Medical Justice provides consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a consultation – or use the tool shared below.
“Can Medical Justice solve my problem?” Click here to review recent consultations…
all. Here’s a sample of typical recent consultation discussions…
- Former employee stole patient list. Now a competitor…
- Patient suing doctor in small claims court…
- Just received board complaint…
- Allegations of sexual harassment by employee…
- Patient filed police complaint doctor inappropriately touched her…
- DEA showed up to my office…
- Patient “extorting” me. “Pay me or I’ll slam you online.”
- My carrier wants me to settle. My case is fully defensible…
- My patient is demanding an unwarranted refund…
- How do I safely terminate doctor-patient relationship?
- How to avoid reporting to Data Bank…
- I want my day in court. But don’t want to risk my nest egg…
- Hospital wants to fire me…
- Sham peer review inappropriately limiting privileges…
- Can I safely use stem cells in my practice?
- Patient’s results are not what was expected…
- Just received request for medical records from an attorney…
- Just received notice of intent to sue…
- Just received summons for meritless case…
- Safely responding to negative online reviews…
We challenge you to supply us with a medico-legal obstacle we haven’t seen before. Know you are in good hands. Schedule your consultation below – or click here to visit our booking page.
This blog deconstructs the recent Texas federal court opinion, explaining its rationale for revoking FDA’s decade’s old approval of mifepristone. Mifepristone is a compound widely used for medication abortions. I’ll also explain why this case if hurtling to the Supreme Court, and in my opinion, will be DOA.
Un-trigger alert. This blog post says nothing about our country’s attitudes towards medical or surgical abortions. So, no reason to get apoplectic. We’ll be discussing “process.”
What happened?
The case was Alliance for Hippocratic Medicine versus Food and Drug Administration.
The plaintiff, the Alliance for Hippocratic Medicine (AHM), argued that the FDA’s approval of mifepristone for pregnancy termination was impermissible under the Federal Food, Drug, and Cosmetic Act and asked for an injunction to immediately suspend its approval, removing it from the market.
District Judge Matthew J. Kacsmaryk issued a preliminary injunction suspending the approval of mifepristone on April 7, 2023, though postponed the suspension for a week to give the government the chance to appeal the ruling. On the same day, a Washington federal district judge issued a separate injunction forcing the FDA to maintain the distribution of mifepristone in at least 17 states and the District of Columbia.
Two competing rulings. In separate parts of the country. On the same day. There’s more drama percolating here than the Real Housewives of Atlanta.
The plaintiffs argued that the protocol for approving mifepristone failed to take into account the full risks of the medication. The plaintiffs argued that they will have to spend time managing such patients when these risks are realized.
Cases are adjudicated first on process, then on merit.
Here’s an example of process, the statute of limitations. A plaintiff has a limited amount of time to file a lawsuit. If he is damaged and believes his case has merit, he cannot sit on his rights. He must act. He has to timely file a lawsuit. It’s not fair to defendants to live in fear of a lawsuit 30 years after plaintiffs experienced some injury. Witnesses become disabled, demented, or die. They move. Evidence becomes stale. Records are lost or cannot be located. So, our legal system balances these challenges by allowing the plaintiff to file a lawsuit with the clock ticking. But not later than the law allows.
Process.
The plaintiff, doctors representing the Alliance for Hippocratic Medicine, argued they had proper standing to file this case. And they argued they will experience damages, a prerequisite for having standing.
The doctors representing the Alliance for Hippocratic Medicine argued the harm they and those like them suffered was not only the harm of being forced to divert time and resources away from their other patients, but also a constitutional injury. They alleged that when they are forced to complete an elective abortion by removing unborn children and pregnancy tissue this causes them to feel complicit in that elective abortion and violate their most deeply held moral, medical, and religious beliefs.
The judge appeared to agree. For now.
Does the plaintiff actually have proper standing? I don’t think so. The damages are speculative and lead to a slippery slope where everything could be litigated and no administrative decision would be stable.
More broadly, the standing argument pressed by AHM would effectively declare open season on health, safety and environmental regulations of all stripes. Under AHM’s theory, for instance, an auto repair shop would have standing to challenge an allegedly lax NHTSA auto safety regulation on the grounds that it will result in auto accidents that will result in more vehicles for the shop to repair. Standing does not work that way.
Adam Unikowsky makes similar point in his post:
The logical implication of the plaintiffs’ position is that medical organizations have standing to challenges literally all rules that are alleged to decrease safety in any way. Suppose OSHA lifts some safety standard. A medical organization can sue claiming that (1) this will make workplaces less safe, (2) hypothetical injured employees will come to the doctor-members, and (3) the doctor-members’ attention to their current patients will be diverted. Or suppose EPA alters some pollution rule. A medical organization can sue claiming that (1) this will cause people to breathe in more toxins, (2) hypothetical people who breathe in these toxins will seek medical care and come to the doctor-members, and (3) the doctor-members’ attention to their current patients will be diverted.
Usually, slippery slope arguments don’t work because courts are able to find a limiting principle, but here, none exists—plaintiffs’ argument is logically identical to those arguments. It’s interesting to note that the defendants’ brief makes this slippery-slope argument, and the plaintiffs’ reply brief ignores it altogether. They have to ignore it, because there are no responses to it.
In the case, the physicians argued that hypothetical future patients will come to them, and they will experience damages. They’ll have to leave the office and attend to these patients in the ER.
The same argument could be made targeting any medication approved by the FDA.
But the plaintiff cannot present specific facts demonstrating that any particular patient will force them to come to the ER.
There are other arguments which may shut this case down on process.
The statute of limitations to file this case expired.
The plaintiffs did not exhaust their administrative remedies before filing a lawsuit, even though regulation specifically required them to do so.
The plaintiffs claimed that the FDA’s actions are contrary to the Food, Drug, and Cosmetic Act (FDCA), but failed to identify any particular provision of the FDCA that the FDA has actually violated.
So, my prediction. This will work its way up to the Supreme Court quickly. And be swatted down. Reversed.
Still, I’m loathe to speak with certainty about anything touching the US legal system. A jury let O.J. go free. At least the first time.
What do you think?
Medical Justice provides consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a consultation – or use the tool shared below.
“Can Medical Justice solve my problem?” Click here to review recent consultations…
all. Here’s a sample of typical recent consultation discussions…
- Former employee stole patient list. Now a competitor…
- Patient suing doctor in small claims court…
- Just received board complaint…
- Allegations of sexual harassment by employee…
- Patient filed police complaint doctor inappropriately touched her…
- DEA showed up to my office…
- Patient “extorting” me. “Pay me or I’ll slam you online.”
- My carrier wants me to settle. My case is fully defensible…
- My patient is demanding an unwarranted refund…
- How do I safely terminate doctor-patient relationship?
- How to avoid reporting to Data Bank…
- I want my day in court. But don’t want to risk my nest egg…
- Hospital wants to fire me…
- Sham peer review inappropriately limiting privileges…
- Can I safely use stem cells in my practice?
- Patient’s results are not what was expected…
- Just received request for medical records from an attorney…
- Just received notice of intent to sue…
- Just received summons for meritless case…
- Safely responding to negative online reviews…
We challenge you to supply us with a medico-legal obstacle we haven’t seen before. Know you are in good hands. Schedule your consultation below – or click here to visit our booking page.
Jeffrey Segal, MD, JD
Chief Executive Officer and Founder
Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. 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 was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.
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.
In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.
Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2023 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With decades of combined experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.
Related:
No matter where you stand, in my opinion the “slippery slope” is real. I used to support an organization called “Compassion and Choices” which marketed their philosophy to “allow for people who were in the process of dying” to take medications that would result in their death, legally, and have physicians be licensed to prescribe them.
It all seemed reasonable to caring people. However, the slippery slope proved real, with the new laws (in Canada and Europe) to allow active euthanasia. This includes patients who are not mortally ill.
We saw this when the Germans “gradually” extended euthanasia to be grotesquely expanded to the Jews of Europe. Like a boiled frog, it was a gradual process.
Historically, we know from past experience that the “slippery slope” is very real. It is not just a mere makeshift construction of arguing lawyers.
Michael M. Rosenblatt, DPM
There was a recent case, that was discussed in the lay press, so it is impossible to actually verify, of a patient that had an incomplete abortion. She required surgical completion of this incomplete abortion with a D&C. However, the treating physician/hospital, were so afraid of running afoul of anti abortion laws that they sought administrative guidance, if I remember correctly from licensing authorities. The woman in the interim period became septic, then after approval had the procedure, but required a far longer hospitalization for recovery.
The ability to provide appropriate care to save the life of the mother should have been the doctrine that applied. The incomplete abortion was never going to come to term. So what harm was there in doing the D&C? None. But the political environment has so overwhelmed the medical environment, that doing the right thing medically is overshadowed.
Primum non nocere — first do no harm. That woman was harmed by medical inaction due to medical indecision caused by overthinking legal ramifications.
Infanticide is wrong.
Fetuses unable to live outside the womb are not viable.
There has to be some common ground that can be hammered out, so that we are not having infanticide committed, while at the same time, we are not forcing women to die because of withheld appropriate medical care. We need to defend the rights of those fetuses that can live outside the womb. We should also be teaching social responsibility in terms of not having unprotected sex. The number of abortion clinics has declined rapidly. But a great deal of anxiety has been created, within those of child bearing age, as to what happens if they have a defective, non viable fetus and need to have a pregnancy termination done. Some degree of common sense needs to be injected here. The world is a far more complicated place today because advocacy groups obtain government funding to perpetuate division.
Very informative. This blog is a great resource.