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Single-use medical devices (SUDs) are designed and approved by the FDA to be used once and thrown away. The practice of cleaning and reusing disposable medical devices has resulted from hospitals' continuing search for cost-cutting alternatives. The safety and efficacy of reprocessing SUDs has been the subject of significant - and heated - debate.

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Drug counterfeiting robs pharmaceutical manufacturers of their investment in patents, trademarks, copyrights, and trade dress. It robs pharmacists and consumers of money, for worthless and sometimes dangerous products. It undermines the integrity of and consumer confidence in the American health care industry and in the government's ability to regulate it. More troubling than all these systemic evils, drug counterfeiting has the potential to allow controllable illnesses to ravage patients unchecked, to spread rather than stop disease, and to injure and kill.

Litigators have seen massive technological changes occur during the past two decades. Perhaps some of the greatest of these changes have taken place in the time-honored discovery tradition of document production.

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Once considered the realm of Rube Goldberg contraptions, medical technology is now a key feature of patient care. Longer life expectancy corresponds with the growth in entrepreneurial device companies making everything from tongue depressors to Jarvik-7 artificial hearts. Patients often expect perfect device performance along with flawless medical outcomes. Medical devices now comprise a multi-billion dollar industry, with vigorous growth forecast well into this century.

Before the clinical trials are run, before the Food and Drug Administration approves, before hope is held out to millions of patients, new drugs start with scientists asking elemental questions about human life. Now, the pipeline that leads from their laboratories through drug development to the FDA may be shut off at the source.

The most recent rulings of importance to you and your practice.

The FDA has just approved (April 24) the first drug eluting stent for angioplasty procedures to open clogged coronary arteries. In most cases, a stent is left permanently in the artery to keep the vessel open after angioplasty. The new stent slowly releases a drug, and has been shown in clinical studies to significantly reduce the rate of re-blockage that occurs with existing stents.

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Due to the rising cost of "defensive medicine," the U.S. House of Representatives recently passed legislation to limit or ban punitive damages in product liability lawsuits over injuries allegedly caused by FDA-approved products. 2003 H.R. 5. The HEALTH "Help Efficient, Accessible, Low-Cost Timely Healthcare" Act of 2003 was introduced in the House on February 5. This bill passed in the House on March 13 and is currently on the calendar of the Senate.