We’ve often thought that tort reform should be a major goal of those interested in preserving women’s reproductive choice. Every prescription medicine has risks, which is why the FDA requires a prescription in the first place, and prescription contraceptives are no exception. But ever since the very first birth control pills, back in the 1960s, the other side of the “v.” has consistently attacked every innovation in contraceptive technology and attempted to drive it off the market. It’s happened over and over again – with IUDs, Norplant, OrthoEvra, Yasmin, NuvaRing, Mirena, Essure. Except for the Dalkon Shield IUD forty years ago (and occasional idiosyncratic manufacturing errors), all these products were (or are being) ultimately vindicated, and the FDA continues to consider their designs to be both safe and effective. Unfortunately their users have had to pay a significant tort tax in order to continue exercising their personal choice of contraceptive method.
Niedner v. Ortho-McNeil Pharmaceutical, Inc., ___ N.E.3d ___, 2016 WL 5106479 (Mass. App. Sept. 21, 2016), is both an example of the plaintiff’s bar’s ongoing attempt to deprive women of reproductive choice and an exemplar of how to beat such efforts. Niedner involved a time-release contraceptive patch:
The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.
Id. at *1. The decedent decided to use this product in preference to both condoms and daily birth control pills. Id.
It is a well-known scientific fact that any hormonal contraceptive places its user at an increased risk of stroke, myocardial infarction, and blood clots generally. This product was no exception:
[The prescribing physician] informed [the decedent minor and her mother] of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled by [the] pharmacy, the package included an insert prepared by . . . the manufacturer, as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots.
Id. Unfortunately, after three months use the decedent suffered a fatal “massive bilateral pulmonary embolus.” Id.
So plaintiff tried to remove the product from the market through litigation, alleging inter alia consumer fraud, breach of warranty, design defect, and of course inadequate warnings. Id. All those claims were baseless, and the defendant received summary judgment. On appeal, plaintiff persisted with all these claims, see id. at 5, but the warning and design-based allegations were most prominent.
Warnings about risks of cardiovascular conditions were literally all over the defendant’s materials – including the FDA-mandated patient labeling. Id. at *3-4 (block quoting two pages of warnings, just from the direct-to-patient materials). Even though Massachusetts follows a little-recognized (and generally rejected) exception to the learned intermediary rule that targets contraceptives, id. at *2, the product warnings were adequate as a matter of law to inform anyone of these risks:
Here, it is undisputed that [the decedent] developed blood clots in her lungs. This is a risk expressly set forth in the insert, where it is described in no less than four places. The greater dose of estrogen, and the corresponding increased risk of adverse events, such as blood clots, also is clearly stated in plain language. . . . As a matter of law, the insert adequately warned both [the minor decedent and the plaintiff mother] of the increased risk of developing blood clots that could result in death, as compared to the risks associated with the birth control pill, in terms understandable to a lay person.
Niedner, 2016 WL 5106479, at *4 (emphasis added). Plaintiff criticized these extensive warnings because the defendant didn’t admit that the product shouldn’t be sold. According to plaintiff, summary judgment was inappropriate because “the insert failed to warn that the patch ‘delivers a variable and unreasonably dangerous amount of estrogen . . ., unlike any contraceptive on the market and, as a result, it is twice as likely to cause a fatal blood clot.’” Id. The court saw through this assertion that warnings must concede that the product was “unreasonably dangerous.” Clear warnings about the risks – not plaintiff’s supposed statistics – are all that the law requires. “[T]he insert was abundant in its warning of the possibility of blood clots in the lungs that could lead to death . . . . [T]he warnings were plain, numerous, and comprehensive.” Id.
Good for the court. The undisputed fact that hormonal contraceptives have inherent risks is no reason to deprive women of this product. Plaintiff’s claim that warnings must admit an “unreasonably dangerous” product is straight out of their playbook to restrict contraceptive choice.
As was plaintiff’s design defect claim.
In Massachusetts, any claim for design defect “requires proof of the existence of a safer alternative design.” Id. at *5. So plaintiff claimed that women should be restricted to birth control pills that had to be taken daily. “[Plaintiff] contends that oral contraceptives, which are taken daily, are a feasible and safer alternative design to the patch, which is applied once per week for three weeks, with the fourth week being patch-free.” Id. Fortunately for the future of reproductive choice, the court rejected this argument, which was tantamount to saying that no extended-release contraceptives should be allowed. A different product could not be an alternative design:
While both products are hormonal contraceptives that prevent pregnancy, the difference in the drug delivery method, each of which has its own advantages and disadvantages, makes the pill fundamentally different from the patch. As such, one cannot serve as a safer alternative for the other.
Id. (citations omitted). Thus, product liability in Massachusetts does not permit plaintiffs to argue that all women should be forced, despite being adequately warned, to use less convenient daily contraceptive pills (which the same lawyers also claim are defective in other cases), rather than a purportedly “less safe” contraceptive that provides other benefits that some women find more valuable.
Tort reform – a feminist issue for the new millennium.