Principles and Practice of Pharmaceutical Medicine

knowledgeable about the many laws and regula- tions that directly affect pharmaceutical manufac- turers and their employees. San ...

See Data Protection Act 1998, Schedule 1 Parts I and II. See generally Clerk & Lindsell on Torts, London: Sweet & Maxwel ...

...

47 Pharmaceutical Product Liability Han W. ChoiandHoward B. Yeon Product liability is one of the fastest growing and most econom ...

pharmaceutical product liability law, review recent developents and emerging trends among pharmaceutical companies and product l ...

ever, as more information about drugs have become available to the consumer and as plaintiffs’ lawyers continue to search for ne ...

Negligence Negligence is a principle of tort law that may be defined as the breach of a duty of care owed by one party, the defe ...

statutes that allow regulatory compliance as a valid defense in pharmaceutical product liability actions (N.J Code Section 2A:58 ...

designed to identify documents and data relating to their dealings with foreign regulatory agencies. Plaintiffs’ counsel regular ...

included burning pain in the feet, cramping pain in the calves, loss of ankle and knee reflexes, and tingling in hands (Crawford ...

claim, too, was questionable, however, in light of the contemporaneous Hamilton v. Fife Health Board(1993) decision, holding tha ...

clinical benefit. InBarker v. Lull Engineering Co. (1978), a California court adopted a ‘risk–benefit’ test to assess whether a ...

47.6 Recent cases and developments Since the thalidomide and DES cases, a growing number of drugs have been the subject of produ ...

valve damage in Fen-Phen users, all of whom were women. The FDA subsequently issued a warning about heart valve problems associa ...

References Allen DK. 1997. ‘The return of thalidomide: are we ready to forget images like this and give the drug another chance? ...

Robertson G. 1972. ‘Thalidomide revisited’.J. Okla. State Med. Assoc. 65 : 45. Schreiber L, Hirssh HL. 1985. ‘Theories of liabil ...

...

48 Patents Gabriel Lopez The realities of modern international corporations and the international marketplace for pharmaceu- tic ...

Patent Term Adjustment is not limited to pharma- ceutical patents. ‘When does this U.S. patent expire?’ used to be, but no longe ...

in not likely to be sought by the inventor, as a new chemical entity is often the invention that needs protection and such an in ...