Baycol was approved for use in the U.S. in 1997, and is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins such as Baycol lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. 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.
On August 8, 2001, Bayer Pharmaceutical Division announced that it was voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe adverse reaction that can result from Baycol use. A flood of legal claims began soon after the recall, brought by Baycol users and their loved ones who suffered harm from side effects of the anti-cholesterol drug. As of January 2004, Bayer estimated that it had settled over 2,000 Baycol-related claims out of court, and still faces over 10,000 existing lawsuits.
Rhabdomyolysis is a condition that results in muscle cell breakdown and the release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles, or may be generalized throughout the body.
Most frequently, affected muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases, the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal. Fatal rhabdomyolysis has been reported most frequently when Baycol was used at higher doses, used by elderly patients, and particularly when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug.
Legal Issues Surrounding Baycol
If you are suffering from rhabdomyolysis or another illness related to use of Baycol, you may have a medical malpractice or drug liability claim against your physician or pharmacist, or against the manufacturer of Baycol (Bayer Pharmaceutical Division). No matter what the facts of your particular case happen to be, claims connected with liability for prescription drugs are some of the most complex of any type of personal injury matter. The facts and liability issues involved in your case, including manufacturer and medical practitioner compliance with federal safety and professional practice standards, complex medical conditions and procedures, technological issues, and issues of potential federal preemption of state law, all make your claim particularly well-suited for handling by an attorney who is experienced in the area of drug liability.
Claims involving prescription drugs usually follow much the same principles as those used in assessing liability for any defective product, so an overview of the concept of strict liability will be useful in understanding what you will need to show in a claim based on Baycol side effects.
Ordinarily, to hold someone liable for your injuries, you must show that they were careless -- in legal terms, negligent -- and that their carelessness led to an accident or injury. With products such as drugs that are administered and sold to the general public, however, it would be extremely difficult and prohibitively expensive for one individual to have to show how and when a manufacturer was careless in administering or selling a drug. For these reasons, the law has developed a set of rules known as "strict liability", which allows a person injured by a drug to recover compensation from the liable manufacturer or medical professional, without showing that they were actually negligent.
The concept of strict liability can work in a number of ways in the prescription drug context. For example, liability can be found for a prescription drug if foreseeable risks of harm posed by the drug are sufficiently great in relation to the foreseeable therapeutic benefits of the drug. Also, a plaintiff who seeks recovery on the basis of strict liability for an injurious side effect from a properly manufactured prescription drug must prove both that the drug caused the injury, and that the manufacturer breached a duty to warn of the possibility that an injurious reaction might occur. For example, pharmacists and doctors share the blame for prescribing dangerous combinations of drugs without obtaining a sufficient medical history to ensure that problems do not occur. The FDA has recalled a number of drugs recently that have caused death or serious injuries to innocent victims of the pharmaceutical industry.
Theories of Liability
Depending on the facts and legal questions in your particular situation, your attorney may pursue a Baycol claim on your behalf using one or more of the following legal theories:
- Inadequate warnings, or a failure to warn of a drug's potential danger or side effects (including reactions with other medications); against a physician or pharmacist.
- Prescription error by a physician or pharmacist.
- Inadequate testing on a medication prior to its use, which can include issues of testing on animals or humans; against a drug manufacturer.
- Over-promotion. An increase in more aggressive marketing and advertising efforts by manufacturers of prescription drugs (especially by pharmaceutical companies through print, internet, and television advertising) has led to a corresponding increase in liability for injuries attributed to the drugs being marketed; against a drug manufacturer.
- Defectively designed drug, one that is arguably unfit for its intended purpose; against a drug manufacturer.
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While almost all medications have some anticipated side effects, a drug manufacturer has a duty to adequately inform physicians regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability".
If you or a loved one have taken Baycol and experienced any unusual side effects or suffered injury, you should contact a physician for proper medical attention. Your next step should be to contact an experienced attorney, who will assess and protect your legal rights.
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