We love to read opinions that reach conclusions in a direct and precise manner (more so when we agree with the conclusion). There is a certain skill in using simple language to convey complex ideas. In this blogger’s opinion, nobody does it better than Hemingway. That’s not really going out on a limb; using a Pulitzer Prize and Nobel Prize winning journalist and novelist as the benchmark. Writing simply isn’t about dumbing things down. You can’t accuse Hemingway of that. It’s about making writing accessible and easy to read. For instance, a statistician who analyzed authors’ writing styles found that Hemingway used less –ly adverbs per 10,000 words than any other writer other than Toni Morrison. Not bad company to be in.
This praise for simplicity came after reading the decision in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020). It’s not Hemingway – by any stretch. But it is simple and straightforward and so we will strive to make our report the same.
The case involves the birth control device Essure, which is a Pre-Market Approved product. Plaintiff brought eleven causes of action ranging from failure to warn to negligent risk management. Id. at *1. The court took them in turn.
Design Defect: It is “nearly impossible for a design-defect claim to survive pre-emption because such a claim would challenge the FDA-approved design.” Id. at *3. Therefore, “[a] claim that Essure’s design is deficient seeks to invalidate the FDA’s approval of the device and is inherently pre-empted.” Id. Brevity is the soul of wit. William Shakespeare.
Manufacturing Defect: Because plaintiff alleges defendant’s manufacturing of the device did not conform to FDA requirements, the claim is not preempted – doesn’t create a state requirement that is different than or in addition to a federal requirement. But, plaintiff failed to allege facts establishing causation. Id. Plaintiff is given a chance to re-plead this claim. Id. at *10.
Failure to Warn — Traditional: This claim is preempted because there is
no FDA requirement for [manufacturers] to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling as [manufacturers] learn of issues with the device.
Id. at *4. A state cannot make obligatory an FDA requirement that is voluntary. Id. Less is more. Ludwig Mies van der Rohe
Failure to Warn – Failure to Report: Federal law does require device manufacturers to report adverse events to the FDA. “However, Montana law provides no such parallel duty.” Id. Plaintiff tried to draw an analogy to cases extending a manufacturer’s duty to warn to all foreseeable users (bat manufacturer’s duty to warn extended to other players, not just batter) or to all healthcare providers responsible for a patient’s care, not just the prescriber. Id. However, “[a] government regulator is not a foreseeable user or consumer of a product.” Id. Simplicity is the ultimate sophistication. Leonardo da Vinci
Misrepresentation-based claims: “When a claim challenges marketing that complied with FDA-approved requirements” it is preempted “because success on those claims requires a showing that the FDA requirements themselves were deficient.” Id. at *5. Therefore, to survive preemption, statements and express warranties “must have gone beyond the statements the FDA approved.” Id. The court compared plaintiff’s allegations of misstatements and found them “functionally equivalent to FDA-approved language.” Id. at *6. For example, saying implanting the device was “quick and easy” is functionally equivalent to the FDA-approved language that the device is a “simple procedure that can be done in 10 minutes.” Plaintiff’s last alleged misrepresentation is that the device is “the best alternative.” “This is clearly an opinion and cannot be the basis for a misrepresentation claim.” Id. Make everything as simple as possible, but not simpler. Albert Einstein
Negligent Training: There are FDA-training guidelines which plaintiff alleges defendant failed to adhere to. Because Montana has adopted Restatement (Second) of Torts §324A recognizing a duty to exercise due care in rendering a service to another, “Montana law provides a parallel claim for the negligent training [plaintiff] alleges.” Id. at *7. But, plaintiff did not allege any facts demonstrating that defendant’s training differed from the FDA guidelines or how that deviation was a cause of her injuries. Therefore, while the claim is not preempted, it is dismissed with leave to amend. The same reasoning applied to plaintiff’s claims for negligent entrustment and training for hysteroscopic equipment. This is equipment that is independent of but necessary to the implantation of the Essure device.
Negligent Distribution: Plaintiff alleged defendant required physicians to purchase to kits per month. But, a purchase minimum would only pose a danger if “the device itself was defective, which would require a showing the FDA requirements themselves were deficient.” Id. at *9. So that claim is preempted. Our life is frittered away by detail. . . Simplify, simplify. Henry David Thoreau
Negligent Risk Management: Plaintiff alleged defendant was required to have a risk management plan in place to deal with consumer complaints. But, since Montana law doesn’t recognize a failure to report claim, this claim is preempted. Id.
Unfair Trade Practices: This claim was premised on warranties and deceptive advertisements. Since it is “founded on expressly or impliedly pre-empted claims,” it too was dismissed. Id.
And we’ll leave it there because simplicity is the glory of expression. Walt Whitman