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DePuy Spine announced recently the U.S. District Court for the Central District of California ruled in favor of the company and dismissed virtually all claims of product liability relating to its CHARITEŽ Artificial Disc, an artificial disc used in the treatment of degenerative disc disease. "We are pleased with the court's decision. We think it's an important decision that recognizes the rigorous testing and evaluation the CHARITÉ Artificial Disc went under before being approved by the FDA," said Gary Fischetti, President, DePuy Spine, Inc. "We will continue to vigorously defend the use of the product for carefully selected patients suffering from degenerative disc disease." Earlier this year, DePuy Spine moved to have the product liability case dismissed on the grounds that a device-specific evaluation and approval by the federal government preempts any state court jury redetermination of the same issues. The plaintiff, a 38-year-old California woman, had claimed that the disc was not designed, tested and labeled properly. On June 21, 2007, the Court agreed with DePuy Spine and dismissed all but one of the plaintiff's claims, stating that "claims alleging a defective design, failure to warn, inadequate labeling of a Class III PMA-approved device are preempted." The Court held the same for breach of warranty claims. In October 2004, the U.S. Food and Drug Administration (FDA) approved the CHARITÉ Artificial Disc after the agency had conducted the most detailed and stringent evaluation a medical device can receive. Specifically, the FDA found the CHARITÉ Artificial Disc to be "safe and effective" when used in appropriate patients and approved it for sale in the U.S. The Court explained why a local jury should not be permitted to second guess the judgment of expert evaluators assigned by the FDA to review the safety and efficacy of the CHARITÉ Artificial Disc. The Court held that "were a jury to conclude that the [CHARITÉ Artificial Disc] was negligently designed, that conclusion would directly conflict with the FDA's determination that it was safe for use. Similarly, were a jury to conclude that different or additional warnings were required, that would conflict with the device-specific requirements imposed by the FDA." The Court said it would allow plaintiff to attempt to prove that the particular CHARITÉ Artificial Disc implanted in her body had a manufacturing defect (i.e., a deviation from manufacturing specifications). DePuy Spine will vigorously defend against this one remaining claim and provide factual evidence to dispute the plaintiff's allegation. About DePuy Spine DePuy Spine, a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies.
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For more information can be found at www.depuyspine.com
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