Legal Glossary R

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 trial.

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.