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The challenges of litigation in US courts and the actions tissue banks can take to meet those challenges

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Abstract

The growth of tissue banking from local non-profit organizations to national and multi-national 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.

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Notes

  1. The history of tissue banking in Europe is described at the website of the European Association of Tissue Banks. The complete history may be found at http://www.eatb.org/media/uploads/1.3history_of_eatb.pdf.

  2. See, August 17, 2010 press release from Medtronic, Inc. at: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1281988777809&lang=en_US.

  3. The law firm press release is available on the internet at: http://www.kendalllawgroup.com/blog/2010/08/securities/17/osteotech-inc-nasdaq-oste/.

  4. In states like Texas, the original pleading may be called a “petition.” Regardless of its title, all lawsuits begin with a formalized legal writing that identifies the parties involved, the facts giving rise to the alleged injury and the plaintiff’s demand for relief.

  5. Bourquin v. Melsungen (1993) No. CV-88-0346322S, 1993 Westlaw 280304 (Conn. Super., filed July 15, 1993).

  6. Arneson v. Michigan Tissue Bank, No. CV05-189-M-JCL, 2007 Westlaw 4698986 (D. Mont., filed March 26, 2007).

  7. Condos v. Musculoskeletal Transplant Foundation, 208 F. Supp.2d 1226 (D. Utah 2002).

  8. Osborn v. Irwin Memorial Blood Bank (1992) 5 Cal. App. 4th 234.

  9. Osborn v. Irwin Memorial Blood Bank, supra at 282.

  10. More precisely, a “failure to warn” may be either a negligence claim or a strict liability claim. The difference between negligence and strict liability theories is beyond the scope of this paper. Since California law exempts human tissue from products liability laws, this paper discusses only the negligence branch of “failure to warn” claims.

  11. Conte v. Wyeth, Inc. (2008) 168 Cal. App. 4th 89, 101 (describing a failure to warn claim under a negligence theory), review denied. (January 21, 2009). A failure to warn case against a health care provider is an action for professional negligence. Hedlund v. Superior Court (1983) 34 Cal. 3D 695, 704.

  12. Valentine v. Baxter Healthcare Corp. (1999) 68 Cal. App. 4th 1467, 1483 (patient learns of properties and proper uses of drug through physician; thus duty to warn runs to physician, not to the patient).

  13. Carey v. New England Organ Bank, 446 Mass. 270, 843 N.E. 2d 1070, (Mass. 2006) (parents alleged the tissue bank recovered tissue knowing it was ineligible for transplantation, then discarded the tissue without any anatomical gifts, but failed to inform the donor family).

  14. Snyder v. American Assoc. of Blood Banks, 144 N.J. 269, 676 A.2d 1036 (N.J. 1996); But see, N.N.V. v. American Assoc. of Blood Banks, (1999) 75 Cal. App. 4th 1358 (California rejected negligence actions against AATB).

  15. In re Human Tissue Products Liability Litigation, 582 F. Supp. 2d 644 (D.N.J. 2008).

  16. In re Cryolife, Inc., No. 02 CV1868-BBM, 2003 Westlaw 24015055 (N.D. Ga., filed May 27, 2003) (alleging that Cryolife’s press releases issued after the death of Brian Lykins contained inaccurate or misleading statements).

  17. See, Cryolife, Inc. v. Superior Court, (2003) 110 Cal. App. 4th 1145, 1155 (by statute, tissue banks are deemed to provide a service for all purposes and are thus immune from products liability laws).

  18. Arneson v. Michigan Tissue Bank, No CV05-189-M-DWM, 2006 Westlaw 2528465 (D. Montana, filed August 28, 2006) (immunity from strict liability law under Montana law only applies to hospital, long-term care facility or doctor, not to tissue bank).

  19. On this point, U.S. law is very different from the privacy laws of the European Union. U.S. law customarily allows discovery of an employee’s e-mail sent using the employer’s computer system.

References

  • Arneson v. Michigan Tissue Bank (2006) No. CV05-189-M-DWM, 2006 Westlaw 2528465 (D. Montana, filed August 28, 2006)

  • Arneson v. Michigan Tissue Bank (2007) No. CV05-189-M-JCL, 2007 Westlaw 4698986 (D. Mont., filed March 26, 2007)

  • Bourquin v. Melsungen (1993) No. CV-88-0346322S, 1993 Westlaw 280304 (Conn. Super., filed July 15, 1993)

  • Carey v. New England Organ Bank (2006) 446 Mass. 270, 843 N.E. 2d 1070, (Mass. 2006)

  • Condos v. Musculoskeletal Transplant Foundation (2002) 208 F. Supp.2d 1226 (D. Utah 2002)

  • Conte v. Wyeth, Inc. (2008) 168 Cal App 4th 89, 101

  • Cryolife, Inc. v. Superior Court (2003) 110 Cal App 4th 1145, 1155

  • Hedlund v. Superior Court (1983) 34 Cal 3d 695, 704

  • In re Cryolife, Inc., No. 02 CV1868-BBM, 2003 Westlaw 24015055 (N.D. Ga. filed 27 May 2003)

  • In re Human Tissue Products Liability Litigation, 582 F. Supp 2d 644 (D.N.J. 2008)

  • N.N.V. v. American Assoc. of Blood Banks (1999) 75 Cal App 4th 1358

  • Osborn v. Irwin Memorial Blood Bank (1992) 5 Cal App 4th 234

  • Snyder v. American Assoc. of Blood Banks (1996) 144 N.J. 269, 676 A.2d 1036 (N.J. 1996)

  • Valentine v. Baxter Healthcare Corp (1999) 68 Cal App 4th 1467, 1483

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Correspondence to Glyn O. Phillips.

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Harshman, D.D., Phillips, G.O. The challenges of litigation in US courts and the actions tissue banks can take to meet those challenges. Cell Tissue Bank 13, 167–174 (2012). https://doi.org/10.1007/s10561-011-9242-8

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  • DOI: https://doi.org/10.1007/s10561-011-9242-8

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