Legal Glossaries

Pharmaceutical Legal Glossary
 

Glossary of Pharmaceutical Law Terms

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Baxter Dialysis Filter: A filter for dialysis machines produced by Baxter International, Inc. The manufacturer has recalled certain filters that were found to be defective.

Baycol: Between 1997 and 2001, Baycol, a potentially defective drug, was commonly prescribed to lower cholesterol by preventing lipid production. Unfortunately, it was also linked to at least 31 deaths in the United States and more than 52 worldwide. Baycol has also been said to cause rhabdomyolysis, a typically non life-threatening ailment that puts undue stress on the kidneys. Symptoms of rhabdomyolysis include fatigue, muscle pain, joint pain, dark urine, nausea, and other discomforts. German drug manufacturer Bayer AG pulled their popular cholesterol lowering drug Baycol from the market. Baycol was withdrawn from the market because it has been linked to 31 US deaths from a muscle-related side effect, according to the US Food and Drug Administration. Baycol is one of an extraordinarily popular family of cholesterol-lowering drugs called "statins." Baycol was approved in the United States by the FDA in 1997. The FDA had received reports of Baycol patients experiencing severe rhabdomyolysis. Rhabdomyolysis is a condition that causes muscle-cell breakdown (atrophy) and causes muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting. In a Reuters article the FDA claimed that in some cases, rhabdomyolysis is so severe that patients develop failure of the kidney or other organs, which can be fatal. Twelve of the 31 deaths involved patients taking another drug, gemfibrozil, the FDA said. "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.'' Baycol patients who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician, the FDA said. Others taking Baycol should talk to their doctors about switching to alternative medications, the agency advised.

Bench Trial: A trial without a jury. The judge rules on facts and evidence presented to him.

Benefit: A valued or desired outcome; an advantage.

Benzene: Benzene is colorless liquid with a characteristic odor and burning taste that is one of the most commonly used solvents in the United States. Benzene is used as an additive in gasoline and an ingredient in paints, inks, adhesives, rubbers, glues, old spot removers, and furniture wax. Benzene is also used to make some types of plastics, glues, rubbers, lubricants, dyes, detergents, drugs, and pesticides. It is also natural component of cigarette smoke. Benzene ranks in the top 20 chemicals for production volume in the United States. However, Benzene is a known human carcinogen. Long-term exposure to high levels of benzene in the air can cause leukemia, a cancer of the blood-forming organs. There are several ways to be exposed to unhealthy levels of Benzene. Workers in industries that make or use benzene may be exposed to the highest levels of Benzene and are at the highest level of risk. You can also be exposed to dangerous levels of the solvent from indoor air that contains benzene from products that contain it such as glues, paints, furniture wax, and detergents. Air around hazardous waste sites or gas stations will contain higher levels of benzene. Leakage from underground storage tanks or from hazardous waste sites containing benzene can result in benzene contamination of well water. Another major source of benzene exposure is cigarette smoke. Industrial processes are the main source of benzene in the environment. Benzene can pass into the air from water and soil. It reacts with other chemicals in the air and breaks down within a few days. Benzene in the air can attach to rain or snow and be carried back down to the ground. It breaks down more slowly in water and soil, and can pass through the soil into underground water. If you believe that you have been exposed to benzene you should report your suspicions to your employer and be tested. Several tests can measure your exposure to Benzene. There is test for measuring benzene in the breath which must be done shortly after exposure. Benzene can also be measured in the blood. However, benzene disappears rapidly from the blood and test results are only accurate if the test is performed after recent exposure.

Bextra: A non-steroidal anti-inflammatory drug designed to alleviate the symptoms of rheumatoid arthritis, including joint inflammation and swelling. The drug, classified as a COX 2 inhibitor, reportedly prevents the stomach ulcers and gastrointestinal bleeding believed to be caused by other NSAIDs. However, some research shows that Bextra can cause a number of serious side effects, from stomach bleeding to upper respiratory infection.

Biologic: Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

Breach of Warranty: When a retailer/manufacturer fails to follow through with a promise or claim about a product.

Burden of Proof: The obligation of one party in a suit to prove all the requirements necessary to show entitlement to recovery. If the burden is not met, the party with the burden will lose the issue or the case.