Baycol Lawsuit

Baycol Lawsuit News

The Baycol recall of August 2001 affected the over 6 million people worldwide that were taking the cholesterol-lowering drug. Bayer, Baycol’s manufacturer was criticized for allowing patients to continue using the cholesterol drug for such an extended amount of time despite the increased risk of fatality due to the condition rhabdomyolysis, a breakdown of muscle tissue causing renal failure and liver damage. The company has claimed the Baycol recall was issued because doctors were not using the drug as directed by Baycol labeling.

Although Baycol belonged to the most widely prescribed drug class called statins, which was linked to instances of rhabdomyolysis, Baycol was considered a significantly greater risk of death occurring because of rhabdomyolysis. Bayer has since been left defending itself since the 2001 Baycol recall but once again can be found making Baycol lawsuit news. At the time of the Baycol recall, Baycol was linked to over 50 Baycol deaths worldwide, however since then the number has risen to over 100 Baycol deaths, in addition to 1,600 injuries worldwide. For more information on the Baycol lawsuit news, please contact us to confer with a Baycol lawyer.

September 18, 2003 BREAKING NEWS!!
Baycol class action lawsuit denied but Bayer still faces large legal battles. A U.S. federal court on September 17, 2003 denied certification of a Baycol class action lawsuit that had been filed against Bayer AG. In 2001, Baycol cholesterol drug was pulled off the market because of deadly Baycol side effects reported, including rhabdomyolysis, a disease causing muscle damage, kidney failure, and other injuries.

The Baycol recall has been linked to over 100 deaths and 1,600 injuries. The recent Baycol class action lawsuit denial was filed in representation of over 1,000 cases. Judge Michael Davis denied the Baycol class action lawsuit because he ruled the cases were too diverse.

Bayer has said that the company has so far paid $477 million to settle out of court 1,342 Baycol cases in the U.S. There are still 11,000 Baycol lawsuits that Bayer must still face, in which the company refused to acknowledge legal liability.

The company has said its legal strategy will be to continue analyzing specific Baycol lawsuits in order to agree on “fair compensation” for those people that have suffered serious Baycol side effects. For more information on Baycol contact us to confer with a Baycol lawyer.

June 23, 2003 BREAKING NEWS!!
Statins use expands but so does safety concerns. The use of statins in the U.S. has reached the millions. Originally designed to lower cholesterol, statins have been linked in rare cases to a fatal condition called rhabdomyolysis. Baycol cholesterol drug was a newer statin but its success did not last. After reports of 52 deaths linked to Baycol use, Bayer and the FDA issued a Baycol recall. Baycol was found to have an increased risk for suffering adverse effects like rhabdomyolysis and has now been linked to more than 100 deaths.

Baycol lawsuits were filed in a frenzy following the Baycol recall that has continued to plague Bayer. Public Citizen consumer group has been actively pushing for the FDA to require that all statins contain warnings on the labeling to warn of these possible risk factors. Now, the use of statins has been expanded, and studies have suggested there may be other benefits other than lowering cholesterol levels. While there are high hopes for this drug class, experts are still worried that the potential benefits are being exaggerated and overshadowing the serious adverse effects.

Contact us for more information on Baycol.

-April 10, 2003
Another Baycol lawsuit settled, according to Bayer. The Baycol lawsuit was supposed to be heard in a Texas courtroom late April however, settled for undisclosed reasons and an undisclosed amount.

-April 9, 2003
A Baycol class action lawsuit was announced in the U.S. District Court for Southern District of New York. The Baycol lawsuit has alleged that Baycol maker Bayer AG violated sections of the Securities Exchange Act of 1934 when issuing false and misleading statements to the marketing in order to boost sales. In addition, the Baycol lawsuit alleges that Baycol side effects were minimized despite the knowledge by top Bayer executives that Baycol patients were suffering deadly Baycol side effects. For more information on Baycol lawsuits contact us to confer with a Baycol attorney.

-April 4, 2003
Baycol maker, Bayer AG announced that the number of out of court settlements for its recalled drug was on the rise. Bayer has already settled around 500 Baycol cases out of court at $150.1 million. The company said it would update the Baycol settlement and Baycol lawsuit figures later in April 2003. Bayer is still facing around 8,400 Baycol cases. There have been over 100 deaths linked to the use of Baycol, many of the Baycol deaths attributed to a rare condition called rhabdomyolysis.

March 5, 2003
Documents that have been presented in court at Baycol trials showing that Baycol executives became increasingly more alarmed about the instances of Baycol side effect rhabdomyolysis that was occurring at a much higher rate than competing statins. Bayer has maintained the company acted responsibly with Baycol and had to issue the Baycol recall because doctors were improperly prescribing the cholesterol drug.

-March 3, 2003
A German lawyer is hoping to settle about 100 Baycol cases out of court in Germany. Of the 2,000 German Baycol patients the lawyer is representing, he believes that 5% of the instances involve serious Baycol side effects damage.

-March 3, 2003
Bayer has taken out full page ads defending Baycol on February 28, 2003 entitled “Facts not Mood-stirring” in order to reassure worried Bayer investors. Bayer stated it was impossible to forecast the outcome of future Baycol lawsuits despite predictions made by attorneys and analysts. The company has already paid a total of $125 million to settle 450 Baycol lawsuits but faces thousands more.

-March 2, 2003
Bayer is trying to calm the speculation talk of the impact Baycol lawsuits will have on the company following the statements a lawyer made saying Bayer faced damages of up to $50 billion. Bayer released a statement claiming the Baycol lawsuit predictions have been wildly overestimated and were press efforts to affect Bayer stock and help legal battles. Analysts have estimated Bayer could suffer damages of over $5 billion to almost $10 billion if Baycol negligence is proved.

-February 28, 2003
GlaxoSmithKline is worried as its shares have continued to slip for the fifth day in a row. Glaxo and Bayer jointly marketed Baycol and Glaxo has been named in some Baycol recall lawsuits for the deaths and serious injuries, including rhabdomyolysis that occurred while the cholesterol drug was on the market. Most Baycol lawsuits have only named Bayer because it was predominantly responsible for the marketing and selling of Baycol. Glaxo is still not sure what type of liability the company holds in the future Baycol lawsuits.

-February 28, 2003
The high profile Baycol lawsuit in Texas has drawn in dozens of spectators. The Baycol trial is proving to continue being controversial. Already, allegations of attempted jury tampering have been made. In addition, the county district attorney is looking into matters in response to the trial judges request after Bayer had sent thousands of letters to city residents urging them to keep an open mind about the company just a day before jury selections had begun. The company’s response to the letters was that they were a mistake, however the trial judge found the letters to be “outlandish”.

-February 27, 2003
Lawyer for a plaintiff in Germany are seeking $500 million in punitive damages for recalled cholesterol drug Baycol, marketed as Libobay outside of the U.S. The Baycol lawsuit is in addition to the already present Baycol case occurring in Texas with demands for a $100 million payout.

-February 27, 2003
Investors are quickly dropping Bayer’s stock fearful that the company will be forced to pay large quantities of money to settle even more Baycol lawsuits. The investors have been unable to determine what type of loss Bayer will suffer when all the Baycol lawsuits have come to a close. The 7,800 Baycol lawsuits in the U.S. that Bayer faces, in addition to any claims that are filed from 700,000 Baycol patients that live outside of the U.S., Bayer may end up making payment of more than $5 billion. Bayer officials are still denying its executives knew of the deadly and serious Baycol side effects well before adequately responding.

-February 25, 2003
Bayer announced the company has paid a total of $125 million to settle 450 Baycol cases out of court. The company said that it is in active discussions with plaintiff lawyer about settling 500 more Baycol cases. Bayer’s worry about its Baycol liabilities do not seem to be lessening, especially following the publication of company documents that indicate Bayer executives knew long before the Baycol recall that the drug had deadly risks.

-February 24, 2003
Bayer shares fell almost 10% after the New York Times reported a senior company executive was aware of the deadly risks associated to Baycol long before a Baycol recall was issued. Of the more than 7,800 Baycol lawsuits filed against Bayer, around 450 of them have already been settled out of court for amounts ranging between $200,000 and $1.2 million. The maximum estimated cost the Baycol recall problems for Bayer could result in is around $1.6 billion. Court papers show that in 1997 the President of Bayer’s North American pharmaceutical operations had received a letter from executive vice president of pharmaceuticals at SmithKline Beecham that he had “serious concerns” about using Baycol with some other medicines the day after Baycol received FDA approval.

-February 22, 2003
Internal Bayer emails and depositions indicate that Bayer was promoting Baycol with the knowledge that it can cause rhabdomyolysis-induced deaths. A February 2000 Bayer email included an executive noting that the word was leaking about deaths related to Baycol and issuing an official statement before the situation worsened. When the vice president for scientific affairs at Bayer was asked in a deposition if the company had delayed any knowledge of the link between Baycol and life-threatening instances of rhabdomyolysis, the employee responded that no knowledge was known. Other internal Bayer documents showed the officials were more concerned with Baycol becoming financially successful enough to fuel company operations and compete with other pharmaceutical companies.

-February 21, 2003
A Baycol lawsuit opened, which marked the first lawsuit of its kind in the U.S. Alleging that Bayer officials were aware of the deadly side effects, the Baycol lawsuit is the first of many awaiting trial. The plaintiff suffered rhabdomyolysis after taking samples of Baycol for less than a month.

-January 16, 2003
Bayer announced the number of Baycol lawsuits the company is facing has increased to 7,400, up from 5,700 in November 2002.

October 31, 2002
Researchers at Chicago's Cook County Hospital surveyed patients using Baycol (cerivastatin), the August 2001 FDA withdrawn cholesterol drug. Baycol was recalled after 416 cases of severe muscle damage, which included 31 deaths, was attributed to the drug. Drug recalls are voluntary so the FDA has only a limited power to make certain patients have become aware of the action, including in the case of Baycol.

Public Citizen consumer group believes Baycol manufacturer should have adequately alerted patients using Baycol of the recalled status. The Baycol survey discovered a high number of patients were unaware of the Baycol recall and of rhabdomyolysis, the severe muscle damage caused by Baycol. There were 67 Cook County patients that were prescribed both Baycol and gemfibrozil together, a combination found to cause an even greater risk of muscle damage.

Of the patients still prescribed the Baycol/gemfibrozil combination, only a fifth had heard of the Baycol recall. Forty percent of the Baycol surveyed patients had symptoms of muscle damage with almost half of these cases being severe. For more information on the Baycol recall please contact us.

June 2002
In the UK, the British Baycol users are waiting to hear if they have won legal aid to sue Bayer, the Baycol manufacturer. This is the first attempt for a class action in the UK for the Baycol side effects British patients claimed to have suffered.

August 31, 2001
The Public Citizen advocacy group petitioned the FDA to add black box warnings to the label of some cholesterol-lowering drugs to warn patients of the side effects that can occur, including rhabdomyolysis. All statins have been shown to have risk for rhabdomyolysis but Baycol showed a much higher frequency of fatal rhabdomyolysis. After Baycol was recalled following the 31 U.S. deaths, the other five statins remained on the market.

August 23, 2001
Bayer finally pulled Baycol from Japanese shelves, two weeks after Baycol was no longer made available to the rest of the world. The German company withdrew Baycol in every other market after 50 deaths were reported, and the German health minister criticized the company’s delay before telling patients of the dangers of Baycol.

August 20, 2001
Bayer published an open letter to deny that the Baycol recall is threatening their existence. The CEO of Bayer did claim that “the withdrawal of the medicine (Baycol) has shaken our company- but not to its foundation.” After the Baycol recall due to the link to at least 30 deaths, the company’s shares had fallen about 27%. The Baycol recall prompted a number of class actions suits to be filed in the U.S. for the damages Baycol patients experienced.

August 16, 2001
Bayer, Baycol manufacturer, put back plans t list its shares in New York after the recent Baycol recall, one of their key drugs. Bayer claimed they were conducting a review of its pharmaceutical division.

August 14, 2001
The first class action Baycol lawsuit is set to be filed representing Baycol patients that currently link the statin drug to 52 deaths. Individual Baycol lawsuits have also been filed on behalf of Baycol patients suffering from rhabdomyolysis.

August 13, 2001
Dateline questions and answers about the Baycol recall.

What is rhabdomyolysis?

Rhabdomyolysis occurs when a large number of skeletal muscle cells die, thus releasing a massive amount of muscle protein into the bloodstream. This muscle protein becomes entrapped in the kidneys, essentially clogging up the filtering process of the kidneys and leading to kidney failure and other organ system disorders.

Rhabdomyolysis is extremely rare as a drug side effect. It is most commonly seen after massive muscle trauma (after an auto accident, for instance,) or as a chief component of heat stroke - the condition that recently killed Minnesota Vikings star Korey Stringer. While all statin drugs are known to cause a low-grade muscle disorder in some patients - a disorder similar to rhabdomyolysis but on a much smaller scale - the report with Baycol was the first time a statin had been implicated in actually causing death by producing a severe muscle disorder.

Is the problem limited to Baycol, or do other statins do the same thing?

As noted, all statins can and do cause problems with the skeletal muscles in some patients, and muscular pain is one of the more common reasons that statins must be discontinued in some individuals.

However, it is now recognized that Baycol has a much greater propensity for causing muscle problems than do the other statins - in fact, it is not at all clear that other statins can cause actual rhabdomyolysis. So while precautions need to be taken when using any statin (see below,) at this point the potentially fatal problem of rhabdomyolysis seems to be limited to Baycol.

Is the Baycol problem due to the drug itself, or to the doctors?

Of the 31 people who died from Baycol-induced rhabdomyolysis, 12 were also taking gemfibrozil, another lipid-lowering agent. It has been known for some time that using statins in combination with gemfibrozil can make muscle problems more likely to occur, and the warning labeling for statin drugs have reflected this fact.

In the remaining 19 patients who died taking Baycol, it has been reported that the large majority were started directly on the highest dose of the drug. (The usual starting dose - and the recommended starting dose - was 0.4 mg. Most of the cases of rhabdomyolysis occurred after a 0.8 mg tablet was introduced in August 2000, when, apparently, many doctors took to prescribing the higher dose immediately.)

In other words, if the prescribing practices of doctors had followed a more conservative (i.e., the recommended) path, it seems likely that most of these fatal cases of rhabdomyolysis might not have occurred. Indeed, Bayer withdrew Baycol from every country in the world except Japan - where gemfibrozil is not used, and where the 0.8 mg tablet is not available. The available data supports this decision.

What are the recommendations for people taking statins?

Patients now taking Baycol need to see their doctors about switching to a different drug. Baycol will simply be no longer available.

For patients taking the more established statin drugs (lovastatin, simvastatin, pravastatin, and atorvastatin) the recent problems with Baycol should not create any additional concern. These older drugs have been used in hundreds of thousands of patients for more than a decade without causing similar problems. Thus, for these drugs the recommendations have not changed. Statins should generally not be used in combination with gemfibrozil - for reasons that are not at all clear, this combination of drugs greatly increases the risk of muscular disorders. Additionally, people taking statins who experience muscle aches and pains should report this symptom to their doctors. A simple blood test (the CPK level) should reveal whether the statin drug is causing any degree of skeletal muscle destruction - if so, the statin should be discontinued.

About Heart Disease

August 8, 2001
700,000 Americans were taking Baycol when it was pulled from the shelves due to at least 40 deaths due to rhabdomyolysis. All statins, the class of drug Baycol belongs to, has been linked to the very rare condition rhabdomyolysis, but Baycol was found to cause significantly more fatal cases than other statins. There are 8 million Americans that use statins seen as a revolutionary treatment of high cholesterol. Rhabdomyolysis is a life-threatening condition that destroys muscle cells and releases it into the bloodstream. The result can be severe muscle pain that is most frequently experienced in the calves and lower back. Rhabdomyolysis can lead to fatal kidney failure.

August 8, 2001
Baycol is the 12th prescription drug to be recalled due to dangerous side effects since 1997. British regulators banned high doses of Baycol prior to the Baycol recall, and U.S. regulators also considered doing the same. Baycol had raised concern for months prior to the Baycol recall.

Here are some educational sites about baycol and statins:

Lipids Online - educational resources in dyslipidemia, atherosclerosis, insulin resistance, triglycerides, metabolic syndrome, ACE inhibitors, coronary heart disease, and statins for health professionals.

A Baycol Lawyer - Legal resource educates consumers on the latest developments surrounding Baycol, a cholesterol-reducing drug recalled in August of 1998.  Click here to contact a baycol lawyer.

Baycol Advocate - Offers details about the Baycol recall and FDA recommendations, as well as advice to those affected by the drug regarding legal rights.

Baycol Recall Resource - Legal resource providing information on the Baycol recall.  Contact a baycol attorney to learn your legal rights.

Statin Drugs and Adverse Effects - All prescription cholesterol-lowering drugs

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