Legal Glossary S

Serentil: An antipsychotic drug for schizophrenics. Serentil has been associated with  other drugs that may cause cardiac arrhythmias and sudden death.

Serzone: A prescription medication used to  treat depression. Cases of life-threatening liver failure have been reported in  patients treated with Serzone. Patients should be alert for signs and symptoms  of liver dysfunction and report them to their doctor immediately if they occur.

Service of Process: Providing a formal  notice to the defendant that orders him to appear in court to answer  plaintiff's allegations.

Settlement: An arrangement by which  parties in dispute come to an agreement, usually involving some type of  compromise exchange of valued things. Over 90% of all lawsuits are settled out  of court before a trial ever takes place.

Sporanox: On May 9, 2001, The Food and  Drug Administration issued a Public Health Advisory to announce significant  safety-related updates to the labeling of Sporanox products and Lamisil tablets.  Sporanox and Lamisil are used to treat nail (onychomycosis), skin and other  systemic fungal infections. The FDA believes there is real risk of developing  congestive heart failure (CHF) associated with the use of Sporanox. Both  Sporanox and Lamisil have been associated with serious liver problems resulting  in liver failure, transplantation and even death. Results of recent studies of  Sporanox showed that the drug can weaken the force of the heart muscle's  contractions. This condition, sometimes called "negative inotropic  effect" was observed when Sporanox was injected intravenously into  anesthetized dogs and healthy human volunteers. In these studies, the adverse  effect on the heart muscle resolved once the drug was stopped. Since becoming  aware of the study findings, the FDA analyzed US and international  post-marketing adverse event reports involving Sporanox that were received  between its approval in September 1992 and April 2001. During this period, FDA  received the following event reports:

• 94 cases in which patients receiving Sporanox developed CHF
• In 58 of the 94 cases, FDA believes Sporanox contributed to or may have been the cause of CHF.
• In 26 of these 58 cases, Sporanox was being administered to treat fungal nail infections.
• Of these 58 patients, 28 were hospitalized. Death was reported in 13 cases.

In response to the study findings and the  analysis of the post-marketing adverse event reports, the FDA has added  additional information to the current warning in the Sporanox labeling. The  warning now states that Sporanox should not be administered for the treatment of  fungal nail infections in patients with evidence of cardiac dysfunction, such as  CHF, or a history of CHF. The revised Sporanox warning also includes important  information about heart-related adverse events caused by drug interactions. If  signs and symptoms of CHF occur during treatment of fungal nail infections, the  revised labeling recommends that the use of Sporanox should be discontinued. The  advisory also alerts healthcare professionals to rare cases of serious liver  problems including liver failure, transplantation and death associated with the  use of Sporanox products and Lamisil tablets. While adverse liver effects were  previously included in the labeling for both products, the FDA decided to  include this information in the advisory because some cases involved patients  with no preexisting liver disease or any serious underlying medical condition.  As of March 2001, FDA has received and reviewed 24 cases of liver failure  possibly associated with Sporanox, including 11 deaths. In almost half of the  liver failure cases, subjects received Sporanox for fungal nail infections or  other dermatological infections. Given the possible serious risks associated  with Sporanox products and Lamisil tablets, the new labeling for both products  now recommends that healthcare professionals should obtain nail specimens for  laboratory testing prior to prescribing the medications for fungal nail  infections, to confirm the diagnosis.

Stadol: A nasal spray form of analgesic  (pain killer). Bristol-Myers Squibb claims that Stadol has a much reduced risk  of the addictive qualities of other narcotics used to treat pain. Due to  manufacturer's claim of an extremely low potential for abuse, the FDA allowed  physicians to prescribe Stadol without government control. Contrary to the  manufacturer's claims, in the last few years it has been revealed that the  synthetic opiate in Stadol is extremely addictive and has been blamed for  several deaths. The FDA has logged reports a significant amount of deaths and  severe addictions associated with the drug. An injectable version took the blame  in some of those cases. However the nasal spray has brought most of the  complaints. The spray has been linked to hundreds of cases of addiction and  numerous deaths. In February 1995 Bristol-Myers Squibb asked the FDA to  recommend that Stadol NS be considered a controlled substance. A year later, the  company expanded its request to contol Stadol NS by including the injectable  form of the drug used to sedate patients before surgery. For Bristol-Myers, the  request to control Stadol NS and restrict its sales was unprecedented. By making  a drug a controlled substance, makes it more difficult for doctors to prescribe  and may prompt some to choose another painkiller. The question arises as to why  Bristol-Myers Squibb did not initially recommend Stadol NS to be labeled as a  controlled substance and why the company worked hard to argue the drugs  non-addictive benefits to FDA. These questions started to be asked when the  suicide of a medical doctor's son occurred. The father was Morris A. Fisherl  M.D., professor of neurology at Loyola University, Stritch School of Medicine,  Maywood, Illinois. After Fisher's son conunitted suicide during treatment for an  addiction for a supposedly "safe" treatment for migraine headaches,  Dr. Fisher and investigative reporter Stephanie Glass gathered information on  the drug. According to Fisher, medical professionals and patients are not being  informed about the serious dangers associated with the drug Stadol which is  delivered as a nasal spray. Medical evidence, says Fisher, has always indicated  that Stadol should be scheduled for both effective control and as a caution to  physicians and patients as an addiction/dependence drug. In 1978, the Federal  Drug Administration Advisory Committee reviewed an indictable form of Stadol.  The committee recommended scheduling Stadol as addictive, pointing out its abuse  potential and withdrawal symptoms in people who had received the drug during  clinical trials. The committee's recommendation was not followed.

Statute of Limitations: The time period  within which a plaintiff must file his action against the defendant. This time  frame varies by state. In North Carolina, the statute of limitations is three  years.

Strict Liability: This holds manufacturers  responsible for the goods they produce, especially if they cause consumers  injury.

Subpoena: A form issued by the court   requiring someone to appear in court and/or bring documents. (Also referred to   as a "Summons.")

Summary Judgment: In a civil action, any  party may make this procedural motion, after the Discovery phase, to dispose of  the suit before trial has begun. If a defendant files a summary judgment motion,  it essentially means that the defendant believes that the plaintiff's case is  too weak to go to trial and the suit should be thrown out.

Synthroid: On June 1st, 20001, the Wall  Street Journal reported that the Food and Drug Administration has told Abbott  Laboratories the maker of Synthroid, one of the nation's most frequently  prescribed drugs, that the medicine has a "history of problems" and  can not be recognized as safe and effective. Synthroid is taken by patients who  have hypothyroidism or other disorders of the thyroid. Tyroid replacement  therapy usually continues throughout the patient's lifetime. The agency's  statements raise the possibility that the 40-year-old drug, which has never been  officially approved for use by the FDA, will be subject to regulatory action  that could possibly remove the drug from the market. Patients using Synthroid  should be monitored with regular blood tests to assess the effect the medication  is having on thyroid function and also to check for toxicity. Too much Synthroid  can cause a condition known as "thyroid storm". Patients might  experience heart rate irregularities. Clots can be dislodged, and, in some  cases, may help lead to stroke. At worst, a general hyperactive metabolic state  can even lead to death. The FDA has indicated that Synthroid needed to be  approved by August 14, 2001, but as of June 1, 2001, Abbott has indicated that  they have not even applied for approval. The FDA stated they wouldn't rule out  asking for the drug's removal and noted that there are two other approved drugs  in Synthroid's class that could potentially fill any void left by Synthroid.  Synthroid had sales of $541.3 million in 2000 and, ranked by number of  prescriptions written, was the third most frequently prescribed drug in the  country, according to data compiled by IMS Health. Synthroid went on the market  more than four decades ago and never received formal approval from the FDA.  According to the Wall Street Journal, such approval was required but neither the  agency nor the drug's current owner is certain why it was never received. In the  mid-1990s, the FDA began compiling data on adverse events associated with the  use of Synthroid as well as with the use of its competitors. In 1997, it noted  that "almost every manufacturer" of such drugs had reported recalls  because of potency problems.