FDA to Fight Lethal Racial Bias With Only Ineffective Voluntary Guidelines

WASHINGTON - Jan. 9, 2025 - PRLog -- Despite a growing consensus that oximeters often provide dangerously misleading readings in patients with dark skin which can lead to major health problems and even death, the FDA is proposing to issue only ineffective voluntary guidelines to address this serious medical problem, charges public interest law professor John Banzhaf.

A plea to the FDA more than a year ago from more than a dozen state attorneys general - to "act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin" because of the devices' "potentially fatal unreliability in people with darker skin tones" - has unsurprisingly gone unheeded.

Moreover, even these ineffective voluntary guidelines are very likely to be withdrawn before they are even finalized by the FDA once the new anti-regulation Trump administration takes over, notes Banzhaf, who believes that hard-hitting legal action is likely to be much more effective in forcing change than any guidelines, or polite requests by government officials, or other approaches.

One law suit has already resulted in settlements by several  oximeter companies which provide for significant and potentially life-saving changes, but more far-reaching and powerful legal actions are still necessary, says Banzhaf.

He suggests  both lawsuits and agency complaints under the powerful and far-reaching District of Columbia Human Right Act which permits suits even if cause and effect cannot be established.  The law professor has won over 100 legal actions under that statute and, in a recent health-related victory, helped convince the FDA to authorize the use of CPAP machines to treat Covid patients.

While it may be very difficult if not impossible to prove in individual cases that a misleading reading of oxygen saturation in a dark skinned patient caused him serious medical harm, it probably would be possible to sue under the D.C. statute by proving only the propensity of the devices to cause substantially more false readings in Black patients than among the those who are white, the law professor explains.

He notes that a key portion of this unique D.C. law permits law suits – and unlimited monetary damages and penalties, including attorneys' fees, litigation costs, and civil penalties – if any pattern or practice (even if it cannot be precisely identified, much less proven) has the "effect or consequence" of discriminating on the basis of factors such as race.

http://banzhaf.net/ jbanzhaf3ATgmail.com @profbanzhaf