This week we are pleased to report on yet another breast implant case in which a plaintiff’s effort to circumvent preemption failed. In Diodato v. Mentor Worldwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), the plaintiff brought manufacturing defect, breach of warranty, and failure to warn claims that were typically skimpy in terms of laying out what federal law/regulation/specification the defendant allegedly violated.

The plaintiff had breast implants placed in 2014, experienced some symptoms (including a lump in her breast) in 2019, and had the implants removed at which time the left implant was found to have ruptured. Based on that concatenation of facts, the plaintiff alleged that the “hole” in the implant must have been due to a manufacturing defect and must have existed at the time the implant left the possession of the manufacturer and was simply undetected by the implanting physician because the manufacturer failed to warn the doctor to inspect the implant before surgery.

It turns out that there was a great big hole in the plaintiff’s legal theories.

In a blessedly concise opinion (we’re noticing a lot of that during this pandemic lockdown – it almost makes up for the horrible Covid dreams and Covid digestion problems) the Diodato court summarized the preemption analysis nicely: for claims against a class III medical device to survive, they must rest on conduct that both violates the federal scheme and also would give rise to recovery under state law even absent the federal violation. The court also wasted a minimum of time and ink in rejecting the plaintiff’s conclusory allegations, observing that “The Complaint does not disclose the foundation for Plaintiff’s belief that the rupture existed at the time the implant left Mentor’s possession. Likewise, the Complaint includes no discussion of Mentor’s manufacturing process or of any warnings Mentor provides.”

In concluding that the plaintiff’s manufacturing defect claim was preempted, the Diodato court held that “The Complaint alleges that a hole existed at the time the implant left Mentor’s possession, and reasons that the alleged existence of such a hole necessarily implies a manufacturing defect. However, in a case involving a Class III medical device, it is not enough that the plaintiff allege the existence of a deficiency. In addition, the plaintiff must allege ‘how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.’” So much for the manufacturing defect claim.

The failure to warn and warranty claims also flunked. Again, there was no alleged divergence between the defendant’s conduct and FDA requirements. Moreover, the Diodato court emphasized that the plaintiff entirely failed to address the product’s FDA-approved warnings, which specifically warn of rupture and notifies physicians that they should carefully inspect the MemoryGel implant before implantation for rupture or holes.

The Diodato court’s conclusion that these claims were preempted seems straightforward and inevitable, but is nonetheless important because so many breast implant claims seem to follow this same playbook. You might even call the Diodato case a gift from God. (That is what Diodato literally means.). It is hard for breast implant plaintiffs to get around preemption. Check that; it is almost always impossible.

All that being said, the dismissal in Diodato was without prejudice: “Though Plaintiff has failed to state a claim, the Court is not convinced that any amendment is certain to be futile.” Perhaps we will see an amended complaint. Perhaps (Probably? Certainly?) it will meet with an identical, preempted fate.

Congrats to the victorious defense team, which includes Dustin Rawlin, Monee Hanna, and Rachel Byrnes (all of Tucker Ellis) and Craig Thompson (Venable).