Stem Cell Fraud Attorney

Product liability and consumer safety attorney reviewing deceptive marketing cases and stem cell fraud lawsuits on behalf of plaintiffs nationwide

Stem cell companies and a variety of physicians offer consumers and patients claims of “government-approved” stem cell treatments, often touted as miracle cures. Stem cells are being promoted as a new and advanced treatment for pain relief and other conditions at medical centers and pain clinics across the nation.

But even with costly treatment plans, there is no guarantee the therapy will work on an individual basis. In fact, they may even harm patients, as seen in several lawsuits filed due to stem cell treatment injury. Such unproven stem cell therapies are a two-billion-dollar industry.

Plaintiffs’ attorneys are investigating cases of stem cell fraud, where doctors and medical facilities heavily market stem cell treatment to patients, many of whom are aging and perhaps could be taken advantage of. Stem cell regimens can cost tens of thousands of dollars, and the fact is the vast majority of the treatments are unproven in clinical trials.

In 2017, the Food and Drug Administration (FDA) closed a loophole exploited by health clinics across the nation that pitched unproven and potentially hazardous stem cell therapy.

Unproven stem cell treatments are illegal, the FDA ruled, and they began regulating and enforcing the decree. But change has been slow, and unregulated stem cell therapy clinics are still operating illegally.

There are still so many stem cell clinics the FDA has a difficult time keeping track of who is in compliance and who is selling fraudulent stem cell therapy. There are reportedly over 2,700 clinics nationwide. Critics of stem cell treatment claim these clinics are manipulating consumer vulnerabilities, and urge more regulation.

The FDA has issued more than 400 warning letters to stem cell marketers and healthcare providers, and consumer safety lawyers have filed class action lawsuits against some clinics.

Stem cell treatments are offered to consumers to treat pain, sports injuries, heart and lung disease, multiple sclerosis, Parkinson’s, Alzheimer’s, autism, diabetes, vision loss and erectile dysfunction. But little to no science supports the benefits of such treatments.

Not only could they be completely ineffective, but the treatments can cost tens of thousands of dollars and are rarely covered by insurance.

The offered treatments may also be dangerous, and hundreds of patients have reported injury. Consumer fraud attorneys believe the threat to public health from unlicensed and unproven stem cell claims will get worse if the FDA fails to act soon.

Joe Lyon is a consumer safety lawyer reviewing cases of stem cell fraud and deceptive medical advertising. Following stem cell treatment, plaintiffs may contact a legal professional to discuss the legality and ethics of pushing unproven treatments on unknowing patients.

Does Stem Cell Treatment Work?

Because stem cell treatments are not required to undergo clinical trials for F.D.A. approval, there is little data or research for doctors to lean on. Their efficacy is highly questionable, though one thing is for certain: they are very expensive, and patients have paid thousands of dollars out of pocket for a treatment that did not work as intended or promised by a physician.

There is no special training or education required for nurses or medical staff to administer stem cell treatments, so chiropractors, beauticians, and sports therapists can enter the field and sell treatments. A common procedure may take ten minutes and cost ten thousand dollars. Will the treatment work? Yes. No. Maybe. It is anybody’s guess.

Stem cell manufacturers currently send cryogenically preserved amniotic stem cells to a doctor’s office, where they are to be injected into a patient. Research suggests that many of the supposed beneficial cells do not survive, however, and the dead cells have no positive effect.

A recent investigation by ProPublica and The New Yorker found doctors working with clinics that offer stem cell treatments for conditions like chronic pain, multiple sclerosis and kidney disease. The report concluded that deceptive marketing, price gouging, and a general disregard for patients’ well-being were common in the amniotic-stem-cell-therapy industry.

Even well-known scientists that have studied stem cell therapies for decades have admitted there is little to no evidence to show that products made from amniotic cells are beneficial for a number of medical conditions.

There is only one FDA-approved stem-cell treatment, and it is for blood disorders like leukemia. But stem cell clinics sell consumers treatments for dozens of conditions that could include pain relief, cosmetic procedures, arthritis, tendinitis, psoriasis, lupus, hair loss, scarring, erectile dysfunction, heart failure, cardiomyopathy, chronic obstructive pulmonary disease, asthma, emphysema, stroke, Alzheimer’s disease, multiple sclerosis, ALS, neuropathy, diabetes, dry eye syndrome, macular degeneration, and kidney failure.

Such stem cell treatments are still considered experimental. Doctors have a duty to approach treatments as such and refrain from selling consumers on a “miracle cure.”

Is Stem Cell Treatment Safe?

Stem cell treatments are still in the clinical trial stages, but even so, the treatments are popular and it is legal for cells to be injected into the body in the hopes of repairing and regenerating new tissue.

Albeit, some patients have been sickened and hospitalized after being injected with tainted products, prompting new warnings from health officials about the risks of unproven and harmful stem cell treatments.

As with many medical procedures, there are health risks involved. Physicians may downplay these risks when offering the treatments to patients, but they have a duty to disclose all outcomes. There have been cases where bacteria contaminated the stem cell supplies, and led to infections for a dozen patients.

The CDC has said it has documented at least a dozen patients who following treatments developed a variety of maladies from the injections, including swollen spinal discs, infected bones and joints, and abscesses.

The FDA has warned of severe adverse events associated with stem cell therapy.  Potential safety concerns include poor injection site reactions, failure of cells to work as intended, the growth of tumors, and the risk of cell contamination.

The FDA has stated that it is committed to advancing the field of cell-based regenerative medicine, but emphasizes the safe development of promising new technologies. They have derided companies who “skirt safety measures” and “put patients at risk.”

Stem Cell Fraud Lawsuits

A Pennsylvania woman recently sued a stem cell producer and her chiropractor, alleging that the defendants misled her into trying a stem cell treatment for her arthritis, which the lawsuit claims was not only prohibitively expensive but ineffective.

Researchers, doctors, and for-profit companies have convinced a large part of the public that stem cell therapy will regenerate tissue, cure cancers and diseases, and combat chronic pain. Some companies sell products they call “miraculous” and “stimulates regenerative healing,” though these claims cannot always be backed by science, leading to some attorneys investigating widespread stem cell fraud.

In theory, the experts agree that the benefits of stem cell therapy are wide-ranging. Stem cell therapy has the potential to repair, restore, replace, and regenerate damaged cells. Even so, health professionals have said stem cell therapies could violate Food and Drug Administration rules against using unapproved drugs, and are potentially dangerous to consumers.

The Lyon Firm is investigating instances of deceptive stem cell marketing and stem cell fraud in which consumers and patients were sold expensive treatments with ultimately no health benefits. If you or a loved one has received stem cell therapy for a condition that has not improved or worsened, contact Joe Lyon for a free consultation and confidential case review.