By Emma Gallegos Los Angeles Daily Journal Posted with the permission of the Daily Journal Corp. (2010)
A false advertising spat in federal court between competing California companies that manufacture hyperbaric chambers could have unintended consequences – highlighting the questionable marketing practices of an industry that thrives largely outside the purview of the U.S. Food and Drug Administration.
Hyperbaric chambers are large, pressurized units that increase the flow of oxygen, and are prescribed for very limited uses. Some manufacturers market the devices for a wider variety of non-medical therapeutic uses, including autism, sports injuries, brain trauma and “clearing out toxins.”
Oxy-health LLC, based in Santa Fe Springs, is suing competitor Healing Dives Inc., and other firms, for alleged false advertising and unfair competition over their long list of potential uses for the pricey at-home chambers that are of questionable benefit.
In its lawsuit, Oxy-health alleges that Healing Dives’ website fails to explain that “off-label treatments have not been subjected to the rigorous testing and review of the FDA clearance process.”
The complaint states that these “false and misleading advertisements” make it difficult for the firm to fairly compete.
Legal experts who track the medical device industry, said the dispute wades into larger debate over “off-label” uses of drugs and devices.
Oxy-health’s complaints could undercut its own business model if it too profits from the off-label market, said Bob Bohrer, a professor at California Western School of Law in San Diego who follows drug and device law.
“They can’t claim their market is being affected,” Bohrer said. “They shouldn’t be selling to that market anyway.”
U.S. District Court Judge Ronald Lew granted Oxy-health a partial summary judgment last week, which is a good sign for the plaintiff, which already won a similar case.
Last April, Oxy-health won $11.5 million judgment against Performance Hyperbarics Inc. in front of the same judge.
Representatives for the Woodland-Hills-based Healing Dives declined to comment, as did their attorneys.
Hyperbaric chambers were developed to help mountain climbers adjust to high altitudes and help undersea divers recover from decompression sickness. The FDA has authorized the chambers only for those and other rare conditions – including cyanide poisoning and flesh-eating bacterial diseases – but the companies conduct brisk business selling chambers directly to patients interested in off-label uses.
Defendant Healing Dives gives physicians the hard sell on its website, stating that “a single patient can generate between $6,000 and $12,000 in revenue over a three-month period.”
Oxy-health takes a softer approach in its marketing. The firm doesn’t make any explicit suggestions for off-label uses, but the website does provide links to other sites that recommend oxygen therapy for a wide range of conditions, such as autism.
Oxy-health Chief Executive Officer Samir Patel said most of the 1,500 hyperbaric chambers his firm sells in a year end up in patients’ homes, but sees opportunities for growth in the niche market.
“Maybe insurance will start covering [autism], and then we can grow the field even further,” Patel said.
The chambers are not cheap. Healing Dives offers models that range from $4,995 to $27,995.
In the past decade, the FDA, which regulates how the chambers are marketed, has clamped down on companies claiming that their chambers could treat spider bites, AIDS and traumatic brain injuries. The FDA sent warning letters to companies to stop marketing their products to people with these conditions.
But as with any drug or device, the FDA doesn’t regulate the way physicians choose to prescribe their use, said Keith Barritt, a principal at Fish & Richardson in Washington D.C. who follows FDA regulation.
“As far as the FDA is concerned,” he said, “doctors can do whatever they want.”