Generic abortion pill company GenBioPro dismisses lawsuit against Mississippi

Generic abortion pill manufacturer GenBioPro (GBP) has voluntarily dismissed a lawsuit challenging pro-life legislation in the State of Mississippi. The case, GenBioPro, Inc. v. Edney, filed in the United States District Court for the Southern District of Mississippi, specifically challenged the state’s requirement for in-person distribution of the abortion pill (mifepristone), reported Reuters.

Mifepristone had long been under a Food and Drug Administration (FDA) safety regulation known as REMS. But recently, the FDA expanded access to the drug by permanently allowing it to be shipped by mail — a decision that Denise Harle, Senior Counsel and Director of the Center for Life with Alliance Defending Freedom (ADF), claimed could result in “no ultrasound confirming the baby’s gestational age.” Harle noted that such “a miscalculation can be deadly for even the woman.”

GenBioPro contended that the FDA had established a federal policy for accessing the abortion pill, claiming that this policy preempted Mississippi law. In response, the state argued “that GenBioPro’s case unlawfully interfered with the ‘inherent police power’ of states to regulate abortion,” Reuters reported. GBP claimed that the state’s trigger law banning almost all abortions at any stage “prevents GBP from selling its product in Mississippi” and “prevents access to an FDA-approved medication that has been deemed safe and effective,” wrote the Mississippi Free Press.

Dormant Commerce Clause defense 

Core to GBP’s claim was the dormant Commerce Clause which holds that state and local laws cannot place an undue burden on interstate commerce. GBP contended that by “impos[ing] a number of additional requirements before mifepristone can be dispensed,” Mississippi had “improperly displaced the FDA’s judgment concerning the necessary precautions . . . and patient safety protections for safe use of mifepristone.” GBP also claimed that the challenged laws violated the “dormant” Commerce Clause by “imposing a burden on interstate commerce that clearly exceeds their local benefits.”

The State argued that the Commerce Clause’s “principles pose no barrier to the challenged Mississippi laws” because “Mississippi law does not ban the sale of mifepristone,” adding, “there is no evidence that Congress ever intended the FDA to have the power to nullify a state’s ability to regulate in the controversial and highly sensitive area of abortion.”

The “state laws at issue are non-discriminatory and do not impose an unreasonable burden on interstate commerce,” argued the State, adding, “The police power to protect the health and safety of its citizens has been traditionally recognized as one of the most fundamental aspects of State sovereignty under our federal system of government.”

READ: Bloomberg writer parrots claim that abortion pill is safer than Tylenol – but here’s the truth

“Defendant does not dispute that GBP’s product is, at least theoretically, an object of trade moving in interstate commerce,” the State noted. “However, Mississippi’s safety requirements in question are non-discriminatory — they do not distinguish between intrastate and interstate commerce. Therefore, those requirements must be upheld unless Plaintiff demonstrates to the Court that the laws are so unreasonable and clearly excessive in light of the putative local benefits. Thus, the Court must balance the burden imposed on interstate commerce by Mississippi’s safety requirements for the administration of the drug (de minimus at most) against the benefits of the safety requirements, which are substantial. There is a strong presumption that the exercise of state police powers should be sustained unless the exercise of such powers is clearly excessive.”

GenBioPro lacked standing

The generic abortion pill manufacturer called Mississippi’s law “draconian” claiming the restrictions “severely curtailed the sale and use of GBP’s product within the state of Mississippi, causing financial harm to GBP.” In response, the State argued that GBP lacked standing “to assert its broad claims for relief,” and held that “GBP is a corporate entity that readily admits that its only interest is ‘to promote and sell mifepristone in Mississippi.'” The state also asserted that “GBP is only interested in profit, not providers or people” claiming further that “GBP does not have a confidential relationship analogous to that of a physician and patient.”

Court documents describe GenBioPro, Inc. as a “privately-held corporation majority-owned by Xenia Holdco LLC.” GBP certified in the documents that “no publicly held corporation owns 10% or more of its stock,” listing itself as a Nevada corporation with its “principal place of business located at 651 Lindell Road, Suite D1041 (P.O. Box 32011), Las Vegas, Nevada, 89103.” Read more about GenBioPro’s corporate history here.

A letter submitted to the court acknowledged that GBP had not sold the abortion pill in Mississippi. This was key to the state’s argument that GBP lacked standing, since “GBP has never attempted to sell its drug in Mississippi, and it only speculates that it would be able to do so if the challenged laws were enjoined.” The state later pointed out that because Jackson Women’s Health Organization (previously the only abortion business in Mississippi) closed soon after the Supreme Court decision overturning Roe v. Wade, GBP alleged that “there are no abortion clinics to which [it] may sell its product,” the Court document shows.

GenBioPro is “placing profits over people by insisting on selling abortion drugs online and attempting to preempt the state’s ability to protect unborn children and ensure women have real support,” ADF’s Harle stated. “Chemical abortion drugs cause abortions up to 10 weeks of pregnancy, when the baby has all of his fingers, toes, and has a heartbeat and brain waves. Taking chemical abortion drugs after this point has long been banned by the FDA as highly dangerous.”

State argued laws prohibit distribution of abortion drugs through the mail

Opposing a GenBioPro motion in the case, Mississippi Attorney General Lynn Fitch pointed to two federal laws, which she claimed prohibit distribution of abortion drugs through the mail. She claimed, “Federal law criminalizes the use of the mails to do what GBP demands this Court allow it to do: distribute abortion-inducing drugs.

The Mississippi Free Press explained, “[Fitch] cited two sections of the U.S. code. The first, 18 U.S.C. § 1461, says that ‘every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use’ is ‘nonmailable,'” the media outlet reported. “The second law, 18 U.S.C. § 1462, prohibits using ‘any express company or other common carrier or interactive computer service for carriage in interstate or foreign commerce … any drug, medicine, article, or thing designed, adapted, or intended for producing abortion.’”

According to the news outlet, breaking either of those laws could lead to up to five years in prison for a first offense or up to 10 years for subsequent offenses. And according to Fitch, anyone convicted under 1461 and 1462 could face racketeering charges under the federal Racketeer Influenced and Corrupt Organization Act, also known as RICO.

Case dismissal hailed as a victory

It is unclear what motivated GenBioPro to suddenly dismiss its case, but Mississippi Today speculated that “GenBioPro may have decided it could make a better argument in a different state or a more favorable appellate circuit. The U.S. 5th Circuit Court of Appeals, which hears cases from Mississippi, is the country’s most politically conservative,” the outlet wrote.

Some believe GBP could be planning to file a new lawsuit in a different jurisdiction.

Still, according to Harle, “While the abortion industry could try to attack Mississippi’s life-saving laws on chemical abortion in the future, the case’s dismissal is a win for unborn babies and their mothers.”

AG Fitch agreed, also viewing the dismissal as a victory. “We are pleased to have again successfully defended Mississippi’s abortion laws,” the AG stated. “These laws represent the will of the people and the intent of the Legislature to promote life, protect the health and safety of women, and preserve the integrity of the medical profession. With Roe v. Wade behind us, it is time for all parties to come together to enact the laws that will empower women and promote life.”

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