Baycol Law - Personal Injury law defective drugs personal injury wrongful death resources for attorneys

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Bayer Voluntarily Withdraws Baycol
FDA Talk Paper - August 8, 2001

WASHINGTON (Reuters) - Bayer AG's cholesterol-fighting drug Baycol, which the German drug giant pulled from the market Wednesday, was linked to 31 U.S. deaths from a muscle-related side effect, health officials said.

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FDA says Withdrawn Bayer Drug Linked to 31 Deaths
Reuters News Service - August 8, 2001

FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.

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Drug's Problems Raise Questions on Warnings
New York Times - August 21, 2001, By Philip J. Hilts

When Baycol, a cholesterol-lowering drug, was approved in 1997, it appeared to be a potentially lifesaving drug with few side effects. It had been tested on more than 3,000 patients, and no serious problems had turned up. ...

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If you took Baycol and experienced any adverse reactions you may have a valid legal claim.

Baycol, a 'statin' drug sold for lowering cholesterol, was approved by the FDA in 1997. Prior to its release, it had been tested on more than 3,000 patients. Statins are powerful anti-cholesterol drugs that save lives by prevention of heart attacks and strokes. Six statins are left on the market in the United States, and about 12 million people take them.

Sales of Baycol (generic name cerivastatin) were projected to reach $800 million in 2001, but the German manufacturing company, Bayer A.G., took Baycol off the market after 31 patients on the drug had died suspiciously of rhabdomyolysis.

Rhabdomyolysis is classed as a disorder rather than a disease. In rhabdomyolysis, muscle cells break down, flooding the kidneys with cellular waste. Death occurs when the kidneys are overwhelmed and shut down.

As early as December 1999, with the original reports of muscle problems and deaths linked to Baycol, both Bayer and the Food and Drug Administration warned doctors to take precautions when prescribing it. As the problem continued, Baycol had to be taken off the market.

Doctors were sent advisories to:

not start patients on the highest dose
not to give patients both cerivastatin and Lopid, or gemfibrozil, a nonstatin drug that lowers blood triglyceride levels and cholesterol. These drug combinations seem to increase risk.

Many doctors deny receiving such advisories.

In the United States, Public Citizen's Health Research Group, a medical watchdog organization in Washington, said it had found 81 reports of deaths from rhabdomyolysis linked to statin drugs other than cerivastatin since the late 1980's.

Government statisticians have calculated that there were probably about 10 cases of side effects for each case reported to the F.D.A.

Product liability laws and medical malpractice or negligence laws are guided by personal injury law. The primary aim of personal injury law is to provide relief through compensation to injured parties for the damages incurred. Among the types of recoverable damages are: loss of earning capacity, pain and suffering, and reasonable medical expenses. Damages include both present and future expected losses.

Product Liability: Defective products such as prescription drugs which are not properly labeled as to interactions or other contraindications. Your attorney can evaluate your legal rights and advise you of possible compensation.
Professional Malpractice: Medical malpractice or negligence may involve delay in treatment or incorrect treatment or missed diagnosis. Your lawyer can protect your rights and represent your interests.
Wrongful death: Fatal injuries due to negligence or other liability may bring compensation to heirs or estate. Seek legal counsel before the statute of limitations becomes an issue.

If you have rhabdomyolysis and kidney failure after or during use of a statin drug, the maker of Baycol, Bayer Corporation, or another manufacturer of another statin drug may be liable for compensation. Your lawyer can counsel you as to your right to recover damages to help defray the costs of treatment and provide compensation for your pain and suffering.

Drug litigation can be complex. It is best to seek the counsel of a personal injury attorney with experience in this field of law.

If you feel that you are having a reaction to a statin drug, stop the drug immediately and call your physician.

Symptoms of Rhabdomyolysis :

abnormal urine color (dark, red, or cola colored)
muscle tenderness
weakness of the affected muscle(s)
generalized weakness
muscle stiffness or aching (myalgia)
weight gain (unintentional)
seizures
joint pain
fatigue

Signs And Tests for Rhabdomyolysis :

An examination reveals tender or damaged skeletal muscles.
A urinalysis may reveal casts and hemoglobin without formed red blood cells.
A urine myoglobin test is positive.
A serum myoglobin test is positive.
A CPK is very high.
A serum potassium may be very high (potassium is released from cells into the bloodstream when there is cell breakdown).
creatinine - urine
creatinine
CPK isoenzymes

Prior to accepting an insurance settlement, it is wise to speak with a personal injury lawyer to evaluate your situation and to ensure that your interests are protected. Most personal injury attorneys provide free initial consultations and most will only be paid if you win your case and receive a judgment. Most frequently, personal injury attorneys will receive a percentage of the settlement awarded to you. Legal advice can save you time, trouble and money and can insure that you are treated fairly.

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