We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options. This dynamic has not been limited to drugs or drug-device combination products. Contraceptive devices without a pharmacologic action have not avoided litigation. One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our posts go back for more than six years.) While most contraceptives are short-acting, in part to allow for the possibility of conception when desired, there is clearly a role from public health perspective—among other perspectives—for long-acting and permanent contraception. Patient choice is extremely important, but FDA has been tasked by Congress with looking at the big picture and ensuring that safe and effective drugs and devices are available for the benefit of the public as a whole. What risk is acceptable for a device in a high risk category (i.e., class III) is determined by FDA based upon consideration of medical need, the other available options, and the risks and benefits of those options, not just the safety and efficacy of the specific device in a vacuum.
One of the reasons that Congress included an express preemption provision in the MDA is because a jury in a state law product liability trial about a specific patient has no business deciding whether a class III device should have been approved, a decision FDA makes based on an evaluation of its safety and efficacy (i.e., risks and benefits) for all patients. The fact that an individual patient experiences a complication is not reason to second-guess the decision to approve. Nor is it for the jury applying state law to question whether the IFU approved with the PMA should have provided physicians with different information at the time of approval. The implied preemption corollary of both of these express preemption principles is that whether the FDA’s decision should be set aside because the individual plaintiff claims something else should have been provided to FDA is also not within the jury’s proper purview. The basics of preemption do not change because the device has safety issues that arise after implant/prescription or even when it is later discontinued or recalled. Sympathies and atmospherics may shift, but the preemption analysis should stay the same.
As we implied, the permanent contraceptive device at issue in Garcia v. Bayer Essure, Inc., No. 1:21-cv-00666 MIS/JFR, 2022 WL 4536240 (D.N.M. Sept. 28, 2022), has spawned some litigation for years and the decisions we have seen have generally followed the correct path on preemption. See here, here, here, and here. Yet the plaintiff lawyers still come up with causes of actions and arguments that they will hope will navigate them the between the limits of express preemption and implied preemption, between Riegel and Buckman, or the oft-cited (by Garcia and us) mythological monsters Scylla and Charybdis. In part because these cases were not put in an MDL, the plaintiffs continue to make these arguments and offer recycled complaints in the hopes that some courts will let them slip past motions to dismiss. The court in Garcia did not do that, but it allowed plaintiff another shot to re-plead preempted and pointless claims and injected more regret about following the law than we would have expected. From our perspective, dismissal of preempted claims in cases about class III medical devices, warnings claims about known risks, and boilerplate claims in shoddily pleaded complaints is how motions to dismiss are supposed to work.
The facts of Garcia are sparse. Plaintiff had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. 2022 WL 4536240, *1. (This is the inference from plaintiff’s anti-SOL claim that she only discovered injuries upon explant, although it does not exactly square with claimed weight gain, bloating, swelling, pain, bleeding, and infection.) Skeptics that we are, we suspect that the removal was prompted by press reports about discontinuation of the device after sixteen years on the market since its PMA was approved. The lawsuit, in turn, may have been prompted by the removal. Plaintiff brought her case with the standard assortment of claims crafted to avoid preemption. The court took each in turn.
First up was the obligatory design defect claim. Because plaintiff is from New Mexico and New Mexico is in the Tenth Circuit, the court had the benefit of the strong and well-reasoned decisions in Brooks (#2 best last year) and Caplinger (below and above), which rejected similar claims. Had plaintiff been from the state to the immediate west, Arizona, and her case were in federal court there, then she would have had Ninth Circuit law and the bad Stengel decision (#2 worst in 2013). (In Arizona state court, she would not, because the Arizona Supreme Court has repudiated Stengel.) She cited Stengel anyway in arguing there is a presumption against preemption. 2022 WL 4536240, *3. Citing Buckman and CSX, the court correctly held that there is no presumption against express or implied preemption. Id. It might have gone a step farther with Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. __, 136 S. Ct. 1938 (2016), but the lack of a presumption meant plaintiff’s claim was preempted. Its pleading of causation was also inadequate.
Next up was plaintiff’s failure to warn claim, which was based on the approved label being inadequate rather than the product not being accompanied by the approved label. After making the argument that failure to warn claims with PMA devices are normally not preempted—they are—plaintiff switched to arguing that the FDA’s regulations governing reporting adverse event provided federal requirements that are parallel to the New Mexico requirements to warn doctors about the risks of prescription medical devices. Id. at *4. Rather than just laugh at the silliness of this argument, the court pointed out that Brooks had rejected it.
Plaintiff also offered a claim based directly on failure to report adverse events to FDA. Clearly, this does not derive from a state law, so there can be no parallel claim. Id. at *5. As Brooks recognized, FDA has exclusive enforcement authority over alleged failure to report. Id. That is a double whammy on preemption.
Plaintiff also offered a vague claim that defendant misrepresented something to FDA and to physicians. Obviously, under Buckman direct fraud-on-the-FDA claims, however titled, are impliedly preempted. Id. at *6. The purported misrepresentations to doctors “flow factually from her allegations of fraud-on-the-FDA,” so they were also preempted. Id.
Plaintiff also offered a confusing attempt at a manufacturing defect claim, which can be a parallel claim if the product does not comply with the terms of the PMA approval. While plaintiff alleged that there was “use of uncertified materials and non-conforming of the contract manufacturer . . . and failing to maintain proper procedure in inventory transfer,” creating a risk of perforation, she did not allege that she had a perforation or that her specific device had a defect that injured her. Id. at **6-7. So, this claim was dismissed for inadequate pleading. Her negligent training claim, which also had a chance of not being preempted, was similarly inadequately pled. Id. at *7.
The court also found that the warranty claims were time-barred as pled and that the pleading of causation for all claims was inadequate. We will gloss over those to get to the decision to let plaintiff try to amend all her claims. The court was correct that Rule 15 favors amendment, but courts in this posture often do not permit re-pleading of claims that are preempted or time-barred because amendment will be futile. That should have been the case for several of the claims here. Instead, the court took two unnecessary shots at the device that seems to factor into the leniency. First, in dismissing the manufacturing claim, the court stated “Unfortunately for her and other patients, it appears the parties are in agreement that even a conforming Essure device can cause the symptoms she alleges.” Id. at *7. Later, when ruling that plaintiff failed to plead causation properly, the court stated “Dismissal of a case where a patient alleges injury from a medical device has been discontinued, with many documented cases of unacceptable side effects, is a harsh result.” Id. at *8.
Here, however, when the device was discontinued, FDA still allowed previously sold devices to be implanted for another year, noting “Women who have been using Essure successfully to prevent pregnancy can and should continue to do so.” This is hardly a conclusion about unacceptable risks. See also here for some history omitted in Garcia. When courts apply different standards to cases about products have been recalled, withdrawn, or discontinued, you can get some bad law. At the motion to dismiss stage, there certainly should not be any conclusions about what the facts will show. When plaintiff does amend, we hope that the Garcia court can follow the law without regret.