A Texas lawsuit could stifle Michigan access to the abortion pill

•  A federal lawsuit in Texas seeks to halt the use of two abortion drugs nationwide
• The drugs, mifepristone and misoprostol, are used in about half of all abortions
• The case is unlikely to have an impact in Michigan in the near term

Even before Michigan’s abortion rights constitutional amendment take effect, a new court challenge 1,100 miles away threatens to halt about half of abortions performed in the state and across the nation.

On Friday, an anti-abortion group, the Alliance for Defending Freedom, filed a lawsuit in federal court in Amarillo, Texas, seeking to overturn the Food and Drug Administration’s approval 22 years ago of the abortion drug mifepristone. The lawsuit also asks to overturn approval of its companion pill, misoprostol.

Mifepristone and misoprostol, when taken in combination, induce abortions. Medical abortions account for about half of all abortions in the U.S., as well as in Michigan. The drug combination can be given in clinics, or obtained at pharmacies through a prescription.

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The group, representing four Texas doctors and four anti-abortion groups, sued the FDA and the U.S. Department of Health and Human Services claiming the government exceeded its authority by, in part, approving a drug that doesn’t have a therapeutic effect.

If the Trump-appointed judge presiding over the case rules in favor of the anti-abortion groups, abortions by medication could be halted nationwide, unless that ruling is put on hold or overruled by a higher court.

In Michigan, voters approved Prop 3 earlier this month, enshrining abortion rights in the state Constitution. The proposal officially takes effect 45 days after Election Day, which is Dec. 23.

A federal court issuing a nationwide injunction against the commonly used abortion drug wouldn’t stop abortions in the state, but could force providers to turn to more intrusive medical procedures, or use only one of the two drugs commonly used in medication abortions, making the service less effective.

In a statement released Monday to Bridge Michigan, Planned Parenthood of Michigan said “The science is clear: mifepristone is safe. This is backed by nearly 20 years of data demonstrating the safety and effectiveness of medication abortion using mifepristone.

“This lawsuit filed in Texas is a dangerous, unfounded political attack against abortion access that would have massive implications for sexual and reproductive health care in Michigan and beyond. And it’s yet another brazen and dangerous attempt at controlling people’s ability to make decisions about their own bodies, lives, and futures.”

John Bursch, former Michigan solicitor general and the chief of appellate advocacy for the Alliance for Defending Freedom, the group behind the lawsuit, was not immediately available for comment.

The judge presiding over the case, Matthew Kacsmark, was appointed by President Donald Trump and has a record of conservative rulings and viewpoints. 

In one recent case Kacsmark threw out anti-discrimination protections for LGBTQ people seeking healthcare. And before he was appointed to the bench, Kacsmark expressed disagreement with the Supreme Court decision that legalized gay marriage. 

When Kacsmaryk was being considered for the federal court, Planned Parenthood issued a statement claiming Kacsmaryk was “an active opponent of reproductive rights, including access to birth control and emergency contraception.”

Mifepristone, first developed in France in the 1980s and called RU-486, inhibits the development of progesterone, which is key for fetal development. Taken together with misoprostol, which induces labor by stimulating the uterus, the drug combination is 95 to 97 percent effective at terminating pregnancies up to about 10 weeks.

Mifepristone also is used in some cancer treatment, and in the treatment of miscarriages.

“To take it (mifepristone) off the market would mean a whole lot of women who are benefitting from it for a lot of uses couldn’t use it,” said Dr. Timothy Johnson, an OB/GYN and professor at the University of Michigan. “It’s one of the safest drugs out there.”

The lawsuit filed Friday argues that the FDA erred in approving the drugs for use when the agency said they provided “meaningful therapeutic benefit” over existing treatments.

“Pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” the lawsuit argues. “In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”

Greer Donley, a University of Pittsburgh associate law professor and an expert on abortion law, told Bridge Michigan that the Texas case is “a very frivolous lawsuit.

“They are trying to allege medication abortion is unsafe and should never have been approved. But it’s one of the most studied drugs on the planet. It’s really much safer than drugs people assume are safe like Penicillin and Viagra.”

Between 1998 and 2010, there were about 16.1 million abortion procedures in the U.S., with 108 deaths, according to a study published by the National Institutes of Health. Among those deaths, 20 died after medication abortions, primarily from infections. That’s fewer than two women a year dying from complications after taking abortion pills.

By comparison, there were 522 deaths connected to Viagra use in the first 13 months the erectile dysfunction drug was on the market.

Donley acknowledged the federal district court judge presiding over the case “could” issue an order halting the use of mifepristone nationwide. “In general, district courses, although supposed to be rare, can issue nationwide injunctions,” Donley said.

U-M’s Johnson said he doubted that a ruling that tries to ban the abortion drugs would last long. “The idea that anytime soon mifepristone will be off the market is unimaginable to me,” he said. “There would be an immediate injunction against (a ban),” Johnson said, “either by the district court of Texas or an appellate court above that.”

Dr. Melissa Bayne, an OB/GYN in Fremont in west Michigan, told Bridge in a statement that mifepristone “has helped millions of women be able to have access to medication management for pregnancy termination — this includes for miscarriage and fetal demise management.

“This medication helps women avoid costly and more risky management options like surgery,” Bayne said. “The medical community absolutely supports the … availability of this life-saving medication and will fight against any special interest group trying to deny what is medically best for a patient.”