How to thread the needle to bring a successful medical device case like Essure

Often plaintiff attorneys decide on medical device cases by taking ones where the FDA has not made a safety and efficacy determination under 510(k), and declining cases where the device is subject to the more rigorous FDA Premarket Approval (PMA) process. The latter category typically may be dismissed or summary judgment for the device manufacture because the federal law (PMA) preempts state tort law.

There are, however, some claims against medical device manufacturers for PMA approved devices not preempted. Essure is a PMA approved birth control device. It has been the subject of a Netflix documentary, The Bleeding Edge, and one can only leave the Essure segment of the documentary with disgust over a manufacturer who disregarded the safety of patients. We will use the Essure litigation to highlight how a case can survive the defense of preemption.

Let’s start with the Essure claims considered preempted due to the PMA approval process:

1. Design Defect: The FDA gives a manufacturer PMA when they expressly approve the device’s design. Once a manufacturer receives PMA, the manufacturer is forbidden from changing the design that would affect its safety or effectiveness. Therefore, imposing liability based upon a device’s design would impose a requirement that is “different from, or in addition to” the federal requirements.
2. Manufacturing Defect: Claims that a device was defectively manufactured are preempted because plaintiff attorney would have to prove that the device should have been manufactured in a manner different from that approved by the FDA through the PMA process. In McLaughlin v. Bayer Corp., plaintiffs failed to prove how the supposedly non-conforming materials, misleading labeling, or unsanitary manufacturing conditions were related to their injuries. No. CV 14-7315, 2017 WL 697047, at *18 (E.D. Pa. Feb. 21, 2017).

Here are the claims not preempted:

1. Negligent Training: The first way plaintiff attorneys can survive the defense of preemption is a failure to train claim. Medical device companies provide enough training to make sure consumers using the device know how to use it safely. Often, a device required specialized knowledge or training and the manufacturer failed to provide it. Plaintiff attorneys can ask doctors three questions before suing to survive the defense of preemption.
   1. Did the doctor complete 5 preceptorings?
   2. Did the doctor read and understand the training manual?
   3. Did the doctor complete the simulator training?

   All three questions must be answered no for an attorney to survive a preemption defense. So, it is vital for attorneys to develop ask doctors these questions at discovery. Id. at *6.

2. Negligent Risk Management: A second way plaintiff attorneys can survive a preemption defense is pleading a failure to warn claim in their complaints. Specifically, plaintiffs must plead a causation theory between the medical device manufacturer’s breach and the resulting harm. Id. * at 7. For example, Illinois plaintiff attorneys must show that the manufacturer negligently failed to warn of a danger of the product and that failure proximately caused the plaintiff’s injuries. Norabuena v. Medtronic, Inc., 2017 IL App (1st) 162928, ¶ 30, 86 N.E.3d 1198, 1207, case dismissed, 111 N.E.3d 959 (Ill. 2018).
3. Breach of Express Warranty: A third way plaintiff attorneys can survive a preemption defense, is an express warranty claim. Or, pleading the manufacturer’s specific warranties were directed towards the plaintiff. For example, the court in McLaughlin granted the defendant’s motion to dismiss specific warranties alleged by plaintiffs because the warranties were directed to physicians and not the plaintiffs. No. CV 14-7315, 2017 WL 697047, at *10. So, plaintiff attorneys must prove the defendant made, and plaintiff relied on actual affirmations of fact or promises which formed the bases of the bargain between Plaintiff and Defendant. Id. at 9. To illustrate, Essure’s express warranty claim in McLaughlin was on its website aimed towards the plaintiffs. Id. The plaintiffs believed Essure’s training program to be a comprehensive course designed to provide information and skills to appropriate patients, perform competent procedures and manage technical issues related to placing the device. Id. Essure’s warranty created the basis of the bargain as the plaintiff then wanted an implanting physician properly trained in placing the device. The defendants failed to train the implanting physicians under FDA guidelines. Id. Another example of an express warranty not preempted was also found on Essure’s website. Id. Essure requires that a doctor be a skilled operative hysteroscopist. If they are not, then they should attend a related course before learning about the medical device. The plaintiffs discovered this on Essure’s website when researching birth control options. Id.
4. Fraudulent Misrepresentation: Lastly, plaintiff attorneys can survive a preemption defense by arguing a misrepresentation claim. Plaintiff attorneys need to allege that medical device manufacturer’s statements are not FDA-approved. The two bases to support a misrepresentation claim are:
   1. Medical device manufacturer misrepresented statements in unapproved advertising or promotional materials.
   2. The advertising and promotional materials undermined approved FDA materials.

Id. at 12. For example, the McLaughlin court found Bayer’s statements there is “no pain” from Essure, statements that qualified physicians must perform at least one Essure procedure every six to eight weeks and statements about pregnancy occurring and confirmation of implantation contradicted FDA brochures. Id.