Wednesday, December 9, 2015

Former Doctor Charged With Conspiring To Defraud The FDA in Marketing His Hyperbaric Chamber as Approved Medical Device And Billing Medicare and Carriers for Alleged Unsafe and Unnecessary Treatments

On November 18, 2015, a former doctor and others were charged with making misrepresentations to the  Food and Drug Administration (‘FDA”)  in order to obtain clearance for a "hyperbaric chamber" that Mr. O’Brien marketed under the name "Hyperox 101."  

This case probably would not have been prosecuted but for the fact that approxmimately $15 million in claims for treatments were submitted to insurance carriers and Medicare. The Medicare billings in this case appear to have triggered the investigation.

William J. O’Brien III of Philadelphia, Pennsylvania was charged in an indictment with conspiring to defraud the FDA and a separate conspiracy to commit health care fraud. 

A hyperbaric chamber is a sophisticated medical device in which patients breathe 100% pure oxygen for a prolonged period in a pressurized environment.  To achieve a therapeutic effect, the chamber is pressurized to at least 1.4 atmospheres below sea level.  The pressure creates a biochemical reaction that increases oxygen absorption into the blood.  A hyperbaric chamber for treating patients must be constructed using pedigree steel and certified as a pressure vessel for human occupancy. 

According to the indictment, Hyperox 101 as constructed did not meet these standards; rather, it was built by welding together pieces of a used propane tank.  The indictment charges that Mr. O’Brien knew of the deficiencies in Hyperox 101, but passed it off as a medical device by submitting false documentation to the FDA.  

The indictment alleges that, due to its substandard construction, Hyperox 101 did not provide patients with the therapeutic benefits associated with hyperbaric oxygen treatment, but instead posed potential risks to patients. 

The indictment charges that defendant O’Brien used the unapproved device to defraud Medicare and other health benefit programs.  From in or around March 2007 through in or around August 2011, it is alleged that Mr. O’Brien obtained millions of dollars based on fraudulent claims that he caused to be submitted to Medicare and IBC, among other health care benefit programs. 

It is also alleged that Mr. O’Brien caused fraudulent claims to be submitted of approximately $15 million for medically unnecessary and potentially unsafe treatments.  Mr. O’Brien obtained reimbursement from Medicare and other insurers of approximately at least $4.2 million based on the fraudulent claims.

Posted by Tracy Green, Esq.


DISCLAIMER: Green & Associates' articles and blog postings are prepared as a service to the public and are not intended to grant rights or impose obligations. Nothing in this website should be construed as legal advice. Green & Associates' articles and blog postings may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations, and other interpretive materials for a full and accurate statement of their contents and contact their attorney for legal advice. The primary purpose of this website is not the commercial advertisement or promotion of a commercial product or service and this website is not an advertisement or solicitation. Anyone viewing this web site in a state where the web site fails to comply with all laws and ethical rules of that state, should disregard this web site.

The information provided on this website is for informational purposes only. It is not intended to create, and does not create, a lawyer-client relationship with Green & Associates, Attorneys at Law. Sending an e-mail to Tracy Green does not contractually obligate them to represent you as your lawyer, or create any type of client relationship. No attorney-client relationship will be formed absent a written engagement or retainer letter agreement signed by both Green & Associates and client and which specifies the scope of the engagement.

Please note that e-mail transmission is not secure unless it is encrypted. E-mail messages sent to Ms. Green should not include confidential or sensitive information.