How FDA regulations and injury litigation cripple the medical device industry.
USA Today Magazine › Vol. 132 Nbr. 2698, July 2003
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Law & Justice
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How FDA regulations and injury litigation cripple the medical device industry.
MEDICAL DEVICES and implants are among the modern marvels that alleviate pain and suffering, as well as prolong and add to the quality of life. However, manufacturers of medical devices face a triple threat in their efforts to develop such products. The U.S. Food.and Drug Administration can use its open-ended powers to drive manufacturers out of business, even when the FDA itself certifies their devices. The personal injury liability system makes it all too easy for predatory lawyers to extract billions of dollars from manufacturers of safe products, forcing them into bankruptcy. Sensationalist media accounts of allegedly dangerous devices, often stoked by the FDA, add to the problems faced by device manufacturers. Three examples illustrate these threats:
The $3,000,000,000 Dalkon Shield "mistake." In 1974, the media highlighted lawsuit allegations that the Dalkon Shield intra-uterine contraceptive device was causing more septic spontaneous abortions and deaths than were other IUDs. The FDA impulsively asked A.H. Robins to remove the Dalkon Shield from the market, even though, at that time, the agency had no statutory authority to ban medical devices. Yet, an FDA r...See the full content of this document
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