily withdrawn from the Canadian market in August 2001, following continuing reports of side effects associated with the drug.

The drug has been linked to two deaths in Canada and 100 others around the world.

"It applies to individuals who ingested Baycol and subsequently, as a result of that developed rhabdomyolysis or kidney disease and in certain cases, death," said a Toronto lawyer.

One of the victims was Pearl Inwood of Belleville, Ont., who died last year. Her family claims Bayer failed to fully test the drug for side effects.

Inwood died in July 2001 of rhabdomyolysis, a condition in which muscle cells are destroyed and released into the bloodstream.

Her daughter Kim Coleman is one of the two representative plaintiffs in the class action.

Lawsuits claim the drug can cause fever, nausea, vomiting and kidney failure, among other symptoms.

A hearing will be held April 21 to determine whether the settlement should be approved.

Notices of the settlement are to be published throughout the country in the coming days.

Plaintiffs who contracted rhabdomyolysis after taking Baycol stand to collect payments ranging from $10,000 for those who didn't have to go to hospital to $100,000 for patients who ended up on dialysis.

The maximum death benefit proposed is $175,000 for someone under the age of 30. ]]> Bayer Reaches Deal On Cholesterol Drug http://www.yourlawyer.com/articles/read/7760 Wed, 10 Mar 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7760
In a statement Tuesday night, Bayer also said it had put aside 300 million euros ($369 million) in its 2003 fiscal year to cover additional settlements and defense costs. The insurers "had previously proceeded only on a provisional basis," the company said.

Bayer pulled Lipobay, marketed as Baycol in the United States, in August 2001 after it was linked to a rare muscle-wasting syndrome and about 100 patient deaths.

On Tuesday, the Leverkusen-based company said it has now reached 2,224 cases related to the drug, paying out $842 million without admitting liability.

Another 9,948 cases were pending in the United States as of March 5, Bayer said.

"Where facts have been developed in the course of the litigation, it so far appears that the vast majority of plaintiffs did not suffer serious side-effects," its statement said.]]> Jury Selection Begins In Trial Against Bayer http://www.yourlawyer.com/articles/read/7176 Tue, 02 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7176
Billy G. Slaughter, 83, of Laurel, is suing pharmaceutical maker Bayer over its drug Baycol. He claims the drug is defective and "carried an unreasonably dangerous risk for severe muscle injury and death," according to a statement by an attorney for Slaughter.

Slaughter took the drug from October 2000 until March 2001, according to the suit, which represents only one side of an argument.

"Slaughter took the drug and suffered sudden and severe muscle weakness, causing him to fall down where he could not get up," his attorney said.

About 100 deaths and 1,600 injuries worldwide have been linked to a muscle disorder caused by the drug.

Bayer pulled the drug off shelves in 2001. The company faces about 11,000 lawsuits nationwide by people who used the drug before it was taken off the market.

There are 71 lawsuits in Mississippi against Bayer, although it could not be immediately determined how many involved Baycol, according to the state Administrative Office for Courts.

As of August, Bayer said it has paid out more than $432 million to settle 1,211 lawsuits involving the drug.]]> Cholesterol Pills Carry Risk, UBC Group Says http://www.yourlawyer.com/articles/read/6648 Tue, 16 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6648
The drugs, called statins, "have not been shown to provide an overall health benefit" when prescribed to people who have not already had a stroke or heart attack and do not have cardiovascular disease, say researchers at the UBC-based Therapeutics Initiative, which assesses the effectiveness of drugs.

The group has sent a bulletin to 12,000 B.C. doctors and pharmacists outlining concern about statins. Last year, Canadian doctors wrote 14 million prescriptions for the drugs. Often, the pills are prescribed to patients who do not have clogged arteries but are considered at risk for a heart attack or stroke because they have risk factors, such as high cholesterol, hypertension or obesity.

Large international studies have found using statins for such "primary prevention" does lead to a 1% to 2% decline in heart attacks and strokes over three to five years. But that benefit appears to be negated by serious adverse effects, said Dr. Jim Wright, head of the UBC group.

He said the studies mention "in the fine print" that the total number of serious adverse events occurred at the same rate in people taking statins and those swallowing dummy pills. "This indicates that the magnitude of the harm caused by taking statins for primary prevention is about the same as the benefit," he said.

Putting it another way, he says the number of heart attacks and strokes was lower for people taking statins, but the incidence of other serious health problems increased.

The studies, which involved close to 40,000 people in North America, Europe and Britain, do not elaborate on what the serious adverse events were. But Dr. Wright says they would include all life-threatening events such as cancer, mental problems and car accidents that land people in hospital.

"They are the kind of thing nobody wants to have happen," says Dr. Wright, who also works with Cochrane Collaborative, an international group that assesses the value of medical inventions and drugs.

Dr. Wright says researchers are required to collect data on serious adverse events as part of drug trials, but do not have to release details. His team at UBC has asked for such information from drug researchers and government regulators in the past and has been told it is proprietary.

"We are challenging them to start releasing the data," Dr. Wright says. Serious adverse event data should be posted on the Web whenever drug trials are published in medical journals, he says.

Statins are racking up multi-

billion-dollar sales worldwide. Use of the pills has more than doubled in Canada in the past five years.

The drugs are frequently described as lifesavers with few side effects. But it is known that statins can cause muscle aches and weakness. In rare cases they can lead to muscle breakdown, known as rhabdomyolysis, which can cause kidney failure and death. One potent statin, called Baycol, was pulled from the market in 2001 after 31 rhabdomyolysis deaths in the United States.

There have been suggestions that long-term use of statins might increase cancer rates and trigger mental and cognitive problems.

Other research has indicated statins may help prevent Alzheimer's disease and treat multiple sclerosis.

"Drugs are all double-edged swords," Dr. Wright says. "They all have some downside and we need to look at adverse effects more carefully than we do."

Note to readers Starting today, our expanded health coverage moves to the front section of the Post and will run every Tuesday and Thursday. Discovery will run Monday and Friday. And a new feature, an Education page, will appear every Wednesday.]]> 3 Arizonans Join Suit Over Baycol http://www.yourlawyer.com/articles/read/6463 Fri, 15 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6463
According to a class-action complaint filed this month at U.S. District Court in Phoenix, the trio suffered from fatigue, muscle pain and other symptoms after taking the product, Baycol, which was withdrawn from the market two years ago after similar complaints worldwide.

Bayer officials could not be reached for comment, but a news release on their Web site says the company "acted responsibly, promptly and appropriately in the management of Baycol."

Chemical News & Intelligence, a trade publication, reported in June that Bayer had reached out-of-court settlements in 1,042 cases and still had nearly 10,000 suits pending. The statutory deadline for seeking damages against Bayer was Aug. 8.

Arizona plaintiffs are identified as Arthur Reiners, 79, Sun City; Ed Dauphinais, 68, Yuma; and Norman Novak, 77, Tucson.

The lawsuit, like others filed elsewhere, alleges that Bayer officials knew the medication could cause a condition known as rhabdomyolysis among some users but aggressively marketed the product to doctors and patients. Rhabdomyolysis attacks muscles and, in severe cases, may cause renal failure, liver damage and death.]]> Oklahomans Sue Companies Over Cholesterol Drug http://www.yourlawyer.com/articles/read/6221 Fri, 27 Jun 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6221
The Garfield County residents are suing Bayer Corporation, GlaxoSmithKline and doctors Bobby Kang and Don Gooch.

The lawsuit filed in Garfield County District Court says the companies knew or should have known Baycol was dangerous and risky.

The two doctors are accused of failing to properly monitor their patients after prescribing the drug.

The eight say they suffer muscle injuries, pain and weakness.

The drug was removed after being linked to a rare but life-threatening condition in which muscle cells are destroyed.]]> Local Couple Files New Lawsuit Over Cholesterol Drug Baycol http://www.yourlawyer.com/articles/read/5799 Sat, 03 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5799
The case comes less than two months after a local jury ruled in favor of the drug's manufacturer, Bayer Corp., during the nation's first trial involving the drug.

Some of the defendants listed in the new case were included in a first draft of the case against Bayer, and a few new names appear on the current list of defendants.

But an attorney for the defendants said the lawsuit doesn't make sense.

Attorneys for the Watts Law Firm sought more than $560 million in actual and punitive damages for 82-year-old Hollis Haltom and wife, Eleanor. Haltom's doctor provided him with 0.8 mg samples of the drug in May 2001. Less than a month into taking the medication, Haltom was paralyzed, suffering from the degenerative muscle disorder rhabdomyolysis.

Defendants in the new lawsuit are Bayer AG, known as the company's German branch, GlaxoSmithKline PLC, and the company it merged with in 2000, SmithKline Beecham Corp. Two pharmaceutical sales representatives are also named in the lawsuit. In it, the plaintiffs claim the drug came without proper warnings regarding its side effects and that the defendants failed to perform adequate testing on the product.

Chris Pinedo, an attorney for the Watts Law Firm, said testimony from the earlier trial showed GlaxoSmithKline provided the samples given to Haltom.

But Tony Canales, attorney for GlaxoSmithKline, said Pinedo's claim is ridiculous.

Canales cited an order signed Friday by County Court-At-Law No. 4 Judge James Klager that showed the plaintiffs voluntarily dismissing their case against SmithKlineBeecham and GlaxoSmithKline.

Pinedo said the Jan. 31 dismissal was "without prejudice," allowing them to file a new lawsuit against the defendants.

Haltom's attorneys accused the company of putting profits before patients when developing and marketing 0.8 mg Baycol, the highest dosage available on the market.

But in March, a jury rejected that notion and said there were no marketing or design defects in the 0.8 mg of Baycol that resulted in Haltom's injury. ]]> Bayer Settles More Baycol Cases http://www.yourlawyer.com/articles/read/5637 Fri, 25 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5637
The chemicals and pharmaceuticals company said it has now settled 740 Baycol cases out-of-court at a cost of around $219 million. That's up from figures released last month that the company had paid $125 million to settle 450 lawsuits.

News of the new settlements boosted Bayer's shares Friday, with stock prices up 4 percent at midday to 17.18 euros ($18.95).

The additional settlements were expected after Bayer won two U.S. court cases clearing it of liability earlier this year.

"This is good evidence that Bayer is making progress in resolving the issue," Merrill Lynch said in a note on Baycol, a view echoed by other analysts.

Bayer forecast double-digit operating profit growth in 2003 and said provisional first-quarter data indicates the operating profit will exceed the 840 million euros ($926 million) recorded during the same period last year.

Sales for the quarter were 7.3 billion euros ($8 billion), a nominal 4 percent increase from the same period a year earlier, according to preliminary figures.

An increase in operating profit this year is to be expected, as Bayer begins to benefit from last year's purchase of Aventis CropScience, making Bayer the world's second largest agrochemicals company after Syngenta.]]> Baycol Court Battle Set To Begin http://www.yourlawyer.com/articles/read/4982 Mon, 17 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4982
It will be only the second trial in the nation over the Bayer Corp. drug pulled from the market in 2001 after being linked to 52 deaths worldwide, including 31 in the United States.

Virgie Hardy, 70, of Jackson, says she suffered muscle soreness after taking the drug for two years. She could not be reached for comment.

The drug has been linked to a muscle weakening disease known as rhabdomyolysis.

Pittsburgh-based Bayer has acknowledged the link to rhabdomyolysis but said it acted responsibly by withdrawing the drug after the Food and Drug Administration linked it to the deaths.

The Mississippi case comes after a Texas jury began deliberating Friday in the nation's first Baycol trial. Jurors were scheduled to resume deliberations today.

Hollis Haltom, 82, is seeking about $560 million in the Texas case.

Hardy's case is limited to $70,000, the maximum allowed in county court. Asked Friday why the case was filed in county court, Hardy's attorney, Roy Wilkins of Jackson, said he had several reasons but wouldn't divulge them.

Jury selection is set for today before Judge William Barnett. Videotaped or live testimony should also take place by the afternoon.

The case is expected to last two weeks. Neither Wilkins nor Robert Johnson III of Natchez, who is representing Bayer in the case, would lay out their strategy Friday.]]> Jurors Begin Deliberations In First Trial On Recalled Cholesterol Drug http://www.yourlawyer.com/articles/read/4969 Sat, 15 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4969
The lawsuit brought by Hollis Haltom, an 82-year-old engineer who said a muscle-wasting disease caused by Baycol severely weakened his legs is the first of about 8,400 cases against Bayer to go to trial.

The panel adjourned for the weekend Friday and will continue deliberations Monday.

Haltom's lawyers produced e-mails and internal documents to argue that the pharmaceutical giant failed to adequately warn doctors about the possible side effects of the billion-dollar drug.

Like other plaintiffs, Haltom suffered from a disease called rhabdomyolysis after his doctor suggested he switch to Baycol.

Pittsburgh-based Bayer has acknowledged the link to rhabdomyolysis but said it acted responsibly by withdrawing the drug in 2001 after the Food and Drug Administration linked it to at least 52 deaths worldwide, including 31 in the United States.

Haltom's lawyers said that number has now grown to 100 deaths worldwide.

They asked for $58 million for suffering and $500 million in punitive damages.

In closing arguments, Bayer attorney Philip Beck acknowledged that Haltom suffered because of Baycol but said the elderly man was blaming unrelated diseases on it. A doctor hired by Bayer found Haltom has many disorders, including diabetes and vascular problems.

"He's an 82-year-old man and he's got a history of really remarkable health problems," Beck said.

Bayer also contended that Haltom's lawyers had taken snippets of e-mails and other internal documents out of context.

Baycol won FDA approval in 1997 and became the fastest-growing drug in Bayer's history and the company's No. 3 seller.

Bayer has paid about $140 million to settle more than 500 Baycol cases. The U.S.-traded stock of German parent Bayer AG has fallen about one-fourth since the trial began in mid-February.

On Wednesday, Bayer said U.S. shareholders had sued Bayer AG over the drop. ]]> Bayer Exec Kept List of Fatalities Associated With Baycol http://www.yourlawyer.com/articles/read/5303 Tue, 11 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/5303
Despite that, Roger Celesk, a senior clinical drug safety officer with Bayer, said the drug was safe and that the drug had been tested extensively.

Celesk's testimony was part of a videotaped deposition shown to jurors Monday. This week begins the fourth week in the civil trial against the drug company. At issue is whether the company is legally responsible for causing 82-year-old Hollis Haltom's muscles to deteriorate after he took the drug to lower his cholesterol. Bayer voluntarily removed Baycol from the market in August 2001.

At one point during questioning, Celesk was asked if Baycol kills people.

"Patients can die as a result of rhabdomyolysis," he said, referring to the muscular disorder Haltom had, which has been identified as a potential side effect.

Later, a Bayer pharmaceutical sales representative told jurors that the company wanted him to focus on Baycol's effectiveness at lowering cholesterol when talking to physicians about the drug.

Pete Curran, who provided samples of the drug to Haltom's physician and is named as a defendant in the lawsuit, said he didn't know that the drug was removed from the market until the company announced it to the public.

Throughout much of his testimony, Curran told Haltom's attorneys that he was only doing what his employers asked. He said marketing Baycol at 0.8 mg, the highest dosage available, was the right thing to do.

"I don't see how it can be the wrong thing," he said. "The (Food and Drug Administration) approved the drug."

Curran's testimony continues today in the fifth floor courtroom of the Nueces County Courthouse. Attorneys for both sides said closing arguments could begin by the end of the week. ]]> $100 Million Lawsuit Questions Bayer's Handling of Recalled Cholesterol Drug http://www.yourlawyer.com/articles/read/4929 Sat, 08 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4929
The lawsuit brought by an 82-year-old retired engineer who says a muscle-destroying side effect made his legs stop working - is the first of thousands against Bayer to go to trial in the United States.

The side effect, known as rhabdomyolysis, can clog the kidneys with disintegrating muscle tissue and cause them to fail. The Food and Drug Administration linked Baycol to at least 52 deaths worldwide, including 31 in the United States.

Pittsburgh-based Bayer has acknowledged the link and said it acted responsibly by withdrawing the drug, known clinically as cerivastatin, in 2001.

The lawsuit paints Bayer as a company overly eager to jump into the lucrative U.S. market for the cholesterol-fighting drugs known as statins. About 8 million Americans use statins to lower their risk of heart attacks, making them the third most widely prescribed drug in the nation.

Baycol won FDA approval in 1997 and became the fastest-growing drug in Bayer's history. By the time it was pulled in August 2001, it was Bayer's No. 3 seller, expected to earn some $720 million that year with 6 million patients worldwide, including 700,000 in the United States.

At the trial, which opened Feb. 18, plaintiff's attorney Mikal Watts said Bayer "knew its drug would kill people, that chose to go ahead and kill people anyway so they could go ahead and make a billion dollars."

Watts' legal team, using an FDA-maintained database, said Baycol was 79 times more likely to cause rhabdomyolysis than competing drugs.

Bayer attorney Philip Beck said that after Bayer finishes presenting its case it began this week, the jury would see that the company worked with the FDA to make sure Baycol was used safely.

The pharmaceutical giant has paid $125 million to settle about 450 cases, and investors are clearly worried. The U.S.-traded stock of German parent Bayer AG has fallen about one-fourth since the Texas trial began.

Internal documents and e-mails released by the plaintiff's lawyers show executives discussing potential dangers long before sales were halted.

In June 2000, an e-mail to a vice president noted that "there have been some deaths related to Baycol," and that people at its marketing partner, SmithKline Beecham, knew it.

"So much for keeping this quiet," the e-mail said.

"How will marketing spin this?" another e-mail wondered.

Beck said the e-mails were taken out of context.

The plaintiff, Hollis Haltom, had his first bypass operation in 1970, but cholesterol drugs had helped keep him sprightly enough for outings with the yacht club, his church and his wife of more than 50 years.

Haltom said he developed problems weeks after his doctor gave him free samples of Baycol in May 2001. He wound up in a wheelchair, then a hospital. He has recovered much of his energy, but his legs still buckle when he tries to rise from the easy chair in his Padre Island home.

Haltom received samples in doses of 0.8 milligrams, a new, larger portion that Bayer had hoped would let Baycol match the effectiveness of rival drugs. An internal letter in June 1999 estimated that the higher dosage would add $25 million a month to Baycol sales.

But the minutes from a teleconference among Bayer executives in April 2001 the month before Haltom got Baycol, show that the company had received "adverse event reports" about the drug. "No samples .8 should be released, and audit of samples and inventory should be done," the minutes said.

An internal e-mail two months later indicated that the company took a different course. It waited two months before sending doctors a letter warning them not to start patients at the higher dosage, and it never printed labels with updated safety information.

"A decision was apparently made to use up the currently existing inventory," wrote Mary Taylor of North American regulatory affairs.

Haltom is seeking $100 million from Bayer and its partner, now known as GlaxoSmithKline.

Bayer said it faces about 7,800 lawsuits from former Baycol users, mostly in the United States. Beck, the Bayer attorney, said the company is taking responsibility for the drug and would rather compensate victims than fight them in court. But he said Haltom's lawyer had backed Bayer up against the wall by demanding a settlement covering 1,600 plaintiffs.

"Most of those cases are meritless," Beck said. "We weren't going to be held hostage like that."

South Texas juries have a reputation of favoring plaintiffs with large awards in personal-injury cases. And Watts, 35, was part of the team that won a $7.5 million settlement in a suit against Ford and Bridgestone/Firestone in 2001. He also won a $43 million verdict against Pfizer over its diabetes drug, Rezulin, though that case was settled in January for a lesser, undisclosed sum.

As a jury was being selected in the Baycol case, Bayer sent a letter to about 2,000 businesses and homes in Corpus Christi, telling people they might soon see negative news about the company and asking them to "keep an open mind."

The letter prompted cries of jury tampering. The district attorney's office is investigating. Beck apologized for the letter but said no jurors never saw it.]]> Bayer On Trial in Corpus Christi http://www.yourlawyer.com/articles/read/4909 Thu, 06 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4909
Bayer says it acted responsibly by pulling the anti-cholesterol drug from the market in 2001, after it was linked to dozens of deaths.

But internal documents and e-mails released by the retired engineer's lawyers show executives discussing the possible dangers of Baycol, especially at proposed higher dosages, long before sales were halted.

The company now faces thousands of lawsuits , the one in South Texas against Bayer's U.S. subsidiary is the first to go to trial and investors are wary about large verdicts or expensive settlements.

U.S.-traded shares of Bayer have lost nearly one-fourth of their value since the trial began two weeks ago.

The plaintiff, Hollis Haltom, says his legs stopped working weeks after his doctor gave him free samples of Baycol, a substitute for other drugs that block production of harmful cholesterol that builds up on artery walls.

Haltom had his first coronary bypass operation in 1970, but anti-cholesterol drugs called statins had helped keep him sprightly enough for outings with the yacht club, his church, and his wife of more than 50 years.

Within weeks of switching to Baycol in May 2001, Haltom says, he was in a wheelchair, then a hospital. He has recovered much of his energy, but his legs still buckle when he tries to rise from the easy chair in his Padre Island home.

Haltom's lawyers say his condition is rhabdomyolysis, a muscle-destroying condition, and they are seeking $100 million in damages from Pittsburgh-based Bayer Corp. They say Baycol, sold in Europe before it was approved for U.S. sales by the Food and Drug Administration, caused rhabdomyolysis up to 79 times more often than competing drugs.

Haltom's doctor testified that he never would have dispensed the medicine if he knew of its problems.

By the time Bayer pulled Baycol from the market in August 2001, at least 52 deaths, including 31 in the United States, were linked to the drug.

Bayer says there are about 7,800 lawsuits pending from former Baycol users, mostly in the United States. The company has paid $125 million to settle about 450 cases and is in negotiations on another 500 cases.

Bayer's outside attorney, Philip Beck, said this week that the company is taking responsibility for the drug and would rather compensate victims than fight them in court. But, he said, Haltom's attorney backed the company up against a wall by demanding a settlement for all 1,600 plaintiffs he and a group of other lawyers represent.

"Most of those cases are meritless," Beck said. "We weren't going to be held hostage like that."

Haltom's lawyer, Mikal Watts, 35, is considered a rising star among trial attorneys in South Texas. He was part of the team that brought a widely watched case against Ford Motor Corp. and tire maker Bridgestone/Firestone to trial in 2001. A $7.5 million settlement was reached as the jury deliberated.

Watts won a $43 million verdict against Pfizer Inc. over its diabetes drug, Rezulin, although the case, on appeal, was settled in January for a lesser, undisclosed sum, Pfizer lawyers said.

In the Baycol case, Watts has introduced Bayer documents that paint a picture of a company so eager to jump into the U.S. market for anti-cholesterol drugs that it ignored or covered up its own troubling research.

"Today was the first day that Bayer's file cabinets were opened to the world," Watts said Friday, after grilling Bayer's head of worldwide regulatory affairs, Lawrence Posner.

"The jury saw documents of a company who knew its drug would kill people, that chose to go ahead and kill people anyway so they could go ahead and make a billion dollars," Watts said.

About 8 million Americans use statins, making them the third most widely prescribed drug in the nation. Bayer officials say research for cerivastatin, the clinical name for Baycol, began in 1985 and product research continued until it won FDA approval in 1997.

Documents introduced so far in the trial show internal dialogue about Baycol dosages. A stronger dosage would add $25 million a month to sales and allow Bayer to match the effectiveness of competing drugs, but the higher dosage alarmed company scientists.

By the time Baycol was pulled from the market, 6 million patients worldwide were taking the drug, including 700,000 in the United States. It was the fastest-growing drug in Bayer's history.

But by then, internal company e-mails were circulating, warning of reports that the drug was causing deaths. "So much for keeping this quiet," read one message. Another said, "how will marketing spin this."

Beck, the Bayer lawyer, said the e-mails were taken out of context. He said that after Bayer presents its case, it was due to begin late Tuesday jurors would see that the company worked with the FDA to make sure Baycol was used safely. ]]> Internal Documents Show Concern at Bayer Over Drug http://www.yourlawyer.com/articles/read/4910 Wed, 05 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4910
The lawyers say the documents show Bayer was concerned about the drug long before it was pulled from the market in August 2001, after being blamed for 52 deaths, including 31 in the United States.

"There have been some deaths related to Baycol. Cas has received a call from SmithKline Beecham product management as well as SmithKline reps. Mark and Jim heard of the deaths from the field as well. So much for keeping this quiet."

June 2000 e-mail from Bayer sales and marketing official Patricia Stenger to Richard Goodstein, vice president of scientific affairs, labeled "rumors in the field."

Some of the documents dealt with increasing the dosage of Baycol to 800 micrograms, or .8 gram.

"I understand that your commercial group have estimated 50 percent of future sales will be for the 800 microgram dose. Which are expected to be about 25 million a month for this dosage strength alone at its commercial peak."

June 1999 letter from Bayer's head of worldwide regulatory affairs, Lawrence Posner, to SmithKline Beecham, a partner in marketing Baycol.

"adverse event reports received by Bayer worldwide, no samples .8 should be released, and audit of samples and inventory should be done."

Minutes from April 2001 teleconference among Bayer executives in Germany and West Haven, Conn.

"A Dear Doctor letter agreed upon in April was never mailed until 2 1/2 months later. The label with the updated safety information was never printed. A decision was apparently made to use up the currently existing inventory."

June 2001 e-mail from Mary Taylor, North American regulatory affairs for Bayer, to Posner.

Plaintiffs claim that patients who got Baycol, known by its clinical name, cerivastatin, were more likely to develop a muscle-wasting disease called rhabdomyolysis than patients using other anti-cholesterol drugs, called statins. Bayer studied the connection.

"The findings indicate that in patients receiving (one drug for cholesterol), cerivastatin substantially elevates risk for rhabdomyolysis compared with other statins."]]> E-mails Put Bayer on the Spot http://www.yourlawyer.com/articles/read/4852 Mon, 03 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4852
''So much for keeping this quiet,'' Patricia Stenger, a manager in Bayer's scientific affairs unit, told other executives in a February 2000 e-mail.

Bayer was then seeking critical approval from regulators to sell its Baycol drug at doses double those permitted in order to increase the drug's effectiveness and its sales, documents from lawyers suing the company show. The Food and Drug Administration gave its approval in July 2000.

In a second Stenger e-mail, in June 2000, an attached document says doctors who reported problems were hearing of similar cases. They ''appear to be more angry and concerned and feel that Bayer is hiding information,'' the attached document says.

Bayer pulled Baycol off the market in August 2001, because the higher 0.8 milligram dose was associated with a rare but sometimes fatal muscular disorder that can damage kidneys and other major organs.

The FDA said reports of deaths were most frequent at higher dosages and when Baycol was used in combination with other drugs. Since, Bayer has said that Baycol has been associated with about 100 deaths and 1,600 illnesses worldwide.

The documents were made public Friday by lawyers for a Corpus Christi man, Hollis Haltom, 82, who says he became sick with the disorder rhabdomyolysis after taking Baycol. The lawsuit is the first of possibly thousands to reach trial over the drug.

Other anti-cholesterol drugs also have been linked to rhabdo, but not at the rate reported for Baycol.

Bayer attorney Philip Beck said Sunday that Bayer reported all deaths and illnesses to regulators. ''There was never any effort to keep that sort of thing quiet,'' he said in response to Stenger's e-mail.

The documents disclosed Friday also show that Bayer executives worried about studying possible side effects of the drug because any results would have to be reported to the FDA in the months leading to its decision about the higher dosage.

''Some are scared to uncover such data (bad data) because of launch of 0.8 mg.,'' one executive, who is not identified, wrote on a January 2000 meeting agenda. ''If FDA asks for bad news, we have to give, but if we don't have it, then we can't give it to them.''

Under questioning by Haltom's lawyer, Bayer's head of worldwide regulatory affairs, Lawrence Posner, testified Friday that if a study were important to safety, it would be unethical not to pursue it even if it produced negative results.]]> E-mails Put Bayer on the Spot http://www.yourlawyer.com/articles/read/4912 Sun, 02 Mar 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4912
"So much for keeping this quiet," Patricia Stenger, a manager in Bayer's scientific affairs unit, told other executives in a February 2000 e-mail.

Bayer (BAY) was then seeking critical approval from regulators to sell its Baycol drug at doses double those permitted in order to increase the drug's effectiveness and its sales, documents from lawyers suing the company show. The Food and Drug Administration gave its approval in July 2000.

In a second Stenger e-mail, in June 2000, an attached document says doctors who reported problems were hearing of similar cases. They "appear to be more angry and concerned and feel that Bayer is hiding information," the attached document says.

Bayer pulled Baycol off the market in August 2001, because the higher 0.8 milligram dose was associated with a rare but sometimes fatal muscular disorder that can damage kidneys and other major organs.

The FDA said reports of deaths were most frequent at higher dosages and when Baycol was used in combination with other drugs. Since, Bayer has said that Baycol has been associated with about 100 deaths and 1,600 illnesses worldwide.

The documents were made public Friday by lawyers for a Corpus Christi man, Hollis Haltom, 82, who says he became sick with the disorder rhabdomyolysis after taking Baycol. The lawsuit is the first of possibly thousands to reach trial over the drug.

Other anti-cholesterol drugs also have been linked to rhabdo, but not at the rate reported for Baycol.

Bayer attorney Philip Beck said Sunday that Bayer reported all deaths and illnesses to regulators. "There was never any effort to keep that sort of thing quiet," he said in response to Stenger's e-mail.

The documents disclosed Friday also show that Bayer executives worried about studying possible side effects of the drug because any results would have to be reported to the FDA in the months leading to its decision about the higher dosage.

"Some are scared to uncover such data (bad data) because of launch of 0.8 mg.," one executive, who is not identified, wrote on a January 2000 meeting agenda. "If FDA asks for bad news, we have to give, but if we don't have it, then we can't give it to them."

Under questioning by Haltom's lawyer, Bayer's head of worldwide regulatory affairs, Lawrence Posner, testified Friday that if a study were important to safety, it would be unethical not to pursue it even if it produced negative results.]]> Documents Suggest Bayer Knew Baycol Problems http://www.yourlawyer.com/articles/read/4753 Sun, 23 Feb 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4753
The papers, given to CNN by an attorney in a personal injury suit against the company, include e-mails and depositions that appear to indicate Bayer was promoting the drug at the same time there were internal discussions about deaths related to Baycol. The documents were first reported in The New York Times Saturday.

One executive wrote in a February 2000 e-mail that word was leaking about deaths related to the drug.

"I am concerned that there is widespread knowledge in the field with both Bayer and SB [marketing partner SmithKline Beecham, which has since become GlaxoSmithKline] representative[s] that there have been some deaths related to Baycol," the executive wrote.

The e-mail suggested Bayer make an official statement before rumors make things worse. "So much for keeping this quiet," it said.

The executive to whom the e-mail was addressed denied in a sworn deposition any attempt to conceal information.

Dr. Richard Goodstein, vice president for scientific affairs at Bayer, was asked in a deposition, "Did you folks at Bayer ever intentionally delay publication of a medical article with the sole purpose of increasing Bayer's profits because the article might give doctors information that was critical of your product?"

Goodstein responded: "I'm personally not aware of that, nor would I ever think that would be the policy of the company."

Bayer's legal counsel, Philip Beck, told the Times the company monitored reports on Baycol, shared the information with regulators, and changed warnings on the drug's label.

"We had a problem getting doctors to use it as directed on the labels, and the majority of cases came from the minority of cases where doctors were not using it as directed on the label," Beck told CNN.

"We concluded that we could not get doctors to use it as directed, and that was the principle for removing it from the market."

Beck emphasized that in only a tiny fraction of cases did users suffer long-term or fatal side effects from taking Baycol.

A spokesman for GlaxoSmithKline told CNN that in marketing Baycol it made no claims inconsistent with product labeling.

Bayer and GlaxoSmithKline are currently facing lawsuits from thousands of people who took Baycol or have relatives who died after taking the drug.

A personal injury case against Bayer just went to trial in Corpus Christi, Texas. The plaintiff in that suit, Hollis Heltom, 82, is suing the company for $100 million.

Holtom's suit claims Bayer acted negligently and with malice. He says he suffered various problems within two weeks after switching from a competing drug to Baycol.

Beck said the documents released by the plaintiff's attorneys are selective. "We are confident that our story is coming in and the jury is understanding it," he said.

"We believe that Bayer acted responsibly and appropriately in how it developed and marketed Baycol," Beck said. "We also believe that Bayer is acting responsibly in its efforts to resolve cases in which patients experience side effects from Baycol."

Baycol is a member of a class of drugs known as statins, which reduce cholesterol by blocking an enzyme called HMG-CoA reductase, which is involved in the formation of cholesterol.

Bayer removed Baycol from the market in July 2001 after the FDA cited concerns about a potentially fatal condition known as rhabdomyolysis the breaking down of muscle that can be associated with all statins.

Holtom's suit says he suffered from the condition.

Although it is a rare side effect, rhabdomyolysis can lead to kidney failure and death. The FDA found that the link between it and Baycol was much stronger than with other statins.

Symptoms of rhabdomyolysis include muscle pain and weakness, fever, dark urine, nausea and vomiting. The muscles most frequently involved include the calves and lower back, though some patients reported no symptoms, the FDA said.

Baycol was considered extremely important to Bayer, internal documents show. Bayer was hoping it would compete with Pfizer's successful anti-cholesterol drug Lipitor.

While deaths have also been associated with Lipitor, the rate is low considering that millions more people use Lipitor than use each of the other statins, including Baycol.

"We need to do everything possible to maximize sales results since Baycol must carry the company for the short and long haul," a sales executive wrote in an e-mail dated May 1998. ]]> Bayer Knew Baycol Was Harmful http://www.yourlawyer.com/articles/read/4754 Sun, 23 Feb 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4754
Company documents, including e-mails, memos and sworn depositions by executives, suggest that Bayer continued to promote the drug despite a company analysis that found patients on Baycol contracted a rare muscle condition much more often than patients on alternative drugs, The New York Times reported.

The condition, called rhabdomyolysis, causes muscle cells to break down, allowing their contents to flow into the blood. Even mild cases can cause severe pain and muscle weakness, and serious cases can shut down the kidneys and cause paralysis or death.

About 100 deaths and 1,600 injuries worldwide have been linked to rhabdomyolysis caused by the drug, according to the company's regulatory filings. According to Bayer, at least 6 million people worldwide took the drug before it was pulled from the market in 2001, when the U.S. Food and Drug Administration raised serious concerns.

About 7,800 lawsuits have been filed against Bayer and its British marketing partner, GlaxoSmithKline. The first trial, in Corpus Christi, Texas, began Tuesday.

Randy Hopper, an attorney for the plaintiffs, said Saturday that the documents cited by the Times were used during a hearing Feb. 7-8 in federal court in Minneapolis and copies were provided to the newspaper. U.S. District Judge Michael Davis in Minneapolis is considering whether the cases should proceed as a class action.

Bayer and GlaxoSmithKline deny wrongdoing, and Bayer contends that most patients who sued have suffered no injury. But the companies already have settled more than 400 cases for individual amounts ranging from $200,000 to $1.2 million, according to patients' lawyers.

A letter in the court filings shows senior executives at Bayer and GlaxoSmithKline knew as early as 1997 the year before Baycol sales began that higher doses of the drug might cause more problems for patients than lower doses, which had been found to be less effective than competing medicines.

Attorney Philip S. Beck, representing Bayer, said the company monitored doctors' reports on Baycol, shared those reports with regulators and repeatedly added to the written warnings on the drug's label.

Beck said Bayer believed that Baycol was safe when prescribed according to the instructions. He said the company took the drug off the market because doctors were not using it as directed.

On June 27, 1997, the day after the FDA approved Baycol, an executive at SmithKline Beecham which later merged with Glaxo wrote to a Bayer executive that he had "serious concerns" about the drug, according to excerpts of the letter included in court papers.

Jerry Karabelas, executive vice president for pharmaceuticals at SmithKline Beecham, wrote that Baycol appeared to be no stronger than a competing drug but caused "drug interactions that could be magnified at higher doses."

"Simple and safe no longer appears to be a viable promotional platform," Karabelas wrote.

Fred T. Magaziner, a lawyer representing GlaxoSmithKline, said Karabelas was writing about drug interactions that were later proved not to be a problem.]]> Baycol Trial Opens, The First of Its Kind In Nation http://www.yourlawyer.com/articles/read/4740 Fri, 21 Feb 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4740
Opening arguments began Thursday in a lawsuit against Bayer Pharmaceutical Co. over its recalled drug Baycol. At issue is the company's role in producing and marketing the drug and its responsibility in causing Hollis Haltom's health problems. The case is considered the first of its kind to go on trial in the nation.

An attorney for the company said researchers had been working on a cholesterol-fighting drug since the mid-1980s and that Haltom, 82, suffered from various medical ailments before he was prescribed Baycol.

Bayer removed the drug from the U.S. market in August 2001 after reports of rhabdomyolysis-induced fatalities. Rhabdomyolysis is a breakdown of muscle tissue that causes renal failure and liver damage. The condition is believed to have appeared after Haltom took samples of Baycol for less than a month. When the drug was removed from the market, the FDA reported 31 deaths in the United States because of rhabdomyolysis associated with the use of Baycol.

Plaintiff's attorney Rickey Brantley told jurors that officials within Bayer were warning of the drug's effects. Despite that, the company sought to market the drug in higher dosages for profit, he said.

Bayer attorney Philip Beck told jurors the company pulled the drug because some doctors weren't prescribing the drug properly. Bayer repeatedly notified doctors and users that muscle breakdown could occur if the drug was initially prescribed in its highest dosage available and if taken with gemfibrozil, another cholesterol-lowering drug.

Attorneys are seeking an unspecified amount of damages in the lawsuit. A pharmaceutical sales representative who provided the drug to Haltom's doctor is also named in the lawsuit.

The trial is being held in County Court-at-Law No. 4. Testimony is expected to continue today in the fifth floor courtroom of the Nueces County Courthouse. The trial is expected to last three weeks. ]]> Bayer Faces Minneapolis Fight Over Pulled Drug Baycol http://www.yourlawyer.com/articles/read/4636 Fri, 07 Feb 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4636
The Coon Rapids man had gotten up in the middle of the night to go to the bathroom and his "leg muscles stopped working," Darsie said.

Ronald Darsie's kidneys failed in the hospital and he died 10 days later. The cause of death: Rhabdomyolysis, a muscle-weakening condition, can be fatal and has been linked with the cholesterol-lowering drug Baycol.

Bayer, the German pharmaceutical maker, pulled Baycol off the market in August 2001 after the drug was linked to more than 50 deaths worldwide. That number now has risen to at least 100 and the drug is at the center of thousands of lawsuits in federal and state courts across the country.

Bayer says the number of Baycol-related lawsuits has risen to 7,800, with 805 filed in Minnesota.

On Thursday, attorneys argued over whether the cases should be consolidated into one class-action suit in U.S. District Court in Minneapolis.

"We think there are dozens of fact questions that have global applicability. Judicial economy dictates that these be resolved at one time, in one place rather than in 50 states around the country," said Richard Arsenault, who argued the plaintiffs' case before Judge Michael Davis.

The courtroom was packed with teams of attorneys from around the country who have worked on complicated mass litigation cases, including suits against tobacco companies and the makers of breast implants and diet drugs.

Arthur Miller, Harvard law professor, television personality and an expert in civil procedures, took part in some of the arguments for the plaintiffs.

Philip Beck, Bayer's lead counsel on the Baycol case, was the main trial lawyer for the Justice Department in the Microsoft antitrust case. He also led President Bush's legal team in the dispute over the 2000 election results in Florida.

Two Twin Cities law firms Zimmerman Reed and Lockridge Grindal Nauen are the lead plaintiffs' counsels in the lawsuit.

Bayer already has settled 430 cases and individual trials, and settlements will probably play a key role in resolving many of the pending cases, regardless of whether a class action is ordered, Beck said..

He argued that the number of people who have suffered serious side effects from the drug is small and that those people would not stay within the confines of a class action anyway.

"Reality No. 1 is that for the vast, vast, vast majority of the people who took Baycol, the drug worked perfectly," Beck said. According to Bayer, 900,000 people in the United States took the drug over a three-and-a-half-year period from January 1998 to August 2001.

Because of the different individual circumstances for each patient, "There will be potentially hundreds of thousands of unique individual fact patterns in this case," Beck said.

The certification hearing will continue today.

Darsie, the woman whose husband died after taking Baycol, plans to go ahead with her own suit regardless of the judge's decision.

Ronald Darsie had been taking Lipitor, another cholesterol-lowering drug, for years but switched to Baycol because he wanted to take something that was less expensive. He collapsed after taking the drug for only a week and a half.

Baycol "was the only thing we figured it had to be," his widow said.]]> Local Residents Learn Effects of Recalled Cholesterol Drug http://www.yourlawyer.com/articles/read/4469 Sun, 26 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4469
Parrish, 80, said she suffered from muscle pain, weakness and a variety of other symptoms for the 14 months she took Baycol, which manufacturer Bayer withdrew from the market in August 2001.

"I had just refilled it the day before they took it off," said the retired Enid resident.

Parrish attended a seminar Saturday at Best Western Inn because she wanted a medical explanation of what the cholesterol drug had done to her. It was sponsored by a pair of law firms representing people who took Baycol before it was taken off the market.

"It's a drug that never should have been put on the market because we didn't need this drug," said attorney James Belote of Stipe Law Firm in Oklahoma City.

Belote said there already were five other cholesterol-fighting drugs called statins available in 1998 when Bayer made Baycol available in the United States.

Dr. W. Wesley Mar-shall said Baycol caused a variety of side effects. The most severe is rhabdomyolysis, a breakdown of muscle cells that can be fatal.

All statins can cause that kind of breakdown, but it happens at a rate 10 times higher in people who took Baycol, he said.

Several hundred deaths worldwide have been blamed on the drug, Belote said.

Marshall said Bayer performed inadequate testing on the drug before it was made available to consumers, then officials were slow to warn doctors about harmful reactions experienced by some who took Baycol.

He said 2.3 million people worldwide took Baycol, including about 700,000 in the United States.

Belote said the drug company introduced a cheaper cholesterol drug to break into that market, which is driven by the fact more than half of all adults have high cholesterol.

Many people were forced to switch to Baycol from other statins because their insurance companies would cover only the cheaper drug, which accounted for $500 million in sales for Bayer in 2000, he said.

About 40 people attended Saturday's seminar to discuss health issues and their legal options.

At Marshall's urging, roughly two-thirds indicated they had taken Baycol, with about half of those suffering some kind of side effects from the drug.

One woman said she uses a cane because of the muscle loss caused by the drug, which sometimes left her weak enough she didn't get out of bed all day.

Another said she suffered similar symptoms despite only taking the drug for about a month.

Marshall said Baycol caused permanent muscle breakdown in many people who took the drug. Their only recourse is to build up muscle that is left.

Parrish has been able to overcome some of the drug's side effects, but she said many still linger, even though she isn't taking it or any other medication any longer.

Belote said complaints voiced at Saturday's seminar have been repeated by people all over the country who took Baycol.

"What you're telling us was experienced by thousands," he said.

As the seminar wrapped up, Belote urged people not to stop taking cholesterol medication. He said they should consult their doctor to discuss any health concerns raised by what they learned there Saturday.

Belote distributed legal documents that he said would allow his firm to pursue claims on behalf of people at the seminar, if possible.

He said it is important for people who took Baycol to decide soon if they want to initiate legal action because the statute of limitations likely will expire in August, two years after the drug was withdrawn by the manufacturer.

Belote didn't promise any results, but he said there wouldn't be any financial obligation for those who wish to investigate a claim against Bayer.

"If we don't make a recovery for you, you don't owe us anything," he said.

Belote said a number of different law firms are pursuing claims against the drug manufacturer.

"We think Bayer ought to compensate people who have been injured by their drug," he said.

Parrish and at least one other person at Saturday's seminar are pursuing claims with other attorneys. ]]> Cholesterol Drug Damaged Woman, She Says http://www.yourlawyer.com/articles/read/4363 Fri, 17 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4363
Patients were given the drug Baycol to lower their cholesterol.

Experts now say the drug killed hundreds. Baycol is part of a family of drugs called statins, which includes drugs such as lipitor, zocor and pravachol.

But doctors say there's something very different about Baycol. They say it's poison.

"I can't open a bottle of pills if I have a headache, said Joyce Stark, who took Baycol. I can't take laundry out of the washer and into the dryer. It's changed My life, definitely changed my whole life."

55-year-old Stark is a shadow of the person she was two years ago. Thanks to her cholesterol pills, she said, she can't hold her grandkids. The drug Baycol, she said, ate away at her muscles until she could barely move.

"My legs, my arms, I don't rest at night because of the pain in my arms and my shoulders," she said.

Dr. Wesley Marshall is trying to reach thousands of patients such as Stark, people who took Baycol for help.

"If I had taken the medication I would be very mad about what Bayer hid from the FDA," Marshall said.

Marshall says Bayer, the makers of Baycol, knew the drug would fail and kept it a secret. It cost some their lives.

"This was all about making money for bayer," he said.

"It's a shame that money means that much to people. It really is, Stark said. "They would rather have money and not care about people's health."

Marshall says if you think you're a victim of Baycol you need to start building your muscles back right now. He suggests light weight-lifting to replace what's lost. Right now, there is no pill that can replace lost muscle tissue.

A team of Oklahoma lawyers were certified for a class-action lawsuit last year, but, that decision was appealed. It'll be months before the state supreme court will make a decision.]]> Bayer Faces More Suits http://www.yourlawyer.com/articles/read/4340 Thu, 16 Jan 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/4340
That number is far above earlier estimates. Bayer said it had settled 400 suits out of court.

Investors are worried that Bayer could face an unforeseeably high financial burden if the claimants win the lawsuits.

Bayer said it expects the first case to be heard in the spring.

Bayer has repeatedly said that it sees no reason to make special provision for the lawsuits.

It argues its insurance will pay for potential claims.

The withdrawal of Baycol, sold as Lipobay in the US, has left the German conglomerate vulnerable and in urgent need of a pharmaceuticals partner to boost its drugs pipeline.

In 2001 alone, the withdrawal of Baycol is estimated to have lowered the group's operating profit by about 800m ($845m). Since then, Bayer's share price has halved.]]> South Dakota Widow Sues Bayer Over Recalled Drug http://www.yourlawyer.com/articles/read/3208 Fri, 22 Nov 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/3208
Pamela Sutterfield's federal court lawsuit seeks unspecified damages against Bayer Corp., GlaxoSmithKline and other parent companies on behalf of her late husband, John Sutterfield.

He died Aug. 4, 2001, from complications from the prescription drug Baycol, according to the lawsuit.

"This was a case where he died of a heart attack and he'd been healthy before that, had recently undergone physical evaluation, and it was shortly after he was started on the Baycol medication that he died unexpectedly," said Mark Connot, Sutterfield's Rapid City lawyer.

Bayer's lawyer did not immediately return a telephone call Friday.

Baycol, a type of drug called a statin, lowers cholesterol levels and reduces the risk of heart disease.

In June 1997, the U.S. Food and Drug Administration let Bayer market Baycol in lower doses. It allowed higher doses in May 1999.

But at least by early 1998, Bayer and GlaxoSmithKline learned that Baycol was linked to a death caused by muscle deterioration. Since then, 52 deaths have been reported that are associated with Baycol. Other patients have suffered muscle damage, the lawsuit states.

Still, Baycol's makers asked the FDA for increased dosages, it states.

They "knew or should have known that Baycol created significant risks of serious injuries or disorders, including damage to kidneys, liver and heart" and did not warn doctors or patients, the lawsuit said.

On Aug. 8, 2001, Bayer announced it was withdrawing Baycol from the market and "finally revealed the dangers associated with Baycol" by sending a letter to doctors, according to the court filing.

For John Sutterfield, it was too late.

He died four days earlier, just a month after starting to use Baycol.

Sutterfield had a physical exam in April 2001. Though it showed his risk of heart problems to be low, he had high cholesterol.

His physician, Dr. David Johnson, prescribed Baycol and also gave Sutterfield some free samples.

Sutterfield started taking Baycol in early July 2001 and immediately developed back and leg muscle pain and cramping, dark-colored urine, fatigue and tiredness all symptoms of muscle deterioration caused by Baycol, the lawsuit states.

He was found dead in his yard.

"The death was directly related to Baycol," the lawsuit states. It "had an adverse effect upon the liver, kidneys, heart and other organs, contributing to and causing the death of John Howard Sutterfield."

Specifically, the lawsuit says Baycol was defective, more dangerous than other statin drugs, not adequately tested and not accompanied with warnings to doctors or patients about its risk of damage to muscle tissue, kidneys, liver and heart or death.

The lawsuit says Baycol's parent companies knew about the risks but ignored them.

Before it was recalled, Baycol had 5 percent of the market for such drugs and was used by more than 700,000 patients, the lawsuit states.

Bayer and GlaxoSmithKline "falsely and deceptively misrepresented or omitted a number of material facts concerning Baycol, including but not limited to, adverse health effects caused by Baycol," the lawsuit states.]]> Eleven Sue Bayer Over Cold Drug, Joining Hundreds Nationwide http://www.yourlawyer.com/articles/read/2882 Thu, 31 Oct 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/2882
The plaintiffs say Bayer should have known that a drug in its Alka-Seltzer Plus and Alka-Seltzer Cold medicines called phenylpropanolamine, or PPA, was dangerous.

In November 2000, the Food and Drug Administration warned that dozens of over-the-counter cold medicines and diet pills containing PPA could cause hemorrhagic strokes. Although the FDA has yet to formally ban the drug, most manufacturers, including Bayer, either pulled those products from the market or reformulated them without PPA.

But the plaintiffs in the Pittsburgh case, and hundreds of others filed in federal courts across the country, say the drug's risks were well-known even before the FDA warning.

"I think we'll be able to show the dangers of PPA were commonly known within the medical and drug manufacturing community and they withheld that information from the public," said H. Blair Kahn, of Richardson Patrick Westbrook and Brickman, LLC, a Columbia, S.C. firm representing the Pittsburgh plaintiffs.

Kahn said his firm represents more than 100 people nationwide who have sued Bayer, or soon will, over PPA.

Bayer spokeswoman Anne Coiley said the company doesn't comment on pending litigation.

The 11 plaintiffs in the lawsuits filed in U.S. District Court in Pittsburgh on Tuesday include six men and five women from Alabama, California, Florida, North Carolina, Ohio, South Carolina and Texas. Four were under 40 and all but one were younger than 60 when they suffered strokes between November 1995 and March 2001.

The youngest plaintiff, Vera Davenport, 33, of Berkeley County, S.C., suffered a stroke on Nov. 2, 2000 - four days before the FDA issued the drug warning.

FDA spokeswoman Laura Bradbard said PPA never received formal FDA approval as an over-the-counter drug. PPA was grandfathered in because it was in use before the federal Food, Drug and Cosmetics Act of 1938 was passed, creating federal drug oversight.

PPA relieves nasal congestion by causing blood vessels to become narrower. This can cause a rise in blood pressure that is harmless for most users but puts some people at risk of strokes. The drug was used in diet pills because it also suppresses the appetite, Bradbard said.

By the 1970s, questions about the drug's safety were raised and the FDA asked the industry, now known as the Non-Prescription Drug Manufacturers Association, to study the drug's safety. After getting no answers for about 20 years, the FDA and the drug manufacturers co-sponsored a Yale University study in 1994, Bradbard said.

Manufacturers were asked to pull the drug from shelves at the end of that six-year study, which examined FDA records showing 44 cases of hemorrhagic stroke among PPA users in the past 30 years. While the study showed women were more at risk, the FDA said not enough cases involving men were studied to conclude they weren't at risk, too.

Bradbard said that although the risk of stroke is very low, the FDA was concerned because it couldn't predict who might be at risk for the strokes and because the strokes could result in severe paralysis or death.

Although Bayer officials wouldn't comment on the Pittsburgh lawsuits, the company's attorneys have filed documents in other lawsuits saying Bayer had no evidence beyond "anecdotal reports" that the drug was dangerous, and that PPA has "been safely used for decades."

The 11 Pittsburgh cases will be transferred to U.S. District Judge Barbara Jacobs Rothstein of the Western District of Washington, in Seattle, who is overseeing the other Bayer PPA lawsuits.

Complex federal cases that arise in several jurisdictions are often consolidated for discovery, the pretrial phase during which the sides exchange evidence and take depositions. Once that process is finished, the cases will go back to the district court where they were filed for trial, assuming that they are not settled first.

Bayer is already facing more than 300 lawsuits in Pennsylvania over the company's anti-cholesterol drug, Baycol, which has been blamed for 100 deaths worldwide. The Baycol cases have attracted more than 100 law firms and estimated 40,000 to 50,000 plaintiffs.

Madison, N.J.-based American Home Products, makers of Dimetapp - another cold drug that contained PPA - have also been targeted by lawsuits, including one by the parent of a 10-year-old Oregon boy who died after a stroke.]]> Cholesterol Medicines Side Effects Questioned http://www.yourlawyer.com/articles/read/2884 Tue, 29 Oct 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/2884
Though their safety and effectiveness have been proven in long-term clinical trials on more than 50,000 people, statins have come under fire recently for causing adverse side effects, including muscle pain and nerve damage. One study, published last month in the Annals of Internal Medicine, found that in some people the muscle damage may be going undetected. Left untreated, that can lead to a rare but more serious muscle disorder called rhabdomyolysis, which can cause kidney failure and death.

More than a year ago, Baycol (cerivastatin) was voluntarily withdrawn from the market after it was linked to 31 deaths caused by rhabdomyolysis. It's not clear just why Baycol was linked to so many deaths compared to the other statins - Mevacor (lovastatin), Pravachol (pravastatin sodium), Zocor (simvastatin), Lescol (fluvastatin sodium) and Lipitor (atorvastatin calcium).

About half the cases were found in patients who also were taking Lopid (gemfibrozil), another cholesterol-lowering agent. According to Dr. Antonio Gotto, a professor of medicine and dean of the Weill Cornell Medical College in New York, "The Lopid interfered with the breakdown of \[Baycol\], so there was a much higher level of exposure of the drug to the muscle." However, the other half involved use of Baycol alone. "It just turned out that Baycol had more toxicity to muscle than the other statins," Gotto said.

The other statins have been shown to cause muscle pain and tenderness, and Phillips is concerned that more serious muscle damage may be going unchecked because many doctors don't change their patients' statin therapy unless they find elevated levels of a muscle enzyme called creatine kinase. As the lead author of the Annals of Internal Medicine study, Phillips reported that muscle disorders may be present when creatine kinase levels are normal. In research Phillips conducted at Scripps Mercy Hospital in San Diego, where he is director of interventional cardiology, he found evidence of four people with muscle symptoms associated with statin therapy who did not have any changes in their creatine kinase levels.

"We decided to report on the four people before we finished the trial because the results were really significant," said Phillips. "Even though it was a small number, they represent a much larger group, and they are the first proof that creatine kinase is not a sensitive enough indicator."

That's important, he says, because a June advisory from the Joint American College of Cardiology, American Heart Association, and the National Heart Lung and Blood Institute told doctors to keep patients on statins if their creatine kinase remains less than 10 times normal even if they have muscle complaints. "The advisory came out because some people are unnecessarily stopping their statins," Phillips said. "It was important that they put out this advisory, but it highlights how little we know about their toxicity."

A recent study published in the journal Neurology also links statins to nerve damage in the form of weakness, tingling and pain in the hands and feet, as well as difficulty walking. According to the report, which looked at 500,000 Danish residents, one year of statin therapy raised the risk of nerve damage by about 15 percent. Taking statins for two years raised the risk to 26 percent.

Phillips says the Danish study provides "just one more example of a toxicity that wasn't picked up [in earlier] trials, largely because they aren't designed to look at toxicity. They are designed to look at efficacy."

He believes the new studies suggest the need for changing the current guidelines. "Because they [statins] are so safe, our current guidelines have accelerated who we should give them to. People with lower cholesterol are recommended to be on the drug because they have no toxicity. Maybe we shouldn't be using the drugs on everyone."

Gotto, a leading investigator in one of the statin trials and a consultant to several pharmaceutical companies that manufacture the drugs, disagrees. Now, about 12 million Americans are taking statins. But "up to 36 million Americans should be on statin therapy," according to the guidelines, he says.

"I think we're underusing them," he said. "People with a wide variety of diseases are treated with statins. I'm not saying we should ignore the observations, but to reduce the recommendations for the use of statins based on this would be irresponsible."

Doctors are also concerned that the recent reports will prompt patients to stop taking their medicine. "It's important to note that these results are preliminary," says Dr. Allison Spatz, director of the coronary care unit at North Shore University Hospital in Manhasset. "The numbers of patients who experience muscle symptoms without elevation of [creatine kinase] were really small. More studies need to be done. It's not a reason to stop your statins."

Bernard Siegal, 69, a pharmacist from Roslyn, began experiencing sharp back pain five years after he started taking Mevacor, but he was switched to Zocor and hasn't complained since. He knows the benefits of statin therapy far outweigh the risks.

"There is always a controversy," he says. "It's all a risk, whatever you do in life. I figure, I survived this long, I'll go with the program."

Anyone experiencing muscle tenderness and soreness from statin therapy should speak with his or her doctor. It's possible the condition can be remedied. For example, Louise Spadaro, a cardiologist in Roslyn, switches her patients to different medications - people react differently to each statin - or she suggests taking the medicine at different times of the day, with food or with lots of water. Spadaro has also been able to reduce muscle symptoms by combining therapy with antioxidants. However, that must be done under a physician's care because some vitamins, such as niacin, can exacerbate muscle aches. ]]> Bayer Faces 3,500 Drug Lawsuits http://www.yourlawyer.com/articles/read/2594 Mon, 21 Oct 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/2594
In August, the company had said it faced 2,000 claims regarding its once-lucrative Baycol, marketed outside the United States as LipobayLibobay drug, which was sold in the United States as Baycol.

Spokesman Guenter Forneck said Bayer has settled 100 lawsuits linked to patients who suffered severe side effects from taking the medication. He declined to say how much Bayer had paid.

News of the rising number of claims sent the company's shares tumbling. The stock was down 7.5 percent in Frankfurt on Monday afternoon, trading at 19.95 euros ($19.40).

The drug was associated with a rare muscle-wasting syndrome, rhabdomyolysis.

Bayer has repeatedly said the lawsuits against it are groundless and it has settled the cases without admitting responsibility.

The company said last month that its product-liability insurance would likely cover any damages. The company has set aside no additional funds. ]]> Bayer Says It Has Settled Some Individual Suits Over Deaths Linked To Cholesterol Lowering Drug http://www.yourlawyer.com/articles/read/1736 Wed, 18 Sep 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/1736
In filings with the U.S. Securities and Exchange Commission, the company said it had settled "a small number" of individual cases brought over Baycol, marketed outside the United States as Lipobay, and said it might settle more.

The SEC filing dates from June and is posted on Bayer's Web site.

Spokesman Michael Diehl declined to say how much Bayer had paid, or give other details. He said he had no information about further settlements.

The drug was associated with a rare toxic muscle-wasting syndrome, rhabdomyolysis. Bayer said it had settled the cases without admitting responsibility. It said about 2,000 lawsuits have been filed against the company worldwide seeking damages because of Baycol, most of them in the United States.

"We may, on a case-by-case basis, settle additional cases for reasonable amounts when, in our judgement, settlement is economically feasible given the risks and costs inherent in litigation," the company said.

Lawyers for the plaintiffs in the United States have sought to pursue damages under class-action suits that represent people as a group, but none of the cases have gone to trial yet.

Bayer's product-liability insurance is likely to cover the extent of the legal damages, Diehl said. The company has set aside no provisions for any further liability, Diehl said.

Bayer has repeatedly said the lawsuits against it are groundless. It withdrew the drug in August, 2001. ]]> Bayer May Settle Some Baycol Claims http://www.yourlawyer.com/articles/read/1249 Wed, 07 Aug 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/1249
In a preview of an interview with the WirtschaftsWoche weekly, Werner Wenning also said Bayer could cut another 4,000 jobs as it combines its farm chemicals business with its $7 billion acquisition, Aventis CropScience, that was completed in June.

Beyond that, "there may be further job cuts due to restructuring," Wenning told the weekly.

The decision adds to 6,300 job cuts already announced to the 128,000 Bayer employees. The company had planned to drop 5,000 jobs by 2005 under cuts decided before its key Baycol drug was withdrawn, and it has announced 1,300 more since.

Bayer, based in Leverkusen, is in the midst of an overhaul launched last year after links to more than 50 patient deaths forced it to pull Baycol, marketed as Lipobay in some countries.

Bayer was hit by lawsuits seeking damages for patients and their relatives over the recalled drug. It insisted the claims are groundless and says it has set no money aside for possible compensation payments.

In the interview, Wenning said the company might consider settling some individual lawsuits brought over the drug, but insisted that Bayer "acted properly on the basis of the contemporary state of knowledge." ]]> New Label Fears Sink Merck Stock http://www.yourlawyer.com/articles/read/779 Thu, 06 Jun 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/779
The new label for cholesterol-lowering agent Zocor highlights the risk of patients developing Myopathy and Rhabdomyolysis from taking the drug alone or in combination with other medicines. Myopathy is a condition which causes muscle pain and weakness. Rhabdomyolysis is a related, potentially lethal condition which destroys muscle cells and releases them into the blood stream, sometimes causing kidney failure.

Both conditions have been linked to the cholesterol-lowering drugs known as statins. However, last year, Bayer Corp. withdrew its cholesterol-lowering drug Baycol because it was tied to 31 deaths in the United States caused by Rhabdomyolysis.

Merck spokesman Greg Reaves said the revision was not connected to any severe patient side effects from the drug. He added Merck requested the change from the Food and Drug Administration based on some routine follow-up studying of Zocor because "it was in the best interest of patients and doctors."

"We think this adds clarity. It does not change the safety and efficacy profile of Zocor which have been well established," he said.

Prudential analyst Tim Anderson, who reported the changes in a report released Thursday, said he expected the revision to hurt Zocor sales, which totaled $6.8 billion last year. Anderson anticipated Zocor's competitors would use the information to boost their own sales_unless the FDA requires similar label changes from the other statins.

Both Pfizer Inc, which makes market leader Lipitor and Bristol-Myers Squibb Co, which makes Pravachol, said they were not discussing any similar label changes with the FDA. Neither would comment on whether they would use Merck's new label to benefit their drugs.

"I think Pfizer will use it," said Anderson of the company noted for its marketing practice.

Indeed, Anderson expects Lipitor's sales to grow even though AstraZeneca PLC will be introducing a statin called Crestor either later this year or in early 2003. Analysts studies have shown that Crestor works better than Lipitor but that the later is more safe. Anderson says that will become more important in the wake of Zocor's label change.

Anderson hasn't lowered either his Zocor sales estimates or 2002 earning forecast for Merck because he said they were already conservative. He expects Zocor sales to reach $7.3 billion and earnings to hit $31.3 a share. Last year, Merck said 2002 earnings would be flat because of patent expirations and slow growth of pain reliever Vioxx.

Specifically, the new label uses "Myopathy and Rhabdomyolysis" is a warnings section that had previously referred to "skeletal muscle" issues. Another sections uses bullets, underlines and bold text in the section of the label discussing Myopathy and Rhabdomyolysis

The new label also states the risk of the conditions is higher with larger does of the drug and warns patients taking a heat drug called Amiodarone not to exceed a 20 mg. dose of Zocor.]]> Bayer Issues Partial Drug Recall http://www.yourlawyer.com/articles/read/226 Sat, 16 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/226

Bayer said someone diluted at least 13 vials of its liquid drug Gamimune N with saline. The company is recalling about 8,000 of the vials distributed nationwide, and the Food and Drug Administration (news - web sites) is investigating.

Bayer said it knew of no patients harmed by the diluted drug, and was unsure what effects it would have on a patient.

Gamimune N is used by about 20,000 patients with weakened immune systems, including bone marrow transplant recipients.

Bayer said it believes the tampering occurred after the drug left its North Carolina plant and is limited to two lots handled by a single distributor, which the company refused to identify.

"We have really isolated this incident to the two lots," said company vice president Michael Fournel. "We have no reason to believe the other lots are affected."

Bayer makes two million vials of Gamimune N each year.

The FDA said it is comfortable with Bayer's limited recall decision.

"I think at this point the information indicates that the actions taken by Bayer are appropriate," said Steve Masiello, director of the office of compliance and biologics quality.

Bayer said customer complaints earlier this year that their vials of Gamimune N contained uncharacteristically cloudy liquid prompted it to recall one lot on Feb. 1. Fournel said the company has since received 500 vials from that first lot. Several of those vials showed obvious signs of tampering, Fournel said.

Bayer began recalling the second lot Thursday. Fournel said the company waited that long because it didn't conclude until Monday that someone had tampered with the drugs.

Earlier this month, a Kansas City, Mo., pharmacist pleaded guilty to diluting two chemotherapy drugs made by Eli Lilly and Co. and Bristol-Myers Squibb. Prosecutors said Robert Courtney made hundreds of dollars extra per dose.

Pittsburgh-based Bayer Corp. is a subsidiary of German conglomerate Bayer AG. The company voluntarily removed the anti-cholesterol treatment Baycol from the U.S. market last August after the FDA linked it to 31 deaths.]]> Oregon Filed Against Baycol Maker http://www.yourlawyer.com/articles/read/179 Wed, 06 Mar 2002 00:00:00 -0800 http://www.yourlawyer.com/articles/read/179
The lawsuits, filed Tuesday, assert that German pharmaceutical company Bayer AG pushed the drug onto the U.S. market without adequate warning to doctors or federal regulators about potential side effects, such as kidney or lung failure.

"They rammed it through the FDA (news - web sites) when in fact the medicine was never tested on a long-term basis," said Diane Craine, one of the lawyers representing the four plaintiffs.

Officials at Bayer Corp., the drug company's U.S. subsidiary in Pittsburgh, did not immediately return phone calls.

Bayer voluntarily removed Baycol from the market last August after the U.S. Food and Drug Administration linked it to 31 deaths.

Baycol, like other anti-cholesterol drugs called "statins," has been linked to rare reports of rhabdomyolysis — the destruction of muscle cells which are released into the bloodstream, causing severe muscle pain and leading to potential organ failure and death.

Craine said Baycol has accounted for 42 percent of the deaths linked to statins when it has just 2 percent of the market for the drug.

"Bayer wanted a piece of big, financially rewarding market so they brought in this high potency drug and promoted it," Craine said.

One of the Oregon plaintiffs, Kathryn McKewen, 70, a former nurse, said she took Baycol after returning from medical missionary work in Russia and her doctor initially told her it had significantly lowered her cholesterol.

But then McKewen and her doctor became alarmed at the gradual onset of symptoms, including severe pain and swelling in her legs that since have confined her to a wheelchair.

Three of the lawsuits were filed Tuesday in Multnomah County Circuit Court while the fourth was filed in U.S. District Court in Oregon. The federal lawsuit did not list any doctors as defendants, unlike the complaints filed in state court, attorneys said.]]> Bayer legal action over Baycol gathers pace in US http://www.yourlawyer.com/articles/read/44 Tue, 04 Sep 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/44
The troubled chemicals and pharmaceuticals group also faces an investigation by the state prosecutor in the German city of Cologne, which launched an inquiry into whether Bayer withdrew Baycol quick enough after it was linked to more than 50 deaths worldwide.

The lawyers, representing hundreds of patients and their families, will decide how to extract maximum damages from the German company. "It's all about rolling up our sleeves and working together," said Kenneth Moll, one of the organisers of the meeting.

Mr Moll said some of the tasks included looking at patients' medical records and Bayer's marketing campaigns. The law firms have already filed a petition to consolidate their moves into one class-action lawsuit.

On Wednesday, three doctors who specialise in heart disease will make a presentation to the lawyers.

Bayer, which blames the deaths on a cross-reaction with another fat-reducing drug, Gemfibrozil, said that it had acted responsibly and in its patients' interest at all times.

Marc Pfeffer, a Harvard professor who has studied the safety of Pravastatin, a cholesterol-lowering treatment made by Bayer's rival Bristol-Myers Squibb, said it was extremely difficult for companies to spot rare side-effects, even in studies with tens of thousands of patients.

How quickly Bayer knew about the problem with Baycol - known as Lipobay outside the US - would have been "a mathematics game," dependent on how many patients took the drug over a long period of time, he said.

"It's a question of who knew what, when and how long does it take them to cry 'uncle'" he said.

The company faces more than 15 applications for class actions in the US, and analysts have put the potential cost of litigation at between $500m-$3bn.

However, lawyers concede that it would not be easy to prove a connection between the deaths and the drug, or to establish fault on the part of Bayer.

Bayer will take a charge of between E250m-E300m ($363.5m-$436.1m) to cover the cost of withdrawing Baycol, but has made no provision for costs arising from the lawsuits.

Bayer shares have fallen 20 per cent since the withdrawal on August 8 on worries over profit implications, uncertainty over the company's future corporate strategy and concerns about potentially costly legal action from those claiming to have suffered from the drug.

Andreas Theisen, analyst at West LB Panmure said the legal claims could haunt Bayer for some time unless it decided to settle out of court.

"Despite the fact that Bayer believes it has acted correctly, it cannot be excluded that the company will make efforts to reach settlements soon," he said. ]]> Pulled drug may be linked to 52 deaths http://www.yourlawyer.com/articles/read/43 Mon, 13 Aug 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/43
The Leverkusen-based company said the deaths occurred following treatment with Baycol's active ingredient, cerivastatin. It said the chances of the drug, known as Lipobay outside the United States, ever returning to the market are "slim."

"If the use of this medicine has resulted in damage to health, that is something we deeply regret," chief executive Manfred Schneider said at a news conference Monday. "We do everything we can to eliminate such risks," stressing that there is still no proof that the drug caused the deaths.

The German Health Ministry, meanwhile, said it ordered a report from regulators into whether the drug should have been recalled earlier. The findings are to be presented Thursday.

Bayer's stock dropped by 20% in three days after it announced the recall because of possible links to deaths. Schneider pledged to overhaul his pharmaceuticals strategy, sparking speculation it will seek a joint venture or sell the unit.

"We will now examine what strategy we adopt, what new targets we set ourselves, and how we achieve them — on our own or in partnerships," he said.

Schneider said that two rival companies had approached Bayer about a partnership, but he didn't identify the companies or indicate what they proposed. The news helped Bayer's stock recover in early afternoon trading Monday.

Bayer plans to cut 5,000 jobs across the company and close 15 polymers plants by 2005 under a plan to save $1.3 billion and offset mounting problems at the drug unit and the impact of the slowing world economy. That's even before possible job cuts as a result of the withdrawal of Baycol.

On Thursday, it announced a 45% drop in second-quarter operating profit and warned full-year operating profit before one-time items would fall "significantly" below its already lowered target of $2.7 billion.]]> Cholesterol Drug Pulled off Market http://www.yourlawyer.com/articles/read/41 Wed, 08 Aug 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/41
EVERY STATIN has been linked to very rare reports of the muscle side effect called rhabdomyolysis, but Baycol — made by Bayer Pharmaceutical — has been linked to significantly more fatal cases than its competitors, said the FDA’s Dr. John Jenkins.

There are no plans to strengthen existing warnings or take other action against the other statins — Mevacor, Pravachol, Zocor, Lescol and Lipitor. Still, people suffering muscle pain who take any of those statins should report it to their physicians, because they may need a lower dose or a change in medication, Jenkins said.

Baycol users are advised to call their doctors about switching medications. Statins, which are taken by 8 million Americans, have revolutionized the treatment of high cholesterol. They have been shown to lower the risk of a heart attack by one-third.

“The overall benefit greatly outweighs the risks, as long as patients and their physicians are on the lookout for possible complicating issues of these drugs,” said Dr. Robert Bonow of Northwestern Memorial Hospital in Chicago.

Bayer executives refused to say how many rhabdomyolysis victims they have counted worldwide. But in addition to 31 deaths in the United States, the FDA has reports of at least nine Baycol-related fatalities abroad.
Rhabdomyolysis is a life-threatening condition in which muscle cells are destroyed and released into the bloodstream. It can cause severe muscle pain, most frequently in the calves and lower back — and occasionally the condition is so severe that patients develop potentially fatal kidney failure.

Philip Ebel of North Carolina experienced the painful complication and was hospitalized for 10 days.

“I felt like I had been thrown out of a car, every muscle in my body hurt,” he recalled. “I think it was a very close call; I think they just caught it in time.”

In addition to muscle pain, symptoms of rhabdomyolysis include weakness, tenderness, fever, dark urine, nausea and vomiting.

Baycol is the 12th prescription drug taken off the U.S. market for dangerous side effects since 1997.

Some critics said many of those bans happened because the FDA, under political pressure, had sped up drug approvals during the 1990s. But Baycol was not a “fast-track” drug: The agency spent 11 months reviewing it before approving it in 1997.

Concern about Baycol has simmered for months, as British regulators banned a high dose of the drug and FDA officials debated similar steps, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

Bayer cooperated in the FDA action Wednesday, announcing it would stop sales of Baycol, also called cerivastatin, in every country except Japan.
]]> Baycol Rhabdomyolysis Side Recall Lawsuit Lawyer http://www.yourlawyer.com/topics/overview/baycol Wed, 08 Aug 2001 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/baycol DOWNLOAD OUR BAYCOL INFORMATION PACKAGE

Injured by Baycol?

Baycol (generic: cerivastatin) was approved in the United States in 1997. Baycol is part of a class of drugs used to lower cholesterol levels called statins. In August 2001, Baycol was pulled from the market. Baycol was withdrawn from the market because it has been linked to Rhabdomyolysis, which caused 31 deaths in the United States.

Rhabdomyolysis is a condition that causes muscle-cell breakdown (atrophy) and causes muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting. Rhabdomyolysis is a potentially life threatening condition.

"While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins," the FDA said.

Rhabdomyolysis involves injuries to the kidneys caused by toxic effects of the contents of muscle cells. Myoglobin is an iron-containing pigment found in the skeletal muscle. When the skeletal muscle is damaged, the myoglobin is released into the bloodstream. It is filtered out of the bloodstream by the kidneys. Myoglobin may occlude the structures of the kidney, causing damage such as acute tubular necrosis or kidney failure. Myoglobin breaks down into potentially toxic compounds, which will also cause kidney failure.

If you or a loved one took Baycol and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>