By Claire Horner
In 2016, a law firm in California began looking for individuals who were “misled or harmed by stem cell treatment” in the southern California area (which was discussed on this blog here). While there had been other lawsuits filed by plaintiffs against individual clinics, this firm was looking to take a different approach: a proposed class action combining multiple harmed patients into a single lawsuit. With the rapid expansion of clinics operating in the United States that offer unproven – and sometimes harmful – stem cell interventions to patients, this raised an interesting question for our team: could lawsuits be an effective tool in the fight against unethical stem cell practices? We reasoned the answer is yes (discussed in our paper here).
First, we do not want to paint a picture with a broad-brush stroke claiming that all stem cell businesses are engaging in potentially harmful practices. Some are trying to balance providing patients with the best care while also engaging in clinical research. Second, there has been a lack of clarity on whether some stem cell procedures are within the medical doctor’s scope of practice or whether they should be regulated by the U.S. Food and Drug Administration (FDA) as a new drug. To this end, the FDA has recently published guidance here and here. But clinical innovation itself should not transition into standard of care without having evidence of safety and efficacy – most commonly evaluated through clinical research (see a paper by Lindvall and Hyun here).
If particular types of stem cell interventions fall outside the purview of clinical research or the FDA, there may not be any of the built-in protections for patients who would be considered research participants. In such situations, patients who have been harmed may not have many options other than to file a lawsuit against a clinic. In these lawsuits, patients have made several different claims, including claims that the clinics have falsely advertised treatments, been negligent in providing stem cell interventions, committed medical malpractice, or provided an unsafe product to consumers.
Some readers might be concerned that some plaintiffs are filing frivolous lawsuits in order to get their money back for an experimental treatment. But in some of the lawsuits we analyzed, patients were seeking recourse for physical harm, such as the patients who suffered vision loss from a stem cell clinic. Causing physical injury or conveying inaccurate information about even experimental treatments are serious claims, and taking on a clinic is not something anyone would do lightly.
What we thought was that not only can patients receive compensation for harms from a lawsuit, but also several lawsuits in this space might be advantageous from a public health standpoint. Public health litigation is a legal approach intended to address issues that affect public health policy beyond the harm to individual plaintiffs. This strategy has been used with varying degrees of success by lawyers in many other arenas including the clergy sex abuse scandal, lawsuits against big tobacco, and lawsuits against gun manufacturers.
What sets public health litigation apart from other civil lawsuits is the impact it can have on an issue of public concern. Often, filing lawsuits garners media attention about the harms to patients and concerns about bad business practices. The more attention the media gives to the case, the more likely that other injured parties will step forward to file their own cases as well. As this cycle continues, the increasing number of cases could change how this issue is represented in the media. It can emphasize a problem on a larger scale which is how the clergy abuse scandal grew in the public eye.
As a strategy, public health litigation has its limitations. But in the stem cell context, it may provide a platform for greater public awareness of some of the physical and emotional harms and financial hardships patients have faced from untested stem cell treatments. It may help emphasize that not only is the patient’s right to try an important issue, but also that what they are trying should be safe and potentially effective. In addition, the fear of legal liability may cause stem cell businesses to improve their practices. Ultimately, if enough patients take legal action, regulatory agencies may be forced to further address the problem of the proliferation of harmful stem cell practices in a more public way.
The California law firm that was looking for plaintiffs eventually filed the proposed class action case against StemGenex. It is one of only 9 reported cases we found filed by injured patients against stem cell clinics, but with recent public attention to some of these injuries, it is possible that many more will be filed in the years to come. Public health litigation will not likely be the only key to ending the spread of unproven stem cell treatments, but it may be another tool in the tool kit to protect patients from harm.
Disclaimer: The views expressed here are personal and do not necessarily reflect the policy or position of Baylor College of Medicine.
Guest Post was written by Ms. Claire Horner, Assistant Professor at Baylor College of Medicine.