Vioxx Withdrawal and Drug LitigationWritten by Richard Martin
On Sept. 30, 2004 Merck announced a worldwide withdrawal of Vioxx® (rofecoxib). Vioxx had previously been prescribed in treatment of arthritis and pain. Worldwide sales of Vioxx in 2003 were an estimated $2.5Billion and drug was marketed in more than 80 countries around world. This is one of several recent pharmaceutical products to have been put in spotlight by both national media and plaintiff lawyers. Since sometime in mid to late 90s a substantial number of pharmaceutical medications and medical devices have been removed from market due to possible adverse health implications. The FDA acts as a regulatory body in approving health related products before they are marketed to consumers. The FDA moved to ban Ephedra in US in 2004. However, recent headlines about voluntary drug withdrawals have produced questions as to FDA's recent performance. Many people believe that FDA did not test drugs rigorously enough to determine all possible health problems that they might cause. People believe that rise in litigation over these medications was due to fact that FDA now allows pharmaceutical companies to “fast track” their products and get them through process in a year. In fact, Vioxx was only released in 1999.
The Right Focus on Tort ReformWritten by Richard Martin
The recent headlines about Merck's Vioxx withdrawal and FDA's move to ban ephedra have brought a lot of media attention to growing area of drug litigation. On April 12, 2004 FDA published a rule banning health supplements that contain ephedra alkaloids. The FDA concluded that limited short term weight loss effects were outweighed by possible heart problems and stroke risks. The market gap caused by banning of ephedra has been filled by many new companies that are marketing products similar to ephedra. However, these “ephedra alternatives” may not be any safer than banned ephedra that they replace. The FDA's ephedra ban, and Merck's Vioxx withdrawal have been hot news topics. These drug recalls and ephedra banning have brought lawsuits from many different angles. Obviously, some people think that some of lawsuits will be frivolous. In fact, there has been a lot of news during last decade about “frivolous lawsuits” brought by injured consumers against large companies for defective products. However, according to one report from Public Citizen (http://www.citizen.org/congress/civjus/tort/myths/articles.cfm?ID=12369 ), businesses file many more times amount of lawsuits than consumers do and are more likely to be sanctioned by a court for bringing a frivolous claim.