Attorney General Chris Carr has filed suit against Elite Integrated Medical, LLC, formerly known as Superior Healthcare of Woodstock, LLC d/b/a Superior Healthcare Group, Superior Healthcare Sandy Springs, and Superior Healthcare Morrow, along with its owner, Justin Paulk, (collectively “Elite”) for allegedly violating the Georgia Fair Business Practices Act (FBPA) by making false and misleading claims about the regenerative medicine products they offered to Georgia consumers.
“The use of unproven products or therapies can be harmful to consumers’ health and/or set them back thousands of dollars without affording them any results,” said Attorney General Chris Carr. “Our office will continue to hold accountable businesses that make unsubstantiated claims and violate the law.”
The complaint contends that Elite made over $6.4 million by using aggressive marketing techniques and high-pressure sales tactics to convince at least 842 consumers, most of whom were elderly and/or disabled, to purchase expensive, unproven medical treatments that are not covered by Medicare or health insurance. The office seeks injunctive relief, consumer restitution and civil penalties of up to $5,000 per violation of the FBPA and up to $10,000 per FBPA violation committed against elderly and/or disabled consumers.
According to the complaint, Elite represents that it has a staff of medical doctors who provide its products to patients, when in fact, medical doctors administer a very limited number of product injections. The vast majority of patients interact only with chiropractors and nurse practitioners, and most of the injections are administered by nurse practitioners.
The Attorney General’s office also alleges that Elite acted deceptively by featuring on its website a customer testimonial from a purported customer who is actually an owner of Elite’s advertising agency, without disclosing the material connections between itself and this person or the fact that this “customer” received his treatments for free.
It should be noted that the Attorney General’s Office has also reached a settlement with Grow Smart Marketing, LLC and its two owners, who were responsible for writing content for Elite Integrated Medical’s website, social media ads, and emails about upcoming seminars. The settlement requires the company to refrain from making unsubstantiated claims on behalf of its clients who market stem cell therapy products to Georgia consumers and to pay restitution to the state.
You can read the complaint here.
The U.S. Food and Drug Administration (FDA) has warned consumers of the potential dangers associated with unapproved stem cell, exosome and other products marketed as regenerative medicine products, which include administration site reactions; the ability of cells to move from placement sites and change into inappropriate cell types or multiply; failure of cells to work as expected; and the growth of tumors. Using unapproved regenerative medicine products that have no proven clinical benefit could also end up delaying a proper diagnosis or discouraging patients with serious illnesses from getting safe and effective treatments.
The FDA encourages consumers who are considering regenerative medicine therapies to consider the following advice and information:
- Before receiving treatment, ask if the FDA has approved the product and whether it has been approved for this particular use. Ask your health care provider to confirm this information.
- Ask whether the product is being studied in a clinical trial that has been reviewed and allowed to proceed by the FDA. You can also ask the clinical investigator to give you the FDA-issued Investigational New Drug (IND) Application number and the chance to review the FDA communication acknowledging the IND.
- Request the facts and ask questions if you don’t understand something. Make sure you understand the entire process and the potential risks before you sign a consent form.
- Be aware that even if the products are made from your own cells, the FDA still needs to review and approve the treatment. If anyone tells you otherwise, don’t believe them.
- Claims that a clinic’s FDA registration or inspection equates to FDA approval or endorsement, or that listing a “clinical study” on clinicaltrials.gov means that a product has been reviewed and allowed to proceed by the FDA, are also false.
- If you’re considering treatment in another country:
- Learn about regulations that cover products in that country.
- Know that the FDA does not have oversight of treatments done in other countries. The FDA typically has little information about foreign establishments or their stem cell products.
- Be cautious. If you’re considering a stem cell-based product in a country that may not require regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.
- If you experience any adverse effects or have complaints related to the use of regenerative medicine products, report it to the FDA.