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Apr 3, 2018

Protecting Patients by Encouraging Oversight: Can Civil Lawsuits Help?

Lawsuit Document

Stem cell treatments have been advertised as miracle cures for many illnesses, including vision loss—but not all advertised “treatments” work, and some have even 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 filed lawsuits. We analyzed the public health impact of these lawsuits in this report.

Stem cell treatments aren’t the only example where “miracle cures” can fall short of their promise. There are many other kinds of treatments for different diseases that could potentially harm someone. For example, consider injectable iron treatments for someone with low iron levels who cannot take oral iron supplements. While this treatment was initially considered a good solution, it was later shown that it could actually be dangerous. Now, people are filing claims as a result of the problems 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, so there is no federal or state/provincial oversight. As a result, patients that are harmed by these treatments are left with few options, other than to litigate.

In our report, we examined nine 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 included many more patients. The claims brought against clinics include fraud, misrepresentation, false advertising, battery, and product liability, among others. Two of the patients 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 Fighting Blindness Canada (FBC) to share this message with the patient community and with government.

Many promising stem cell treatments are in development, but only a handful of those 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 help patients who have already been harmed, and raise 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.

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