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Baycol Litigation News

Bayer slow to pull Baycol from the market
November 22, 2004

An editorial in the Journal of the American Medical Association is one of just several articles to appear in next week's edition that focuses on the FDA's ability to effectively monitor drug safety. Following the September Vioxx recall, more critics have been questioning the FDA's capability to adequately monitor drug safety considering its recent track record. The ability for drug companies to influence federal regulation has also come under intense scrutiny.

Now, additional information regarding the Baycol recall of August 2001 indicates Bayer AG may have known its cholesterol- lowering drug caused a high rate of rhabdomyolysis, a serious muscle condition, over a year before it added a warning to its label. Baycol was withdrawn from the U.S. market after it was linked to more than 100 deaths.

David Graham, a high profile FDA reviewer who accused the FDA of being incapable of protecting Americans from unsafe drugs one week ago in a Senate hearing, said in a separate article that three of the most popular cholesterol-lowering drugs pose a low risk of rhabdomyolysis, according to a study. The drugs include Pfizer Inc.'s Lipitor, Merck's Zocor and Bristol-Myers Squibb Co.'s Pravachol, which are in the same statin class as Baycol. The study found when the statins were taken with medicines that lower triglycerides, called fibrates, a 12-fold risk versus statins alone was present.

"Baycol class action status granted in Pennsylvania"
March 2004

Bayer's Baycol cholesterol drug was recalled in August 2001 and is now linked to over 100 deaths. The company has so far paid $842 million to settle 2,224 cases but still faces 9,948 more Baycol cases. Now the company is facing a class action in Pennsylvania that would force Bayer to pay for monitoring the effects of former Baycol patients. While the certification ruling is just the first step in a possible Baycol class action trial, Bayer appears to be facing many more battles over its recalled drug in the future.

-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 10, 2003
888 more Baycol lawsuits settled. Bayer had announced in its’ May 2003 update that 785 of the Baycol lawsuits had been settled out of court, amounting to $240 million for the German based pharmaceutical company. Now, Bayer has announced it has settled 888 Baycol lawsuits, but has not announced how much the additional Baycol settlements cost the company. The company is still facing around 9,400 more Baycol lawsuits that are pending, an increase from 8,800 in May.

-June 2, 2003
More Baycol cases settled. Bayer claims the company no longer faces individual Baycol lawsuits following even more out of court settlements and an individual Baycol lawsuit withdrawal. The next Baycol lawsuit cases are scheduled to occur in July. By the start of May 2003, Bayer had already paid $240 million to settle 785 Baycol lawsuits.

-May 20, 2003
Baycol plaintiff files new case. The first plaintiff to take Bayer to court over Baycol health effects lost his case but has just filed a new Baycol suit. Baycol has been linked to over 100 deaths and faces around 8,800 U.S. filed Baycol lawsuits. The plaintiff has filed the new Baycol case against Bayer AG after losing the case against Bayer’s U.S. unit.

-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.