Essure Court Finds Narrow Window to Avoid Preemption
A California federal court decision involving complications allegedly caused by placement of Bayer’s controversial Essure permanent contraception device is interesting for its treatment of preemption and, even more so, for its treatment of causation, according to attorney Steven Boranian (Reed Smith), writing in an online blog post. The device had been approved by FDA as a Class 3 device through the PMA process.
Boranian says the plaintiff sued Bayer for manufacturing defect, design defect, negligence, failure to warn, strict liability, implied warranty, express warranty, and a variety of fraud claims. The company moved to dismiss all the claims based on both express and implied preemption. The court offered a lengthy discussion of both types of preemption and, Boranian says, “recognized the narrow gap through which a state-law claim must fit to escape preemption by the Medical Device Amendments.”
As the post explains, a plaintiff must sue for conduct that violates federal law, or else the claims would be expressly preempted. But the plaintiff also must not be suing because the conduct violates federal requirements under the Medical Device Amendments or the claims would be impliedly preempted. To sustain an action, according to Boranian, the plaintiff must allege a viable claim under state law that parallels federal requirements.
The court dismissed the design defect and implied warranty claims as expressly preempted. For manufacturing defect, Boranian says the court took note of FDA-483 inspection observations of manufacturing issues requiring correction. The plaintiff said the FDA-483 observations meant that the product was adulterated, but the court dismissed the claim because the plaintiff had not alleged that the manufacturing issues actually caused a manufacturing defect in any device or caused her alleged injuries. “This is a very good ruling,” Boranian says, “because it recognizes … that an alleged wrong in the abstract does not a lawsuit make. The alleged breach of duty has to actually have a consequence, which the plaintiff did not allege here.”
The negligence claim was based on alleged negligent training, and the court dismissed it on similar reasoning. For the failure-to-warn claim, the court held that even accepting the allegation that the manufacturer did not timely report similar adverse events to FDA, and even accepting that California recognizes a negligence claim based on failure to report, the plaintiff did not allege that her doctor would have learned of the events even if they had been reported. “Timely reporting would not have changed the physician’s treating decision,” Boranian says. “This again is a failure of causation.”
For the express warranty and fraud claims, the court looked at the manufacturer’s blog. It held that the plaintiff did not allege that the product failed to conform to statements made in the blog, and did not allege with the required particularity how fraud had occurred.
The main downside of the decision, according to Boranian, is that the court said that the plaintiff could amend many of the claims. “But the court’s stated intention to hold plaintiff to her pleading burden, and particularly her burden to plead causation for each of the non-exempted claims, certainly gave her a tough row to hoe,” he says. He says that he wondered how it would be possible to plead viable claims and the plaintiff apparently wondered the same thing and voluntarily dismissed her complaint.