Skydiving is dangerous. Most skydivers land safely. But, not all. And if your chute does not timely open (and properly), death or injury are likely. How is it skydiving facilities are rarely sued? And, if they are sued, the facility usually prevails.
There’s a legal defense known as “assumption of risk.” The skydiver presumably knows that skydiving is a dangerous sport; and that expectations of safety are different, from say, riding a roller coaster at an amusement park. So, a skydiving facility would need to engage in something beyond ordinary negligence – perhaps gross negligence – to be liable for an injury. Gross negligence might include not training a freshly hired high school student to pack the parachutes.
What about the practice of medicine? Can patients “assume the risk” for a treatment or procedure? Can the standard of care rise to “gross negligence” if the patient does assume the risk?
The answer in most cases is no.
Which brings me to private membership associations. Such organizations are premised on the idea that the US Constitution guarantees freedom of association. And members of such groups are free to do so without government interference.
A private membership association in a medical context is a contractual relationship between providers and patients. Those providing treatments are healers, therapists, practitioners the world over, whether traditional or nontraditional, conventional or unconventional.
Members of such organizations waive formal complaint processes. The only redress is by the Association Committee.
The member’s activities within the association are considered a private matter and the patient refuses to share any information with the State Medical Board, FDA, etc. without the practitioner’s written permission. Records remain the property of the Association. The member will not file a medical malpractice lawsuit unless the practitioner has exposed the patient to clear and present danger of substantial evil.
There’s more. But you get the point.
Lots of grand claims. Let’s look at the track record.
In US vs. 2035 Inc., the government sought permanent injunction against Mr. Lytle for marketing a laser device. Lytle claimed the government had no authority over him via the Federal Food, Drug, and Cosmetic Act (FDCA). This is the Act the FDA uses to enforce the law. Lytle argued that “the FDA lacks regulatory jurisdiction over [his] marketing of laser devices because [he] distributes them in non-commercial transactions through private membership associations.” The 8th Circuit Appellate Court rejected that argument. “That a product is sold through a Private Membership Association does not exempt it from the application of the provision [FDCA].” So, the government ruled the FDA was authorized to regulate the commercial activity of a person who distributed lasers to treat patients. When a case is heard at the appellate court level, you can be sure the defendant has already spent a lot of money to get to that level.
Then there’s the appellate case of Diruzzo versus State of Texas.
Appellant, Joseph Andrew DiRuzzo, was convicted on sixteen counts of the illegal practice of medicine, each a third degree felony. See TEX. OCC. CODE ANN. § 165.152 (West, Westlaw through 2017 1st C.S.). Punishment was assessed at four years’ imprisonment and a $1,500 fine for each count, and the trial court ordered the prison terms to run concurrently. Appellant argued, among other things, that the convictions violate his constitutional rights to freedom of association, freedom of choice, and privacy.
The sixteen counts each alleged that DiRuzzo violated the statute “by providing treatment including withdrawal of blood and fluids and injections purported to be ‘stem cells’ in treatment of medical conditions while not holding a license to practice medicine.”
In order to undergo the procedure, the patient was required to sign a contract and pay a $10 lifetime membership fee to join DiRuzzo’s organization, SSCMB.
The standard contract noted SSCMB is “a private membership association under common law whose members seek to help each other achieve better health and live longer with the best possible quality of life.” The contract set forth a fee schedule under which an initial consultation was $1,000, the “initial procedure” was $1,500 for three “tubes,” and follow-up visits are $500 per “tube,” with three tubes recommended for members fifty years of age and older.
Additionally, the contract set forth the organization’s “Articles of Association” and contained the following “Memorandum of Understanding”:
I hereby acknowledge acceptance of the above Articles of Association. I also acknowledge my understanding those fellow Association members that provide diagnosis, procedures, care and related activities, do so in the capacity of a fellow member. In this relationship between fellow members, they do not act in the capacity of a licensed health care provider.
I further understand that within the SSCMB Association there is never a patient-practitioner, or a patient-physician relationship. Rather, there are only individual membership contracts that provide for member-to-member relationships within the Association.
In addition, I hereby freely choose to reject any legal status as a patient within the present medical health care system, and adopt the legal status of private member of the SSCMB Association. I further understand that it is entirely my own responsibility to consider, accept and adopt any advice, recommendations and services offered to me by my fellow members as to the efficacy, risks and desirability of same.
Accordingly, I acknowledge that any and all assistance given to me by fellow members is provided through my exercise of my free decision in an exercise of my rights that are made for individual members, agents and employees from any unintended adverse experiences and any liability, except for instances of clear and present danger that result from substantial maliciousness or evil acts as may be determined by due process of the SSCMB Association as stated and defined by the United States Supreme Court.
I hereby accept that any and all complaints or grievances against the SSCMB Association, its individual members, agents and employees will be resolved outside of the jurisdictional and authority of federal and state agencies and authorities. A SSCMB Association committee established to insure fairness and integrity will settle all rights of complaints and grievances.
. . . .
l hereby accept that all information about activities within the SSCMB Association are confidential, and agree not to disclose such information to federal, state or local agencies or jurisdictions without prior Association approval from a spokesperson (ASP). Further, I understand that members of the Association are not protected by malpractice insurance, and therefore agree to not pursue civil action for malpractice against a follow member of the Association. Any such malpractice action is considered as a grievance and is handled within the Association, as described above.
I hereby agree to join the SSCMB as a private medical membership association under the legal provisions of United States common law. I enter into this Agreement of my own free will, or on behalf of my dependent, without pressure or undue influence, and without any promise of specific beneficial results.
I affirm that I do not represent any federal or state agency whose purpose is to monitor, supervise or regulate the practice of medicine, understanding that such membership disqualifies me from SSCMB Association membership.
The Appellate Court was unpersuaded and ruled against the provider.
The Court agreed
with the State that the licensing requirements of the Act do not infringe upon the constitutional rights of appellant, SSCMB, or its members. It is well established that the regulation of medical practice generally does not violate federal due process rights, see id.; Dent, 129 U.S. at 121–23, and appellant does not argue that there is anything specifically about the Act that is arbitrary, capricious, or otherwise unreasonable. Instead, the Texas Constitution explicitly grants authority to the Legislature to make laws prescribing the qualifications of practitioners of medicine. See TEX. CONST. art. XVI, § 31.
So the track record of Private Member Associations in avoiding the scrutiny of the regulatory or legal system is not good.
For those wanting to offer patients cutting edge treatments, a better path is to do it under cover of IRB (Institutional Review Board). By cutting edge, I mean those treatments not currently considered the “standard of care.” Many academic centers perform research under IRB. There are also private organizations that sponsor IRB affiliated research. IRB enables clinical research through a formal process.
In sum, don’t just walk away from private membership associations as the end all and be all to protect your practice from medico-legal and regulatory threats. Run.
A private membership association will not succeed in allowing a patient to assume the full risk of treatments an association provider delivers. Skydiving is a different matter.
What do you think?
ABOUT THE AUTHOR
Jeffrey Segal, MD, JD
Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
If you have a medico-legal question, write to Medical Justice at firstname.lastname@example.org.