Civil court actions

Under Hatch-Waxman Big Pharma received a guaranteed extension for its pharmaceutical patents if it could demonstrate that there were FDA delays in approving a new drug, that is the FDA would have certain time constraints put upon it and if these were exceeded the innovator was granted an extension on its patent term. The term of extension was fact-dependent for each drug approval, but could be as long as five years. The procedure was administrative no civil court action was necessary. 

Competitors may take action directly through the civil courts and they often seek injunctive relief to stop advertisements that are considered to be violating their rights on the basis of the German Law against Unfair Competition. 

There is also the possibility for an action for unfair competition under Mexican law as a result of a company s advertising activities this is based on the provisions of the industrial property law. The affected party can also claim damages and lost profits in a civil court, as a result of unfair competition activities. 

Other advantages of the environmental audit is to allow time to properly assess the problem, plan its solution and allow for funding the capital cost required. There are potential problems in having an environmental audit performed. The results of recent court decisions indicate that the environmental audit results may not be able to be kept in confidence and furthermore, they may be used as evidence of noncompliance in civil or criminal court actions. It is conceivable that an audit can increase the potential liabilities. Consequently, management should be prepared to commit to satisfy any negative findings before the audit is undertaken. 

A Title VII action is considered equitable in nature, and the primary objective is to stop or eigoin the unlawful discrimination practices. Potential remedies can include injunctive relief, back pay, attorney fees, punitive damages, and other relief Class actions are permitted under Title VII if the rules of civil procedure are met. Although safety professionals will seldom be involved in a Title VII court action, there are a number of possible defenses, including, but not limited to, business necessity defense, statistical data, and bona fide occupational qualifications. 

Barnard, D., The Civil Court in Action, 2nd edn, Butterworths, London (1985)... 

The only tort (civil wrong) of real significance in health and safety is negligence. Negligence is the lack of reasonable care or conduct which results in the injury (or financial loss) of or to another. Whether the act or omission was reasonable is usually decided as a result of a court action. 

Ffowever, perhaps the most important legal redress available to an individual working in the United Kingdom who wishes to seek compensation from his or her employer for a work-related illness or injury is through the civil court, where claims under common law are heard. Possibly contrary to popular belief, the phrase safe system of work was not defined by any action brought under a safety law, but under common law. 

Both agencies worked within the confines of ancient Progressive Era statutes that provided inadequate authority to operate effective deterrence-based enforcement programs. FDA s primary enforcement tool was a court action to seize adulterated products, for which it had the burden of proving that the particular items seized were probably contaminated. USDA s only weapon was the atom bomb of closing down the production facility. Neither agency had authority to assess civil penalties tailored to fit particular violations. FDA even concluded that it lacked authority to require repeat violators to take corrective action. ... 

It is not uncommon for civil actions to be brought against law enforcement personnel who have come into contact with individuals under the influence of PCP. Helen A. Burns vs. City and County of Honolulu et al. represents an issue that is being brought before the courts with increasing frequency. 

The Indiana Supreme Court rules that the mayor of Gary, Indiana, violated the state constitution when he denied gun permits to city residents. The court cites the 1871 Civil Rights Act, which had been passed to counter the actions of Ku Klux Klan members. 

United States v. Barr Laboratories. Civil Action no. 92-1744. U.S. District Court for the District of New Jersey. 

Even after the firm is permitted to resume operations, the company is perpetually enjoined by order of the court. This means that any violation of the order constitutes contempt of court. If FDA encounters such a breech, it can file a civil or criminal contempt action, which can result in additional monetary penalties or even jail time for some of the individual defendants. 

Michael Aquino, Plaintiff, v. The Honorable Michael Stone, Secretary of the Army, Defendant - Civil Action No. 90-1547-A, dated 1st July 1991, US District Court for the Eastern District of Virginia, Alexandria Division. 

Barr Court Decision, United States of America, Plaintiff, v. Barr Laboratories, Inc., et al. Defendants, Civil Action No. 92-1744,1992. 

In the United States, this is a civil action brought in the federal courts. The specific federal district court in which a patent owner can sue an infringer is governed by federal law. Patent litigation is very expensive and time-consuming. For this reason, it is not entered into without careful consideration of the consequences and analysis of all options available. In recent years, various alternative dispute-resolution proceedings have been used more often. 

Bano et al. versus Union Carbide Corp. Warren Anderson, United States District Court Southern District of New York, Civil Action No. 99, Civ. 11329 (JFK). 

Perceptive Biosystems Inc., Pharmacia Biotech Inc., Sepracor Inc., Pharmacia LKB Biotechnology AB, Pharmacia Bioprocess Technology AB, and Procordia AB, United District Court, District of Massachussetts, Boston, MA, Civil Action No. 93-12237-PBS, Memorandum and Order, March 31 (1997). 

Pretrial Conferences. The court may, particularly in civil cases, direct the attorneys for the parties concerned to appear before it for pretrial conferences to consider simplification of the issues, the desirability or necessity of amending the pleadings, the possibility of avoiding unnecessary proof by obtaining admissions of fact and of the authenticity of documents, limitation of the number of expert witnesses, and any other matters. In civil cases, the court then issues an order which recites the action taken at the pretrial conferences and limits the issues for trial to those not thereby disposed of and which thus control the subsequent course of the action, unless later modified by the court to prevent mainfest injustice. 

Depositions. By permission of the court after jurisdiction has been obtained over any defendant in a civil case, or without such permission after an answer has been served, the testimony of any person, whether a party to the action or not, may be taken at the instance of any party by deposition upon oral examination or written interrogatories for the purpose of discovery, or for use as evidence in the action, or for both purposes. 

U.S. District Court, People With AIDS Health Group, William Ceyrolles, and William Nei-thamer v. Burroughs Wellcome Company and the United States of America, Civil Action No. 91-574, March 19,1991. 

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