Scott C. Gottlieb, Injury Law Attorney

Radioactive Drug Research Committee: An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members

Radioactive Drug: Any substance/drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Included are any non-radioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products." Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.

Raplon: Pharmaceutical maker Organon Inc. withdrew its anesthetic Raplon from the market after reports that five patients died while being given the drug. Organon, a unit of Akzo Nobel NV, notified regulators that it was voluntarily pulling Raplon after reports showed it may be linked to breathing trouble that can lead to permanent injury or death. The FDA cleared Raplon for sale in the United States in August 1999. Critics have charged the agency with approving drugs too quickly and later having them come off the market for safety reasons. The Raplon review took more than a year, the FDA said. Raplon was given by injection in hospitals or other surgical facilities. It was used as a muscle relaxant for when doctors placed breathing tubes or for surgery. Officials knew before they approved Raplon that some patients had an adverse reaction known as bronchospasm, an inability to breathe normally that can be mild to severe. In clinical trials before its approval, 3.2 percent of patients given Raplon had bronchospasm, compared with 2.1 percent for a comparison drug. That was "not enough to be worrisome," Jenkins said. But the numbers seen after the drug became widely available "indicate that the risk of injury may be greater than was suggested," an FDA statement said. All drugs similar to Raplon have been linked with the same problem, "but this drug (Raplon) seems to be causing more severe bronchospasm." The problem occurred "very rapidly" after the drug was injected, Jenkins said. Patients who received Raplon during previous procedures without serious trouble "probably don't need to worry" about having a complication now, he said.

Reasonable Care: The standard of care in negligence cases; the duty to act reasonably so as to avoid harming others.

Relenza: A medicine used to treat influenza (the flu). Some patients have had serious breathing problems while using Relenza, and it is not recommended for those with chronic respiratory disease.

Remand: The decision of an appellate court to send a case back to the trial court with instructions on how to correctly decide the case; often used with the term “reversed.”

Remedies: Relief that the plaintiff receives from the defendant in a lawsuit. Often this will include monetary damages or equitable relief (i.e. injunctions).

Respondent: The party that won at trail.

Reversed: Reversed means that the appellate court overturned the trial court’s decision.

Rezulin: Rezulin is an anti-hyperglycemic drug used to treat Type II diabetes. While it is not an insulin substitute, Rezulin helps the body better use the insulin it does produce. Since its approval by the FDA in 1997, Rezulin, now believed to be a defective drug, has consistently been linked to heart failure, thickening in the left ventricular wall of the heart, severe liver damage, liver failure, an increased demand for liver treatments, and at least 63 deaths. Rezulin was finally pulled from the shelves in March 2000.

RhoGAM: A medicine which was injected into pregnant women to avoid specific pregnancy complications. RhoGAM used to contain Thimerosal, which some suspect is related to the development of autism.

Scott C. Gottlieb is licensed by the State of New York.