We’re giving that toothpaste slightly more attention today.
In Adkins, plaintiff pleaded that a corporate representative of Cytyc — presumably a sales representative — was physically present in the operating room during a surgical procedure involving Cytyc’s NovaSure medical device. The sales rep allegedly “advised and directed” the treating physician “on the proper way to measure the size of Adkins’ uterus and to test the integrity of her uterine wall.” Slip op. at 2. The physician allegedly messed up; the patient allegedly was injured; the lawsuit named the device manufacturer as a defendant.
Defendants moved to dismiss. The trial judge granted the motion, dismissing with prejudice “all those causes of action that sound in negligence or breach of a duty related to the design, manufacturing, and labeling of the NovaSure device.” Id. at 3. Since the FDA had approved the NovaSure device under the premarket approval process, those claims were preempted under Riegel.
As to the remaining claims, however — those pleading that Cytyc, by virtue of having had a representative in the operating room, had a duty to ensure that the treating physician used the device correctly — the court dismissed only without prejudice. According to the court, the “FDA does not regulate interactions between corporate representatives and physicians on-site at a particular surgery, and . . . it does not specify how such an interaction at surgery must be performed.” Id. at 5. In that situation, said the court, traditional common law claims might survive.
Adkins’ complaint, however, did not plead “any facts that explain what Defendants’ representative did or failed to do as part of his alleged duty, such that more than mere suspicion of a cognizable right of action is created.” Under Twombley, a complaint that fails to plead those facts does not state a claim. Id.
Additionally, the complaint didn’t specify whether Adkins’ alleged injuries were caused by failure of the NovaSure device or by a treatment error induced by the sales rep’s instructions. “Where there are two explanations for the damages complained of within the four corners of the Complaint, one of which would allow recovery if true and the other of which could not allow any recovery due to preemption, a plaintiff has failed to state a claim . . . .” Id. at 5-6. The court thus gave plaintiff leave to re-plead.
What lessons does Adkins teach?
1. Riegel, as we knew, is strong medicine in cases involving PMA-approved devices.
2. Twombley applies to product liability claims. We never doubted that, but we urge defense counsel to make full use of that precedent.
3. Plaintiffs will do whatever they can to avoid preemption. (Film at 11!)
4. Device manufacturers should think long and hard about instructing sales reps as to whether they should enter the operating room during surgery and, if so, what the reps should appropriately say.
5. Device manufacturers should make sure they have sufficient insurance coverage for claims such as the one pleaded in Adkins.
6. Faced with a case such as this one, don’t overlook Kennedy v. Medtronic, 851 N.E.2d 778, 787 (Ill. App. 2006) (“Medtronic’s clinical specialist attended the surgery to provide technical support and ensure that the lead parameters were correctly calibrated and the lead was functioning properly. This limited role did not entail her voluntarily assuming a duty, under section 324A of the Restatement (Second) of Torts, for the placement of the lead into the correct ventricle of the patient’s heart.”).
7. As the sign in the dentist’s office says: “Don’t floss all your teeth. Just the ones you want to keep.”
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