The challenges of litigation in US courts and the actions tissue banks can take to meet those challenges
- PDF / 167,431 Bytes
- 8 Pages / 547.087 x 737.008 pts Page_size
- 28 Downloads / 139 Views
The challenges of litigation in US courts and the actions tissue banks can take to meet those challenges Daniel D. Harshman • Glyn O. Phillips
Received: 17 December 2010 / Accepted: 3 February 2011 / Published online: 1 March 2011 Springer Science+Business Media B.V. 2011
Abstract The growth of tissue banking from local non-profit organizations to national and multinational corporations has increased the likelihood of litigation against tissue banks. The acquisition of tissue banks by corporate entities, many of whom are based in the US, means that tissue banks need to be prepared for the challenge of litigation in the US courts. The purpose of this paper is to help tissue banks meet those challenges by describing the nature of US litigation, the most common types of lawsuits against tissue banks and the steps that tissue banks can take to prepare for litigation in the US. Keywords Litigation US courts Lawsuits Regulations Professional negligence Products liability Standards Quality Plaintiff Defendants Discovery
D. D. Harshman Cozen O’Connor, 601 S. Figueroa St., Suite 3700, Los Angeles, CA 90017, USA e-mail: [email protected] URL: www.cozen.com G. O. Phillips (&) Hydrocolloid Research Centre, Glyndwr University, Plas Coch, Mold Road, Wrexham LL112AW, Wales, UK e-mail: [email protected]
Introduction The Bethesda Naval Tissue Bank, formed in 1949, is widely credited as being the first tissue bank in the United States. For many years thereafter, tissue banking in the US was largely a solitary endeavor. It would take another 30 years to form the American Association of Tissue Banks (‘‘AATB’’) and 35 years before the profession adopted tissue banking standards. When the AATB published ‘‘Standards for Tissue Banking’’ in 1984, the standards were entirely voluntary. Government regulation of tissue banking was motivated by the fear of transmission of HIV infections. The Food and Drug Administration (‘‘FDA’’), the regulatory agency concerned with tissue banking in the US, adopted an interim rule requiring laboratory tests and donor screening in December 1993. This interim rule became final 4 years later. In 2001, the FDA required all tissue banks to register with the FDA. That same year, the FDA proposed voluntary Good Tissue Practices. In November of 2004, the FDA adopted Good Tissue Practices in a final regulatory rule. European Tissue banking followed a similar path to that of its American counterparts. The Hradec Kralove bank was formed in Czechoslovakia in 1952, the Berlin Charite Hospital Tissue Bank was formed in 1956, the Leeds Tissue Bank in Great Britain was established in 1955 and Poland’s tissue
123
168
bank was founded in 1962.1 While these and other tissue banks thrived throughout the European continent, there was little or no cohesive, professional organization until 1991. In that year, twenty-seven founding members from seventeen different countries formed the European Association of Tissue Banks (‘‘EATB’’). While there may be other notable examples, the experience from Ame
Data Loading...
