Stem Cells & Pumpkin Spice: Autumn Brings Denial of FDA-Challenged Treatment for Lumbar Spine

The case is Kevin Kurych v. Idexx-US-Virtual, IAB No. 1504289 (9/23/22) and the issue is propriety of various modalities of medical treatment in a lumbar spine injury.  Spinal injections, ablations, hardware blocks and hardware removal surgery were awarded. The stem call treatment endorsed vociferously by Dr. Zaslasky was denied, however, with the Board adopting the same concerns as the DME doc, Dr. Rushton. The case is  noteworthy in its careful scrutiny applied to stem cells in the context of spinal injury,  noting that case law to date has gone both ways. 

Guest Blogger Wade Adams who represented the carrier offers the following:

It was a challenging case because the Plaintiff was a really nice guy and there were a lot of complications given his 2007 fusion and periodic low back complaints pre- accident.  We anticipated the injections/ablations and hardware removal would be an uphill battle, but with the claimant’s prior history and the strong DME with Dr. Rushton,  a full court press on all components of treatment was appropriate. There’s a wealth of information on the FDA website about the use of stem cells and it was really helpful in undermining  Dr. Z’s testimony.  It seems to me that the application of stem cells in Delaware is exactly what the FDA is warning the public about. 

Guidance from the FDA specifically says “Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.”

The FDA further states:

FDA has repeatedly notified manufacturers, clinics, and health care practitioners of the need for Investigational New Drug applications (INDs)
to legally administer these products and to ensure safety measures are in place prior to administration. These regenerative medicine products have risks but are often illegally marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they haven’t been adequately studied under an IND to demonstrate the claims of safety and effectiveness.

Viviana last Halloween

Dr. Zaslavsky had no idea this was the FDA’s stance.  Hopefully, it’s never in the Guidelines because the current evidence is that it is ineffective, at least where the spine is concerned. There was also an evidentiary challenge which was upheld by the Board as to the inclusion of deposition testimony of Dr. Bruce Rudin from an unrelated workers’ compensation matter, commenting that while Dr. Rudin may have issued an opinion seemingly inconsistent with the commentary offered by Dr. Zaslavsky, denying claimant the opportunity to cross examine Dr. Rudin regarding the potential differences “was more prejudicial than probative.”

Irreverently Yours,

Cassandra Roberts