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Defective Human Tissue Transplants: Product Defect or Medical Malpractice?

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The recent second recall of Human Tissue harvested for use in surgical procedures by the FDA has raised eyebrows about the safety of the use of human Tissue during medical procedures. What has also become apparent is that many physicians and dentists never bother to inform their patients that they would be or had received transplanted tissue from cadavers during their surgical procedures. In most situations, doctors properly obtain and document consent from their patients and cannot be culpable for utilizing this recalled tissue. The responsibility for damages caused by the defective tissue will be borne by the tissue suppliers; however, where a doctor does not obtain informed consent, the physician may be guilty of battery, having participated in implanting improperly screened, unsafe, unwanted and unauthorized tissue into the patient.

More than 1.3 million procedures are performed each year using allograft tissue, ranging from knee repairs to cornea transplants to spine surgeries, utilizing tissue from donated cadavers. Most are supplied by reputable companies and do a lot of good, but the industry is little regulated.

On Wednesday, the FDA urged doctors to contact patients who received tissue from [the Company Donor Referral Services, Inc.], saying that additional information from the ongoing investigation “has heightened our concern” about the situation.

Companies voluntarily recalling tissues supplied by the Raleigh firm are Alamo Tissue Services of San Antonio, Texas; Lost Mountain Tissue Bank of Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of US Tissue’s assets in March, is handling US Tissue’s recall).

However, tissues typically are distributed nationwide, so patients anywhere could be affected.