Protecting Patients by Encouraging Oversight: Can Civil Lawsuits Help?

April 3rd, 2018 by Guest Contributor

Stem cell treatments have been advertised as miracle cures for many illnesses, including vision loss. But, not all advertised “treatments” have evidence that they will work, and some have proven dangerous. Last year, three patients with age-related macular degeneration (AMD) were blinded after paying for stem cell injections. As a result, several patients, including those who were blinded by stem cell treatments, have filed lawsuits. We analyzed the public health impact of these law suits in this report. It’s not even just stem cell treatments where things can go wrong. There are many other kinds of treatments for different things that could potential harm someone. For example, someone who has low iron levels might not be able to take oral iron supplements so instead they get iron injected directly into the body. Although at first this was thought of as a good solution it could actually be dangerous and people are now having to file a claim against the problems that this treatment has now caused.

The U.S. Food & Drug Administration (FDA) – similar to Health Canada – oversees medical treatments that are developed through clinical trials. But many stem cell clinics are providing these “treatments” outside of a clinical trial and so there is no federal or state/provincial oversight. Patients who are harmed by these treatments are therefore left with few options –  one of which is to litigate.

In our report, we examined 9 different cases where an injured plaintiff (a patient) filed a lawsuit against a stem cell clinic. Most were individual lawsuits but two were proposed class action cases that include many more patients. The claims brought against clinics include fraud, misrepresentation, false advertising, battery, and products liability, among others. Two of the patients mentioned earlier who were blinded by stem cell treatments at a Florida clinic also filed lawsuits and were captured in our report.

Although these lawsuits are meant to compensate injured patients, they can also have a wider public health impact. Through the media, lawsuits can get the message across to patients, lawmakers, and the public that unproven stem cell treatments can be harmful. It can help mobilize patient groups like FFB to share this message with the patient community and with the government.

There are many promising stem cell treatments still being developed but only a handful that are proven treatments. Currently, there are no proven stem cell treatments for patients who are living with a vision impairment or with a blinding eye disease. Despite this, it is possible to find lots of information about unproven treatments on the internet.

Although lawsuits are not likely to solve the problem of providers giving unapproved treatments, they have an important role to play. In our report we show that these lawsuits are helping patients who have already been harmed, and are raising awareness about the dangers of unproven stem cell “treatments,” which we hope will have a larger, long-term impact on public health.

Read more and stay safe:

There are tons of great materials to help patients including general handbooks shown here and here. The International Society for Stem Cell Research’s A Closer Look website has a specific section on AMD.

Disclaimer: The views expressed here are the authors’ personal views, and do not necessarily reflect the policy or position of Baylor College of Medicine or Mayo Clinic.

Guest Post by Ms. Claire Horner, Assistant Professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine, and Dr. Zubin Master, Associate Consultant II in the Biomedical Ethics Research Program at Mayo Clinic.