Washington, D.C. – Cause of Action Institute (“CoA Institute”) filed an Amicus Curiae brief on behalf of nine medical doctors who outlined to the court how regulatory overreach by the Federal Trade Commission (“FTC”) has harmed their patients’ welfare. The doctors argue that patients benefit from more competition and more providers of specialized cancer-diagnostic services. When the FTC put LabMD, a small cancer-detection laboratory, out of business for no reason, the FTC harmed the very consumers it was supposed to help.
Many of them former LabMD clients, the Amici doctors offer unique insight into the practical benefits of LabMD’s cancer-detection services. While in operation, they say that LabMD’s business model was years ahead of its time and its services benefited doctors, healthcare providers, and patients through more accurate tests, reduced costs, and faster turn-around for patients to receive test results.
Congress chose to regulate medical data security by giving the Department of Health and Human Services (“HHS”) comprehensive authority to protect patient health information. HHS has exercised this authority by creating regulations that set medical data security standards, which it actively enforces. While LabMD was in business, its work required securely storing personal health data and medical records in compliance with these HHS regulations.
In their Amicus brief, the doctors argue that the FTC overstepped its authority to regulate the practice of medicine by imposing new, confusing, and burdensome patient information data security obligations inconsistent with established federal healthcare law through HHS.
The doctors wrote:
“Amici doctors are extremely concerned that, given its wholesale lack of healthcare expertise, the FTC’s recent decision to layer conflicting medical data-security requirements on top of those set by federal healthcare law will endanger their patients and have a deleterious effect on the practice of medicine and the patients whose care is entrusted to these providers.”
Ultimately, the doctors conclude that the FTC’s lack of medical expertise will “endanger patient welfare and stifle healthcare innovation.”
“In its disregard for the rule of law and due process, the FTC destroyed a small cancer detection laboratory whose primary mission was to serve its physician-clients and save lives,” said CoA Institute Assistant Vice President Patrick Massari. “The FTC’s ill-conceived foray into medical data security, where it has neither legal authority nor expertise, has endangered patient welfare.”
“The healthcare market does not need another player inserting itself into the complex field of medicine,” added Amicus Doctor David L. Black, founder of Nashville-based Aegis Sciences Corporation. Aegis performs numerous types of laboratory testing and analysis, including workplace drug testing, prenatal monitoring, behavioral health testing, testing of food supplements to ensure that athletes do not ingest prohibited substances, and toxicology and consulting services to medical examiners, crime laboratories and police departments throughout the country.
Dr. David Black’s extensive work presenting at programs around the nation, authoring dozens of industry publications, and serving as an expert witness for testimony in federal, state, local and international courts of law, has made him a highly-respected industry leader. Dr. Black is acutely familiar with regulators in the healthcare space and has never before heard of the FTC wielding such authority as it has against LabMD in his 30-plus years of experience.
Last year, LabMD appealed a crippling FTC order that found the company’s data security practices were unreasonable. The case is now before the U.S. Court of Appeals in the 11th Circuit.
The agency has already caused irreparable harm to LabMD, forcing the small business to close its doors in 2014. If upheld, the agency’s order would cause continued harm to LabMD, requiring the company to submit to 20 years of monitoring that could cost the company, now virtually defunct, hundreds of thousands of dollars. This brief was filed in support of LabMD’s request to the Court to vacate the FTC’s order.
Amici are as follows: Dr. David Lee Black, Ph.D., D-ABFT, FAIC, Aegis Sciences Corporation; Dr. Bruce G. Green, MD, FAC, Urology Specialists of Atlanta; Dr. Joan E. Hader, MD, Urology Specialists of Atlanta; Dr. Brian E. Hill, MD, Urology Specialists of Atlanta; Dr. Warren Hitt, MD, Gulf Coast Regional Medical Center; Dr. William L. Nabors, MD, FACS, Urology Specialists of Atlanta; Dr. Robert R. Ross, M.D., F.A.C.S., RTR Urology; Dr. Bradley N. Secrest, MD, Hattiesburg Clinic; and Dr. David C. Stout, MD, Hattiesburg Clinic.
Institutional affiliations of the individual signatories are given for purposes of identification only and do not constitute endorsement by any institution listed with respect to the contents of Cause of Action Institute’s brief.
Read the full Amicus brief here