Henry Young, a researcher who specializes in study of adult stem cells and is Professor of Anatomy at Mercer University, and Bioregenesis Institute, Nevada-based clinic marketing stem cell procedures for variety of illnesses, are being sued following the death of a patient, Karen Allison Hones. The lawsuit, Hones v. Young et al., was filed August 20, 2012, in the District Court of the State of Nevada. Plaintiff is Edward P. Hones, Karen Hones’ husband.
According to the lawsuit, Michigan resident Karen Hones suffered for many years from asthma and thyroid disease. In October 2006 her health deteriorated and she began experiencing shortness of breath. Later that year she was diagnosed with idiopathic bronchiectasis. Her symptoms worsened and by 2009 her pulmonologist suggested that lung transplantation should be considered as a treatment option. Hones was subsequently referred to transplant physicians. Instead of undergoing lung transplantation Hones learned of stem cell procedures marketed by Bioregenesis Institute. According to the lawsuit, Bioregenesis Institute claims that it conducts “therapeutic cellular research for a variety of difficult diseases and ailments.” The lawsuit alleges that despite claims about engaging in “therapeutics research” Bioregenesis Institute “was not operating under IRB guidelines.”
When Hones began undergoing stem cell interventions allegedly provided by Henry Young and his colleagues at the Bioregenesis Institute, she weighed approximately ninety pounds. Given her frail status it is surprising that part of her treatment regimen reportedly included having 400 ml of blood withdrawn every few months. The lawsuit states, “such practice could have been detrimental given Ms. Hones’s low body weight.”
Karen Hones died August 31, 2011. According to the lawsuit, “The treatment rendered by Young was not FDA approved, was not subject to a human research protocol, and was not reviewed by any Institutional Review Board.” Plaintiffs allege that Hones was “treated with a proprietary stem cell therapy designed by Young.”
In May 2012, Henry Young and Bioregenesis Institute were asked to provide all medical records and bills related to Hones’ treatment. The lawsuit states that to date Young and Bioregenesis Institute have not provided records related to stem cell procedures Hones underwent.
According to the counts listed in the lawsuit, Edward Hones is suing Henry Young and Bioregenesis Institute for negligence, breach of fiduciary duty (for this count Bioregenesis Institute is not listed), lack of informed consent, loss of consortium, fraud-intentional misrepresentation, and negligent representation of fact. The lawsuit alleges, “As a Ph.D. without a medical degree or license, Young’s actions constitute the unlawful practice of medicine.” In addition, it alleges, “all conduct undertaken at Young’s direction, whether by licensed physicians or staff, also constitutes the unlawful practice of medicine.” The lawsuit asserts that “Young was at all times charged with the professional responsibility of conducting an ethical experiment where risks did not exceed benefits, of determining the universe of harm through proper preclinical animal studies, of properly conducting the informed consent process, of rendering proper care and treatment to Ms. Hones, of properly and carefully designing and administering the experiment’s protocol in a careful and prudent fashion, of assuring that proper care and attention were provided during all periods of time during which she remained under his care and treatment, and of candidly and honestly advising her of the results and consequences of the experiment.” Plaintiff alleges, “Young breached his obligations and duties under these regulations” and administered to Hones an experimental stem cell intervention that “carries a high probability of causing harm.” According to the lawsuit, “As a result of the careless, negligent and reckless conduct of the Young (sic), Ms. Hones was caused to suffer excruciating and agonizing pain and discomfort.”
The lawsuit filed by Edward Hones alleges a series of negligent acts by Henry Young and Bioregenesis Institute. The list includes:
- failing to conduct an ethical experiment in accordance with the standards and guidelines governing human subjects research;
- failing to determine the universe of harm through preclinical animal studies;
- failing to properly conduct the informed consent process;
- failing to disclose the conflicts of interest inherent in the experiment;
- failing to provide a subject advocate;
- failing to properly and adequately treat and care for her condition;
- failing to perform proper care and careful research practices and procedures in accordance with the standards prevailing in the community;
- caring for Ms. Hones in a negligent and improper manner;
- failing to properly monitor her condition both prior to and subsequent to the delivery of the experiment’s therapies;
- failing to inform Ms. Hones of all the risks of the experiment so as to afford her with the opportunity to make an informed decision as to whether to participate;
- failing to properly and timely observe, discover, diagnose, treat and care for her condition;
- failing to exercise reasonable care under all of the circumstances, in accordance with the accepted practices and procedures in the community;
- failing to design, implement and monitor an experiment in accordance with the ethical standards for such experiments;
- failing to warn Ms. Hones regarding the risks of the study;
- failing to perform the study in a careful and prudent manner;
- failing to treat Ms. Hones with respect for her human dignity as a human subject; and
- practicing medicine without a license.
The lawsuit proceeds to allege, “As a direct and proximate result of the carelessness, negligence, gross negligence, recklessness and willful and wanton conduct of Young and Bioregenesis Institute…Ms. Hones was caused to sustain serious and debilitating personal injuries. As a direct and proximate result of the misrepresentations of Young, Ms. Hones decided to forgo other therapies. Even if the procedures performed on Ms. Hones did not directly cause her death, her failure to seek proper medical treatment at the urging of defendants certainly contributed to her death.” Plaintiff further alleges that as result of stem cell interventions Ms. Hones received, “She was caused to suffer agonizing aches, pains and mental anguish; she sustained loss of enjoyment of life and loss of life’s pleasures, and she suffered dignitary harm, and, ultimately, death.” Plaintiff seeks “compensatory damages, pre-and post-judgment interest, dignitary damages, and allowable costs of suit.” Henry Young has until February 19, 2013 to file a response to the allegations in the lawsuit.
This lawsuit, much like ongoing lawsuit by clients of RNL Bio and Human Biostar (the latter business was formerly known as RNL Life Science), draws attention to risks related to individuals reportedly undergoing stem cell interventions that are of unknown safety and efficacy and provided outside framework of FDA and IRB oversight. Claims made in Hones v. Young et al. constitute allegations that have not been established in court. Nonetheless, the lawsuit raises disturbing questions about marketing of purported stem cell interventions by clinics located in the US, reported failure to balance risks and benefits by individuals allegedly marketing and providing stem cell procedures, safety of stem cell intervention allegedly provided by Henry Young and Bioregenesis Institute, disclosure of risks and adequacy of informed consent processes in Karen Hones’ case and in other instances in which ill individuals allegedly undergo stem cell procedures, quality of care in treatment of individuals receiving stem cell interventions that are not subject of investigational new drug applications or approved biologics applications, provision of stem cell “therapies” as “research” performed without oversight by IRBs and FDA, and alleged involvement of nonphysician stem cell researcher in practice of medicine. This lawsuit merits close attention by individuals who are concerned with domestic and international proliferation of clinics marketing stem cell-based interventions that are not provided in context of rigorously designed and conducted clinical studies reviewed and approved by both FDA and qualified, competent institutional review boards.