FDA issues warning letter to Florida stem cell clinic

There are many different medications and medical treatments in use in Florida. These are constantly being improved and new drugs and treatments are being developed. This can be a good thing and can help patients recover from medical conditions where other treatments have failed. However, these new treatments and medications can also be dangerous if they have not been properly investigated or have not been approved for use by the FDA.

Recently the FDA issued a warning letter to a stem cell clinic in South Florida. This same clinic had three different lawsuits against it a couple of years ago after stem cell injections caused patients’ retinas to detach. The new warning letter is for a separate issue though. The letter states that the clinic failed to maintain records on machine maintenance and cleaning. There were also violations for not properly testing stem cell batches for toxins prior to using them.

The FDA gave the clinic 15 days to rectify the violations. The clinic has denied the violations though. It is unclear what will happen is this specific situation, but this story highlights the importance of FDA regulations and safe products. Defective products and medical treatments can cause very serious injuries like what happen to the three patients who lost their vision after treatment from this clinic.

People in Florida use many different products everyday as well as receive medical treatment and take medications. They expect to be safe when using the products properly or at least be warned ahead of time of the potential dangers. If people are injured by defective products they may have a products liability claim. The company who makes the product or administers the treatment may be required to compensate the victim for their injuries. These are very fact specific though and experienced attorneys may be a useful resource.

Source: Sun Sentinel, “Sunrise stem cell clinic violating federal regulations, FDA says” Diane C. Lade, August 28, 2017