Medical Justice provides free 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 free consultation – or use the tool shared below.

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 free 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 free consultation – or use the tool shared below.

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 over 50 combined years of 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.