Legal Glossary P

PPA: A chemical used in over the counter and prescription medications. PPA was very  common in diet drugs, nasal decongestants and cough medications. PPA might cause  between 200 and 500 hemorrhagic strokes per year in patients age 18 to 49. U.S.  consumers bought about 6 billion doses of PPA last year. Popular PPA Products  containing PPA include:

• Dexatrim Weight Control Candy and Tablets
• Acutrim Weight Control Candy and Tablets
• Permathene Mega 16 Weight Control Tablets
• Robitussin CF Cough Syrup
• Triaminic DM Cough Syrup
• Tavist D Cold, allergy and sinus tablet

On November 6, 2000, while regulators moved to take it off the market, U.S.  health officials urged consumers to stop taking decongestants and diet drugs  containing a key ingredient linked to cases of strokes. The ingredient,  phenylpropanolamine (PPA), is found in hundreds of over-the-counter and  prescription products, including the cold medicine Dimetapp and such weight-loss  drugs as Dexatrim and Acutrim. It works as a decongestant in cough and cold  remedies and as an appetite suppressant in diet drugs. The Food and Drug  Administration (FDA) said it has asked all drug companies to voluntarily stop  marketing products containing PPA. Makers would have the option to reformulate  the products with other ingredients. The agency also is writing a proposal that  will make the sale of PPA products, both prescription and over-the-counter,  illegal. That process is likely to take several months. Regulators determined  that PPA is linked to cases of bleeding strokes in adults under age 50. Research  pointed to a higher risk of hemorrhagic strokes, or bleeding into the brain, for  women, but the FDA cautioned that men were also at risk. The strokes occurred  within three days after people took the products. Other popular products that  contain PPA include some versions of Alka-Seltzer Plus, Comtrex, Coricidin,  Tavist-D and Triaminic.

Paxil: An antidepressant drug belonging to  a class of medications known as selective serotonin reuptake inhibitors (SSRIs).  Paxil is believed to be very addictive, and many users report severe withdrawal  symptoms after discontinuing use. Some experts even link Paxil to an increased  suicide risk. The manufacturer has been accused of misleading the public and  medical profession by downplaying side effects.

Peremptory Challenge: A challenge to a  particular juror that requires no reason. Normally an attorney has a limited  number of these challenges.

Percocet: A prescription pain reliever  containing Oxycodone and acetaminophen. Classified in the same category as  Oxycontin, Percocet contains no more than 5mg of Oxycodone.

Percodan: A prescription pain reliever  containing Oycodone and aspirin. Classified in the same category as Oxycontin,  Percodan-Demi only contains 2.25mg of Oxycodone.

Petition: A formal request that the court  take some action; a complaint.

Personal Property: Defined by the law as  "things movable." This is distinguished from the term "real property,"  which includes things such as trees, buildings and land.

Pharmacology: The scientific discipline  that studies the action of drugs on living systems (animals or human beings).

PHASE 1, 2, 3, 4 DRUG TRIALS: Different  stages of testing drugs in humans, from first application in humans (Phase 1)  through limited and broad clinical tests (Phase 3), to post-marketing studies  (Phase 4).

• PHASE 1 DRUG TRIAL Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness;  they are typically closely monitored. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies.
• PHASE 2 DRUG TRIAL Phase 2 trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.
• PHASE 3 DRUG TRIAL Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide and adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug.
• PHASE 4 DRUG TRIAL Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain post-marketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.
  • Sudden cardiac death
  • Heart attack
  • Irregular heartbeat
  • QT interval prolongation

Physical Dependence: A physiological need  for a substance, the absence of which leads to withdrawal. Physical dependence  is distinguishable from addiction in that addiction also involves mental  fixation.

Placebo: A chemically inert substance  given in the guise of medicine for its psychologically suggestive effect; used  in controlled clinical trials to determine whether improvement and side effects  may reflect imagination or anticipation rather than actual power of a drug.

Plaintiff: The party bringing the case  against another.

Pleading: The process of making formal,  written statements by litigants during a lawsuit. All papers filed with the  court are collectively referred to as "pleadings." 

Prempro: A hormone replacement therapy (HRT)  drug prescribed to treat menopause symptoms, Prempro was recently a subject of  a drug recall. It was pulled from shelves in 2002 after the Women's Health  Initiative Study found that it increased women' s risk of stroke by 41 percent,  cardiovascular disease by 29 percent, and breast cancer by 26 percent. Warnings  from the American Heart Association and the Journal of the American Medical  Association also prompted the recall.

Precedent: The value that a completed case  has on deciding future cases.

Process Serving: The method by which a  defendant in a lawsuit is notified that a plaintiff has filed a suit against  him.

Product liability: A manufacturer of a  product may be held liable for damage caused by that product if it was somehow  defective, to the point that it was unreasonably dangerous to the consumer. A  product can be defective in 3 ways: Manufacturing Defect (When one particular  product out of many like products has a flaw that makes it unreasonably  dangerous, it is said to have a manufacturing defect); Design Defect (If the  actual design makes it unreasonably dangerous); Information Defect or Failure to  Warn (A defendant may be liable for not adequately warning of a product's risk  that were known in light of scientific knowledge at the time of manufacturing).

Pro Se: On one's own behalf; not using  an attorney.

Propulsid: Propulsid (Cisapride) may cause  irregular heartbeats and even sudden death. At least 341 reports of heart-rhythm  abnormalities, including 80 reports of deaths, have been associated with  Propulsid. Report of deaths and hospitalizations have mounted since the FDA  first warned that Propulsid can cause serious heart problems in June 1998. Some  30 million U.S. residents, including President Clinton, have taken the  medication since it hit the market in 1993 for Gastroesophageal Reflux Disease (GERD).  Propulsid can cause serious side effects such as:

After the drug's approval in 1993, there were  several revisions to the Propulsid label, informing health care professionals  and patients about various side effects and risks, the most serious of which  involved cardiac irregularities. Although Propulsid was only associated with  mild adverse effects upon approval, the drug was soon linked to life-threatening  heart rhythm abnormalities (arrhythmias) and cardiac arrest in people with no  prior heart disease. After years of escalating fatalities and pressure from the  FDA, Janssen Pharmaceutical Inc., a division of Johnson & Johnson, announced  that it would voluntarily stop marketing Propulsid in the United States  beginning July 14, 2000.

Purity: The relative absence of extraneous  matter in a drug or vaccine that may or may not be harmful to the recipient or  deleterious to the product.

Punitive Damages: Damages given for the  purpose of punishing the defendant.