The authors admit at the outset that the main goal of their campaign is to propagandize the public and policy-makers. They state plainly that “stem cell lawsuits may help raise public awareness and influence public policy” and would help draw “attention to negative outcomes and engender moral outrage on the behalf of vulnerable and sympathetic plaintiffs.”

This tactic would shift attention away from pesky patients’ rights advocates who support broader availability of the potentially life-saving treatments offered by stem cells. They see this strategy as viable because it worked for consumers injured by the tobacco industry, victims of gun violence, and sexual abuse victims molested by Catholic priests. The fact that the authors would put stem cell clinics – and by extension stem cell patients – in the same category as Philip Morris, AR-15 gun manufacturers and pedophile Catholic priests is simply ludicrous.

For the authors, civil litigation is essentially a propaganda tool in their misguided war against a non-existent enemy. They advocate using civil litigation to “attract public attention” and “shape the media narrative.” Information operations such as these are an age-old concept in international relations and warfare, that includes the collection of tactical information about an adversary as well as the dissemination of propaganda in the pursuit of a competitive advantage over an opponent.

And how do the authors intend to collect their tactical information? They will use the civil litigation discovery process to uncover “previously undisclosed information about a provider’s practices” that could potentially trigger FDA investigations.

Overall, the tone of the authors’ proposal is that of combativeness and belligerence, not negotiation and reconciliation. As with all misguided wars, it is civilians – those who the war is allegedly waged to protect – are the ones who suffer the most.

Little Evidence to Support ‘War on Stem Cells’

Even worse, they don’t show their “war on stem cells” is supported by any real-world evidence. Their methodology is insufficiently rigorous; it lacks integrity to the point of being flimsy, porous and leaky. The data which serve as the cornerstone of the authors’ argument are 9 court cases in which plaintiffs allege that the stem cell therapy they received was either ineffective or injurious.

This sample is far too small to seriously support any meaningful conclusions, much less the authors’ conclusion that the number of legal claims is growing. The 9 cases cited were filed between 2012 and 2017 for a wide variety of medical conditions and for a wide variety of causes of action.

Not only are we not told how many stem cell procedures were actually performed in American clinics over the same time span, but in none of the 9 cases cited was there a disposition in favor of the plaintiffs! In fact, one was voluntarily dismissed by the plaintiffs and another was dismissed on appeal. Of the remaining seven, 4 were settled and 4 have yet to be decided.

So none of the claims of negligence, misrepresentation, fraud, lack of informed consent, or unfair trade practices were ever proven. The authors acknowledge that this is a problem, and in desperation turn to a Japanese case to support their claims. The problem is the authors openly admit that “the U.S. administrative and legal systems differ greatly from Japan’s.” It’s never a good idea to undermine your own argument.

If the authors are truly motivated by the safety and welfare of stem cell patients, then perhaps their efforts would be better spent advocating for the increased democratization and liberalization of stem cell policy.

This can be accomplished by supporting policies geared toward the availability and affordability of stem cell therapies, such as the patient-centered ethos of “Right to Try” legislation, the regenerative medicine provisions of the 21st Century Cures Act, and the constitutionally-protected privacy right in a patient’s use of their own stem cells.

We need less antagonism and asymmetry in stem cell policy-making, and more alliance-building and acceptance of a new paradigm of progress. The solution is not more litigation against people, but more listening to the people.