Legal Glossaries

Pharmaceutical Legal Glossary
 

Glossary of Pharmaceutical Law Terms

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Cardura: A U.S. advisory panel recommended that regulators require changes to the label for Pfizer Inc.'s blood pressure drug Cardura. U.S. researchers determined last year that Cardura was less effective than an older medicine for treating certain types of heart disease. "The committee concluded that something should be communicated to physicians so they know the results of this trial," said Dr. Jeffrey Borer, the panel's acting chairman. Pfizer Inc.’s Cardura drug is marketed as a class of blood-pressure medicines known as alpha-blockers. Researchers said the results of the study suggest the drugs might not be the best choice as first-line therapy for high blood pressure and patients now using them as first-line treatment should talk to their doctors about whether to change therapy. Last year, a National Institutes of Health study found that Cardura users had experienced congestive heart failure more frequently than those who used a cheaper diuretic. The FDA advisory panel heard a petition from a Cardura user who also has filed suit against Pfizer. The user sought to compel the FDA and Pfizer to change the drug's labeling and officially notify users and doctors of the findings from the NIH study. The lawsuit claims that Pfizer officials intentionally maneuvered around negative reports on Cardura, because sales of the drug were approximately $800 million in 2000. Internal Pfizer documents and e-mails have surfaced demonstrating that company officials were less than truthful about Cardura while avoiding drawing attention to the NIH study. For example, a company e-mail said that Pfizer decided at one point not to issue a statement on the NIH study, which Pfizer paid $30 million to help fund, and a related announcement from the American College of Cardiology because "a Pfizer-issued statement in defense of Cardura would likely draw more media attention to the situation. To date, there has been limited media coverage."

Casualty: A loss of property due to fire, storm shipwreck or other casualty, which is allowable as a deduction in computing taxable income.

Cause of Action: The plaintiff’s legal claim against the defendant. There is often more than one cause of action in a lawsuit.

Celebrex: Celebrex is a non-steroidal, anti-inflammatory COX-2 inhibitor drug intended to treat joint inflammation and arthritis pain, but like Vioxx it has been deemed dangerous. Celebrex has been linked to at least 10 deaths, 11 cases of gastrointestinal bleeding that required hospitalization, and an increased risk of stomach ulcers. There is also some evidence that taking Celebrex can increase or double users' risk of blood clots, heart attack, and stroke. Despite this evidence, the makers of Celebrex asked the FDA to remove label warnings about stomach ulcers, claiming that medical reviewers did not find any evidence to suggest that Celebrex was associated with a lower rate of stomach ulcers than traditional NSAIDs. The FDA denied the request, as it found that taking low-dose aspirin (to prevent heart attack) in combination with Celebrex increased the risk of developing ulcers.

Cipro: Cipro (Generic name: Ciprofloxacin hydrochloride) has been linked to side effects including ruptured tendons and neurological damage resulting from seizures. Cipro, a member of the quinolone group of antibiotics is used to treat bacterial infections of the abdomen, skin, bones, urinary tract, and lower respiratory system. A number of side effects have been linked to the use of Cipro. Side effects may include rashes, fever, jaundice, shortness of breath, tingling, itching and hives. Cipro has been linked to tendon ruptures. The incidences of tendon rupture is more common in the elderly and individuals on steroid therapy, however, younger users are at risk too. In 2001, the Epilepsy Foundation warned that fluoroquinolone antibiotics such as Cipro can induce seizures in people with epilepsy.

Civil Law: That part of the law which governs relationships between people where there is no criminal activity involved

Civil Liability: In a civil lawsuit, if a party is found to be at fault, that party is liable. This is equivalent to a guilty verdict in the criminal system, except that civil liability usually means that the party at fault pays money damages to the other party, whereas the guilty party in a criminal suit may have to go to prison.

Clinical Trial: A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

Clozaril/ Clozapine: Clozapine is an anti-psychotic drug used to treat only patients who have failed to respond to alternative treatment. New research links Zyprexia (Olanzapine) and Clozaril (Clozapine) with causing serious side effects including: Diabetes, Myocarditis, Tachycardia, Tardive Dyskinesia. Clozaril is manufactured by Novartis. Clozapine is the generic version of the Novartis drug Clozaril. Clozaril has been linked to diabetes. A recent study found 384 diabetes cases, 25 fatal, have been report to the FDA by Clozaril users. In February 2001, the FDA and Novartis strengthened the boxed warning and warning sections as follows: “The previously existing boxed warning has been relocated to the beginning of the patient instructions and revised to advise health care providers of the association of myocarditis with Clozapine therapy.” A subsection has been added to the warnings section entitled "Myocarditis" to provide data and Clozapine treatment guidelines related to this issue.

Co-Defendant: A defendant joined together with one or more other defendants in the same case.

Cognitively Impaired: Having either a psychiatric disorder (psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

Comfrey: On Friday July 6, 2001, The US Food and Drug Administration asked makers of dietary supplements containing the herb comfrey to withdraw their products due to the danger of liver damage and its possible role as a cancer-causing agent. Comfrey is an herbal medicine that has been marketed to bruises, wounds, muscle aches and sprains, broken bones, and ulcers. Comfrey products are made from the leaves or other parts of the plant grown above the ground. They can also be made from the roots, but root preparations are more likely to cause poisoning. Comfrey contains allantoin, rosmarinic acid, and pyrrolizidine-type alkaloids. Some believe that comfrey is a beneficial herb, but scientific studies show that this herb can be very toxic. If you drink comfrey preparations or take it internally in other forms you run the risk of being poisoned. The FDA stated that "In addition to being toxic to the liver, there is also evidence that implicates these substances as carcinogens." Some people have even died from eating or drinking comfrey remedies. In a letter to industry groups representing herbal product makers, the FDA said it was aware of dietary supplements derived from three types of comfrey that contain toxic alkaloids. ``The agency strongly recommends that firms marketing a product containing comfrey, or another source of pyrrolizidine alkaloids, remove the product from the market and alert its customers to immediately stop using the product,'' FDA said. The following companies have products that my contain comfrey: Nature's Way, Dr. Christophers, Herb Farm, Naturade, Bioforce of America, Solaray and GNC.

Common Law: Body of law that has grown based on the decisions of courts long ago. It originated in England and has since passed to the United States. It is always changing to reflect the current needs society.

Comparative Negligence: A defense to negligence used when it is believed that the plaintiff’s negligence contributed to his or her injuries. Based on the amount of negligence by each party, the amount of damages is adjusted accordingly.

Compensation: Monetary award transferred from defendant to plaintiff to make up for some wrong, damage or injury caused by the defendant's actions or inaction.

Compensatory Damages: Damages awarded to plaintiffs in order to restore them to the position they were in prior to being wronged.

Competence: A legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting on that information and to make a choice.

Complaint: A pretrial document filed in a court by one party against another that states a grievance, called a “cause of action.”

Contingency Fee Agreement: An agreement between an attorney and their client, which allows the attorney to be paid only if the client prevails in a lawsuit and collects monetary damages. The lawyer then receives a percentage of the damages, generally 1/3 of the award.

Contributory Negligence: A defense to negligence, which points out that the plaintiff’s negligence contributed to his or her injuries. Contributory negligence is an absolute bar to the plaintiff’s recovery against the defendant.

Counterclaim: A demand by the defendant against the plaintiff asserting an independent cause of action in the same lawsuit.

Cox-2 Inhibitor: A drug designed to treat chronic pain without irritating the stomach and stomach lining.

Crestor: Crestor is an HMG-CoA reductase inhibitor drug designed to lower cholesterol levels by halting production of a certain enzyme in the liver. The drug has been linked to a slew of serious health problems, ranging from muscle weakness and asthenia to kidney damage and total renal failure. This possibly defective drug is particularly dangerous to pregnant or nursing mothers, although it is not currently on the list of drug recalls.

Cross Examination: Questioning the witness who has been presented by the opposition at trail or a deposition.