Bayer's cholesterol-lowering drug Baycol was approved by the Food and Drug Administration (FDA) in 1997. Baycol later became a popular drug for patients who suffer from high cholesterol. Unfortunately, after taking Baycol, some patients have experienced rhabdomyolysis, a rare medical condition that damages muscle tissue. The damaged muscle tissue is then released into the bloodstream, causing kidney failure and death in some cases. Due to reports that Baycol was allegedly linked to patient deaths, Bayer subsequently removed the drug from the market in 2001.
Because rhabdomyolysis can cause death, it's important to recognize the symptoms of the condition. Signs and symptoms of rhabdomyolysis may include the following:
- Dark-colored urine
- Little or no urine production
- Muscle pain and stiffness
- General weakness
In some cases, there may be no symptoms. If a patient suspects that he or she is suffering from rhabdomyolysis, it's extremely important to seek immediate medical attention.
Under product liability law, drug manufacturers and sellers have a duty to ensure that their prescription drugs are safe for patient use. If a prescription drug is unreasonably dangerous and defective, manufacturers and sellers can be held liable for resulting injuries. 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 plaintiffs have to show in proving a product liability drug case.
Ordinarily, to hold someone liable for injuries, the plaintiff must show that the defendant was careless - in legal terms, negligent - and that this carelessness led to the 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 prove that a manufacturer was careless, or negligent. For this reason, the law has developed a set of rules known as "strict liability," which allows a person injured by a drug to recover damages from the liable manufacturer without showing that it was actually negligent.
The concept of strict liability can work in a number of ways in the prescription drug context. For example, liability can attach 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 failed to warn of the possibility that the injury could occur.
If a patient died as the result of taking Baycol, a wrongful death action can be filed. Generally, immediate family members such as spouses, children, and parents have the right to pursue legal action. In addition, some states allow registered domestic partners to sue as well. If the lawsuit is successful, the plaintiffs can be awarded damages for any medical costs, funeral expenses, the loss of the deceased's financial support, and the loss of emotional support or companionship.
Under medical malpractice law, doctors have a duty to provide their patients with a reasonable standard of care. If a doctor provides a patient with negligent care, and the patient is injured as a result, the patient can sue the doctor for medical malpractice. For example, if a doctor gave Baycol to a patient despite the fact the drug had been withdrawn from the market years ago, the doctor could be held liable for medical malpractice if the patient is injured.
Numerous product liability lawsuits involving Baycol have been filed in the state and federal courts. Federal product liability lawsuits involving the drug were consolidated into multidistrict litigation in the U.S. District Court for the District of Minnesota. Over the years, the assigned federal court coordinated more than 9,000 lawsuits during pretrial proceedings. This phase included discovery and settlement conferences. As a result, many of the lawsuits subsequently settled. Bayer reportedly paid more than $1 billion in settlements.