Despite our use of plural pronouns, almost all of our posts come from a single author. We occasionally have guest posts by multiple authors or a post that pairs one of us with a subject matter expert. For this post, however, all seven authors of the Blog are joining together.
We are just simple defense hacks writing about product liability law and some other things that matter to medical product manufacturers. We do, however, pay some attention to what is going on in the broader context of U.S. law and, while we try to not be too “political,” there are some developments we cannot ignore. The apparent pending reversal of Roe v. Wade in the Dobbs v. Jackson Women’s Health Org. case pending before the Supreme Court is one. Without even going into the body of law leading up to and flowing from Roe or principles of jurisprudence, we can say that the impacts of the Dobbs decision, assuming the leaked draft reflects the final opinion, will be profound and far-reaching. Even with some attempt to “stay in our lane,” we can see significant impacts on the legal framework in which a number of medical product manufacturers, to say nothing of distributors, pharmacies, and healthcare providers, operate.
This is not a matter of us injecting our personal and political views into areas we do not belong. (Although the male authors here agree wholeheartedly that individual choices about women’s contraception, reproduction, and sexual health are not for us to make.) From its founding, the Blog has been addressing plaintiff attacks on medications and devices for contraception, state attempts to limit medical options for abortion, and other legal disputes affecting women’s health issues. This has been more than us saying, in essence, that drug and device companies should get to do whatever they want without liability or that any preemption argument should carry the day. To the contrary, we have written a number of times that the tendency of the plaintiff bar to mount serial product liability attacks against the makers of every new contraceptive medication or device since the 1970s is bad for women’s health because, among other things, it discourages innovation and reduces the rate of effective usage of standard-of-care medications. It so happens that quite a bit of product liability law, some good and some bad, has come out of litigation over contraception. MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65 (Mass. 1985), White v. Wyeth Labs., Inc., 533 N.E.2d 748, 755 (Ohio 1988), and Perez v. Wyeth Labs., Inc., 734 A.2d 1245 (N.J. 1999), come to mind. More recently, the merits decisions coming out of serial product liability litigation over prescription contraceptive products have been pretty favorable, although the failures of the MDL system have certainly been seen as well. (See here, here, here, and here, for instance.) Even though defendants have done pretty well on lawsuit-after-lawsuit claiming every combination hormonal contraceptive has a risk of blood clots—if they have estrogen, then they do, as has been widely known in the medical community for more than fifty years—these litigations and the lawyer advertising that spawn them are not good for society. Volumes of research have described a range of societal benefits when women have the ability to control their reproduction with safe and effective options. It is also clear that litigation like this negatively impacts the availability of quality contraceptive choices (which tend to be most effective when used consistently).
Contraception is only one piece of the reproductive choice that should be available to women across the U.S. As we discussed here, McCormack v. Hiedeman, 694 F.3d 1004 (9th Cir. 2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. The prosecution against the plaintiff was dropped, but she turned around and brought a proposed class action pursuant to § 1983, which got up to the Ninth Circuit on an appeal of a preliminary injunction. We commented that the “Interstate commerce in prescription drugs, once they’re approved by the FDA, can’t be prohibited by state law” because of the Supremacy Clause—i.e., the state action would be preempted. This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. Strickland, 531 F.3d 406 (6th Cir. 2008). The district court later struck down the challenged provisions as unconstitutional and the Ninth Circuit affirmed in McCormack v. Herzog, 788 F.3d 1017 (9th Cir. 2015). Those decisions cited Roe, Griswold, and other decisions threatened by Dobbs. If the draft Dobbs decision becomes the final decision, then preemption may take on an increasingly prominent role in combatting state laws designed to limit reproductive rights by, at least in part, limiting the use of medical products on the market pursuant to FDA decisions.
FDA has approved multiple prescription medications for “emergency contraception” since 1998 and a number of other medications can be used off-label for “emergency contraception” or as abortifacients. Plan B, which utilizes the progestin levonorgestrel that is also used in a number of oral contraceptives, received FDA approval for over-the-counter use in 2006. State efforts to limit both the on-label and off-label use of these approved medications have led to a number of decisions. In this post, we examined interim decisions on a Texas statute on off-label use and an Oklahoma statute on all use. In discussing Planned Parenthood of Greater Texas Surgical Health Services v. Abbott, 951 F. Supp. 2d 891 (W. D. Tex. 2013), we focused on the court’s endorsement of the “off-label protocol” for RU-486 (mifepristone), which was approved as an abortifacient, as “standard of care.” The case got up to the Supreme Court on a request to vacate a stay from the Fifth Circuit, which ultimately reversed and upheld the Texas law. The decision of the usually “conservative” Oklahoma Supreme Court in Cline v. Oklahoma Coalition for Reproductive Justice, 292 P.3d 27 (Okla. 2013), went to lengths to endorse physicians’ ability to use “evidence-based regimens,” including for medication-induced abortions. After a 2017 trial struck down the challenged Oklahoma law, the case got back to the Oklahoma Supreme Court in 2019, where the judgment was affirmed. Both of these cases applied the U.S. Supreme Court’s decision in Gonzales v. Carhart, 550 U.S. 124 (2007), which would also be knocked out by Dobbs if it sticks. Preemption did not feature in those decisions, but Dobbs is likely to usher in a wave of state laws limiting the use of FDA-approved medications for abortion, emergency contraception, and—it would seem to be only a matter of time—contraception.
In the context of tort law, we have been dealing with preemption arguments on state law attempting to impose liability for a drug company’s decision to market an FDA-approved medication since way since way before Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). (See this post on one of our decisions from 2008.) But Bartlett and its clear preemption of “stop selling” theories of liability have had wide-ranging implications. For instance, Massachusetts tried to ban the use of Zohydro ER, an FDA-approved extended release opioid, and that was preempted. Maine amended its pharmacy act to allow non-US pharmacies to sell and ship drugs to Maine residents even if the drugs were not approved by FDA under an NDA or ANDA. That was also preempted. Arizona took another shot at the off-label use of mifepristone and the Ninth Circuit ruled in Planned Parenthood Arizona, Inc. v. Humble, 753 F.3d 905 (9th Cir. 2014), that the Arizona statute was likely unconstitutional. The Humble decision did not mention “preemption” or the Conflict Clause, but it did mention FDA twenty-six times. As we noted, “it seems that states attempting to regulate medical care by prohibiting ‘off label’ use in the name of promoting health are setting a dangerous precedent.” They should also be walking right into vigorous preemption arguments.
Recently, the manufacturer of a generic version of mifepristone has challenged additional limits on the prescription and use of the drug in Mississippi. The complaint in GenBioPro, Inc. v. Dobbs expressly raises preemption, the Supremacy Clause, and even the dormant Commerce Clause. (We have written a few times about the third of these, which is powerful yet underused.) There are no rulings yet in this case, but, yes, the defendant in GenBioPro v. Dobbs is the appellant in the other Dobbs case—the party that lost in the Southern District of Mississippi and the Fifth Circuit. We do not purport to know how GenBioPro v. Dobbs will play out.
We do know, however, that medical product companies should be paying attention to both cases, and not just the companies that make drugs approved for use as emergency contraception or abortifacients. Looking at the laws enacted, bills that have been introduced, and state actions that have been threatened, it is not hard to see that the makers of hormonal medications and other medications that could be used as part of “evidence-based regimens” as emergency contraception or as abortifacients may become civil or even criminal targets even if they never promote such use. Could the makers of drugs that a patient is taking when a miscarriage or spontaneous abortion occurs be targeted? If healthcare providers, pharmacies, and drug distributors can be targeted for the dispensation of “excessive” quantities of certain drugs in a certain location, like on one side of the border between states with very different abortion laws, then will some enterprising plaintiffs or state officials also target drug companies? Public nuisance was a rarely-used basis for liability before its expansion in opioid litigation. Entities from pharmacies up to medical product manufacturers would be wise to be thinking about what is coming next. We certainly will.