In recent years there has been a lot of debate over the effectiveness of the Food and Drug Administrations’ medical device review system, i.e., the 501(k) process. Its critics say that the review system is not comprehensive enough and allows for the approval of unsafe medical devices. However, its advocates…
Over the years, medical advances have led to countless innovative inventions that have saved many lives. However, not every medical innovation lives up to its expectations. The recall of DuPuy’s metal-on-metal hip joint is a perfect example of a medical device that failed to delivery as promised. The first artificial…
Johnson & Johnson has announced that it will be dropping one of its medical devices from production – by the end of 2011, the company will cease manufacturing its drug-coated heart stents. The company explains its decision was due its decreasing market share in the heart stent category; Johnson &…
A recent New York Times article reported that a new study indicated that in recent years the Food and Drug Administration (FDA) has not rigorously studied or tested many of its approved medical devices before clearing them for sale. The study specifically assessed many medical devices which have been the…
Radiation therapy is a common treatment for a large range of cancers and has been responsible for saving, or at least extending, many peoples’ lives. However, the basic premise of radiation therapy involves targeting and killing cancerous cells in one’s body. And while properly administered radiation therapy can save lives,…
Federal preemption of medical device liability lawsuits has been a volatile issue in recent years, with the courts typically preempting product liability lawsuits citing violations of individual state safety standards. However, in Bausch v. Stryker Corporation, et al., No. 09-3434, the issue was whether a product defect claim citing federal…
Medicine is an area where new advances are being made on a regular basis that lead to better care and treatment for patients. However, this means that in some cases, patients who received older forms of treatment develop unforeseen complications, particularly in the area of Illinois defective medical devices. Consider…