This post is from the non-Reed Smith side of the blog.
In Glennen v. Allergan, Inc., — Cal. Rptr.3d –, 2016 WL 1732243 (Cal. Ct. App. Apr. 29, 2016), plaintiff brought one cause of action – negligent failure to adequately train physicians in the use of a medical device. Id. at *1. That’s it. Not that the product was defectively designed. Not that the defendant erred in the manufacturing process. Not that the device came with inadequate warnings. The plaintiff made none of those allegations. Instead she asserted only that she was injured as a result of implantation of the device done poorly by her physician. But rather than lay that blame at the foot of the physician, plaintiff sued the manufacturer claiming it was the manufacturer’s fault for not properly training the physician.
Quick sidebar: Plaintiff’s pronounced focus on the doctor’s alleged negligence made use stop and think. Plaintiff filed her lawsuit nine years after her surgery and alleged injury. California has a 1-year statute of limitations for medical malpractice, and while the products liability statute is only 2 years, plaintiff probably saw more leeway in arguing when she “discovered” her claim against the manufacturer then against her surgeon. Just a little supposition on how this essentially med-mal claim turned into a products liability claim.
We’ve talked a little about the “duty to train” here. It’s not a theory that has generated much traction for plaintiffs, especially in prescription medical device cases. It is after all just a failure to warn to claim trying to disguise itself. In a Class III, Pre-Market Approval medical device case, we understand why plaintiffs are trying to put lipstick on a pig. In PMA cases, it is practically unanimous that between express and implied preemption, there remains only a “narrow gap” through which state law claims can fit to survive preemption. Id. at *5. Fortunately for the defendant, the Glennen court did not allow failure to train to slip through.
The case is on appeal because the trial court dismissed plaintiff’s lone failure to train claim with prejudice. Id. at *2. On de novo review, the appellate court affirmed. The device at issue was a Lap-Band, designed to be surgically implanted for weight loss. Plaintiff suffered complications from the surgery which required removal surgery and resulted in significant injury. Id. The PMA for the Lap-Band included a requirement that the device’s labeling specify the training procedures for surgeons who could use the device. Id. at *1. The manufacturer prepared a brochure outlining the training that was necessary for practitioners. Id.
Plaintiff alleged that her failure to train claim was a parallel claim that survived preemption. To support her contention, plaintiff cited to some of our not so favorite cases – Bausch v. Stryker, 630 F.3d 546 (7th Cir. 2010); Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011); Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012); and Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013). But as the court pointed out, none of them had anything to do with failure to train. Id. at *6. They dealt with manufacturing defects and failure to warn the FDA. We don’t agree with the results of any of those cases, but we do agree they are inapplicable here. In fact, the court couldn’t find any case cited by plaintiff in which a failure to train claim was successfully maintained in a medical device case, “let alone a Class III device that has undergone the PMA review process.” Id.
Putting aside irrelevant precedent the court had to determine if plaintiff had alleged a violation of a PMA regulation such that her claim was a non-preempted parallel claim. She had not. The court first looked at the actual allegations of the complaint. They focused exclusively on “what her surgeon did incorrectly.” Id. at *7. “Physician error is not enough to support a claim against a manufacturer for improper training or marketing of an approved Class III device.” Id. There were no allegations about the defendant’s brochure or training protocols – both of which were approved by the FDA during PMA review. And no allegation that the training defendant provided deviated from the approved FDA requirements. Id. “The PMA process does not obligate [manufacturers] to follow their products into the surgery room.” Id. Indeed, the FDCA is set up to explicitly not interfere in the practice of medicine. Id. So, the court’s analysis started with the conclusion that plaintiff had not alleged a violation of a federal duty.
Plaintiff was relying on the Current Good Manufacturing Practice (“CGMPs”) requirements, specifically provisions contained in the Quality System Regulation. Id. As the court noted, there is a split in authority regarding whether the CGMPs can be used as a basis for a parallel violation claim due to their vague and non-specific nature. Id. at *8. The court didn’t have to choose a side in that debate because it found that the CGMPs do not apply to physician training programs. It’s right there in the title – manufacturing processes. The CGMPs are about the manufacturing process, the quality of the manufacturing process, the training of internal manufacturer employees in the manufacturing process. They have nothing to do with physician training. Id. at *8-9. Which isn’t surprising based on the aforementioned FDA principle of not interfering in the practice of medicine. Id. at *10. The court observed that
Plaintiff effectively seeks to write in a new provision to the FDCA, namely, that medical device companies who are required to provide training to physicians as a condition of premarket approval must insure such training is designed to satisfy the standard of care applicable to medical malpractice actions. We do not pass judgment on whether this would be a wise rule for the FDA to adopt. It is sufficient for our inquiry that it has not done so.
Id. at *10 (emphasis added). And since it has not done so, any such state law requirement (such as one imposed by a jury) would be different from or in addition to federal requirements and therefore preempted.
The court also found that the claim was impliedly preempted because it arose solely out of the FDA’s mandate that the manufacturer provide physician training. Plaintiff tried to distance herself from Buckman by arguing that she wasn’t making a fraud-on-the FDA claim, but the court was unwilling to adopt such a narrow interpretation of Buckman. Id. Instead, the court ruled that plaintiff could not make out a negligent voluntary undertaking claim because the manufacturer was not involved in a voluntary undertaking. The device’s PMA required physician training. Therefore, plaintiff’s failure to train claim “exists solely by virtue of the FDCA requirements.” Id. at *11. Because the claim does not exist independent of the FDCA, it is impliedly preempted. Id.
Moreover, there were no allegations or evidence presented that the FDA had evaluated the adequacy of the manufacturer’s training program during the PMA process. So any allegation that the training that was provided was inadequate “goes beyond whatever the FDA did do, or chose not to do, in approving the product.” Id. at *12. The plaintiff’s private cause of action cannot be allowed to “displace” the FDA’s exclusive role in enforcing its regulations. Id.
Plaintiffs cannot impose into federal PMA requirements state law medical malpractice standards. Defendant had a federal obligation to provide training and to specify that training in its labeling. It complied with both requirements. If the FDA was concerned or dissatisfied with the way in which those obligations were being fulfilled, that is a matter for the FDA to deal with. If a plaintiff is dissatisfied with the medical care she received, there are appropriate avenues for addressing those grievances – a products liability lawsuit against a device manufacturer is not one of them.